MPEP 2100

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Chapter 2100 Patentability

Contents


2103 Patent Examination Process[edit | edit source]

USPTO personnel follow the below mentioned steps when examining a patent application:

1- DETERMINE WHAT APPLICANT HAS INVENTED AND IS SEEKING TO PATENT

2- CONDUCT A THOROUGH SEARCH OF THE PRIOR ART

3- DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 101

4- EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

5- DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 102 AND 103

6- CLEARLY COMMUNICATE FINDINGS,CONCLUSIONS AND THEIR BASES


1- DETERMINE WHAT APPLICANT HAS INVENTED AND IS SEEKING TO PATENT

A USPTO personnel follows the principles of compact prosecution wherein each claim should be reviewed for compliance with every statutory requirement for patentability in the initial review of the application,even if one or more claims are found to be deficient with respect to some statutory requirement.

Thus, USPTO personnel should state all reasons and bases for rejecting claims in the first Office action. Whenever practicable, USPTO personnel should indicate how rejections may be overcome and how problems may be resolved. A failure to follow this approach can lead to unnecessary delays in the prosecution of the application.

USPTO personnel must begin examination by determining what, precisely, the applicant has invented and is seeking to patent, and how the claims relate to and define that invention. USPTO personnel will review the complete specification, including the detailed description of the invention, any specific embodiments that have been disclosed, the claims and any specific, substantial, and credible utilities that have been asserted for the invention.

In order to clearly understand what the applicant has invented and is seeking to patent, USPTO personnel must follow the following approach:

A. Identify and Understand Any Utility and/or Practical Application Asserted for the Invention B.Review the Detailed Disclosure and Specific Embodiments of the Invention To Understand What the Applicant Has Invented C.Review the Claims

A. Identify and Understand Any Utility and/or Practical Application Asserted for the Invention

The claimed invention as a whole must be useful. The purpose of this requirement is to limit patent protection to inventions that possess a certain level of “real world”value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research.

USPTO personnel should review the application to identify any asserted utility. The applicant is in the best position to explain why an invention is believed useful.Accordingly, the applicant should incorporate a statement of utility in the complete disclosure to indicate the practical application for the claimed invention. Such a statement will usually explain the purpose of the invention or how the invention may be used (e.g., a compound is believed to be useful in the treatment of a particular disorder).

The form of statement of utility is not important as long as it enables one ordinarily skilled in the art to understand why the applicant believes the claimed invention is useful. An applicant may assert more than one utility and practical application, but only one is necessary.

Alternatively, an applicant may rely on the contemporaneous art to provide that the claimed invention has a well-established utility.

B.Review the Detailed Disclosure and Specific Embodiments of the Invention To Understand What the Applicant Has Invented

The written description will provide the clearest explanation of the applicant’s invention, by exemplifying the invention, explaining how it relates to the prior art and explaining the relative significance of various features of the invention. Accordingly, USPTO personnel should continue their evaluation by

(A) determining the function of the invention, that is, what the invention does when used as disclosed (e.g., the functionality of a programmed computer); and

(B) determining the features necessary to accomplish at least one asserted practical application.

C.Review the Claims

The goal of claim analysis is to identify the boundaries of the protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention.

For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials. Product claims are claims that are directed to either machines, manufactures or compositions of matter.

USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. Limitations appearing in the specification but not recited in the claim should not be read into the claim.

The subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope.Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. The following are examples of language that may raise a question as to the limiting effect of the language in a claim:

(A) statements of intended use or field of use, (B) “adapted to” or “adapted for” clauses, (C) "wherein" clauses, or (D) “whereby” clauses.

Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim. Any special meaning assigned to a term must be sufficiently clear in the specification that any departure from common usage would be so understood by a person of experience in the field of the invention.

If the applicant asserts that a term has a meaning that conflicts with the term’s art-accepted meaning, USPTO personnel should encourage the applicant to amend the claim to better reflect what applicant intends to claim as the invention.

Where means plus function language is used to define the characteristics of a machine or manufacture invention, such language must be interpreted to read on only the structures or materials disclosed in the specification and "equivalents thereof" that correspond to the recited function. The USPTO is to interpret means plus function language according to 35 U.S.C. § 112, sixth paragraph.

While it is appropriate to use the specification to determine what applicant intends a term to mean, a positive limitation from the specification cannot be read into a claim that does not itself impose that limitation. A broad interpretation of a claim by USPTO personnel will reduce the possibility that the claim, when issued, will be interpreted more broadly than is justified or intended. An applicant can always amend a claim during prosecution to better reflect the intended scope of the claim.

Finally, when evaluating the scope of a claim, every limitation in the claim must be considered. USPTO personnel may not dissect a claimed invention into discrete elements and then evaluate the elements in isolation. Instead, the claim as a whole must be considered.

2- CONDUCT A THOROUGH SEARCH OF THE PRIOR ART

Prior to evaluating the claimed invention under 35 U.S.C. 101, USPTO personnel are expected to conduct a thorough search of the prior art. Generally, a thorough search involves reviewing both U.S. and foreign patents and non patent literature.

3- DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 101

A.Consider the Breadth of 35 U.S.C. 101 Under Controlling Law

Section 101 of title 35, United States Code, provides:

35 U.S.C. 101

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

35 U.S.C. 101 defines four categories of inventions that Congress deemed to be the appropriate subject matter of a patent:

1- processes,

2- machines,

3- manufactures and

4- compositions of matter.

The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b)

The term 'process' is defined as art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

Subject Matter Outside The Four Statutory Categories:

  • abstract ideas
  • laws of nature
  • natural phenomena


Patentability of Practical application of abstract ideas, laws of nature and natural phenomenon'


A subject matter that is not a practical application of an idea, a law of nature or a physical phenomenon is not patentable. A scientific truth, or the mathematical expression of it, is not patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.

The courts have also held that a claim may not preempt abstract ideas, laws of nature or physical phenomena; i.e.,one may not patent every “substantial practical application” of an abstract idea, law of nature or physical phenomenon. This is because such a patent would “in practical effect be a patent on the abstract idea, law of nature or physical phenomenon itself.”

Patentability of business method claims

The text of 35 U.S.C. 101 is expansive, specifying four independent categories of inventions eligible for protection, including processes, machines, manufactures,and compositions of matter. As stated by the Court, "in choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope."

Therefore, business methods are not "categorically outside of § 101’s scope. The Court stated that "a business method is simply one kind of method’ that is, at least in some circumstances and is eligible for patenting under § 101.However, the Examiners were reminded that 35 U.S.C. 101 is not the sole tool for determining patentability in case of claims that encompasses an abstract idea. 35 U.S.C. 112 , 102 , and 103 will provide additional tools for ensuring that the claim meets the conditions for patentability.

The § 101 patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act’s protection the claimed invention must also satisfy the conditions and requirement of § 102, § 103, and fully and particularly described, § 112. Those requirements include that the invention be novel, § 102, non obvious, § 103, and fully and particularly described, § 112.

Therefore, examiners should avoid focusing on issues of patent-eligibility under 35 U.S.C. 101 to the detriment of considering an application for compliance with the requirements of 35 U.S.C. 112, 102, and 103, and should avoid treating an application solely on the basis of patent-eligibility under 35 U.S.C. 101 except in the most extreme cases.

4- EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

In order to evaluate application for compliance with 35 U.S.C 112 the following two steps are to be performed:

A. Determine Whether the Claimed InventionComplies with 35 U.S.C. 112, Second Paragraph Requirements

The second paragraph of 35 U.S.C. 112 contains two separate and distinct requirements:

(1) that the claim(s)set forth the subject matter applicants regard as the invention, and

(2) that the claim(s) particularly point out and distinctly claim the invention.


An application will be deficient under the first requirement of 35 U.S.C. 112,second paragraph when evidence including admissions,other than in the application as filed, shows that an applicant has stated what he or she regards the invention to be different from what is claimed.

An application fails to comply with the second requirement of 35 U.S.C. 112, second paragraph when the claims do not set out and define the invention with a reasonable degree of precision and particularity. In this regard, the definiteness of the language must be analyzed,not in a vacuum, but always in light of the teachings of the disclosure as it would be interpreted by one of ordinary skill in the art. Applicant’s claims, interpreted in light of the disclosure, must reasonably apprise a person of ordinary skill in the art of the invention.

B. Determine Whether the Claimed Invention Complies with 35 U.S.C. 112, First Paragraph Requirements

The first paragraph of 35 U.S.C. 112 contains three separate and distinct requirements:

(A) adequate written description,

(B) enablement, and

(C) best mode.

1. Adequate Written Description

For the written description requirement, an applicant’s specification must reasonably convey to those skilled in the art that the applicant was in possession of the claimed invention as of the date of invention.

2. Enabling Disclosure

An applicant’s specification must enable a person skilled in the art to make and use the claimed invention without undue experimentation. The fact that experimentation is complex, however, will not make it undue if a person of skill in the art typically engages in such complex experimentation.

3. Best Mode

Determining compliance with the best mode requirement requires a two-prong inquiry:

(1) at the time the application was filed, did the inventor possess a best mode for practicing the invention; and

(2) if the inventor did possess a best mode, does the written description disclose the best mode such that a person skilled in the art could practice it.


5- DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 102 AND 103

Reviewing a claimed invention for compliance with 35 U.S.C. 102 and 103 begins with a comparison of the claimed subject matter to what is known in the prior art. If no differences are found between the claimed invention and the prior art, then the claimed invention lacks novelty and is to be rejected by USPTO personnel under 35 U.S.C. 102.

Once differences are identified between the claimed invention and the prior art, those differences must be assessed and resolved in light of the knowledge possessed by a person of ordinary skill in the art. Against this backdrop, one must determine whether the invention would have been obvious at the time the invention was made. If not, the claimed invention satisfies 35 U.S.C. 103.


6- CLEARLY COMMUNICATE FINDINGS,CONCLUSIONS AND THEIR BASES

Once USPTO personnel have concluded the above analyses of the claimed invention under all the statutory provisions, including 35 U.S.C. 101, 112, 102, and 103,they should review all the proposed rejections and their bases to confirm that they are able to set forth a prima facie case of un-patentability. Only then should any rejection be imposed in an Office action. The Office action should clearly communicate the findings, conclusions and reasons which support them.



2105 Patentable Subject Matter — Living Subject Matter[edit | edit source]

35 U.S.C. 101 defines Inventions which are patentable

According to 35 U.S.C. 101 :

"Whoever invents or discovers any new and useful process,machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title.

  • By using such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress plainly contemplated that the patent laws would be given wide scope.This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable.

The use of the comprehensive term "any" in 35 U.S.C 101 may encompass living subject matter. The test set down for patentable subject matter in this area is whether the living matter is the result of human intervention. Therefore, the relevant distinction is not between living and inanimate things, but between products of nature, whether living or not, and human made inventions. This determination was made in the US Supreme Court Case Diamond v Chakrabarty wherein the Court held that microorganisms produced by genetic engineering are not excluded from patent protection.

The tests set forth by the Court for determining the patentability of Living Subject matter are:

(A) “The laws of nature, physical phenomena and abstract ideas” are not patentable subject matter.

(B) A “non-naturally occurring manufacture or composition of matter — a product of human ingenuity—having a distinctive name, character, [and] use” is patentable subject matter.

(C) “[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of... nature,free to all men and reserved exclusively to none.’”

(D) “The production of articles for use from raw materials prepared by giving to these materials new forms,qualities, properties, or combinations whether by hand labor or by machinery” [emphasis added] is a“manufacture” under 35 U.S.C. 101.

Patentability of Animals:

Following the reasoning in Chakrabarty, the Board of Patent Appeals and Interferences determined that animals are patentable subject matter under 35 U.S.C.101. The Commissioner of Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) that the Patent and Trademark Office would now consider non naturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.

Patentability of Human organism:

The Leahy-Smith America Invents Act (AIA), Public Law112-29, sec. 33(a), 125 Stat. 284, states:

Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.

The legislative history of the AIA includes the following statement, which sheds light on the meaning of this provision:

"The U.S. Patent Office has already issued patents on genes, stems cells, animals with human genes,and a host of non-biologic products used by humans,but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former,but would simply affirm the latter."

If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human organism, then a rejection under 35 U.S.C. 101 and AIA sec.33(a)must be made indicating that the claimed invention is directed to a human organism and is therefore non-statutory subject matter. Furthermore, the claimed invention must be examined with regard to all issues pertinent to patentability, and any applicable rejections under 35 U.S.C. 102, 103, or 112 must also be made.

Patentability of Plant Subject Matter

The Supreme Court held that patentable subject matter under 35 U.S.C. 101 includes newly developed plant breeds, even though plant protection is also available under the Plant Patent Act and the Plant Variety Protection Act. The work of the plant breeder ‘in aid of nature’ is a patentable invention.



2106 Patent Subject Matter Eligibility[edit | edit source]

T o determine the subject matter eligibility the following two steps are conducted:


Step 1: Determining that the invention is directed to one of the four statutory categories, which are as follows:


i. Process – an act, or a series of acts or steps.It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing


ii. Machine – a concrete thing, consisting of parts, or of certain devices and combination of devices. This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result.


iii. Manufacture – an article produced from raw or prepared materials by giving to these materials new forms,qualities, properties, or combinations, whether by hand labor or by machinery


iv. Composition of matter – all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids,


Examples of Non statutory categories:

i. Transitory forms of signal transmission for example, a propagating electrical or electromagnetic signal per se

ii. a naturally occurring organism,

iii. a human per se,

iv. a legal contractual agreement between two parties

v. a game defined as a set of rules

vi. a computer program per se

vii. a company

viii. a mere arrangement of printed matter

Patentability of a claim covering both statutory and non- statutory embodiments

A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step and should be rejected under 35 U.S.C. 101, for at least this reason.

If the claimed invention is clearly not within one of the four categories, it is not patent eligible. However, when the claim fails under Step 1 and it appears from applicant’s disclosure that the claim could be amended to be directed to a statutory category, Step 2 should still be conducted.


Step- 2: Determining that the invention is not wholly directed to subject matter encompassing a judicially recognized exception.

Judicially recognized exception are as follows:

1- laws of nature,

2- physical phenomena, and

3- abstract ideas

While abstract ideas, physical phenomena, and laws of nature are not eligible for patenting, methods and products employing abstract ideas, physical phenomena, and laws of nature to perform a real-world function may well be.

A claim that is limited to a particular practical application of a judicially recognized exception is eligible for patent protection.

A “practical application” relates to how a judicially recognized exception is applied in a real world product or a process,and not merely to the result achieved by the invention.When subject matter has been reduced to a particular practical application having a real world use, the claimed practical application is evidence that the subject matter is not abstract (e.g., not purely mental) and does not encompass substantially all uses (preemption) of a law of nature or a physical phenomenon.

A. Practical Application of Machines, Manufactures,and Compositions of Matter (Products)

If the claimed product falls within one of the three product categories of invention and does not recite judicially excepted subject matter, e.g., a law of nature, a physical phenomenon, or an abstract idea, it qualifies as eligible subject matter. If a judicial exception is recited in the claim, it must be determined if the judicially excepted subject matter has been practically applied in the product.


ELIGIBILITY TESTS ON PRODUCTS FOR PATENTABILITY

1- TANGIBLE EMBODIMENT:

Eligible machines, manufactures, and compositions of matter are non-naturally occurring products typically formed of tangible elements or parts that embody a particular or specific, tangible practical application of the invention. Thus, for these product categories, a particular practical application is often self-evident based on the claim limitations that define the tangible embodiment.This is because an idea that is tangibly applied to a structure is no longer abstract, and a law of nature or physical phenomenon that is practically applied to a structure is limited to that particular application of the concept. For example, a cup is the tangible application of the abstract idea of containing a liquid and is one limited embodiment of that idea (which is no longer abstract). As another example, a magnetic door latch is the tangible application of the concept of magnetism and does not wholly embrace the concept of magnetism but, rather, is one limited application of the concept.

A claim that includes terms that imply that the invention is directed to a product, but fails to include tangible limitations in accordance with its broadest reasonable interpretation is not limited to a practical application, but rather wholly embraces or encompasses the concept upon which the invention is based. This is impermissible as such claim coverage would extend to every way of applying the abstract idea, law of nature or physical phenomenon.

2- OCCURRENCE OF PREEMPTION

Once a practical application has been established, the limited occurrence of preemption must be evaluated to determine whether the claim impermissibly covers substantially all practical applications of the judicially excepted subject matter. If so, the claim is not patent-eligible. If the claim covers only a particular practical application of the judicially excepted subject matter, it is patent eligible.


B. Practical Application of Processes (Methods)


A process claim, to be statutory under 35 U.S.C. 101 , must be limited to a particular practical application. This ensures that the process is not simply claiming an abstract idea, or substantially all practical uses of (preempting) a law of nature, or a physical phenomenon.

A claim that attempts to patent an abstract idea is ineligible subject matter under 35 U.S.C. 101 . The recitation of some structure, such as a machine, or the recitation of some transformative component will in most cases limit the claim to such an application. However, not all such recitations necessarily save the claim. Moreover,the fact that the steps of a claim might occur in the ‘‘real world’’ does not necessarily save it from a 35 U.S.C. 101 rejection.

1. Factors To Be Considered in an Abstract Idea Determination of a Method Claim

a) A machine or a transformation test:

“The machine-or-transformation test is a useful and important clue, and investigative tool, for determining whether some claimed inventions are processes under §101.” If so, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.

With respect to these factors, a “machine” is a concrete thing, consisting of parts, or of certain devices and combination of devices.This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. This definition is interpreted broadly to include electrical, electronic,optical, acoustic, and other such devices that accomplish a function to achieve a certain result. An “apparatus” does not have a significantly different meaning from a machine and can include a machine or group of machines or a totality of means by which a designated function or specific task is executed.

For the machine or transformation test following factors have to be considered:

1- The particularity or generality of the elements of the machine or apparatus:

The degree to which the machine in the claim can be specifically identified (not any and all machines). Incorporation of a particular machine or apparatus into the claimed method steps weighs toward eligibility.

In case of computer implemented processes the “machine” is often disclosed as a general purpose computer. In these cases, the general purpose computer may be sufficiently“particular” when programmed to perform the process steps. Such programming creates a new machine because a general purpose computer, in effect, becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software.

However, "adding a'computer-aided' limitation to a claim covering an abstract concept, without more, is insufficient to render a patent claim eligible where the claims are silent as to how

1- a computer aids the method,

2- the extent to which a computer aids the method, or

3- the significance of a computer to the performance of the method.


To qualify as a particular machine under the test,the claim must clearly convey that the computer is programmed to perform the steps of the method because such programming, in effect, creates a special purpose computer limited to the use of the particularly claimed combination of elements (i.e., the programmed instructions) performing the particularly claimed combination of functions. If the claim is so abstract and sweeping that performing the process as claimed would cover substantially all practical applications of a judicial exception, such as a mathematical algorithm, the claim would not satisfy the test as the machine would not be sufficiently particular.

2- Whether the machine or apparatus implements the steps of the method.

Integral use of a machine or apparatus to achieve performance of the method weighs toward eligibility, as compared to where the machine or apparatus is merely an object on which the method operates, which weighs against eligibility.

3- Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method(e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.


(b) Whether performance of the claimed method results in or otherwise involves a transformation of a particular article

“Transformation and reduction of an article ‘to a different state or thing’ is the clue to patentability of a process claim that does not include particular machines. If such a transformation exists, the claims are less likely to be drawn to an abstract idea; if not, they are more likely to be so drawn.

An “article” includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. An article can also be electronic data that represents a physical object or substance. For the test, the data should be more than an abstract value. Data can be specifically identified by indicating what the data represents, the particular type or nature of the data, and/or how or from where the data was obtained.

“Transformation” of an article means that the “article” has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Manufactures and compositions of matter are the result of transforming raw materials into something new with a different function or use. Purely mental processes in which thoughts or human based actions are “changed” are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs i.e, the paradigmatic 'abstract idea'," has not been deemed a transformation. However, transformation of electronic data has been found when the nature of the data has been changed such that it has a different function or is suitable for a different use.

Where a transformation occurs, the following factors are relevant:

(a) The particularity or generality of the transformation: A more particular transformation would weigh in favor of eligibility.

(b) The degree to which the recited article is particular i.e., can be specifically identified (not any and all articles).A transformation applied to a generically recited article would weigh against eligibility.

(c) The nature of the transformation in terms of the type or extent of change in state or thing, for instance by having a different function or use, which would weigh toward eligibility, compared to merely having a different location,which would weigh against eligibility.

(d) The nature of the article transformed, i.e., whether it is an object or substance, weighing toward eligibility,compared to a concept such as a contractual obligation or mental judgment, which would weigh against eligibility.

(e) Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the transformation imposes meaningful limits on the execution of the claimed method steps.A transformation that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.

(c) Whether performance of the claimed method involves an application of a law of nature, even in the absence of a particular machine, apparatus, or transformation:

An application of a law of nature may represent patent-eligible subject matter even in the absence of a particular machine, apparatus, or transformation.

Where such an application is present, the following factors are relevant:

(a) The particularity or generality of the application.

Application of a law of nature having broad applicability across many fields of endeavor weighs against eligibility,such as where the claim generically recites an effect of the law of nature or claims every mode of accomplishing that effect, such that the claim would monopolize a natural force or patent a scientific fact.

For instance in O'Reilly v. Morse,56 U.S. 62 (1853) "the use of electromagnetism for transmitting signals at a distance was considered un-patentable.

(b) Whether the claimed method recites an application of a law of nature solely involving subjective determinations;e.g., ways to think about the law of nature. Application of a law of nature to a particular way of thinking about,or reacting to, a law of nature would weigh against eligibility.

(c) Whether its involvement is extra solution activity or a field-of-use, i.e., the extent to which (or how) the application imposes meaningful limits on the execution of the claimed method steps. An application of the law of nature that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.

(d) Whether a general concept (which could also be recognized in such terms as a principle, theory, plan or scheme) is involved in executing the steps of the method The presence of such a general concept can be a clue that the claim is drawn to an abstract idea. Where a general concept is present, the following factors are relevant:

(a) The extent to which use of the concept, as expressed in the method, would preempt its use in other fields; i.e.,that the claim would effectively grant a monopoly over the concept.

(b) The extent to which the claim is so abstract and sweeping as to cover both known and unknown uses of the concept, and be performed through any existing or future-devised machinery, or even without any apparatus. Gottschalk v. Benson, 409 U.S. 63, 68, 175 USPQ 673,___ (1972) (stating “here the process' claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary conversion. The end use may(1) vary from the operation of a train to verification of drivers' licenses to researching the law books for precedents and (2) be performed through any existing machinery or future-devised machinery or without any apparatus”).

(c) The extent to which the claim would effectively coverall possible solutions to a particular problem; i.e., that the claim is a statement of the problem versus a description of a particular solution to the problem.

For example in The TelephoneCases, 126 U.S. 1, 161-162 (1888) (discussing Tilghmanv. Proctor, 102 U.S. 707 (1880)(“‘The claim of the patent[in Tilghman] is not for a mere principle.’ . . . In that case there was a problem. Find a way, if you can, to combine each atom of water with an atom of acid. If you can do that, then you can reach this important result of resolving the neutral fats into glycerine and acids.

(d) Whether the concept is disembodied or whether it is instantiated; i.e., implemented, in some tangible way. A concept that is well-instantiated weighs in favor of eligibility.

(e) The mechanism(s) by which the steps are implemented; e.g., whether the performance of the process is observable and verifiable rather than subjective or imperceptible. Steps that are observable and verifiable weigh in favor of eligibility.

(f) Examples of general concepts include, but are not limited to:

• Basic economic practices or theories (e.g., hedging,insurance, financial transactions, marketing);

• Basic legal theories (e.g., contracts, dispute resolution, rules of law);

• Mathematical concepts (e.g., algorithms, spatial relationships, geometry);

• Mental activity (e.g., forming a judgment,observation, evaluation, or opinion);

• Interpersonal interactions or relationships (e.g.,conversing, dating);

• Teaching concepts (e.g., memorization, repetition);

• Human behavior (e.g., exercising, wearing clothing,following rules or instructions);

• Instructing ‘‘how business should be conducted.’


2. Making the Determination of Eligibility

Each of the factors relevant to the particular patent application should be weighed to determine whether the method is claiming an abstract idea by covering a general concept, or combination of concepts, or whether the method is limited to a particular practical application of the concept.

The presence or absence of a single factor will not be determinative as the relevant factors need to be considered and weighed to make a proper determination as to whether the claim as a whole is drawn to an abstract idea such that the claim would effectively grant a monopoly over an abstract idea and be ineligible for patent protection.

If the factors indicate that the method claim is not merely covering an abstract idea, the claim is eligible for patent protection under 35 U.S.C. 101 and must be further evaluated for patentability under all of the statutory requirements, including utility and double patenting (35U.S.C. 101 ); novelty (35 U.S.C. 102); non-obviousness( 35 U.S.C. 103 ); and definiteness and adequate description, enablement, and best mode (35 U.S.C. 112).

35 U.S.C. 101 is merely a coarse filter and thus a determination of eligibility under 35 U.S.C. 101 is only a threshold question for patentability. 35 U.S.C. 102, 103, and 112 are typically the primary tools for evaluating patentability unless the claim is truly abstract.

If the factors indicate that the method claim is attempting to cover an abstract idea, the examiner will reject the claim under 35 U.S.C. 101 , providing clear rationale supporting the determination that an abstract idea has been claimed, such that the examiner establishes a prima facie case of patent-ineligibility. The conclusion made by the examiner must be based on the evidence as a whole.In making a rejection or if presenting reasons for allowance when appropriate, the examiner should specifically point out the factors that are relied upon in making the determination. If a claim is rejected under 35 U.S.C. 101 on the basis that it is drawn to an abstract idea,the applicant then has the opportunity to explain why the claimed method is not drawn to an abstract idea.Specifically identifying the factors used in the analysis will allow the applicant to make specific arguments in response to the rejection if the applicant believes that the conclusion that the claim is directed to an abstract idea is in error.


3. Establish on the Record a Prima Facie Case

USPTO personnel should review the totality of the evidence (e.g., the specification, claims, relevant prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. USPTO personnel must weigh the determinations made above to reach a conclusion as to whether it is more likely than not that the claimed invention as a whole either falls outside of one of the enumerated statutory classes or within one of the exceptions to statutory subject matter.The examiner bears the initial burden … of presenting a prima facie case of un-patentability.

After USPTO personnel identify and explain in the record the reasons why a claim is for an abstract idea, physical phenomenon, or law of nature with no practical application, then the burden shifts to the applicant to either amend the claim or make a showing of why the claim is eligible for patent protection.


2106.01 Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature [R-9][edit | edit source]

Process claims having a natural principle as a limiting element or step should be evaluated by determining whether the claim includes additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself.

If the claim as a whole satisfies this inquiry, the claim is directed to patent-eligible subject matter. If the claim as a whole does not satisfy this inquiry, it should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.

ESSENTIAL INQUIRIES FOR SUBJECT MATTER ELIGIBILITY UNDER 35 U.S.C. 101

After determining what applicant invented and establishing the broadest reasonable interpretation of the claimed invention, conduct the following three inquiries on the claim as a whole to determine whether the claim is drawn to patent-eligible subject matter. Further details regarding each inquiry are provided below.

1. Is the claimed invention directed to a process,defined as an act, or a series of acts or steps?

Under this analysis, the claim must be drawn to a process. A process is defined as an act, or a series of acts or steps. Process claims are sometimes called method claims.


- If no, this analysis is not applicable.

- If yes, proceed to Inquiry 2.


2. Does the claim focus on use of a law of nature,a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?)

A natural principle is the handiwork of nature and occurs without the hand of man. For example, the disinfecting property of sunlight is a natural principle. The relationship between blood glucose levels and diabetes is a natural principle. A correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood, is also considered a natural principle because, while it takes a human action to trigger a manifestation of the correlation,the correlation exists in principle apart from any human action.

For this analysis, a claim focuses on a natural principle when the natural principle is a limiting element or step.

In that case, the claim must be analyzed (in Inquiry 3) to ensure that the claim is directed to a practical application of the natural principle that amounts to substantially more than the natural principle itself. So, for instance, a claim that recites a correlation used to make a diagnosis focuses on a natural principle and would require further analysis under Inquiry 3.

If a natural principle is not a limitation of the claim, the claim does not focus on the use of a natural principle and requires no further analysis under this procedure. If the claim focuses on an abstract idea, such as steps that can be performed entirely in one’s mind, methods of controlling human activity, or mere plans for performing an action, refer to MPEP § 2106 to evaluate eligibility.

- If no, this analysis is complete,and the claim should be analyzed to determine if an abstract idea is claimed (see MPEP § 2106).

- If yes,proceed to Inquiry 3.

3. Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply “apply it”?)

A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself.

To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation,albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry.

It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies,relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.

Elements or steps that do not integrate the natural principle and are merely appended to it would not be sufficient. For example, a claim to diagnosing an infection that recites the step of correlating the presence of a certain bacterium in a person’s blood with a particular type of bacterial infection with the additional step of recording the diagnosis on a chart would not be eligible because the step of recording the diagnosis on the chart is extra-solution activity that is unrelated to the correlation and does not integrate the correlation into the invention.

Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.”

The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation.

Elements or steps that are well-understood, purely conventional,and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. A claim with steps that add something of significance to the natural laws themselves would be eligible because it would confine its reach to particular patent-eligible applications of those laws, such as a typical patent on a new drug (including associated method claims) or a new way of using an existing drug.

In other words, the claim must be limited so that it does not preempt the natural principle being recited by covering every substantial practical application of that principle.The process must have additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.


- If no, the claim is not patent-eligible and should be rejected.

- If yes,the claim is patent-eligible, and the analysis is complete.

SAMPLE ANALYSIS

Sample Claim Drawn to a Patent-Eligible PracticalApplication - Diamond v. Diehr

1. A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising:

providing said computer with a data base for said press including at least,

natural logarithm conversion data (ln),

the activation energy constant (C) unique to each batch of said compound being molded, and

a constant (x)dependent upon the geometry of the particular mold of the press,

initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure,

constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding,

constantly providing the computer with the temperature (Z),

repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure,

which is ln v = CZ + x where v is the total required cure time,

repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time,

and opening the press automatically when a said comparison indicates equivalence.

The above claim was found to be a patent- eligible practical application in Diamond v. Diehr, 450 U.S. 175(1981).

Recently, the Supreme Court looked back to this claim as an example of a patent-eligible practical application as explained in the following excerpt from Mayo:

The Court pointed out that the basic mathematical equation, like a law of nature, was not patentable.

But it found the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole. Those steps included “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time.”

It no where suggested that all these steps, or at least the combination of those steps, were in context obvious,already in use, or purely conventional. And so the patentees did not “seek to pre-empt the use of the equation,” but sought “only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process.”

These other steps apparently added to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.


This claim would pass Inquiries 1-3 in the above analysis as it is a process that includes the Arrhenius equation as a limitation, with additional steps that integrate the Arrhenius equation into the process and are sufficient to narrow the scope of the claim so that others are not foreclosed from using the Arrhenius equation in different applications


Sample Claim Drawn to Ineligible Subject Matter - Mayo v. Prometheus

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastro intestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastro intestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The above claim was found to be ineligible in Mayo. The Supreme Court determined that the claim focused on use of a law of nature that was given weight during prosecution of the claim – specifically the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. The Court analyzed the claim as follows:

The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no.

The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine,conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform un-patentable natural correlations into patentable applications of those regularities.

This claim would pass Inquiries 1-2 and fail Inquiry 3. It is a process claim that includes a natural principle that was construed as a limiting feature of a claim during prosecution - the natural principle being the naturally occurring relationships noted above, which are a consequence of the ways in which thiopurine compounds are metabolized by the body.

The Court emphasized that while it takes a human action to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The additional steps integrate the relationship into the process as the administering step involves the thiopurine drug, the determining step establishes the thiopurine drug level and the wherein clauses set forth the critical levels.

The steps are not sufficient, however,to narrow the application such that others could still make use of the naturally occurring relationship in other practical applications. The claim essentially sets forth a law of nature with generalized instructions to apply it.


Making a Rejection

After performing the appropriate Inquiries, a claim that fails Inquiry 3 should be rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter.

When making the rejection,

- identify the natural principle,

- identify that the claim is effectively directed to a natural principle itself, and

- explain the reason(s) that the additional claim features or combination of features, when the claim is taken as a whole, fail to integrate the natural principle into the claimed invention so that the natural principle is practically applied, and/or

- fail to be sufficient to ensure that the claim amounts to significantly more than the natural principle itself.


A sample rejection of the following claim could read as follows:

Claim 1. A method of determining effective dosage of insulin to a patient, comprising the steps of administering a dose of insulin to a patient, testing the patient’s blood for the blood sugar level, and evaluating whether the insulin dosage is effective based on the blood sugar level.

Analysis:


The claim passes Inquiry 1 because it is drawn to a process.

The claim passes Inquiry 2 because a naturally occurring correlation between insulin and blood glucose levels is a limitation of the claim.

The claim does not pass Inquiry 3 because, although the additional steps integrate or make use of the correlation in the process by administering insulin in one step and testing for the correlation in another step, the steps are not sufficient to ensure that the claim amounts to significantly more than the correlation itself since every application of the correlation would require an administration of insulin and testing of blood to observe the relationship between insulin and blood glucose levels.

The rejection:

Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because it is not a patent-eligible practical application of a law of nature.

The claim is directed to a naturally occurring correlation between insulin and blood glucose levels. The combination of steps recited in the claim taken as a whole, including the steps of administering insulin to a patient and testing blood sugar levels, are not sufficient to qualify as a patent-eligible practical application as the claim covers every substantial practical application of the correlation.

Evaluating a Response

A proper response to a rejection based on failure to claim patent-eligible subject matter would be an amendment adding additional steps/features or amending existing steps/features that integrate the natural principle into the process (by practically applying or making use of the principle) and are sufficient to limit the application of the natural principle to more than the principle itself + steps that do more than simply “apply it” at a high level of generality.

Examples of both eligible and ineligible hypothetical claims follow. It would also be proper for the applicant to present persuasive arguments that the additional steps add something significantly more to the claim than merely describing the natural principle. A showing that the steps are not routine, well-known or conventional could be persuasive.

For example, a claim that uses the natural disinfecting properties of sunlight would require additional steps beyond exposing an item requiring disinfection to sunlight. The additional steps could involve constructing a sanitizing device that uses ultraviolet light for disinfection with steps that integrate the ultraviolet light into the device and are sufficient to confine the use of the ultraviolet light to a particular application (not so broad as to cover all practical ways of applying ultraviolet light).

A claim that sets forth the relationship between blood glucose levels and the incidence of diabetes would require additional steps that do significantly more to apply this principle than conventional blood sample testing or diagnostic activity based on recognizing a threshold blood glucose level. Such additional steps could involve a testing technique or treatment steps that would not be conventional or routine.


2107 Guidelines for Examination of Applications for Compliance with the Utility Requirement[edit | edit source]

EXAMINATION GUIDELINES FOR THE UTILITY REQUIREMENT

Office personnel are to adhere to the following procedures when reviewing patent applications for compliance with the “useful invention” (“utility”) requirement of 35 U.S.C. 101 and 112, first paragraph.

(A) Read the claims and the supporting written description:

When reading the claims and the written disclosure the examiner is required to consider the following-:

(1) Determine what the applicant has claimed, noting any specific embodiments of the invention.

(2) Ensure that the claims define statutory subject matter (i.e., a process, machine, manufacture, composition of matter, or improvement thereof).

(3) If at any time during the examination, it becomes readily apparent that the claimed invention has a well-established utility, do not impose a rejection based on lack of utility.

Criteria for a well-established utility:

(i) Immediate appreciation by a person of ordinary skill in the art on the usefulness of the invention based on the characteristics of the invention (e.g., properties or applications of a product or process), and

(ii) Presence of specific, substantial and credible utility.


(B) Determine if the applicant has asserted for the claimed invention any specific and substantial utility that is credible:

An assertion of the usefulness of the claimed invention which is considered credible by a person of ordinary skill, eliminates the imposition of rejection based on lack of utility.

Credibility is assessed from the perspective of one of ordinary skill in the art in view of the disclosure and any other evidence of record (e.g., test data, affidavits or declarations from experts in the art, patents or printed publications) that is probative of the applicant’s assertions. An applicant need only provide one credible assertion of specific and substantial utility for each claimed invention to satisfy the utility requirement.

A claimed invention must have a specific and substantial utility. This requirement excludes “throw-away,” “insubstantial,” or “nonspecific” utilities, such as the use of a complex invention as landfill, as a way of satisfying the utility requirement of 35 U.S.C. 101.


If no assertion of specific and substantial utility for the claimed invention made by the applicant is credible, and the claimed invention does not have a readily apparent well-established utility, reject the claim(s) under 35 U.S.C. 101 on the grounds that the invention as claimed lacks utility.

Also reject the claims under 35 U.S.C. 112, first paragraph, on the basis that the disclosure fails to teach how to use the invention as claimed. The 35 U.S.C. 112, first paragraph, rejection imposed in conjunction with a 35 U.S.C. 101 rejection should incorporate by reference the grounds of the corresponding 35 U.S.C. 101 rejection.

Further, if the applicant has not asserted any specific and substantial utility for the claimed invention and it does not have a readily apparent well-established utility, impose a rejection under 35 U.S.C. 101, emphasizing that the applicant has not disclosed a specific and substantial utility for the invention. Also impose a separate rejection under 35 U.S.C. 112, first paragraph, on the basis that the applicant has not disclosed how to use the invention due to the lack of a specific and substantial utility.


The 35 U.S.C. 101 and 112 rejections shift the burden of coming forward with evidence to the applicant to:

(i)Explicitly identify a specific and substantial utility for the claimed invention; and

(ii)Provide evidence that one of ordinary skill in the art would have recognized that the identified specific and substantial utility was well-established at the time of filing.

The examiner should review any subsequently submitted evidence of utility using the criteria outlined above. The examiner should also ensure that there is an adequate nexus between the evidence and the properties of the now claimed subject matter as disclosed in the application as filed. That is, the applicant has the burden to establish a probative relation between the submitted evidence and the originally disclosed properties of the claimed invention.

(C) Any rejection based on lack of utility should include a detailed explanation why the claimed invention has no specific and substantial credible utility.


Whenever possible, the examiner should provide documentary evidence regardless of publication date (e.g., scientific or technical journals, excerpts from treatises or books, or U.S. or foreign patents) to support the factual basis for the prima facie showing of no specific and substantial credible utility. If documentary evidence is not available, the examiner should specifically explain the scientific basis for his or her factual conclusions.

(1)Where the asserted utility is not specific or substantial:

a prima facie showing must establish that it is more likely than not that a person of ordinary skill in the art would not consider that any utility asserted by the applicant would be specific and substantial.

The prima facie showing must contain the following elements:

(i)An explanation that clearly sets forth the reasoning used in concluding that the asserted utility for the claimed invention is not both specific and substantial nor well-established;

(ii)Support for factual findings relied upon in reaching this conclusion; and

(iii)An evaluation of all relevant evidence of record, including utilities taught in the closest prior art.

(2)Where the asserted specific and substantial utility is not credible:

a prima facie showing of no specific and substantial credible utility must establish that it is more likely than not that a person skilled in the art would not consider credible any specific and substantial utility asserted by the applicant for the claimed invention.

The prima facie showing must contain the following elements:

(i)An explanation that clearly sets forth the reasoning used in concluding that the asserted specific and substantial utility is not credible;

(ii)Support for factual findings relied upon in reaching this conclusion; and

(iii)An evaluation of all relevant evidence of record, including utilities taught in the closest prior art.

(3)Where no specific and substantial utility is disclosed or is well-established:

a prima facie showing of no specific and substantial utility need only establish that applicant has not asserted a utility and that, on the record before the examiner, there is no known well-established utility.


(D)A rejection based on lack of utility should not be maintained if an asserted utility for the claimed invention would be considered specific, substantial, and credible by a person of ordinary skill in the art in view of all evidence of record.

Office personnel are reminded that they must treat as true a statement of fact made by an applicant in relation to an asserted utility, unless countervailing evidence can be provided that shows that one of ordinary skill in the art would have a legitimate basis to doubt the credibility of such a statement.

Similarly, Office personnel must accept an opinion from a qualified expert that is based upon relevant facts whose accuracy is not being questioned; it is improper to disregard the opinion solely because of a disagreement over the significance or meaning of the facts offered.

Once a prima facie showing of no specific and substantial credible utility has been properly established, the applicant bears the burden of rebutting it. The applicant can do this by amending the claims, by providing reasoning or arguments, or by providing evidence in the form of a declaration under 37 CFR 1.132 or a patent or a printed publication that rebuts the basis or logic of the prima facie showing.

If the applicant responds to the prima facie rejection, the Office personnel should review the original disclosure, any evidence relied upon in establishing the prima facie showing, any claim amendments, and any new reasoning or evidence provided by the applicant in support of an asserted specific and substantial credible utility. It is essential for Office personnel to recognize, fully consider and respond to each substantive element of any response to a rejection based on lack of utility. Only where the totality of the record continues to show that the asserted utility is not specific, substantial, and credible should a rejection based on lack of utility be maintained.

If the applicant satisfactorily rebuts a prima facie rejection based on lack of utility under 35 U.S.C. 101, withdraw the 35 U.S.C. 101 rejection and the corresponding rejection imposed under 35 U.S.C. 112, first paragraph.

2107.01 General Principles Governing Utility Rejections [R-5][edit | edit source]

35 U.S.C. 101 Inventions patentable.

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.


As interpreted by the Federal courts, 35 U.S.C. 101 has two purposes.

1- First, 35 U.S.C. 101 defines which categories of inventions are eligible for patent protection. An invention that is not a machine, an article of manufacture, a composition or a process cannot be patented.

2- Second, 35 U.S.C. 101 serves to ensure that patents are granted on only those inventions that are “useful.”


Deficiencies under the “useful invention” requirement of 35 U.S.C. 101 will arise in one of two forms.

1- Where it is not apparent why the invention is “useful.”

This can occur when an applicant fails to identify any specific and substantial utility for the invention or fails to disclose enough information about the invention to make its usefulness immediately apparent to those familiar with the technological field of the invention.

2- Where an assertion of specific and substantial utility for the invention made by an applicant is not credible.


I.SPECIFIC AND SUBSTANTIAL REQUIREMENTS

To satisfy 35 U.S.C. 101, an invention must be “useful.” Courts have recognized that the term “useful” used with reference to the utility requirement can be a difficult term to define.

Where an applicant has set forth a specific and substantial utility, courts have been reluctant to uphold a rejection under 35 U.S.C. 101 solely on the basis that the applicant’s opinion as to the nature of the specific and substantial utility was inaccurate.

For example, in Nelsonv. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980), the court reversed a finding by the Office that the applicant had not set forth a “practical” utility under 35 U.S.C. 101. In this case the applicant asserted that the composition was “useful” in a particular pharmaceutical application and provided evidence to support that assertion.

Courts have used the labels “practical utility,” “substantial utility,” or “specific utility” to refer to this aspect of the “useful invention” requirement of 35 U.S.C. 101.


The Court of Customs and Patent Appeals has stated:

Practical utility is a shorthand way of attributing “real- world” value to claimed subject matter. In other words, one skilled in the art can use a claimed discovery in a manner which provides some immediate benefit to the public.

Practical considerations require the Office to rely on the inventor’s understanding of his or her invention in determining whether and in what regard an invention is believed to be “useful.” Because of this, Office personnel should focus on and be receptive to assertions made by the applicant that an invention is “useful” for a particular reason.

A.Specific Utility

A “specific utility” is specific to the subject matter claimed and can “provide a well-defined and particular benefit to the public.

This contrasts with a general utility that would be applicable to the broad class of the invention. Office personnel should distinguish between situations where an applicant has disclosed a specific use for or application of the invention and situations where the applicant merely indicates that the invention may prove useful without identifying with specificity why it is considered useful.

For example, indicating that a compound may be useful in treating unspecified disorders, or that the compound has “useful biological” properties, would not be sufficient to define a specific utility for the compound.

Similarly, a claim to a polynucleotide whose use is disclosed simply as a “gene probe” or “chromosome marker” would not be considered to be specific in the absence of a disclosure of a specific DNA target.

A general statement of diagnostic utility, such as diagnosing an unspecified disease, would ordinarily be insufficient absent a disclosure of what condition can be diagnosed. Contrast the situation where an applicant discloses a specific biological activity and reasonably correlates that activity to a disease condition. Assertions falling within the latter category are sufficient to identify a specific utility for the invention. Assertions that fall in the former category are insufficient to define a specific utility for the invention, especially if the assertion takes the form of a general statement that makes it clear that a “useful” invention may arise from what has been disclosed by the applicant.

B.Substantial Utility

An application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must show that the claimed invention has a significant and presently available benefit to the public.”

Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at issue in Fisher were directed to expressed sequence tags (ESTs), which are short nucleotide sequences that can be used to discover what genes and downstream proteins are expressed in a cell.

The court held that “the claimed ESTs can be used only to gain further information about the underlying genes and the proteins encoded for by those genes. The claimed ESTs themselves are not an end of applicant’s research effort, but only tools to be used along the way in the search for a practical utility….

Applicant does not identify the function for the underlying protein-encoding genes. Absent such identification, we hold that the claimed ESTs have not been researched and understood to the point of providing an immediate, well- defined, real world benefit to the public meriting the grant of a patent.”

Thus a “substantial utility” defines a “real world” use. Utilities that require or constitute carrying out further research to identify or reasonably confirm a “real world” context of use are not substantial utilities.

For example, both a therapeutic method of treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a “substantial utility” define a “real world” context of use. An assay that measures the presence of a material which has a stated correlation to a predisposition to the onset of a particular disease condition would also define a “real world” context of use in identifying potential candidates for preventive measures or further monitoring.

On the other hand, the following are examples of situations that require or constitute carrying out further research to identify or reasonably confirm a “real world” context of use and, therefore, do not define “substantial utilities”:

(A)Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved;

(B)A method of treating an unspecified disease or condition;

(C)A method of assaying for or identifying a material that itself has no specific and/or substantial utility;

(D)A method of making a material that itself has no specific, substantial, and credible utility; and

(E)A claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility.

Office personnel must be careful not to interpret the phrase “immediate benefit to the public” or similar formulations in other cases to mean that products or services based on the claimed invention must be “currently available” to the public in order to satisfy the utility requirement.

Rather, any reasonable use that an applicant has identified for the invention that can be viewed as providing a public benefit should be accepted as sufficient, at least with regard to defining a “substantial” utility.

C.Research Tools

Some confusion can result when one attempts to label certain types of inventions as not being capable of having a specific and substantial utility based on the setting in which the invention is to be used.

One example is inventions to be used in a research or laboratory setting. Many research tools such as gas chromatographs, screening assays, and nucleotide sequencing techniques have a clear, specific and unquestionable utility (e.g., they are useful in analyzing compounds).

An assessment that focuses on whether an invention is useful only in a research setting thus does not address whether the invention is in fact “useful” in a patent sense. Instead, Office personnel must distinguish between inventions that have a specifically identified substantial utility and inventions whose asserted utility requires further research to identify or reasonably confirm. Labels such as “research tool,” “intermediate” or “for research purposes” are not helpful in determining if an applicant has identified a specific and substantial utility for the invention.

II.WHOLLY INOPERATIVE INVENTIONS; “INCREDIBLE” UTILITY

An invention that is “inoperative” (i.e., it does not operate to produce the results claimed by the patent applicant) is not a “useful” invention in the meaning of the patent law.

Wholly inoperative cases are rarest to find. A small degree of utility is sufficient in an application. The claimed invention must only be capable of performing some beneficial function . An invention does not lack utility merely because the particular embodiment disclosed in the patent lacks perfection or performs crudely.

A commercially successful product is not required nor is it essential that the invention accomplish all its intended functions or operate under all conditions. Partial success is sufficient to demonstrate patentable utility.

In short, the defense of non-utility cannot be sustained without proof of total incapacity.” If an invention is only partially successful in achieving a useful result, a rejection of the claimed invention as a whole based on a lack of utility is not appropriate.


Situations where an invention is found to be “inoperative” and therefore lacking in utility are rare, and rejections maintained solely on this ground by a Federal court even rarer. In many of these cases, the utility asserted by the applicant was thought to be “incredible in the light of the knowledge of the art, or factually misleading” when initially considered by the Office.

Other cases suggest that on initial evaluation, the Office considered the asserted utility to be inconsistent with known scientific principles or “speculative at best” as to whether attributes of the invention necessary to impart the asserted utility were actually present in the invention.

However cast, the underlying finding by the court in these cases was that, based on the factual record of the case, it was clear that the invention could not and did not work as the inventor claimed it did.

Indeed, the use of many labels to describe a single problem (e.g., a false assertion regarding utility) has led to some of the confusion that exists today with regard to a rejection based on the “utility” requirement.

Examples of such cases include: - an invention asserted to change the taste of food using a magnetic field (Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)),

- a perpetual motion machine (Newman v. Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir. 1989)), a flying machine operating on “flapping or flutter function” (In re Houghton, 433 F.2d 820, 167 USPQ 687 (CCPA 1970)),

- a “cold fusion” process for producing energy (In re Swartz, 232 F.3d 862, 56 USPQ2d 1703, (Fed. Cir. 2000)),

a method for increasing the energy output of fossil fuels upon combustion 

through exposure to a magnetic field (In re Ruskin, 354 F.2d 395, 148 USPQ 221 (CCPA 1966)),

uncharacterized compositions for curing a wide array of cancers (In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963)), and

a method of controlling the aging process (In re Eltgroth, 419 F.2d 918, 164 USPQ 221 (CCPA 1970)).

III.THERAPEUTIC OR PHARMACOLOGICAL UTILITY

Inventions asserted to have utility in the treatment of human or animal disorders are subject to the same legal requirements for utility as inventions in any other field of technology.

Pharmacological or therapeutic inventions that provide any “immediate benefit to the public” satisfy 35 U.S.C. 101.

In order to determine the patentability of pharmacological or therapeutic invention, the Office Personnel are advised to rely on Nelson and other cases as providing general guidance when evaluating the utility of an invention.

The Court of Customs and Patent Appeals held in Nelson v. Bowler:

Knowledge of the pharmacological activity of any compound is obviously beneficial to the public. It is inherently faster and easier to combat illnesses and alleviate symptoms when the medical profession is armed with an arsenal of chemicals having known pharmacological activities. Since it is crucial to provide researchers with an incentive to disclose pharmacological activities in as many compounds as possible, we conclude that adequate proof of any such activity constitutes a showing of practical utility.

Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980)


In Nelson v. Bowler, the court addressed the practical utility requirement in the context of an interference proceeding.

Bowler challenged the patentability of the invention claimed by Nelson on the basis that Nelson had failed to sufficiently and persuasively disclose in his application a practical utility for the invention.

Nelson had developed and claimed a class of synthetic prostaglandins modeled on naturally occurring prostaglandins. Naturally occurring prostaglandins are bioactive compounds that, at the time of Nelson’s application, had a recognized value in pharmacology (e.g., the stimulation of uterine smooth muscle which resulted in labor induction or abortion, the ability to raise or lower blood pressure, etc.).

To support the utility he identified in his disclosure, Nelson included in his application the results of tests demonstrating the bioactivity of his new substituted prostaglandins relative to the bioactivity of naturally occurring prostaglandins.

The court concluded that Nelson had satisfied the practical utility requirement in identifying the synthetic prostaglandins as pharmacologically active compounds. In reaching this conclusion, the court considered and rejected arguments advanced by Bowler that attacked the evidentiary basis for Nelson’s assertions that the compounds were pharmacologically active.


Reference case where asserted utility was incredible


Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980), an invention claiming protection for pharmaceutical compositions for treating leukemia.

The active ingredient in the compositions was a structural analog to a known anticancer agent. The applicant provided evidence showing that the claimed analogs had the same general pharmaceutical activity as the known anticancer agents. The court reversed the Board’s finding that the asserted pharmaceutical utility was “incredible,” pointing to the evidence that showed the relevant pharmacological activity.


Utility of Therapeutic inventions at a very early stage of development

Courts have found utility for therapeutic inventions despite the fact that an applicant is at a very early stage in the development of a pharmaceutical product or therapeutic regimen based on a claimed pharmacological or bioactive compound or composition.

A successful vitro testing shall marshal resources and direct the expenditure of effort to further in vivo testing of the most potent compounds, thereby providing an immediate benefit to the public, analogous to the benefit provided by the showing of an in vivo utility.


Utility judgement by USPTO and the requirements of FDA.

The Federal Circuit has reiterated that therapeutic utility sufficient under the patent laws is not to be confused with the requirements of the FDA with regard to safety and efficacy of drugs to marketed in the United States.

FDA approval, however, is not a prerequisite for finding a compound useful within the meaning of the patent laws. Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development. The stage at which an invention in this field becomes useful is well before it is ready to be administered to humans.

If Phase II testing is considered for proving utility, the associated costs would prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue, through research and development, potential cures in many crucial areas such as the treatment of cancer.


These general principles are equally applicable to situations where an applicant has claimed a process for treating a human or animal disorder. In such cases, the asserted utility is usually clear — the invention is asserted to be useful in treating the particular disorder. If the asserted utility is credible, there is no basis to challenge such a claim on the basis that it lacks utility under 35 U.S.C. 101.


IV.RELATIONSHIP BETWEEN 35 U.S.C. 112, FIRST PARAGRAPH, AND 35 U.S.C. 101

A deficiency under the utility prong of 35 U.S.C. 101 also creates a deficiency under 35 U.S.C. 112, first paragraph. If a claimed invention does not have utility, the specification cannot enable one to use it.


Courts have also cast the 35 U.S.C. 101/35 U.S.C. 112 relationship such that 35 U.S.C. 112 presupposes compliance with 35 U.S.C. 101.

If the application fails as a matter of fact to satisfy 35 U.S.C. § 101, then the application also fails as a matter of law to enable one of ordinary skill in the art to use the invention under 35 U.S.C. § 112.


As such, a rejection properly imposed under 35 U.S.C. 101 for lack of utility should be accompanied with a rejection under 35 U.S.C. 112, first paragraph. It is equally clear that a rejection based on “lack of utility,” whether grounded upon 35 U.S.C. 101 or 35 U.S.C. 112, first paragraph, rests on the same basis (i.e., the asserted utility is not credible).

To avoid confusion, any lack of utility rejection that is imposed on the basis of 35 U.S.C. 101 should be accompanied by a rejection based on 35 U.S.C. 112, first paragraph.

The 35 U.S.C. 112, first paragraph, rejection should be set out as a separate rejection that incorporates by reference the factual basis and conclusions set forth in the 35 U.S.C. 101rejection.

The 35 U.S.C. 112, first paragraph, rejection should indicate that because the invention as claimed does not have utility, a person skilled in the art would not be able to use the invention as claimed, and as such, the claim is defective under 35 U.S.C. 112, first paragraph.

A 35 U.S.C. 112, first paragraph, rejection based on lack of utility should not be imposed or maintained unless an appropriate basis exists for imposing a utility rejection under 35 U.S.C. 101. In other words, Office personnel should not impose a 35 U.S.C. 112, first paragraph, rejection grounded on a “lack of utility” basis unless a 35 U.S.C. 101 rejection is proper. In particular, the factual showing needed to impose a rejection under 35 U.S.C. 101 must be provided if a rejection under 35 U.S.C. 112, first paragraph, is to be imposed on “lack of utility” grounds.

It is important to recognize that 35 U.S.C. 112, first paragraph, addresses matters other than those related to the question of whether or not an invention lacks utility.

These matters include :

- whether the claims are fully supported by the disclosure

- whether the applicant has provided an enabling disclosure of the claimed subject matter

- whether the applicant has provided an adequate written description of the invention and

- whether the applicant has disclosed the best mode of practicing the claimed invention

The fact that an applicant has disclosed a specific utility for an invention and provided a credible basis supporting that specific utility does not provide a basis for concluding that the claims comply with all the requirements of 35 U.S.C. 112, first paragraph.

For example, if an applicant has claimed a process of treating a certain disease condition with a certain compound and provided a credible basis for asserting that the compound is useful in that regard, but to actually practice the invention as claimed a person skilled in the relevant art would have to engage in an undue amount of experimentation, the claim may be defective under 35 U.S.C. 112, but not 35 U.S.C. 101.

To avoid confusion during examination, any rejection under 35 U.S.C. 112, first paragraph, based on grounds other than “lack of utility” should be imposed separately from any rejection imposed due to “lack of utility” under 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph.

2107.02 Procedural Considerations Related to Rejections for Lack of Utility [R-5][edit | edit source]

I.THE CLAIMED INVENTION IS THE FOCUS OF THE UTILITY REQUIREMENT

The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements.

Generally speaking, however, a dependent claim will define an invention that has utility if the independent claim from which the dependent claim depends is drawn to the same statutory class of invention as the dependent claim and the independent claim defines an invention having utility.

An exception to this general rule is where the utility specified for the invention defined in a dependent claim differs from that indicated for the invention defined in the independent claim from which the dependent claim depends. Where an applicant has established utility for a species that falls within an identified genus of compounds, and presents a generic claim covering the genus, as a general matter, that claim should be treated as being sufficient under 35 U.S.C. 101. Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility.

Only one credible assertion of specific utility for the claimed invention is required.

It is common and sensible for an applicant to identify several specific utilities for an invention, particularly where the invention is a product (e.g., a machine, an article of manufacture or a composition of matter). However, regardless of the category of invention that is claimed (e.g., product or process), an applicant need only make one credible assertion of specific utility for the claimed invention to satisfy 35 U.S.C. 101and 35 U.S.C. 112; additional statements of utility, even if not “credible,” do not render the claimed invention lacking in utility.

Example:

1- USPQ 665, 668 (CCPA 1964) :

"Having found that the antibiotic is useful for some purpose, it becomes unnecessary to decide whether it is in fact useful for the other purposes ‘indicated’ in the specification as possibly useful.”;

Statements made by the applicant in the specification or incident to prosecution of the application before the Office cannot, standing alone, be the basis for a lack of utility rejection under 35 U.S.C. 101 or 35 U.S.C. 112.


An applicant may include statements in the specification whose technical accuracy cannot be easily confirmed if those statements are not necessary to support the patentability of an invention with regard to any statutory basis. Thus, the Office should not require an applicant to strike nonessential statements relating to utility from a patent disclosure, regardless of the technical accuracy of the statement or assertion it presents. Office personnel should also be especially careful not to read into a claim unclaimed results, limitations or embodiments of an invention. Doing so can inappropriately change the relationship of an asserted utility to the claimed invention and raise issues not relevant to examination of that claim.


II.IS THERE AN ASSERTED OR WELL-ESTABLISHED UTILITY FOR THE CLAIMED INVENTION?

Upon initial examination, the examiner should review the specification to determine if there are any statements asserting that the claimed invention is useful for any particular purpose. A complete disclosure should include a statement which identifies a specific and substantial utility for the invention.


A.An Asserted Utility Must Be Specific and Substantial

A statement of specific and substantial utility should fully and clearly explain why the applicant believes the invention is useful. Such statements will usually explain the purpose of or how the invention may be used (e.g., a compound is believed to be useful in the treatment of a particular disorder). Regardless of the form of statement of utility, it must enable one ordinarily skilled in the art to understand why the applicant believes the claimed invention is useful.

Except where an invention has a well-established utility, the failure of an applicant to specifically identify why an invention is believed to be useful renders the claimed invention deficient under 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph.


In such cases, the applicant has failed to identify a “specific and substantial utility” for the claimed invention. For example, a statement that a composition has an unspecified “biological activity” or that does not explain why a composition with that activity is believed to be useful fails to set forth a “specific and substantial utility.”

USPQ2d 1600, 1604 (Fed. Cir. 1993):

disclosure that composition is “plastic-like” and can form “films” not sufficient to identify specific and substantial utility for invention;

In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967):

indication that compound is “biologically active” or has “biological properties” insufficient standing alone.

A disclosure that identifies a particular biological activity of a compound and explains how that activity can be utilized in a particular therapeutic application of the compound does contain an assertion of specific and substantial utility for the invention.

Situations where an applicant either fails to indicate why an invention is considered useful, or where the applicant inaccurately describes the utility should rarely arise.

One reason for this is that applicants are required to disclose the best mode known to them of practicing the invention at the time they file their application. An applicant who omits a description of the specific and substantial utility of the invention, or who incompletely describes that utility, may encounter problems with respect to the best mode requirement of 35 U.S.C. 112, first paragraph.

B.No Statement of Utility for the Claimed Invention in the Specification Does Not Per Se Negate Utility

Occasionally, an applicant will not explicitly state in the specification or otherwise assert a specific and substantial utility for the claimed invention. If no statements can be found asserting a specific and substantial utility for the claimed invention in the specification, Office personnel should determine if the claimed invention has a well-established utility.

An invention has a well-established utility if :

(i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g., properties or applications of a product or process), and

(ii) the utility is specific, substantial, and credible.

If an invention has a well- established utility, rejections under 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph, based on lack of utility should not be imposed.

In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an application teaches the cloning and characterization of the nucleotide sequence of a well-known protein such as insulin, and those skilled in the art at the time of filing knew that insulin had a well-established use, it would be improper to reject the claimed invention as lacking utility solely because of the omitted statement of specific and substantial utility.

If a person of ordinary skill would not immediately recognize a specific and substantial utility for the claimed invention (i.e., why it would be useful) based on the characteristics of the invention or statements made by the applicant, the examiner should reject the application under 35 U.S.C. 101 and under 35 U.S.C. 112, first paragraph, as failing to identify a specific and substantial utility for the claimed invention.

The rejection should clearly indicate that the basis of the rejection is that the application fails to identify a specific and substantial utility for the invention. The rejection should also specify that the applicant must reply by indicating why the invention is believed useful and where support for any subsequently asserted utility can be found in the specification as filed.

If the applicant subsequently indicates why the invention is useful, Office personnel should review that assertion according to the standards articulated below for review of the credibility of an asserted utility.


III.EVALUATING THE CREDIBILITY OF AN ASSERTED UTILITY

A.An Asserted Utility Creates a Presumption of Utility

In most cases, an applicant’s assertion of utility creates a presumption of utility that will be sufficient to satisfy the utility requirement of 35 U.S.C. 101.

As a matter of Patent Office practice, a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope.

In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in original). The “Langer” test for utility has been used by both the Federal Circuit and the Court of Customs and Patent Appeals in evaluation of rejections under 35 U.S.C. 112, first paragraph, where the rejection is based on a deficiency under 35 U.S.C. 101. In In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of Customs and Patent Appeals formulation of the “Langer” standard for 35 U.S.C. 112, first paragraph rejections, as it was expressed in a slightly reworded format in In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971), namely:

A specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support.


Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true.

For obvious reasons of efficiency and in deference to an applicant’s understanding of his or her invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on “lack of utility” is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.


Compliance with 35 U.S.C. 101 is a question of fact. Thus, to overcome the presumption of truth that an assertion of utility by the applicant enjoys, Office personnel must establish that it is more likely than not that one of ordinary skill in the art would doubt (i.e., “question”) the truth of the statement of utility. The evidentiary standard to be used throughout ex parte examination in setting forth a rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”); In re Corkill, 771 F.2d 1496,




1500,

226 USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance of the evidence exists when it suggests that it is more likely than not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must provide evidence sufficient to show that the statement of asserted utility would be considered “false” by a person of ordinary skill in the art. Of course, a person of ordinary skill must have the benefit of both facts and reasoning in order to assess the truth of a statement. This means that if the applicant has presented facts that support the reasoning used in asserting a utility, Office personnel must present countervailing facts and reasoning sufficient to establish that a person of ordinary skill would not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during evaluation of this question is a preponderance of the evidence (i.e., the totality of facts and reasoning suggest that it is more likely than not that the statement of the applicant is false).

B.When Is an Asserted Utility Not Credible?

Where an applicant has specifically asserted that an invention has a particular utility, that assertion cannot simply be dismissed by Office personnel as being “wrong,” even when there may be reason to believe that the assertion is not entirely accurate. Rather, Office personnel must determine if the assertion of utility is credible (i.e., whether the assertion of utility is believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided). An assertion is credible unless (A) the logic underlying the assertion is seriously flawed, or (B) the facts upon which the assertion is based are inconsistent with the logic underlying the assertion. Credibility as used in this context refers to the reliability of the statement based on the logic and facts that are offered by the applicant to support the assertion of utility.

One situation where an assertion of utility would not be considered credible is where a person of ordinary skill would consider the assertion to be “incredible in view of contemporary knowledge” and where nothing offered by the applicant would counter what contemporary knowledge might otherwise suggest. Office personnel should be careful, however, not to label certain types of inventions as “incredible” or “speculative” as such labels do not provide the correct focus for the evaluation of an assertion of utility. “Incredible utility” is a conclusion, not a starting point for analysis under 35 U.S.C. 101. A conclusion that an asserted utility is incredible can be reached only after the Office has evaluated both the assertion of the applicant regarding utility and any evidentiary basis of that assertion. The Office should be particularly careful not to start with a presumption that an asserted utility is, per se, “incredible” and then proceed to base a rejection under 35 U.S.C. 101 on that presumption.

Rejections under 35 U.S.C. 101 based on a lack of credible utility have been sustained by federal courts when, for example, the applicant failed to disclose any utility for the invention or asserted a utility that could only be true if it violated a scientific principle, such as the second law of thermodynamics, or a law of nature, or was wholly inconsistent with contemporary knowledge in the art. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special care should be taken when assessing the credibility of an asserted therapeutic utility for a claimed invention. In such cases, a previous lack of success in treating a disease or condition, or the absence of a proven animal model for testing the effectiveness of drugs for treating a disorder in humans, should not, standing alone, serve as a basis for challenging the asserted utility under 35 U.S.C. 101.


IV.INITIAL BURDEN IS ON THE OFFICE TO ESTABLISH A PRIMA FACIE CASE AND PROVIDE EVIDENTIARY SUPPORT THEREOF

To properly reject a claimed invention under 35 U.S.C. 101, the Office must (A) make a prima facie showing that the claimed invention lacks utility, and (B) provide a sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie showing. In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA 1975) (“Accordingly, the PTO must do more than merely question operability - it must set forth factual reasons which would lead one skilled in the art to question the objective truth of the statement of operability.”). If the Office cannot develop a proper prima facie case and provide evidentiary support for a rejection under 35 U.S.C. 101, a rejection on this ground should not be imposed.




See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant.... If examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent.”). See also Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) (applying prima facie case law to 35 U.S.C. 101); In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).

The prima facie showing must be set forth in a well-reasoned statement. Any rejection based on lack of utility should include a detailed explanation why the claimed invention has no specific and substantial credible utility. Whenever possible, the examiner should provide documentary evidence regardless of publication date (e.g., scientific or technical journals, excerpts from treatises or books, or U.S. or foreign patents) to support the factual basis for the prima facie showing of no specific and substantial credible utility. If documentary evidence is not available, the examiner should specifically explain the scientific basis for his or her factual conclusions.

Where the asserted utility is not specific or substantial, 

a prima facie showing must establish that it is more likely than not that a person of ordinary skill in the art would not consider that any utility asserted by the applicant would be specific and substantial. The prima facie showing must contain the following elements:


(A)An explanation that clearly sets forth the reasoning used in concluding that the asserted utility for the claimed invention is neither both specific and substantial nor well-established;

(B)Support for factual findings relied upon in reaching this conclusion; and

(C)An evaluation of all relevant evidence of record, including utilities taught in the closest prior art.

Where the asserted specific and substantial utility is not credible, a prima facie showing of no specific and substantial credible utility must establish that it is more likely than not that a person skilled in the art would not consider credible any specific and substantial utility asserted by the applicant for the claimed invention. The prima facie showing must contain the following elements:

(A)An explanation that clearly sets forth the reasoning used in concluding that the asserted specific and substantial utility is not credible;

(B)Support for factual findings relied upon in reaching this conclusion; and

(C)An evaluation of all relevant evidence of record, including utilities taught in the closest prior art.

Where no specific and substantial utility is disclosed or is well-established, a prima facie showing of no specific and substantial utility need only establish that applicant has not asserted a utility and that, on the record before the examiner, there is no known well- established utility.

It is imperative that Office personnel use specificity in setting forth and initial rejection under 35 U.S.C. 101 and support any factual conclusions made in the prima facie showing.

By using specificity, the applicant will be able to identify the assumptions made by the Office in setting forth the rejection and will be able to address those assumptions properly.

V.EVIDENTIARY REQUESTS BY AN EXAMINER TO SUPPORT AN ASSERTED UTILITY

In appropriate situations the Office may require an applicant to substantiate an asserted utility for a claimed invention. See In re Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the operativeness of any process would be deemed unlikely by one of ordinary skill in the art, it is not improper for the examiner to call for evidence of operativeness.”). See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962). In In re Citron, the court held that when an “alleged utility appears to be incredible in the light of the knowledge of the art, or factually misleading, applicant must establish the asserted utility by acceptable proof.” 325 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which affirmed




the rejection under 35 U.S.C. 101 “in view of the art knowledge of the lack of a cure for cancer and the absence of any clinical data to substantiate the allegation.” 325 F.2d at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the applicant where the statement of use is incredible or misleading. In such a case, the examiner should challenge the use and require sufficient evidence of operativeness. The purpose of this authority is to enable an applicant to cure an otherwise defective factual basis for the operability of an invention. Because this is a curative authority (e.g., evidence is requested to enable an applicant to support an assertion that is inconsistent with the facts of record in the application), Office personnel should indicate not only why the factual record is defective in relation to the assertions of the applicant, but also, where appropriate, what type of evidentiary showing can be provided by the applicant to remedy the problem.

Requests for additional evidence should be imposed rarely, and only if necessary to support the scientific credibility of the asserted utility (e.g., if the asserted utility is not consistent with the evidence of record and current scientific knowledge). As the Federal Circuit recently noted, “[o]nly after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention’s asserted utility.” In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995) (citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)). In Brana,

the court pointed out that the purpose of treating cancer with chemical compounds does not suggest,

per se,

an incredible utility. Where the prior art disclosed “structurally similar compounds to those claimed by applicants which have been proven in vivo to be effective as chemotherapeutic agents against various tumor models . . ., one skilled in the art would be without basis to reasonably doubt applicants’ asserted utility on its face.” 51 F.3d at 1566, 34 USPQ2d at 1441. As courts have stated, “it is clearly improper for the examiner to make a demand for further test data, which as evidence would be essentially redundant and would seem to serve for nothing except perhaps to unduly burden the applicant.” In re Isaacs, 347 F.2d 887, 890, 146 USPQ 193, 196 (CCPA 1965).

VI.CONSIDERATION OF A REPLY TO A PRIMA FACIE REJECTION FOR LACK OF UTILITY

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant. . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument.”). An applicant can do this using any combination of the following: amendments to the claims, arguments or reasoning, or new evidence submitted in an affidavit or declaration under 37 CFR 1.132, or in a printed publication. New evidence provided by an applicant must be relevant to the issues raised in the rejection. For example, declarations in which conclusions are set forth without establishing a nexus between those conclusions and the supporting evidence, or which merely express opinions, may be of limited probative value with regard to rebutting a prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through §

716.01(c).

If the applicant responds to the prima facie rejection, Office personnel should review the original disclosure, any evidence relied upon in establishing the prima facie showing, any claim amendments, and any new reasoning or evidence provided by the applicant in support of an asserted specific and substantial credible utility. It is essential for Office personnel to recognize, fully consider and respond to each substantive element of any response to a rejection based on lack of utility. Only where the totality of the record continues to show that the asserted utility is not specific, substantial, and credible should a rejection based on lack of utility be maintained. If the record as a whole would make it more likely than not that the asserted utility for the claimed invention would be considered credible by a person of ordinary skill in the art, the




Office cannot maintain the rejection. In re Rinehart, 531 F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 1976).

VII.EVALUATION OF EVIDENCE RELATED TO UTILITY

There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility, therapeutic or otherwise. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it establishes an asserted utility as a matter of statistical certainty. Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980) (reversing the Board and rejecting Bowler’s arguments that the evidence of utility was statistically insignificant. The court pointed out that a rigorous correlation is not necessary when the test is reasonably predictive of the response). See also Rey-Bellet v. Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted human therapeutic utility if there is a “satisfactory correlation between the effect on the animal and that ultimately observed in human beings”). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true.

2107.03 Special Considerations for Asserted Therapeutic or Pharmacological Utilities[edit | edit source]

The Federal courts have consistently reversed rejections by the Office asserting a lack of utility for inventions claiming a pharmacological or therapeutic utility where an applicant has provided evidence that reasonably supports such a utility. In view of this, Office personnel should be particularly careful in their review of evidence provided in support of an asserted therapeutic or pharmacological utility.

I.A REASONABLE CORRELATION BETWEEN THE EVIDENCE AND THE ASSERTED UTILITY IS SUFFICIENT

As a general matter, evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility.

An applicant can establish this reasonable correlation by relying on

1- statistically relevant data documenting the activity of a compound or composition,

2- arguments or reasoning,

3-documentary evidence (e.g., articles in scientific journals), or any combination thereof.

The applicant does not have to prove that a correlation exists between a particular activity and an asserted therapeutic use of a compound as a matter of statistical certainty, nor does he or she have to provide actual evidence of success in treating humans where such a utility is asserted. Instead, as the courts have repeatedly held, all that is required is a reasonable correlation between the activity and the asserted use.


II.STRUCTURAL SIMILARITY TO COMPOUNDS WITH ESTABLISHED UTILITY

Courts have routinely found evidence of structural similarity to a compound known to have a particular therapeutic or pharmacological utility as being supportive of an assertion of therapeutic utility for a new compound.

In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980), the claimed compounds were found to have utility based on a finding of a close structural relationship to daunorubicin and doxorubicin and shared pharmacological activity with those compounds, both of which were known to be useful in cancer chemotherapy. The evidence of close structural similarity with the known compounds was presented in conjunction with evidence demonstrating substantial activity of the claimed compounds in animals customarily employed for screening anticancer agents.

Such evidence should be given appropriate weight in determining whether one skilled in the art would find the asserted utility credible. Office personnel should evaluate not only the existence of the structural relationship, but also the reasoning used by the applicant or a declarant to explain why that structural similarity is believed to be relevant to the applicant's assertion of utility.

III.DATA FROM IN VITRO OR ANIMAL TESTING IS GENERALLY SUFFICIENT TO SUPPORT THERAPEUTIC UTILITY

If reasonably correlated to the particular therapeutic or pharmacological utility, data generated using in vitro assays, or from testing in an animal model or a combination thereof almost invariably will be sufficient to establish therapeutic or pharmacological utility for a compound, composition or process.

A cursory review of cases involving therapeutic inventions where 35 U.S.C. 101 was the dispositive issue illustrates the fact that the Federal courts are not particularly receptive to rejections under 35 U.S.C. 101 based on inoperability.

Most striking is the fact that in those cases where an applicant supplied a reasonable evidentiary showing supporting an asserted therapeutic utility, almost uniformly the 35 U.S.C. 101-based rejection was reversed.

Only in those cases where the applicant was unable to come forward with any relevant evidence to rebut a finding by the Office that the claimed invention was inoperative was a 35 U.S.C. 101 rejection affirmed by the court.

In re Citron, 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963) (therapeutic utility for an uncharacterized biological extract not supported or scientifically credible);

In re Buting, 418 F.2d 540, 543, 163 USPQ 689, 690 (CCPA 1969) (record did not establish a credible basis for the assertion that the single class of compounds in question would be useful in treating disparate types of cancers);

In re Novak, 306 F.2d 924, 134 USPQ 335 (CCPA 1962) (claimed compounds did not have capacity to effect physiological activity upon which utility claim based).

Contrast, however, In re Buting to In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973), reh'g denied, 480 F.2d 879 (CCPA 1973), in which the court held that utility for a genus was found to be supported through a showing of utility for one species. In no case has a Federal court required an applicant to support an asserted utility with data from human clinical trials.

If an applicant provides data, whether from in vitroassays or animal tests or both, to support an asserted utility, and an explanation of why that data supports the asserted utility, the Office will determine if the data and the explanation would be viewed by one skilled in the art as being reasonably predictive of the asserted utility.

Office personnel must be careful to evaluate all factors that might influence the conclusions of a person of ordinary skill in the art as to this question, including the test parameters, choice of animal, relationship of the activity to the particular disorder to be treated, characteristics of the compound or composition, relative significance of the data provided and,

most importantly, the explanation offered by the applicant as to why the information provided is believed to support the asserted utility. If the data supplied is consistent with the asserted utility, the Office cannot maintain a rejection under 35 U.S.C. 101.

Evidence does not have to be in the form of data from an art-recognized animal model for the particular disease or disease condition to which the asserted utility relates. Data from any test that the applicant reasonably correlates to the asserted utility should be evaluated substantively. Thus, an applicant may provide data generated using a particular animal model with an appropriate explanation as to why that data supports the asserted utility. The absence of a certification that the test in question is an industry- accepted model is not dispositive of whether data from an animal model is in fact relevant to the asserted utility. Thus, if one skilled in the art would accept the animal tests as being reasonably predictive

of utility in humans, evidence from those tests should be considered sufficient to support the credibility of the asserted utility.

Office personnel should be careful not to find evidence unpersuasive simply because no animal model for the human disease condition had been established prior to the filing of the application.


IV.HUMAN CLINICAL DATA

Office personnel should not impose on applicants the unnecessary burden of providing evidence from human clinical trials. There is no decisional law that requires an applicant to provide data from human clinical trials to establish utility for an invention related to treatment of human disorders (see In re Isaacs, even with respect to situations where no art- recognized animal models existed for the human disease encompassed by the claims.

Before a drug can enter human clinical trials, the sponsor, often the applicant, must provide a convincing rationale to those especially skilled in the art (e.g., the Food and Drug Administration) that the investigation may be successful. Such a rationale would provide a basis for the sponsor’s expectation that the investigation may be successful. In order to determine a protocol for phase I testing, the first phase of clinical investigation, some credible rationale of how the drug might be effective or could be effective would be necessary. Thus, as a general rule, if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility.

V.SAFETY AND EFFICACY CONSIDERA- TIONS

The Office must confine its review of patent applications to the statutory requirements of the patent law. Other agencies of the government have been assigned the responsibility of ensuring conformance to standards established by statute for the advertisement, use, sale or distribution of drugs. The FDA pursues a two-prong test to provide approval for testing. Under that test, a sponsor must show that the investigation does not pose an unreasonable and significant risk of illness or injury and that there is an acceptable rationale for the study. As a review matter, there must be a rationale for believing that the compound could be effective. If the use reviewed by the FDA is not set forth in the specification, FDA review may not satisfy 35 U.S.C. 101. However, if the reviewed use is one set forth in the specification, Office personnel must be extremely hesitant to challenge utility. In such a situation, experts at the FDA have assessed the rationale for the drug or research study upon which an asserted utility is based and found it satisfactory. Thus, in challenging utility, Office personnel must be able to carry their burden that there is no sound rationale for the asserted utility even though experts designated by Congress to decide the issue have come to an opposite conclusion. “FDA approval, however, is not a prerequisite for finding a compound useful within the meaning of the patent laws.



Thus, while an applicant may on occasion need to provide evidence to show that an invention will work as claimed, it is improper for Office personnel to request evidence of safety in the treatment of humans, or regarding the degree of effectiveness.

VI.TREATMENT OF SPECIFIC DISEASE CONDITIONS

Claims directed to a method of treating or curing a disease for which there have been no previously successful treatments or cures warrant careful review for compliance with 35 U.S.C. 101. The credibility of an asserted utility for treating a human disorder may be more difficult to establish where current scientific understanding suggests that such a task would be impossible. Such a determination has always required a good understanding of the state of the art as of the time that the invention was made. For example, prior to the 1980’s, there were a number of cases where an asserted use in treating cancer in humans was viewed as “incredible.”

The fact that there is no known cure for a disease, however, cannot serve as the basis for a conclusion that such an invention lacks utility. Rather, Office personnel must determine if the asserted utility for the invention is credible based on the information disclosed in the application. Only those claims for which an asserted utility is not credible should be rejected. In such cases, the Office should carefully review what is being claimed by the applicant. An assertion that the claimed invention is useful in treating a symptom of an incurable disease may be considered credible by a person of ordinary skill in the art on the basis of a fairly modest amount of evidence or support. In contrast, an assertion that the claimed invention will be useful in “curing” the disease may require a significantly greater amount of evidentiary support to be considered credible by a person of ordinary skill in the art.

In these cases, it is important to note that the Food and Drug Administration has promulgated regulations that enable a party to conduct clinical trials for drugs used to treat life threatening and severely-debilitating illnesses, even where no alternative therapy exists.

Implicit in these regulations is the recognition that experts qualified to evaluate the effectiveness of therapeutics can and often do find a sufficient basis to conduct clinical trials of drugs for incurable or previously untreatable illnesses. Thus, affidavit evidence from experts in the art indicating that there is a reasonable expectation of success, supported by sound reasoning, usually should be sufficient to establish that such a utility is credible.


2111 Claim Interpretation; Broadest Reasonable Interpretation[edit | edit source]

CLAIMS MUST BE GIVEN THEIR BROADEST REASONABLE INTERPRETATION

During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification.

The Patent and Trademark Office (“PTO”) determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art.

Indeed, the rules of the PTO require that application claims must “conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.

Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified.

In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969)

Claim 9 was directed to a process of analyzing data generated by mass spectrographic analysis of a gas. The process comprised selecting the data to be analyzed by subjecting the data to a mathematical manipulation. The examiner made rejections under 35 U.S.C. 101 and 102. In the 35 U.S.C. 102 rejection, the examiner explained that the claim was anticipated by a mental process augmented by pencil and paper markings. The court agreed that the claim was not limited to using a machine to carry out the process since the claim did not explicitly set forth the machine. The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim..

In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997) .The court held that the PTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the “PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.

The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach.

In re Cortright, 165 F.3d 1353, 1359, 49 USPQ2d 1464, 1468 (Fed. Cir. 1999).

The Board’s construction of the claim limitation “restore hair growth” as requiring the hair to be returned to its original state was held to be an incorrect interpretation of the limitation. The court held that, consistent with applicant’s disclosure and the disclosure of three patents from analogous arts using the same phrase to require only some increase in hair growth, one of ordinary skill would construe “restore hair growth” to mean that the claimed method increases the amount of hair grown on the scalp, but does not necessarily produce a full head of hair.

2111.01 Plain Meaning[edit | edit source]

I.THE WORDS OF A CLAIM MUST BE GIVEN THEIR “PLAIN MEANING” UNLESS SUCH MEANING IS INCONSISTENT WITH THE SPECIFICATION

Although claims of issued patents are interpreted in light of the specification, prosecution history, prior art and other claims, this is not the mode of claim interpretation to be applied during examination. During examination, the claims must be interpreted as broadly as their terms reasonably allow.

The words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the specification.

Ordinary, simple English words whose meaning is clear and unquestionable, absent any indication that their use in a particular context changes their meaning, are construed to mean exactly what they say. Thus, “heating the resulting batter-coated dough to a temperature in the range of about 400oF to 850oF” required heating the dough, rather than the air inside an oven, to the specified temperature.

II.IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION

Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim.

For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.

In Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004)

The court expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.

E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) :

Interpretation of descriptive statements in a patent’s written description is a difficult task, as an inherent tension exists as to whether a statement is a clear lexicographic definition or a description of a preferred embodiment. The problem is to interpret claims ‘in view of the specification’ without unnecessarily importing limitations from the specification into the claims.

Altiris Inc. v. Symantec Corp., 318 F.3d 1363, 1371, 65 USPQ2d 1865, 1869-70 (Fed. Cir. 2003):

Although the specification discussed only a single embodiment, the court held that it was improper to read a specific order of steps into method claims where, as a matter of logic or grammar, the language of the method claims did not impose a specific order on the performance of the method steps, and the specification did not directly or implicitly require a particular order.

The specification must be consulted to determine the structure, material, or acts corresponding to the function recited in the claim.

In In re Zletz, supra, the examiner and the Board had interpreted claims reading “normally solid polypropylene” and “normally solid polypropylene having a crystalline polypropylene content” as being limited to “normally solid linear high homopolymers of propylene which have a crystalline polypropylene content.” The court ruled that limitations, not present in the claims, were improperly imported from the specification.

In re Weiss, 989 F.2d 1202, 26 USPQ2d 1885 (Fed. Cir. 1993):

The claim related to an athletic shoe with cleats that “break away at a preselected level of force” and thus prevent injury to the wearer. The examiner rejected the claims over prior art teaching athletic shoes with cleats not intended to break off and rationalized that the cleats would break away given a high enough force.

The court reversed the rejection stating that when interpreting a claim term which is ambiguous, such as “a preselected level of force”, we must look to the specification for the meaning ascribed to that term by the inventor.” The specification had defined “preselected level of force” as that level of force at which the breaking away will prevent injury to the wearer during athletic exertion.

III.“PLAIN MEANING” REFERS TO THE ORDINARY AND CUSTOMARY MEAN- ING GIVEN TO THE TERM BY THOSE OF ORDINARY SKILL IN THE ART

The ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.”

In the absence of an express intent to impart a novel meaning to the claim terms, the words are presumed to take on the ordinary and customary meanings attributed to them by those of ordinary skill in the art.

It is the use of the words in the context of the written description and customarily by those skilled in the relevant art that accurately reflects both the “ordinary” and the “customary” meaning of the terms in the claims.

In construing claim terms, the general meanings gleaned from reference sources, such as dictionaries, must always be compared against the use of the terms in context, and the intrinsic record must always be consulted to identify which of the different possible dictionary meanings is most consistent with the use of the words by the inventor.

ACTV, Inc. v. The Walt Disney Company, 346 F.3d 1082, 1092, 68 USPQ2d 1516, 1524 (Fed. Cir. 2003)

Since there was no express definition given for the term “URL” in the specification, the term should be given its broadest reasonable interpretation consistent with the intrinsic record and take on the ordinary and customary meaning attributed to it by those of ordinary skill in the art; thus, the term “URL” was held to encompass both relative and absolute URLs.

E-Pass Technologies, Inc. v. 3Com Corporation, 343 F.3d 1364, 1368, 67 USPQ2d 1947, 1949 (Fed. Cir. 2003)

Where no explicit definition for the term “electronic multi-function card” was given in the specification, this term should be given its ordinary meaning and broadest reasonable interpretation; the term should not be limited to the industry standard definition of credit card where there is no suggestion that this definition applies to the electronic multi-function card as claimed, and should not be limited to preferred embodiments in the specification.

The ordinary and customary meaning of a term may be evidenced by a variety of sources, including “the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.”

If extrinsic reference sources, such as dictionaries, evidence more than one definition for the term, the intrinsic record must be consulted to identify which of the different possible definitions is most consistent with applicant’s use of the terms.

Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.

Words in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.

In MSM Investments Co. v. Carolwood Corp., 259 F.3d 1335, 1339-40, 59 USPQ2d 1856, 1859-60 (Fed. Cir. 2001)

Claims directed to a method of feeding an animal a beneficial amount of methylsulfonylmethane (MSM) to enhance the animal’s diet were held anticipated by prior oral administration of MSM to human patients to relieve pain. Although the ordinary meaning of “feeding” is limited to provision of food or nourishment, the broad definition of “food” in the written description warranted finding that the claimed method encompasses the use of MSM for both nutritional and pharmacological purposes.


IV. APPLICANT MAY BE OWN LEXICOGRAPHER

An applicant is entitled to be his or her own lexicographer and may rebut the presumption that claim terms are to be given their ordinary and customary meaning by clearly setting forth a definition of the term that is different from its ordinary and customary meaning(s).

Inventor may define specific terms used to describe invention, but must do so with reasonable clarity, deliberateness, and precision and, if done, must set out his uncommon definition in some manner within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change in meaning.

Meaning of words used in a claim is not construed in a “lexicographic vacuum, but in the context of the specification and drawings. Any special meaning assigned to a term “must be sufficiently clear in the specification that any departure from common usage would be so understood by a person of experience in the field of the invention.”

The specification should also be relied on for more than just explicit lexicography or clear disavowal of claim scope to determine the meaning of a claim term when applicant acts as his or her own lexicographer; the meaning of a particular claim term may be defined by implication, that is, according to the usage of the term in the context in the specification.

When a patentee acts as his own lexicographer in redefining the meaning of particular claim terms away from their ordinary meaning, he must clearly express that intent in the written description.

See also MPEP § 2173.05(a).

2111.02 Effect of Preamble[edit | edit source]

The determination of whether a preamble limits a claim is made on a case-by-case basis in light of the facts in each case; there is no litmus test defining when a preamble limits the scope of a claim.


If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim.

In Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003)

In considering the effect of the preamble in a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to “a human in need thereof,” the court held that the claims’ recitation of a patient or a human “in need” gives life and meaning to the preamble’s statement of purpose.

Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)

A preamble reciting “An abrasive article” was deemed essential to point out the invention defined by claims to an article comprising abrasive grains and a hardened binder and the process of making it. The court stated “it is only by that phrase that it can be known that the subject matter defined by the claims is comprised as an abrasive article. Every union of substances capable inter alia of use as abrasive grains and a binder is not an ‘abrasive article.’” Therefore, the preamble served to further define the structure of the article produced.

I. PREAMBLE STATEMENTS LIMITING STRUCTURE

Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation.

The determination of whether preamble recitations are structural limitations can be resolved only on review of the entirety of the application to gain an understanding of what the inventors actually invented and intended to encompass by the claim.

Determining that preamble language that constitutes a structural limitation is actually part of the claimed invention.

In re Stencel, 828 F.2d 751, 4 USPQ2d 1071 (Fed. Cir. 1987).

The claim at issue was directed to a driver for setting a joint of a threaded collar; however, the body of the claim did not directly include the structure of the collar as part of the claimed article. The examiner did not consider the preamble, which did set forth the structure of the collar, as limiting the claim. The court found that the collar structure could not be ignored. While the claim was not directly limited to the collar, the collar structure recited in the preamble did limit the structure of the driver.

The framework - the teachings of the prior art - against which patentability is measured is not all drivers broadly, but drivers suitable for use in combination with this collar, for the claims are so limited.

II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE

The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use “can be resolved only on review of the entirety of the record to gain an understanding of what the inventors actually invented and intended to encompass by the claim.”

Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966.

If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.

Preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim.

Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003)

In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to “a human in need thereof,” the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.

In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002)

A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase “rich in glucosinolates” helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently “rich in glucosinolates).

During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.

See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963)

The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. Court held that the intended use of hair curling was of no significance to the structure and process of making.


In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962)

Statement of intended use in an apparatus claim did not distinguish over the prior art apparatus. If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim.

See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)

Anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.

However, a preamble may provide context for claim construction, particularly, where … that preamble’s statement of intended use forms the basis for distinguishing the prior art in the patent’s prosecution history.

Metabolite Labs., Inc. v. Corp. of Am. Holdings, 370 F.3d 1354, 1358-62, 71 USPQ2d 1081, 1084-87 (Fed. Cir. 2004).


The patent claim at issue was directed to a two-step method for detecting a deficiency of vitamin B12 or folic acid, involving (i) assaying a body fluid for an “elevated level” of homocysteine, and (ii) “correlating” an “elevated” level with a vitamin deficiency.

The court stated that the disputed claim term “correlating” can include comparing with either an unelevated level or elevated level, as opposed to only an elevated level because adding the “correlating” step in the claim during prosecution to overcome prior art tied the preamble directly to the “correlating” step. The recitation of the intended use of “detecting” a vitamin deficiency in the preamble rendered the claimed invention a method for “detecting,” and, thus, was not limited to detecting “elevated” levels. Id.

2111.03 Transitional Phrases[edit | edit source]

The transitional phrases “comprising”, “consisting essentially of” and “consisting of” define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim.

The transitional terms: 1- “Comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.

“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.

In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.”

In contrast, the court noted the phrase “group consisting of” is a closed term, which is often used in claim drafting to signal a “Markush group” that is by its nature closed.

The court also emphasized that reference to “first,” “second,” and “third” blades in the claim was not used to show a serial or numerical limitation but instead was used to distinguish or identify the various members of the group. Id.

2- The transitional phrase “consisting of” excludes any element, step, or ingredient not specified in the claim.

But see Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331-32, 70 USPQ2d 1508, 1516 (Fed. Cir. 2004) (holding that a bone repair kit “consisting of” claimed chemicals was infringed by a bone repair kit including a spatula in addition to the claimed chemicals because the presence of the spatula was unrelated to the claimed invention). A claim which depends from a claim which “consists of” the recited elements or steps cannot add an element or step. When the phrase “consists of” appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole.


3- The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention.

“A ‘consisting essentially of’ claim occupies a middle ground between closed claims that are written in a ‘consisting of’ format and fully open claims that are drafted in a ‘comprising’ format.”

For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.”


OTHER TRANSITIONAL PHRASES

Transitional phrases such as “having” must be interpreted in light of the specification to determine whether open or closed claim language is intended.

See, e.g., Lampi Corp. v. American Power Products Inc., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453 (Fed. Cir. 2000)

The term “having” was interpreted as open terminology, allowing the inclusion of other components in addition to those recited;


The transitional phrase “composed of” has been interpreted in the same manner as either “consisting of” or “consisting essentially of,” depending on the facts of the particular case.

In re Bertsch, 132 F.2d 1014, 1019- 20, 56 USPQ 379, 384 (CCPA 1942)

Composed of interpreted in same manner as “consisting of”; however, court further remarked that “the words ‘composed of’ may under certain circumstances be given, in patent law, a broader meaning than ‘consisting of.

2111.04 "Adapted to," "Adapted for," "Wherein," and "Whereby" Clauses[edit | edit source]

Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:

(A)“adapted to” or “adapted for” clauses;

(B)“wherein” clauses; and

(C)“whereby” clauses.

The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’”


2112 Requirements of Rejection Based on Inherency; Burden of Proof[edit | edit source]

The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103.

I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY

The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.

Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.

In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.

II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION

There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.

Schering Corp.v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d1664, 1668 (Fed. Cir. 2003)

Rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency;

Toro Co.v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584,1590 (Fed. Cir. 2004)

The fact that a characteristic is a necessary feature or result of a prior-art embodiment that is itself sufficiently described and enabled is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.

Abbott Labs v.Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d1307, 1310 (Fed.Cir.1999)

If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics.

III. A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC

Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection.


This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.

IV. EXAMINER MUST PROVIDE RATIONALE OR EVIDENCE TENDING TO SHOW INHERENCY

The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic.

To establish inherency, the extrinsic evidence 'must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.

Also, an invitation to investigate is not an inherent disclosure” where a prior art reference “discloses no more than a broad genus of potential applications of its discoveries.”

In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art.

V. ONCE A REFERENCE TEACHING PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS MADE THE BASIS OF A REJECTION, AND THE EXAMINER PRESENTS EVIDENCE OR REASONING TENDING TO SHOW INHERENCY, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN UN-OBVIOUS DIFFERENCE

The PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.

The burden of proof is similar to that required with respect to product-by-process claims. I


2112.01 Composition, Product, and Apparatus Claims[edit | edit source]

I. PRODUCT AND APPARATUS CLAIMS — WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT

Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.

When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.

The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product.

In Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985):

Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9%Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.

In re Ludtke, 441 F.2d 660, 169 USPQ 563(CCPA 1971)

Claim 1 was directed to a parachute canopy having concentric circumferential panels radially separated from each other by radially extending tie lines.The panels were separated “such that the critical velocity of each successively larger panel will be less than the critical velocity of the previous panel, whereby said parachute will sequentially open and thus gradually decelerate.” The court found that the claim was anticipated by Menget. Menget taught a parachute having three circumferential panels separated by tie lines. The court upheld the rejection finding that applicant had failed to show that Menget did not possess the functional characteristics of the claims.);

Northam WarrenCorp. v. D. F. Newfield Co., 7 F. Supp . 773, 22 USPQ313 (E.D.N.Y. 1934)

A patent to a pencil for cleaning fingernails was held invalid because a pencil of the same structure for writing was found in the prior art.

II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES

“Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.

III. PRODUCT CLAIMS – NONFUNCTIONAL PRINTED MATTER DOES NOT DISTINGUISH CLAIMED PRODUCT FROM OTHERWISE IDENTICAL PRIOR ART PRODUCT

Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.

2112.02 Process Claims[edit | edit source]

PROCESS CLAIMS — PRIOR ART DEVICE ANTICIPATES A CLAIMED PROCESS IF THE DEVICE CARRIES OUT THE PROCESS DURING NORMAL OPERATION

Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.

Sample Cases:

In re King, 801 F.2d 1324, 231 USPQ136 (Fed. Cir. 1986)

The claims were directed to a method of enhancing color effects produced by ambient light through a process of absorption and reflection of the light off a coated substrate. A prior art reference to Donley disclosed a glass substrate coated with silver and metal oxide 200-800 angstroms thick. While Donley disclosed using the coated substrate to produce architectural colors, the absorption and reflection mechanisms of the claimed process were not disclosed.However, King’s specification disclosed using a coated substrate of Donley’s structure for use in his process. TheFederal Circuit upheld the Board’s finding that “Donley inherently performs the function disclosed in the method claims on appeal when that device is used in ‘normal and usual operation’ ” and found that a prima facie case of anticipation was made out.

It was up to applicant to prove that Donley's structure would not perform the claimed method when placed in ambient light.

In re Best, 562 F.2d 1252, 1255,195 USPQ 430, 433 (CCPA 1977)

Applicant claimed a process for preparing a hydrolytically-stable zeoliticaluminosilicate which included a step of “cooling the steam zeolite ... at a rate sufficiently rapid that the cooled zeolite exhibits a X-ray diffraction pattern ....” All the process limitations were expressly disclosed by a U.S.patent to Hansford except the cooling step. The court stated that any sample of Hansford’s zeolite would necessarily be cooled to facilitate subsequent handling.Therefore, a prima facie case under 35 U.S.C. 102/103 was made. Applicant had failed to introduce any evidence comparing X-ray diffraction patterns showing a difference in cooling rate between the claimed process and that of Hansford or any data showing that the process of Hansford would result in a product with a different X-ray diffraction. Either type of evidence would have rebutted the prima facie case under 35 U.S.C. 102. A further analysis would be necessary to determine if the process

PROCESS OF USE CLAIMS — NEW AND UNOBVIOUS USES OF OLD STRUCTURES AND COMPOSITIONS MAY BE PATENTABLE

The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated.



2113 Product-by-Process Claims[edit | edit source]

PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS[edit | edit source]

Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.

In the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. A product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim.

The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.

ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A 35 U.S.C. 102/103 REJECTION MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN UNOBVIOUS DIFFERENCE[edit | edit source]

"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product.

THE USE OF 35 U.S.C. 102/103 REJECTIONS FOR PRODUCT-BY-PROCESS CLAIMS HAS BEEN APPROVED BY THE COURTS[edit | edit source]

The lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. . . . when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable."



2114 Apparatus and Article Claims —Functional Language[edit | edit source]

For a discussion of case law which provides guidance in interpreting the functional portion of means- plus-function limitations see MPEP § 2181 - § 2186.

APPARATUS CLAIMS MUST BE STRUCTUR- ALLY DISTINGUISHABLE FROM THE PRIOR ART

While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).

MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART

A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was “for mixing flowing developer material” and the body of the claim recited “means for mixing ..., said mixing means being stationary and completely submerged in the developer material”. The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).

A PRIOR ART DEVICE CAN PERFORM ALL THE FUNCTIONS OF THE APPARATUS CLAIM AND STILL NOT ANTICIPATE THE CLAIM

Even if the prior art device performs all the functions recited in the claim, the prior art cannot anticipate the claim if there is any structural difference. It should be noted, however, that means plus function limitations are met by structures which are equivalent to the corresponding structures recited in the specification. In re Ruskin, 347 F.2d 843, 146 USPQ 211 (CCPA 1965) as implicitly modified by In re Donaldson, 16 F.3d 1189, 29 USPQ2d 1845 (Fed. Cir. 1994). See also In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1951 (Fed. Cir. 1999) (The claims were drawn to a disposable diaper having three fastening elements. The reference disclosed two fastening elements that could perform the same function as the three fastening elements in the claims. The court construed the claims to require three separate elements and held that the reference did not disclose a separate third fastening element, either expressly or inherently.).


2115 Material or Article Worked Upon by Apparatus[edit | edit source]

MATERIAL OR ARTICLE WORKED UPON DOES NOT LIMIT APPARATUS CLAIMS

“Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)).

In In re Young, a claim to a machine for making concrete beams included a limitation to the concrete reinforced members made by the machine as well as the structural elements of the machine itself. The court held that the inclusion of the article formed within the body of the claim did not, without more, make the claim patentable.

In In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967), an apparatus claim recited “[a] taping machine comprising a supporting structure, a brush attached to said supporting structure, said brush being formed with projecting bristles which terminate in free ends to collectively define a surface to which adhesive tape will detachably adhere, and means for providing relative motion between said brush and said supporting structure while said adhesive tape is adhered to said surface.” An obviousness rejection was made over a reference to Kienzle which taught a machine for perforating sheets. The court upheld the rejection stating that “the references in claim 1 to adhesive tape handling do not expressly or impliedly require any particular structure in addition to that of Kienzle.” The perforating device had the structure of the taping device as claimed, the difference was in the use of the device, and “the manner or method in which such machine is to be utilized is not germane to the issue of patentability of the machine itself.”

Note that this line of cases is limited to claims directed to machinery which works upon an article or material in its intended use. It does not apply to product claims or kit claims (i.e., claims directed to a plurality of articles grouped together as a kit).


2116 Material Manipulated in Process[edit | edit source]

The materials on which a process is carried out must be accorded weight in determining the patentability of a process.

2116.01 Novel, Unobvious Starting Material or End Product[edit | edit source]

All the limitations of a claim must be considered when weighing the differences between the claimed invention and the prior art in determining the obviousness of a process or method claim. See MPEP § 2143.03.

The Federal Circuit has held that the use of per se rules is improper in applying the test for obviousness under 35 U.S.C. 103. Rather, 35 U.S.C. 103 requires a highly fact-dependent analysis involving taking the claimed subject matter as a whole and comparing it to the prior art.

To support a rejection under 35 U.S.C. 103, the collective teachings of the prior art must have suggested to one of ordinary skill in the art that, at the time the invention was made, applicant’s claimed invention would have been obvious.

Interpreting the claimed invention as a whole requires consideration of all claim limitations. Thus, proper claim construction requires treating language in a process claim which recites the making or using of a nonobvious product as a material limitation. Motivation to make or use the nonobvious product must be present in the prior art for a 35 U.S.C. 103 rejection to be sustained.

Obviousness must be assessed on a case-by-case basis. The following decisions are illustrative of the lack of per se rules in applying the test for obviousness under 35 U.S.C. 103 and of the fact-intensive comparison of claimed processes with the prior art:

  • In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985) (The examiner rejected a claim directed to a process in which patentable starting materials were reacted to form patentable end products. The prior art showed the same chemical reaction mechanism applied to other chemicals. The court held that the process claim was obvious over the prior art.);
  • In re Albertson, 332 F.2d 379, 141 USPQ 730 (CCPA 1964) (Process of chemically reducing one novel, nonobvious material to obtain another novel, nonobvious material was claimed. The process was held obvious because the reduction reaction was old.);
  • In re Kanter, 399 F.2d 249, 158 USPQ 331 (CCPA 1968) (Process of siliconizing a patentable base material to obtain a patentable product was claimed. Rejection based on prior art teaching the siliconizing process as applied to a different base material was upheld.);
  • Cf. In re Pleuddemann, 910 F.2d 823, 15 USPQ2d 1738 (Fed. Cir. 1990) (Methods of bonding polymer and filler using a novel silane coupling agent held patentable even though methods of bonding using other silane coupling agents were well known because the process could not be conducted without the new agent);
  • In re Kuehl, 475 F.2d 658, 177 USPQ 250 (CCPA 1973) (Process of cracking hydrocarbons using novel zeolite catalyst found to be patentable even though catalytic cracking process was old. “The test under 103 is whether in view of the prior art the invention as a whole would have been obvious at the time it was made, and the prior art here does not include the zeolite, ZK-22. The obviousness of the process of cracking hydrocarbons with ZK-22 as a catalyst must be determined without reference to knowledge of ZK-22 and its properties.” 475 F.2d at 664-665, 177 USPQ at 255.); and
  • In re Mancy, 499 F.2d 1289, 182 USPQ 303 (CCPA 1974) (Claim to a process for the production of a known antibiotic by cultivating a novel, unobvious microorganism was found to be patentable.).



2121 Prior Art; General Level of Operability Required to Make a Prima Facie Case[edit | edit source]

PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING[edit | edit source]

When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07.

WHAT CONSTITUTES AN "ENABLING DISCLOSURE" DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE DISCLOSURE IS CONTAINED IN[edit | edit source]

The level of disclosure required within a reference to make it an "enabling disclosure" is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. There is no basis in the statute (35 U.S.C. 102 or 103) for discriminating either in favor of or against prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).

2121.01 Use of Prior Art in Rejections Where Operability Is in Question[edit | edit source]

“In determining that quantum of prior art disclosure which is necessary to declare an applicant’s invention ‘not novel’ or ‘anticipated’ within section 102, the stated test is whether a reference contains an ‘enabling disclosure’... .” In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968). The disclosure in an assertedly anticipating reference must provide an enabling disclosure of the desired subject matter; mere naming or description of the subject matter is insufficient, if it cannot be produced without undue experimentation. Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346 F.3d 1051, 1054, 68 USPQ2d 1373, 1376 (Fed. Cir. 2003) (At issue was whether a prior art reference enabled one of ordinary skill in the art to produce Elan’s claimed transgenic mouse without undue experimentation. Without a disclosure enabling one skilled in the art to produce a transgenic mouse without undue experimentation, the reference would not be applicable as prior art.). A reference contains an “enabling disclosure” if the public was in possession of the claimed invention before the date of invention. “Such possession is effected if one of ordinary skill in the art could have combined the publication’s description of the invention with his [or her] own knowledge to make the claimed invention.” In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).

I. 35 U.S.C. 102 REJECTIONS AND ADDITION OF EVIDENCE SHOWING REFERENCE IS OPERABLE[edit | edit source]

It is possible to make a 35 U.S.C. 102 rejection even if the reference does not itself teach one of ordinary skill how to practice the invention, i.e., how to make or use the article disclosed. If the reference teaches every claimed element of the article, secondary evidence, such as other patents or publications, can be cited to show public possession of the method of making and/or using. In re Donohue, 766 F.2d at 533, 226 USPQ at 621. See MPEP § 2131.01 for more information on 35 U.S.C. 102 rejections using secondary references to show that the primary reference contains an “enabling disclosure.”

II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART[edit | edit source]

“Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.” Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991).

2121.02 Compounds and Compositions — What Constitutes Enabling Prior Art[edit | edit source]

I. ONE OF ORDINARY SKILL IN THE ART MUST BE ABLE TO MAKE OR SYNTHESIZE[edit | edit source]

Where a process for making the compound is not developed until after the date of invention, the mere naming of a compound in a reference, without more, cannot constitute a description of the compound. In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968). Note, however, that a reference is presumed operable until applicant provides facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Therefore, applicant must provide evidence showing that a process for making was not known at the time of the invention. See the following paragraph for the evidentiary standard to be applied.

II. A REFERENCE DOES NOT CONTAIN AN “ENABLING DISCLOSURE” IF ATTEMPTS AT MAKING THE COMPOUND OR COMPOSITION WERE UNSUCCESSFUL BEFORE THE DATE OF INVENTION[edit | edit source]

When a prior art reference merely discloses the structure of the claimed compound, evidence showing that attempts to prepare that compound were unsuccessful before the date of invention will be adequate to show inoperability. In re Wiggins, 488 F.2d 538, 179 USPQ 421 (CCPA 1971). However, the fact that an author of a publication did not attempt to make the compound disclosed, without more, will not overcome a rejection based on that publication. In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (In this case, the examiner had made a rejection under 35 U.S.C. 102(b) over a publication, which disclosed the claimed compound, in combination with two patents teaching a general process of making the particular class of compounds. The applicant submitted an affidavit stating that the authors of the publication had not actually synthesized the compound. The court held that the fact that the publication’s author did not synthesize the disclosed compound was immaterial to the question of reference operability. The patents were evidence that synthesis methods were well known. The court distinguished Wiggins, in which a very similar rejection was reversed. In Wiggins, attempts to make the compounds using the prior art methods were all unsuccessful.). Compare In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968) (A claim to a compound was rejected over a patent to De Boer which disclosed compounds similar in structure to those claimed (obvious homologs) and a process of making these compounds. Applicant responded with an affidavit by an expert named Wiley which stated that there was no indication in the De Boer patent that the process disclosed in De Boercould be used to produce the claimed compound and that he did not believe that the process disclosed in De Boer could be adapted to the production of the claimed compound. The court held that the facts stated in this affidavit were legally sufficient to over come the rejection and that applicant need not show that all known processes are incapable of producing the claimed compound for this showing would be practically impossible.).

2121.03 Plant Genetics — What Constitutes Enabling Prior Art[edit | edit source]

THOSE OF ORDINARY SKILL MUST BE ABLE TO GROW AND CULTIVATE THE PLANT[edit | edit source]

When the claims are drawn to plants, the reference, combined with knowledge in the prior art, must enable one of ordinary skill in the art to reproduce the plant. In re LeGrice, 301 F.2d 929, 133 USPQ 365 (CCPA 1962) (National Rose Society Annual of England and various other catalogues showed color pictures of the claimed roses and disclosed that applicant had raised the roses. The publications were published more than 1 year before applicant's filing date. The court held that the publications did not place the rose in the public domain. Information on the grafting process required to reproduce the rose was not included in the publications and such information was necessary for those of ordinary skill in the art (plant breeders) to reproduce the rose.). Compare Ex parteThomson, 24 USPQ2d 1618 (Bd. Pat. App. & Inter. 1992) (Seeds were commercially available more than 1 year prior to applicant’s filing date. One of ordinary skill in the art could grow the claimed cotton cultivar from the commercially available seeds. Thus, the publications describing the cotton cultivar had “enabled disclosures.” The Board distinguished In re LeGriceby finding that the catalogue picture of the rose of In re LeGrice was the only evidence in that case. There was no evidence of commercial availability in enabling form since the asexually reproduced rose could not be reproduced from seed. Therefore, the public would not have possession of the rose by its picture alone, but the public would have possession of the cotton cultivar based on the publications and the availability of the seeds.).

In In re Elsner, 381 F.3d 1125, 1126, 72 USPQ2d 1038, 1040 (Fed. Cir. 2004), prior to the critical date of a plant patent application, the plant had been sold in Germany and a foreign Plant Breeder’s Rights (PBR) application for the same plant had been published in the Community Plant Variety Office Official Gazette. The court held that when (i) a publication identifies claimed the plant, (ii) a foreign sale occurs that puts one of ordinary skill in the art in possession of the plant itself, and (iii) such possession permits asexual reproduction of the plant without undue experimentation to one of ordinary skill in the art, then that combination of facts and events directly conveys the essential knowledge of the invention and constitutes a 35 U.S.C. 102(b) statutory bar. 381 F.3d at 1129, 72 USPQ2d at 1041. Although the court agreed with the Board that foreign sales may enable an otherwise non-enabling printed publication, the case was remanded for additional fact-finding in order to determine if the foreign sales of the plant were known to be accessible to the skilled artisan and if the skilled artisan could have reproduced the plant asexually after obtaining it without undue experimentation. 381 F.3d at 1131, 72 USPQ2d at 1043.

2121.04 Apparatus and Articles — What Constitutes Enabling Prior Art[edit | edit source]

PICTURES MAY CONSTITUTE AN "ENABLING DISCLOSURE"[edit | edit source]

Pictures and drawings may be sufficiently enabling to put the public in the possession of the article pictured. Therefore, such an enabling picture may be used to reject claims to the article. However, the picture must show all the claimed structural features and how they are put together. Jockmus v. Leviton, 28 F.2d 812 (2d Cir. 1928). See also MPEP § 2125 for a discussion of drawings as prior art.



2122 Discussion of Utility in the Prior Art[edit | edit source]

UTILITY NEED NOT BE DISCLOSED IN REF- ERENCE

In order to constitute anticipatory prior art, a reference must identically disclose the claimed compound, but no utility need be disclosed by the reference. In reSchoenwald, 964 F.2d 1122, 22 USPQ2d 1671 (Fed. Cir. 1992) (The application claimed compounds used in ophthalmic compositions to treat dry eye syndrome. The examiner found a printed publication which disclosed the claimed compound but did not disclose a use for the compound. The court found that the claim was anticipated since the compound and a process of making it was taught by the reference. The court explained that “no utility need be disclosed for a reference to be anticipatory of a claim to an old compound.” 964 F.2d at 1124, 22 USPQ2d at 1673. It is enough that the claimed compound is taught by the reference.).


2123 Rejection Over Prior Art's Broad Disclosure Instead of Preferred Embodiments[edit | edit source]

I. PATENTS ARE RELEVANT AS PRIOR ART FOR ALL THEY CONTAIN[edit | edit source]

The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.

A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments.

See also MPEP § 2131.05 and § 2145, subsection X.D., which discuss prior art that teaches away from the claimed invention in the context of anticipation and obviousness, respectively.

II. NONPREFERRED AND ALTERNATIVE EMBODIMENTS CONSTITUTE PRIOR ART[edit | edit source]

Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.

Furthermore, a prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.



2124 Exception to the Rule That the Critical Reference Date Must Precede the Filing Date[edit | edit source]

IN SOME CIRCUMSTANCES A FACTUAL REFERENCE NEED NOT ANTEDATE THE FILING DATE

In certain circumstances, references cited to show a universal fact need not be available as prior art before applicant’s filing date. Such facts include the characteristics and properties of a material or a scientific truism.

Some specific examples in which later publications showing factual evidence can be cited include situations where the facts shown in the reference are evidence “that, as of an application’s filing date, undue experimentation would have been required, In re Corneil, 347 F.2d 563, 568, 145 USPQ 702, 705 (CCPA 1965), or that a parameter absent from the claims was or was not critical, In re Rainer, 305 F.2d 505, 507 n.3, 134 USPQ 343, 345 n.3 (CCPA 1962), or that a statement in the specification was inaccurate, In re Marzocchi, 439 F.2d 220, 223 n.4, 169 USPQ 367, 370 n.4 (CCPA 1971), or that the invention was inoperative or lacked utility, In re Langer, 503 F.2d 1380, 1391, 183 USPQ 288, 297 (CCPA 1974), or that a claim was indefinite, In re Glass, 492 F.2d 1228,1232 n.6, 181 USPQ 31, 34 n.6 (CCPA 1974), or that characteristics of prior art products were known, In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962).” In re Koller, 613 F.2d 819, 823 n.5, 204 USPQ 702, 706 n.5 (CCPA 1980) (quoting In re Hogan, 559 F.2d 595, 605 n.17, 194 USPQ 527, 537 n.17 (CCPA 1977) (emphasis in original)). However, it is impermissible to use a later factual reference to determine whether the application is enabled or described as required under 35 U.S.C. 112, first paragraph. In re Koller, 613 F.2d 819, 823 n. 5, 204 USPQ 702, 706 n.5 (CCPA 1980). References which do not qualify as prior art because they postdate the claimed invention may be relied upon to show the level of ordinary skill in the art at or around the time the invention was made. Ex parte Erlich, 22 USPQ 1463 (Bd. Pat. App. & Inter. 1992).


2125 Drawings as Prior Art[edit | edit source]

DRAWINGS CAN BE USED AS PRIOR ART[edit | edit source]

Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. However, the picture must show all the claimed structural features and how they are put together. The origin of the drawing is immaterial. For instance, drawings in a design patent can anticipate or make obvious the claimed invention as can drawings in utility patents. When the reference is a utility patent, it does not matter that the feature shown is unintended or unexplained in the specification. The drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. See MPEP § 2121.04 for more information on prior art drawings as "enabled disclosures."

PROPORTIONS OF FEATURES IN A DRAWING ARE NOT EVIDENCE OF ACTUAL PROPORTIONS WHEN DRAWINGS ARE NOT TO SCALE[edit | edit source]

When the reference does not disclose that the drawings are to scale and is silent as to dimensions, arguments based on measurement of the drawing features are of little value.

However, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art.


2126 Availability of a Document as a "Patent" for Purposes of Rejection Under 35 U.S.C. 102(a), (b), and (d)[edit | edit source]

THE NAME "PATENT" ALONE DOES NOT MAKE A DOCUMENT AVAILABLE AS A PRIOR ART PATENT UNDER 35 U.S.C. 102(a) OR (b)

What a foreign country designates to be a patent may not be a patent for purposes of rejection under 35 U.S.C. 102(a) and (b); it is the substance of the rights conferred and the way information within the "patent" is controlled that is determinative.

See MPEP § 2135.01 for a further discussion of the use of "patents" in 35 U.S.C. 102(d) rejections.

A SECRET PATENT IS NOT AVAILABLE AS A REFERENCE UNDER 35 U.S.C. 102(a) or (b) UNTIL IT IS AVAILABLE TO THE PUBLIC BUT IT MAY BE AVAILABLE UNDER 35 U.S.C. 102(d) AS OF GRANT DATE

Secret patents are defined as patents which are insufficiently accessible to the public to constitute "printed publications." Decisions on the issue of what is sufficiently accessible to be a "printed publication" are located in MPEP § 2128 - § 2128.01.

Even if a patent grants an exclusionary right (is enforceable), it is not available as prior art under 35 U.S.C. 102(a) or (b) if it is secret or private. The document must be at least minimally available to the public to constitute prior art. The patent is sufficiently available to the public for the purposes of 35 U.S.C. 102(a) or (b) if it is laid open for public inspection or disseminated in printed form.

The date that the patent is made available to the public is the date it is available as a 35 U.S.C. 102(a) or (b) reference. But a period of secrecy after granting the patent has been held to have no effect in connection with 35 U.S.C. 102(d). These patents are usable in rejections under 35 U.S.C. 102(d) as of the date patent rights are granted. See MPEP § 2135 - § 2135.01 for more information on 35 U.S.C. 102(d).

2126.01 Date of Availability of a Patent as a Reference[edit | edit source]

DATE FOREIGN PATENT IS EFFECTIVE AS A REFERENCE IS USUALLY THE DATE PATENT RIGHTS ARE FORMALLY AWARDED TO ITS APPLICANT

The date the patent is available as a reference is generally the date that the patent becomes enforceable. This date is the date the sovereign formally bestows patents rights to the applicant. In re Monks, 588 F.2d 308, 200 USPQ 129 (CCPA 1978). There is an exception to this rule when the patent is secret as of the date the rights are awarded. In re Ekenstam, 256 F.2d 321, 118 USPQ 349 (CCPA 1958).

Note that MPEP § 901.05 summarizes in tabular form dates of patenting for many foreign patents. Chisum, Patents § 3.06[4] n.2 gives a good summary of decisions which specify reference availability dates for specific classes of foreign patents. A copy of Chisum is kept in the law library of the Solicitor’s Office and in the Lutrelle F. Parker, Sr., Memorial Law Library located in the Madison West Building, Room 1C35, 600 Dulany Street, Alexandria, Virginia 22314.

2126.02 Scope of Reference's Disclosure Which Can Be Used to Reject Claims When the Reference Is a "Patent" but Not a "Publication"[edit | edit source]

OFTEN UNCLAIMED DETAILS FOUND IN THE PATENT SPECIFICATION CAN BE RELIED ON EVEN IF PATENT IS SECRET

When the patented document is used as a patent and not as a publication, the examiner is not restricted to the information conveyed by the patent claims but may use any information provided in the specification which relates to the subject matter of the patented claims when making a rejection under 35 U.S.C. 102(a), (b) or (d). Ex parte Ovist, 152 USPQ 709, 710 (Bd. App. 1963) (The claim of an Italian patent was generic and thus embraced the species disclosed in the examples, the Board added that the entire specification was germane to the claimed invention and upheld the examiner’s 35 U.S.C. 102(b) rejection.); In re Kathawala, 9 F.3d 942, 28 USPQ2d 1785 (Fed. Cir. 1993) (The claims at issue where rejected under 35 U.S.C. 102(d) by applicant’s own parent applications in Greece and Spain. The applicant argued that the “invention ... patented in Spain was not the same ‘invention’ claimed in the U.S. application because the Spanish patent claimed processes for making [compounds for inhibition of cholesterol biosynthesis] and claims 1 and 2 were directed to the compounds themselves.” 9 F.3d at 944, 28 USPQ2d at 1786. The Federal Circuit held that “when an applicant files a foreign application fully disclosing his invention and having the potential to claim his invention in a number of ways, the reference in section 102(d) to ‘invention ... patented’ necessarily includes all disclosed aspects of the invention.” 9 F.3d at 945-46, 28 USPQ2d at 1789.)

In re Fuge, 272 F.2d 954, 957, 124 USPQ 105, 107 (CCPA 1959), does not conflict with the above decisions. This decision simply states “that, at the least, the scope of the patent embraces everything included in the [claim].” (emphasis added).

Note that the courts have interpreted the phrase “invention ... patented” in 102(a), (b), and (d) the same way and have cited decisions without regard to which of these subsections of 35 U.S.C. 102 was at issue in the particular case at hand. Therefore, it does not seem to matter to which subsection of 102 the cases are directed; the court decisions are interchangeable as to this issue.


2127 Domestic and Foreign Patent Applications as Prior Art[edit | edit source]

I. ABANDONED APPLICATIONS, INCLUDING PROVISIONAL APPLICATIONS[edit | edit source]

Abandoned Applications Disclosed to the Public Can Be Used as Prior Art

An abandoned patent application may become evidence of prior art only when it has been appropriately disclosed, as, for example, when the abandoned patent application is referenced in the disclosure of another patent, in a publication, or by voluntary disclosure

An abandoned patent application becomes available as prior art only as of the date the public gains access to it. However, the subject matter of an abandoned application, including both provisional and nonprovisional applications, referred to in a prior art U.S. patent may be relied on in a 35 U.S.C. 102(e) rejection based on that patent if the disclosure of the abandoned application is actually included or incorporated by reference in the patent.

See MPEP § 2136.02 and § 2136.03 for the 35 U.S.C. 102(e) date of a U.S. patent claiming priority under 35 U.S.C. 119 or 120.

II. APPLICATIONS WHICH HAVE ISSUED AS PATENTS[edit | edit source]

A 35 U.S.C. 102(e) Rejection Cannot Rely on Matter Which Was Canceled from the Application and Thus Did Not Get Published in the Issued Patent

Canceled matter in the application file of a U.S. patent cannot be relied upon in a rejection under 35 U.S.C. 102(e). The canceled matter only becomes available as prior art as of the date the application issues into a patent since this is the date the application file history becomes available to the public.

For more information on available prior art for use in 35 U.S.C. 102(e) rejections see MPEP § 2136.02.

A 102(b) Rejection Over a Published Application May Rely on Information that Was Canceled Prior to Publication

Figures that had been canceled from a Canadian patent application before issuance of the patent were available as prior art under 35 U.S.C. 102(b) as of the date the application became publicly accessible. Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 78 USPQ2d 1684 (Fed. Cir. 2006).

III. FOREIGN APPLICATIONS OPEN FOR PUBLIC INSPECTION (LAID OPEN APPLICATIONS)[edit | edit source]

Laid Open Applications May Constitute “Published” Documents

When the specification is not issued in printed form but is announced in an official journal and anyone can inspect or obtain copies, it is sufficiently accessible to the public to constitute a “publication” within the meaning of 35 U.S.C. 102(a) and (b).

Older cases have held that laid open patent applications are not “published” and cannot constitute prior art. However, whether or not a document is “published” for the purposes of 35 U.S.C. 102 and 103 depends on how accessible the document is to the public. As technology has made reproduction of documents easier, the accessibility of the laid open applications has increased. Items provided in easily reproducible form have thus become “printed publications” as the phrase is used in 35 U.S.C. 102.

IV. PENDING U.S. APPLICATIONS[edit | edit source]

As specified in 37 CFR 1.14(a), all pending U.S. applications are preserved in confidence except for published applications, reissue applications, and applications in which a request to open the complete application to inspection by the public has been granted by the Office (37 CFR 1.11(b)). However, if an application that has not been published has an assignee or inventor in common with the application being examined, a rejection will be proper in some circumstances. For instance, when the claims between the two applications are not independent or distinct, a provisional double patenting rejection is made. See MPEP § 804. If the copending applications differ by at least one inventor and at least one of the applications would have been obvious in view of the other, a provisional rejection over 35 U.S.C. 102(e) or 103 is made when appropriate. See MPEP § 706.02(f)(2), § 706.02(k), § 706.02(l)(1), and § 706.02(l)(3).

See MPEP § 706.02(a), § 804 and § 2136 et seq. for information pertaining to rejections relying on U.S. application publications.



2128 "Printed Publications" as Prior Art[edit | edit source]

A REFERENCE IS A "PRINTED PUBLICATION" IF IT IS ACCESSIBLE TO THE PUBLIC

A reference is proven to be a "printed publication" upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.

ELECTRONIC PUBLICATIONS AS PRIOR ART

Status as a "Printed Publication"

An electronic publication, including an on-line database or Internet publication, is considered to be a "printed publication" within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) (“Accordingly, whether information is printed, handwritten, or on microfilm or a magnetic disc or tape, etc., the one who wishes to characterize the information, in whatever form it may be, as a ‘printed publication’ should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.’” (citations omitted).). See also Amazon.com v. Barnesandnoble.com, 73 F. Supp. 2d 1228, 53 USPQ2d 1115, 1119 (W.D. Wash. 1999) (Pages from a website were relied on by defendants as an anticipatory reference (to no avail), however status of the reference as prior art was not challenged.); In re Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed. Cir. 1994) (Database printouts of abstracts which were not themselves prior art publications were properly relied as providing evidence that the software products referenced therein were “first installed” or “released” more than one year prior to applicant’s filing date.).

The Office policy requiring recordation of the field of search and search results (see MPEP § 719.05) weighs in favor of finding that Internet and on-line database references cited by the examiner are “accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” Wyer, 655 F.2d at 221, 210 USPQ at 790. Office copies of an electronic document must be retained if the same document may not be available for retrieval in the future. This is especially important for sources such as the Internet and online databases.

Date of Availability

Prior art disclosures on the Internet or on an on- line database are considered to be publicly available as of the date the item was publicly posted. Absent evidence of the date that the disclosure was publicly posted, if the publication itself does not include a publication date (or retrieval date), it cannot be relied upon as prior art under 35 U.S.C. 102(a) or (b). However, it may be relied upon to provide evidence regarding the state of the art. Examiners may ask the Scientific and Technical Information Center to find the earliest date of publication or posting. See MPEP § 901.06(a), paragraph IV. G.

Extent of Teachings Relied Upon

An electronic publication, like any publication, may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP § 2121.01 and § 2123. Note, however, that if an electronic document which is the abstract of a patent or printed publication is relied upon in a rejection under 35 U.S.C. 102 or 103, only the text of the abstract (and not the underlying document) may be relied upon to support the rejection. In situations where the electronic version and the published paper version of the same or a corresponding patent or printed publication differ appreciably, each may need to be cited and relied upon as independent references based on what they disclose.

Internet Usage Policy

See MPEP § 904.02(c) for the portions of the Internet Usage Policy pertaining to Internet searching and documenting search strategies. See MPEP § 707.05for the proper citation of electronic documents.

EXAMINER NEED NOT PROVE ANYONE ACTUALLY LOOKED AT THE DOCUMENT

One need not prove someone actually looked at a publication when that publication is accessible to the public through a library or patent office. See In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981); In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986).

2128.01 Level of Public Accessibility Required[edit | edit source]

I.A THESIS PLACED IN A UNIVERSITY LIBRARY MAY BE PRIOR ART IF SUFFICIENTLY ACCESSIBLE TO THE PUBLIC

A doctoral thesis indexed and shelved in a library is sufficiently accessible to the public to constitute prior art as a “printed publication.” In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986). Even if access to the library is restricted, a reference will constitute a “printed publication” as long as a presumption is raised that the portion of the public concerned with the art would know of the invention. In re Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA 1978).

In In re Hall, general library cataloging and shelving practices showed that a doctoral thesis deposited in university library would have been indexed, cataloged and shelved and thus available to the public before the critical date. Compare In re Cronyn, 890 F.2d 1158, 13 USPQ2d 1070 (Fed. Cir. 1989) wherein doctoral theses were shelved and indexed by index cards filed alphabetically by student name and kept in a shoe box in the chemistry library. The index cards only listed the student name and title of the thesis. Two of three judges held that the students’ theses were not accessible to the public. The court reasoned that the theses had not been either cataloged or indexed in a meaningful way since thesis could only be found if the researcher’s name was known, but the name bears no relationship to the subject of the thesis. One judge, however, held that the fact that the theses were shelved in the library was enough to make them sufficiently accessible to the public. The nature of the index was not determinative. This judge relied on prior Board decisions (Gulliksen v. Halberg, 75 USPQ 252, 257 (Bd. App. 1937) and Ex parte Hershberger, 96 USPQ 54, 56 (Bd. App. 1952)), which held that shelving a single copy in a public library makes the work a “printed publication.” It should be noted that these Board decisions have not been expressly overruled but have been criticized in other decisions. See In re Tenney, 254 F.2d 619, 117 USPQ 348 (CCPA 1958) (concurring opinion by J.Rich) (A document, of which there is but one copy, whether it be handwritten, typewritten or on microfilm, may be technically accessible to anyone who can find it. Such a document is not “printed” in the sense that a printing press has been used to reproduce the document. If only technical accessibility were required “logic would require the inclusion within the term [printed] of all unprinted public documents for they are all ‘accessible.’ While some tribunals have gone quite far in that direction, as in the ‘college thesis cases’ I feel they have done so unjustifiably and on the wrong theory. Knowledge is not in the possession of the public where there has been no dissemination, as distinguished from technical accessibility...” The real significance of the word “printed” is grounded in the “probability of wide circulation.”). See also Deep Welding, Inc. v. Sciaky Bros., 417 F.2d 1227, 163 USPQ 144 (7th Cir. 1969) (calling the holding of Ex parte Hershberger “extreme”). Compare In re Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA 1978) (A reference will constitute a “printed publication” as long as a presumption is raised that the portion of the public concerned with the art would know of the invention even if accessibility is restricted to only this part of the public. But accessibility to applicant’s thesis was restricted to only three members of a graduate committee. There can be no presumption that those concerned with the art would have known of the invention in this case.).

II.ORALLY PRESENTED PAPER CAN CONSTITUTE A “PRINTED PUBLICATION” IF WRITTEN COPIES ARE AVAILABLE WITHOUT RESTRICTION

A paper which is orally presented in a forum open to all interested persons constitutes a “printed publication” if written copies are disseminated without restriction. Massachusetts Institute of Technology v. AB Fortia, 774 F.2d 1104, 1109, 227 USPQ 428, 432 (Fed. Cir. 1985) (Paper orally presented to between 50 and 500 persons at a scientific meeting open to all persons interested in the subject matter, with written copies distributed without restriction to all who requested, is a printed publication. Six persons requested and obtained copies.).

III.INTERNAL DOCUMENTS INTENDED TO BE CONFIDENTIAL ARE NOT “PRINTED PUBLICATIONS”

Documents and items only distributed internally within an organization which are intended to remain confidential are not “printed publications” no matter how many copies are distributed. There must be an existing policy of confidentiality or agreement to remain confidential within the organization. Mere intent to remain confidential is insufficient. In re George, 2 USPQ2d 1880 (Bd. Pat. App. & Inter. 1987) (Research reports disseminated in-house to only those persons who understood the policy of confidentiality regarding such reports are not printed publications even though the policy was not specifically stated in writing.); Garret Corp. v. United States, 422 F.2d 874, 878, 164 USPQ 521, 524 (Ct. Cl.1970) (“While distribution to government agencies and personnel alone may not constitute publication ... distribution to commercial companies without restriction on use clearly does.”); Northern Telecom Inc. v. Datapoint Corp., 908 F.2d 931, 15 USPQ2d 1321 (Fed. Cir. 1990) (Four reports on the AESOP-B military computer system which were not under security classification were distributed to about fifty organizations involved in the AESOP-B project. One document contained the legend “Reproduction or further dissemination is not authorized.” The other documents were of the class that would contain this legend. The documents were housed in Mitre Corporation’s library. Access to this library was restricted to those involved in the AESOP-B project. The court held that public access was insufficient to make the documents “printed publications.”).

IV.PUBLICLY DISPLAYED DOCUMENTS CAN CONSTITUTE A “PRINTED PUB- LICATION” EVEN IF THE DURATION OF DISPLAY IS FOR ONLY A FEW DAYS AND THE DOCUMENTS ARE NOT DIS- SEMINATED BY COPIES OR INDEXED IN A LIBRARY OR DATABASE

A publicly displayed document where persons of ordinary skill in the art could see it and are not precluded from copying it can constitute a “printed publication,” even if it is not disseminated by the distribution of reproductions or copies and/or indexed in a library or database. As stated in In re Klopfenstein, 380 F.3d 1345, 1348, 72 USPQ2d 1117, 1119 (Fed. Cir. 2004), “the key inquiry is whether or not a reference has been made ‘publicly accessible.’” Prior to the critical date, a fourteen-slide presentation disclosing the invention was printed and pasted onto poster boards. The printed slide presentation was displayed with no confidentiality restrictions for approximately three cumulative days at two different industry events. 380 F.3d at 1347, 72 USPQ2d at 1118. The court noted that “an entirely oral presentation that includes neither slides nor copies of the presentation is without question not a ‘printed publication’ for the purposes of 35 U.S.C. § 102(b). Furthermore, a presentation that includes a transient display of slides is likewise not necessarily a ‘printed publication.’” 380 F.3d at 1349 n.4, 72 USPQ2d at 1122 n.4. In resolving whether or not a temporarily displayed reference that was neither distributed nor indexed was nonetheless made sufficiently publicly accessible to count as a “printed publication” under 35 U.S.C. 102(b), the court considered the following factors: “the length of time the display was exhibited, the expertise of the target audience, the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and the simplicity or ease with which the material displayed could have been copied.” 380 F.3d at 1350, 72 USPQ2d at 1120. Upon reviewing the above factors, the court concluded that the display “was sufficiently publicly accessible to count as a ‘printed publication.’” 380 F.3d at 1352, 72 USPQ2d at 1121.

2128.02 Date Publication Is Available as a Reference[edit | edit source]

DATE OF ACCESSIBILITY CAN BE SHOWN THROUGH EVIDENCE OF ROUTINE BUSINESS PRACTICES

Evidence showing routine business practices can be used to establish the date on which a publication became accessible to the public. Specific evidence showing when the specific document actually became available is not always necessary. Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 7 USPQ2d 1057 (Fed. Cir.), cert. denied, 988 U.S. 892 (1988) (Court held that evidence submitted by Intel regarding undated specification sheets showing how the company usually treated such specification sheets was enough to show that the sheets were accessible by the public before the critical date.); In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986) (Librarian’s affidavit establishing normal time frame and practice for indexing, cataloging and shelving doctoral theses established that the thesis in question would have been accessible by the public before the critical date.).

A JOURNAL ARTICLE OR OTHER PUBLICATION BECOMES AVAILABLE AS PRIOR ART ON DATE OF IT IS RECEIVED BY A MEMBER OF THE PUBLIC

A publication disseminated by mail is not prior art until it is received by at least one member of the public. Thus, a magazine or technical journal is effective as of its date of publication (date when first person receives it) not the date it was mailed or sent to the publisher. In re Schlittler, 234 F.2d 882, 110 USPQ 304 (CCPA 1956).


2129 Admissions as Prior Art[edit | edit source]

I. ADMISSIONS BY APPLICANT CONSTITUTE PRIOR ART[edit | edit source]

A statement by an applicant during prosecution identifying the work of another as "prior art" is an admission that that work is available as prior art against the claims, regardless of whether the admitted prior art would otherwise qualify as prior art under the statutory categories of 35 U.S.C. 102.

However, even if labeled as "prior art," the work of the same inventive entity may not be considered prior art against the claims unless it falls under one of the statutory categories.

II. DISCUSSION OF PRIOR ART IN SPECIFICATION[edit | edit source]

Where the specification identifies work done by another as “prior art,” the subject matter so identified is treated as admitted prior art.

III. JEPSON CLAIMS[edit | edit source]

Drafting a claim in Jepson format (i.e., the format described in 37 CFR 1.75(e); see MPEP § 608.01(m)) is taken as an implied admission that the subject mater of the preamble is the prior art work of another.

However, this implication may be overcome where applicant gives another credible reason for drafting the claim in Jepson format.

Moreover, where the preamble of a Jepson claim describes applicant’s own work, such may not be used against the claims.

IV. INFORMATION DISCLOSURE STATEMENT (IDS)[edit | edit source]

Mere listing of a reference in an information disclosure statement is not taken as an admission that the reference is prior art against the claims.



2131 Anticipation — Application of 35 U.S.C. 102(a), (b), and (e)[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

(a)the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent, or

(b)the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States, or

(c)he has abandoned the invention, or

(d)the invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or

(e)the invention was described in — (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or

(f)he did not himself invent the subject matter sought to be patented, or

(g)(1)during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.


TO ANTICIPATE A CLAIM, THE REFERENCE MUST TEACH EVERY ELEMENT OF THE CLAIM

  • A claim is anticipated only if every single element of that claim is found, either expressly or inherently, in a single prior art reference.
  • When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.
  • The elements in the prior art must be arranged as required by the claim, but identity of terminology is not required.
  • Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.

2131.01 Multiple Reference 35 U.S.C. 102 Rejections[edit | edit source]

Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:

(A) Prove the primary reference contains an "enabled disclosure;" (See para. I, below)

(B) Explain the meaning of a term used in the primary reference (See para. II, below); or

(C) Show that a characteristic not disclosed in the reference is inherent (See para. III, below).

I. TO PROVE REFERENCE CONTAINS AN "ENABLED DISCLOSURE"

  • When the claimed composition or machine is disclosed identically by the reference, an additional reference may be relied on to show that the primary reference has an "enabled disclosure."
  • A "motivation to combine the references" is not required because such patents were only submitted as evidence of what was in the public's possession before invention.

II. TO EXPLAIN THE MEANING OF A TERM USED IN THE PRIMARY REFERENCE

  • Extra references or Other evidence can be used to show meaning of a term used in the primary reference

III. TO SHOW THAT A CHARACTERISTIC NOT DISCLOSED IN THE REFERENCE IS INHERENT

  • Extra Reference or Evidence Can Be Used To Show an Inherent Characteristic of the Thing Taught by the Primary Reference
  • To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence
  • Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.
  • As long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation.
  • Note: the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. (See MPEP 2124.)

See MPEP § 2112 - § 2112.02 for case law on inherency.

2131.02 Genus-Species Situations[edit | edit source]

A SPECIES WILL ANTICIPATE A CLAIM TO A GENUS

  • A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.
  • The species in that case will anticipate the genus.

Example:

In re Slayter, 276 F.2d 408 (Application claimed a genus of 21 specific chemical species of compounds. The prior art reference applied against the claims disclosed two of the chemical species. The parties agreed that the prior art species would anticipate the claims unless applicant was entitled to his foreign priority date.)

A REFERENCE THAT CLEARLY NAMES THE CLAIMED SPECIES ANTICIPATES THE CLAIM NO MATTER HOW MANY OTHER SPECIES ARE NAMED

  • A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named.

A GENERIC CHEMICAL FORMULA WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THE FORMULA WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE FORMULA

  • When the compound is not specifically named, but instead it is necessary to select portions of teachings within a reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated.

Example:

In In re Petering, the prior art disclosed a generic chemical formula "wherein X, Y, Z, P, and R'- represent either hydrogen or alkyl radicals, R a side chain containing an OH group." The court held that this formula, without more, could not anticipate a claim to 7- methyl-9-[d, l'-ribityl]-isoalloxazine because the generic formula encompassed a vast number and perhaps even an infinite number of compounds. However, the reference also disclosed preferred substituents for X, Y, Z, R, and R' as follows: where X, P, and R' are hydrogen, where Y and Z may be hydrogen or methyl, and where R is one of eight specific isoalloxazines. The court determined that this more limited generic class consisted of about 20 compounds. The limited number of compounds covered by the preferred formula in combination with the fact that the number of substituents was low at each site, the ring positions were limited, and there was a large unchanging structural nucleus, resulted in a finding that the reference sufficiently described "each of the various permutations here involved as fully as if he had drawn each structural formula or had written each name." The claimed compound was 1 of these 20 compounds. Therefore, the reference "described" the claimed compound and the reference anticipated the claims.

2131.03 Anticipation of Ranges[edit | edit source]

I. A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE ANTICIPATES THE RANGE

  • When, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is anticipated if one of them is in the prior art

II. PRIOR ART WHICH TEACHES A RANGE OVERLAPPING OR TOUCHING THE CLAIMED RANGE ANTICIPATES IF THE PRIOR ART RANGE DISCLOSES THE CLAIMED RANGE WITH "SUFFICIENT SPECIFICITY"

  • When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation.
  • In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with "sufficient specificity to constitute an anticipation under the statute."
    • What constitutes a "sufficient specificity" is fact dependent. If the claims are directed to a narrow range, and the reference teaches a broad range, depending on the other facts of the case, it may be reasonable to conclude that the narrow range is not disclosed with "sufficient specificity" to constitute an anticipation of the claims.

See, e.g., Atofina v. Great Lakes Chem. Corp, 441 F.3d 991, 999, wherein the court held that a reference temperature range of 100-500 degrees C did not describe the claimed range of 330-450 degrees C with sufficient specificity to be anticipatory.

Further, while there was a slight overlap between the reference’s preferred range (150-350 degrees C) and the claimed range, that overlap was not sufficient for anticipation.

III. PRIOR ART WHICH TEACHES A VALUE OR RANGE THAT IS VERY CLOSE TO, BUT DOES NOT OVERLAP OR TOUCH, THE CLAIMED RANGE DOES NOT ANTICIPATE THE CLAIMED RANGE

  • Anticipation under § 102 can be found only when the reference discloses exactly what is claimed and that where there are differences between the reference disclosure and the claim, the rejection must be based on § 103 which takes differences into account.

2131.04 Secondary Considerations[edit | edit source]

Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based.

2131.05 Nonanalogous or Disparaging Prior Art[edit | edit source]

Arguments that the alleged anticipatory prior art is "nonanalogous art" or "teaches away from the invention" or is not recognized as solving the problem solved by the claimed invention, are not germane to a rejection under section 102.

A reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims.

A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it. The question whether a reference "teaches away" from the invention is inapplicable to an anticipation analysis.


2132 35 U.S.C. 102(a)[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.

.          .          .


I. "KNOWN OR USED"

  • The statutory language "known or used by others in this country" means knowledge or use which is accessible to the public.
  • The knowledge or use is accessible to the public if there has been no deliberate attempt to keep it secret.
  • The nonsecret use of a claimed process in the usual course of producing articles for commercial purposes is a public use.
  • But a secret use of the process coupled with the sale of the product does not result in a public use of the process unless the public could learn the claimed process by examining the product.
  • Therefore, secret use of a process by another, even if the product is commercially sold, cannot result in a rejection under 35 U.S.C. 102(a) if an examination of the product would not reveal the process.

II. "IN THIS COUNTRY"

  • The knowledge or use relied on in a 35 U.S.C. 102(a) rejection must be knowledge or use "in this country."
  • Prior knowledge or use which is not present in the United States, even if widespread in a foreign country, cannot be the basis of a rejection under 35 U.S.C. 102(a).

III. "BY OTHERS"

  • The term "others" in 35 U.S.C. 102(a) refers to any entity which is different from the inventive entity.
  • The entity need only differ by one person to be "by others."
  • This holds true for all types of references eligible as prior art under 35 U.S.C. 102(a) including publications as well as public knowledge and use.

IV. "PATENTED IN THIS OR A FOREIGN COUNTRY"

See MPEP 2126 for information on the use of secret patents as prior art.

2132.01 Publications as 35 U.S.C. 102(a) Prior Art[edit | edit source]

35 U.S.C. 102(a) PRIMA FACIE CASE IS ESTABLISHED IF REFERENCE PUBLICATION IS "BY OTHERS"

A prima facie case is made out under 35 U.S.C. 102(a) if, within 1 year prior to the filing date, the invention, or an obvious variant thereof, is described in a "printed publication" whose authorship differs in any way from the inventive entity unless it is stated within the publication itself that the publication is describing the applicant's work.

See MPEP 2128 for case law on what constitutes a "printed publication."

Note that when the reference is a U.S. patent published within the year prior to the application filing date, a 35 U.S.C. 102(e) rejection should be made. See MPEP § 2136 - § 2136.05 for case law dealing with 102(e).

APPLICANT CAN REBUT PRIMA FACIE CASE BY SHOWING REFERENCE’S DISCLOSURE WAS DERIVED FROM APPLICANT’S OWN WORK

Applicant's disclosure of his or her own work within the year before the application filing date cannot be used against him or her under 35 U.S.C. 102(a).

Such a rejection can be overcome by:

  • filing an affidavit made out by the other authors establishing that the relevant portions of the publication originated with, or were obtained from, applicant (called a disclaiming affidavit)
  • submitting a specific declaration by the applicant establishing that the article is describing applicant's own work.
  • adding the coauthors as inventors to the application if the requirements of 35 U.S.C. 116, third paragraph are met.

Relevant Cases:

See also case law dealing with overcoming 102(e) rejections as presented in MPEP § 2136.05. Many of the issues are the same.

A 37 CFR 1.131 AFFIDAVIT CAN BE USED TO OVERCOME A 35 U.S.C. 102(a) REJECTION

When the reference is not a statutory bar under 35 U.S.C. 102(b), (c), or (d), applicant can overcome the rejection by swearing back of the reference through the submission of an affidavit under 37 CFR 1.131. If the reference is disclosing applicant's own work as derived from him or her, applicant may submit either a 37 CFR 1.131 affidavit to antedate the reference or a 37 CFR 1.132 affidavit to show derivation of the reference subject matter from applicant and invention by applicant.

See MPEP 715 for more information on when an affidavit under 37 CFR 1.131 can be used to overcome a reference and what evidence is required.

Relevant Cases:



2133 35 U.S.C. 102(b)[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

.          .          .

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.


THE 1-YEAR GRACE PERIOD IS EXTENDED TO THE NEXT WORKING DAY IF IT WOULD OTHERWISE END ON A HOLIDAY OR WEEKEND[edit | edit source]

Publications, patents, public uses and sales must occur “more than one year prior to the date of application for patent in the United States” in order to bar a patent under 35 U.S.C. 102(b). However, applicant’s own activity will not bar a patent if the 1-year grace period expires on a Saturday, Sunday, or Federal holiday and the application’s U.S. filing date is the next succeeding business day.

THE 1-YEAR TIME BAR IS MEASURED FROM THE U.S. FILING DATE[edit | edit source]

If one discloses his or her own work more than one year before the filing of the patent application, that person is barred from obtaining a patent. The 1-year time bar is measured from the U.S. filing date. Thus, applicant will be barred from obtaining a patent if the public came into possession of the invention on a date before the 1-year grace period ending with the U.S. filing date. It does not matter how the public came into possession of the invention. Public possession could occur by a public use, public sale, a publication, a patent or any combination of these. In addition, the prior art need not be identical to the claimed invention but will bar patentability if it is an obvious variant thereof.

See MPEP § 706.02 regarding the effective U.S. filing date of an application.

2133.01 Rejections of Continuation-In-Part (CIP) Applications[edit | edit source]

When applicant files a continuation-in-part whose claims are not supported by the parent application, the effective filing date is the filing date of the child CIP. Any prior art disclosing the invention or an obvious variant thereof having a critical reference date more than 1 year prior to the filing date of the child will bar the issuance of a patent under 35 U.S.C. 102(b).

2133.02 Rejections Based on Publications and Patents[edit | edit source]

APPLICANT’S OWN WORK WHICH WAS AVAILABLE TO THE PUBLIC BEFORE THE GRACE PERIOD MAY BE USED IN A 35 U.S.C. 102(b) REJECTION[edit | edit source]

Any invention described in a printed publication more than one year prior to the date of a patent application is prior art under Section 102(b), even if the printed publication was authored by the patent applicant.

Once an inventor has decided to lift the veil of secrecy from his [or her] work, he [or she] must choose between the protection of a federal patent, or the dedication of his [or her] idea to the public at large.”

A 35 U.S.C. 102(b) REJECTION CREATES A STATUTORY BAR TO PATENTABILITY OF THE REJECTED CLAIMS[edit | edit source]

A rejection under 35 U.S.C. 102(b) cannot be overcome by affidavits and declarations under 37 CFR 1.131 (Rule 131 Declarations), foreign priority dates, or evidence that applicant himself invented the subject matter. Outside the 1-year grace period, applicant is barred from obtaining a patent containing any anticipated or obvious claims.

2133.03 Rejections Based on "Public Use" or “On Sale”[edit | edit source]

35 U.S.C. 102(b) contains several distinct bars to patentability, each of which relates to activity or disclosure more than one year prior to the date of the application. Two of these - the 'public use' and the 'on sale' objections - are sometimes considered together although either may apply when the other does not.

There may be a public use of an invention absent any sales activity. Likewise, there may be a nonpublic, e.g., “secret,” sale or offer to sell an invention which nevertheless constitutes a statutory bar.

In similar fashion, not all “public use” and “on sale” activities will necessarily occasion the identical result. Although both activities affect how an inventor may use an invention prior to the filing of a patent application, “non-commercial” 35 U.S.C. 102(b) activity may not be viewed the same as similar “commercial” activity. See MPEP § 2133.03(a) and § 2133.03(e)(1).

Likewise, “public use” activity by an applicant may not be considered in the same light as similar “public use” activity by one other than an applicant. See MPEP § 2133.03(a) and § 2133.03(e)(7). Additionally, the concept of “experimental use” may have different significance in “commercial” and “non-commercial” environments. See MPEP § 2133.03(c) and § 2133.03(e) - § 2133.03(e)(6).

It should be noted that 35 U.S.C. 102(b) may create a bar to patentability either alone, if the device in public use or placed on sale anticipates a later claimed invention, or in conjunction with 35 U.S.C. 103, if the claimed invention would have been obvious from the device in conjunction with the prior art. LaBounty Mfg. v. United States Int’l Trade Comm’n, 958 F.2d 1066, 1071, 22 USPQ2d 1025, 1028 (Fed. Cir. 1992).

POLICY CONSIDERATIONS

(A)“One policy underlying the [on-sale] bar is to obtain widespread disclosure of new inventions to the public via patents as soon as possible.” RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1062, 12 USPQ2d 1449, 1454 (Fed. Cir. 1989).

(B)Another policy underlying the public use and on-sale bars is to prevent the inventor from commercially exploiting the exclusivity of his [or her] invention substantially beyond the statutorily authorized period. RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1062, 12 USPQ2d 1449, 1454 (Fed. Cir. 1989). See MPEP § 2133.03(e)(1).

(C)Another underlying policy for the public use and on-sale bars is to discourage “the removal of inventions from the public domain which the public justifiably comes to believe are freely available.” Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 549, 16 USPQ2d 1587, 1591 (Fed. Cir. 1990).

2133.03(a) “Public Use”[edit | edit source]

I. TEST FOR “PUBLIC USE[edit | edit source]

The public use bar under 35 U.S.C. 102(b) arises where the invention is in public use before the critical date and is ready for patenting. Invitrogen Corp. v. Biocrest Manufacturing L.P., 424 F.3d 1374, 76 USPQ2d 1741 (Fed. Cir. 2005). As explained by the court,

The proper test for the public use prong of the § 102 (b) statutory bar is whether the purported use: (1) was accessible to the public; or (2) was commercially exploited. Commercial exploitation is a clear indication of public use, but it likely requires more than, for example, a secret offer for sale. Thus, the test for the public use prong includes the consideration of evidence relevant to experimentation, as well as, inter alia, the nature of the activity that occurred in public; public access to the use; confidentiality obligations imposed on members of the public who observed the use; and commercial exploitation…. That evidence is relevant to discern whether the use was a public use that could raise a bar to patentability, but it is distinct from evidence relevant to the ready for patenting component of Pfaff ’s two-part test, another necessary requirement of a public use bar

Id. at 1380, 76 USPQ2d at 1744 (citations omitted). See MPEP § 2133.03(c) for a discussion of the “ready for patenting” prong of the public use and on sale statutory bars.

“[T]o constitute the public use of an invention it is not necessary that more than one of the patent articles should be publicly used. The use of a great number may tend to strengthen the proof, but one well defined case of such use is just as effectual to annul the patent as many.” Likewise, it is not necessary that more than one person use the invention. Egbert v. Lippmann, 104 U.S. 333, 336 (1881).

II. PUBLIC KNOWLEDGE IS NOT NECESSARILY PUBLIC USE UNDER 35 U.S.C. 102(b)[edit | edit source]

Mere knowledge of the invention by the public does not warrant rejection under 35 U.S.C. 102(b). 35 U.S.C. 102(b) bars public use or sale, not public knowledge. TP Labs., Inc., v. Professional Positioners, Inc., 724 F.2d 965, 970, 220 USPQ 577, 581 (Fed. Cir. 1984).

Note, however, that public knowledge may provide grounds for rejection under 35 U.S.C. 102(a). See MPEP § 2132.

A. Commercial Versus Noncommercial Use and the Impact of Secrecy

There are limited circumstances in which a secret or confidential use of an invention may give rise to the public use bar. “[S]ecrecy of use alone is not sufficient to show that existing knowledge has not been withdrawn from public use; commercial exploitation is also forbidden.” Invitrogen, 424 F.3d at 1382, 76 USPQ2d at 1745-46 (The fact that patentee secretly used the claimed invention internally before the critical date to develop future products that were never sold was by itself insufficient to create a public use bar to patentability.).

1. “Public Use” and “Non-secret Use” Are Not Necessarily Synonymous

“Public” is not necessarily synonymous with “non- secret.” The fact “that non-secret uses of the device were made [by the inventor or someone connected with the inventor] prior to the critical date is not itself dispositive of the issue of whether activity barring a patent under 35 U.S.C. 102(b) occurred. The fact that the device was not hidden from view may make the use not secret, but nonsecret use is not ipso facto ‘public use’ activity. Nor, it must be added, is all secret use ipso facto not ‘public use’ within the meaning of the statute,” if the inventor is making commercial use of the invention under circumstances which preserve its secrecy. TP Labs., Inc. v. Professional Positioners, Inc., 724 F.2d 965, 972, 220 USPQ 577, 583 (Fed. Cir. 1983) (citations omitted).

2. Even If the Invention Is Hidden, Inventor Who Puts Machine or Article Embodying the Invention in Public View Is Barred from Obtaining a Patent as the Invention Is in Public Use

When the inventor or someone connected to the inventor puts the invention on display or sells it, there is a “public use” within the meaning of 35 U.S.C. 102(b) even though by its very nature an invention is completely hidden from view as part of a larger machine or article, if the invention is otherwise used in its natural and intended way and the larger machine or article is accessible to the public. In re Blaisdell, 242 F.2d 779, 783, 113 USPQ 289, 292 (CCPA 1957); Hall v. Macneale, 107 U.S. 90, 96-97 (1882); Ex parteKuklo, 25 USPQ2d 1387, 1390 (Bd. Pat. App. & Inter. 1992) (Display of equipment including the structural features of the claimed invention to visitors of laboratory is public use even though public did not see inner workings of device. The person to whom the invention is publicly disclosed need not understand the significance and technical complexities of the invention.).

3.There Is No Public Use If Inventor Restricted Use to Locations Where There Was a Reasonable Expectation of Privacy and the Use Was for His or Her Own Enjoyment

An inventor’s private use of the invention, for his or her own enjoyment is not a public use. Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265, 229 USPQ 805, 809 (Fed. Cir. 1986) (Inventor showed inventive puzzle to close friends while in his dorm room and later the president of the company at which he was working saw the puzzle on the inventor’s desk and they discussed it. Court held that the inventor retained control and thus these actions did not result in a “public use.”).

4. The Presence or Absence of a Confidentiality Agreement is Not Dispositive of the Public Use Issue

“The presence or absence of a confidentiality agreement is not dispositive of the public use issue, but ‘is one factor to be considered in assessing all the evidence.’” Bernhardt, L.L.C. v. Collezione Europa USA, Inc., 386 F.3d 1371, 1380-81, 72 USPQ2d, 1901, 1909 (Fed. Cir. 2004) (quoting Moleculon Research Corp. v. CBS Inc., 793 F.2d 1261, 1266, 229 USPQ 805, 808 (Fed. Cir. 1986)). The court stressed that it is necessary to analyze the evidence of public use in the context of policies that underlie the public use and on sale bar that include “‘discouraging removal of inventions from the public domain that the public justifiably believes are freely available, prohibiting an extension of the period for exploiting an invention, and favoring prompt and widespread disclosure of inventions.’” Bernhardt, 386 F.3d at 1381, 72 USPQ2d at 1909. See also Invitrogen, 424 F.3d at 1379, 76 USPQ2d at 1744; MPEP § 2133.03, Policy Considerations. Evidence that the court emphasized included the “‘nature of the activity that occurred in public; the public access to and knowledge of the public use; [and] whether there were any confidentiality obligations imposed on persons who observed the use.’” Bernhardt, 386 F.3d at 1381, 72 USPQ2d at 1909. For example, the court in Bernhardt noted that an exhibition display at issue in the case “was not open to the public, that the identification of attendees was checked against a list of authorized names by building security and later at a reception desk near the showroom, that attendees were escorted through the showroom, and that the attendees were not permitted to make written notes or take photographs inside the showroom.” Id. The court remanded the issue of whether the exhibition display was a public use for further proceedings since the district court “focused on the absence of any confidentiality agreements and did not discuss or analyze how the totality of the circumstances surrounding” the exhibition “comports with the policies underlying the public use bar.” Id.

B. Use by Third Parties Deriving the Invention from Applicant

An Invention Is in Public Use If the Inventor Allows Another To Use the Invention Without Restriction or Obligation of Secrecy

“Public use” of a claimed invention under 35 U.S.C. 102(b) occurs when the inventor allows another person to use the invention without limitation, restriction or obligation of secrecy to the inventor.” In re Smith, 714 F.2d 1127, 1134, 218 USPQ 976, 983 (Fed. Cir. 1983). The presence or absence of a confidentiality agreement is not itself determinative of the public use issue, but is one factor to be considered along with the time, place, and circumstances of the use which show the amount of control the inventor retained over the invention. Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265, 229 USPQ 805, 809 (Fed. Cir. 1986). See Ex parte C, 27 USPQ2d 1492, 1499 (Bd. Pat. App. & Inter. 1992) (Inventor sold inventive soybean seeds to growers who contracted and were paid to plant the seeds to increase stock for later sale. The commercial nature of the use of the seed coupled with the “on-sale” aspects of the contract and apparent lack of confidentiality requirements rose to the level of a “public use” bar.); Egbert v. Lippmann, 104 U.S. 333, 336 (1881) (Public use found where inventor allowed another to use inventive corset insert, though hidden from view during use, because he did not impose an obligation of secrecy or restrictions on its use.).

C.Use by Independent Third Parties

Use by an Independent Third Party Is Public Use If It Sufficiently “Informs” the Public of the Invention or a Competitor Could Reasonably Ascertain the Invention

Any “nonsecret” use of an invention by someone unconnected to the inventor, such as someone who has independently made the invention, in the ordinary course of a business for trade or profit may be a “public use,” Bird Provision Co. v. Owens Country Sausage, Inc., 568 F.2d 369, 374-76, 197 USPQ 134, 138-40 (5th Cir. 1978). Additionally, even a “secret” use by another inventor of a machine or process to make a product is “public” if the details of the machine or process are ascertainable by inspection or analysis of the product that is sold or publicly displayed. Gillman v. Stern, 114 F.2d 28, 46 USPQ 430 (2d Cir. 1940); Dunlop Holdings, Ltd. v. Ram Golf Corp., 524 F.2d 33, 36-7, 188 USPQ 481, 483-484 (7th Cir. 1975). If the details of an inventive process are not ascertainable from the product sold or displayed and the third party has kept the invention as a trade secret then that use is not a public use and will not bar a patent issuing to someone unconnected to the user. W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1550, 220 USPQ 303, 310 (Fed. Cir. 1983). However, a device qualifies as prior art if it places the claimed features in the public's possession before the critical date even if other unclaimedaspects of the device were not publicly available. Lockwood v. American Airlines, Inc., 41 USPQ2d 1961, 1964-65 (Fed. Cir. 1997) (Computer reservation system was prior art even though “essential algorithms of the SABRE software were proprietary and confidential and...those aspects of the system that were readily apparent to the public would not have been sufficient to enable one skilled in the art to duplicate the [unclaimed aspects of the] system.”). The extent that the public becomes “informed” of an invention involved in public use activity by one other than an applicant depends upon the factual circumstances surrounding the activity and how these comport with the policies underlying the on sale and public use bars. Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 549, 16 USPQ2d 1587, 1591 (Fed. Cir. 1990) (quoting King Instrument Corp. v. Otari Corp., 767 F.2d 833, 860, 226 USPQ 402, 406 (Fed. Cir. 1985)). By way of example, in an allegedly “secret” use by a third party other than an applicant, if a large number of employees of such a party, who are not under a promise of secrecy, are permitted unimpeded access to an invention, with affirmative steps by the party to educate other employees as to the nature of the invention, the public is “informed.” Chemithon Corp. v. Proctor & Gamble Co., 287 F. Supp. 291, 308, 159 USPQ 139, 154 (D.Md. 1968), aff’d., 427 F.2d 893, 165 USPQ 678 (4th Cir. 1970).

Even if public use activity by one other than an applicant is not sufficiently “informing,” there may be adequate grounds upon which to base a rejection under 35 U.S.C. 102(f) and 35 U.S.C. 102(g). See Dunlop Holdings Ltd. v. Ram Golf Corp., 524 F.2d 33, 188 USPQ 481 (7th Cir. 1975). See MPEP § 2137 and § 2138.

2133.03(b) “On Sale”[edit | edit source]

An impermissible sale has occurred if there was a definite sale, or offer to sell, more than 1 year before the effective filing date of the U.S. application and the subject matter of the sale, or offer to sell, fully anticipated the claimed invention or would have rendered the claimed invention obvious by its addition to the prior art. Ferag AG v. Quipp, Inc., 45 F.3d 1562, 1565, 33 USPQ2d 1512, 1514 (Fed. Cir. 1995). The on-sale bar of 35 U.S.C. 102(b) is triggered if the invention is both (1) the subject of a commercial offer for sale not primarily for experimental purposes and (2) ready for patenting. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67, 48 USPQ2d 1641, 1646-47 (1998). Traditional contract law principles are applied when determining whether a commercial offer for sale has occurred. See Linear Tech. Corp. v. Micrel, Inc., 275 F.3d 1040, 1048, 61 USPQ2d 1225, 1229 (Fed. Cir. 2001), petition for cert. filed, 71 USLW 3093 (Jul. 03, 2002) (No. 02-39); Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041,1047, 59 USPQ2d 1121, 1126 (Fed. Cir. 2001) (“As a general proposition, we will look to the Uniform Commercial Code (‘UCC’) to define whether … a communication or series of communications rises to the level of a commercial offer for sale.”).

I. THE MEANING OF “SALE”[edit | edit source]

A sale is a contract between parties wherein the seller agrees “to give and to pass rights of property” in return for the buyer’s payment or promise “to pay the seller for the things bought or sold.” In re Caveney, 761 F.2d 671, 676, 226 USPQ 1, 4 (Fed. Cir. 1985). A contract for the sale of goods requires a concrete offer and acceptance of that offer. See, e.g., Linear Tech., 275 F.3d at 1052-54, 61 USPQ2d at 1233-34 (Court held there was no sale within the meaning of 35 U.S.C. 102(b) where prospective purchaser submitted an order for goods at issue, but received an order acknowledgement reading “will advise-not booked.” Prospective purchaser would understand that order was not accepted.).

A. Conditional Sale May Bar a Patent

An invention may be deemed to be “on sale” even though the sale was conditional. The fact that the sale is conditioned on buyer satisfaction does not, without more, prove that the sale was for an experimental purpose. Strong v. General Elec. Co., 434 F.2d 1042, 1046, 168 USPQ 8, 12 (5th Cir. 1970).

B. Nonprofit Sale May Bar a Patent

A “sale” need not be for profit to bar a patent. If the sale was for the commercial exploitation of the invention, it is “on sale” within the meaning of 35 U.S.C. 102(b). In re Dybel, 524 F.2d 1393, 1401, 187 USPQ 593, 599 (CCPA 1975) (“Although selling the devices for a profit would have demonstrated the purpose of commercial exploitation, the fact that appellant realized no profit from the sales does not demonstrate the contrary.”).

C. A Single Sale or Offer To Sell May Bar a Patent

Even a single sale or offer to sell the invention may bar patentability under 35 U.S.C. 102(b). Consolidated Fruit-Jar Co. v. Wright, 94 U.S. 92, 94 (1876); Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834, 836-37, 23 USPQ2d 1481, 1483 (Fed. Cir. 1992).

D.A Sale of Rights Is Not a Sale of the Invention and Will Not in Itself Bar a Patent

“[A]n assignment or sale of the rights in the invention and potential patent rights is not a sale of ‘the invention’ within the meaning of section 102(b).” Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1267, 229 USPQ 805, 809 (Fed. Cir. 1986); see also Elan Corp., PLC v. Andrx Pharms. Inc., 366 F.3d 1336, 1341, 70 USPQ2d 1722, 1728 (Fed. Cir. 2004); In re Kollar, 286 F.3d 1326, 1330 n.3, 1330-1331, 62 USPQ2d 1425, 1428 n.3, 1428-1429 (Fed. Cir. 2002) (distinguishing licenses which trigger the on-sale bar (e.g., a standard computer software license wherein the product is just as immediately transferred to the licensee as if it were sold), from licenses that merely grant rights to an invention which do not per se trigger the on-sale bar (e.g., exclusive rights to market the invention or potential patent rights)); Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 1049 n. 2, 59 USPQ2d 1121, 1129 n. 2 (Fed. Cir. 2001).

E. Buyer Must Be Uncontrolled by the Seller or Offerer

A sale or offer for sale must take place between separate entities. In re Caveney, 761 F.2d 671, 676, 226 USPQ 1, 4 (Fed. Cir. 1985). “Where the parties to the alleged sale are related, whether there is a statutory bar depends on whether the seller so controls the purchaser that the invention remains out of the public’s hands. Ferag AG v. Quipp, Inc., 45 F.3d 1562, 1566, 33 USPQ2d 1512, 1515 (Fed. Cir. 1995) (Where the seller is a parent company of the buyer company, but the President of the buyer company had “essentially unfettered” management authority over the operations of the buyer company, the sale was a statutory bar.).

II. OFFERS FOR SALE[edit | edit source]

“Only an offer which rises to the level of a commercial offer for sale, one which the other party could make into a binding contract by simple acceptance (assuming consideration), constitutes an offer for sale under §102(b).” Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041,1048, 59 USPQ2d 1121, 1126 (Fed. Cir. 2001).

A. Rejected or Unreceived Offer for Sale Is Enough To Bar a Patent

Since the statute creates a bar when an invention is placed “on sale,” a mere offer to sell is sufficient commercial activity to bar a patent. In re Theis, 610 F.2d 786, 791, 204 USPQ 188, 192 (CCPA 1979). Even a rejected offer may create an on sale bar. UMC Elecs. v. United States, 816 F.2d 647, 653, 2 USPQ2d 1465, 1469 (Fed. Cir. 1987). In fact, the offer need not even be actually received by a prospective purchaser. Wende v. Horine, 225 F. 501 (7th Cir. 1915).

B. Delivery of the Offered Item Is Not Required

“It is not necessary that a sale be consummated for the bar to operate.” Buildex v. Kason Indus., Inc., 849 F.2d 1461, 1463-64, 7 USPQ2d 1325, 1327-28 (Fed. Cir. 1988) (citations omitted). See also Weatherchem Corp. v. J.L. Clark Inc., 163 F.3d 1326, 1333, 49 USPQ2d 1001, 1006-07 (Fed. Cir. 1998) (A signed purchase agreement prior to the critical date constituted a commercial offer; it was immaterial that there was no delivery of later patented caps and no exchange of money until after critical date.).

C. Seller Need Not Have the Goods “On Hand” when the Offer for Sale Is Made

Goods need not be “on hand” and transferred at the time of the sale or offer. The date of the offer for sale is the effective date of the “on sale” activity. J. A. La Porte, Inc. v. Norfolk Dredging Co., 787 F.2d 1577, 1582, 229 USPQ 435, 438 (Fed. Cir. 1986). However, the invention must be complete and “ready for patenting” (see MPEP § 2133.03(c)) before the critical date. Pfaff v. Wells Elecs., Inc. , 525 U.S. 55, 67, 119 S.Ct. 304, 311-12, 48 USPQ2d 1641, 1647 (1998). See also Micro Chemical, Inc. v. Great Plains Chemical Co., 103 F.3d 1538, 1545, 41 USPQ2d 1238, 1243 (Fed. Cir. 1997) (The on-sale bar was not triggered by an offer to sell because the inventor “was not close to completion of the invention at the time of the alleged offer and had not demonstrated a high likelihood that the invention would work for its intended purpose upon completion.”); Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 225 USPQ 634 (Fed. Cir. 1985) (Where there was no evidence that the samples shown to the potential customers were made by the new process and apparatus, the offer to sell did not rise to the level of an on sale bar.). Compare Barmag Barmer Maschinenfabrik AG v. Murata Mach., Ltd., 731 F.2d 831, 221 USPQ 561 (Fed. Cir. 1984) (Where a “make shift” model of the inventive product was shown to the potential purchasers in conjunction with the offer to sell, the offer was enough to bar a patent under 35 U.S.C. 102(b).).

D. Material Terms of an Offer for Sale Must be Present

“[A] communication that fails to constitute a definite offer to sell the product and to include material terms is not an ‘offer’ in the contract sense.” Elan Corp., PLC v. Andrx Pharms. Inc., 366 F.3d 1336, 1341, 70 USPQ2d 1722, 1728 (Fed. Cir. 2004). The court stated that an “offer to enter into a license under a patent for future sale of the invention covered by the patent when and if it has been developed... is not an offer to sell the patented invention that constitutes an on-sale bar.” Id., 70 USPQ2d at 1726. Accordingly, the court concluded that Elan’s letter was not an offer to sell a product. In addition, the court stated that the letter lacked material terms of a commercial offer such as pricing for the product, quantities, time and place of delivery, and product specifications and that the dollar amount in the letter was not a price term for the sale of the product but rather the amount requested was to form and continue a partnership, explicitly referred to as a “licensing fee.” Id.

III.SALE BY INVENTOR, ASSIGNEE OR OTHERS ASSOCIATED WITH THE INVENTOR IN THE COURSE OF BUSINESS[edit | edit source]

A. Sale Activity Need Not Be Public

Unlike questions of public use, there is no requirement that “on sale” activity be “public.” “Public” as used in 35 U.S.C. 102(b) modifies “use” only. “Public” does not modify “sale.” Hobbs v. United States, 451 F.2d 849, 171 USPQ 713, 720 (5th Cir. 1971).

B. Inventor’s Consent to the Sale Is Not a Prerequisite To Finding an On Sale Bar

If the invention was placed on sale by a third party who obtained the invention from the inventor, a patent is barred even if the inventor did not consent to the sale or have knowledge that the invention was embodied in the sold article. Electric Storage Battery Co. v. Shimadzu, 307 U.S. 5, 41 USPQ 155 (1938); In re Blaisdell, 242 F.2d 779, 783, 113 USPQ 289, 292 (CCPA 1957); CTS Corp. v. Electro Materials Corp. of America, 469 F. Supp. 801, 819, 202 USPQ 22, 38 (S.D.N.Y. 1979).

C. Objective Evidence of Sale or Offer To Sell Is Needed

In determining if a sale or offer to sell the claimed invention has occurred, a key question to ask is whether the inventor sold or offered for sale a product that embodies the invention claimed in the application. Objective evidence such as a description of the inventive product in the contract of sale or in another communication with the purchaser controls over an uncommunicated intent by the seller to deliver the inventive product under the contract for sale. Ferag AG v. Quipp, Inc., 45 F.3d 1562, 1567, 33 USPQ2d 1512, 1516 (Fed. Cir. 1995) (On sale bar found where initial negotiations and agreement containing contract for sale neither clearly specified nor precluded use of the inventive design, but an order confirmation prior to the critical date did specify use of inventive design.). The purchaser need not have actual knowledge of the invention for it to be on sale. The determination of whether “the offered product is in fact the claimed invention may be established by any relevant evidence, such as memoranda, drawings, correspondence, and testimony of witnesses.” RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1060, 12 USPQ2d 1449, 1452 (Fed. Cir. 1989). However, “what the purchaser reasonably believes the inventor to be offering is relevant to whether, on balance, the offer objectively may be said to be of the patented invention.” Envirotech Corp. v. Westech Eng’g, Inc., 904 F.2d 1571, 1576, 15 USPQ2d 1230, 1234 (Fed. Cir. 1990) (Where a proposal to supply a general contractor with a product did not mention a new design but, rather, referenced a prior art design, the uncommunicated intent of the supplier to supply the new design if awarded the contract did not constitute an “on sale” bar to a patent on the new design, even though the supplier’s bid reflected the lower cost of the new design.).

IV. SALES BY INDEPENDENT THIRD PARTIES[edit | edit source]

A. Sales or Offers for Sale by Independent Third Parties Will Bar a Patent

Sale or offer for sale of the invention by an independent third party more than 1 year before the filing date of applicant’s patent will bar applicant from obtaining a patent. “An exception to this rule exists where a patented method is kept secret and remains secret after a sale of the unpatented product of the method. Such a sale prior to the critical date is a bar if engaged in by the patentee or patent applicant, but not if engaged in by another.” In re Caveney, 761 F.2d 671, 675-76, 226 USPQ 1, 3-4 (Fed. Cir. 1985).

B. Nonprior Art Publications Can Be Used as Evidence of Sale Before the Critical Date

Abstracts identifying a product’s vendor containing information useful to potential buyers such as whom to contact, price terms, documentation, warranties, training and maintenance along with the date of product release or installation before the inventor’s critical date may provide sufficient evidence of prior sale by a third party to support a rejection based on 35 U.S.C. 102(b) or 103. In re Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed. Cir. 1994) (Examiner's rejection was based on nonprior art published abstracts which disclosed software products meeting the claims. The abstracts specified software release dates and dates of first installation which were more than 1 year before applicant’s filing date.).

2133.03(c) The “Invention”[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

.          .          .

(b) the invention was in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States

(Emphasis added).

I. The Invention Must Be “Ready for Patenting”[edit | edit source]

The Supreme Court's two-prong test for determining whether an invention was "on sale" within the meaning of 35 U.S.C. 102(b) even if it has not yet been reduced to practice:

  • The on-sale bar applies when two conditions are satisfied before the critical date [more than one year before the effective filing date of the U.S. application]:
    1. the product must be the subject of a commercial offer for sale; and
    2. the invention must be ready for patenting.”

Relevant case:

The Federal Circuit explained that the Supreme Court's "ready for patenting" prong applies in the context of both the on sale and public use bars. Invitrogen Corp. v. Biocrest Manuf., 424 F.3d 1374, 1379, 76 USPQ2d 1741, 1744 (Fed. Cir. 2005)

“Ready for patenting” may be satisfied in at least two ways:

  1. by proof of reduction to practice before the critical date; or
  2. by proof that prior to the critical date, the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.

If the invention was actually reduced to practice before being sold or offered for sale more than 1 year before filing of the application, a patent will be barred.

Actual reduction to practice in the context of an on-sale bar issue usually requires testing under actual working conditions in such a way as to demonstrate the practical utility of an invention for its intended purpose beyond the probability of failure, unless by virtue of the very simplicity of an invention its practical operativeness is clear.

The invention need not be ready for satisfactory commercial marketing for sale to bar a patent.

II. INVENTOR HAS SUBMITTED A 37 CFR 1.131 AFFIDAVIT OR DECLARATION[edit | edit source]

Affidavits or declarations submitted under 37 CFR 1.131 to swear behind a reference may constitute, among other things, an admission that an invention was “complete” more than 1 year before the filing of an application. See MPEP § 715.10.

III. SALE OF A PROCESS[edit | edit source]

A claimed process, which is a series of acts or steps, is not sold in the same sense as is a claimed product, device, or apparatus, which is a tangible item. "Know-how" describing what the process consists of and how the process should be carried out may be sold in the sense that the buyer acquires knowledge of the process and obtains the freedom to carry it out pursuant to the terms of the transaction. However, such a transaction is not a ‘sale’ of the invention within the meaning of §102(b) because the process has not been carried out or performed as a result of the transaction.

However, sale of a product made by the claimed process by the patentee or a licensee would constitute a sale of the process within the meaning of 35 U.S.C. 102(b). Even though such a sale of a product made by a claimed method before the critical date may not reveal anything about the method to the public, the sale could result in a "forfeiture" of any right to a patent to that method)

Relevant cases:

The application of 35 U.S.C. 102(b) would also be triggered by actually performing the claimed process itself for consideration. Moreover, the sale of a device embodying a claimed process may trigger the on-sale bar. However, the sale of a prior art device different from that disclosed in a patent that is asserted after the critical date to be capable of performing the claimed method is not an on-sale bar of the process.

2133.03(d) "In This Country"[edit | edit source]

For purposes of judging the applicability of the 35 U.S.C. 102(b) bars, public use or on sale activity must take place in the United States. The “on sale” bar does not generally apply where both manufacture and delivery occur in a foreign country. However, “on sale” status can be found if substantial activity prefatory to a “sale” occurs in the United States.

An offer for sale, made or originating in this country, may be sufficient prefatory activity to bring the offer within the terms of the statute, even though sale and delivery take place in a foreign country. The same rationale applies to an offer by a foreign manufacturer which is communicated to a prospective purchaser in the United States prior to the critical date.

2133.03(e) Permitted Activity; Experimental Use[edit | edit source]

The question posed by the experimental use doctrine is “whether the primary purpose of the inventor at the time of the sale, as determined from an objective evaluation of the facts surrounding the transaction, was to conduct experimentation.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1354, 63 USPQ2d 1769, 1780 (Fed. Cir. 2002), quoting EZ Dock v. Schafer Sys., Inc., 276 F.3d 1347, 1356-57, 61 USPQ2d 1289, 1295-96 (Fed. Cir. 2002) (Linn, J., concurring). Experimentation must be the primary purpose and any commercial exploitation must be incidental.

If the use or sale was experimental, there is no bar under 35 U.S.C. 102(b). “A use or sale is experimental for purposes of section 102(b) if it represents a bona fide effort to perfect the invention or to ascertain whether it will answer its intended purpose.…If any commercial exploitation does occur, it must be merely incidental to the primary purpose of the experimentation to perfect the invention.” LaBounty Mfg. v. United States Int’l Trade Comm’n, 958 F.2d 1066, 1071, 22 USPQ2d 1025, 1028 (Fed. Cir. 1992) (quoting Pennwalt Corp. v. Akzona Inc., 740 F.2d 1573, 1581, 222 USPQ 833, 838 (Fed. Cir. 1984)). “The experimental use exception…does not include market testing where the inventor is attempting to gauge consumer demand for his claimed invention. The purpose of such activities is commercial exploitation and not experimentation.” In re Smith, 714 F.2d 1127, 1134, 218 USPQ 976, 983 (Fed. Cir. 1983).

2133.03(e)(1) Commercial Exploitation[edit | edit source]

One policy of the on sale and public use bars is the prevention of inventors from exploiting their inventions commercially more than 1 year prior to the filing of a patent application. Therefore, if applicant’s precritical date activity isa sale or offer for sale that is an attempt at market penetration, a patent is barred. Thus, even if there is bona fide experimental activity, an inventor may not commercially exploit an invention more than 1 year prior to the filing date of an application. In re Theis, 610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA 1979).

THE COMMERCIAL ACTIVITY MUST LEGITIMATELY ADVANCE DEVELOPMENT OF THE INVENTION TOWARDS COMPLETION

As the degree of commercial exploitation surrounding 35 U.S.C. 102(b) activity increases, the burden on an applicant to establish clear and convincing evidence of experimental activity with respect to a public use becomes more difficult. Where the examiner has found a prima facie case of a sale or an offer to sell, this burden will rarely be met unless clear and convincing necessity for the experimentation is established by the applicant. This does not mean, of course, that there are no circumstances which would permit alleged experimental activity in an atmosphere of commercial exploitation. In certain circumstances, even a sale may be necessary to legitimately advance the experimental development of an invention if the primary purpose of the sale is experimental. In re Theis, 610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA 1979); Robbins Co. v. Lawrence Mfg. Co., 482 F.2d 426, 433, 178 USPQ 577, 582 (9th Cir. 1973). However, careful scrutiny by the examiner of the objective factual circumstances surrounding such a sale is essential. See Ushakoff v. United States, 327 F.2d 669, 140 USPQ 341 (Ct.Cl. 1964); Cloud v. Standard Packaging Corp., 376 F.2d 384, 153 USPQ 317 (7th Cir. 1967).

SIGNIFICANT FACTORS INDICATIVE OF “COMMERCIAL EXPLOITATION”

As discussed in MPEP § 2133.03, a policy consideration in questions of 35 U.S.C. 102(b) activity is premature “commercial exploitation” of a “completed” or “ready for patenting” invention (see MPEP § 2133.03(c)). The extent of commercial activity which constitutes 35 U.S.C. 102(b) “on sale” status depends upon the circumstances of the activity, the basic indicator being the subjective intent of the inventor as manifested through objective evidence. The following activities should be used by the examiner as indicia of this subjective intent:

(A) Preparation of various contemporaneous “commercial” documents, e.g., orders, invoices, receipts, delivery schedules, etc.;

(B) Preparation of price lists;

(C) Display of samples to prospective customers;

(D) Demonstration of models or prototypes;

(E) Use of an invention where an admission fee is charged ; and

(F) Advertising in publicity releases, brochures, and various periodicals.

See MPEP § 2133.03(e)(4) for factors indicative of an experimental purpose.

2133.03(e)(2) Intent[edit | edit source]

“When sales are made in an ordinary commercial environment and the goods are placed outside the inventor’s control, an inventor’s secretly held subjective intent to ‘experiment,’ even if true, is unavailing without objective evidence to support the contention. Under such circumstances, the customer at a minimum must be made aware of the experimentation.” LaBounty Mfg., Inc. v. United States Int’l Trade Comm’n, 958 F.2d 1066, 1072, 22 USPQ2d 1025, 1029 (Fed. Cir. 1992) (quoting Harrington Mfg. Co. v. Powell Mfg. Co., 815 F.2d 1478, 1480 n.3, 2 USPQ2d 1364, 1366 n.3 (Fed. Cir. 1986); Paragon Podiatry Laboratory, Inc. v. KLM Labs., Inc., 984 F.2d 1182, 25 USPQ2d 1561 (Fed. Cir. 1993) (Paragon sold the inventive units to the trade as completed devices without any disclosure to either doctors or patients of their involvement in alleged testing. Evidence of the inventor’s secretly held belief that the units were not durable and may not be satisfactory for consumers was not sufficient, alone, to avoid a statutory bar.).

2133.03(e)(3) "Completeness" of the Invention[edit | edit source]
I. EXPERIMENTAL USE ENDS WHEN THE INVENTION IS ACTUALLY REDUCED TO PRACTICE[edit | edit source]

Experimental use “means perfecting or completing an invention to the point of determining that it will work for its intended purpose.” Therefore, experimental use “ends with an actual reduction to practice.” RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1061, 12 USPQ2d 1449, 1453 (Fed. Cir. 1989). If the examiner concludes from the evidence of record that an applicant was satisfied that an invention was in fact “complete,” awaiting approval by the applicant from an organization such as Underwriters’ Laboratories will not normally overcome this conclusion. InterRoyal Corp. v. Simmons Co., 204 USPQ 562, 566 (S.D.N.Y. 1979); Skil Corp. v. Rockwell Manufacturing Co., 358 F. Supp. 1257, 1261, 178 USPQ 562, 565 (N.D.Ill. 1973), aff’d. in part, rev’d in part sub nom. Skil Corp. v. Lucerne Products Inc., 503 F.2d 745, 183 USPQ 396, 399 (7th Cir. 1974), cert. denied, 420 U.S. 974, 185 USPQ 65 (1975). See MPEP § 2133.03(c) for more information of what constitutes a “complete” invention.

The fact that alleged experimental activity does not lead to specific modifications or refinements of an invention is evidence, although not conclusive evidence, that such activity is not within the realm permitted by the statute. This is especially the case where the evidence of record clearly demonstrates to the examiner that an invention was considered “complete” by an inventor at the time of the activity. Nevertheless, any modifications or refinements which did result from such experimental activity must at least be a feature of the claimed invention to be of any probative value. In re Theis, 610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA 1979).

II. DISPOSAL OF PROTOTYPES[edit | edit source]

Where a prototype of an invention has been disposed of by an inventor before the critical date, inquiry by the examiner should focus upon the intent of the inventor and the reasonableness of the disposal under all circumstances. The fact that an otherwise reasonable disposal of a prototype involves incidental income is not necessarily fatal. In re Dybel, 524 F.2d 1393, 1399, n.5, 187 USPQ 593, 597 n.5 (CCPA 1975). However, if a prototype is considered “complete” by an inventor and all experimentation on the underlying invention has ceased, unrestricted disposal of the prototype constitutes a bar under 35 U.S.C. 102(b). In re Blaisdell, 242 F.2d 779, 113 USPQ 289 (CCPA 1957); contra, Watson v. Allen, 254 F.2d 342, 117 USPQ 68 (D.C. Cir. 1958).

2133.03(e)(4) Factors Indicative of an Experimental Purpose[edit | edit source]

The courts have considered a number of factors in determining whether a claimed invention was the subject of a commercial offer for sale primarily for purposes of experimentation. “These factors include: (1) the necessity for public testing, (2) the amount of control over the experiment retained by the inventor, (3) the nature of the invention, (4) the length of the test period, (5) whether payment was made, (6) whether there was a secrecy obligation, (7) whether records of the experiment were kept, (8) who conducted the experiment, ... (9) the degree of commercial exploitation during testing[,] ... (10) whether the invention reasonably requires evaluation under actual conditions of use, (11) whether testing was systematically performed, (12) whether the inventor continually monitored the invention during testing, and (13) the nature of contacts made with potential customers.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353, 63 USPQ2d 1769, 1780 (Fed. Cir. 2002) quoting EZ Dock v. Schafer Sys., Inc., 276 F.3d 1347, 1357, 61 USPQ2d 1289, 1296 (Fed. Cir. 2002) (Linn, J., concurring). Another critical attribute of experimentation is the “customer’s awareness of the purported testing in the context of a sale.” Electromotive Div. of Gen. Motors Corp. v. Transportation Sys. Div. of Gen. Elec. Co., 417 F.3d 1203, 1241, 75 USPQ2d 1650, 1658 (Fed. Cir. 2005).

Once alleged experimental activity is advanced by an applicant to explain a prima facie case under 35 U.S.C. 102(b), the examiner must determine whether the scope and length of the activity were reasonable in terms of the experimental purpose intended by the applicant and the nature of the subject matter involved. No one of, or particular combination of, factors is necessarily determinative of this purpose.

See MPEP § 2133.03(e)(1) for factors indicative of commercial exploitation.

2133.03(e)(5) Experimentation and Degree of Supervision and Control[edit | edit source]

THE INVENTOR MUST MAINTAIN SUFFICIENT CONTROL OVER THE INVENTION DURING TESTING BY THIRD PARTIES

The significant determinative factors in questions of experimental purpose are the extent of supervision and control maintained by an inventor over an invention during an alleged period of experimentation , and the customer’s awareness of the experimentation. Electromotive Div. of Gen. Motors Corp. v. Transportation Sys. Div. of Gen. Elec. Co., 417 F.3d 1203, 1214,75 USPQ2d 1650, 1658 (Fed. Cir. 2005)(“control and customer awareness ordinarily must be proven if experimentation is to be found”). Once a period of experimental activity has ended and supervision and control has been relinquished by an inventor without any restraints on subsequent use of an invention, an unrestricted subsequent use of the invention is a 35 U.S.C. 102(b) bar. In re Blaisdell, 242 F.2d 779, 784, 113 USPQ 289, 293 (CCPA 1957).

2133.03(e)(6) Permitted Experimental Activity and Testing[edit | edit source]
I. DEVELOPMENTAL TESTING IS PERMITTED[edit | edit source]

Testing of an invention in the normal context of its technological development is generally within the realm of permitted experimental activity. Likewise, experimentation to determine utility, as that term is applied in 35 U.S.C. 101, may also constitute permissible activity. See General Motors Corp. v. Bendix Aviation Corp., 123 F. Supp. 506, 521, 102 USPQ 58, 69 (N.D.Ind. 1954). For example, where an invention relates to a chemical composition with no known utility, i.e., a patent application for the composition could not be filed (35 U.S.C. 101; 35 U.S.C. 112, first paragraph), continued testing to find utility would likely be permissible under 35 U.S.C. 102(b), absent a sale of the composition or other evidence of commercial exploitation.

II. MARKET TESTING IS NOT PERMITTED[edit | edit source]

Experimentation to determine product acceptance, i.e., market testing, is typical of a trader’s and not an inventor’s experiment and is thus not within the area of permitted experimental activity. Smith & Davis Mfg. Co. v. Mellon, 58 F. 705, 707 (8th Cir. 1893) Likewise, testing of an invention for the benefit of appeasing a customer, or to conduct “minor ‘tune up’ procedures not requiring an inventor’s skills, but rather the skills of a competent technician,” are also not within the exception. In re Theis, 610 F.2d 786, 793, 204 USPQ 188, 193-94 (CCPA 1979).

III. EXPERIMENTAL ACTIVITY IN THE CONTEXT OF DESIGN APPLICATIONS[edit | edit source]

The public use of an ornamental design which is directed toward generating consumer interest in the aesthetics of the design is not an experimental use. In re Mann, 861 F.2d 1581, 8 USPQ2d 2030 (Fed. Cir. 1988) (display of a wrought iron table at a trade show held to be public use). However, “experimentation directed to functional features of a product also containing an ornamental design may negate what otherwise would be considered a public use within the meaning of section 102(b).” Tone Brothers, Inc. v. Sysco Corp., 28 F.3d 1192, 1196, 31 USPQ2d 1321, 1326 (Fed. Cir. 1994) (A study wherein students evaluated the effect of the functional features of a spice container design may be considered an experimental use.).

2133.03(e)(7) Activity of an Independent Third Party Inventor[edit | edit source]

EXPERIMENTAL USE EXCEPTION IS PERSONAL TO AN APPLICANT

The statutory bars of 35 U.S.C. 102(b) are applicable even though public use or on sale activity is by a party other than an applicant. Where an applicant presents evidence of experimental activity by such other party, the evidence will not overcome the prima faciecase under 35 U.S.C. 102(b) based upon the activity of such party unless the activity was under the supervision and control of the applicant. Magnetics v. Arnold Eng’g Co., 438 F.2d 72, 74, 168 USPQ 392, 394 (7th Cir. 1971), Bourne v. Jones, 114 F.Supp. 413, 419, 98 USPQ 206, 210 (S.D. Fla. 1951), aff'd., 207 F.2d 173, 98 USPQ 205 (5th Cir. 1953), cert. denied, 346 U.S. 897, 99 USPQ 490 (1953); contra, Watson v. Allen, 254 F.2d 342, 117 USPQ 68 (D.C.Cir. 1957). In other words, the experimental use activity exception is personal to an applicant.



2134 35 U.S.C. 102(c)[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

.          .          .

(c)he has abandoned the invention.

.          .          .


UNDER 35 U.S.C. 102(c), AN ABANDONMENT MUST BE INTENTIONAL

"Actual abandonment under 35 U.S.C. 102(c) requires that the inventor intend to abandon the invention, and intent can be implied from the inventor’s conduct with respect to the invention. In re Gibbs, 437 F.2d 486, 168 USPQ 578 (CCPA 1971). Such intent to abandon the invention will not be imputed, and every reasonable doubt should be resolved in favor of the inventor." Ex parte Dunne, 20 USPQ2d 1479 (Bd. Pat. App. & Inter. 1991).

DELAY IN MAKING FIRST APPLICATION

Abandonment under 35 U.S.C. 102(c) requires a deliberate, though not necessarily express, surrender of any rights to a patent. To abandon the invention the inventor must intend a dedication to the public. Such dedication may be either express or implied, by actions or inactions of the inventor. Delay alone is not sufficient to infer the requisite intent to abandon. Moore v. United States, 194 USPQ 423, 428 (Ct. Cl. 1977) (The drafting and retention in his own files of two patent applications by inventor indicates an intent to retain his invention; delay in filing the applications was not sufficient to establish abandonment); but see Davis Harvester Co., Inc. v. Long Mfg. Co., 252 F. Supp. 989, 1009-10, 149 USPQ 420, 435-436 (E.D. N.C. 1966) (Where the inventor does nothing over a period of time to develop or patent his invention, ridicules the attempts of another to develop that invention and begins to show active interest in promoting and developing his invention only after successful marketing by another of a device embodying that invention, the inventor has abandoned his invention under 35 U.S.C. 102(c).).

DELAY IN REAPPLYING FOR PATENT AFTER ABANDONMENT OF PREVIOUS PATENT APPLICATION

Where there is no evidence of expressed intent or conduct by inventor to abandon his invention, delay in reapplying for patent after abandonment of a previous application does not constitute abandonment under 35 U.S.C. 102(c). Petersen v. Fee Int’l, Ltd., 381 F. Supp. 1071, 182 USPQ 264 (W.D. Okla. 1974).

DISCLOSURE WITHOUT CLAIMING IN A PRIOR ISSUED PATENT

Any inference of abandonment (i.e., intent to dedicate to the public) of subject matter disclosed but not claimed in a previously issued patent is rebuttable by an application filed at any time before a statutory bar arises. Accordingly, a rejection of a claim of a patent application under 35 U.S.C. 102(c) predicated solely on the issuance of a patent which discloses the subject matter of the claim in the application without claiming it would be improper, regardless of whether there is copendency between the application at issue and the application which issued as the patent. In re Gibbs, 437 F.2d 486, 168 USPQ 578 (CCPA 1971).

ONLY WHEN THERE IS A PRIORITY CON- TEST CAN A LAPSE OF TIME BAR A PATENT

The mere lapse of time will not bar a patent. The only exception is when there is a priority contest under 35 U.S.C. 102(g) and applicant abandons, suppresses or conceals the invention. Panduit Corp. v. Dennison Mfg. Co., 774 F.2d 1082, 1101, 227 USPQ 337, 350 (Fed. Cir. 1985). Abandonment, suppression and concealment are treated by the courts under 35 U.S.C. 102(g). See MPEP § 2138.03 for more information on this issue.


2135 35 U.S.C. 102(d)[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

.          .          .

(d) the invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor’s certificate filed more than twelve months before the filing of the application in the United States.

.          .          .


GENERAL REQUIREMENTS OF 35 U.S.C. 102(d)

35 U.S.C. 102(d) establishes four conditions which, if all are present, establish a bar against the granting of a patent in this country:

(A) The foreign application must be filed more than 12 months before the effective U.S. filing date (See MPEP § 706.02 regarding effective U.S. filing date of an application);

(B) The foreign application must have been filed by the same applicant as in the United States or by his or her legal representatives or assigns.

(C) The foreign patent or inventor’s certificate must be actually granted (e.g., by sealing of the papers in Great Britain) before the U.S. filing date. It need not be published.

(D) The same invention must be involved.

If such a foreign patent or inventor’s certificate is discovered by the examiner, the rejection is made under 35 U.S.C. 102(d) on the ground of statutory bar.

See MPEP § 2135.01 for further clarification of each of the four requirements of 35 U.S.C. 102(d).

2135.01 The Four Requirements of 35 U.S.C. 102(d)[edit | edit source]

I.FOREIGN APPLICATION MUST BE FILED MORE THAN 12 MONTHS BEFORE THE EFFECTIVE U.S. FILING DATE

A.An Anniversary Date Ending on a Weekend or Holiday Results in an Extension to the Next Business Day

The U.S. application is filed in time to prevent a 35 U.S.C. 102(d) bar from arising if it is filed on the 1 year anniversary date of the filing date of the foreign application. If this day is a Saturday, Sunday or Federal holiday, the year would be extended to the following business day. See Ex parte Olah, 131 USPQ 41 (Bd. App. 1960.) Despite changes to 37 CFR 1.6(a)(2) and 1.10, which require the PTO to accord a filing date to an application as of the date of deposit as “Express Mail” with the U.S. Postal Service in accordance with 37 CFR 1.10 (e.g., a Saturday filing date), the rule changes do not affect applicant’s concurrent right to defer the filing of an application until the next business day when the last day for “taking any action” falls on a Saturday, Sunday, or a Federal holiday (e.g., the last day of the 1-year grace period falls on a Saturday).


B.A Continuation-in-Part Breaks the Chain of Priority as to Foreign as Well as U.S. Parents

In the case where applicant files a foreign application, later files a U.S. application claiming priority based on the foreign application, and then files a continuation- in-part (CIP) application whose claims are not entitled to the filing date of the U.S. parent, the effective filing date is the filing date of the CIP and applicant cannot obtain the benefit of either the U.S. parent or foreign application filing dates.

If the foreign application issues into a patent before the filing date of the CIP, it may be used in a 35 U.S.C. 102(d)/103 rejection if the subject matter added to the CIP does not render the claims nonobvious over the foreign patent. Ex parte Appeal No. 242-47, 196 USPQ 828 (Bd. App. 1976) (Foreign patent can be combined with other prior art to bar a U.S. patent in an obviousness rejection based on 35 U.S.C. 102(d)/103).

II.FOREIGN APPLICATION MUST HAVE BEEN FILED BY SAME APPLICANT, HIS OR HER LEGAL REPRESENTATIVE OR ASSIGNS

Note that where the U.S. application was made by two or more inventors, it is permissible for these inventors to claim priority from separate applications, each to one of the inventors or a subcombination of inventors. For instance, a U.S. application naming inventors A and B may be entitled to priority from one application to A and one to B filed in a foreign country.

III.THE FOREIGN PATENT OR INVENTOR’S CERTIFICATE WAS ACTUALLY GRANTED BEFORE THE U.S. FILING DATE

A.To Be "Patented" an Exclusionary Right Must Be Awarded to the Applicant

"Patented" means "a formal bestowal of patent rights from the sovereign to the applicant." In re Monks, 588 F.2d 308, 310, 200 USPQ 129, 131 (CCPA 1978); American Infra-Red Radiant Co. v. Lambert Indus., 360 F.2d 977, 149 USPQ 722 (8th Cir.), cert. denied, 385 U.S. 920 (1966) (German Gebrauchsmuster petty patent was held to be a patent usable in a 35 U.S.C. 102(d) rejection. Gebrauchmustern are not examined and only grant a 6-year patent term. However, except as to duration, the exclusionary patent right granted is as extensive as in the U.S.).

B.A Published Application Is Not a "Patent"

An application must issue into a patent before it can be applied in a 35 U.S.C. 102(d) rejection. Ex parte Fujishiro, 199 USPQ 36 (Bd. App. 1977) (“Patenting,” within the meaning of 35 U.S.C. 102(d), does not occur upon laying open of a Japanese utility model application (kokai or kohyo)); Ex parte Links, 184 USPQ 429 (Bd. App. 1974) (German applications, which have not yet been published for opposition, are published in the form of printed documents called Offenlegungsschriften 18 months after filing. These applications are unexamined or in the process of being examined at the time of publication. The Board held that an Offenlegungsschrift is not a patent under 35 U.S.C. 102(d) even though some provisional rights are granted. The Board explained that the provisional rights are minimal and do not come into force if the application is withdrawn or refused.).

C.An Allowed Application Can Be a "Patent" for Purposes of 35 U.S.C. 102(d) as of the Date Published for Opposition Even Though It Has Not Yet Been Granted as a Patent

An examined application which has been allowed by the examiner and published to allow the public to oppose the grant of a patent has been held to be a "patent" for purposes of rejection under 35 U.S.C. 102(d) as of the date of publication for opposition if substantial provisional enforcement rights arise. Ex parte Beik, 161 USPQ 795 (Bd. App. 1968) (This case dealt with examined German applications. After a determination that an application is allowable, the application is published in the form of a printed document called an Auslegeschrift. The publication begins a period of opposition were the public can present evidence showing unpatentability. Provisional patent rights are granted which are substantially the same as those available once the opposition period is over and the patent is granted. The Board found that an Auslegeschrift provides the legal effect of a patent for purposes of rejection under 35 U.S.C. 102(d).).

D.Grant Occurs When Patent Becomes Enforceable

The critical date of a foreign patent as a reference under 35 U.S.C. 102(d) is the date the patent becomes enforceable (issued, sealed or granted). In re Monks, 588 F.2d 308, 310, 200 USPQ 129, 131 (CCPA 1978) (British reference became available as prior art on date the patent was “sealed” because as of this date applicant had the right to exclude others from making, using or selling the claimed invention.).

E.35 U.S.C. 102(d) Applies as of Grant Date Even If There Is a Period of Secrecy After Patent Grant

A period of secrecy after granting the patent, as in Belgium and Spain, has been held to have no effect in connection with 35 U.S.C. 102(d). These patents are usable in rejections under 35 U.S.C. 102(d) as of the date patent rights are granted. In re Kathawala, 9 F.3d 942, 28 USPQ2d 1789 (Fed. Cir. 1993) (An invention is “patented” for purposes of 35 U.S.C. 102(d) when the patentee’s rights under the patent become fixed. The fact that applicant’s Spanish application was not published until after the U.S. filing date is immaterial since the Spanish patent was granted before U.S. filing.); Gramme Elec. Co. v. Arnoux and Hochhausen Elec. Co., 17 F. 838, 1883 C.D. 418 (S.D.N.Y. 1883) (Rejection made under a predecessor of 35 U.S.C. 102(d) based on an Austrian patent granted an exclusionary right for 1 year but was kept secret, at the option of the patentee, for that period. The court held that the Austrian patent grant date was the relevant date under the statute for purposes of 35 U.S.C. 102(d) but that the patent could not have been used to in a rejection under 35 U.S.C. 102(a) or (b).); In re Talbott, 443 F.2d 1397, 170 USPQ 281 (CCPA 1971) (Applicant cannot avoid a 35 U.S.C. 102(d) rejection by exercising an option to keep the subject matter of a German Gebrauchsmuster (petty patent) in secrecy until time of U.S. filing.).

IV.THE SAME INVENTION MUST BE INVOLVED

"Same Invention" Means That the Application Claims Could Have Been Presented in the Foreign Patent

Under 35 U.S.C. 102(d), the “invention... patented” in the foreign country must be the same as the invention sought to be patented in the U.S. When the foreign patent contains the same claims as the U.S. application, there is no question that “the invention was first patented... in a foreign country.” In re Kathawala, 9 F.3d 942, 945, 28 USPQ2d 1785, 1787 (Fed. Cir. 1993). However, the claims need not be identical or even within the same statutory class. If applicant is granted a foreign patent which fully discloses the invention and which gives applicant a number of different claiming options in the U.S., the reference in 35 U.S.C. 102(d) to "'invention... patented' necessarily includes all the disclosed aspects of the invention. Thus, the section 102(d) bar applies regardless whether the foreign patent contains claims to less than all aspects of the invention." 9 F.3d at 946, 28 USPQ2d at 1788. In essence, a 35 U.S.C. 102(d) rejection applies if applicant’s foreign application supports the subject matter of the U.S. claims. In re Kathawala, 9 F.3d 942, 28 USPQ2d 1785 (Fed. Cir. 1993) (Applicant was granted a Spanish patent claiming a method of making a composition. The patent disclosed compounds, methods of use and processes of making the compounds. After the Spanish patent was granted, the applicant filed a U.S. application with claims directed to the compound but not the process of making it. The Federal Circuit held that it did not matter that the claims in the U.S. application were directed to the composition instead of the process because the foreign specification would have supported claims to the composition. It was immaterial that the formulations were unpatentable pharmaceutical compositions in Spain.).


2136 35 U.S.C. 102(e)[edit | edit source]

35 U.S.C. 102(e) applies in the examination of all applications, and the reexamination of, or other proceedings to contest, all patents, with only one exception: when the potential reference is based on an international application filed prior to November 29, 2000.

The prior art date of a reference under 35 U.S.C. 102(e) may be the international filing date if the international filing date was on or after November 29, 2000, the international application designated the United States, and the international application was published by the World Intellectual Property Organization (WIPO) under the Patent Cooperation Treaty (PCT) Article 21(2) in the English language. See MPEP § 706.02(f)(1) for examination guidelines on the application of 35 U.S.C. 102(e).

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless-

.          .          .

(e) the invention was described in — (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.


As mentioned above, references based on international applications that were filed prior to November 29, 2000 are subject to the former (pre-AIPA) version of 35 U.S.C. 102(e) as set forth below.

Former 35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless-

.          .          .

(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.

I. STATUTORY INVENTION REGISTRATIONS (SIRs) ARE ELIGIBLE AS PRIOR ART UNDER 35 U.S.C. 102(e)[edit | edit source]

In accordance with 35 U.S.C. 157(c), a published SIR will be treated the same as a U.S. patent for all defensive purposes, usable as a reference as of its filing date in the same manner as a U.S. patent. A SIR is prior art under all applicable sections of 35 U.S.C. 102 including 35 U.S.C. 102(e). See MPEP § 1111.

II. DEFENSIVE PUBLICATIONS ARE NOT PRIOR ART AS OF THEIR FILING DATE[edit | edit source]

The Defensive Publication Program, available between April 1968 and May 1985, provided for the voluntary publication of the abstract of the technical disclosure of a pending application under certain conditions. A defensive publication is not a patent or an application publication under 35 U.S.C. 122(b); it is a publication. Therefore, it is prior art only as of its publication date. Ex parte Osmond, 191 USPQ 334 (Bd. App. 1973). See MPEP § 711.06(a) for more information on Defensive Publications.

2136.01 Status of U.S. Application as aReference[edit | edit source]

I. WHEN THERE IS NO COMMON ASSIGNEE OR INVENTOR, A U.S. APPLICATION MUST ISSUE AS A PATENT OR BE PUBLISHED AS A SIR OR AS AN APPLICATION PUBLICATION BEFORE IT IS AVAILABLE AS PRIOR ART UNDER 35 U.S.C. 102(e)[edit | edit source]

In addition to U.S. patents and SIRs, certain U.S. application publications and certain international application publications are also available as prior art under 35 U.S.C. 102(e) as of their effective U.S. filing dates (which will include certain international filing dates). See MPEP § 706.02(a).

II. WHEN THERE IS A COMMON ASSIGNEE OR INVENTOR, A PROVISIONAL 35 U.S.C. 102(e) REJECTION OVER AN EARLIER FILED UNPUBLISHED APPLICATION CAN BE MADE[edit | edit source]

Based on the assumption that an application will ripen into a U.S. patent (or into an application publication), it is permissible to provisionally reject a later application over an earlier filed, and unpublished, application under 35 U.S.C. 102(e) when there is a common assignee or inventor. In addition, a provisional 35 U.S.C. 102(e) rejection may be made if the earlier filed copending U.S. application has been published as redacted (37 CFR 1.217) and the subject matter relied upon in the rejection is not supported in the redacted publication of the patent application.

Such a provisional rejection “serves to put applicant on notice at the earliest possible time of the possible prior art relationship between copending applications” and gives applicant the fullest opportunity to overcome the rejection by amendment or submission of evidence. In addition, since both applications are pending and usually have the same assignee, more options are available to applicant for overcoming the provisional rejection than if the other application were already issued.

Note that provisional rejections over 35 U.S.C. 102(e) are only authorized when there is a common inventor or assignee, otherwise the copending application prior to publication must remain confidential.

For applications filed on or after November 29, 1999 or pending on or after December 10, 2004, a provisional rejection under 35 U.S.C. 103(a) using prior art under 35 U.S.C. 102(e) is not proper if the application contains evidence that the application and the prior art reference were owned by the same person, or subject to an obligation of assignment to the same person, at the time the invention was made.

In addition, certain non-commonly owned references may be disqualified from being applied in a rejection under 35 U.S.C. 103(a) due to the Cooperative Research and Technology Enhancement Act of 2004 (CREATE Act). The CREATE Act amended 35 U.S.C. 103(c) to provide that subject matter developed by another person shall be treated as owned by the same person or subject to an obligation of assignment to the same person for purposes of determining obviousness if certain conditions are met.

35 U.S.C. 103(c), as amended by the CREATE Act, continues to apply only to subject matter which qualifies as prior art under 35 U.S.C. 102(e), (f) or (g), and which is being relied upon in a rejection under 35 U.S.C. 103. It does not apply to or affect subject matter which is applied in a rejection under 35 U.S.C. 102 or a double patenting rejection (see MPEP 804). In addition, if the subject matter qualifies as prior art under any other subsection of 35 U.S.C. 102 (e.g., 35 U.S.C. 102(a) or (b)) it will not be disqualified as prior art under 35 U.S.C. 103(c).

2136.02 Content of the Prior Art Available Against the Claims[edit | edit source]

I. A 35 U.S.C. 102(e) REJECTION MAY RELY ON ANY PART OF THE PATENT OR APPLICATION PUBLICATION DISCLOSURE[edit | edit source]

Under 35 U.S.C. 102(e), the entire disclosure of a U.S. patent, a U.S. patent application publication, or an international application publication having an earlier effective U.S. filing date (which will include certain international filing dates) can be relied on to reject the claims.

II. REFERENCE MUST ITSELF CONTAIN THE SUBJECT MATTER RELIED ON IN THE REJECTION[edit | edit source]

When a U.S. patent, a U.S. patent application publication, or an international application publication is used to reject claims under 35 U.S.C. 102(e), the disclosure relied on in the rejection must be present in the issued patent or application publication. It is the earliest effective U.S. filing date (which will include certain international filing dates) of the U.S. patent or application publication being relied on as the critical reference date and subject matter not included in the patent or application publication itself can only be used when that subject matter becomes public. Portions of the patent application which were canceled are not part of the patent or application publication and thus cannot be relied on in a 35 U.S.C. 102(e) rejection over the issued patent or application publication.

Likewise, subject matter which is disclosed in a parent application, but not included in the child continuation- in-part (CIP) cannot be relied on in a 35 U.S.C. 102(e) rejection over the issued or published CIP.

III. THE SUPREME COURT HAS AUTHORIZED 35 U.S.C. 103 REJECTIONS BASED ON 35 U.S.C. 102(e)[edit | edit source]

U.S. patents may be used as of their filing dates to show that the claimed subject matter is anticipated or obvious. Obviousness can be shown by combining other prior art with the U.S. patent reference in a 35 U.S.C. 103 rejection.

Similarly, certain U.S. application publications and certain international application publications may also be used as of their earliest effective U.S. filing dates (which will include certain international filing dates) to show that the claimed subject matter would have been anticipated or obvious.

See MPEP § 706.02(l)(1) - § 706.02(l)(3) for additional information on rejections under 35 U.S.C. 103 and evidence of common ownership or a joint research agreement.

2136.03 Critical Reference Date[edit | edit source]

I. FOREIGN PRIORITY DATE[edit | edit source]

Reference’s Foreign Priority Date Under 35 U.S.C. 119(a)-(d) and (f) Cannot Be Used as the 35 U.S.C. 102(e) Reference Date

35 U.S.C. 102(e) is explicitly limited to certain references “filed in the United States before the invention thereof by the applicant” (emphasis added). Foreign applications’ filing dates that are claimed (via 35 U.S.C. 119(a) – (d), (f) or 365(a)) in applications, which have been published as U.S. or WIPO application publications or patented in the U.S., may not be used as 35 U.S.C. 102(e) dates for prior art purposes. This includes international filing dates claimed as foreign priority dates under 35 U.S.C. 365(a).Therefore, the foreign priority date of the reference under 35 U.S.C. 119(a)-(d) (f), and 365(a) cannot be used to antedate the application filing date. In contrast, applicant may be able to overcome the 35 U.S.C. 102(e) rejection by proving he or she is entitled to his or her own 35 U.S.C. 119 priority date which is earlier than the reference’s U.S. filing date. In re Hilmer, 359 F.2d 859, 149 USPQ 480 (CCPA 1966) (Hilmer I) (Applicant filed an application with a right of priority to a German application. The examiner rejected the claims over a U.S. patent to Habicht based on its Swiss priority date. The U.S. filing date of Habicht was later than the application’s German priority date. The court held that the reference’s Swiss priority date could not be relied on in a 35 U.S.C. 102(e) rejection. Because the U.S. filing date of Habicht was later than the earliest effective filing date (German priority date) of the application, the rejection was reversed.). See MPEP § 201.15 for information on procedures to be followed in considering applicant's right of priority.

Note that certain international application (PCT) filings are considered to be “filings in the United States” for purposes of applying an application publication as prior art. See MPEP § 706.02(a).

II. INTERNATIONAL (PCT) APPLICATIONS; INTERNATIONAL APPLICATION PUBLICATIONS[edit | edit source]

If the potential reference resulted from, or claimed the benefit of, an international application, the following must be determined:

(A) If the international application meets the following three conditions:

(1) an international filing date on or after November 29, 2000;

(2) designated the United States; and

(3) published under PCT Article 21(2) in English,

the international filing date is a U.S. filing date for prior art purposes under 35 U.S.C. 102(e). If such an international application properly claims benefit to an earlier-filed U.S. or international application, or priority to an earlier-filed U.S. provisional application, apply the reference under 35 U.S.C. 102(e) as of the earlier filing date, assuming all the conditions of 35 U.S.C. 102(e) and 35 U.S.C. 119(e), 120, or 365(c) are met. In addition, the subject matter relied upon in the rejection must be disclosed in the earlier-filed application in compliance with 35 U.S.C. 112, first paragraph, in order to give that subject matter the benefit of the earlier filing date under 35 U.S.C. 102(e). Note, where the earlier application is an international application, the earlier international application must satisfy the same three conditions (i.e., filed on or after November 29, 2000, designated the U.S., and had been published in English under PCT Article 21(2)) for the earlier international filing date to be a U.S. filing date for prior art purposes under 35 U.S.C.102(e).

(B)If the international application was filed on or after November 29, 2000, but did not designate the United States or was not published in English under PCT Article 21(2), do not treat the international filing date as a U.S. filing date. In this situation, do notapply the reference as of its international filing date, its date of completion of the 35 U.S.C. 371(c)(1), (2) and (4) requirements, or any earlier filing date to which such an international application claims benefit or priority. The reference may be applied under 35 U.S.C. 102(a) or (b) as of its publication date, or 35 U.S.C. 102(e) as of any later U.S. filing date of an application that properly claimed the benefit of the international application (if applicable).

(C) If the international application has an international filing date prior to November 29, 2000, apply the reference under the provisions of 35 U.S.C. 102and 374, prior to the AIPA amendments:

(1) For U.S. patents, apply the reference under 35 U.S.C. 102(e) as of the earlier of the date of completion of the requirements of 35 U.S.C. 371(c)(1), (2) and (4) or the filing date of the later-filed U.S. application that claimed the benefit of the international application;

(2) For U.S. application publications and WIPO publications directly resulting from international applications under PCT Article 21(2), never apply these references under 35 U.S.C. 102(e). These references may be applied as of their publication dates under 35 U.S.C. 102(a) or (b);

(3) For U.S. application publications of applications that claim the benefit under 35 U.S.C. 120 or 365(c) of an international application filed prior to November 29, 2000, apply the reference under 35 U.S.C. 102(e) as of the actual filing date of the later-filed U.S. application that claimed the benefit of the international application.

Examiners should be aware that although a publication of, or a U.S. patent issued from, an international application may not have a 35 U.S.C. 102(e) date at all, or may have a 35 U.S.C. 102(e) date that is after the effective filing date of the application being examined (so it is not “prior art”), the corresponding WIPO publication of an international application may have an earlier 35 U.S.C. 102(a) or (b) date.

See MPEP 706.02(f) for examination guidelines and examples.

III. PRIORITY FROM PROVISIONAL APPLICATION UNDER 35 U.S.C. 119(e)[edit | edit source]

The 35 U.S.C. 102(e) critical reference date of a U.S. patent or U.S. application publications and certain international application publications entitled to the benefit of the filing date of a provisional application under 35 U.S.C. 119(e) is the filing date of the provisional application with certain exceptions if the provisional application(s) properly supports the subject matter relied upon to make the rejection in compliance with 35 U.S.C. 112, first paragraph. See MPEP § 706.02(f)(1), examples 5 to 9. Note that international applications which (1) were filed prior to November 29, 2000, or (2) did not designate the U.S., or (3) were not published in English under PCT Article 21(2) by WIPO, may not be used to reach back (bridge) to an earlier filing date through a priority or benefit claim for prior art purposes under 35 U.S.C. 102(e).

IV.PARENT’S FILING DATE WHEN REFERENCE IS A CONTINUATION-IN-PART OF THE PARENT[edit | edit source]

Filing Date of U.S. Parent Application Can Only Be Used as the 35 U.S.C. 102(e) Date If It Supports the Claims of the Issued Child

In order to carry back the 35 U.S.C. 102(e) critical date of the U.S. patent reference to the filing date of a parent application, the U.S. patent reference must have a right of priority to the earlier date under 35 U.S.C. 120 or 365(c) and the parent application must support the invention claimed as required by 35 U.S.C. 112, first paragraph. “For if a patent could not theoretically have issued the day the application was filed, it is not entitled to be used against another as ‘secret prior art’” under 35 U.S.C. 102(e). In re Wertheim, 646 F.2d 527, 537, 209 USPQ 554, 564 (CCPA 1981) (The examiner made a 35 U.S.C. 103 rejection over a U.S. patent to Pfluger. The Pfluger patent (Pfluger IV) was the child of a string of abandoned parent applications (Pfluger I, the first application, Pfluger II and III, both CIPs). Pfluger IV was a continuation of Pfluger III. The court characterized the contents of the applications as follows: Pfluger I - subject matter A, II-AB, III-ABC, IV- ABC. ABC anticipated the claims of the examined application, but the filing date of III was later than the application filing date. So the examiner reached back to “A” in Pfluger I and combined this disclosure with another reference to establish obviousness. The court held that the examiner impermissibly carried over “A” and should have instead determined which of the parent applications contained the subject matter which made Pfluger patentable. Only if B and C were not claimed, or at least not critical to the patentability of Pfluger IV, could the filing date of Pfluger I be used. The court reversed the rejection based on a determination that Pfluger IV was only entitled to the Pfluger III filing date. The added new matter (C) was critical to the claims of the issued patent.). Note that In re Wertheim modified the holding of In re Lund, 376 F.2d 982, 153 USPQ 625 (CCPA 1967) as to “carrying back” the subject matter to the parent applications.

See also Ex parte Gilderdale, 1990 Pat. App. LEXIS 25 (Bd. Pat. App. & Inter. Appeal no. 89- 0352) (The examiner made a 35 U.S.C. 102(e) rejection over a U.S. patent to Hernandez. Hernandez was a continuation of a continuation-in-part. Both the parent and grandparent had been abandoned. The parent listed a different inventive entity but supported the subject matter of the child’s claims. The parent was filed on the same day as the examined application and thus no 35 U.S.C. 102(e) rejection could be made based on the parent’s filing date. The Board reversed the rejection, explaining that the Hernandez patent was entitled to the filing date of its parent, as the parent supported the patent claims and 35 U.S.C. 120was satisfied. Under 35 U.S.C. 120, an application can claim the benefit of an earlier filing date even if not all inventors are the same. However, Hernandez was not entitled to the grandparent filing date because the parent and child applications contained new matter as compared to the grandparent.).

Compare Ex parte Ebata, 19 USPQ2d 1952 (Bd. Pat. App. & Inter. 1991) (The claims were directed to a method of administering a salt of lysocellin to animals. A 35 U.S.C. 102(e) rejection was made over Martin. Martin was a continuation of an application which was in turn a continuation-in-part of an abandoned application. The grandparent application disclosed administering a manganese complex of lysocellin to animals. The Board found that “the new matter relates to additional forms of lysocellin which are useful in Martin’s process, i.e., species or embodiments other than the manganese complex. This is far different from adding limitations which are required or necessary for patentability.” Unlike the situation in In re Wertheim, Martin’s invention was patentable as presented in the grandparent application.).

See also MPEP § 706.02(f)(1), examples 2 and 5 to 9.

V. DATE OF CONCEPTION OR REDUCTION TO PRACTICE[edit | edit source]

35 U.S.C. 102(e) Reference Date Is the Filing Date Not Date of Inventor’s Conception or Reduction to Practice

If a reference available under 35 U.S.C. 102(e) discloses, but does not claim the subject matter of the claims being examined or an obvious variant, the reference is not prior art under 35 U.S.C. 102(g). Furthermore, the reference does not qualify as “prior art” under 35 U.S.C. 102 as of a date earlier than its filing date based upon any prior inventive activity that is disclosed in the U.S. patent or U.S. patent application publication in the absence of evidence that the subject matter was actually reduced to practice in this country on an earlier date. See MPEP § 2138. When the cases are not in interference, the effective date of the reference as prior art is its filing date in the United States (which will include certain international filing dates), as stated in 35 U.S.C. 102(e). See MPEP § 706.02(a). The date that the prior art subject matter was conceived or reduced to practice is of no importance when 35 U.S.C. 102(g) is not at issue. Sun Studs, Inc. v. ATA Equip. Leasing, Inc., 872 F.2d 978, 983, 10 USPQ2d 1338, 1342 (Fed. Cir. 1989) (The defendant sought to invalidate patents issued to Mason and Sohn assigned to Sun Studs. The earliest of these patents issued in June 1973. A U.S. patent to Mouat was found which issued in March 1976 and which disclosed the invention of Mason and Sohn. While the patent to Mouat issued after the Mason and Sohn patents, it was filed 7 months earlier than the earliest of the Mason and Sohn patents. Sun Studs submitted affidavits showing conception in 1969 and diligence to the constructive reduction to practice and therefore antedated the patent to Mouat. The defendant sought to show that Mouat conceived the invention in 1966. The court held that conception of the subject matter of the reference only becomes an issue when the claims of the conflicting patents cover inventions which are the same or obvious over one another. When 35 U.S.C. 102(e) applies but not 35 U.S.C. 102(g), the filing date of the prior art patent is the earliest date that can be used to reject or invalidate claims.).

2136.04 Different Inventive Entity; Meaning of "By Another"[edit | edit source]

IF THERE IS ANY DIFFERENCE IN THE INVENTIVE ENTITY, THE REFERENCE IS "BY ANOTHER"[edit | edit source]

"Another" means other than applicants, In re Land, 368 F.2d 866, 151 USPQ 621 (CCPA 1966), in other words, a different inventive entity. The inventive entity is different if not all inventors are the same. The fact that the application and reference have one or more inventors in common is immaterial. Ex parte DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. & Inter. 1992) (The examiner made a 35 U.S.C. 102(e) rejection based on an issued U.S. patent to three inventors. The rejected application was a continuation- in-part of the issued parent with an extra inventor. The Board found that the patent was “by another” and thus could be used in a 35 U.S.C. 102(e)/103 rejection of the application.).

A DIFFERENT INVENTIVE ENTITY IS PRIMA FACIE EVIDENCE THAT THE REFERENCE IS "BY ANOTHER"[edit | edit source]

As stated by the House and Senate reports on the bills enacting section 35 U.S.C. 102(e) as part of the 1952 Patent Act, this subsection of 102 codifies the Milburn rule of Milburn v. Davis-Bournonville, 270 U.S. 390 (1926). The Milburn rule authorized the use of a U.S. patent containing a disclosure of the invention as a reference against a later filed application as of the U.S. patent filing date. The existence of an earlier filed U.S. application containing the subject matter claimed in the application being examined indicates that applicant was not the first inventor. Therefore, a U.S. patent, a U.S. patent application publication or international application publication, by a different inventive entity, whether or not the application shares some inventors in common with the patent, is prima facie evidence that the invention was made “by another” as set forth in 35 U.S.C. 102(e). In re Mathews, 408 F.2d 1393, 161 USPQ 276 (CCPA 1969); In re Facius, 408 F.2d 1396, 161 USPQ 294 (CCPA 1969); Ex parte DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. & Inter. 1992). See MPEP § 706.02(b) and § 2136.05 for discussion of methods of overcoming 35 U.S.C. 102(e) rejections.

2136.05 Overcoming a Rejection Under 35 U.S.C. 102(e)[edit | edit source]

A 35 U.S.C. 102(e) REJECTION CAN BE OVERCOME BY ANTEDATING THE FILING DATE OR SHOWING THAT DISCLOSURE RELIED ON IS APPLICANT'S OWN WORK[edit | edit source]

When a prior U.S. patent, U.S. patent application publication, or international application publication is not a statutory bar, a 35 U.S.C. 102(e) rejection can be overcome by antedating the filing date (see MPEP § 2136.03 regarding critical reference date of 35 U.S.C. 102(e) prior art) of the reference by submitting an affidavit or declaration under 37 CFR 1.131 or by submitting an affidavit or declaration under 37 CFR 1.132 establishing that the relevant disclosure is applicant’s own work.

The filing date can also be antedated by applicant's earlier foreign priority application or provisional application if 35 U.S.C. 119 is met and the foreign application or provisional application "supports" (conforms to 35 U.S.C. 112, first paragraph, requirements) all the claims of the U.S. application.

But a prior application which was not copending with the application at issue cannot be used to antedate a reference. A terminal disclaimer also does not overcome a 35 U.S.C. 102(e)rejection.

See MPEP § 706.02(b) for a list of methods which can be used to overcome rejections based on 35 U.S.C. 102(e) rejections. An affidavit or declaration is not appropriate if the reference describes applicant’s own work. In this case, applicant must submit an affidavit or declaration under 37 CFR 1.132.

A 35 U.S.C. 102(e) REJECTION CAN BE OVERCOME BY SHOWING THE REFERENCE IS DESCRIBING APPLICANT’S OWN WORK[edit | edit source]

“The fact that an application has named a different inventive entity than a patent does not necessarily make that patent prior art.” Applied Materials Inc. v. Gemini Research Corp., 835 F.2d 279, 15 USPQ2d 1816 (Fed. Cir. 1988). The issue turns on what the evidence of record shows as to who invented the subject matter. In fact, even if applicant’s work was publicly disclosed prior to his or her application, applicant’s own work may not be used against him or her unless there is a time bar under 35 U.S.C. 102(b). In re DeBaun, 687 F.2d 459, 214 USPQ 933 (CCPA 1982).

Therefore, when the unclaimed subject matter of a reference is applicant’s own invention, applicant may overcome a prima facie case based on the patent, U.S. patent application publication, or international application publication, by showing that the disclosure is a description of applicant’s own previous work. Such a showing can be made by proving that the patentee, or the inventor(s) of the U.S. patent application publication or the international application publication, was associated with applicant (e.g. worked for the same company) and learned of applicant’s invention from applicant. In re Mathews, 408 F.2d 1393, 161 USPQ 276 (CCPA 1969). In the situation where one application is first filed by inventor X and then a later application is filed by X & Y, it must be proven that the joint invention was made first, was thereafter described in the sole applicant’s patent, or was thereafter described in the sole applicant’s U.S. patent application publication or international application publication, and then the joint application was filed. In re Land, 368 F.2d 866, 151 USPQ 621 (CCPA 1966).

In In re Land, separate U.S. patents to Rogers and to Land were used to reject a joint application to Rogers and Land under 35 U.S.C. 102(e)/103. The inventors worked for the same company (Polaroid) and in the same laboratory. All the patents flowed from the same research. In addition, the patent applications were prepared by the same attorneys, were interrelated and contained cross-references to each other. The court affirmed the rejection because (1) the inventive entities of the patents (one to Rogers and one to Land) were different from the inventive entity of the joint application (Rogers and Land) and (2) Land and Rogers brought their knowledge of their individual work with them when they made the joint invention. There was no indication that the portions of the references relied on disclosed anything they did jointly. Neither was there any showing that what they did jointly was done before the filing of the reference patent applications.

See also In re Carreira, 532 F.2d 1356, 189 USPQ 461 (CCPA 1976) (The examiner rejected claims to a joint application to Carreira, Kyrakakis, Solodar, and Labana under 35 U.S.C. 102(e) and 103 in view of a U.S. patent issued to Tulagin and Carreira or a patent issued to Clark. The applicants submitted declarations under 37 CFR 1.132 by Tulagin and Clark in which each declarant stated he was “not the inventor of the use of compounds having a hydroxyl group in a position ortho to an azo linkage.” The court held that these statements were vague and inconclusive because the declarants did not disclose the use of this generic compound but rather species of this generic compound in their patents and it was the species which met the claims. The declaration that each did not invent the use of the generic compound does not establish that Tulagin and Clark did not invent the use of the species.)

APPLICANT NEED NOT SHOW DILIGENCE OR REDUCTION TO PRACTICE WHEN THE SUBJECT MATTER DISCLOSED IN THE REFERENCE IS APPLICANT'S OWN WORK[edit | edit source]

When the reference reflects applicant’s own work, applicant need not prove diligence or reduction to practice to establish that he or she invented the subject matter disclosed in the reference. A showing that the reference disclosure arose from applicant’s work coupled with a showing of conception by the applicant before the filing date of the reference will overcome the 35 U.S.C. 102(e) rejection. The showing can be made by submission of an affidavit by the inventor under 37 CFR 1.132. The other patentees need not submit an affidavit disclaiming inventorship, but, if submitted, a disclaimer by all other patentees should be considered by the examiner. In re DeBaun, 687 F.2d 459, 214 USPQ 933 (CCPA 1982) (Declaration submitted by DeBaun stated that he was the inventor of subject matter disclosed in the U.S. patent reference of DeBaun and Noll. Exhibits were attached to the declaration showing conception and included drawings DeBaun had prepared and given to counsel for purposes of preparing the application which issued as the reference patent. The court held that, even though the evidence was not sufficient to antedate the prior art patent under 37 CFR 1.131, diligence and/or reduction to practice was not required to show DeBaun invented the subject matter. Declarant’s statement that he conceived the invention first was enough to overcome the 35 U.S.C. 102(e) rejection.).

CLAIMING OF INDIVIDUAL ELEMENTS OR SUBCOMBINATIONS IN A COMBINATION CLAIM OF THE REFERENCE DOES NOT ITSELF ESTABLISH THAT THE PATENTEE INVENTED THOSE ELEMENTS[edit | edit source]

The existence of combination claims in a reference is not evidence that the patentee invented the individual elements or subcombinations included if the elements and subcombinations are not separately claimed apart from the combination.



2137 35 U.S.C. 102(f)[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

.          .          .

(f) he did not himself invent the subject matter sought to be patented.

.          .          .


Where it can be shown that an applicant "derived" an invention from another, a rejection under 35 U.S.C. 102(f) is proper.

While derivation will bar the issuance of a patent to the deriver, a disclosure by the deriver, absent a bar under 35 U.S.C. 102(b), will not bar the issuance of a patent to the party from which the subject matter was derived.

Such a derived prior art reference may be overcome by two generally recognized methods:

  • an affidavit under 37 CFR 1.131, or
  • an affidavit under 37 CFR 1.132 showing that the relevant disclosure is a description of the applicant's own work").

It is the burden of the applicant to provide a satisfactory showing that the applicant is the inventor of the subject matter disclosed in a publication and claimed in the application.

DERIVATION REQUIRES COMPLETE CONCEPTION BY ANOTHER AND COMMUNICATION TO THE ALLEGED DERIVER[edit | edit source]

The mere fact that a claim recites the use of various components, each of which can be argumentatively assumed to be old, does not provide a proper basis for a rejection under 35 U.S.C. 102(f).

Derivation requires complete conception by another and communication of that conception by any means to the party charged with derivation prior to any date on which it can be shown that the one charged with derivation possessed knowledge of the invention.

PARTY ALLEGING DERIVATION DOES NOT HAVE TO PROVE AN ACTUAL REDUCTION TO PRACTICE, DERIVATION OF PUBLIC KNOWLEDGE, OR DERIVATION IN THIS COUNTRY[edit | edit source]

The party alleging derivation need not prove actual reduction to practice in order to show derivation. Furthermore, the application of subsection (f) is not limited to public knowledge derived from another, and the site of derivation need not be in this country to bar a deriver from patenting the subject matter.

DERIVATION DISTINGUISHED FROM PRIORITY OF INVENTION[edit | edit source]

Although derivation and priority of invention both focus on inventorship, derivation addresses originality (i.e., who invented the subject matter), whereas priority focuses on which party first invented the subject matter.

35 U.S.C. 102(f) MAY APPLY WHERE 35 U.S.C. 102(a) AND 35 U.S.C. 102(e) ARE NOT AVAILABLE STATUTORY GROUNDS FOR REJECTION[edit | edit source]

35 U.S.C. 102(f) does not require an inquiry into the relative dates of a reference and the application, and therefore may be applicable where subsections (a) and (e) are not available for references having an effective date subsequent to the effective date of the application being examined. However for a reference having a date later than the date of the application some evidence may exist that the subject matter of the reference was derived from the applicant in view of the relative dates.

2137.01 Inventorship[edit | edit source]

The requirement that the applicant for a patent be the inventor is a characteristic of U.S. patent law not generally shared by other countries. Consequently, foreign applicants may misunderstand U.S. law regarding naming of the actual inventors causing an error in the inventorship of a U.S. application that may claim priority to a previous foreign application under 35 U.S.C. 119. A request under 37 CFR 1.48(a) is required to correct any error in naming the inventors in the U.S. application as filed. MPEP § 201.03.

If a determination is made that the inventive entity named in a U.S. application is not correct, such as when a request under 37 CFR 1.48(a) is not granted or is not entered for technical reasons, but the admission therein regarding the error in inventorship is uncontroverted, a rejection under 35 U.S.C. 102(f) should be made.

I. EXECUTORS OF OATH OR DECLARATION UNDER 37 CFR 1.63 ARE PRESUMED TO BE THE INVENTORS[edit | edit source]

The party or parties executing an oath or declaration under 37 CFR 1.63 are presumed to be the inventors.

II. AN INVENTOR MUST CONTRIBUTE TO THE CONCEPTION OF THE INVENTION[edit | edit source]

The definition for inventorship can be simply stated: “The threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the conception of the invention, he is not an inventor. . . . Insofar as defining an inventor is concerned, reduction to practice, per se, is irrelevant [except for simultaneous conception and reduction to practice]. One must contribute to the conception to be an inventor.” In re Hardee, 223 USPQ 1122, 1123 (Comm’r Pat. 1984).

With regard to the inventorship of chemical compounds, an inventor must have a conception of the specific compounds being claimed.

See MPEP § 2138.04 - § 2138.05 for a discussion of what evidence is required to establish conception or reduction to practice.

III. AS LONG AS THE INVENTOR MAINTAINS INTELLECTUAL DOMINATION OVER MAKING THE INVENTION, IDEAS, SUGGESTIONS, AND MATERIALS MAY BE ADOPTED FROM OTHERS[edit | edit source]

“In arriving at … conception [the inventor] may consider and adopt ideas and materials derived from many sources … [such as] a suggestion from an employee, or hired consultant … so long as he maintains intellectual domination of the work of making the invention down to the successful testing, selecting or rejecting as he goes…even if such suggestion [or material] proves to be the key that unlocks his problem.” Morse v. Porter, 155 USPQ 280, 283 (Bd. Pat. Inter. 1965).

IV. THE INVENTOR IS NOT REQUIRED TO REDUCE THE INVENTION TO PRACTICE[edit | edit source]

Difficulties arise in separating members of a team effort, where each member of the team has contributed something, into those members that actually contributed to the conception of the invention, such as the physical structure or operative steps, from those members that merely acted under the direction and supervision of the conceivers.

However, “it is not essential for the inventor to be personally involved in carrying out process steps . . . where implementation of those steps does not require the exercise of inventive skill.”

  • One following oral instructions is viewed as merely a technician.
  • Inventors need not personally construct and test their invention.
  • A noninventor's work can merely be that of a skilled mechanic carrying out the details of a plan devised by another).
V. REQUIREMENTS FOR JOINT INVENTORSHIP[edit | edit source]

The inventive entity for a particular application is based on some contribution to at least one of the claims made by each of the named inventors. Inventors may apply for a patent jointly even though:

  • they did not physically work together or at the same time,
  • each did not make the same type or amount of contribution, or
  • each did not make a contribution to the subject matter of every claim of the patent.

35 U.S.C. 116 neither states nor implies that two inventors can be 'joint inventors' if they have had no contact whatsoever and are completely unaware of each other's work. What is required is some "quantum of collaboration or connection." There must be some element of joint behavior, such as collaboration or working under common direction, one inventor seeing a relevant report and building upon it or hearing another's suggestion at a meeting." It is not necessary that the inventive concept come to both joint inventors at the same time.

Each joint inventor must generally contribute to the conception of the invention. A coinventor need not make a contribution to every claim of a patent. A contribution to one claim is enough.

VI. INVENTORSHIP IS GENERALLY "TO ANOTHER" WHERE THERE ARE DIFFERENT INVENTIVE ENTITIES WITH AT LEAST ONE INVENTOR IN COMMON[edit | edit source]

A joint application or patent and a sole application or patent by one of the joint inventors are by different legal entities and accordingly, the issuance of the earlier filed application as a patent becomes a reference for everything it discloses except where:

(A) the claimed invention in a later filed application is entitled to the benefit of an earlier filed application under 35 U.S.C. 120 (an overlap of inventors rather than an identical inventive entity is permissible). In this situation, a rejection under 35 U.S.C. 102(e) is precluded; and

(B) the subject matter developed by another person and the claimed subject matter were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person or involved in a joint research agreement which meets the requirements of 35 U.S.C. 103(c)(2) and (c)(3). See MPEP § 706.02(l) and § 706.02(l)(1).

For case law relating to inventorship by “another” involving different inventive entities with at least one inventor in common see Ex parte DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. & Inter. 1992) (the presence of a common inventor in a reference patent and a pending application does not preclude the determination that the reference inventive entity is to "another" within the meaning of 35 U.S.C. 102(e)) and the discussion of prior art available under 35 U.S.C. 102(e) in MPEP § 2136.04.

2137.02 Applicability of 35 U.S.C. 103(c)[edit | edit source]

35 U.S.C. 103(c) states that subsection (f) of 35 U.S.C. 102 will not preclude patentability where subject matter developed by another person, that would otherwise qualify under 35 U.S.C. 102(f), and the claimed invention of an application under examination were owned by the same person, subject to an obligation of assignment to the same person, or involved in a joint research agreement, which meets the requirements of 35 U.S.C. 103(c)(2) and (c)(3), at the time the invention was made. See MPEP § 706.02(l) and § 2146.



2138 35 U.S.C. 102(g)[edit | edit source]

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless -

.          .          .

(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.


35 U.S.C. 102(g) issues such as conception, reduction to practice and diligence, while more commonly applied to interference matters, also arise in other contexts.

35 U.S.C. 102(g) may form the basis for an ex parte rejection if: (1) the subject matter at issue has been actually reduced to practice by another before the applicant’s invention; and (2) there has been no abandonment, suppression or concealment. See, e.g., Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1205, 18 USPQ2d 1016, 1020 (Fed. Cir. 1991); New Idea Farm Equipment Corp. v. Sperry Corp., 916 F.2d 1561, 1566, 16 USPQ2d 1424, 1428 (Fed. Cir. 1990); E.I. DuPont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1434, 7 USPQ2d 1129, 1132 (Fed. Cir. 1988); Kimberly-Clark v. Johnson & Johnson, 745 F.2d 1437, 1444-46, 223 USPQ 603, 606-08 (Fed. Cir. 1984). To qualify as prior art under 35 U.S.C. 102(g), however, there must be evidence that the subject matter was actually reduced to practice, in that conception alone is not sufficient. See Kimberly-Clark, 745 F.2d at 1445, 223 USPQ at 607. While the filing of an application for patent is a constructive reduction to practice, the filing of an application does not in itself provide the evidence necessary to show an actual reduction to practice of any of the subject matter disclosed in the application as is necessary to provide the basis for an ex parte rejection under 35 U.S.C. 102(g). Thus, absent evidence showing an actual reduction to practice (which is generally not available during ex parte examination), the disclosure of a United States patent application publication or patent falls under 35 U.S.C. 102(e) and not under 35 U.S.C. 102(g). Cf. In re Zletz, 893 F.2d 319, 323, 13 USPQ2d 1320, 1323 (Fed. Cir. 1990) (the disclosure in a reference United States patent does not fall under 35 U.S.C. 102(g) but under 35 U.S.C. 102(e)).

In addition, subject matter qualifying as prior art only under 35 U.S.C. 102(g) may also be the basis for an ex parte rejection under 35 U.S.C. 103. See In re Bass, 474 F.2d 1276, 1283, 177 USPQ 178, 183 (CCPA 1973) (in an unsuccessful attempt to utilize a 37 CFR 1.131 affidavit relating to a combination application, applicants admitted that the subcombination screen of a copending application which issued as a patent was earlier conceived than the combination). 35 U.S.C. 103(c), however, states that subsection (g) of 35 U.S.C. 102 will not preclude patentability where subject matter developed by another person, that would otherwise qualify under 35 U.S.C. 102(g), and the claimed invention of an application under examination were owned by the same person, subject to an obligation of assignment to the same person, or involved in a joint research agreement, which meets the requirements of 35 U.S.C. 103(c)(2) and (c)(3), at the time the invention was made. See MPEP § 706.02(l) and § 2146.

For additional examples of 35 U.S.C. 102(g) issues such as conception, reduction to practice and diligence outside the context of interference matters, see In re Costello, 717 F.2d 1346, 219 USPQ 389 (Fed. Cir. 1983) (discussing the concepts of conception and constructive reduction to practice in the context of a declaration under 37 CFR 1.131), and Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973) (holding constructive reduction to practice for priority under 35 U.S.C. 119 requires meeting the requirements of 35 U.S.C. 101 and 35 U.S.C. 112).

2138.01 Interference Practice[edit | edit source]

I. 35 U.S.C. 102(g) IS THE BASIS OF INTERFERENCE PRACTICE

Subsection (g) of 35 U.S.C. 102 is the basis of interference practice for determining priority of invention between two parties. See Bigham v. Godtfredsen, 857 F.2d 1415, 1416, 8 USPQ2d 1266, 1267 (Fed. Cir. 1988), 35 U.S.C. 135, 37 CFR Part 41, Subparts D and E and MPEP Chapter 2300. An interference is an inter partes proceeding directed at determining the first to invent as among the parties to the proceeding, involving two or more pending applications naming different inventors or one or more pending applications and one or more unexpired patents naming different inventors. The United States is unusual in having a first to invent rather than a first to file system. Paulik v. Rizkalla, 760 F.2d 1270, 1272, 226 USPQ 224, 225 (Fed. Cir. 1985) (reviews the legislative history of the subsection in a concurring opinion by Judge Rich). The first of many to reduce an invention to practice around the same time will be the sole party to obtain a patent, Radio Corp. of America v. Radio Eng’g Labs., Inc., 293 U.S. 1, 2, 21 USPQ 353, 353-4 (1934), unless another was the first to conceive and couple a later-in-time reduction to practice with diligence from a time just prior to when the second conceiver entered the field to the first conceiver’s reduction to practice. Hull v. Davenport, 90 F.2d 103, 105, 33 USPQ 506, 508 (CCPA 1937). See the priority time charts below illustrating this point. Upon conclusion of an interference, subject matter claimed by the losing party that was the basis of the interference is rejected under 35 U.S.C. 102(g), unless the acts showing prior invention were not in this country.

It is noted that 35 U.S.C. 101 requires that whoever invents or discovers is the party who may obtain a patent for the particular invention or discovery. 35 U.S.C. 111 (applicant) or 35 U.S.C. 116 (applicants) set forth the requirement that the actual inventor( s) be the party who applies for a patent or that a patent be applied for on behalf of the inventor. Where it can be shown that an applicant has “derived” an invention from another, a rejection under 35 U.S.C. 102(f) is proper. Ex parte Kusko, 215 USPQ 972, 974 (Bd. App. 1981) (“most, if not all, determinations under Section 102(f) involve the question of whether one party derived an invention from another”); Price v. Symsek, 988 F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir. 1993) (Although derivation and priority of invention both focus on inventorship, derivation addresses originality, i.e., who invented the subject matter, whereas priority focuses on which party invented the subject matter first.).


II. PRIORITY TIME CHARTS

The following priority time charts illustrate the award of invention priority in several situations. The time charts apply to interference proceedings and are also applicable to declarations or affidavits filed under 37 CFR 1.131 to antedate references which are available as prior art under 35 U.S.C. 102(a) or 102(e). Note, however, in the context of 37 CFR 1.131, an applicant does not have to show that the invention was not abandoned, suppressed, or concealed from the time of an actual reduction to practice to a constructive reduction to practice because the length of time taken to file a patent application after an actual reduction to practice is generally of no consequence except in an interference proceeding. Paulik v. Rizkalla, 760 F.2d 1270, 226 USPQ 224 (Fed. Cir. 1985). See the discussion of abandonment, suppression, and concealment in MPEP § 2138.03.

For purposes of analysis under 37 CFR 1.131, the conception and reduction to practice of the reference to be antedated are both considered to be on the effective filing date of domestic patent or foreign patent or the date of printed publication.

In the charts, C = conception, R = reduction to practice (either actual or constructive), Ra = actual reduction to practice, Rc = constructive reduction to practice, and TD = commencement of diligence.

Example 1

Example 1


A is awarded priority in an interference, or antedates B as a reference in the context of a declaration or affidavit filed under 37 CFR 1.131, because A conceived the invention before B and constructively reduced the invention to practice before B reduced the invention to practice. The same result would be reached if the conception date was the same for both inventors A and B.

Example 2

Example 2


A is awarded priority in an interference, or antedates B as a reference in the context of a declaration or affidavit filed under 37 CFR 1.131, if A can show reasonable diligence from TD (a point just prior to B’s conception) until Rc because A conceived the invention before B, and diligently constructively reduced the invention to practice even though this was after B reduced the invention to practice.

Example 3

Example 3


A is awarded priority in an interference in the absence of abandonment, suppression, or concealment from Ra to Rc, because A conceived the invention before B, actually reduced the invention to practice before B reduced the invention to practice, and did not abandon, suppress, or conceal the invention after actually reducing the invention to practice and before constructively reducing the invention to practice.

A antedates B as a reference in the context of a declaration or affidavit filed under 37 CFR 1.131because A conceived the invention before B and actually reduced the invention to practice before B reduced the invention to practice.

Example 4

Example 4


A is awarded priority in an interference if A can show reasonable diligence from TD (a point just prior to B’s conception) until Ra in the absence of abandonment, suppression, or concealment from Ra to Rc, because A conceived the invention before B, diligently actually reduced the invention to practice (after B reduced the invention to practice), and did not abandon, suppress, or conceal the invention after actually reducing the invention to




practice and before constructively reducing the invention to practice.

A antedates B as a reference in the context of a declaration or affidavit filed under 37 CFR 1.131because A conceived the invention before B, and diligently actually reduced the invention to practice, even though this was after B reduced the invention to practice.


III. 37 CFR 1.131 DOES NOT APPLY IN INTERFERENCE PROCEEDINGS

Interference practice operates to the exclusion of ex parte practice under 37 CFR 1.131 which permits an applicant to show an actual date of invention prior to the effective date of a patent or literature reference applied under 35 U.S.C. 102(a) or (e), as long as the patent is not a domestic patent claiming the same patentable invention. Ex parte Standish, 10 USPQ2d 1454, 1457 (Bd. Pat. App. & Inter. 1988) (An application claim to the “same patentable invention” claimed in a domestic patent requires interference rather than an affidavit under 37 CFR 1.131 to antedate the patent. The term “same patentable invention” encompasses a claim that is either anticipated by or obvious in view of the subject matter recited in the patent claim.). Subject matter which is available as prior art only under 35 U.S.C. 102(g) is by definition made before the applicant made his invention and is therefore not open to further inquiry under 37 CFR 1.131.


IV. LOST COUNTS IN AN INTERFERENCE ARE NOT, PER SE, STATUTORY PRIOR ART

Loss of an interference count alone does not make its subject matter statutory prior art to losing party; however, lost count subject matter that is available as prior art under 35 U.S.C. 102 may be used alone or in combination with other references under 35 U.S.C. 103. But see In re Deckler, 977 F.2d 1449, 24 USPQ2d 1448 (Fed. Cir. 1992) (Under the principles of res judicata and collateral estoppel, Deckler was not entitled to claims that were patentably indistinguishable from the claim lost in interference even though the subject matter of the lost count was not available for use in an obviousness rejection under 35 U.S.C. 103.).

2138.02 "The Invention Was Made in This Country"[edit | edit source]

An invention is made when there is a conception and a reduction to practice. Dunn v. Ragin, 50 USPQ 472, 474 (Bd. Pat. Inter. 1941). Prior art under 35 U.S.C. 102(g) is limited to an invention that is made. In re Katz, 687 F.2d 450, 454, 215 USPQ 14, 17 (CCPA 1982) (the publication of an article, alone, is not deemed a constructive reduction to practice, and therefore its disclosure does not prove that any invention within the meaning of 35 U.S.C. 102(g) has ever been made).

Subject matter under 35 U.S.C. 102(g) is available only if made in this country. 35 U.S.C. 104. Kondo v. Martel, 220 USPQ 47 (Bd. Pat. Inter. 1983) (acts of conception, reduction to practice and diligence must be demonstrated in this country). Compare Colbert v. Lofdahl, 21 USPQ2d 1068, 1071 (Bd. Pat. App. & Inter. 1991) (“[i]f the invention is reduced to practice in a foreign country and knowledge of the invention was brought into this country and disclosed to others, the inventor can derive no benefit from the work done abroad and such knowledge is merely evidence of conception of the invention”).

In accordance with 35 U.S.C. 102(g)(1), a party involved in an interference proceeding under 35 U.S.C. 135 or 291 may establish a date of invention under 35 U.S.C. 104. 35 U.S.C. 104, as amended by GATT (Public Law 103-465, 108 Stat. 4809 (1994)) and NAFTA (Public Law 103-182, 107 Stat. 2057 (1993)), provides that an applicant can establish a date of invention in a NAFTA member country on or after December 8, 1993 or in WTO member country other than a NAFTA member country on or after January 1, 1996. Accordingly, an interference count may be won or lost on the basis of establishment of invention by one of the parties in a NAFTA or WTO member country, thereby rendering the subject matter of that count unpatentable to the other party under the principles of res judicata and collateral estoppel, even though such subject matter is not available as statutory prior art under 35 U.S.C. 102(g). See MPEP § 2138.01 regarding lost interference counts which are not statutory prior art.

2138.03 "By Another Who Has Not Abandoned, Suppressed, or Concealed It"[edit | edit source]

35 U.S.C. 102(g) generally makes available as prior art within the meaning of 35 U.S.C. 103, the prior invention of another who has not abandoned, suppressed or concealed it. In re Bass, 474 F.2d 1276, 177 USPQ 178 (CCPA 1973); In re Suska, 589 F.2d 527, 200 USPQ 497 (CCPA 1979) (The result of applying the suppression and concealment doctrine is that the inventor who did not conceal (but was the de facto last inventor) is treated legally as the first to invent, while the de facto first inventor who suppressed or concealed is treated as a later inventor. The de facto first inventor, by his suppression and concealment, lost the right to rely on his actual date of invention not only for priority purposes, but also for purposes of avoiding the invention of the counts as prior art.).

“The courts have consistently held that an invention, though completed, is deemed abandoned, suppressed, or concealed if, within a reasonable time after completion, no steps are taken to make the invention publicly known. Thus failure to file a patent application; to describe the invention in a publicly disseminated document; or to use the invention publicly, have been held to constitute abandonment, suppression, or concealment.” Correge v. Murphy, 705 F.2d 1326, 1330, 217 USPQ 753, 756 (Fed. Cir. 1983) (quoting International Glass Co. v. United States, 408 F.2d 395, 403, 159 USPQ 434, 441 (Ct. Cl. 1968)). In Correge, an invention was actually reduced to practice, 7 months later there was a public disclosure of the invention, and 8 months thereafter a patent application was filed. The court held filing a patent application within 1 year of a public disclosure is not an unreasonable delay, therefore reasonable diligence must only be shown between the date of the actual reduction to practice and the public disclosure to avoid the inference of abandonment.

DURING AN INTERFERENCE PROCEEDING, AN INFERENCE OF SUPPRESSION OR CONCEALMENT MAY ARISE FROM DELAY IN FILING PATENT APPLICATION

Once an invention is actually reduced to practice an inventor need not rush to file a patent application. Shindelar v. Holdeman, 628 F.2d 1337, 1341, 207 USPQ 112, 116 (CCPA 1980). The length of time taken to file a patent application after an actual reduction to practice is generally of no consequence except in an interference proceeding. Paulik v. Rizkalla, 760 F.2d 1270, 1271, 226 USPQ 225, 226 (Fed. Cir. 1985) (suppression or concealment may be deliberate or may arise due to an inference from a “too long” delay in filing a patent application). Peeler v. Miller, 535 F.2d 647, 656, 190 USPQ 117,124 (CCPA 1976) (“mere delay, without more, is not sufficient to establish suppression or concealment.” “What we are deciding here is that Monsanto’s delay is not ‘merely delay’ and that Monsanto's justification for the delay is inadequate to overcome the inference of suppression created by the excessive delay.” The word “mere” does not imply a total absence of a limit on the duration of delay. Whether any delay is “mere” is decided only on a case-by-case basis.).

Where a junior party in an interference relies upon an actual reduction to practice to demonstrate first inventorship, and where the hiatus in time between the date for the junior party's asserted reduction to practice and the filing of its application is unreasonably long, the hiatus may give rise to an inference that the junior party in fact suppressed or concealed the invention and the junior party will not be allowed to rely upon the earlier actual reduction to practice. Young v. Dworkin, 489 F.2d 1277, 1280 n.3, 180 USPQ 388, 391 n.3 (CCPA 1974) (suppression and concealment issues are to be addressed on a case- by-case basis).

SUPPRESSION OR CONCEALMENT NEED NOT BE ATTRIBUTED TO INVENTOR

Suppression or concealment need not be attributed to the inventor. Peeler v. Miller, 535 F.2d 647, 653-54, 190 USPQ 117, 122 (CCPA 1976) (“four year delay from the time an inventor … completes his work … and the time his assignee-employer files a patent application is, prima facie, unreasonably long in an interference with a party who filed first”); Shindelar v. Holdeman, 628 F.2d 1337, 1341-42, 207 USPQ 112, 116-17 (CCPA 1980) (A patent attorney’s workload will not preclude a holding of an unreasonable delay—a total of 3 months was identified as possible of excuse in regard to the filing of an application.).




INFERENCE OF SUPPRESSION OR CONCEALMENT IS REBUTTABLE

Notwithstanding a finding of suppression or concealment, a constructive reduction to practice such as renewed activity just prior to other party’s entry into field coupled with the diligent filing of an application would still cause the junior party to prevail. Lutzker v. Plet, 843 F.2d 1364, 1367-69, 6 USPQ2d 1370, 1371- 72 (Fed. Cir. 1988) (activities directed towards commercialization not sufficient to rebut inference); Holmwood v. Cherpeck, 2 USPQ2d 1942, 1945 (Bd. Pat. App. & Inter. 1986) (the inference of suppression or concealment may be rebutted by showing activity directed to perfecting the invention, preparing the application, or preparing other compounds within the scope of the generic invention); Engelhardt v. Judd, 369 F.2d 408, 411, 151 USPQ 732, 735 (CCPA 1966) (“We recognize that an inventor of a new series of compounds should not be forced to file applications piecemeal on each new member as it is synthesized, identified and tested for utility. A reasonable amount of time should be allowed for completion of the research project on the whole series of new compounds, and a further reasonable time period should then be allowed for drafting and filing the patent application(s) thereon.”); Bogoslowsky v. Huse, 142 F.2d 75, 77, 61 USPQ 349, 351 (CCPA 1944) (The doctrine of suppression and concealment is not applicable to conception without an actual reduction to practice.).

ABANDONMENT

A finding of suppression or concealment may not amount to a finding of abandonment wherein a right to a patent is lost. Steierman v. Connelly, 197 USPQ 288, 289 (Comm'r Pat. 1976); Correge v. Murphy, 705 F.2d 1326, 1329, 217 USPQ 753, 755 (Fed. Cir. 1983) (an invention cannot be abandoned until it is first reduced to practice).

2138.04 "Conception"[edit | edit source]

Conception has been defined as “the complete performance of the mental part of the inventive act” and it is “the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is thereafter to be applied in practice….” Townsend v. Smith, 36 F.2d 292, 295, 4 USPQ 269, 271 (CCPA 1930). “[C]onception is established when the invention is made sufficiently clear to enable one skilled in the art to reduce it to practice without the exercise of extensive experimentation or the exercise of inventive skill.” Hiatt v. Ziegler, 179 USPQ 757, 763 (Bd. Pat. Inter. 1973). Conception has also been defined as a disclosure of an invention which enables one skilled in the art to reduce the invention to a practical form without “exercise of the inventive faculty.” Gunter v. Stream, 573 F.2d 77, 197 USPQ 482 (CCPA 1978). See also Coleman v. Dines, 754 F.2d 353, 224 USPQ 857 (Fed. Cir. 1985) (It is settled that in establishing conception a party must show possession of every feature recited in the count, and that every limitation of the count must have been known to the inventor at the time of the alleged conception. Conception must be proved by corroborating evidence.); Hybritech Inc. v. Monoclonal Antibodies Inc., 802 F. 2d 1367, 1376, 231 USPQ 81, 87 (Fed. Cir. 1986) (Conception is the “formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.”); Hitzeman v. Rutter, 243 F.3d 1345, 58 USPQ2d 1161 (Fed. Cir. 2001) (Inventor’s “hope” that a genetically altered yeast would produce antigen particles having the particle size and sedimentation rates recited in the claims did not establish conception, since the inventor did not show that he had a “definite and permanent understanding” as to whether or how, or a reasonable expectation that, the yeast would produce the recited antigen particles.).


I.CONCEPTION MUST BE DONE IN THE MIND OF THE INVENTOR

The inventor must form a definite and permanent idea of the complete and operable invention to establish conception. Bosies v. Benedict, 27 F.3d 539, 543, 30 USPQ2d 1862, 1865 (Fed. Cir. 1994) (Testimony by a noninventor as to the meaning of a variable of a generic compound described in an inventor’s notebook was insufficient as a matter of law to establish the meaning of the variable because the testimony was not probative of what the inventors conceived.).





II. AS LONG AS THE INVENTOR MAINTAINS INTELLECTUAL DOMINATION OVER MAKING THE INVENTION, IDEAS, SUGGESTIONS, AND MATERIALS MAY BE ADOPTED FROM OTHERS

An inventor may consider and adopt ideas, suggestions and materials derived from many sources: a suggestion from an employee, a hired consultant or a friend even if the adopted material proves to be the key that unlocks the problem so long as the inventor “maintains intellectual domination of the work of making the invention down to the successful testing, selecting or rejecting….” Morse v. Porter, 155 USPQ 280, 283 (Bd. Pat. Inter. 1965); Staehelin v. Secher, 24 USPQ2d 1513, 1522 (Bd. Pat. App. & Inter. 1992) (“evidence of conception naming only one of the actual inventive entity inures to the benefit of and serves as evidence of conception by the complete inventive entity”).


III. CONCEPTION REQUIRES CONTEMPORANEOUS RECOGNITION AND APPRECIATION OF THE INVENTION

There must be a contemporaneous recognition and appreciation of the invention for there to be conception. Silvestri v. Grant, 496 F.2d 593, 596, 181 USPQ 706, 708 (CCPA 1974) (“an accidental and unappreciated duplication of an invention does not defeat the patent right of one who, though later in time was the first to recognize that which constitutes the inventive subject matter”); Invitrogen, Corp. v. Clontech Laboratories, Inc., 429 F.3d 1052, 1064, 77 USPQ2d 1161, 1169 (Fed. Cir. 2005)(In situations where there is unrecognized accidental duplication, establishing conception requires evidence that the inventor actually made the invention and understood the invention to have the features that comprise the inventive subject matter at issue). Langer v. Kaufman, 465 F.2d 915, 918, 175 USPQ 172, 174 (CCPA 1972) (new form of catalyst was not recognized when it was first produced; conception cannot be established nunc pro tunc). However, an inventor does not need to know that the invention will work for there to be complete conception. Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228, 32 USPQ2d 1915, 1919 (Fed. Cir. 1994) (Draft patent application disclosing treatment of AIDS with AZT reciting dosages, forms, and routes of administration was sufficient to collaborate conception whether or not the inventors believed the inventions would work based on initial screening tests.) Furthermore, the inventor does not need to appreciate the patentability of the invention. Dow Chem. Co. v. Astro-Valcour, Inc., 267 F.3d 1334, 1341, 60 USPQ2d 1519, 1523 (Fed. Cir. 2001).

The first to conceive of a species is not necessarily the first to conceive of the generic invention. In re Jolley, 308 F.3d 1317, 1323 n.2, 64 USPQ2d 1901, 1905 n.2 (Fed. Cir. 2002). Further, while conception of a species within a genus may constitute conception of the genus, conception of one species and the genus may not constitute conception of another species in the genus. Oka v. Youssefyeh, 849 F.2d 581, 7 USPQ2d 1169 (Fed. Cir. 1988) (conception of a chemical requires both the idea of the structure of the chemical and possession of an operative method of making it). See also Amgen v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (in the isolation of a gene, defining a gene by its principal biological property is not sufficient for conception absent an ability to envision the detailed constitution as well as a method for obtaining it); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1605 (Fed. Cir. 1993) (“[b]efore reduction to practice, conception only of a process for making a substance, without conception of a structural or equivalent definition of that substance, can at most constitute a conception of the substance claimed as a process” but cannot constitute conception of the substance; as “conception is not enablement,” conception of a purified DNA sequence coding for a specific protein by function and a method for its isolation that could be carried out by one of ordinary skill in the art is not conception of that material).

On rare occasions conception and reduction to practice occur simultaneously. Alpert v. Slatin, 305 F.2d 891, 894, 134 USPQ 296, 299 (CCPA 1962). “[I]n some unpredictable areas of chemistry and biology, there is no conception until the invention has been reduced to practice.” MacMillan v. Moffett, 432 F.2d 1237, 1234-40, 167 USPQ 550, 552-553 (CCPA 1970). See also Hitzeman v. Rutter, 243 F.3d 1345, 58 USPQ2d 1161 (Fed. Cir. 2001)




(conception simultaneous with reduction to practice where appellant lacked reasonable certainty that yeast’s performance of certain intracellular processes would result in the claimed antigen particles); Dunn v. Ragin, 50 USPQ 472, 475 (Bd. Pat. Inter. 1941) (a new variety of asexually reproduced plant is conceived and reduced to practice when it is grown and recognized as a new variety). Under these circumstances, conception is not complete if subsequent experimentation reveals factual uncertainty which “so undermines the specificity of the inventor’s idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice.” Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1229, 32 USPQ2d 1915, 1920 (Fed. Cir. 1994).


IV. A PREVIOUSLY ABANDONED APPLICATION WHICH WAS NOT COPENDING WITH A SUBSEQUENT APPLICATION IS EVIDENCE ONLY OF CONCEPTION

An abandoned application with which no subsequent application was copending serves to abandon benefit of the application’s filing as a constructive reduction to practice and the abandoned application is evidence only of conception. In re Costello, 717 F.2d 1346, 1350, 219 USPQ 389, 392 (Fed. Cir. 1983).

2138.05 "Reduction to Practice"[edit | edit source]

Reduction to practice may be an actual reduction or a constructive reduction to practice which occurs when a patent application on the claimed invention is filed. The filing of a patent application serves as conception and constructive reduction to practice of the subject matter described in the application. Thus the inventor need not provide evidence of either conception or actual reduction to practice when relying on the content of the patent application. Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, 1130 (Fed. Cir. 1998). A reduction to practice can be done by another on behalf of the inventor. De Solms v. Schoenwald, 15 USPQ2d 1507, 1510 (Bd. Pat. App. & Inter. 1990). “While the filing of the original application theoretically constituted a constructive reduction to practice at the time, the subsequent abandonment of that application also resulted in an abandonment of the benefit of that filing as a constructive reduction to practice. The filing of the original application is, however, evidence of conception of the invention.” In re Costello, 717 F.2d 1346, 1350, 219 USPQ 389, 392 (Fed. Cir. 1983)(The second application was not co- pending with the original application and it did not reference the original application. Because of the requirements of 35 U.S.C. 120 had not been satisfied, the filing of the original application was not recognized as constructive reduction to practice of the invention.).

I.CONSTRUCTIVE REDUCTION TO PRACTICE REQUIRES COMPLIANCE WITH 35 U.S.C. 112, FIRST PARAGRAPH

When a party to an interference seeks the benefit of an earlier-filed U.S. patent application, the earlier application must meet the requirements of 35 U.S.C. 120 and 35 U.S.C. 112, first paragraph for the subject matter of the count. The earlier application must meet the enablement requirement and must contain a written description of the subject matter of the interference count. Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, 1130 (Fed. Cir. 1998). Proof of a constructive reduction to practice requires sufficient disclosure under the “how to use” and “how to make” requirements of 35 U.S.C. 112, first paragraph. Kawai v. Metlesics, 480 F.2d 880, 886, 178 USPQ 158, 163 (CCPA 1973) (A constructive reduction to practice is not proven unless the specification discloses a practical utility where one would not be obvious. Prior art which disclosed an anticonvulsant compound which differed from the claimed compound only in the absence of a -CH2- group connecting two functional groups was not sufficient to establish utility of the claimed compound because the compounds were not so closely related that they could be presumed to have the same utility.). The purpose of the written description requirement is “to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The written description must include all of the limitations of the interference count, or the applicant must show that any absent text is necessarily comprehended in the description provided and would have been so understood at the time the patent application was filed. Furthermore, the written description must be sufficient, when the entire specification is considered, such that




the “necessary and only reasonable construction” that would be given it by a person skilled in the art is one that clearly supports each positive limitation in the count. Hyatt v. Boone, 146 F.3d at 1354-55, 47 USPQ2d at 1130-1132 (Fed. Cir. 1998) (The claim could be read as describing subject matter other than that of the count and thus did not establish that the applicant was in possession of the invention of the count.). See also Bigham v. Godtfredsen, 857 F.2d 1415, 1417, 8 USPQ2d 1266, 1268 (Fed. Cir. 1988) (“[t]he generic term halogen comprehends a limited number of species, and ordinarily constitutes a sufficient written description of the common halogen species,” except where the halogen species are patentably distinct).

II.REQUIREMENTS TO ESTABLISH ACTUAL REDUCTION TO PRACTICE

“In an interference proceeding, a party seeking to 

establish an actual reduction to practice must satisfy a two-prong test: (1) the party constructed an embodiment or performed a process that met every element of the interference count, and (2) the embodiment or process operated for its intended purpose.” Eaton v. Evans, 204 F.3d 1094, 1097, 53 USPQ2d 1696, 1698 (Fed. Cir. 2000).

The same evidence sufficient for a constructive reduction to practice may be insufficient to establish an actual reduction to practice, which requires a showing of the invention in a physical or tangible form that shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ 223, 227 (CCPA 1976). For an actual reduction to practice, the invention must have been sufficiently tested to demonstrate that it will work for its intended purpose, but it need not be in a commercially satisfactory stage of development. See, e.g., Scott v. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115, 1118-19 (Fed. Cir. 1994)(citing numerous cases wherein the character of the testing necessary to support an actual reduction to practice varied with the complexity of the invention and the problem it solved). If a device is so simple, and its purpose and efficacy so obvious, construction alone is sufficient to demonstrate workability. King Instrument Corp. v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, 407 (Fed. Cir. 1985).

For additional cases pertaining to the requirements necessary to establish actual reduction to practice see DSL Dynamic Sciences, Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, 1155 (Fed. Cir. 1991) (“events occurring after an alleged actual reduction to practice can call into question whether reduction to practice has in fact occurred”); Fitzgerald v. Arbib, 268 F.2d 763, 765- 66, 122 USPQ 530, 531-32 (CCPA 1959) (“the reduction to practice of a three-dimensional design invention requires the production of an article embodying that design” in “other than a mere drawing”); Birmingham v. Randall,

171 F.2d 957, 80 USPQ 371, 372 (CCPA 1948) (To establish an actual reduction to practice of an invention directed to a method of making a product, it is not enough to show that the method was performed. “[S]uch an invention is not reduced to practice until it is established that the product made by the process is satisfactory, and [ ] this may require successful testing of the product.”).

III.TESTING REQUIRED TO ESTABLISH AN ACTUAL REDUCTION TO PRAC- TICE

“The nature of testing which is required to establish a reduction to practice depends on the particular facts of each case, especially the nature of the invention.” Gellert v. Wanberg, 495 F.2d 779, 783, 181 USPQ 648, 652 (CCPA 1974) (“an invention may be tested sufficiently … where less than all of the conditions of actual use are duplicated by the tests”); Wells v. Fremont, 177 USPQ 22, 24-5 (Bd. Pat. Inter. 1972) (“even where tests are conducted under ‘bench’ or laboratory conditions, those conditions must ‘fully duplicate each and every condition of actual use’ or if they do not, then the evidence must establish a relationship between the subject matter, the test condition and the intended functional setting of the invention,” but it is not required that all the conditions of all actual uses be duplicated, such as rain, snow, mud, dust and submersion in water).

IV.REDUCTION TO PRACTICE RE-QUIRES RECOGNITION AND APPRE-CIATION OF THE INVENTION

The invention must be recognized and appreciated for a reduction to practice to occur. “The rule that conception and reduction to practice cannot be established nunc pro tunc simply requires that in order for an experiment to constitute an actual reduction to




practice, there must have been contemporaneous appreciation of the invention at issue by the inventor…. Subsequent testing or later recognition may not be used to show that a party had contemporaneous appreciation of the invention. However, evidence of subsequent testing may be admitted for the purpose of showing that an embodiment was produced and that it met the limitations of the count.” Cooper v. Goldfarb, 154 F.3d 1321, 1331, 47 USPQ2d 1896, 1904 (Fed. Cir. 1998) (citations omitted). Meitzner v. Corte, 537 F.2d 524, 528, 190 USPQ 407, 410 (CCPA 1976) (there can be no conception or reduction to practice of a new form or of a process using such a new form of an otherwise old composition where there has been no recognition or appreciation of the existence of the new form); Estee Lauder, Inc. v. L’Oreal S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1615 (Fed. Cir. 1997) (“[W]hen testing is necessary to establish utility, there must be recognition and appreciation that the tests were successful for reduction to practice to occur.” A showing that testing was completed before the critical date, and that testing ultimately proved successful, was held insufficient to establish a reduction to practice before the critical date, since the success of the testing was not appreciated or recognized until after the critical date.); Parker v. Frilette, 462 F.2d 544, 547, 174 USPQ 321, 324 (CCPA 1972) (“[an] inventor need not understand precisely why his invention works in order to achieve an actual reduction to practice”).

V.RECOGNITION OF THE INVENTION BY ANOTHER MAY INURE TO THE BENEFIT OF THE INVENTOR

“Inurement involves a claim by an inventor that, as 

a matter of law, the acts of another person should accrue to the benefit of the inventor.” Cooper v. Goldfarb, 154 F.3d 1321, 1331, 47 USPQ2d 1896, 1904 (Fed. Cir. 1998). Before a non-inventor’s recognition of the utility of the invention can inure to the benefit of the inventor, the following three-prong test must be met: (1) the inventor must have conceived of the invention, (2) the inventor must have had an expectation that the embodiment tested would work for the intended purpose of the invention, and (3) the inventor must have submitted the embodiment for testing for the intended purpose of the invention. Genentech Inc. v. Chiron Corp., 220 F.3d 1345, 1354, 55 USPQ2d 1636, 1643 (Fed. Cir. 2000). In Genentech, a non-inventor hired by the inventors to test yeast samples for the presence of the fusion protein encoded by the DNA construct of the invention recognized the growth-enhancing property of the fusion protein, but did not communicate this recognition to the inventors. The court found that because the inventors did not submit the samples for testing growth-promoting activity, the intended purpose of the invention, the third prong was not satisfied and the uncommunicated recognition of the activity of the fusion protein by the non-inventor did not inure to their benefit. See also Cooper v. Goldfarb, 240 F.3d 1378, 1385, 57 USPQ2d 1990, 1995 (Fed. Cir. 2001) (Cooper sent to Goldfarb samples of a material for use in vascular grafts. At the time the samples were sent, Cooper was unaware of the importance of the fibril length of the material. Cooper did not at any time later convey to, or request from, Goldfarb any information regarding fibril length. Therefore, Goldfarb’s determination of the fibril lengths of the material could not inure to Cooper’s benefit.).

VI.IN AN INTERFERENCE PROCEEDING, ALL LIMITATIONS OF A COUNT MUST BE REDUCED TO PRACTICE

The device reduced to practice must include every limitation of the count. Fredkin v. Irasek, 397 F.2d 342, 158 USPQ 280, 285 (CCPA 1968); every limitation in a count is material and must be proved to establish an actual reduction to practice. Meitzner v. Corte, 537 F.2d 524, 528, 190 USPQ 407, 410. See also Hull v. Bonis, 214 USPQ 731, 734 (Bd. Pat. Inter. 1982) (no doctrine of equivalents—remedy is a preliminary motion to amend the count to conform to the proofs).

VII.CLAIMED INVENTION IS NOT ACT- UALLY REDUCED TO PRACTICE UN- LESS THERE IS A KNOWN UTILITY

Utility for the invention must be known at the time of the reduction to practice. Wiesner v. Weigert, 666 F.2d 582, 588, 212 USPQ 721, 726 (CCPA 1981) (except for plant and design inventions); Azar v. Burns, 188 USPQ 601, 604 (Bd. Pat. Inter. 1975) (a composition and a method cannot be actually reduced to practice unless the composition and the product produced by the method have a practical utility);




Ciric v. Flanigen, 511 F.2d 1182, 1185, 185 USPQ 103, 105-6 (CCPA 1975) (“when a count does not recite any particular utility, evidence establishing a substantial utility for any purpose is sufficient to prove a reduction to practice”; “the demonstrated similarity of ion exchange and adsorptive properties between the newly discovered zeolites and known crystalline zeolites … have established utility for the zeolites of the count”); Engelhardt v. Judd, 369 F.2d 408, 411, 151 USPQ 732, 735 (CCPA 1966) (When considering an actual reduction to practice as a bar to patentability for claims to compounds, it is sufficient to successfully demonstrate utility of the compounds in animals for somewhat different pharmaceutical purposes than those asserted in the specification for humans.); Rey-Bellet v. Engelhardt, 993 F.2d 1380, 1384, 181 USPQ 453, 455 (CCPA 1974) (Two categories of tests on laboratory animals have been considered adequate to show utility and reduction to practice: first, tests carried out to prove utility in humans where there is a satisfactory correlation between humans and animals, and second, tests carried out to prove utility for treating animals.).

VIII.A PROBABLE UTILITY MAY NOT BE SUFFICIENT TO ESTABLISH UTILITY

A probable utility does not establish a practical utility, which is established by actual testing or where the utility can be “foretold with certainty.” Bindra v. Kelly, 206 USPQ 570, 575 (Bd. Pat. Inter. 1979) (Reduction to practice was not established for an intermediate useful in the preparation of a second intermediate with a known utility in the preparation of a pharmaceutical. The record established there was a high degree of probability of a successful preparation because one skilled in the art may have been motivated, in the sense of 35 U.S.C. 103, to prepare the second intermediate from the first intermediate. However, a strong probability of utility is not sufficient to establish practical utility.); Wu v. Jucker, 167 USPQ 467, 472 (Bd. Pat. Inter. 1968) (screening test where there was an indication of possible utility is insufficient to establish practical utility). But see Nelson v. Bowler, 628 F.2d 853, 858, 206 USPQ 881, 885 (CCPA 1980) (Relevant evidence is judged as a whole for its persuasiveness in linking observed properties to suggested uses. Reasonable correlation between the two is sufficient for an actual reduction to practice.).

2138.06 "Reasonable Diligence"[edit | edit source]

The diligence of 35 U.S.C. 102(g) relates to reasonable “attorney-diligence” and “engineering-diligence” (Keizer v. Bradley, 270 F.2d 396, 397, 123 USPQ 215, 216 (CCPA 1959)), which does not require that “an inventor or his attorney … drop all other work and concentrate on the particular invention involved….” Emery v. Ronden, 188 USPQ 264, 268 (Bd. Pat. Inter. 1974).

CRITICAL PERIOD FOR ESTABLISHING DILIGENCE BETWEEN ONE WHO WAS FIRST TO CONCEIVE BUT LATER TO REDUCE TO PRACTICE THE INVENTION

The critical period for diligence for a first conceiver but second reducer begins not at the time of conception of the first conceiver but just prior to the entry in the field of the party who was first to reduce to practice and continues until the first conceiver reduces to practice. Hull v. Davenport, 90 F.2d 103, 105,

33 USPQ 506, 508 (CCPA 1937) (“lack of diligence from the time of conception to the time immediately preceding the conception date of the second conceiver is not regarded as of importance except as it may have a bearing upon his subsequent acts”). What serves as the entry date into the field of a first reducer is dependent upon what is being relied on by the first reducer, e.g., conception plus reasonable diligence to reduction to practice (Fritsch v. Lin, 21 USPQ2d 1731, 1734 (Bd. Pat. App. & Inter. 1991), Emery v. Ronden, 188 USPQ 264, 268 (Bd. Pat. Inter. 1974)); an actual reduction to practice or a constructive reduction to practice by the filing of either a U.S. application (Rebstock v. Flouret, 191 USPQ 342, 345 (Bd. Pat. Inter. 1975)) or reliance upon priority under 35 U.S.C. 119 of a foreign application (Justus v. Appenzeller, 177 USPQ 332, 339 (Bd. Pat. Inter. 1971) (chain of priorities under 35 U.S.C. 119 and 120, priority under 35 U.S.C. 119 denied for failure to supply certified copy of the foreign application during pendency of the application filed within the twelfth month)).




THE ENTIRE PERIOD DURING WHICH DILI- GENCE IS REQUIRED MUST BE ACCOUNTED FOR BY EITHER AFFIRMATIVE ACTS OR ACCEPTABLE EXCUSES

An applicant must account for the entire period during which diligence is required. Gould v. Schawlow, 363 F.2d 908, 919, 150 USPQ 634, 643 (CCPA 1966) (Merely stating that there were no weeks or months that the invention was not worked on is not enough.); In re Harry, 333 F.2d 920, 923, 142 USPQ 164, 166 (CCPA 1964) (statement that the subject matter “was diligently reduced to practice” is not a showing but a mere pleading). A 2-day period lacking activity has been held to be fatal. In re Mulder, 716 F.2d 1542, 1545, 219 USPQ 189, 193 (Fed. Cir. 1983) (37 CFR 1.131 issue); Fitzgerald v. Arbib, 268 F.2d 763, 766, 122 USPQ 530, 532 (CCPA 1959) (Less than 1 month of inactivity during critical period. Efforts to exploit an invention commercially do not constitute diligence in reducing it to practice. An actual reduction to practice in the case of a design for a three-dimensional article requires that it should be embodied in some structure other than a mere drawing.); Kendall v. Searles, 173 F.2d 986, 993, 81 USPQ 363, 369 (CCPA 1949) (Diligence requires that applicants must be specific as to dates and facts.).

The period during which diligence is required must be accounted for by either affirmative acts or acceptable excuses. Rebstock v. Flouret, 191 USPQ 342, 345 (Bd. Pat. Inter. 1975); Rieser v. Williams, 225 F.2d 419, 423, 118 USPQ 96, 100 (CCPA 1958) (Being last to reduce to practice, party cannot prevail unless he has shown that he was first to conceive and that he exercised reasonable diligence during the critical period from just prior to opponent’s entry into the field); Griffith v. Kanamaru, 816 F.2d 624, 2 USPQ2d 1361 (Fed. Cir. 1987) (Court generally reviewed cases on excuses for inactivity including vacation extended by ill health and daily job demands, and held lack of university funding and personnel are not acceptable excuses.); Litchfield v. Eigen, 535 F.2d 72, 190 USPQ 113 (CCPA 1976) (budgetary limits and availability of animals for testing not sufficiently described); Morway v. Bondi, 203 F.2d 741, 749, 97 USPQ 318, 323 (CCPA 1953) (voluntarily laying aside inventive concept in pursuit of other projects is generally not an acceptable excuse although there may be circumstances creating exceptions); Anderson v. Crowther, 152 USPQ 504, 512 (Bd. Pat. Inter. 1965) (preparation of routine periodic reports covering all accomplishments of the laboratory insufficient to show diligence); Wu v. Jucker, 167 USPQ 467, 472-73 (Bd. Pat. Inter. 1968) (applicant improperly allowed test data sheets to accumulate to a sufficient amount to justify interfering with equipment then in use on another project); Tucker v. Natta, 171 USPQ 494,498 (Bd. Pat. Inter. 1971) (“[a]ctivity directed toward the reduction to practice of a genus does not establish, prima facie, diligence toward the reduction to practice of a species embraced by said genus”); Justus v. Appenzeller, 177 USPQ 332, 340-1 (Bd. Pat. Inter. 1971) (Although it is possible that patentee could have reduced the invention to practice in a shorter time by relying on stock items rather than by designing a particular piece of hardware, patentee exercised reasonable diligence to secure the required hardware to actually reduce the invention to practice. “[I]n deciding the question of diligence it is immaterial that the inventor may not have taken the expeditious course….”).

WORK RELIED UPON TO SHOW REASONABLE DILIGENCE MUST BE DIRECTLY RELATED TO THE REDUCTION TO PRACTICE

The work relied upon to show reasonable diligence must be directly related to the reduction to practice of the invention in issue. Naber v. Cricchi, 567 F.2d 382, 384, 196 USPQ 294, 296 (CCPA 1977), cert. denied, 439 U.S. 826 (1978). See also Scott v. Koyama, 281 F.3d 1243, 1248-49, 61 USPQ2d 1856, 1859 (Fed. Cir. 2002) (Activities directed at building a plant to practice the claimed process of producing tetrafluoroethane on a large scale constituted efforts toward actual reduction to practice, and thus were evidence of diligence. The court distinguished cases where diligence was not found because inventors either discontinued development or failed to complete the invention while pursuing financing or other commercial activity.); In re Jolley, 308 F.3d 1317, 1326-27, 64 USPQ2d 1901, 1908-09 (Fed. Cir. 2002) (diligence found based on research and procurement activities related to the subject matter of the interference count). “[U]nder some circumstances an inventor should also be able to rely on work on closely related inventions as support for diligence toward the reduction to practice on an invention in issue.” Ginos




v. Nedelec, 220 USPQ 831, 836 (Bd. Pat. Inter. 1983) (work on other closely related compounds that were considered to be part of the same invention and which were included as part of a grandparent application). “The work relied upon must be directed to attaining a reduction to practice of the subject matter of the counts. It is not sufficient that the activity relied on concerns related subject matter.” Gunn v. Bosch, 181 USPQ 758, 761 (Bd. Pat. Inter. 1973) (An actual reduction to practice of the invention at issue which occurred when the inventor was working on a different invention “was fortuitous, and not the result of a continuous intent or effort to reduce to practice the invention here in issue. Such fortuitousness is inconsistent with the exercise of diligence toward reduction to practice of that invention.” 181 USPQ at 761. Furthermore, evidence drawn towards work on improvement of samples or specimens generally already in use at the time of conception that are but one element of the oscillator circuit of the count does not show diligence towards the construction and testing of the overall combination.); Broos v. Barton, 142 F.2d 690, 691, 61 USPQ 447, 448 (CCPA 1944) (preparation of application in U.S. for foreign filing constitutes diligence); De Solms v. Schoenwald, 15 USPQ2d 1507 (Bd. Pat. App. & Inter. 1990) (principles of diligence must be given to inventor’s circumstances including skill and time; requirement of corroboration applies only to testimony of inventor); Huelster v. Reiter, 168 F.2d 542, 78 USPQ 82 (CCPA 1948) (if inventor was not able to make an actual reduction to practice of the invention, he must also show why he was not able to constructively reduce the invention to practice by the filing of an application).


DILIGENCE REQUIRED IN PREPARING AND FILING PATENT APPLICATION

The diligence of attorney in preparing and filing patent application inures to the benefit of the inventor. Conception was established at least as early as the date a draft of a patent application was finished by a patent attorney on behalf of the inventor. Conception is less a matter of signature than it is one of disclosure. Attorney does not prepare a patent application on behalf of particular named persons, but on behalf of the true inventive entity. Six days to execute and file application is acceptable. Haskell v. Coleburne, 671 F.2d 1362, 213 USPQ 192, 195 (CCPA 1982). See also Bey v. Kollonitsch, 866 F.2d 1024, 231 USPQ 967 (Fed. Cir. 1986) (Reasonable diligence is all that is required of the attorney. Reasonable diligence is established if attorney worked reasonably hard on the application during the continuous critical period. If the attorney has a reasonable backlog of unrelated cases which he takes up in chronological order and carries out expeditiously, that is sufficient. Work on a related case(s) that contributed substantially to the ultimate preparation of an application can be credited as diligence.).

END OF DILIGENCE PERIOD IS MARKED BY EITHER ACTUAL OR CONSTRUCTIVE REDUCTION TO PRACTICE

"[I]t is of no moment that the end of that period [for diligence] is fixed by a constructive, rather than an actual, reduction to practice." Justus v. Appenzeller, 177 USPQ 332, 340-41 (Bd. Pat. Inter. 1971).


2141 35 U.S.C. 103; the Graham Factual Inquiries[edit | edit source]

35 U.S.C. 103. Conditions for patentability; non-obvious subject matter.

(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.

(b)

(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if-

(A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and

(B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person.

(2) A patent issued on a process under paragraph (1)-

(A) shall also contain the claims to the composition of matter used in or made by that process, or

(B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.

(3) For purposes of paragraph (1), the term “biotechnological process” means-

(A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to-

(i) express an exogenous nucleotide sequence,

(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or

(iii) express a specific physiological characteristic not naturally associated with said organism;

(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and

(C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).

(c)

(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.

(2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if —

(A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;

(B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and

(C)the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.

(3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.


I. STANDARD OF PATENTABILITY TO BE APPLIED IN OBVIOUSNESS REJECTIONS

Patent examiners carry the responsibility of making sure that the standard of patentability enunciated by the Supreme Court and by the Congress is applied in each and every case. The Supreme Court in Graham v. John Deere, 383 U.S. 1, 148 USPQ 459 (1966), stated:

Under § 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquires may have relevancy. . .

This in not to say, however, that there will not be difficulties in applying the nonobviousness test. What is obvious is not a question upon which there is likely to be uniformity of thought in every given factual context. The difficulties, however, are comparable to those encountered daily by the courts in such frames of reference as negligence and scienter, and should be amenable to a case-by- case development. We believe that strict observance of the requirements laid down here will result in that uniformity and definitiveness which Congress called for in the 1952 Act.

Office policy is to follow Graham v. John Deere Co. in the consideration and determination of obviousness under 35 U.S.C. 103. As quoted above, the four factual inquires enunciated therein as a background for determining obviousness are as follows:

  1. Determining the scope and contents of the prior art
  2. Ascertaining the differences between the prior art and the claims in issue
  3. Resolving the level of ordinary skill in the pertinent art and
  4. Evaluating evidence of secondary considerations.

The Supreme Court reaffirmed and relied upon the Graham three pronged test in its consideration and determination of obviousness in the fact situations presented in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied, 426 U.S. 955 (1976) and Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969). In each case, the Court discussed whether the claimed combinations produced a “new or different function” and a “synergistic result,” but it clearly decided whether the claimed inventions were nonobviousness on the basis of the three-way test in Graham. Nowhere in its decisions in these cases does the Court state that the “new or different function” and “synergistic result” tests supersede a finding of nonobvious or obviousness under the Graham test.

Accordingly, examiners should apply the test for patentability under 35 U.S.C. 103 set forth in Graham. See below for a detailed discussion of each of the Graham factual inquiries. It should be noted that the Supreme Court’s application of the Graham test to the fact circumstances in Ag Pro was somewhat stringent, as it was in Black Rock. Note Republic Industries, Inc. v. Schlage Lock Co., 592 F.2d 963, 200 USPQ 769 (7th Cir. 1979). The Court of Appeals for the Federal Circuit stated in Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1540, 218 USPQ 871, 880 (Fed. Cir. 1983) that

A requirement for “synergism” or a “synergistic effect” is nowhere found in the statute, 35 U.S.C. When present, for example in a chemical case, synergism may point toward nonobviousness, but its absence has no place in evaluating the evidence on obviousness. The more objective findings suggested in Graham, supra, are drawn from the language of the statute and are fully adequate guides for evaluating the evidence relating to compliance with 35 U.S.C. § 103. Bowser Inc. v. United States, 388 F. 2d 346, 156 USPQ 406 (Ct. Cl. 1967).

II. BASIC CONSIDERATIONS WHICH APPLY TO OBVIOUSNESS REJECTIONS

When applying 35 U.S.C. 103, the following tenets of patent law must be adhered to:

  1. The claimed invention must be considered as a whole
  2. The references must be considered as a whole and must suggest the desirability and thus the obviousness of making the combination
  3. The references must be viewed without the benefit of impermissible hindsight vision afforded by the claimed invention and
  4. Reasonable expectation of success is the standard with which obviousness is determined.

Hodosh v. Block Drug Co., Inc., 786 F.2d 1136, 1143 n.5, 229 USPQ 182, 187 n.5 (Fed. Cir. 1986).

III. OBJECTIVE EVIDENCE MUST BE CONSIDERED

Objective evidence or secondary considerations such as unexpected results, commercial success, long- felt need, failure of others, copying by others, licensing, and skepticism of experts are relevant to the issue of obviousness and must be considered in every case in which they are present. When evidence of any of these secondary considerations is submitted, the examiner must evaluate the evidence. The weight to be accorded to the evidence depends on the individual factual circumstances of each case. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 231 USPQ 81 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987). The ultimate determination on patentability is made on the entire record. In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). However, evidence developed after the patent grant in response to challenge to the patent validity’s should not be excluded from consideration since “understanding the full range of the invention is not always achieved at the time of filing the patent application.” Knoll Pharms. Co., Inc. v. Teva Pharms. USA Inc., 367 F.3d 1381, 1385, 70 USPQ2d 1957, 1960 (Fed. Cir. 2004). (reversing the lower court’s grant of summary judgement of invalidity for failure to consider ‘unexpected results’ evidence obtained from post-filing that could be relevant to the patent validity inquiry).

See MPEP § 716 - § 716.06 for a discussion of objective evidence and its role in the final legal determination of whether a claimed invention would have been obvious under 35 U.S.C. 103.

2141.01 Scope and Content of the Prior Art[edit | edit source]

I. PRIOR ART AVAILABLE UNDER 35 U.S.C. 102 IS AVAILABLE UNDER 35 U.S.C. 103

“Before answering Graham’s ‘content’ inquiry, it must be known whether a patent or publication is in the prior art under 35 U.S.C. § 102.” Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593, 1597 (Fed. Cir.), cert. denied, 481 U.S. 1052 (1987). Subject matter that is prior art under 35 U.S.C. 102 can be used to support a rejection under section 103. Ex parte Andresen, 212 USPQ 100, 102 (Bd. Pat. App. & Inter. 1981) (“it appears to us that the commentator [of 35 U.S.C.A.] and the [congressional] committee viewed section 103 as including all of the various bars to a patent as set forth in section 102.”).

A 35 U.S.C. 103 rejection is based on 35 U.S.C. 102(a), 102(b), 102(e), etc. depending on the type of prior art reference used and its publication or issue date. For instance, an obviousness rejection over a U.S. patent which was issued more than 1 year before the filing date of the application is said to be a statutory bar just as if it anticipated the claims under 35 U.S.C. 102(b). Analogously, an obviousness rejection based on a publication which would be applied under 102(a) if it anticipated the claims can be overcome by swearing behind the publication date of the reference by filing an affidavit or declaration under 37 CFR 1.131.

For an overview of what constitutes prior art under 35 U.S.C. 102, see MPEP § 901 - § 901.06(d) and § 2121 - § 2129.

II. SUBSTANTIVE CONTENT OF THE PRIOR ART

See § 2121 - § 2129 for case law relating to the substantive content of the prior art (e.g., availability of inoperative devices, extent to which prior art must be enabling, broad disclosure rather than preferred embodiments, admissions, etc.).

III. CONTENT OF THE PRIOR ART IS DETERMINED AT THE TIME THE INVENTION WAS MADE TO AVOID HINDSIGHT

The requirement “at the time the invention was made” is to avoid impermissible hindsight. See MPEP § 2145, paragraph X.A. for a discussion of rebutting applicants’ arguments that a rejection is based on hindsight.

“It is difficult but necessary that the decisionmaker forget what he or she has been taught . . . about the claimed invention and cast the mind back to the time the invention was made (often as here many years), to occupy the mind of one skilled in the art who is presented only with the references, and who is normally guided by the then-accepted wisdom in the art.” W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303, 313 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984).

IV. 35 U.S.C. 103(c) — EVIDENCE REQUIRED TO SHOW CONDITIONS OF 35 U.S.C. 103 (c) APPLY

An applicant who wants to avail himself or herself of the benefits of 35 U.S.C. 103(c) has the burden of establishing that subject matter which only qualifies as prior art under subsection (e), (f) or (g) of section 102 used in a rejection under 35 U.S.C. 103(a) and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. Ex parte Yoshino, 227 USPQ 52 (Bd. Pat. App. & Inter. 1985). Likewise, an applicant who wants to avail himself or herself of the benefits of the joint research provisions of 35 U.S.C. 103(c) (for applications pending on or after December 10, 2004) has the burden of establishing that:

(A)the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;

(B)the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and

(C)the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.

This prior art disqualification is only applicable for subject matter which only qualifies as prior art under subsection (e), (f) or (g) of 35 U.S.C. 102 used in a rejection under 35 U.S.C. 103(a).

Note that for applications filed prior to November 29, 1999, and granted as patents prior to December 10, 2004, 35 U.S.C. 103(c) is limited on its face to subject matter developed by another person which qualifies as prior art only under subsection (f) or (g) of section 102. See MPEP § 706.02(l)(1). See also In re Bartfeld, 925 F.2d 1450, 1453-54, 17 USPQ2d 1885, 1888 (Fed. Cir. 1991) (Applicant attempted to overcome a 35 U.S.C. 102(e)/103 rejection with a terminal disclaimer by alleging that the public policy intent of 35 U.S.C 103(c) was to prohibit the use of “secret” prior art in obviousness determinations. The court rejected this argument, holding “We may not disregard the unambiguous exclusion of § 102(e) from the statute’s purview.”).

See MPEP § 706.02(l)(2) for the requirements which must be met to establish common ownership or a joint research agreement.

2141.01(a) Analogous and Nonanalogous Art[edit | edit source]

I. TO RELY ON A REFERENCE UNDER 35 U.S.C. 103, IT MUST BE ANALOGOUS PRIOR ART

The examiner must determine what is “analogous prior art” for the purpose of analyzing the obviousness of the subject matter at issue. “In order to rely on a reference as a basis for rejection of an applicant’s invention, the reference must either be in the field of applicant's endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned.” In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). See also In re Deminski, 796 F.2d 436, 230 USPQ 313 (Fed. Cir. 1986); In re Clay, 966 F.2d 656, 659, 23 USPQ2d 1058, 1060-61 (Fed. Cir. 1992) (“A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem.”); Wang Laboratories Inc. v. Toshiba Corp., 993 F.2d 858, 26 USPQ2d 1767 (Fed. Cir. 1993); and State Contracting & Eng’g Corp. v. Condotte America, Inc., 346 F.3d 1057, 1069, 68 USPQ2d 1481, 1490 (Fed. Cir. 2003) (where the general scope of a reference is outside the pertinent field of endeavor, the reference may be considered analogous art if subject matter disclosed therein is relevant to the particular problem with which the inventor is involved).

II. PTO CLASSIFICATION IS SOME EVIDENCE OF ANALOGY, BUT SIMILARITIES AND DIFFERENCES IN STRUCTURE AND FUNCTION CARRY MORE WEIGHT

While Patent Office classification of references and the cross-references in the official search notes of the class definitions are some evidence of “nonanalogy” or “analogy” respectively, the court has found “the similarities and differences in structure and function of the inventions to carry far greater weight.” In re Ellis, 476 F.2d 1370, 1372, 177 USPQ 526, 527 (CCPA 1973) (The structural similarities and functional overlap between the structural gratings shown by one reference and the shoe scrapers of the type shown by another reference were readily apparent, and therefore the arts to which the reference patents belonged were reasonably pertinent to the art with which appellant’s invention dealt (pedestrian floor gratings).); In re Clay, 966 F.2d 656, 23 USPQ2d 1058 (Fed. Cir. 1992) (Claims were directed to a process for storing a refined liquid hydrocarbon product in a storage tank having a dead volume between the tank bottom and its outlet port wherein a gelled solution filled the tank’s dead volume to prevent loss of stored product while preventing contamination. One of the references relied upon disclosed a process for reducing the permeability of natural underground hydrocarbon bearing formations using a gel similar to that of applicant to improve oil production. The court disagreed with the PTO’s argument that the reference and claimed inventions were part of the same endeavor, “maximizing withdrawal of petroleum stored in petroleum reserves,” and found that the inventions involved different fields of endeavor since the reference taught the use of the gel in a different structure for a different purpose under different temperature and pressure conditions, and since the application related to storage of liquid hydrocarbons rather than extraction of crude petroleum. The court also found the reference was not reasonably pertinent to the problem with which the inventor was concerned because a person having ordinary skill in the art would not reasonably have expected to solve the problem of dead volume in tanks for refined petroleum by considering a reference dealing with plugging underground formation anomalies.).

III. ANALOGY IN THE CHEMICAL ARTS

See, for example, Ex parte Bland, 3 USPQ2d 1103 (Bd. Pat App. & Inter. 1986) (Claims were drawn to a particulate composition useful as a preservative for an animal foodstuff (or a method of inhibiting fungus growth in an animal foodstuff therewith) comprising verxite having absorbed thereon propionic acid. All references were concerned with absorbing biologically active materials on carriers, and therefore the teachings in each of the various references would have been pertinent to the problems in the other references and the invention at hand.); Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983) (Problem confronting inventor was preventing electrostatic buildup in PTFE tubing caused by hydrocarbon fuel flow while precluding leakage of fuel. Two prior art references relied upon were in the rubber hose art, both referencing the problem of electrostatic buildup caused by fuel flow. The court found that because PTFE and rubber are used by the same hose manufacturers and experience the same and similar problems, a solution found for a problem experienced with either PTFE or rubber hosing would be looked to when facing a problem with the other.); In re Mlot-Fijalkowski, 676 F.2d 666, 213 USPQ 713 (CCPA 1982) (Problem faced by appellant was enhancement and immobilization of dye penetrant indications. References which taught the use of dyes and finely divided developer materials to produce colored images preferably in, but not limited to, the duplicating paper art were properly relied upon because the court found that appellant’s problem was one of dye chemistry, and a search for its solution would include the dye arts in general.).

IV. ANALOGY IN THE MECHANICAL ARTS

See, for example, In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992) (Applicant claimed an improvement in a hose clamp which differed from the prior art in the presence of a preassembly “hook” which maintained the preassembly condition of the clamp and disengaged automatically when the clamp was tightened. The Board relied upon a reference which disclosed a hook and eye fastener for use in garments, reasoning that all hooking problems are analogous. The court held the reference was not within the field of applicant’s endeavor, and was not reasonably pertinent to the particular problem with which the inventor was concerned because it had not been shown that a person of ordinary skill, seeking to solve a problem of fastening a hose clamp, would reasonably be expected or motivated to look to fasteners for garments. The Commissioner further argued in the brief on appeal that a disengageable catch is a common everyday mechanical concept, however the court held that the Commissioner did not explain why a “catch” of unstated structure is such a concept, and why it would have made the claimed invention obvious.). Compare Stevenson v. International Trade Comm., 612 F.2d 546, 550, 204 USPQ 276, 280 (CCPA 1979) (“In a simple mechanical invention a broad spectrum of prior art must be explored and it is reasonable to permit inquiry into other areas where one of ordinary skill in the art would be aware that similar problems exist.”). See also In re Bigio, 381 F.3d 1320, 1325-26, 72 USPQ2d 1209, 1211-12 (Fed. Cir. 2004). The patent application claimed a “hair brush” having a specific bristle configuration. The Board affirmed the examiner’s rejection of the claims as being obvious in view of prior art patents disclosing toothbrushes. 381 F.3d at 1323, 72 USPQ2d at 1210. The applicant disputed that the patent references constituted analogous art. On appeal, the court upheld the Board’s interpretation of the claim term “hair brush” to encompass any brush that may be used for any bodily hair, including facial hair. 381 F.3d at 1323-24, 72 USPQ2d at 1211. With this claim interpretation, the court applied the “field of endeavor test” for analogous art and determined that the references were within the field of applicant’s endeavor and hence was analogous art because toothbrushes are structurally similar to small brushes for hair, and a toothbrush could be used to brush facial hair. 381 F.3d at 1326, 72 USPQ2d at 1212.

Also see In re Deminski, 796 F.2d 436, 230 USPQ 313 (Fed. Cir. 1986) (Applicant’s claims related to double-acting high pressure gas transmission line compressors in which the valves could be removed easily for replacement. The Board relied upon references which taught either a double-acting piston pump or a double-acting piston compressor. The court agreed that since the cited pumps and compressors have essentially the same function and structure, the field of endeavor includes both types of double-action piston devices for moving fluids.); Pentec, Inc. v. Graphic Controls Corp., 776 F.2d 309, 227 USPQ 766 (Fed. Cir. 1985) (Claims at issue were directed to an instrument marker pen body, the improvement comprising a pen arm holding means having an integrally molded hinged member for folding over against the pen body. Although the patent owners argued the hinge and fastener art was nonanalogous, the court held that the problem confronting the inventor was the need for a simple holding means to enable frequent, secure attachment and easy removal of a marker pen to and from a pen arm, and one skilled in the pen art trying to solve that problem would have looked to the fastener and hinge art.); and Ex parte Goodyear Tire & Rubber Co., 230 USPQ 357 (Bd. Pat. App. & Inter. 1985) (A reference in the clutch art was held reasonably pertinent to the friction problem faced by applicant, whose claims were directed to a braking material, because brakes and clutches utilize interfacing materials to accomplish their respective purposes.).

V. ANALOGY IN THE ELECTRICAL ARTS

See, for example, Wang Laboratories, Inc. v. Toshiba Corp., 993 F.2d 858, 26 USPQ2d 1767 (Fed. Cir. 1993) (Patent claims were directed to single in- line memory modules (SIMMs) for installation on a printed circuit motherboard for use in personal computers. Reference to a SIMM for an industrial controller was not necessarily in the same field of endeavor as the claimed subject matter merely because it related to memories. Reference was found to be in a different field of endeavor because it involved memory circuits in which modules of varying sizes may be added or replaced, whereas the claimed invention involved compact modular memories. Furthermore, since memory modules of the claims at issue were intended for personal computers and used dynamic random-access-memories, whereas reference SIMM was developed for use in large industrial machine controllers and only taught the use of static random- access-memories or read-only-memories, the finding that the reference was nonanalogous was supported by substantial evidence.); Medtronic, Inc. v. Cardiac Pacemakers, 721 F.2d 1563, 220 USPQ 97 (Fed. Cir. 1983) (Patent claims were drawn to a cardiac pacemaker which comprised, among other components, a runaway inhibitor means for preventing a pacemaker malfunction from causing pulses to be applied at too high a frequency rate. Two references disclosed circuits used in high power, high frequency devices which inhibited the runaway of pulses from a pulse source. The court held that one of ordinary skill in the pacemaker designer art faced with a rate-limiting problem would look to the solutions of others faced with rate limiting problems, and therefore the references were in an analogous art.).

VI. EXAMPLES OF ANALOGY IN THE DESIGN ARTS

See MPEP § 1504.03 for a discussion of the relevant case law setting forth the general requirements for analogous art in design applications.

For examples of analogy in the design arts, see In re Rosen, 673 F.2d 388, 213 USPQ 347 (CCPA 1982) (The design at issue was a coffee table of contemporary styling. The court held designs of contemporary furniture other than coffee tables, such as the desk and circular glass table top designs of the references relied upon, would reasonably fall within the scope of the knowledge of the designer of ordinary skill.); Ex parte Pappas, 23 USPQ2d 1636 (Bd. Pat. App. & Inter. 1992) (At issue was an ornamental design for a feed bunk with an inclined corner configuration. Examiner relied upon references to a bunk lacking the inclined corners claimed by appellant and the Architectural Precast Concrete Drafting Handbook. The Board found the Architectural Precast Concrete Drafting Handbook was analogous art, noting that a bunk may be a wood or concrete trough, and that both references relied upon “disclose structures in which at least one upstanding leg is generally perpendicular to a base portion to define a corner configuration between the leg and base portion.”); In re Butera, 1 F.3d 1252, 28 USPQ2d 1399 (Fed. Cir. 1993) (unpublished - not citable as precedent) (The claimed invention, a spherical design for a combined insect repellent and air freshener, was rejected by the Board as obvious over a single reference to a design for a metal ball anode. The court reversed, holding the reference design to be nonanalogous art. “A prior design is of the type claimed if it has the same general use as that claimed in the design patent application . . . . One designing a combined insect repellent and air freshener would therefore not have reason to know of or look to a design for a metal ball anode.” 28 USPQ2d at 1400.).

2141.02 Differences Between Prior Art and Claimed Invention[edit | edit source]

Ascertaining the differences between the prior art and the claims at issue requires interpreting the claim language, and considering both the invention and the prior art references as a whole. See MPEP § 2111 - § 2116.01 for case law pertaining to claim interpretation.

I.THE CLAIMED INVENTION AS A WHOLE MUST BE CONSIDERED

In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form “a single integral and gaplessly continuous piece.” Nortronargued the invention is just making integral what had been made in four bolted pieces, improperly limiting the focus to a structural difference from the prior art and failing to consider the invention as a whole. The prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure. “Because that insight was contrary to the understandings and expectations of the art, the structure effectuating it would not have been obvious to those skilled in the art.” 713 F.2d at 785, 218 USPQ at 700 (citations omitted).).

See also In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) (Claims were directed to a three step process for preparing sweetened foods and drinks. The first two steps were directed to a process of producing high purity maltose (the sweetener), and the third was directed to adding the maltose to foods and drinks. The parties agreed that the first two steps were unobvious but formed a known product and the third step was obvious. The Solicitor argued the preamble was directed to a process for preparing foods and drinks sweetened mildly and thus the specific method of making the high purity maltose (the first two steps in the claimed process) should not be given weight, analogizing with product-by-process claims. The court held “due to the admitted unobviousness of the first two steps of the claimed combination of steps, the subject matter as a whole would not have been obvious to one of ordinary skill in the art at the time the invention was made.” 535 F.2d at 69, 190 USPQ at 17 (emphasis in original). The preamble only recited the purpose of the process and did not limit the body of the claim. Therefore, the claimed process was a three step process, not the product formed by two steps of the process or the third step of using that product.).

II.DISTILLING THE INVENTION DOWN TO A “GIST” OR “THRUST” OF AN INVENTION DISREGARDS “AS A WHOLE” REQUIREMENT

Distilling an invention down to the “gist” or “thrust” of an invention disregards the requirement of analyzing the subject matter “as a whole.” W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984) (restricting consideration of the claims to a 10% per second rate of stretching of unsintered PTFE and disregarding other limitations resulted in treating claims as though they read differently than allowed); Bausch & Lomb v. Barnes-Hind/ Hydrocurve, Inc., 796 F.2d 443, 447-49, 230 USPQ 416, 419-20 (Fed. Cir. 1986), cert. denied, 484 U.S. 823 (1987) (District court focused on the “concept of forming ridgeless depressions having smooth rounded edges using a laser beam to vaporize the material,” but “disregarded express limitations that the product be an ophthalmic lens formed of a transparent cross- linked polymer and that the laser marks be surrounded by a smooth surface of unsublimated polymer.”). See also Jones v. Hardy, 727 F.2d 1524, 1530, 220 USPQ 1021, 1026 (Fed. Cir. 1984) (“treating the advantage as the invention disregards statutory requirement that the invention be viewed ‘as a whole’”); Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1 USPQ2d 1593 (Fed. Cir.), cert. denied, 481 U.S. 1052 (1987) (district court improperly distilled claims down to a one word solution to a problem).

III.DISCOVERING SOURCE/CAUSE OF A PROBLEM IS PART OF “AS A WHOLE” INQUIRY

“[A] patentable invention may lie in the discovery of the source of a problem even though the remedy may be obvious once the source of the problem is identified. This is part of the ‘subject matter as a whole’ which should always be considered in determining the obviousness of an invention under 35 U.S.C. § 103.” In re Sponnoble, 405 F.2d 578, 585, 160 USPQ 237, 243 (CCPA 1969). However, “discovery of the cause of a problem . . does not always result in a patentable invention. . . . [A] different situation exists where the solution is obvious from prior art which contains the same solution for a similar problem.” In re Wiseman, 596 F.2d 1019, 1022, 201 USPQ 658, 661 (CCPA 1979) (emphasis in original).

In In re Sponnoble, the claim was directed to a plural compartment mixing vial wherein a center seal plug was placed between two compartments for temporarily isolating a liquid-containing compartment from a solids-containing compartment. The claim differed from the prior art in the selection of butyl rubber with a silicone coating as the plug material instead of natural rubber. The prior art recognized that leakage from the liquid to the solids compartment was a problem, and considered the problem to be a result of moisture passing around the center plug because of microscopic fissures inherently present in molded or blown glass. The court found the inventor discovered the cause of moisture transmission was through the center plug, and there was no teaching in the prior art which would suggest the necessity of selecting applicant's plug material which was more impervious to liquids than the natural rubber plug of the prior art.

In In re Wiseman, 596 F.2d at 1022, 201 USPQ at 661, claims directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action to minimize fading of the brakes were rejected as obvious over a reference showing carbon disc brakes without grooves in combination with a reference showing grooves in noncarbon disc brakes for the purpose of cooling the faces of the braking members and eliminating dust, thereby reducing fading of the brakes. The court affirmed the rejection, holding that even if applicants discovered the cause of a problem, the solution would have been obvious from the prior art which contained the same solution (inserting grooves in disc brakes) for a similar problem.

IV.APPLICANTS ALLEGING DISCOVERY OF A SOURCE OF A PROBLEM MUST PROVIDE SUBSTANTIATING EVIDENCE

Applicants who allege they discovered the source of a problem must provide evidence substantiating the allegation, either by way of affidavits or declarations, or by way of a clear and persuasive assertion in the specification. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (unsubstantiated statement of counsel was insufficient to show appellants discovered source of the problem); In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983) (Claims were directed to a method for redeeming merchandising coupons which contain a UPC “5-by-5” bar code wherein, among other steps, the memory at each supermarket would identify coupons by manufacturer and transmit the data to a central computer to provide an audit thereby eliminating the need for clearinghouses and preventing retailer fraud. In challenging the propriety of an obviousness rejection, appellant argued he discovered the source of a problem (retailer fraud and manual clearinghouse operations) and its solution. The court found appellant’s specification did not support the argument that he discovered the source of the problem with respect to retailer fraud, and that the claimed invention failed to solve the problem of manual clearinghouse operations.).

V.DISCLOSED INHERENT PROPERTIES ARE PART OF “AS A WHOLE” INQUIRY

“In determining whether the invention as a whole would have been obvious under 35 U.S.C. 103, we must first delineate the invention as a whole. In delineating the invention as a whole, we look not only to the subject matter which is literally recited in the claim in question... but also to those properties of the subject matter which are inherent in the subject matter and are disclosed in the specification. . . Just as we look to a chemical and its properties when we examine the obviousness of a composition of matter claim, it is this invention as a whole, and not some part of it, which must be obvious under 35 U.S.C. 103.” In re Antonie, 559 F.2d 618, 620, 195 USPQ 6,8 (CCPA 1977) (emphasis in original) (citations omitted) (The claimed wastewater treatment device had a tank volume to contractor area of 0.12 gal./sq. ft. The court found the invention as a whole was the ratio of 0.12 and its inherent property that the claimed devices maximized treatment capacity regardless of other variables in the devices. The prior art did not recognize that treatment capacity was a function of the tank volume to contractor ratio, and therefore the parameter optimized was not recognized in the art to be a result-effective variable.). See also In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) (“From the standpoint of patent law, a compound and all its properties are inseparable.”).

Obviousness cannot be predicated on what is not known at the time an invention is made, even if the inherency of a certain feature is later established. In re Rijckaert, 9 F.2d 1531, 28 USPQ2d 1955 (Fed. Cir. 1993). See MPEP § 2112 for the requirements of rejections based on inherency.

VI.PRIOR ART MUST BE CONSIDERED IN ITS ENTIRETY, INCLUDING DISCLOSURES THAT TEACH AWAY FROM THE CLAIMS

A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984) (Claims were directed to a process of producing a porous article by expanding shaped, unsintered, highly crystalline poly(tetrafluoroethylene) (PTFE) by stretching said PTFE at a 10% per second rate to more than five times the original length. The prior art teachings with regard to unsintered PTFE indicated the material does not respond to conventional plastics processing, and the material should be stretched slowly. A reference teaching rapid stretching of conventional plastic polypropylene with reduced crystallinity combined with a reference teaching stretching unsintered PTFE would not suggest rapid stretching of highly crystalline PTFE, in light of the disclosures in the art that teach away from the invention, i.e., that the conventional polypropylene should have reduced crystallinity before stretching, and that PTFE should be stretched slowly.).

However, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also MPEP § 2123.

2141.03 Level of Ordinary Skill in the Art[edit | edit source]

FACTORS TO CONSIDER IN DETERMINING LEVEL OF ORDINARY SKILL

“Factors that may be considered in determining level of ordinary skill in the art include (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).

The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (The Board disagreed with the examiner’s definition of one of ordinary skill in the art (a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering.).

References which do not qualify as prior art because they postdate the claimed invention may be relied upon to show the level of ordinary skill in the art at or around the time the invention was made. Ex parte Erlich, 22 USPQ 1463 (Bd. Pat. App. & Inter. 1992). Moreover, documents not available as prior art because the documents were not widely disseminated may be used to demonstrate the level of ordinary skill in the art. For example, the document may be relevant to establishing “a motivation to combine which is implicit in the knowledge of one of ordinary skill in the art.” National Steel Car Ltd. v. Canadian Pacific Railway Ltd., 357 F.3d 1319, 1338, 69 USPQ2d 1641, 1656 (Fed. Cir. 2004)(holding that a drawing made by an engineer that was not prior art may nonetheless “be used to demonstrate a motivation to combine implicit in the knowledge of one of ordinary skill in the art”).

SPECIFYING A PARTICULAR LEVEL OF SKILL IS NOT NECESSARY WHERE THE PRIOR ART ITSELF REFLECTS AN APPROPRIATE LEVEL

If the only facts of record pertaining to the level of skill in the art are found within the prior art of record, the court has held that an invention may be held to have been obvious without a specific finding of a particular level of skill where the prior art itself reflects an appropriate level. Chore-Time Equipment, Inc. v. Cumberland Corp., 713 F.2d 774, 218 USPQ 673 (Fed. Cir. 1983). See also Okajima v. Bourdeau, 261 F.3d 1350, 1355, 59 USPQ2d 1795, 1797 (Fed. Cir. 2001).

ASCERTAINING LEVEL OF ORDINARY SKILL IS NECESSARY TO MAINTAIN OBJECTIVITY

“The importance of resolving the level of ordinary skill in the art lies in the necessity of maintaining objectivity in the obviousness inquiry.” Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718, 21 USPQ2d 1053, 1057 (Fed. Cir. 1991). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).



2142 Legal Concept of Prima Facie Obviousness[edit | edit source]

The legal concept of prima facie obviousness is a procedural tool of examination which applies broadly to all arts. It allocates who has the burden of going forward with production of evidence in each step of the examination process.

The examiner bears the initial burden of factually supporting any prima facie conclusion of obviousness. If the examiner does not produce a prima facie case, the applicant is under no obligation to submit evidence of nonobviousness. If, however, the examiner does produce a prima facie case, the burden of coming forward with evidence or arguments shifts to the applicant who may submit additional evidence of nonobviousness, such as comparative test data showing that the claimed invention possesses improved properties not expected by the prior art. The initial evaluation of prima facie obviousness thus relieves both the examiner and applicant from evaluating evidence beyond the prior art and the evidence in the specification as filed until the art has been shown to suggest the claimed invention.

To reach a proper determination under 35 U.S.C. 103, the examiner must step backward in time and into the shoes worn by the hypothetical “person of ordinary skill in the art” when the invention was unknown and just before it was made. In view of all factual information, the examiner must then make a determination whether the claimed invention “as a whole” would have been obvious at that time to that person. Knowledge of applicant’s disclosure must be put aside in reaching this determination, yet kept in mind in order to determine the “differences,” conduct the search and evaluate the “subject matter as a whole” of the invention. The tendency to resort to “hindsight” based upon applicant's disclosure is often difficult to avoid due to the very nature of the examination process. However, impermissible hindsight must be avoided and the legal conclusion must be reached on the basis of the facts gleaned from the prior art.

ESTABLISHING A PRIMA FACIE CASE OF OBVIOUSNESS[edit | edit source]

To establish a prima facie case of obviousness, three basic criteria must be met:

  1. there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings.
  2. there must be a reasonable expectation of success.
  3. the prior art reference (or references when combined) must teach or suggest all the claim limitations.

The teaching or suggestion to make the claimed combination and the reasonable expectation of success must both be found in the prior art, and not based on applicant’s disclosure.

The initial burden is on the examiner to provide some suggestion of the desirability of doing what the inventor has done. “To support the conclusion that the claimed invention is directed to obvious subject matter, either the references must expressly or impliedly suggest the claimed invention or the examiner must present a convincing line of reasoning as to why the artisan would have found the claimed invention to have been obvious in light of the teachings of the references.” Ex parte Clapp, 227 USPQ 972, 973 (Bd. Pat. App. & Inter. 1985). See MPEP § 2144 - § 2144.09 for examples of reasoning supporting obviousness rejections.

When the motivation to combine the teachings of the references is not immediately apparent, it is the duty of the examiner to explain why the combination of the teachings is proper. Ex parte Skinner, 2 USPQ2d 1788 (Bd. Pat. App. & Inter. 1986). A statement of a rejection that includes a large number of rejections must explain with reasonable specificity at least one rejection, otherwise the examiner procedurally fails to establish a prima facie case of obviousness. Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989) (Rejection based on nine references which included at least 40 prior art rejections without explaining any one rejection with reasonable specificity was reversed as procedurally failing to establish a prima facie case of obviousness.).

If the examiner determines there is factual support for rejecting the claimed invention under 35 U.S.C. 103, the examiner must then consider any evidence supporting the patentability of the claimed invention, such as any evidence in the specification or any other evidence submitted by the applicant. The ultimate determination of patentability is based on the entire record, by a preponderance of evidence, with due consideration to the persuasiveness of any arguments and any secondary evidence. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). The legal standard of “a preponderance of evidence” requires the evidence to be more convincing than the evidence which is offered in opposition to it. With regard to rejections under 35 U.S.C. 103, the examiner must provide evidence which as a whole shows that the legal determination sought to be proved (i.e., the reference teachings establish a prima facie case of obviousness) is more probable than not.

When an applicant submits evidence, whether in the specification as originally filed or in reply to a rejection, the examiner must reconsider the patentability of the claimed invention. The decision on patentability must be made based upon consideration of all the evidence, including the evidence submitted by the examiner and the evidence submitted by the applicant. A decision to make or maintain a rejection in the face of all the evidence must show that it was based on the totality of the evidence. Facts established by rebuttal evidence must be evaluated along with the facts on which the conclusion of obviousness was reached, not against the conclusion itself. In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990).

See In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984) for a discussion of the proper roles of the examiner’s prima facie case and applicant’s rebuttal evidence in the final determination of obviousness. See MPEP § 706.02(j) for a discussion of the proper contents of a rejection under 35 U.S.C. 103.



2143 Basic Requirements of a Prima Facie Case of Obviousness[edit | edit source]

To establish a prima facie case of obviousness, three basic criteria must be met. First, there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings. Second, there must be a reasonable expectation of success. Finally, the prior art reference (or references when combined) must teach or suggest all the claim limitations.

The teaching or suggestion to make the claimed combination and the reasonable expectation of success must both be found in the prior art, not in applicant’s disclosure. In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991).

2143.01 Suggestion or Motivation To Modify the References[edit | edit source]

I.THE PRIOR ART MUST SUGGEST THE DESIRABILITY OF THE CLAIMED INVENTION

“There are three possible sources for a motivation to combine references: the nature of the problem to be solved, the teachings of the prior art, and the knowledge of persons of ordinary skill in the art.” In re Rouffet, 149 F.3d 1350, 1357, 47 USPQ2d 1453, 1457-58 (Fed. Cir. 1998) (The combination of the references taught every element of the claimed invention, however without a motivation to combine, a rejection based on a prima facie case of obvious was held improper.). The level of skill in the art cannot be relied upon to provide the suggestion to combine references. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 50 USPQ2d 1161 (Fed. Cir. 1999).

“In determining the propriety of the Patent Office case for obviousness in the first instance, it is necessary to ascertain whether or not the reference teachings would appear to be sufficient for one of ordinary skill in the relevant art having the reference before him to make the proposed substitution, combination, or other modification.” In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).

Obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so . In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation- suggestion-teaching requirement as a guard against using hindsight in an obviousness analysis). The teaching, suggestion, or motivation must be found either explicitly or implicitly in the references themselves or in the knowledge generally available to one of ordinary skill in the art. “The test for an implicit showing is what the combined teachings, knowledge of one of ordinary skill in the art, and the nature of the problem to be solved as a whole would have suggested to those of ordinary skill in the art.” In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000). See also In re Lee, 277 F.3d 1338, 1342-44, 61 USPQ2d 1430, 1433-34 (Fed. Cir. 2002) (discussing the importance of relying on objective evidence and making specific factual findings with respect to the motivation to combine references); In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992).

In In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004), the claims of a utility patent application were directed to a shoe sole with increased traction having hexagonal projections in a “facing orientation.” 391 F.3d at 1196-97, 73 USPQ2d at 1142. The Board combined a design patent having hexagonal projections in a facing orientation with a utility patent having other limitations of the independent claim. 391 F.3d at 1199, 73 USPQ2d at 1144. Applicant argued that the combination was improper because (1) the prior art did not suggest having the hexagonal projections in a facing (as opposed to a “pointing”) orientation was the “most desirable” configuration for the projections, and (2) the prior art “taught away” by showing desirability of the “pointing orientation.” 391 F.3d at 1200-01, 73 USPQ2d at 1145-46. The court stated that “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” Id. The court emphasized that the proper inquiry is “‘whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination,’ not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available.” Id. In affirming the Board’s obviousness rejection, the court held that the prior art as a whole suggested the desirability of the combination of shoe sole limitations claimed, thus providing a motivation to combine, which need not be supported by a finding that the prior art suggested that the combination claimed by the applicant was the preferred, or most desirable combination over the other alternatives. Id.

In Ruiz v. A.B. Chance Co., 357 F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004), the patent claimed underpinning a slumping building foundation using a screw anchor attached to the foundation by a metal bracket. One prior art reference taught a screw anchor with a concrete bracket, and a second prior art reference disclosed a pier anchor with a metal bracket. The court found motivation to combine the references to




arrive at the claimed invention in the “nature of the problem to be solved” because each reference was directed “to precisely the same problem of underpinning slumping foundations.” Id. at 1276, 69 USPQ2d at 1690. The court also rejected the notion that “an express written motivation to combine must appear in prior art references….” Id. at 1276, 69 USPQ2d at 1690.

In In re Kotzab, the claims were drawn to an injection 

molding method using a single temperature sensor to control a plurality of flow control valves. The primary reference disclosed a multizone device having multiple sensors, each of which controlled an associated flow control valve, and also taught that one system may be used to control a number of valves. The court found that there was insufficient evidence to show that one system was the same as one sensor. While the control of multiple valves by a single sensor rather than by multiple sensors was a “technologically simple concept,” there was no finding “as to the specific understanding or principle within the knowledge of the skilled artisan” that would have provided the motivation to use a single sensor as the system to control more than one valve. 217 F.3d at 1371, 55 USPQ2d at 1318.

In In re Fine, the claims were directed to a system for detecting and measuring minute quantities on nitrogen compounds comprising a gas chromatograph, a converter which converts nitrogen compounds into nitric oxide by combustion, and a nitric oxide detector. The primary reference disclosed a system for monitoring sulfur compounds comprising a chromatograph, combustion means, and a detector, and the secondary reference taught nitric oxide detectors. The examiner and Board asserted that it would have been within the skill of the art to substitute one type of detector for another in the system of the primary reference, however the court found there was no support or explanation of this conclusion and reversed.

In In re Jones, the claimed invention was the 2-(2¢- aminoethoxy) ethanol salt of dicamba, a compound with herbicidal activity. The primary reference disclosed inter alia the substituted ammonium salts of dicamba as herbicides, however the reference did not specifically teach the claimed salt. Secondary references teaching the amine portion of the salt were directed to shampoo additives and a byproduct of the production of morpholine. The court found there was no suggestion to combine these references to arrive at the claimed invention.

II.WHERE THE TEACHINGS OF THE PRIOR ART CONFLICT, THE EXAMINER MUST WEIGH THE SUGGESTIVE POWER OF EACH REFERENCE

The test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts. Where the teachings of two or more prior art references conflict, the examiner must weigh the power of each reference to suggest solutions to one of ordinary skill in the art, considering the degree to which one reference might accurately discredit another. In re Young, 927 F.2d 588, 18 USPQ2d 1089 (Fed. Cir. 1991) (Prior art patent to Carlisle disclosed controlling and minimizing bubble oscillation for chemical explosives used in marine seismic exploration by spacing seismic sources close enough to allow the bubbles to intersect before reaching their maximum radius so the secondary pressure pulse was reduced. An article published several years later by Knudsen opined that the Carlisle technique does not yield appreciable improvement in bubble oscillation suppression. However, the article did not test the Carlisle technique under comparable conditions because Knudsen did not use Carlisle’s spacing or seismic source. Furthermore, where the Knudsen model most closely approximated the patent technique there was a 30% reduction of the secondary pressure pulse. On these facts, the court found that the Knudsen article would not have deterred one of ordinary skill in the art from using the Carlisle patent teachings.).

III.FACT THAT REFERENCES CAN BE COMBINED OR MODIFIED IS NOT SUFFICIENT TO ESTABLISH PRIMA FACIEOBVIOUSNESS

The mere fact that references can be combined or modified does not render the resultant combination obvious unless the prior art also suggests the desirability of the combination. In re Mills, 916 F.2d 680, 16 USPQ2d 1430 (Fed. Cir. 1990) (Claims were directed to an apparatus for producing an aerated cementitious composition by drawing air into the




cementitious composition by driving the output pump at a capacity greater than the feed rate. The prior art reference taught that the feed means can be run at a variable speed, however the court found that this does not require that the output pump be run at the claimed speed so that air is drawn into the mixing chamber and is entrained in the ingredients during operation. Although a prior art device “may be capable of being modified to run the way the apparatus is claimed, there must be a suggestion or motivation in the reference to do so.” 916 F.2d at 682, 16 USPQ2d at 1432.). See also In re Fritch, 972 F.2d 1260, 23 USPQ2d 1780 (Fed. Cir. 1992) (flexible landscape edging device which is conformable to a ground surface of varying slope not suggested by combination of prior art references).

IV.FACT THAT THE CLAIMED INVENTION IS WITHIN THE CAPABILITIES OF ONE OF ORDINARY SKILL IN THE ART IS NOT SUFFICIENT BY ITSELF TO ESTABLISH PRIMA FACIE OBVIOUSNESS

A statement that modifications of the prior art to meet the claimed invention would have been “‘well within the ordinary skill of the art at the time the claimed invention was made’” because the references relied upon teach that all aspects of the claimed invention were individually known in the art is not sufficient to establish a prima facie case of obviousness without some objective reason to combine the teachings of the references. Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993). See also In re Kotzab, 217 F.3d 1365, 1371, 55 USPQ2d 1313, 1318 (Fed. Cir. 2000) (Court reversed obviousness rejection involving technologically simple concept because there was no finding as to the principle or specific understanding within the knowledge of a skilled artisan that would have motivated the skilled artisan to make the claimed invention); Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 50 USPQ2d 1161 (Fed. Cir. 1999) (The level of skill in the art cannot be relied upon to provide the suggestion to combine references.).


V.THE PROPOSED MODIFICATION CANNOT RENDER THE PRIOR ART UNSATISFACTORY FOR ITS INTENDED PURPOSE

If proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification. In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984) (Claimed device was a blood filter assembly for use during medical procedures wherein both the inlet and outlet for the blood were located at the bottom end of the filter assembly, and wherein a gas vent was present at the top of the filter assembly. The prior art reference taught a liquid strainer for removing dirt and water from gasoline and other light oils wherein the inlet and outlet were at the top of the device, and wherein a pet-cock (stopcock) was located at the bottom of the device for periodically removing the collected dirt and water. The reference further taught that the separation is assisted by gravity. The Board concluded the claims were prima facie obvious, reasoning that it would have been obvious to turn the reference device upside down. The court reversed, finding that if the prior art device was turned upside down it would be inoperable for its intended purpose because the gasoline to be filtered would be trapped at the top, the water and heavier oils sought to be separated would flow out of the outlet instead of the purified gasoline, and the screen would become clogged.).

“Although statements limiting the function or capability of a prior art device require fair consideration, simplicity of the prior art is rarely a characteristic that weighs against obviousness of a more complicated device with added function.” In re Dance, 160 F.3d 1339, 1344, 48 USPQ2d 1635, 1638 (Fed. Cir. 1998) (Court held that claimed catheter for removing obstruction in blood vessels would have been obvious in view of a first reference which taught all of the claimed elements except for a “means for recovering fluid and debris” in combination with a second reference describing a catheter including that means. The court agreed that the first reference, which stressed simplicity of structure and taught emulsification of the debris, did not teach away from the addition of a channel for the recovery of the debris.).




VI.THE PROPOSED MODIFICATION CANNOT CHANGE THE PRINCIPLE OF OPERATION OF A REFERENCE

If the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious. In re Ratti, 270 F.2d 810, 123 USPQ 349 (CCPA 1959) (Claims were directed to an oil seal comprising a bore engaging portion with outwardly biased resilient spring fingers inserted in a resilient sealing member. The primary reference relied upon in a rejection based on a combination of references disclosed an oil seal wherein the bore engaging portion was reinforced by a cylindrical sheet metal casing. Patentee taught the device required rigidity for operation, whereas the claimed invention required resiliency. The court reversed the rejection holding the “suggested combination of references would require a substantial reconstruction and redesign of the elements shown in [the primary reference] as well as a change in the basic principle under which the [primary reference] construction was designed to operate.” 270 F.2d at 813, 123 USPQ at 352.).

2143.02Reasonable Expectation of Success Is Required

OBVIOUSNESS REQUIRES ONLY A REASONABLE EXPECTATION OF SUCCESS

The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (Claims directed to a method of treating depression with amitriptyline (or nontoxic salts thereof) were rejected as prima facie obvious over prior art disclosures that amitriptyline is a compound known to possess psychotropic properties and that imipramine is a structurally similar psychotropic compound known to possess antidepressive properties, in view of prior art suggesting the aforementioned compounds would be expected to have similar activity because the structural difference between the compounds involves a known bioisosteric replacement and because a research paper comparing the pharmacological properties of these two compounds suggested clinical testing of amitriptyline as an antidepressant. The court sustained the rejection, finding that the teachings of the prior art provide a sufficient basis for a reasonable expectation of success.); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989) (Claims were directed to a process of sterilizing a polyolefinic composition with high-energy radiation in the presence of a phenolic polyester antioxidant to inhibit discoloration or degradation of the polyolefin. Appellant argued that it is unpredictable whether a particular antioxidant will solve the problem of discoloration or degradation. However, the Board found that because the prior art taught that appellant’s preferred antioxidant is very efficient and provides better results compared with other prior art antioxidants, there would have been a reasonable expectation of success.).

AT LEAST SOME DEGREE OF PREDICTABILITY IS REQUIRED; APPLICANTS MAY PRESENT EVIDENCE SHOWING THERE WAS NO REASONABLE EXPECTATION OF SUCCESS


Obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (Claims directed to a method for the commercial scale production of polyesters in the presence of a solvent at superatmospheric pressure were rejected as obvious over a reference which taught the claimed method at atmospheric pressure in view of a reference which taught the claimed process except for the presence of a solvent. The court reversed, finding there was no reasonable expectation that a process combining the prior art steps could be successfully scaled up in view of unchallenged evidence showing that the prior art processes individually could not be commercially scaled up successfully.). See also Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1207-08, 18 USPQ2d 1016, 1022-23 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991) (In the context of a biotechnology case, testimony supported the conclusion that the references did not show that there was a reasonable expectation of success.); In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988) (The court held the claimed method would have been obvious




over the prior art relied upon because one reference contained a detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful.).

PREDICTABILITY IS DETERMINED AT THE TIME THE INVENTION WAS MADE

Whether an art is predictable or whether the proposed modification or combination of the prior art has a reasonable expectation of success is determined at the time the invention was made. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986) (Although an earlier case reversed a rejection because of unpredictability in the field of monoclonal antibodies, the court found “in this case at the time this invention was made, one of ordinary skill in the art would have been motivated to produce monoclonal antibodies specific for human fibroplast interferon using the method of [the prior art] with a reasonable expectation of success.” 3 USPQ2d at 1016 (emphasis in original).).

2143.03All Claim Limitations Must BeTaught or Suggested

To establish prima facie obviousness of a claimed invention, all the claim limitations must be taught or suggested by the prior art. In re Royka, 490 F.2d 981, 180 USPQ 580 (CCPA 1974). “All words in a claim must be considered in judging the patentability of that claim against the prior art.” In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, 496 (CCPA 1970). If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988).

INDEFINITE LIMITATIONS MUST BE CON- SIDERED

A claim limitation which is considered indefinite cannot be disregarded. If a claim is subject to more than one interpretation, at least one of which would render the claim unpatentable over the prior art, the examiner should reject the claim as indefinite under 35 U.S.C. 112, second paragraph (see MPEP §

706.03(d)) and should reject the claim over the prior art based on the interpretation of the claim that renders the prior art applicable. Ex parte Ionescu, 222 USPQ 537 (Bd. Pat. App. & Inter. 1984) (Claims on appeal were rejected on indefiniteness grounds only; the rejection was reversed and the case remanded to the examiner for consideration of pertinent prior art.). Compare In re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA 1970) (if no reasonably definite meaning can be ascribed to certain claim language, the claim is indefinite, not obvious) and In re Steele, 305 F.2d 859,134 USPQ 292 (CCPA 1962) (it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions).

LIMITATIONS WHICH DO NOT FIND SUPPORT IN THE ORIGINAL SPECIFICATION MUST BE CONSIDERED

When evaluating claims for obviousness under 35 U.S.C. 103, all the limitations of the claims must be considered and given weight, including limitations which do not find support in the specification as originally filed (i.e., new matter). Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983) aff’d mem. 738 F.2d 453 (Fed. Cir. 1984) (Claim to a catalyst expressly excluded the presence of sulfur, halogen, uranium, and a combination of vanadium and phosphorous. Although the negative limitations excluding these elements did not appear in the specification as filed, it was error to disregard these limitations when determining whether the claimed invention would have been obvious in view of the prior art.).


2144 Sources of Rationale Supporting a Rejection Under 35 U.S.C. 103[edit | edit source]

RATIONALE MAY BE IN A REFERENCE, OR REASONED FROM COMMON KNOWLEDGE IN THE ART, SCIENTIFIC PRINCIPLES, ART-RECOGNIZED EQUIVALENTS, OR LEGAL PRECEDENT[edit | edit source]

The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.

THE EXPECTATION OF SOME ADVANTAGE IS THE STRONGEST RATIONALE FOR COMBINING REFERENCES[edit | edit source]

The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.

LEGAL PRECEDENT CAN PROVIDE THE RATIONALE SUPPORTING OBVIOUSNESS ONLY IF THE FACTS IN THE CASE ARE SUFFICIENTLY SIMILAR TO THOSE IN THE APPLICATION[edit | edit source]

The examiner must apply the law consistently to each application after considering all the relevant facts. If the facts in a prior legal decision are sufficiently similar to those in an application under examination, the examiner may use the rationale used by the court.

RATIONALE DIFFERENT FROM APPLICANT'S IS PERMISSIBLE[edit | edit source]

The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”)

In In re Linter the claimed invention was a laundry composition consisting essentially of a dispersant, cationic fabric softener, sugar, sequestering phosphate, and brightener in specified proportions. The claims were rejected over the combination of a primary reference which taught all the claim limitations except for the presence of sugar, and secondary references which taught the addition of sugar as a filler or weighting agent in compositions containing cationic fabric softeners. Appellant argued that in the claimed invention, the sugar is responsible for the compatibility of the cationic softener with the other detergent components. The court sustained the rejection, stating “The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be [sic, would have been] prima facie obvious from the purpose disclosed in the references.” 173 USPQ at 562.

See MPEP § 2145, paragraph II for case law pertaining to the presence of additional advantages or latent properties not recognized in the prior art.

2144.01 Implicit Disclosure[edit | edit source]

“[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968) (A process for catalytically producing carbon disulfide by reacting sulfur vapor and methane in the presence of charcoal at a temperature of “about 750-830°C” was found to be met by a reference which expressly taught the same process at 700°C because the reference recognized the possibility of using temperatures greater than 750°C.).

2144.02 Reliance on Scientific Theory[edit | edit source]

The rationale to support a rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle. However, when an examiner relies on a scientific theory, evidentiary support for the existence and meaning of that theory must be provided. Although the theoretical mechanism of an invention may be explained by logic and sound scientific reasoning, this fact does not support an obviousness determination unless logic and scientific reasoning would have led one of ordinary skill in the art to make the claimed invention.

2144.03 Reliance on Common Knowledge in the Art or "Well Known" Prior Art[edit | edit source]

In limited circumstances, it is appropriate for an examiner to take official notice of facts not in the record or to rely on “common knowledge” in making a rejection, however such rejections should be judiciously applied.

PROCEDURE FOR RELYING ON COMMON KNOWLEDGE OR TAKING OFFICIAL NOTICE[edit | edit source]

The standard of review applied to findings of fact is the "substantial evidence" standard under the Administrative Procedure Act (APA). See MPEP § 1216.01.

The following guidance is provided in order to assist the examiners in determining when it is appropriate to take official notice of facts without supporting documentary evidence or to rely on common knowledge in the art in making a rejection, and if such official notice is taken, what evidence is necessary to support the examiner’s conclusion of common knowledge in the art.

A. Determine When It Is Appropriate To Take Official Notice Without Documentary Evidence To Support The Examiner's Conclusion

Official notice unsupported by documentary evidence should only be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art are capable of instant and unquestionable demonstration as being well-known.

For example, it might not be unreasonable to take official notice of the fact that it is desirable to make something faster, cheaper, better, or stronger without the specific support of documentary evidence.

It is never appropriate to rely solely on “common knowledge” in the art without evidentiary support in the record, as the principal evidence upon which a rejection was based. An assessment of basic knowledge and common sense that is not based on any evidence in the record lacks substantial evidence support.

Relevant Cases:

  • In re Ahlert, 424 F.2d 1088, 1091, 165 USPQ 418, 420 (CCPA 1970)
  • In re Fox, 471 F.2d 1405, 1407, 176 USPQ 340, 341 (CCPA 1973)
  • In re Grose, 592 F.2d 1161, 1167-68, 201 USPQ 57, 63 (CCPA 1979)
  • In re Zurko, 258 F.3d 1379, 1385, 59 USPQ2d 1693, 1697 (Fed. Cir. 2001)

B. If Official Notice Is Taken of a Fact, Unsupported by Documentary Evidence, the Technical Line Of Reasoning Underlying a Decision To Take Such Notice Must Be Clear and Unmistakable

Ordinarily, there must be some form of evidence in the record to support an assertion of common knowledge.

In certain older cases, official notice has been taken of a fact that is asserted to be “common knowledge” without specific reliance on documentary evidence where the fact noticed was readily verifiable, such as when other references of record supported the noticed fact, or where there was nothing of record to contradict it. If such notice is taken, the basis for such reasoning must be set forth explicitly. The examiner must provide specific factual findings predicated on sound technical and scientific reasoning to support his or her conclusion of common knowledge.

C. If Applicant Challenges a Factual Assertion as Not Properly Officially Noticed or not Properly Based Upon Common Knowledge, the Examiner Must Support the Finding With Adequate Evidence

To adequately traverse such a finding, an applicant must specifically point out the supposed errors in the examiner's action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. If applicant adequately traverses the examiner’s assertion of official notice, the examiner must provide documentary evidence in the next Office action if the rejection is to be maintained.

If the examiner is relying on personal knowledge to support the finding of what is known in the art, the examiner must provide an affidavit or declaration setting forth specific factual statements and explanation to support the finding. See 37 CFR 1.104(d)(2).

If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate.

D. Determine Whether the Next Office Action Should Be Made Final

If the examiner adds a reference in the next Office action after applicant’s rebuttal, and the newly added reference is added only as directly corresponding evidence to support the prior common knowledge finding, and it does not result in a new issue or constitute a new ground of rejection, the Office action may be made final. If no amendments are made to the claims, the examiner must not rely on any other teachings in the reference if the rejection is made final. If the newly cited reference is added for reasons other than to support the prior common knowledge statement and a new ground of rejection is introduced by the examiner that is not necessitated by applicant’s amendment of the claims, the rejection may not be made final. See MPEP § 706.07(a).

E. Summary

Any rejection based on assertions that a fact is well- known or is common knowledge in the art without documentary evidence to support the examiner’s conclusion should be judiciously applied. Furthermore, as noted by the court in Ahlert, any facts so noticed should be of notorious character and serve only to “fill in the gaps” in an insubstantial manner which might exist in the evidentiary showing made by the examiner to support a particular ground for rejection. It is never appropriate to rely solely on common knowledge in the art without evidentiary support in the record as the principal evidence upon which a rejection was based. See Zurko, 258 F.3d at 1386, 59 USPQ2d at 1697; Ahlert, 424 F.2d at 1092, 165 USPQ 421.

2144.04 Legal Precedent as Source of Supporting Rationale[edit | edit source]

As discussed in MPEP § 2144, if the facts in a prior legal decision are sufficiently similar to those in an application under examination, the examiner may use the rationale used by the court. Examples directed to various common practices which the court has held normally require only ordinary skill in the art and hence are considered routine expedients are discussed below. If the applicant has demonstrated the criticality of a specific limitation, it would not be appropriate to rely solely on case law as the rationale to support an obviousness rejection.

I. AESTHETIC DESIGN CHANGES[edit | edit source]

In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (Claim was directed to an advertising display device comprising a bottle and a hollow member in the shape of a human figure from the waist up which was adapted to fit over and cover the neck of the bottle, wherein the hollow member and the bottle together give the impression of a human body. Appellant argued that certain limitations in the upper part of the body, including the arrangement of the arms, were not taught by the prior art. The court found that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art.). But see In re Dembiczak, 175 F.3d 994, 50 USPQ2d 1614 (Fed. Cir. 1999) (The claims of a utility application, drawn to a generally round, orange plastic trash bag with a jack-o-lantern face, were rejected under 35 U.S.C. 103. However, the court reversed the rejection for lack of motivation to combine conventional trash bags with a reference showing a jack-o-lantern face on an orange paper bag stuffed with newspapers.); Ex parte Hilton, 148 USPQ 356 (Bd. App. 1965) (Claims were directed to fried potato chips with a specified moisture and fat content, whereas the prior art was directed to french fries having a higher moisture content. While recognizing that in some cases the particular shape of a product is of no patentable significance, the Board held in this case the shape (chips) is important because it results in a product which is distinct from the reference product (french fries).).

II. ELIMINATION OF A STEP OR AN ELEMENT AND ITS FUNCTION[edit | edit source]

A. Omission of an Element and Its Function Is Obvious If the Function of the Element Is Not Desired

Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient).

B. Omission of an Element with Retention of the Element's Function Is an Indicia of Unobviousness

Note that the omission of an element and retentionof its function is an indicia of unobviousness. In reEdge, 359 F.2d 896, 149 USPQ 556 (CCPA 1966) (Claims at issue were directed to a printed sheet having a thin layer of erasable metal bonded directly to the sheet wherein said thin layer obscured the original print until removal by erasure. The prior art disclosed a similar printed sheet which further comprised an intermediate transparent and erasure-proof protecting layer which prevented erasure of the printing when the top layer was erased. The claims were found unobvious over the prior art because the although the transparent layer of the prior art was eliminated, the function of the transparent layer was retained since appellant’s metal layer could be erased without erasing the printed indicia.).

III. AUTOMATING A MANUAL ACTIVITY[edit | edit source]

In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined “old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed.” The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.).

IV. CHANGES IN SIZE, SHAPE, OR SEQUENCE OF ADDING INGREDIENTS[edit | edit source]

A. Changes in Size/Proportion

In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).

In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.

B. Changes in Shape

In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).

C. Changes in Sequence of Adding Ingredients

Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facieobvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).

V. MAKING PORTABLE, INTEGRAL, SEPARABLE, ADJUSTABLE, OR CONTINUOUS[edit | edit source]

A. Making Portable

In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952) (Fact that a claimed device is portable or movable is not sufficient by itself to patentably distinguish over an otherwise old device unless there are new or unexpected results.).

B. Making Integral

In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form “a single integral and gaplessly continuous piece.” Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.).

C. Making Separable

In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is “press fitted” and therefore not manually removable. The court held that “if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.”).

D. Making Adjustable

In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954) (Claims were directed to a handle for a fishing rod wherein the handle has a longitudinally adjustable finger hook, and the hand grip of the handle connects with the body portion by means of a universal joint. The court held that adjustability, where needed, is not a patentable advance, and because there was an art- recognized need for adjustment in a fishing rod, the substitution of a universal joint for the single pivot of the prior art would have been obvious.).

E. Making Continuous

In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963) (Claim directed to a method of producing a cementitious structure wherein a stable air foam is introduced into a slurry of cementitious material differed from the prior art only in requiring the addition of the foam to be continuous. The court held the claimed continuous operation would have been obvious in light of the batch process of the prior art.).

VI. REVERSAL, DUPLICATION, OR REARRANGEMENT OF PARTS[edit | edit source]

A. Reversal of Parts

In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious expedient.).

B. Duplication of Parts

In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a “web” which lies in the joint, and a plurality of “ribs” projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).

C. Rearrangement of Parts

In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). However, “The mere fact that a worker in the art could rearrange the parts of the reference device to meet the terms of the claims on appeal is not by itself sufficient to support a finding of obviousness. The prior art must provide a motivation or reason for the worker in the art, without the benefit of appellant’s specification, to make the necessary changes in the reference device.” Ex parte Chicago Rawhide Mfg. Co., 223 USPQ 351, 353 (Bd. Pat. App. & Inter. 1984).

VII. PURIFYING AN OLD PRODUCT

Pure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials. Therefore, the issue is whether claims to a pure material are unobvious over the prior art. In re Bergstrom, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious. Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989).

Factors to be considered in determining whether a purified form of an old product is obvious over the prior art include whether the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and whether the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure. In re Cofer, 354 F.2d 664, 148 USPQ 268 (CCPA 1966) (Claims to the free- flowing crystalline form of a compound were held unobvious over references disclosing the viscous liquid form of the same compound because the prior art of record did not suggest the claimed compound in crystalline form or how to obtain such crystals.).

See also Ex parte Stern, 13 USPQ2d 1379 (Bd. Pat. App. & Inter. 1987) (Claims to interleukin 2 (a protein with a molecular weight of over 12,000) purified to homogeneity were held unpatentable over references which recognized the desirability of purifying interleukin 2 to homogeneity in a view of a reference which taught a method of purifying proteins having molecular weights in excess of 12,000 to homogeneity wherein the prior art method was similar to the method disclosed by appellant for purifying interleukin 2.).

Compare Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (Claims were directed to human nerve growth factor b-NGF free from other proteins of human origin, and the specification disclosed making the claimed factor through the use of recombinant DNA technology. The claims were rejected as prima facie obvious in view of two references disclosing b-NGF isolated from human placental tissue. The Board applied case law pertinent to product-by-process claims, reasoning that the prior art factor appeared to differ from the claimed factor only in the method of obtaining the factor. The Board held that the burden of persuasion was on appellant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The Board further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926.).

2144.05 Obviousness of Ranges[edit | edit source]

See MPEP § 2131.03 for case law pertaining to rejections based on the anticipation of ranges under 35 U.S.C. 102 and 35 U.S.C. 102/103.

I. OVERLAP OF RANGES[edit | edit source]

In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima faciecase of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).

“[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005)(claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). However, if the reference’s disclosed range is so broad as to encompass a very large number of possible distinct compositions, this might present a situation analogous to the obviousness of a species when the prior art broadly discloses a genus. Id. See also In re Baird, 16 F.3d 380, 29 USPQ2d 1550 (Fed. Cir. 1994); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); MPEP § 2144.08.

A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The patent claim at issue was directed to a weight plate having 3 elongated openings that served as handles for transporting the weight plate. Multiple prior art patents each disclosed weight plates having 1, 2 or 4 elongated openings. 392 F.3d at 1319, 73 USPQ2d at 1226. The court stated that the claimed weight plate having 3 elongated openings fell within the “range” of the prior art and was thus presumed obvious. 392 F.3d at 1322, 73 USPQ2d at 1228. The court further stated that the “range” disclosed in multiple prior art patents is “a distinction without a difference” from previous range cases which involved a range disclosed in a single patent since the “prior art suggested that a larger number of elongated grips in the weight plates was beneficial… thus plainly suggesting that one skilled in the art look to the range appearing in the prior art.” Id.

II. OPTIMIZATION OF RANGES[edit | edit source]

A. Optimization Within Prior Art Conditions or Through Routine Experimentation

Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).

B. Only Result-Effective Variables Can Be Optimized

A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) (The claimed wastewater treatment device had a tank volume to contractor area of 0.12 gal./sq. ft. The prior art did not recognize that treatment capacity is a function of the tank volume to contractor ratio, and therefore the parameter optimized was not recognized in the art to be a result- effective variable.). See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (prior art suggested proportional balancing to achieve desired results in the formation of an alloy).

III. REBUTTAL OF PRIMA FACIE CASE OF OBVIOUSNESS[edit | edit source]

Applicants can rebut a prima facie case of obviousness based on overlapping ranges by showing the criticality of the claimed range. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 716.02 - § 716.02(g) for a discussion of criticality and unexpected results.

A prima facie case of obviousness may also be rebutted by showing that the art, in any material respect, teaches away from the claimed invention. In re Geisler, 116 F.3d 1465, 1471, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997) (Applicant argued that the prior art taught away from use of a protective layer for a reflective article having a thickness within the claimed range of “50 to 100 Angstroms.” Specifically, a patent to Zehender, which was relied upon to reject applicant’s claim, included a statement that the thickness of the protective layer “should be not less than about [100 Angstroms].” The court held that the patent did not teach away from the claimed invention. “Zehender suggests that there are benefits to be derived from keeping the protective layer as thin as possible, consistent with achieving adequate protection. A thinner coating reduces light absorption and minimizes manufacturing time and expense. Thus, while Zehender expresses a preference for a thicker protective layer of 200-300 Angstroms, at the same time it provides the motivation for one of ordinary skill in the art to focus on thickness levels at the bottom of Zehender’s ‘suitable’ range- about 100 Angstroms- and to explore thickness levels below that range. The statement in Zehender that ‘[i]n general, the thickness of the protective layer should be not less than about [100 Angstroms]’ falls far short of the kind of teaching that would discourage one of skill in the art from fabricating a protective layer of 100 Angstroms or less. [W]e are therefore ‘not convinced that there was a sufficient teaching away in the art to overcome [the] strong case of obviousness’ made out by Zehender.”). See MPEP § 2145, paragraph X.D., for a discussion of “teaching away” references.

Applicant can rebut a presumption of obviousness based on a claimed invention that falls within a prior art range by showing “(1) [t]hat the prior art taught away from the claimed invention...or (2) that there are new and unexpected results relative to the prior art.” Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The court found that patentee offered neither evidence of teaching away of the prior art nor new and unexpected results of the claimed invention drawn to a weight plate having 3 elongated handle openings. 392 F.3d at 1323, 73 USPQ2d at 1229. The court then turned to considering substantial evidence of pertinent secondary factors such as commercial success, satisfaction of a long-felt need, and copying by others may also support patentability. Id. Nevertheless, the court found that Iron Grip failed to show evidence of commercial success, copying by others, or satisfaction of a long felt need for the following reasons: (A) Iron Grip’s licensing of its patent to three competitors was insufficient to show nexus between the “merits of the invention and the licenses,” and thus did not establish secondary consideration of commercial success; (B) in response to Iron Grip’s argument that the competitor’s production of a three- hole plate is evidence of copying, the court stated that “[n]ot every competing product that falls within the scope of a patent is evidence of copying” since “[o]therwise every infringement suit would automatically confirm the nonobviousness of the patent;” and (C) although Iron Grip offered as evidence that the absence of the three-grip plate on the market prior to its patent showed that the invention was nonobviousness, the court stated that “[a]bsent a showing of a long-felt need or the failure of others, the mere passage of time without the claimed invention is not evidence of nonobviousness.” 392 F.3d at 1324-25, 73 USPQ2d at 1229-30.

2144.06 Art Recognized Equivalence for the Same Purpose[edit | edit source]

COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE[edit | edit source]

“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive.... Appellant argues... hindsight reconstruction or at best,... ‘obvious to try’.... We agree with appellant.”).

SUBSTITUTING EQUIVALENTS KNOWN FOR THE SAME PURPOSE[edit | edit source]

In order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) (The mere fact that components are claimed as members of a Markush group cannot be relied upon to establish the equivalency of these components. However, an applicant’s expressed recognition of an art-recognized or obvious equivalent may be used to refute an argument that such equivalency does not exist.); In re Scott, 323 F.2d 1016, 139 USPQ 297 (CCPA 1963) (Claims were drawn to a hollow fiberglass shaft for archery and a process for the production thereof where the shaft differed from the prior art in the use of a paper tube as the core of the shaft as compared with the light wood or hardened foamed resin core of the prior art. The Board found the claimed invention would have been obvious, reasoning that the prior art foam core is the functional and mechanical equivalent of the claimed paper core. The court reversed, holding that components which are functionally or mechanically equivalent are not necessarily obvious in view of one another, and in this case, the use of a light wood or hardened foam resin core does not fairly suggest the use of a paper core.); Smithv. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. “This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor.” 209 USPQ at 759.).

An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).

2144.07 Art Recognized Suitability for an Intended Purpose[edit | edit source]

The selection of a known material based on its suitability for its intended use supported a prima facieobviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol. “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” 325 U.S. at 335, 65 USPQ at 301.).

See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious); Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988) (Claimed agricultural bagging machine, which differed from a prior art machine only in that the brake means were hydraulically operated rather than mechanically operated, was held to be obvious over the prior art machine in view of references which disclosed hydraulic brakes for performing the same function, albeit in a different environment.).

2144.08 Obviousness of Species When Prior Art Teaches Genus[edit | edit source]

I. GUIDELINES FOR THE EXAMINATION OF CLAIMS DIRECTED TO SPECIES OF CHEMICAL COMPOSITIONS BASED UPON A SINGLE PRIOR ART REFERENCE[edit | edit source]

These “Genus-Species Guidelines” are to assist Office personnel in the examination of applications which contain claims to species or a subgenus of chemical compositions for compliance with 35 U.S.C. 103 based upon a single prior art reference which discloses a genus encompassing the claimed species or subgenus but does not expressly disclose the particular claimed species or subgenus. Office personnel should attempt to find additional prior art to show that the differences between the prior art primary reference and the claimed invention as a whole would have been obvious. Where such additional prior art is not found, Office personnel should follow these guidelines to determine whether a single reference 35 U.S.C. 103 rejection would be appropriate. The guidelines are based on the Office’s current understanding of the law and are believed to be fully consistent with binding precedent of the Supreme Court, the Federal Circuit, and the Federal Circuit’s predecessor courts.

The analysis of the guidelines begins at the point during examination after a single prior art reference is found disclosing a genus encompassing the claimed species or subgenus. Before reaching this point, Office personnel should follow appropriate antecedent examination procedures. Accordingly, Office personnel should first analyze the claims as a whole in light of and consistent with the written description, considering all claim limitations. When evaluating the scope of a claim, every limitation in the claim must be considered. See, e.g., In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995). However, the claimed invention may not be dissected into discrete elements to be analyzed in isolation, but must be considered as a whole. See, e.g., W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1548, 220 USPQ 303, 309 (Fed. Cir. 1983); Jones v. Hardy, 727 F.2d 1524, 1530, 220 USPQ 1021, 1026 (Fed. Cir. 1983) (“treating the advantage as the invention disregards the statutory requirement that the invention be viewed ‘as a whole’”). Next, Office personnel should conduct a thorough search of the prior art and identify all relevant references. Both claimed and unclaimed aspects of the invention should be searched if there is a reasonable expectation that the unclaimed aspects may be later claimed. If the most relevant prior art consists of a single prior art reference disclosing a genus encompassing the claimed species or subgenus, Office personnel should follow the guidelines set forth herein.

These guidelines do not constitute substantive rulemaking and hence do not have the force and effect of law. Rather, they are to assist Office personnel in analyzing claimed subject matter for compliance with substantive law. Thus, rejections must be based upon the substantive law, and it is these rejections which are appealable, not any failure by Office personnel to follow these guidelines.

Office personnel are to rely on these guidelines in the event of any inconsistent treatment of issues between these guidelines and any earlier provided guidance from the Office.

II. DETERMINE WHETHER THE CLAIMED SPECIES OR SUBGENUS WOULD HAVE BEEN OBVIOUS TO ONE OF ORDINARY SKILL IN THE PERTINENT ART AT THE TIME THE INVENTION WAS MADE[edit | edit source]

The patentability of a claim to a specific compound or subgenus embraced by a prior art genus should be analyzed no differently than any other claim for purposes of 35 U.S.C. 103. “The section 103 requirement of unobviousness is no different in chemical cases than with respect to other categories of patentable inventions.” In re Papesch, 315 F.2d 381, 385, 137 USPQ 43, 47 (CCPA 1963). A determination of patentability under 35 U.S.C. 103 should be made upon the facts of the particular case in view of the totality of the circumstances. See, e.g., In re Dillon, 919 F.2d 688, 692-93, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (in banc). Use of per se rules by Office personnel is improper for determining whether claimed subject matter would have been obvious under 35 U.S.C. 103. See, e.g., In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, 1666 (Fed. Cir. 1996); In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995); In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). The fact that a claimed species or subgenus is encompassed by a prior art genus is not sufficient by itself to establish a prima facie case of obviousness. In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) (“The fact that a claimed compound may be encompassed by a disclosed generic formula does not by itself render that compound obvious.”); In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (Federal Circuit has “decline[d] to extract from Merck[& Co. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] the rule that... regardless of how broad, a disclosure of a chemical genus renders obvious any species that happens to fall within it.”). See also In re Deuel, 51 F.3d 1552, 1559, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995).

A proper obviousness analysis involves a three-step process. First, Office personnel should establish a prima facie case of unpatentability considering the factors set out by the Supreme Court in Graham v. John Deere. See, e.g., In re Bell, 991 F.2d 781, 783, 26 USPQ2d 1529, 1531 (Fed. Cir. 1993) (“The PTO bears the burden of establishing a case of prima facieobviousness.”); In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993); In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966), requires that to make out a case of obviousness, one must:

(A) determine the scope and contents of the prior art;

(B) ascertain the differences between the prior art and the claims in issue;

(C) determine the level of skill in the pertinent art; and

(D) evaluate any evidence of secondary considerations.

If a prima facie case is established, the burden shifts to applicant to come forward with rebuttal evidence or argument to overcome the prima facie case.

If a prima facie case is established, the burden shifts to applicant to come forward with rebuttal evidence or argument to overcome the prima facie case. See, e.g., Bell, 991 F.2d at 783-84, 26 USPQ2d at 1531; Rijckaert, 9 F.3d at 1532, 28 USPQ2d at 1956; Oetiker, 977 F.2d at 1445, 24 USPQ2d at 1444. Finally, Office personnel should evaluate the totality of the facts and all of the evidence to determine whether they still support a conclusion that the claimed invention would have been obvious to one of ordinary skill in the art at the time the invention was made. Id.

A. Establishing a Prima Facie Case of Obviousness

To establish a prima facie case of obviousness in a genus-species chemical composition situation, as in any other 35 U.S.C. 103 case, it is essential that Office personnel find some motivation or suggestion to make the claimed invention in light of the prior art teachings. See, e.g., In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, 1666 (Fed. Cir. 1996) (“[T]he mere possibility that one of the esters or the active methylene group-containing compounds... could be modified or replaced such that its use would lead to the specific sulfoalkylated resin recited in claim 8 does not make the process recited in claim 8 obvious ‘unless the prior art suggested the desirability of [such a] modification’ or replacement.”) (quoting In re Gordon, 733 F.2d 900, 902, 221 USPQ 1125, 1127 (Fed. Cir. 1984)); In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438, 1442 (Fed. Cir. 1991) (“[A] proper analysis under § 103 requires, inter alia, consideration of... whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process.”). In order to find such motivation or suggestion there should be a reasonable likelihood that the claimed invention would have the properties disclosed by the prior art teachings. The prior art disclosure may be express, implicit, or inherent. Regardless of the type of disclosure, the prior art must provide some motivation to one of ordinary skill in the art to make the claimed invention in order to support a conclusion of obviousness. See, e.g., Vaeck, 947 F.2d at 493, 20 USPQ2d at 1442 (A proper obviousness analysis requires consideration of “whether the prior art would also have revealed that in so making or carrying out [the claimed invention], those of ordinary skill would have a reasonable expectation of success.”); In re Dow Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988) (“The consistent criterion for determination of obviousness is whether the prior art would have suggested to one of ordinary skill in the art that this process should be carried out and would have a reasonable likelihood of success, viewed in the light of the prior art.”); Hodosh v. Block Drug Co., 786 F.2d 1136, 1143 n.5, 229 USPQ 182, 187 n.5 (Fed. Cir. 1986). These disclosed findings should be made with a complete understanding of the first three “Graham factors.” When evidence of secondary considerations such as unexpected results is initially before the Office, for example in the specification, that evidence should be considered in deciding whether there is a prima faciecase of obviousness. The determination as to whether a prima facie case exists should be made on the full record before the Office at the time of the determination. Thus, Office personnel should:

(A)determine the “scope and content of the prior art”;

(B)ascertain the “differences between the prior art and the claims at issue”; and

(C)determine “the level of ordinary skill in the pertinent art.”

1. Determine the Scope and Content of the Prior Art

As an initial matter, Office personnel should determine the scope and content of the relevant prior art. Each reference must qualify as prior art under 35 U.S.C. 102 (e.g., Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593, 1597 (Fed. Cir. 1987) (“Before answering Graham’s ‘content’ inquiry, it must be known whether a patent or publication is in the prior art under 35 U.S.C. § 102.”)) and should be in the field of applicant’s endeavor, or be reasonably pertinent to the particular problem with which the inventor was concerned. In re Oetiker, 977 F.2d 1443, 1447, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). Accord, e.g., In re Clay, 966 F.2d 656, 658- 59, 23 USPQ2d 1058, 1060 (Fed. Cir. 1992).

In the case of a prior art reference disclosing a genus, Office personnel should make findings as to:

(A) the structure of the disclosed prior art genus and that of any expressly described species or subgenus within the genus;

(B) any physical or chemical properties and utilities disclosed for the genus, as well as any suggested limitations on the usefulness of the genus, and any problems alleged to be addressed by the genus;

(C) the predictability of the technology; and

(D) the number of species encompassed by the genus taking into consideration all of the variables possible.

2. Ascertain the Differences Between the Closest Disclosed Prior Art Species or Subgenus of Record and the Claimed Species or Subgenus

Once the structure of the disclosed prior art genus and that of any expressly described species or subgenus within the genus are identified, Office personnel should compare it to the claimed species or subgenus to determine the differences. Through this comparison, the closest disclosed species or subgenus in the prior art reference should be identified and compared to that claimed. Office personnel should make explicit findings on the similarities and differences between the closest disclosed prior art species or subgenus of record and the claimed species or subgenus including findings relating to similarity of structure, chemical properties and utilities. In Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1537, 218 USPQ 871, 877 (Fed. Cir. 1983), the Court noted that “the question under 35 U.S.C. § 103 is not whether the differences [between the claimed invention and the prior art] would have been obvious” but “whether the claimed invention as a whole would have been obvious.” (emphasis in original).

3. Determine the Level of Skill in the Art

Office personnel should evaluate the prior art from the standpoint of the hypothetical person having ordinary skill in the art at the time the claimed invention was made. See, Ryko Mfg. Co. v. Nu-Star Inc., 950 F.2d 714, 718, 21 USPQ2d 1053, 1057 (Fed. Cir. 1991) (“The importance of resolving the level of ordinary skill in the art lies in the necessity of maintaining objectivity in the obviousness inquiry.”); Uniroyal Inc. v. Rudkin-Wiley Corp., 837 F.2d 1044, 1050, 5 USPQ2d 1434, 1438 (Fed. Cir. 1988) (evidence must be viewed from position of ordinary skill, not of an expert). In most cases, the only facts of record pertaining to the level of skill in the art will be found within the prior art reference. However, any additional evidence presented by applicant should be evaluated.

4. Determine Whether One of Ordinary Skill in the Art Would Have Been Motivated To Select the Claimed Species or Subgenus

In light of the findings made relating to the three Graham factors, Office personnel should determine whether one of ordinary skill in the relevant art would have been motivated to make the claimed invention as a whole, i.e., to select the claimed species or subgenus from the disclosed prior art genus. See, e.g., Ochiai, 71 F.3d at 1569-70, 37 USPQ2d at 1131; Deuel, 51 F.3d at 1557, 34 USPQ2d at 1214 (“[A] prima facie case of unpatentability requires that the teachings of the prior art suggest the claimed compounds to a person of ordinary skill in the art.” (emphasis in original)); Jones, 958 F.2d at 351, 21 USPQ2d at 1943-44 (Fed. Cir. 1992); Dillon, 919 F.2d at 692, 16 USPQ2d at 1901; In re Lalu, 747 F.2d 703, 705, 223 USPQ 1257, 1258 (Fed. Cir. 1984) (“The prior art must provide one of ordinary skill in the art the motivation to make the proposed molecular modifications needed to arrive at the claimed compound.”). See also In re Kemps, 97 F.3d 1427, 1430, 40 USPQ2d 1309, 1311 (Fed. Cir. 1996) (discussing motivation to combine). To address this key issue, Office personnel should consider all relevant prior art teachings, focusing on the following, where present.

(a) Consider the Size of the Genus

Consider the size of the prior art genus, bearing in mind that size alone cannot support an obviousness rejection. See, e.g., Baird, 16 F.3d at 383, 29 USPQ2d at 1552 (observing that “it is not the mere number of compounds in this limited class which is significant here but, rather, the total circumstances involved”). There is no absolute correlation between the size of the prior art genus and a conclusion of obviousness. Id. Thus, the mere fact that a prior art genus contains a small number of members does not create a per serule of obviousness. Some motivation to select the claimed species or subgenus must be taught by the prior art. See, e.g., Deuel, 51 F.3d at 1558-59, 34 USPQ2d at 1215 (“No particular one of these DNAs can be obvious unless there is something in the prior art to lead to the particular DNA and indicate that it should be prepared.”); Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552; Bell, 991 F.2d at 784, 26 USPQ2d at 1531 (“Absent anything in the cited prior art suggesting which of the 1036 possible sequences suggested by Rinderknecht corresponds to the IGF gene, the PTO has not met its burden of establishing that the prior art would have suggested the claimed sequences.”). However, a genus may be so small that, when considered in light of the totality of the circumstances, it would anticipate the claimed species or subgenus. For example, it has been held that a prior art genus containing only 20 compounds and a limited number of variations in the generic chemical formula inherently anticipated a claimed species within the genus because “one skilled in [the] art would... envisage each member” of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962) (emphasis in original). More specifically, the court in Petering stated:

A simple calculation will show that, excluding isomerism within certain of the R groups, the limited class we find in Karrer contains only 20 compounds. However, we wish to point out that it is not the mere number of compounds in this limited class which is significant here but, rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus. With these circumstances in mind, it is our opinion that Karrer has described to those with ordinary skill in this art each of the various permutations here involved as fully as if he had drawn each structural formula or had written each name. Id. (emphasis in original). Accord In re Schaumann, 572 F.2d 312, 316, 197 USPQ 5, 9 (CCPA 1978) (prior art genus encompassing claimed species which disclosed preference for lower alkyl secondary amines and properties possessed by the claimed compound constituted description of claimed compound for purposes of 35 U.S.C. 102(b)). C.f., In re Ruschig, 343 F.2d 965, 974, 145 USPQ 274, 282 (CCPA 1965) (Rejection of claimed compound in light of prior art genus based on Petering is not appropriate where the prior art does not disclose a small recognizable class of compounds with common properties.).

(b) Consider the Express Teachings

If the prior art reference expressly teaches a particular reason to select the claimed species or subgenus, Office personnel should point out the express disclosure which would have motivated one of ordinary skill in the art to select the claimed invention. An express teaching may be based on a statement in the prior art reference such as an art recognized equivalence. For example, see Merck & Co. v. Biocraft Labs., 874 F.2d 804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir. 1989) (holding claims directed to diuretic compositions comprising a specific mixture of amiloride and hydrochlorothiazide were obvious over a prior art reference expressly teaching that amiloride was a pyrazinoylguanidine which could be coadministered with potassium excreting diuretic agents, including hydrochlorothiazide which was a named example, to produce a diuretic with desirable sodium and potassium eliminating properties). See also, In re Kemps, 97 F.3d 1427, 1430, 40 USPQ2d 1309, 1312 (Fed. Cir. 1996) (holding there is sufficient motivation to combine teachings of prior art to achieve claimed invention where one reference specifically refers to the other).

(c) Consider the Teachings of Structural Similarity

Consider any teachings of a “typical,” “preferred,” or “optimum” species or subgenus within the disclosed genus. If such a species or subgenus is structurally similar to that claimed, its disclosure may motivate one of ordinary skill in the art to choose the claimed species or subgenus from the genus, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214 (“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.”). The utility of such properties will normally provide some motivation to make the claimed species or subgenus. Id.

In making an obviousness determination, Office personnel should consider the number of variables which must be selected or modified, and the nature and significance of the differences between the prior art and the claimed invention. See, e.g., In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (reversing obviousness rejection of novel dicamba salt with acyclic structure over broad prior art genus encompassing claimed salt, where disclosed examples of genus were dissimilar in structure, lacking an ether linkage or being cyclic); In re Susi, 440 F.2d 442, 445, 169 USPQ 423, 425 (CCPA 1971) (the difference from the particularly preferred subgenus of the prior art was a hydroxyl group, a difference conceded by applicant “to be of little importance”). In the area of biotechnology, an exemplified species may differ from a claimed species by a conservative substitution (“the replacement in a protein of one amino acid by another, chemically similar, amino acid... [which] is generally expected to lead to either no change or only a small change in the properties of the protein.” Dictionary of Biochemistry and Molecular Biology 97 (John Wiley & Sons, 2d ed. 1989)). The effect of a conservative substitution on protein function depends on the nature of the substitution and its location in the chain. Although at some locations a conservative substitution may be benign, in some proteins only one amino acid is allowed at a given position. For example, the gain or loss of even one methyl group can destabilize the structure if close packing is required in the interior of domains. James Darnell et al., Molecular Cell Biology 51 (2d ed. 1990).

The closer the physical and chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). Cf. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 (disclosure of dissimilar species can provide teaching away).

Similarly, consider any teaching or suggestion in the reference of a preferred species or subgenus that is significantly different in structure from the claimed species or subgenus. Such a teaching may weigh against selecting the claimed species or subgenus and thus against a determination of obviousness. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 (reversing obviousness rejection of species in view of large size of genus and disclosed “optimum” species which differed greatly from and were more complex than the claimed species); Jones, 958 F.2d at 350, 21 USPQ2d at 1943 (reversing obviousness rejection of novel dicamba salt with acyclic structure over broad prior art genus encompassing claimed salt, where disclosed examples of genus were dissimilar in structure, lacking an ether linkage or being cyclic). For example, teachings of preferred species of a complex nature within a disclosed genus may motivate an artisan of ordinary skill to make similar complex species and thus teach away from making simple species within the genus. Baird, 16 F.3d at 382, 29 USPQ2d at 1552. See also Jones, 958 F.2d at 350, 21 USPQ2d at 1943 (disclosed salts of genus held not sufficiently similar in structure to render claimed species prima facieobvious).

Concepts used to analyze the structural similarity of chemical compounds in other types of chemical cases are equally useful in analyzing genus-species cases. For example, a claimed tetra-orthoester fuel composition was held to be obvious in light of a prior art tri- orthoester fuel composition based on their structural and chemical similarity and similar use as fuel additives. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1900- 02. Likewise, claims to amitriptyline used as an antidepressant were held obvious in light of the structural similarity to imipramine, a known antidepressant prior art compound, where both compounds were tricyclic dibenzo compounds and differed structurally only in the replacement of the unsaturated carbon atom in the center ring of amitriptyline with a nitrogen atom in imipramine. In re Merck & Co., 800 F.2d 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir. 1986). Other structural similarities have been found to support a prima facie case of obviousness. See, e.g., In re May, 574 F.2d 1082, 1093-95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Generally, some teaching of a structural similarity will be necessary to suggest selection of the claimed species or subgenus. Id.

(d) Consider the Teachings of Similar Properties or Uses

Consider the properties and utilities of the structurally similar prior art species or subgenus. It is the properties and utilities that provide real world motivation for a person of ordinary skill to make species structurally similar to those in the prior art. Dillon, 919 F.2d at 697, 16 USPQ2d at 1905; In re Stemniski, 444 F.2d 581, 586, 170 USPQ 343, 348 (CCPA 1971). Conversely, lack of any known useful properties weighs against a finding of motivation to make or select a species or subgenus. In re Albrecht, 514 F.2d 1389, 1392, 1395-96, 185 USPQ 585, 587, 590 (CCPA 1975) (The prior art compound so irritated the skin that it could not be regarded as useful for the disclosed anesthetic purpose, and therefore a person skilled in the art would not have been motivated to make related compounds.); Stemniski, 444 F.2d at 586, 170 USPQ at 348 (close structural similarity alone is not sufficient to create a prima facie case of obviousness when the reference compounds lack utility, and thus there is no motivation to make related compounds.). However, the prior art need not disclose a newly discovered property in order for there to be a prima facie case of obviousness. Dillon, 919 F.2d at 697, 16 USPQ2d at 1904-05 (and cases cited therein). If the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species, e.g., id. For example, based on a finding that a tri-orthoester and a tetra-orthoester behave similarly in certain chemical reactions, it has been held that one of ordinary skill in the relevant art would have been motivated to select either structure. 919 F.2d at 692, 16 USPQ2d at 1900-01. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).

(e) Consider the Predictability of the Technology

Consider the predictability of the technology. See, e.g., Dillon, 919 F.2d at 692-97, 16 USPQ2d at 1901- 05; In re Grabiak, 769 F.2d 729, 732-33, 226 USPQ 870, 872 (Fed. Cir. 1985). If the technology is unpredictable, it is less likely that structurally similar species will render a claimed species obvious because it may not be reasonable to infer that they would share similar properties. See, e.g., In re May, 574 F.2d 1082, 1094, 197 USPQ 601, 611 (CCPA 1978) (prima facieobviousness of claimed analgesic compound based on structurally similar prior art isomer was rebutted with evidence demonstrating that analgesia and addiction properties could not be reliably predicted on the basis of chemical structure); In re Schechter, 205 F.2d 185, 191, 98 USPQ 144, 150 (CCPA 1953) (unpredictability in the insecticide field, with homologs, isomers and analogs of known effective insecticides having proven ineffective as insecticides, was considered as a factor weighing against a conclusion of obviousness of the claimed compounds). However, obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).

(f) Consider Any Other Teaching To Support the Selection of the Species or Subgenus

The categories of relevant teachings enumerated above are those most frequently encountered in a genus-species case, but they are not exclusive. Office personnel should consider the totality of the evidence in each case. In unusual cases, there may be other relevant teachings sufficient to support the selection of the species or subgenus and, therefore, a conclusion of obviousness.

5. Make Express Fact-Findings and Determine Whether They Support a Prima Facie Case of Obviousness

Based on the evidence as a whole (In re Bell, 991 F.2d 781,784, 26 USPQ2d 1529, 1531 (Fed. Cir. 1993); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1057 (Fed. Cir. 1990)), Office personnel should make express fact-findings relating to the Graham factors, focusing primarily on the prior art teachings discussed above. The fact-findings should specifically articulate what teachings or suggestions in the prior art would have motivated one of ordinary skill in the art to select the claimed species or subgenus. Kulling, 897 F.2d at 1149, 14 USPQ2d at 1058; Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1579 n.42, 1 USQP2d 1593, 1606 n.42 (Fed. Cir. 1987). Thereafter, it should be determined whether these findings, considered as a whole, support a prima facie case that the claimed invention would have been obvious to one of ordinary skill in the relevant art at the time the invention was made.

B. Determining Whether Rebuttal Evidence Is Sufficient To Overcome the Prima Facie Case of Obviousness

If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., Dillon, 919 F.2d at 692, 16 USPQ2d at 1901. Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789- 90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139- 40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).

Office personnel should consider all rebuttal arguments and evidence presented by applicants. See, e.g., In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995) (error not to consider evidence presented in the specification). C.f., In re Alton, 76 F.3d 1168, 37 USPQ2d 1578 (Fed. Cir. 1996) (error not to consider factual evidence submitted to counter a 35 U.S.C. 112 rejection); In re Beattie, 974 F.2d 1309, 1313, 24 USPQ2d 1040, 1042-43 (Fed. Cir. 1992) (Office personnel should consider declarations from those skilled in the art praising the claimed invention and opining that the art teaches away from the invention.); Piasecki, 745 F.2d at 1472, 223 USPQ at 788 (“[Rebuttal evidence] may relate to any of the Graham factors including the so-called secondary considerations.”). Rebuttal evidence may include evidence of “secondary considerations,” such as “commercial success, long felt but unsolved needs, [and] failure of others.” Graham v. John Deere Co., 383 U.S. at 17, 148 USPQ at 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692- 93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements that claimed compound possesses unusually low immune response or unexpected biological activity that is unsupported by comparative data held insufficient to overcome prima facie case of obviousness). Rebuttal evidence may include evidence that the claimed invention was copied by others. See, e.g., In re GPAC, 57 F.3d 1573, 1580, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Hybritech Inc. v. Monoclonal Antibodies, 802 F.2d 1367, 1380, 231 USPQ 81, 90 (Fed. Cir. 1986). It may also include evidence of the state of the art, the level of skill in the art, and the beliefs of those skilled in the art. See, e.g., In re Oelrich, 579 F.2d 86, 91-92, 198 USPQ 210, 214 (CCPA 1978) (Expert opinions regarding the level of skill in the art were probative of the Nonobviousness of the claimed invention.); Piasecki, 745 F.2d at 1471, 1473-74, 223 USPQ at 790 (Evidence of nontechnological nature is pertinent to the conclusion of obviousness. The declarations of those skilled in the art regarding the need for the invention and its reception by the art were improperly discounted by the Board.); Beattie, 974 F.2d at 1313, 24 USPQ2d at 1042-43 (Seven declarations provided by music teachers opining that the art teaches away from the claimed invention must be considered, but were not probative because they did not contain facts and did not deal with the specific prior art that was the subject of the rejection.). For example, rebuttal evidence may include a showing that the prior art fails to disclose or render obvious a method for making the compound, which would preclude a conclusion of obviousness of the compound. A conclusion of obviousness requires that the reference(s) relied upon be enabling in that it put the public in possession of the claimed invention. The court in In re Hoeksema, 399 F.2d 269, 274, 158 USPQ 596, 601 (CCPA 1968), stated:

Thus, upon careful reconsideration it is our view that if the prior art of record fails to disclose or render obvious a method for making a claimed compound, at the time the invention was made, it may not be legally concluded that the compound itself is in the possession of the public. [footnote omitted.] In this context, we say that the absence of a known or obvious process for making the claimed compounds overcomes a presumption that the compounds are obvious, based on close relationships between their structures and those of prior art compounds.

The Hoeksema court further noted that once a prima facie case of obviousness is made by the PTO through citation of references, the burden is on the applicant to produce contrary evidence establishing that the reference being relied on would not enable a skilled artisan to produce the different compounds claimed. Id. at 274-75, 158 USPQ at 601. See also Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 295, 297, 227 USPQ 657, 666, 667 (Fed. Cir. 1985) (citing Hoeksema for the proposition above); In re Grose, 592 F.2d 1161, 1168, 201 USPQ 57, 63-64 (CCPA 1979) (“One of the assumptions underlying a prima facie obviousness rejection based upon a structural relationship between compounds, such as adjacent homologs, is that a method disclosed for producing one would provide those skilled in the art with a method for producing the other... Failure of the prior art to disclose or render obvious a method for making any composition of matter, whether a compound or a mixture of compounds like a zeolite, precludes a conclusion that the composition would have been obvious.”).

Consideration of rebuttal evidence and arguments requires Office personnel to weigh the proffered evidence and arguments. Office personnel should avoid giving evidence no weight, except in rare circumstances. Id. See also In re Alton, 76 F.3d 1168, 1174- 75, 37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996). However, to be entitled to substantial weight, the applicant should establish a nexus between the rebuttal evidence and the claimed invention, i.e., objective evidence of nonobviousness must be attributable to the claimed invention. The Federal Circuit has acknowledged that applicant bears the burden of establishing nexus, stating:

In the ex parte process of examining a patent application, however, the PTO lacks the means or resources to gather evidence which supports or refutes the applicant’s assertion that the sales constitute commercial success. C.f. Ex parte Remark, 15 USPQ2d 1498, 1503 ([BPAI] 1990) (evidentiary routine of shifting burdens in civil proceedings inappropriate in ex parte prosecution proceedings because examiner has no available means for adducing evidence). Consequently, the PTO must rely upon the applicant to provide hard evidence of commercial success.

In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996). See also GPAC, 57 F.3d at 1580, 35 USPQ2d at 1121; In re Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed. Cir. 1994) (Evidence of commercial success of articles not covered by the claims subject to the 35 U.S.C. 103 rejection was not probative of nonobviousness.). Additionally, the evidence must be reasonably commensurate in scope with the claimed invention. See, e.g., In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990); In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 777 (Fed. Cir. 1983). In re Soni, 54 F.3d 746, 34 USPQ2d 1684 (Fed. Cir. 1995) does not change this analysis. In Soni, the Court declined to consider the Office’s argument that the evidence of nonobviousness was not commensurate in scope with the claim because it had not been raised by the examiner (54 F.3d at 751, 34 USPQ2d at 1688).

When considering whether proffered evidence is commensurate in scope with the claimed invention, Office personnel should not require the applicant to show unexpected results over the entire range of properties possessed by a chemical compound or composition. See, e.g., In re Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987). Evidence that the compound or composition possesses superior and unexpected properties in one of a spectrum of common properties can be sufficient to rebut a prima faciecase of obviousness. Id.

For example, a showing of unexpected results for a single member of a claimed subgenus, or a narrow portion of a claimed range would be sufficient to rebut a prima facie case of obviousness if a skilled artisan “could ascertain a trend in the exemplified data that would allow him to reasonably extend the probative value thereof.” In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Evidence of the unobviousness of a broad range can be proven by a narrower range when one skilled in the art could ascertain a trend that would allow him to reasonably extend the probative value thereof.). But see, Grasselli, 713 F.2d at 743, 218 USPQ at 778 (evidence of superior properties for sodium containing composition insufficient to establish the non-obviousness of broad claims for a catalyst with “an alkali metal” where it was well known in the catalyst art that different alkali metals were not interchangeable and applicant had shown unexpected results only for sodium containing materials); In re Greenfield, 571 F.2d 1185, 1189, 197 USPQ 227, 230 (CCPA 1978) (evidence of superior properties in one species insufficient to establish the nonobviousness of a subgenus containing hundreds of compounds); In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972) (one test not sufficient where there was no adequate basis for concluding the other claimed compounds would behave the same way). However, an exemplary showing may be sufficient to establish a reasonable correlation between the showing and the entire scope of the claim, when viewed by a skilled artisan. See, e.g., Chupp, 816 F.2d at 646, 2 USPQ2d at 1439; Clemens, 622 F.2d at 1036, 206 USPQ at 296. On the other hand, evidence of an unexpected property may not be sufficient regardless of the scope of the showing. Usually, a showing of unexpected results is sufficient to overcome a prima facie case of obviousness. See, e.g., In re Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975). However, where the claims are not limited to a particular use, and where the prior art provides other motivation to select a particular species or subgenus, a showing of a new use may not be sufficient to confer patentability. See Dillon, 919 F.2d at 692, 16 USPQ2d at 1900-01. Accordingly, each case should be evaluated individually based on the totality of the circumstances.

Office personnel should not evaluate rebuttal evidence for its “knockdown” value against the prima facie case, Piasecki, 745 F.2d at 1473, 223 USPQ at 788, or summarily dismiss it as not compelling or insufficient. If the evidence is deemed insufficient to rebut the prima facie case of obviousness, Office personnel should specifically set forth the facts and reasoning that justify this conclusion.

III.RECONSIDER ALL EVIDENCE AND CLEARLY COMMUNICATE FINDINGS AND CONCLUSIONS[edit | edit source]

A determination under 35 U.S.C. 103 should rest on all the evidence and should not be influenced by any earlier conclusion. See, e.g., Piasecki, 745 F.2d at 1472-73, 223 USPQ at 788; In re Eli Lilly & Co., 902 F.2d 943, 945, 14 USPQ2d 1741, 1743 (Fed. Cir. 1990). Thus, once the applicant has presented rebuttal evidence, Office personnel should reconsider any initial obviousness determination in view of the entire record. See, e.g., Piasecki, 745 F.2d at 1472, 223 USPQ at 788; Eli Lilly, 902 F.2d at 945, 14 USPQ2d at 1743. All the proposed rejections and their bases should be reviewed to confirm their correctness. Only then should any rejection be imposed in an Office action. The Office action should clearly communicate the Office’s findings and conclusions, articulating how the conclusions are supported by the findings.

Where applicable, the findings should clearly articulate which portions of the reference support any rejection. Explicit findings on motivation or suggestion to select the claimed invention should also be articulated in order to support a 35 U.S.C. 103 ground of rejection. Dillon, 919 F.2d at 693, 16 USPQ2d at 1901; In re Mills, 916 F.2d 680, 683, 16 USPQ2d 1430, 1433 (Fed. Cir. 1990). Conclusory statements of similarity or motivation, without any articulated rationale or evidentiary support, do not constitute sufficient factual findings.

2144.09 Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers)[edit | edit source]

REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES[edit | edit source]

A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, paragraph II.A.4.(c).

HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS[edit | edit source]

Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).

Isomers having the same empirical formula but different structures are not necessarily considered equivalent by chemists skilled in the art and therefore are not necessarily suggestive of each other. Ex parteMowry, 91 USPQ 219 (Bd. App. 1950) (claimed cyclohexylstyrene not prima facie obvious over prior art isohexylstyrene). Similarly, homologs which are far removed from adjacent homologs may not be expected to have similar properties. In re Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960) (prior art disclosure of C8 to C12 alkyl sulfates was not sufficient to render prima facie obvious claimed C1 alkyl sulfate).

Homology and isomerism involve close structural similarity which must be considered with all other relevant facts in determining the issue of obviousness. In re Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960); In re Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967). Homology should not be automatically equated with prima facie obviousness because the claimed invention and the prior art must each be viewed “as a whole.” In re Langer, 465 F.2d 896, 175 USPQ 169 (CCPA 1972) (Claims to a polymerization process using a sterically hindered amine were held unobvious over a similar prior art process because the prior art disclosed a large number of unhindered amines and only one sterically hindered amine (which differed from a claimed amine by 3 carbon atoms), and therefore the reference as a whole did not apprise the ordinary artisan of the significance of hindered amines as a class.).

PRESENCE OF A TRUE HOMOLOGOUS OR ISOMERIC RELATIONSHIP IS NOT CONTROLLING[edit | edit source]

Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) (Claimed and prior art compounds were both directed to heterocyclic carbamoyloximino compounds having pesticidal activity. The only structural difference between the claimed and prior art compounds was that the ring structures of the claimed compounds had two carbon atoms between two sulfur atoms whereas the prior art ring structures had either one or three carbon atoms between two sulfur atoms. The court held that although the prior art compounds were not true homologs or isomers of the claimed compounds, the similarity between the chemical structures and properties is sufficiently close that one of ordinary skill in the art would have been motivated to make the claimed compounds in searching for new pesticides.).

See also In re Mayne, 104 F.3d 1339, 41 USPQ2d 1451 (Fed. Cir. 1997) (claimed protein was held to be obvious in light of structural similarities to the prior art, including known structural similarity of Ile and Lev); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (claimed and prior art compounds used in a method of treating depression would have been expected to have similar activity because the structural difference between the compounds involved a known bioisosteric replacement) (see MPEP § 2144.08, paragraph II.A.4(c) for a more detailed discussion of the facts in the Mayne and Merck cases); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (The tri-orthoester fuel compositions of the prior art and the claimed tetra-orthoester fuel compositions would have been expected to have similar properties based on close structural and chemical similarity between the orthoesters and the fact that both the prior art and applicant used the orthoesters as fuel additives.) (See MPEP § 2144 for a more detailed discussion of the facts in the Dillon case.).

Compare In re Grabiak, 769 F.2d 729, 226 USPQ 871 (Fed. Cir. 1985) (substitution of a thioester group for an ester group in an herbicidal safener compound was not suggested by the prior art); In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993) (The established relationship between a nucleic acid and the protein it encodes in the genetic code does not render a gene prima facie obvious over its corresponding protein in the same way that closely related structures in chemistry may create a prima facie case because there are a vast number of nucleotide sequences that might encode for a specific protein as a result of degeneracy in the genetic code (i.e., the fact that most amino acids are specified by more than one nucleotide sequence or codon).); In re Deuel, 51 F.3d 1552, 1558-59, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995) (“A prior art disclosure of the amino acid sequence of a protein does not necessarily render particular DNA molecules encoding the protein obvious because the redundancy of the genetic code permits one to hypothesize an enormous number of DNA sequences coding for the protein.” The existence of a general method of gene cloning in the prior art is not sufficient, without more, to render obvious a particular cDNA molecule.).

PRESENCE OR ABSENCE OF PRIOR ART SUGGESTION OF METHOD OF MAKING A CLAIMED COMPOUND MAY BE RELEVANT IN DETERMINING PRIMA FACIE OBVIOUSNESS[edit | edit source]

“[T]he presence—or absence—of a suitably operative, obvious process for making a composition of matter may have an ultimate bearing on whether that composition is obvious—or nonobvious—under 35 U.S.C. 103.” In re Maloney, 411 F.2d 1321, 1323, 162 USPQ 98, 100 (CCPA 1969).

“[I]f the prior art of record fails to disclose or render obvious a method for making a claimed compound, at the time the invention was made, it may not be legally concluded that the compound itself is in the possession of the public. In this context, we say that the absence of a known or obvious process for making the claimed compounds overcomes a presumption that the compounds are obvious, based on the close relationships between their structures and those of prior art compounds.” In re Hoeksema, 399 F.2d 269, 274- 75, 158 USPQ 597, 601 (CCPA 1968).

See In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) for a general discussion of circumstances under which the prior art suggests methods for making novel compounds which are of close structural similarity to compounds known in the prior art. In the biotechnology arts, the existence of a general method of gene cloning in the prior art is not sufficient, without more, to render obvious a particular cDNA molecule. In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995) (“[T]he existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious, in the absence of other prior art that suggests the claimed DNAs.”); In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993). However, it may be proper to apply “methodology in rejecting product claims under 35 U.S.C. 103, depending on the particular facts of the case, the manner and context in which methodology applies, and the overall logic of the rejection.” Ex parte Goldgaber, 41 USPQ2d 1172, 1176 (Bd. Pat. App. & Inter. 1996).

PRESUMPTION OF OBVIOUSNESS BASED ON STRUCTURAL SIMILARITY IS OVERCOME WHERE THERE IS NO REASONABLE EXPECTATION OF SIMILAR PROPERTIES[edit | edit source]

The presumption of obviousness based on a reference disclosing structurally similar compounds may be overcome where there is evidence showing there is no reasonable expectation of similar properties in structurally similar compounds. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (appellant produced sufficient evidence to establish a substantial degree of unpredictability in the pertinent art area, and thereby rebutted the presumption that structurally similar compounds have similar properties); In reSchechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953). See also Ex parte Blattner, 2 USPQ2d 2047 (Bd. Pat. App. & Inter. 1987) (Claims directed to compounds containing a 7-membered ring were rejected as prima facie obvious over a reference which taught 5- and 6- membered ring homologs of the claimed compounds. The Board reversed the rejection because the prior art taught that the compounds containing a 5-membered ring possessed the opposite utility of the compounds containing the 6-membered ring, undermining the examiner’s asserted prima facie case arising from an expectation of similar results in the claimed compounds which contain a 7-membered ring.).

IF PRIOR ART COMPOUNDS HAVE NO UTILITY, OR UTILITY ONLY AS INTERMEDIATES, CLAIMED STRUCTURALLY SIMILAR COMPOUNDS MAY NOT BE PRIMA FACIE OBVIOUS OVER THE PRIOR ART[edit | edit source]

If the prior art does not teach any specific or significant utility for the disclosed compounds, then the prior art is not sufficient to render structurally similar claims prima facie obvious because there is no motivation for one of ordinary skill in the art to make the reference compounds, much less any structurally related compounds. In re Stemniski, 444 F.2d 581, 170 USPQ 343 (CCPA 1971).

Where structurally similar “prior art compounds ‘cannot be regarded as useful’ for the sole use disclosed [by the reference],... a person having ordinary skill in the art would lack the ‘necessary impetus’ to make the claimed compounds.” In re Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975) (prior art reference studied the local anesthetic activity of various compounds, and taught that compounds structurally similar to those claimed were irritating to human skin and therefore “cannot be regarded as useful anesthetics.” 514 F.2d at 1393, 185 USPQ at 587).

Similarly, if the prior art merely discloses compounds as intermediates in the production of a final product, one of ordinary skill in the art would not have been motivated to stop the reference synthesis and investigate the intermediate compounds with an expectation of arriving at claimed compounds which have different uses. In re Lalu, 747 F.2d 703, 223 USPQ 1257 (Fed. Cir. 1984).

PRIMA FACIE CASE REBUTTABLE BY EVIDENCE OF SUPERIOR OR UNEXPECTED RESULTS[edit | edit source]

A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (Affidavit evidence which showed that claimed triethylated compounds possessed anti-inflammatory activity whereas prior art trimethylated compounds did not was sufficient to overcome obviousness rejection based on the homologous relationship between the prior art and claimed compounds.); In re Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967) (a 7-fold improvement of activity over the prior art held sufficient to rebut prima facie obviousness based on close structural similarity).

However, a claimed compound may be obvious because it was suggested by, or structurally similar to, a prior art compound even though a particular benefit of the claimed compound asserted by patentee is not expressly disclosed in the prior art. It is the differences in fact in their respective properties which are determinative of nonobviousness. If the prior art compound does in fact possess a particular benefit, even though the benefit is not recognized in the prior art, applicant’s recognition of the benefit is not in itself sufficient to distinguish the claimed compound from the prior art. In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991).

See MPEP § 716.02 - § 716.02(g) for a discussion of evidence alleging unexpectedly advantageous or superior results.



2145 Consideration of Applicant’s Rebuttal Arguments[edit | edit source]

I. ARGUMENT DOES NOT REPLACE EVIDENCE WHERE EVIDENCE IS NECESSARY[edit | edit source]

Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art.

The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). See MPEP § 716.01(c) for examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration.

II. ARGUING ADDITIONAL ADVANTAGES OR LATENT PROPERTIES[edit | edit source]

Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present in the Prior Art

Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness, however the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).

“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).

In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) discussed in MPEP § 2144 are also pertinent to this issue.

See MPEP § 716.02 - § 716.02(g) for a discussion of declaratory evidence alleging unexpected results.

III. ARGUING THAT PRIOR ART DEVICES ARE NOT PHYSICALLY COMBINABLE[edit | edit source]

“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). See also In reSneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”).

However, the claimed combination cannot change the principle of operation of the primary reference or render the reference inoperable for its intended purpose. See MPEP § 2143.01.

IV. ARGUING AGAINST REFERENCES INDIVIDUALLY[edit | edit source]

One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).

V. ARGUING ABOUT THE NUMBER OF REFERENCES COMBINED[edit | edit source]

Reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991) (Court affirmed a rejection of a detailed claim to a candy sucker shaped like a thumb on a stick based on thirteen prior art references.).

VI. ARGUING LIMITATIONS WHICH ARE NOT CLAIMED[edit | edit source]

Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a superconducting magnet which generates a “uniform magnetic field” were not limited to the degree of magnetic field uniformity required for Nuclear Magnetic Resonance (NMR) imaging. Although the specification disclosed that the claimed magnet may be used in an NMR apparatus, the claims were not so limited.); Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which appellant relied were not stated in the claims; the specification did not provide evidence indicating these limitations must be read into the claims to give meaning to the disputed terms.); Ex parte McCullough, 7 USPQ2d 1889, 1891 (Bd. Pat. App. & Inter. 1987) (Claimed electrode was rejected as obvious despite assertions that electrode functions differently than would be expected when used in nonaqueous battery since “although the demonstrated results may be germane to the patentability of a battery containing appellant’s electrode, they are not germane to the patentability of the invention claimed on appeal.”).

See MPEP § 2111 - § 2116.01, for additional case law relevant to claim interpretation.

VII. ARGUING ECONOMIC INFEASIBILITY[edit | edit source]

The fact that a combination would not be made by businessmen for economic reasons does not mean that a person of ordinary skill in the art would not make the combination because of some technological incompatibility. In re Farrenkopf, 713 F.2d 714, 219 USPQ 1 (Fed. Cir. 1983) (Prior art reference taught that addition of inhibitors to radioimmunoassay is the most convenient, but costliest solution to stability problem. The court held that the additional expense associated with the addition of inhibitors would not discourage one of ordinary skill in the art from seeking the convenience expected therefrom.).

VIII. ARGUING ABOUT THE AGE OF REFERENCES[edit | edit source]

“The mere age of the references is not persuasive of the unobviousness of the combination of their teachings, absent evidence that, notwithstanding knowledge of the references, the art tried and failed to solve the problem.” In re Wright, 569 F.2d 1124, 1127, 193 USPQ 332, 335 (CCPA 1977) (100 year old patent was properly relied upon in a rejection based on a combination of references.). See also Ex parte Meyer, 6 USPQ2d 1966 (Bd. Pat. App. & Inter. 1988) (length of time between the issuance of prior art patents relied upon (1920 and 1976) was not persuasive of unobviousness).

IX. ARGUING THAT PRIOR ART IS NONANALOGOUS[edit | edit source]

A prior art reference is analogous if the reference is in the field of applicant’s endeavor or, if not, the reference is reasonably pertinent to the particular problem with which the inventor was concerned. In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992).

See MPEP § 2141.01(a) for case law pertaining to analogous art.

X. ARGUING IMPROPER RATIONALES FOR COMBINING REFERENCES[edit | edit source]

A. Impermissible Hindsight

Applicants may argue that the examiner’s conclusion of obviousness is based on improper hindsight reasoning. However, “[a]ny judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). Applicants may also argue that the combination of two or more references is “hindsight” because “express” motivation to combine the references is lacking. However, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). For example, motivation to combine prior art references may exist in the nature of the problem to be solved (Ruiz at 1276, 69 USPQ2d at 1690) or the knowledge of one of ordinary skill in the art (National Steel Car v. Canadian Pacific Railway Ltd., 357 F.3d 1319, 1338, 69 USPQ2d 1641, 1656 (Fed. Cir. 2004)). See MPEP § 2143.01 for a discussion of proper motivation to combine references.

B. Obvious To Try Rationale

An applicant may argue the examiner is applying an improper “obvious to try” rationale in support of an obviousness rejection.

“The admonition that ‘obvious to try’ is not the standard under § 103 has been directed mainly at two kinds of error. In some cases, what would have been ‘obvious to try’ would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.... In others, what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.” In reO’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988) (citations omitted) (The court held the claimed method would have been obvious over the prior art relied upon because one reference contained a detailed enabling methodology, a suggestion to modify the prior art to produce the claimed invention, and evidence suggesting the modification would be successful.). See the cases cited in O’Farrell for examples of decisions where the court discussed an improper “obvious to try” approach. See also In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) and In re Ball Corp., 925 F.2d 1480, 18 USPQ2d 1491 (Fed. Cir. 1991) (unpublished) for examples of cases where appellants argued that an improper “obvious to try” standard was applied, but the court found that there was proper motivation to modify the references.

C. Lack of Suggestion To Combine References

As discussed in MPEP § 2143.01, there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify or combine reference teachings. The Federal Circuit has produced a number of decisions overturning obviousness rejections due to a lack of suggestion in the prior art of the desirability of combining references, as discussed in the aforementioned section.

D. References Teach Away from the Invention or Render Prior Art Unsatisfactory for Intended Purpose

In addition to the material below, see MPEP § 2141.02 (prior art must be considered in its entirety, including disclosures that teach away from the claims) and MPEP § 2143.01 (proposed modification cannot render the prior art unsatisfactory for its intended purpose or change the principle of operation of a reference).

1. The Nature of the Teaching Is Highly Relevant

A prior art reference that “teaches away” from the claimed invention is a significant factor to be considered in determining obviousness; however, “the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (Claims were directed to an epoxy resin based printed circuit material. A prior art reference disclosed a polyester- imide resin based printed circuit material, and taught that although epoxy resin based materials have acceptable stability and some degree of flexibility, they are inferior to polyester-imide resin based materials. The court held the claims would have been obvious over the prior art because the reference taught epoxy resin based material was useful for applicant’s purpose, applicant did not distinguish the claimed epoxy from the prior art epoxy, and applicant asserted no discovery beyond what was known to the art.).

Furthermore, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).

2. References Cannot Be Combined Where Reference Teaches Away from Their Combination

It is improper to combine references where the references teach away from their combination. In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 779 (Fed. Cir. 1983) (The claimed catalyst which contained both iron and an alkali metal was not suggested by the combination of a reference which taught the interchangeability of antimony and alkali metal with the same beneficial result, combined with a reference expressly excluding antimony from, and adding iron to, a catalyst.).

3. Proceeding Contrary to Accepted Wisdom Is Evidence of Nonobviousness

The totality of the prior art must be considered, and proceeding contrary to accepted wisdom in the art is evidence of nonobviousness. In re Hedges, 783 F.2d 1038, 228 USPQ 685 (Fed. Cir. 1986) (Applicant’s claimed process for sulfonating diphenyl sulfone at a temperature above 127ºC was contrary to accepted wisdom because the prior art as a whole suggested using lower temperatures for optimum results as evidenced by charring, decomposition, or reduced yields at higher temperatures.).

Furthermore, “[k]nown disadvantages in old devices which would naturally discourage search for new inventions may be taken into account in determining obviousness.” United States v. Adams, 383 U.S. 39, 52, 148 USPQ 479, 484 (1966).



2146 35 U.S.C. 103(c)[edit | edit source]

35 U.S.C. 103. Conditions of patentability; non-obvious subject matter.

(c)(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.

(2)For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if —

(A)the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;

(B)the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and

(C)the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.

(3)For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

Effective November 29, 1999, subject matter which was prior art under former 35 U.S.C. 103 via 35 U.S.C. 102(e) was disqualified as prior art against the claimed invention if that subject matter and the claimed invention “were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person.” This amendment to 35 U.S.C. 103(c) was made pursuant to section 4807 of the American Inventors Protection Act of 1999 (AIPA); see Pub. L. 106-113, 113 Stat. 1501, 1501A-591 (1999). The changes to 35 U.S.C. 102(e) in the Intellectual Property and High Technology Technical Amendments Act of 2002 (Pub. L. 107- 273, 116 Stat. 1758 (2002)) did not affect the exclusion under 35 U.S.C. 103(c) as amended on November 29, 1999. Subsequently, the Cooperative Research and Technology Enhancement Act of 2004 (CREATE Act) (Pub. L. 108-453, 118 Stat. 3596 (2004)) further amended 35 U.S.C. 103(c) to provide that subject matter developed by another person shall be treated as owned by the same person or subject to an obligation of assignment to the same person for purposes of determining obviousness if three conditions are met:

(A)the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;

(B)the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and

(C)the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement (hereinafter “joint research agreement disqualification”).

These changes to 35 U.S.C. 103(c) apply to all patents (including reissue patents) granted on or after December 10, 2004. The amendment to 35 U.S.C. 103(c) made by the AIPA to change “subsection (f) or (g)” to “one of more of subsections (e), (f), or (g)” applies to applications filed on or after November 29, 1999. It is to be noted that, for all applications (including reissue applications), if the application is pending on or after December 10, 2004, the 2004 changes to 35 U.S.C. 103(c), which effectively include the 1999 changes, apply; thus, the November 29, 1999 date of the prior revision to 35 U.S.C. 103(c) is no longer relevant. In a reexamination proceeding, however, one must look at whether or not the patent being reexamined was granted on or after December 10, 2004 to determine whether 35 U.S.C. 103(c), as amended by the CREATE Act, applies. For a reexamination proceeding of a patent granted prior to December 10, 2004 on an application filed on or after November 29, 1999, it is the 1999 changes to 35 U.S.C. 103(c) that are applicable to the disqualifying commonly assigned/owned prior art provisions of 35 U.S.C. 103(c). See MPEP § 706.02(l)(1) for additional information regarding disqualified prior art under 35 U.S.C. 102(e)/103. For a reexamination proceeding of a patent granted prior to December 10, 2004 on an application filed prior to November 29, 1999, neither the 1999 nor the 2004 changes to 35 U.S.C. 103(c) are applicable. Therefore, only prior art under 35 U.S.C. 102(f) or (g) used in a rejection under 35 U.S.C. 103(a) may be disqualified under the commonly assigned/owned prior art provision of 35 U.S.C. 103(c).

35 U.S.C. 103(c), as amended by the CREATE Act, applies only to subject matter which qualifies as prior art under 35 U.S.C. 102(e), (f), or (g), and which is being relied upon in a rejection under 35 U.S.C. 103. If the rejection is anticipation under 35 U.S.C. 102(e), (f), or (g), 35 U.S.C. 103(c) cannot be relied upon to disqualify the subject matter in order to overcome or prevent the anticipation rejection. Likewise, 35 U.S.C. 103(c) cannot be relied upon to overcome or prevent a double patenting rejection. See 37 CFR 1.78(c) and MPEP § 804. See MPEP § 706.02(l) - § 706.02(l)(3).


2161 Three Separate Requirements for Specification Under 35 U.S.C. 112, First Paragraph[edit | edit source]

THE SPECIFICATION MUST INCLUDE A WRITTEN DESCRIPTION OF THE INVENTION, ENABLEMENT, AND BEST MODE OF CARRYING OUT THE CLAIMED INVENTION

The first paragraph of 35 U.S.C. 112 provides:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. [emphasis added].

This section of the statute requires that the specification include the following:

(A) A written description of the invention;

(B) The manner and process of making and using the invention (the enablement requirement); and

(C) The best mode contemplated by the inventor of carrying out his invention.

THE THREE REQUIREMENTS ARE SEPARATE AND DISTINCT FROM EACH OTHER

The written description requirement is separate and distinct from the enablement requirement.

An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).

2161.01 Computer Programming and 35U.S.C. 112, First Paragraph[edit | edit source]

The requirements for sufficient disclosure of inventions involving computer programming are the same as for all inventions sought to be patented. Namely, there must be an adequate written description, the original disclosure should be sufficiently enabling to allow one to make and use the invention as claimed, and there must be presentation of a best mode for carrying out the invention.

The following guidelines, while applicable to a wide range of arts, are intended to provide a guide for analyzing 35 U.S.C. 112, first paragraph, issues in applications involving computer programs, software, firmware, or block diagram cases wherein one or more of the “block diagram” elements are at least partially comprised of a computer software component. It should be recognized that sufficiency of disclosure issues in computer cases necessarily will require an inquiry into both the sufficiency of the disclosed hardware as well as the disclosed software due to the interrelationship and interdependence of computer hardware and software.

I. WRITTEN DESCRIPTION

The function of the written description requirement is to ensure that the inventor had possession of, as of the filing date of the application relied on, the specific subject matter later claimed by him or her; how the specification accomplishes this is not material.

II. BEST MODE

The purpose of the best mode requirement is to "restrain inventors from applying for patents while at the same time concealing from the public the preferred embodiments of their inventions which they have in fact conceived." Only evidence of concealment, "whether accidental or intentional," is considered in judging the adequacy of the disclosure for compliance with the best mode requirement. That evidence, in order to result in affirmance of a best mode rejection, must tend to show that the quality of an applicant's best mode disclosure is so poor as to effectively result in concealment.

There are two factual inquiries to be made in determining whether a specification satisfies the best mode requirement:

  1. there must be a subjective determination as to whether at the time the application was filed, the inventor knew of a best mode of practicing the invention.
  2. if the inventor had a best mode of practicing the invention in mind, there must be an objective determination as to whether that best mode was disclosed in sufficient detail to allow one skilled in the art to practice it.

"As a general rule, where software constitutes part of a best mode of carrying out an invention, description of such a best mode is satisfied by a disclosure of the functions of the software. This is because, normally, writing code for such software is within the skill of the art, not requiring undue experimentation, once its functions have been disclosed. . . . [F]low charts or source code listings are not a requirement for adequately disclosing the functions of software." Fonar Corp., 107 F.3d at 1549, 41 USPQ2d at 1805 (citations omitted).

III. ENABLEMENT

When basing a rejection on the failure of the applicant's disclosure to meet the enablement provisions of the first paragraph of 35 U.S.C. 112, USPTO personnel must establish on the record a reasonable basis for questioning the adequacy of the disclosure to enable a person of ordinary skill in the art to make and use the claimed invention without resorting to undue experimentation.

Once USPTO personnel have advanced a reasonable basis for questioning the adequacy of the disclosure, it becomes incumbent on the applicant to rebut that challenge and factually demonstrate that his or her application disclosure is in fact sufficient.



2162 Policy Underlying 35 U.S.C. 112, First Paragraph[edit | edit source]

To obtain a valid patent, a patent application must be filed that contains a full and clear disclosure of the invention in the manner prescribed by 35 U.S.C. 112, first paragraph. The requirement for an adequate disclosure ensures that the public receives something in return for the exclusionary rights that are granted to the inventor by a patent. The grant of a patent helps to foster and enhance the development and disclosure of new ideas and the advancement of scientific knowledge. Upon the grant of a patent in the U.S., information contained in the patent becomes a part of the information available to the public for further research and development, subject only to the patentee’s right to exclude others during the life of the patent.

In exchange for the patent rights granted, 35 U.S.C. 112, first paragraph, sets forth the minimum requirements for the quality and quantity of information that must be contained in the patent to justify the grant. As discussed in more detail below, the patentee must disclose in the patent sufficient information to put the public in possession of the invention and to enable those skilled in the art to make and use the invention. The applicant must not conceal from the public the best way of practicing the invention that was known to the patentee at the time of filing the patent application. Failure to fully comply with the disclosure requirements could result in the denial of a patent, or in a holding of invalidity of an issued patent.


2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, "Written Description" Requirement[edit | edit source]

The following Guidelines establish the policies and procedures to be followed by Office personnel in the evaluation of any patent application for compliance with the written description requirement of 35 U.S.C. 112. These Guidelines are based on the Office’s current understanding of the law and are believed to be fully consistent with binding precedent of the U.S. Supreme Court, as well as the U.S. Court of Appeals for the Federal Circuit and its predecessor courts.

The Guidelines do not constitute substantive rulemaking and hence do not have the force and effect of law. They are designed to assist Office personnel in analyzing claimed subject matter for compliance with substantive law. Rejections will be based upon the substantive law, and it is these rejections which are appealable. Consequently, any perceived failure by Office personnel to follow these Guidelines is neither appealable nor petitionable.

These Guidelines are intended to form part of the normal examination process. Thus, where Office personnel establish a prima facie case of lack of written description for a claim, a thorough review of the prior art and examination on the merits for compliance with the other statutory requirements, including those of 35 U.S.C. 101, 102, 103, and 112, is to be conducted prior to completing an Office action which includes a rejection for lack of written description.

I.GENERAL PRINCIPLES GOVERNING COMPLIANCE WITH THE “WRITTEN DESCRIPTION” REQUIREMENT FOR APPLICATIONS

The first paragraph of 35 U.S.C. 112 requires that the “specification shall contain a written description of the invention .” This requirement is separate and distinct from the enablement requirement. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991). See also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (“conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description”). The written description requirement has several policy objectives. “[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed.” In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to put the public in possession of what the applicant claims as the invention. See Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). “The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.” Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.

To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). Much of the written description case law addresses whether the specification as originally filed supports claims not originally in the application. The issue raised in the cases is most often phrased as whether the original application provides “adequate support” for the claims at issue or whether the material added to the specification incorporates “new matter” in violation of 35 U.S.C. 132. The “written description” question similarly arises in the interference context, where the issue is whether the specification of one party to the interference can support the newly added claims corresponding to the count at issue, i.e., whether that party can “make the claim” corresponding to the interference count. See, e.g., Martin v. Mayer, 823 F.2d 500, 503, 3 USPQ2d 1333, 1335 (Fed. Cir. 1987). In addition, early opinions suggest the Patent and Trademark Office was unwilling to find written descriptive support when the only description was found in the claims; however, this viewpoint was rejected. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980) (original claims constitute their own description); accord In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); accord In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). It is now well accepted that a satisfactory description may be in the claims or any other portion of the originally filed specification. These early opinions did not address the quality or specificity of particularity that was required in the description, i.e., how much description is enough.

An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it”). “Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’” Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1613. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 (“reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material”); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 (August 22, 1989) (“The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted.” Id. at 34,876. “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement.” Id. at 34,880.). Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). See also 54 FR at 34,880 (“As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.”).

A question as to whether a specification provides an adequate written description may arise in the context of an original claim which is not described sufficiently (see, e.g., LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1733 (Fed. Cir. 2005); Enzo Biochem, 323 F.3d at 968, 63 USPQ2d at 1616 (Fed. Cir. 2002); Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398), a new or amended claim wherein a claim limitation has been added or removed, or a claim to entitlement of an earlier priority date or effective filing date under 35 U.S.C. 119, 120, or 365(c). Most typically, the issue will arise in the context of determining whether new or amended claims are supported by the description of the invention in the application as filed (see, e.g., In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989)), whether a claimed invention is entitled to the benefit of an earlier priority date or effective filing date under 35 U.S.C. 119, 120, or 365(c) (see, e.g., New Railhead Mfg. L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 63 USPQ2d 1843 (Fed. Cir. 2002); Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993); In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993)), or whether a specification provides support for a claim corresponding to a count in an interference (see, e.g., Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971)). Compliance with the written description requirement is a question of fact which must be resolved on a case-by-case basis. Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116 (Fed. Cir. 1991).

A.Original Claims

There is a strong presumption that an adequate written description of the claimed invention is present when the application is filed. In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976) (“we are of the opinion that the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims”). However, as discussed in paragraph I., supra, the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. For example, consider the claim “A gene comprising SEQ ID NO:1.” A determination of what the claim as a whole covers may result in a conclusion that specific structures such as a promoter, a coding region, or other elements are included. Although all genes encompassed by this claim share the characteristic of comprising SEQ ID NO:1, there may be insufficient description of those specific structures (e.g., promoters, enhancers, coding regions, and other regulatory elements) which are also included.

The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence. For example, even though a genetic code table would correlate a known amino acid sequence with a genus of coding nucleic acids, the same table cannot predict the native, naturally occurring nucleic acid sequence of a naturally occurring mRNA or its corresponding cDNA. Cf. In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993), and In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C. 103). The Federal Circuit has pointed out that under United States law, a description that does not render a claimed invention obvious cannot sufficiently describe the invention for the purposes of the written description requirement of 35 U.S.C. 112. Eli Lilly, 119 F.3d at 1567, 43 USPQ2d at 1405. Compare Fonar Corp. v. General Electric Co., 107 F.3d 1543, 1549, 41 USPQ2d 1801, 1805 (Fed. Cir. 1997) (“As a general rule, where software constitutes part of a best mode of carrying out an invention, description of such a best mode is satisfied by a disclosure of the functions of the software. This is because, normally, writing code for such software is within the skill of the art, not requiring undue experimentation, once its functions have been disclosed. Thus, flow charts or source code listings are not a requirement for adequately disclosing the functions of software.”).

A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-propylamine had been used in making the compound instead of n-butylamine, the compound of claim 13 would have resulted. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.”) (emphasis in original); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000) (“the specification does not clearly disclose to the skilled artisan that the inventors ... considered the ratio... to be part of their invention .... There is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion”).

B.New or Amended Claims

The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981). See MPEP § 2163.06through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985). Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).

While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure. An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971). With respect to the correction of sequencing errors in applications disclosing nucleic acid and/or amino acid sequences, it is well known that sequencing errors are a common problem in molecular biology. See, e.g., Peter Richterich, Estimation of Errors in ‘Raw’ DNA Sequences: A Validation Study, 8 Genome Research251-59 (1998). If an application as filed includes sequence information and references a deposit of the sequenced material made in accordance with the requirements of 37 CFR 1.801 et seq., amendment may be permissible. Deposits made after the application filing date cannot be relied upon to support additions to or correction of information in the application as filed. Corrections of minor errors in the sequence may be possible based on the argument that one of skill in the art would have resequenced the deposited material and would have immediately recognized the minor error. Deposits made after the filing date can only be relied upon to provide support for the correction of sequence information if applicant submits a statement in compliance with 37 CFR 1.804 stating that the biological material which is deposited is a biological material specifically defined in the application as filed.

Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor had possession of a broader, more generic invention. See, e.g., PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1248, 64 USPQ2d 1344, 1353 (Fed. Cir. 2002) (Claim for a method of inhibiting sprout growth on tubers by treating them with spaced, sequential application of two chemicals was held invalid for lack of adequate written description where the specification indicated that invention was a method of applying a “composition,” or mixture, of the two chemicals.); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998) (claims to a sectional sofa comprising, inter alia, a console and a control means were held invalid for failing to satisfy the written description requirement where the claims were broadened by removing the location of the control means); Johnson Worldwide Associates v. Zebco Corp., 175 F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (In Gentry Gallery, the “court’s determination that the patent disclosure did not support a broad meaning for the disputed claim terms was premised on clear statements in the written description that described the location of a claim element-- the ‘control means’ --as ‘the only possible location’ and that variations were ‘outside the stated purpose of the invention.’ Gentry Gallery, 134 F.3d at 1479, 45 USPQ2d at 1503. Gentry Gallery, then, considers the situation where the patent’s disclosure makes crystal clear that a particular (i.e., narrow) understanding of a claim term is an ‘essential element of [the inventor’s] invention.’”); Tronzo v. Biomet, 156 F.3d at 1158-59, 47 USPQ2d at 1833 (Fed. Cir. 1998) (claims to generic cup shape were not entitled to filing date of parent application which disclosed “conical cup” in view of the disclosure of the parent application stating the advantages and importance of the conical shape.). A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 (CCPA 1962) (“[O]ne skilled in this art would not be taught by the written description of the invention in the specification that any ‘aryl or substituted aryl radical’ would be suitable for the purposes of the invention but rather that only certain aryl radicals and certain specifically substituted aryl radicals [i.e., aryl azides] would be suitable for such purposes.”) (emphasis in original). A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may also be subject to rejection under 35 U.S.C. 112, para. 1, as not enabling, or under 35 U.S.C. 112, para. 2. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976); and In re Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA 1968). See also MPEP § 2172.01.

The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563- 64, 19 USPQ2d at 1117.

II.METHODOLOGY FOR DETERMINING ADEQUACY OF WRITTEN DESCRIP- TION

A.Read and Analyze the Specification for Compliance with 35 U.S.C. 112, para. 1

Office personnel should adhere to the following procedures when reviewing patent applications for compliance with the written description requirement of 35 U.S.C. 112, para. 1. The examiner has the initial burden, after a thorough reading and evaluation of the content of the application, of presenting evidence or reasons why a person skilled in the art would not recognize that the written description of the invention provides support for the claims. There is a strong presumption that an adequate written description of the claimed invention is present in the specification as filed, Wertheim, 541 F.2d at 262, 191 USPQ at 96; however, with respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See MPEP § 714.02 and § 2163.06 (“Applicant should specifically point out the support for any amendments made to the disclosure.”); and MPEP § 2163.04 (“If applicant amends the claims and points out where and/or how the originally filed disclosure supports the amendment(s), and the examiner finds that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of the filing of the application, the examiner has the initial burden of presenting evidence or reasoning to explain why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.”). Consequently, rejection of an original claim for lack of written description should be rare. The inquiry into whether the description requirement is met is a question of fact that must be determined on a case-by-case basis. See In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (“Precisely how close [to the claimed invention] the description must come to comply with Sec. 112 must be left to case-by-case development.”); In re Wertheim, 541 F.2d at 262, 191 USPQ at 96 (inquiry is primarily factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure).

1.For Each Claim, Determine What the Claim as a Whole Covers

Claim construction is an essential part of the examination process. Each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description. See, e.g., In re Morris, 127 F.3d 1048, 1053-54, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). The entire claim must be considered, including the preamble language and the transitional phrase. “Preamble language” is that language in a claim appearing before the transitional phase, e.g., before “comprising,” “consisting essentially of,” or “consisting of.” The transitional term “comprising” (and other comparable terms, e.g., “containing,” and “including”) is “open- ended” -it covers the expressly recited subject matter, alone or in combination with unrecited subject matter. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.”); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves the “claim open for the inclusion of unspecified ingredients even in major amounts”). See also MPEP § 2111.03. “By using the term ‘consisting essentially of,’ the drafter signals that the invention necessarily includes the listed ingredients and is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention. A ‘consisting essentially of’ claim occupies a middle ground between closed claims that are written in a ‘consisting of’ format and fully open claims that are drafted in a ‘comprising’ format.” PPG Industries v. Guardian Industries, 156 F.3d 1351, 1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 (“PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.”). See also AK Steel Corp. v. Sollac, 344 F3.d 1234, 1239-1240, 68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003); In re Janakirama-Rao, 317 F.2d 951, 954, 137 USPQ 893, 895-96 (CCPA 1963). If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also MPEP § 2111.03. The claim as a whole, including all limitations found in the preamble (see Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, 14 USPQ2d 1871, 1876 (Fed. Cir. 1990) (determining that preamble language that constitutes a structural limitation is actually part of the claimed invention)), the transitional phrase, and the body of the claim, must be sufficiently supported to satisfy the written description requirement. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.

The examiner should evaluate each claim to determine if sufficient structures, acts, or functions are recited to make clear the scope and meaning of the claim, including the weight to be given the preamble. See, e.g., Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed. Cir. 1995) (“[A] claim preamble has the import that the claim as a whole suggests for it.”); Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (The determination of whether preamble recitations are structural limitations can be resolved only on review of the entirety of the application “to gain an understanding of what the inventors actually invented and intended to encompass by the claim.”). The absence of definitions or details for well-established terms or procedures should not be the basis of a rejection under 35 U.S.C. 112, para. 1, for lack of adequate written description. Limitations may not, however, be imported into the claims from the specification.

2.Review the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step

Prior to determining whether the disclosure satisfies the written description requirement for the claimed subject matter, the examiner should review the claims and the entire specification, including the specific embodiments, figures, and sequence listings, to understand how applicant provides support for the various features of the claimed invention. An element may be critical where those of skill in the art would require it to determine that applicant was in possession of the invention. Compare Rasmussen, 650 F.2d at 1215, 211 USPQ at 327 (“one skilled in the art who read Rasmussen’s specification would understand that it is unimportant how the layers are adhered, so long as they are adhered”) (emphasis in original), with Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (“it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it”). The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention. Such a review is conducted from the standpoint of one of skill in the art at the time the application was filed (see, e.g., Wang Labs. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. Generally, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379- 80, 231 USPQ 81, 90 (Fed. Cir. 1986).

3.Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Applicant was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed

(a) Original claims

Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that applicant had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000) (the written description “inquiry is a factual one and must be assessed on a case-by-case basis”); see also Pfaff v. Wells Electronics, Inc., 55 U.S. at 66, 119 S.Ct. at 311, 48 USPQ2d at 1646 (“The word ‘invention’ must refer to a concept that is complete, rather than merely one that is ‘substantially complete.’ It is true that reduction to practice ordinarily provides the best evidence that an invention is complete. But just because reduction to practice is sufficient evidence of completion, it does not follow that proof of reduction to practice is necessary in every case. Indeed, both the facts of the Telephone Cases and the facts of this case demonstrate that one can prove that an invention is complete and ready for patenting before it has actually been reduced to practice.”).

A specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) (“[T]here cannot be a reduction to practice of the invention without a physical embodiment which includes all limitations of the claim.”); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) (“[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose.”); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves). Description of an actual reduction to practice of a biological material may be shown by specifically describing a deposit made in accordance with the requirements of 37 CFR 1.801 et seq. See especially 37 CFR 1.804 and 1.809. See also paragraph I., supra.

An applicant may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118 (“drawings alone may provide a ‘written description’ of an invention as required by Sec. 112”); In re Wolfensperger, 302 F.2d 950, 133 USPQ 537 (CCPA 1962) (the drawings of applicant’s specification provided sufficient written descriptive support for the claim limitation at issue); Autogiro Co. of America v. United States, 384 F.2d 391, 398, 155 USPQ 697, 703 (Ct. Cl. 1967) (“In those instances where a visual representation can flesh out words, drawings may be used in the same manner and with the same limitations as the specification.”); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.”). The description need only describe in detail that which is new or not conventional. See Hybritech v. Monoclonal Antibodies, 802 F.2d at 1384, 231 USPQ at 94; Fonar Corp. v. General Electric Co., 107 F.3d at 1549, 41 USPQ2d at 1805 (source code description not required). This is equally true whether the claimed invention is directed to a product or a process.

An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613. For example, the presence of a restriction enzyme map of a gene may be relevant to a statement that the gene has been isolated. One skilled in the art may be able to determine whether the gene disclosed is the same as or different from a gene isolated by another by comparing the restriction enzyme maps. In contrast, evidence that the gene could be digested with a nuclease would not normally represent a relevant characteristic since any gene would be digested with a nuclease. Similarly, isolation of an mRNA and its expression to produce the protein of interest is strong evidence of possession of an mRNA for the protein.

For some biomolecules, examples of identifying characteristics include a sequence, structure, binding affinity, binding specificity, molecular weight, and length. Although structural formulas provide a convenient method of demonstrating possession of specific molecules, other identifying characteristics or combinations of characteristics may demonstrate the requisite possession. As explained by the Federal Circuit, “(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met … even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure.” Falkner v. Inglis, 448 F.3d 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 2006). See also Capon v. Eshhar, 418 F.3d at 1358, 76 USPQ2d at 1084 (“The Board erred in holding that the specifications do not meet the written description requirement because they do not reiterate the structure or formula or chemical name for the nucleotide sequences of the claimed chimeric genes” where the genes were novel combinations of known DNA segments.). For example, disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository provides an adequate written description of an antibody claimed by its binding affinity to that antigen. Noelle v. Lederman, 355 F.3d 1343, 1349, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (holding there is a lack of written descriptive support for an antibody defined by its binding affinity to an antigen that itself was not adequately described). Additionally, unique cleavage by particular enzymes, isoelectric points of fragments, detailed restriction enzyme maps, a comparison of enzymatic activities, or antibody cross-reactivity may be sufficient to show possession of the claimed invention to one of skill in the art. See Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966 (“written description” requirement may be satisfied by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention”). A definition by function alone “does not suffice” to sufficiently describe a coding sequence “because it is only an indication of what the gene does, rather than what it is.” Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d at 1169- 71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”).

If a claim limitation invokes 35 U.S.C. 112, para. 6, it must be interpreted to cover the corresponding structure, materials, or acts in the specification and “equivalents thereof.” See 35 U.S.C. 112, para. 6. See also B. Braun Medical, Inc. v. Abbott Lab., 124 F.3d 1419, 1424, 43 USPQ2d 1896, 1899 (Fed. Cir. 1997). In considering whether there is 35 U.S.C. 112, para. 1, support for a means- (or step) plus-function claim limitation, the examiner must consider not only the original disclosure contained in the summary and detailed description of the invention portions of the specification, but also the original claims, abstract, and drawings. A means- (or step-) plus-function claim limitation is adequately described under 35 U.S.C. 112, para. 1, if: (1) The written description adequately links or associates adequately described particular structure, material, or acts to the function recited in a means- (or step-) plus-function claim limitation; or (2) it is clear based on the facts of the application that one skilled in the art would have known what structure, material, or acts perform the function recited in a means- (or step-) plus-function limitation. Note also: A rejection under 35 U.S.C. 112, para. 2, “cannot stand where there is adequate description in the specification to satisfy 35 U.S.C. 112, first paragraph, regarding means-plus-function recitations that are not, per se, challenged for being unclear.” In re Noll, 545 F.2d 141, 149, 191 USPQ 721, 727 (CCPA 1976). See Supplemental Examination Guidelines for Determining the Applicability of 35 U.S.C. 112, para. 6, 65 Fed. Reg. 38510, June 21, 2000. See also MPEP § 2181.

What is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d at 1384, 231 USPQ at 94. See also Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005)(“The ‘written description’ requirement must be applied in the context of the particular invention and the state of the knowledge…. As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution.”). If a skilled artisan would have understood the inventor to be in possession of the claimed invention at the time of filing, even if every nuance of the claims is not explicitly described in the specification, then the adequate description requirement is met. See, e.g., Vas-Cath, 935 F.2d at 1563, 19 USPQ2d at 1116; Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ 391, 395 (CCPA 1972) (stating “the description need not be in ipsis verbis [i.e., “in the same words”] to be sufficient”).

A claim which is limited to a single disclosed embodiment or species is analyzed as a claim drawn to a single embodiment or species, whereas a claim which encompasses two or more embodiments or species within the scope of the claim is analyzed as a claim drawn to a genus. See also MPEP § 806.04(e).

i)For Each Claim Drawn to a Single Embodiment Or Species:

(A)Determine whether the application describes an actual reduction to practice of the claimed invention.

(B)If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole.

(C)If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention.

(1)Determine whether the application as filed describes the complete structure (or acts of a process) of the claimed invention as a whole. The complete structure of a species or embodiment typically satisfies the requirement that the description be set forth “in such full, clear, concise, and exact terms” to show possession of the claimed invention. 35 U.S.C. 112, para. 1. Cf. Fields v. Conover, 443 F.2d 1386, 1392, 170 USPQ 276, 280 (CCPA 1971) (finding a lack of written description because the specification lacked the “full, clear, concise, and exact written description” which is necessary to support the claimed invention). If a complete structure is disclosed, the written description requirement is satisfied for that species or embodiment, and a rejection under 35 U.S.C. 112, para. 1, for lack of written description must not be made.

(2)If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing “a result that one might achieve if one made that invention”); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art).

Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. The description needed to satisfy the requirements of 35 U.S.C. 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims present in the application when originally filed, even if the specification discloses only a method of making the invention and the function of the invention. See, e.g., In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) (“One skilled in the art would know how to program a microprocessor to perform the necessary steps described in the specification. Thus, an inventor is not required to describe every detail of his invention. An applicant’s disclosure obligation varies according to the art to which the invention pertains. Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out.”).

In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021. Where the process has actually been used to produce the product, the written description requirement for a product-by-process claim is clearly satisfied; however, the requirement may not be satisfied where it is not clear that the acts set forth in the specification can be performed, or that the product is produced by that process. Furthermore, disclosure of a partial structure without additional characterization of the product may not be sufficient to evidence possession of the claimed invention. See, e.g., Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021 (“A gene is a chemical compound, albeit a complex one, and it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it. Conception does not occur unless one has a mental picture of the structure of the chemical, or is able to define it by its method of preparation, its physical or chemical properties, or whatever characteristics sufficiently distinguish it. It is not sufficient to define it solely by its principal biological property, e.g., encoding human erythropoietin, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. We hold that when an inventor is unable to envision the detailed constitution of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the gene has been isolated.”) (citations omitted). In such instances the alleged conception fails not merely because the field is unpredictable or because of the general uncertainty surrounding experimental sciences, but because the conception is incomplete due to factual uncertainty that undermines the specificity of the inventor’s idea of the invention. Burroughs Wellcome Co. v. Barr Laboratories Inc., 40 F.3d 1223, 1229, 32 USPQ2d 1915, 1920 (Fed. Cir. 1994). Reduction to practice in effect provides the only evidence to corroborate conception (and therefore possession) of the invention. Id.

Any claim to a species that does not meet the test described under at least one of (a), (b), or (c) must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.

ii)For each claim drawn to a genus:

The written description requirement for a claimed 

genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.

A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)(Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.) On the other hand, there may be situations where one species adequately supports a genus. See, e.g., Rasmussen, 650 F.2d at 1214, 211 USPQ at 326- 27 (disclosure of a single method of adheringly applying one layer to another was sufficient to support a generic claim to “adheringly applying” because one skilled in the art reading the specification would understand that it is unimportant how the layers are adhered, so long as they are adhered); In re Herschler, 591 F.2d 693, 697, 200 USPQ 711, 714 (CCPA 1979) (disclosure of corticosteroid in DMSO sufficient to support claims drawn to a method of using a mixture of a “physiologically active steroid” and DMSO because “use of known chemical compounds in a manner auxiliary to the invention must have a corresponding written description only so specific as to lead one having ordinary skill in the art to that class of compounds. Occasionally, a functional recitation of those known compounds in the specification may be sufficient as that description.”); In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 285 (CCPA 1973) (the phrase “air or other gas which is inert to the liquid” was sufficient to support a claim to “inert fluid media” because the description of the properties and functions of the air or other gas segmentizing medium would suggest to a person skilled in the art that appellant’s invention includes the use of “inert fluid” broadly.).

The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112“merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand applicant to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. See also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998), wherein the disclosure of a species in the parent application did not suffice to provide written description support for the genus in the child application.

What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.

(b)New Claims, Amended Claims, or Claims Asserting Entitlement to the Benefit of an Earlier Priority Date or Filing Date under 35 U.S.C. 119, 120, or 365(c)

The examiner has the initial burden of presenting evidence or reasoning to explain why persons skilled in the art would not recognize in the original disclosure a description of the invention defined by the claims. See Wertheim, 541 F.2d at 263, 191 USPQ at 97 (“[T]he PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.”). However, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP § 714.02 and § 2163.06 (“Applicant should specifically point out the support for any amendments made to the disclosure.”).

To comply with the written description requirement of 35 U.S.C. 112, para. 1, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, or 365(c), each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure. When an explicit limitation in a claim “is not present in the written description whose benefit is sought it must be shown that a person of ordinary skill would have understood, at the time the patent application was filed, that the description requires that limitation.” Hyatt v. Boone, 146 F.3d 1348, 1353, 47 USPQ2d 1128, 1131 (Fed. Cir. 1998). See also In re Wright, 866 F.2d 422, 425, 9 USPQ2d 1649, 1651 (Fed. Cir. 1989) (Original specification for method of forming images using photosensitive microcapsules which describes removal of microcapsules from surface and warns that capsules not be disturbed prior to formation of image, unequivocally teaches absence of permanently fixed microcapsules and supports amended language of claims requiring that microcapsules be “not permanently fixed” to underlying surface, and therefore meets description requirement of 35 U.S.C. 112.); In re Robins, 429 F.2d 452, 456-57, 166 USPQ 552, 555 (CCPA 1970) (“[W]here no explicit description of a generic invention is to be found in the specification[,] ... mention of representative compounds may provide an implicit description upon which to base generic claim language.”); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily implicitly described by a genus encompassing it and a species upon which it reads); In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed. Cir. 1999) (“To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’”) (citations omitted). Furthermore, each claim must include all elements which applicant has described as essential. See, e.g., Johnson Worldwide Associates Inc. v. Zebco Corp., 175 F.3d at 993, 50 USPQ2d at 1613; Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d at 1479, 45 USPQ2d at 1503; Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833.

If the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description, or in the case of a claim for priority under 35 U.S.C. 119, 120, or 365(c), the claim for priority must be denied.

III.COMPLETE PATENTABILITY DETER- MINATION UNDER ALL STATUTORY REQUIREMENTS AND CLEARLY COMMUNICATE FINDINGS, CONCLUSIONS, AND THEIR BASES

The above only describes how to determine whether the written description requirement of 35 U.S.C. 112, para. 1, is satisfied. Regardless of the outcome of that determination, Office personnel must complete the patentability determination under all the relevant statutory provisions of title 35 of the U.S. Code.

Once Office personnel have concluded analysis of the claimed invention under all the statutory provisions, including 35 U.S.C. 101, 112, 102, and 103, they should review all the proposed rejections and their bases to confirm their correctness. Only then should any rejection be imposed in an Office action. The Office action should clearly communicate the findings, conclusions, and reasons which support them. When possible, the Office action should offer helpful suggestions on how to overcome rejections.

A.For Each Claim Lacking Written Description Support, Reject the Claim Under 35 U.S.C. 112, para. 1, for Lack of Adequate Written Description

A description as filed is presumed to be adequate, unless or until sufficient evidence or reasoning to the contrary has been presented by the examiner to rebut the presumption. See, e.g., In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). The examiner, therefore, must have a reasonable basis to challenge the adequacy of the written description. The examiner has the initial burden of presenting by a preponderance of evidence why a person skilled in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. Wertheim, 541 F.2d at 263, 191 USPQ at 97. In rejecting a claim, the examiner must set forth express findings of fact regarding the above analysis which support the lack of written description conclusion. These findings should:

(A)Identify the claim limitation at issue; and

(B)Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. A general allegation of “unpredictability in the art” is not a sufficient reason to support a rejection for lack of adequate written description.

When appropriate, suggest amendments to the claims which can be supported by the application’s written description, being mindful of the prohibition against the addition of new matter in the claims or description. See Rasmussen, 650 F.2d at 1214, 211 USPQ at 326.

B.Upon Reply by Applicant, Again Determine the Patentability of the Claimed Invention, Including Whether the Written Description Requirement Is Satisfied by Reperforming the Analysis Described Above in View of the Whole Record

Upon reply by applicant, before repeating any 

rejection under 35 U.S.C. 112, para. 1, for lack of written description, review the basis for the rejection in view of the record as a whole, including amendments, arguments, and any evidence submitted by applicant. If the whole record now demonstrates that the written description requirement is satisfied, do not repeat the rejection in the next Office action. If the record still does not demonstrate that the written description is adequate to support the claim(s), repeat the rejection under 35 U.S.C. 112, para. 1, fully respond to applicant’s rebuttal arguments, and properly treat any further showings submitted by applicant in the reply. When a rejection is maintained, any affidavits relevant to the 112, para. 1, written description requirement, must be thoroughly analyzed and discussed in the next Office action. See In re Alton, 76 F.3d 1168, 1176, 37 USPQ2d 1578, 1584 (Fed. Cir. 1996).

2163.01Support for the Claimed SubjectMatter in Disclosure

A written description requirement issue generally involves the question of whether the subject matter of a claim is supported by [conforms to] the disclosure of an application as filed. If the examiner concludes that the claimed subject matter is not supported [described] in an application as filed, this would result in a rejection of the claim on the ground of a lack of written description under 35 U.S.C. 112, first paragraph or denial of the benefit of the filing date of a previously filed application. The claim should not be rejected or objected to on the ground of new matter. As framed by the court in In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981), the concept of new matter is properly employed as a basis for objection to amendments to the abstract, specification or drawings attempting to add new disclosure to that originally presented. While the test or analysis of description requirement and new matter issues is the same, the examining procedure and statutory basis for addressing these issues differ. See MPEP § 2163.06.

2163.02 Standard for Determining Compliance With the Written Description Requirement[edit | edit source]

The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far- Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).

Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it”).

The subject matter of the claim need not be described literally (i.e., using the same terms or in haec verba) in order for the disclosure to satisfy the description requirement. If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. This conclusion will result in the rejection of the claims affected under 35 U.S.C.112, first paragraph - description requirement, or denial of the benefit of the filing date of a previously filed application, as appropriate.

See MPEP § 2163 for examination guidelines pertaining to the written description requirement.

2163.03 Typical Circumstances Where Adequate Written Description Issue Arises[edit | edit source]

A description requirement issue can arise in a number of different circumstances where it must be determined whether the subject matter of a claim is supported in an application as filed. See MPEP § 2163for examination guidelines pertaining to the written description requirement. While a question as to whether a specification provides an adequate written description may arise in the context of an original claim which is not described sufficiently (see, e.g., Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997)), there is a strong presumption that an adequate written description of the claimed invention is present in the specification as filed. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976). Consequently, rejection of an original claim for lack of written description should be rare. Most typically, the issue will arise in the following circumstances:

I.AMENDMENT AFFECTING A CLAIM

An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). An amendment to the specification (e.g., a change in the definition of a term used both in the specification and claim) may indirectly affect a claim even though no actual amendment is made to the claim.

II.RELIANCE ON FILING DATE OF PARENT APPLICATION UNDER 35 U.S.C. 120

Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112, first paragraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In reScheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978).

III.RELIANCE ON PRIORITY UNDER 35 U.S.C. 119

Under 35 U.S.C. 119 (a) or (e), the claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112, first paragraph. In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).

IV.SUPPORT FOR A CLAIM CORRESPONDING TO A COUNT IN AN INTERFERENCE

In an interference proceeding, the claim corresponding to a count must be supported by the specification in the manner provided by 35 U.S.C. 112, first paragraph. Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971) (A broad generic disclosure to a class of compounds was not a sufficient written description of a specific compound within the class.). Furthermore, when a party to an interference seeks the benefit of an earlier-filed U.S. patent application, the earlier application must meet the requirements of 35 U.S.C. 112, first paragraph for the subject matter of the count. Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, 1130 (Fed. Cir. 1998).

2163.04 Burden on the Examiner with Regard to the Written Description Requirement[edit | edit source]

The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976). A description as filed is presumed to be adequate, unless or until sufficient evidence or reasoning to the contrary has been presented by the examiner to rebut the presumption. See, e.g., In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). The examiner, therefore, must have a reasonable basis to challenge the adequacy of the written description. The examiner has the initial burden of presenting by a preponderance of evidence why a person skilled in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. Wertheim, 541 F.2d at 263, 191 USPQ at 97.

I.STATEMENT OF REJECTION REQUIREMENTS

In rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion (see MPEP § 2163 for examination guidelines pertaining to the written description requirement). These findings should:

(A)Identify the claim limitation at issue; and

(B)Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. A general allegation of “unpredictability in the art” is not a sufficient reason to support a rejection for lack of adequate written description. A simple statement such as “Applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘____’ in the application as filed.” may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported.

When appropriate, suggest amendments to the claims which can be supported by the application’s written description, being mindful of the prohibition against the addition of new matter in the claims or description. See Rasmussen, 650 F.2d at 1214, 211 USPQ at 326.

II.RESPONSE TO APPLICANT’S REPLY

Upon reply by applicant, before repeating any rejection under 35 U.S.C. 112, para. 1, for lack of written description, review the basis for the rejection in view of the record as a whole, including amendments, arguments, and any evidence submitted by applicant. If the whole record now demonstrates that the written description requirement is satisfied, do not repeat the rejection in the next Office action. If the record still does not demonstrate that the written description is adequate to support the claim(s), repeat the rejection under 35 U.S.C. 112, para. 1, fully respond to applicant’s rebuttal arguments, and properly treat any further showings submitted by applicant in the reply. When a rejection is maintained, any affidavits relevant to the 35 U.S.C. 112, para. 1, written description requirement, must be thoroughly analyzed and discussed in the next Office action. See In re Alton, 76 F.3d 1168, 1176, 37 USPQ2d 1578, 1584 (Fed. Cir. 1996).

2163.05 Changes to the Scope of Claims[edit | edit source]

The failure to meet the written description requirement of 35 U.S.C. 112, first paragraph, commonly arises when the claims are changed after filing to either broaden or narrow the breadth of the claim limitations, or to alter a numerical range limitation or to use claim language which is not synonymous with the terminology used in the original disclosure. To comply with the written description requirement of 35 U.S.C. 112, para. 1, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, or 365(c), each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure. See MPEP § 2163 for examination guidelines pertaining to the written description requirement.

I.BROADENING CLAIM

Omission of a Limitation

Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor had possession of a broader, more generic invention. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998) (claims to a sectional sofa comprising, inter alia, a console and a control means were held invalid for failing to satisfy the written description requirement where the claims were broadened by removing the location of the control means.); Johnson Worldwide Associates v. Zebco Corp., 175 F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (In Gentry Gallery, the “court’s determination that the patent disclosure did not support a broad meaning for the disputed claim terms was premised on clear statements in the written description that described the location of a claim element--the ‘control means’--as ‘the only possible location’ and that variations were ‘outside the stated purpose of the invention.’ Gentry Gallery, 134 F.3d at 1479, 45 USPQ2d at 1503. Gentry Gallery, then, considers the situation where the patent’s disclosure makes crystal clear that a particular (i.e., narrow) understanding of a claim term is an ‘essential element of [the inventor’s] invention.’”); Tronzo v. Biomet, 156 F.3d at 1158-59, 47 USPQ2d at 1833 (Fed. Cir. 1998) (claims to generic cup shape were not entitled to filing date of parent application which disclosed “conical cup” in view of the disclosure of the parent application stating the advantages and importance of the conical shape.); In re Wilder, 736 F.2d 1516, 222 USPQ 369 (Fed. Cir. 1984) (reissue claim omitting “in synchronism” limitation with respect to scanning means and indexing means was not supported by the original patent’s disclosure in such a way as to indicate possession, as of the original filing date, of that generic invention.).

A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 (CCPA 1962) (“[O]ne skilled in this art would not be taught by the written description of the invention in the specification that any ‘aryl or substituted aryl radical’ would be suitable for the purposes of the invention but rather that only certain aryl radicals and certain specifically substituted aryl radicals [i.e., aryl azides] would be suitable for such purposes.”) (emphasis in original). Compare In re Peters, 723 F.2d 891, 221 USPQ 952 (Fed. Cir. 1983) (In a reissue application, a claim to a display device was broadened by removing the limitations directed to the specific tapered shape of the tips without violating the written description requirement. The shape limitation was considered to be unnecessary since the specification, as filed, did not describe the tapered shape as essential or critical to the operation or patentability of the claim.). A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may also be subject to rejection under 35 U.S.C. 112, para. 1, as not enabling, or under 35 U.S.C. 112, para. 2. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976); and In re Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA 1968). See also MPEP § 2172.01.

Addition of Generic Claim

The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.) On the other hand, there may be situations where one species adequately supports a genus. See, e.g., In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326-27 (CCPA 1981) (disclosure of a single method of adheringly applying one layer to another was sufficient to support a generic claim to “adheringly applying” because one skilled in the art reading the specification would understand that it is unimportant how the layers are adhered, so long as they are adhered); In re Herschler, 591 F.2d 693, 697, 200 USPQ 711, 714 (CCPA 1979) (disclosure of corticosteriod in DMSO sufficient to support claims drawn to a method of using a mixture of a “physiologically active steroid” and DMSO because “use of known chemical compounds in a manner auxiliary to the invention must have a corresponding written description only so specific as to lead one having ordinary skill in the art to that class of compounds. Occasionally, a functional recitation of those known compounds in the specification may be sufficient as that description.”); In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 285 (CCPA 1973) (the phrase “air or other gas which is inert to the liquid” was sufficient to support a claim to “inert fluid media” because the description of the properties and functions of the air or other gas segmentizing medium would suggest to a person skilled in the art that appellant’s invention



includes the use of “inert fluid” broadly.). However, in Tronzo v. Biomet, 156 F.3d 1154, 1159, 47 USPQ2d 1829, 1833 (Fed. Cir. 1998), the disclosure of a species in the parent application did not suffice to provide written description support for the genus in the child application. Similarly, see In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989) (generic and subgeneric claims in the U.S. application were not entitled to the benefit of foreign priority where the foreign application disclosed only two of the species encompassed by the broad generic claim and the subgeneric Markush claim that encompassed 21 compounds).

II.NARROWING OR SUBGENERIC CLAIM

The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-propylamine had been used in making the compound instead of n-butylamine, the compound of claim 13 would have resulted. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.”) (emphasis in original). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), the Board affirmed the rejection under 35 U.S.C. 112, first paragraph, of claims to an internal combustion engine which recited “at least one of said piston and said cylinder (head) having a recessed channel.” The Board held that the application which disclosed a cylinder head with a recessed channel and a piston without a recessed channel did not specifically disclose the “species” of a channeled piston.

While these and other cases find that recitation of an undisclosed species may violate the description requirement, a change involving subgeneric terminology may or may not be acceptable. Applicant was not entitled to the benefit of a parent filing date when the claim was directed to a subgenus (a specified range of molecular weight ratios) where the parent application contained a generic disclosure and a specific example that fell within the recited range because the court held that subgenus range was not described in the parent application. In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971). On the other hand, in Ex parte Sorenson, 3 USPQ2d 1462 (Bd. Pat. App. & Inter. 1987), the subgeneric language of “aliphatic carboxylic acid” and “aryl carboxylic acid” did not violate the written description requirement because species falling within each subgenus were disclosed as well as the generic carboxylic acid. See also In reSmith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (“Whatever may be the viability of an inductive-deductive approach to arriving at a claimed subgenus, it cannot be said that such a subgenus is necessarily described by a genus encompassing it and a species upon which it reads.” (emphasis added)). Each case must be decided on its own facts in terms of what is reasonably communicated to those skilled in the art. In re Wilder, 736 F.2d 1516, 1520, 222 USPQ 369, 372 (Fed. Cir. 1984).

III.RANGE LIMITATIONS

With respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of “25%- 60%” and specific examples of “36%” and “50%.” A corresponding new claim limitation to “at least 35%” did not meet the description requirement because the phrase “at least” had no upper limit and caused the claim to read literally on embodiments outside the “25% to 60%” range, however a limitation to “between 35% and 60%” did meet the description requirement.

See also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000) (“[T]he specification does not clearly disclose to the skilled artisan that the inventors... considered the... ratio to be part of their invention.... There is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion”). Compare Union Oil of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 997, 54 USPQ2d 1227, 1232-33 (Fed. Cir. 2000) (Description in terms of ranges of chemical properties which work in combination with ranges of other chemical properties to produce an automotive gasoline that reduces emissions was found to provide an adequate written description even though the exact chemical components of each combination were not disclosed and the specification did not disclose any distinct embodiments corresponding to any claim at issue. “[T]he Patent Act and this court’s case law require only sufficient description to show one of skill in the . . . art that the inventor possessed the claimed invention at the time of filing.”).

2163.06 Relationship of Written Description Requirement to New Matter[edit | edit source]

Lack of written description is an issue that generally arises with respect to the subject matter of a claim. If an applicant amends or attempts to amend the abstract, specification or drawings of an application, an issue of new matter will arise if the content of the amendment is not described in the application as filed. Stated another way, information contained in any one of the specification, claims or drawings of the application as filed may be added to any other part of the application without introducing new matter.

There are two statutory provisions that prohibit the introduction of new matter: 35 U.S.C. 132 - No amendment shall introduce new matter into the disclosure of the invention; and, similarly providing for a reissue application, 35 U.S.C. 251 - No new matter shall be introduced into the application for reissue.

I.TREATMENT OF NEW MATTER

If new subject matter is added to the disclosure, whether it be in the abstract, the specification, or the drawings, the examiner should object to the introduction of new matter under 35 U.S.C. 132 or 251 as appropriate, and require applicant to cancel the new matter. If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). The examiner should still consider the subject matter added to the claim in making rejections based on prior art since the new matter rejection may be overcome by applicant.

In an instance in which the claims have not been amended, per se, but the specification has been amended to add new matter, a rejection of the claims under 35 U.S.C. 112, first paragraph should be made whenever any of the claim limitations are affected by the added material.

When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure.

II.REVIEW OF NEW MATTER OBJEC- TIONS AND/OR REJECTIONS

A rejection of claims is reviewable by the Board of Patent Appeals and Interferences, whereas an objection and requirement to delete new matter is subject to supervisory review by petition under 37 CFR 1.181. If both the claims and specification contain new matter either directly or indirectly, and there has been both a rejection and objection by the examiner, the issue becomes appealable and should not be decided by petition.

III.CLAIMED SUBJECT MATTER NOT DISCLOSED IN REMAINDER OF SPECIFICATION


The claims as filed in the original specification are part of the disclosure and therefore, if an application as originally filed contains a claim disclosing material not disclosed in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985). Form Paragraph 7.44 may be used where originally claimed subject matter lacks proper antecedent basis in the specification. See MPEP § 608.01(o).

2163.07 Amendments to Application Which Are Supported in the Original Description[edit | edit source]

Amendments to an application which are supported in the original description are NOT new matter.

I.REPHRASING

Mere rephrasing of a passage does not constitute new matter. Accordingly, a rewording of a passage where the same meaning remains intact is permissible. In re Anderson, 471 F.2d 1237, 176 USPQ 331 (CCPA 1973). The mere inclusion of dictionary or art recognized definitions known at the time of filing an application would not be considered new matter. If there are multiple definitions for a term and a definition is added to the application, it must be clear from the application as filed that applicant intended a particular definition, in order to avoid an issue of new matter and/or lack of written description. See, e.g., Scarring Corp. v. Megan, Inc., 222 F.3d 1347, 1352-53, 55 USPQ2d 1650, 1654 (Fed. Cir. 2000). In Scarring, the original disclosure drawn to recombinant DNA molecules utilized the term “leukocyte interferon.” Shortly after the filing date, a scientific committee abolished the term in favor of “IFN- (a),” since the latter term more specifically identified a particular polypeptide and since the committee found that leukocytes also produced other types of interferon. The court held that the subsequent amendment to the specification and claims substituting the term “IFN-(a)” for “leukocyte interferon” merely renamed the invention and did not constitute new matter. The claims were limited to cover only the interferon subtype coded for by the inventor’s original deposits.

II.OBVIOUS ERRORS

An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of error in the specification, but also the appropriate correction. In reOdd, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).

Where a foreign priority document under 35 U.S.C. 119 is of record in the U.S. application file, applicant may not rely on the disclosure of that document to support correction of an error in the pending U.S. application. Ex parte Bandeau, 132 USPQ 356 (Bd. App. 1961). This prohibition applies regardless of the language of the foreign priority documents because a claim for priority is simply a claim for the benefit of an earlier filing date for subject matter that is common to two or more applications, and does not serve to incorporate the content of the priority document in the application in which the claim for priority is made. This prohibition does not apply where the U.S. application explicitly incorporates the foreign priority document by reference. For applications filed on or after September 21, 2004, where all or a portion of the specification or drawing(s) is inadvertently omitted from the U.S. application, a claim under 37 CFR 1.55for priority of a prior-filed foreign application that is present on the filing date of the application is considered an incorporation by reference of the prior-filed foreign application as to the inadvertently omitted portion of the specification or drawing(s), subject to the conditions and requirements of 37 CFR 1.57(a). See 37 CFR 1.57(a) and MPEP § 201.17.

Where a U.S. application as originally filed was in a non-English language and an English translation thereof was subsequently submitted pursuant to 37 CFR 1.52(d), if there is an error in the English translation, applicant may rely on the disclosure of the originally filed non-English language U.S. application to support correction of an error in the English translation document.

2163.07(a) Inherent Function, Theory, orAdvantage[edit | edit source]

By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it. The application may later be amended to recite the function, theory or advantage without introducing prohibited new matter. In re Reynolds, 443 F.2d 384, 170 USPQ 94 (CCPA 1971); In re Smythe, 480 F. 2d 1376, 178 USPQ 279 (CCPA 1973). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’” In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed. Cir. 1999) (citations omitted).

2163.07(b) Incorporation by Reference[edit | edit source]

Instead of repeating some information contained in another document, an application may attempt to incorporate the content of another document or part thereof by reference to the document in the text of the specification. The information incorporated is as much a part of the application as filed as if the text was repeated in the application, and should be treated as part of the text of the application as filed. Replacing the identified material incorporated by reference with the actual text is not new matter. See 37 CFR 1.57 and MPEP § 608.01(p) for Office policy regarding incorporation by reference. See MPEP § 2181 for the impact of incorporation by reference on the determination of whether applicant has complied with the requirements of 35 U.S.C. 112, second paragraph when 35 U.S.C. 112, sixth paragraph is invoked.



2164 The Enablement Requirement[edit | edit source]

The enablement requirement refers to the requirement of 35 U.S.C. 112, first paragraph that the specification describe how to make and how to use the invention. The invention that one skilled in the art must be enabled to make and use is that defined by the claim(s) of the particular application or patent.

The purpose of the requirement that the specification describe the invention in such terms that one skilled in the art can make and use the claimed invention is to ensure that the invention is communicated to the interested public in a meaningful way. The information contained in the disclosure of an application must be sufficient to inform those skilled in the relevant art how to both make and use the claimed invention. However, to comply with 35 U.S.C. 112, first paragraph, it is not necessary to "enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect."

Detailed procedures for making and using the invention may not be necessary if the description of the invention itself is sufficient to permit those skilled in the art to make and use the invention. A patent claim is invalid if it is not supported by an enabling disclosure.

The enablement requirement of 35 U.S.C. 112, first paragraph, is separate and distinct from the description requirement. Therefore, the fact that an additional limitation to a claim may lack descriptive support in the disclosure as originally filed does not necessarily mean that the limitation is also not enabled. In other words, the statement of a new limitation in and of itself may enable one skilled in the art to make and use the claim containing that limitation even though that limitation may not be described in the original disclosure. Consequently, such limitations must be analyzed for both enablement and description using their separate and distinct criteria.

Furthermore, when the subject matter is not in the specification portion of the application as filed but is in the claims, the limitation in and of itself may enable one skilled in the art to make and use the claim containing the limitation. When claimed subject matter is only presented in the claims and not in the specification portion of the application, the specification should be objected to for lacking the requisite support for the claimed subject matter. This is an objection to the specification only and enablement issues should be treated separately.

2164.01 Test of Enablement[edit | edit source]

Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.

  • The standard for determining whether the specification meets the enablement requirement:
    • is the experimentation needed to practice the invention undue or unreasonable?
  • A patent need not teach, and preferably omits, what is well known in the art.
  • Any part of the specification can support an enabling disclosure, even a background section that discusses, or even disparages, the subject matter disclosed therein.

UNDUE EXPERIMENTATION

  • The fact that experimentation may be complex does not necessarily make it undue, if the art typically engages in such experimentation.
  • The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.

2164.01(a) Undue Experimentation Factors[edit | edit source]

Factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:

  • The breadth of the claims;
  • The nature of the invention;
  • The state of the prior art;
  • The level of one of ordinary skill;
  • The level of predictability in the art;
  • The amount of direction provided by the inventor;
  • The existence of working examples; and
  • The quantity of experimentation needed to make or use the invention based on the content of the disclosure.

It is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others. The examiner’s analysis must consider all the evidence related to each of these factors, and any conclusion of nonenablement must be based on the evidence as a whole.

A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.

The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.

2164.01(b) How to Make the Claimed Invention[edit | edit source]

As long as the specification discloses at least one method for making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of 35 U.S.C. 112 is satisfied.

Failure to disclose other methods by which the claimed invention may be made does not render a claim invalid under 35 U.S.C. 112.

Naturally, for unstable and transitory chemical intermediates, the "how to make' requirement does not require that the applicant teach how to make the claimed product in stable, permanent or isolatable form.

A key issue that can arise when determining whether the specification is enabling is whether the starting materials or apparatus necessary to make the invention are available. In the biotechnical area, this is often true when the product or process requires a particular strain of microorganism and when the microorganism is available only after extensive screening.

If the practice of a method requires a particular apparatus, the application must provide a sufficient disclosure of the apparatus if the apparatus is not readily available. The same can be said if certain chemicals are required to make a compound or practice a chemical process.

2164.01(c) How to Use the Claimed Invention[edit | edit source]

If a statement of utility in the specification contains within it a connotation of how to use, and/or the art recognizes that standard modes of administration are known and contemplated, 35 U.S.C. 112 is satisfied.

For example, it is not necessary to specify the dosage or method of use if it is known to one skilled in the art that such information could be obtained without undue experimentation. If one skilled in the art, based on knowledge of compounds having similar physiological or biological activity, would be able to discern an appropriate dosage or method of use without undue experimentation, this would be sufficient to satisfy 35 U.S.C. 112, first paragraph.

When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.

In contrast, when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use. If multiple uses for claimed compounds or compositions are disclosed in the application, then an enablement rejection must include an explanation, sufficiently supported by the evidence, why the specification fails to enable each disclosed use. In other words, if any use is enabled when multiple uses are disclosed, the application is enabling for the claimed invention.

2164.02 Working Example[edit | edit source]

Compliance with the enablement requirement of 35 U.S.C. 112, first paragraph, does not turn on whether an example is disclosed. An example may be "working" or "prophetic." A working example is based on work actually performed. A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved.

An applicant need not have actually reduced the invention to practice prior to filing.

The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation.

Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. But because only an enabling disclosure is required, applicant need not describe all actual embodiments.

NONE OR ONE WORKING EXAMPLE

When considering the factors relating to a determination of non-enablement, if all the other factors point toward enablement, then the absence of working examples will not by itself render the invention non- enabled. In other words, lack of working examples or lack of evidence that the claimed invention works as described should never be the sole reason for rejecting the claimed invention on the grounds of lack of enablement. A single working example in the specification for a claimed invention is enough to preclude a rejection which states that nothing is enabled since at least that embodiment would be enabled. However, a rejection stating that enablement is limited to a particular scope may be appropriate.

The presence of only one working example should never be the sole reason for rejecting claims as being broader than the enabling disclosure, even though it is a factor to be considered along with all the other factors. To make a valid rejection, one must evaluate all the facts and evidence and state why one would not expect to be able to extrapolate that one example across the entire scope of the claims.

WORKING EXAMPLES AND A CLAIMED GENUS

For a claimed genus, representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art (in view of level of skill, state of the art and the information in the specification) would expect the claimed genus could be used in that manner without undue experimentation. Proof of enablement will be required for other members of the claimed genus only where adequate reasons are advanced by the examiner to establish that a person skilled in the art could not use the genus as a whole without undue experimentation.

2164.03Relationship of Predictability of the Art and the Enablement Requirement[edit | edit source]

The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with a ‘specific and useful teaching.’ The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.” (citations omitted)).

The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. In particular, the court in In re Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971), stated:

[I]n the field of chemistry generally, there may be times when the well-known unpredictability of chemical reactions will alone be enough to create a reasonable doubt as to the accuracy of a particular broad statement put forward as enabling support for a claim. This will especially be the case where the statement is, on its face, contrary to generally accepted scientific principles. Most often, additional factors, such as the teachings in pertinent references, will be available to substantiate any doubts that the asserted scope of objective enablement is in fact commensurate with the scope of protection sought and to support any demands based thereon for proof. [Footnote omitted.]

The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to



support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.

2164.04Burden on the Examiner Under the Enablement Requirement [R-1] [R-1]

Before any analysis of enablement can occur, it is necessary for the examiner to construe the claims. For terms that are not well-known in the art, or for terms that could have more than one meaning, it is necessary that the examiner select the definition that he/she intends to use when examining the application, based on his/her understanding of what applicant intends it to mean, and explicitly set forth the meaning of the term and the scope of the claim when writing an Office action. See Genentech v. Wellcome Foundation, 29 F.3d 1555, 1563-64, 31 USPQ2d 1161, 1167- 68 (Fed. Cir. 1994).

In order to make a rejection, the examiner has the initial burden to establish a reasonable basis to question the enablement provided for the claimed invention. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993) (examiner must provide a reasonable explanation as to why the scope of protection provided by a claim is not adequately enabled by the disclosure). A specification disclosure which contains a teaching of the manner and process of making and using an invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as being in compliance with the enablement requirement of 35 U.S.C. 112, first paragraph, unless there is a reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. Assuming that sufficient reason for such doubt exists, a rejection for failure to teach how to make and/or use will be proper on that basis. In reMarzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). As stated by the court, “it is incumbent upon the Patent Office, whenever a rejection on this basis is made, to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement. Otherwise, there would be no need for the applicant to go to the trouble and expense of supporting his presumptively accurate disclosure.” 439 F.2d at 224, 169 USPQ at 370.

According to In re Bowen, 492 F.2d 859, 862-63, 181 USPQ 48, 51 (CCPA 1974), the minimal requirement is for the examiner to give reasons for the uncertainty of the enablement. This standard is applicable even when there is no evidence in the record of operability without undue experimentation beyond the disclosed embodiments. See also In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)) (discussed in MPEP § 2164.07regarding the relationship of the enablement requirement to the utility requirement of 35 U.S.C. 101).

While the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection. The language should focus on those factors, reasons, and evidence that lead the examiner to conclude that the specification fails to teach how to make and use the claimed invention without undue experimentation, or that the scope of any enablement provided to one skilled in the art is not commensurate with the scope of protection sought by the claims. This can be done by making specific findings of fact, supported by the evidence, and then drawing conclusions based on these findings of fact. For example, doubt may arise about enablement because information is missing about one or more essential parts or relationships between parts which one skilled in the art could not develop without undue experimentation. In such a case, the examiner should specifically identify what information is missing and why one skilled in the art could not supply the information without undue experimentation. See MPEP § 2164.06(a). References should be supplied if possible to support a prima facie case of lack of enablement, but are not always required. In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971).



However, specific technical reasons are always required.

In accordance with the principles of compact prosecution, if an enablement rejection is appropriate, the first Office action on the merits should present the best case with all the relevant reasons, issues, and evidence so that all such rejections can be withdrawn if applicant provides appropriate convincing arguments and/or evidence in rebuttal. Providing the best case in the first Office action will also allow the second Office action to be made final should applicant fail to provide appropriate convincing arguments and/or evidence. Citing new references and/or expanding arguments in a second Office action could prevent that Office action from being made final. The principles of compact prosecution also dictate that if an enablement rejection is appropriate and the examiner recognizes limitations that would render the claims enabled, the examiner should note such limitations to applicant as early in the prosecution as possible.

In other words, the examiner should always look for enabled, allowable subject matter and communicate to applicant what that subject matter is at the earliest point possible in the prosecution of the application.

2164.05Determination of Enablement Based on Evidence as a Whole

Once the examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, the burden falls on applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and use the claimed invention using the application as a guide. In re Brandstadter, 484 F.2d 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973). The evidence provided by applicant need not be conclusive but merely convincing to one skilled in the art.

Applicant may submit factual affidavits under 37 CFR 1.132 or cite references to show what one skilled in the art knew at the time of filing the application. A declaration or affidavit is, itself, evidence that must be considered. The weight to give a declaration or affidavit will depend upon the amount of factual evidence the declaration or affidavit contains to support the conclusion of enablement. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991) (“expert’s opinion on the ultimate legal conclusion must be supported by something more than a conclusory statement”); cf. In re Alton, 76 F.3d 1168, 1174, 37 USPQ2d 1578, 1583 (Fed. Cir. 1996) (declarations relating to the written description requirement should have been considered).

Applicant should be encouraged to provide any evidence to demonstrate that the disclosure enables the claimed invention. In chemical and biotechnical applications, evidence actually submitted to the FDA to obtain approval for clinical trials may be submitted. However, considerations made by the FDA for approving clinical trials are different from those made by the PTO in determining whether a claim is enabled. See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. 1994) (“Testing for full safety and effectiveness of a prosthetic device is more properly left to the [FDA].”). Once that evidence is submitted, it must be weighed with all other evidence according to the standards set forth above so as to reach a determination as to whether the disclosure enables the claimed invention.

To overcome a prima facie case of lack of enablement, applicant must demonstrate by argument and/or evidence that the disclosure, as filed, would have enabled the claimed invention for one skilled in the art at the time of filing. This does not preclude applicant from providing a declaration after the filing date which demonstrates that the claimed invention works. However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope; i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must bear a reasonable correlation to the scope of the claimed invention.

The examiner must then weigh all the evidence before him or her, including the specification and any new evidence supplied by applicant with the evidence and/or sound scientific reasoning previously presented in the rejection and decide whether the claimed invention is enabled. The examiner should nevermake the determination based on personal opinion. The determination should always be based on the weight of all the evidence.



2164.05(a)Specification Must Be Enabling as of the Filing Date [R-2]

Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The initial inquiry is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains. The nature of the invention becomes the backdrop to determine the state of the art and the level of skill possessed by one skilled in the art.

The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b).

The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.

The state of the art for a given technology is not static in time. It is entirely possible that a disclosure filed on January 2, 1990, would not have been enabled. However, if the same disclosure had been filed on January 2, 1996, it might have enabled the claims. Therefore, the state of the prior art must be evaluated for each application based on its filing date.

35 U.S.C. 112 requires the specification to be enabling only to a person “skilled in the art to which it pertains, or with which it is most nearly connected.” In general, the pertinent art should be defined in terms of the problem to be solved rather than in terms of the technology area, industry, trade, etc. for which the invention is used.

The specification need not disclose what is well- known to those skilled in the art and preferably omits that which is well-known to those skilled and already available to the public. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984).

The state of the art existing at the filing date of the application is used to determine whether a particular disclosure is enabling as of the filing date. Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004) (“a patent document cannot enable technology that arises after the date of application”). Publications dated after the filing date providing information publicly first disclosed after the filing date generally cannot be used to show what was known at the time of filing. In reGunn, 537 F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA 1976); In re Budnick, 537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976) (In general, if an applicant seeks to use a patent to prove the state of the art for the purpose of the enablement requirement, the patent must have an issue date earlier than the effective filing date of the application.). While a later dated publication cannot supplement an insufficient disclosure in a prior dated application to make it enabling, applicant can offer the testimony of an expert based on the publication as evidence of the level of skill in the art at the time the application was filed. Gould v. Quigg, 822 F.2d 1074, 1077, 3 USPQ2d 1302, 1304 (Fed. Cir. 1987).

In general, the examiner should not use post-filing date references to demonstrate that the patent is non- enabling. Exceptions to this rule could occur if a later- dated reference provides evidence of what one skilled in the art would have known on or before the effective filing date of the patent application. In re Hogan, 559 F.2d 595, 605, 194 USPQ 527, 537 (CCPA 1977). If individuals of skill in the art state that a particular invention is not possible years after the filing date, that would be evidence that the disclosed invention was not possible at the time of filing and should be considered. In In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513-14 (Fed. Cir. 1993) an article published 5 years after the filing date of the application adequately supported the examiner’s position that the physiological activity of certain viruses was sufficiently unpredictable so that a person skilled in the art would not have believed that the success with one virus and one animal could be extrapolated successfully to all viruses with all living organisms. Claims



not directed to the specific virus and the specific animal were held nonenabled.

2164.05(b)Specification Must Be Enabling to Persons Skilled in the Art

The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. Where different arts are involved in the invention, the specification is enabling if it enables persons skilled in each art to carry out the aspect of the invention applicable to their specialty. In re Naquin, 398 F.2d 863, 866, 158 USPQ 317, 319 (CCPA 1968).

When an invention, in its different aspects, involves distinct arts, the specification is enabling if it enables those skilled in each art, to carry out the aspect proper to their specialty. “If two distinct technologies are relevant to an invention, then the disclosure will be adequate if a person of ordinary skill in each of the two technologies could practice the invention from the disclosures.” Technicon Instruments Corp. v. Alpkem Corp., 664 F. Supp. 1558, 1578, 2 USPQ2d 1729, 1742 (D. Ore. 1986), aff’d in part, vacated in part, rev’d in part, 837 F. 2d 1097 (Fed. Cir. 1987) (unpublished opinion), appeal after remand, 866 F. 2d 417, 9 USPQ 2d 1540 (Fed. Cir. 1989). In Ex parte Zechnall, 194 USPQ 461 (Bd. App. 1973), the Board stated “appellants’ disclosure must be held sufficient if it would enable a person skilled in the electronic computer art, in cooperation with a person skilled in the fuel injection art, to make and use appellants’ invention.” 194 USPQ at 461.

2164.06Quantity of Experimentation

The quantity of experimentation needed to be performed by one skilled in the art is only one factor involved in determining whether “undue experimentation” is required to make and use the invention. “[A]n extended period of experimentation may not be undue if the skilled artisan is given sufficient direction or guidance.” In re Colianni, 561 F.2d 220, 224, 195 USPQ 150, 153 (CCPA 1977). “ ‘The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.’” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d 489, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)). Time and expense are merely factors in this consideration and are not the controlling factors. United States v. Telectronics Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989).

In the chemical arts, the guidance and ease in carrying out an assay to achieve the claimed objectives may be an issue to be considered in determining the quantity of experimentation needed. For example, if a very difficult and time consuming assay is needed to identify a compound within the scope of a claim, then this great quantity of experimentation should be considered in the overall analysis. Time and difficulty of experiments are not determinative if they are merely routine. Quantity of examples is only one factor that must be considered before reaching the final conclusion that undue experimentation would be required. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.

I.EXAMPLE OF REASONABLE EXPERIMENTATION


In United States v. Telectronics, Inc., 857 F.2d 778, 8 USPQ2d 1217 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989), the court reversed the findings of the district court for lack of clear and convincing proof that undue experimentation was needed. The court ruled that since one embodiment (stainless steel electrodes) and the method to determine dose/ response was set forth in the specification, the specification was enabling. The question of time and expense of such studies, approximately $50,000 and 6-12 months standing alone, failed to show undue experimentation.

II.EXAMPLE OF UNREASONABLE EXPERIMENTATION


In In re Ghiron, 442 F.2d 985, 991-92, 169 USPQ 723, 727-28 (CCPA 1971), functional “block diagrams” were insufficient to enable a person skilled in the art to practice the claimed invention with only a reasonable degree of experimentation because the claimed invention required a “modification to prior art overlap computers,” and because “many of the components which appellants illustrate as rectangles in their drawing necessarily are themselves complex



assemblages . . . . It is common knowledge that many months or years elapse from the announcement of a new computer by a manufacturer before the first prototype is available. This does not bespeak of a routine operation but of extensive experimentation and development work. . . .”

2164.06(a)Examples of Enablement Issues-Missing Information [R-1] [R-1]

It is common that doubt arises about enablement because information is missing about one or more essential parts or relationships between parts which one skilled in the art could not develop without undue experimentation. In such a case, the examiner should specifically identify what information is missing and why the missing information is needed to provide enablement.

I.ELECTRICAL AND MECHANICAL DEVICES OR PROCESSES

For example, a disclosure of an electrical circuit apparatus, depicted in the drawings by block diagrams with functional labels, was held to be nonenabling in In re Gunn, 537 F.2d 1123, 1129, 190 USPQ 402, 406 (CCPA 1976). There was no indication in the specification as to whether the parts represented by boxes were “off the shelf” or must be specifically constructed or modified for applicant’s system. Also there were no details in the specification of how the parts should be interconnected, timed and controlled so as to obtain the specific operations desired by the applicant. In In re Donohue, 550 F.2d 1269, 193 USPQ 136 (CCPA 1977), the lack of enablement was caused by lack of information in the specification about a single block labelled “LOGIC” in the drawings. See also Union Pacific Resources Co. v. Chesapeake Energy Corp., 236 F.3d 684, 57 USPQ2d 1293 (Fed. Cir. 2001) (Claims directed to a method of determining the location of a horizontal borehole in the earth failed to comply with enablement requirement of 35 U.S.C. 112 because certain computer programming details used to perform claimed method were not disclosed in the specification, and the record showed that a person of skill in art would not understand how to “compare” or “rescale” data as recited in the claims in order to perform the claimed method.).

In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971), involved a method of facilitating transfers from one subset of program instructions to another which required modification of prior art “overlap mode” computers. The Board rejected the claims on the basis, inter alia, that the disclosure was insufficient to satisfy the requirements of 35 U.S.C. 112, first paragraph and was affirmed. The Board focused on the fact that the drawings were “block diagrams, i.e., a group of rectangles representing the elements of the system, functionally labelled and interconnected by lines.” 442 F.2d at 991, 169 USPQ at 727. The specification did not particularly identify each of the elements represented by the blocks or the relationship therebetween, nor did it specify particular apparatus intended to carry out each function. The Board further questioned whether the selection and assembly of the required components could be carried out routinely by persons of ordinary skill in the art.

An adequate disclosure of a device may require details of how complex components are constructed and perform the desired function. The claim before the court in In re Scarbrough, 500 F.2d 560, 182 USPQ 298 (CCPA 1974) was directed to a system which comprised several component parts (e.g., computer, timing and control mechanism, A/D converter, etc.) only by generic name and overall ultimate function. The court concluded that there was not an enabling disclosure because the specification did not describe how “complex elements known to perform broadly recited functions in different systems would be adaptable for use in Appellant’s particular system with only a reasonable amount of experimentation” and that “an unreasonable amount of work would be required to arrive at the detailed relationships appellant says that he has solved.” 500 F.2d at 566, 182 USPQ at 302.

II.MICROORGANISMS

Patent applications involving living biological products, such as microorganisms, as critical elements in the process of making the invention, present a unique question with regard to availability. The issue was raised in a case involving claims drawn to a fermentative method of producing two novel antibiotics using a specific microorganism and claims to the novel antibiotics so produced. In re Argoudelis, 434 F.2d 1390, 168 USPQ 99 (CCPA 1970). As stated



by the court, “a unique aspect of using microorganisms as starting materials is that a sufficient description of how to obtain the microorganism from nature cannot be given.” 434 F.2d at 1392, 168 USPQ at 102. It was determined by the court that availability of the biological product via a public depository provided an acceptable means of meeting the written description and the enablement requirements of 35 U.S.C. 112, first paragraph.

To satisfy the enablement requirement a deposit must be made “prior to issue” but need not be made prior to filing the application. In re Lundak, 773 F.2d 1216, 1223, 227 USPQ 90, 95 (Fed. Cir. 1985).

The availability requirement of enablement must also be considered in light of the scope or breadth of the claim limitations. The Board of Appeals considered this issue in an application which claimed a fermentative method using microorganisms belonging to a species. Applicants had identified three novel individual strains of microorganisms that were related in such a way as to establish a new species of microorganism, a species being a broader classification than a strain. The three specific strains had been appropriately deposited. The issue focused on whether the specification enabled one skilled in the art to make any member of the species other than the three strains which had been deposited. The Board concluded that the verbal description of the species was inadequate to allow a skilled artisan to make any and all members of the claimed species. Ex parte Jackson, 217 USPQ 804, 806 (Bd. App. 1982).

See MPEP § 2402 - § 2411.03 for a detailed discussion of the deposit rules. See MPEP § 2411.01 for rejections under 35 U.S.C. 112 based on deposit issues.

III.DRUG CASES

See MPEP § 2107 - § 2107.03 for a discussion of the utility requirement under 35 U.S.C. 112, first paragraph, in drug cases.

2164.06(b)Examples of Enablement Issues — Chemical Cases

The following summaries should not be relied on to support a case of lack of enablement without carefully reading the case.

SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS NONENABLING

(A)In Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 52 USPQ2d 1129 (Fed. Cir. 1999), the court held that claims in two patents directed to genetic antisense technology (which aims to control gene expression in a particular organism), were invalid because the breadth of enablement was not commensurate in scope with the claims. Both specifications disclosed applying antisense technology in regulating three genes in E. coli. Despite the limited disclosures, the specifications asserted that the “[t]he practices of this invention are generally applicable with respect to any organism containing genetic material which is capable of being expressed … such as bacteria, yeast, and other cellular organisms.” The claims of the patents encompassed application of antisense methodology in a broad range of organisms. Ultimately, the court relied on the fact that (1) the amount of direction presented and the number of working examples provided in the specification were very narrow compared to the wide breadth of the claims at issue, (2) antisense gene technology was highly unpredictable, and (3) the amount of experimentation required to adapt the practice of creating antisense DNA from E. coli to other types of cells was quite high, especially in light of the record, which included notable examples of the inventor’s own failures to control the expression of other genes in E. coliand other types of cells. Thus, the teachings set forth in the specification provided no more than a “plan” or “invitation” for those of skill in the art to experiment using the technology in other types of cells.

(B)In In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993), the 1983 application disclosed a vaccine against the RNA tumor virus known as Prague Avian Sarcoma Virus, a member of the Rous Associated Virus family. Using functional language, Wright claimed a vaccine “comprising an immunologically effective amount” of a viral expression product. Id., at 1559, 27 USPQ2d at 1511. Rejected claims covered all RNA viruses as well as avian RNA viruses. The examiner provided a teaching that in 1988, a vaccine for another retrovirus (i.e., AIDS) remained an intractable problem. This evidence, along with evidence that the RNA viruses were a diverse and complicated genus, convinced the Federal Circuit



that the invention was not enabled for either all retroviruses or even for avian retroviruses.

(C)In In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993), a 1985 application functionally claimed a method of producing protein in plant cells by expressing a foreign gene. The court stated: “[n]aturally, the specification must teach those of skill in the art ‘how to make and use the invention as broadly as it is claimed.’” Id. at 1050, 29 USPQ2d at 2013. Although protein expression in dicotyledonous plant cells was enabled, the claims covered any plant cell. The examiner provided evidence that even as late as 1987, use of the claimed method in monocot plant cells was not enabled. Id. at 1051, 29 USPQ2d at 2014.

(D)In In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the court found that several claims were not supported by an enabling disclosure “[t]aking into account the relatively incomplete understanding of the biology of cyanobacteria as of appellants’ filing date, as well as the limited disclosure by appellants of the particular cyanobacterial genera operative in the claimed invention....” The claims at issue were not limited to any particular genus or species of cyanobacteria and the specification mentioned nine genera and the working examples employed one species of cyanobacteria.

(E)In In re Colianni, 561 F.2d 220, 222-23, 195 USPQ 150, 152 (CCPA 1977), the court affirmed a rejection under 35 U.S.C. 112, first paragraph, because the specification, which was directed to a method of mending a fractured bone by applying “sufficient” ultrasonic energy to the bone, did not define a “sufficient” dosage or teach one of ordinary skill how to select the appropriate intensity, frequency, or duration of the ultrasonic energy.

SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS ENABLING

(A)In PPG Ind. v. Guardian Ind., 75 F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996), the court ruled that even though there was a software error in calculating the ultraviolet transmittance data for examples in the specification making it appear that the production of a cerium oxide-free glass that satisfied the transmittance limitation would be difficult, the specification indicated that such glass could be made. The specification was found to indicate how to minimize the cerium content while maintaining low ultraviolet transmittance.

(B)In In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988), the court reversed the rejection for lack of enablement under 35 U.S.C. 112, first paragraph, concluding that undue experimentation would not be required to practice the invention. The nature of monoclonal antibody technology is such that experiments first involve the entire attempt to make monoclonal hybridomas to determine which ones secrete antibody with the desired characteristics. The court found that the specification provided considerable direction and guidance on how to practice the claimed invention and presented working examples, that all of the methods needed to practice the invention were well known, and that there was a high level of skill in the art at the time the application was filed. Furthermore, the applicant carried out the entire procedure for making a monoclonal antibody against HBsAg three times and each time was successful in producing at least one antibody which fell within the scope of the claims.

(C)In In re Bundy, 642 F.2d 430, 434, 209 USPQ 48, 51-52 (CCPA 1981), the court ruled that appellant’s disclosure was sufficient to enable one skilled in the art to use the claimed analogs of naturally occurring prostaglandins even though the specification lacked any examples of specific dosages, because the specification taught that the novel prostaglandins had certain pharmacological properties and possessed activity similar to known E-type prostaglandins.


2164.06(c)Examples of Enablement Issues – Computer Programming Cases[R-5]

To establish a reasonable basis for questioning the adequacy of a disclosure, the examiner must present a factual analysis of a disclosure to show that a person skilled in the art would not be able to make and use the claimed invention without resorting to undue experimentation.

In computer applications, it is not unusual for the claimed invention to involve two areas of prior art or more than one technology, e.g., an appropriately programmed computer and an area of application of said computer. White Consol. Indus. v. Vega Servo-Control, Inc., 214 USPQ 796, 821 (S.D.Mich. 1982). In



regard to the “skilled in the art” standard, in cases involving both the art of computer programming, and another technology, the examiner must recognize that the knowledge of persons skilled in both technologies is the appropriate criteria for determining sufficiency. See In re Naquin, 398 F.2d 863, 158 USPQ 317 (CCPA 1968); In re Brown, 477 F.2d 946, 177 USPQ 691 (CCPA 1973); White Consol. Indus., 214 USPQ at 822, aff’d on related grounds, 713 F.2d 788, 218 USPQ 961 (Fed. Cir. 1983).

In a typical computer application, system components are often represented in a “block diagram” format, i.e., a group of hollow rectangles representing the elements of the system, functionally labeled, and interconnected by lines. Such block diagram computer cases may be categorized into (A) systems which include but are more comprehensive than a computer and (B) systems wherein the block elements are totally within the confines of a computer.

I.BLOCK ELEMENTS MORE COMPREHENSIVE THAN A COMPUTER

The first category of such block diagram cases involves systems which include a computer as well as other system hardware and/or software components. In order to meet his or her burden of establishing a reasonable basis for questioning the adequacy of such disclosure, the examiner should initiate a factual analysis of the system by focusing on each of the individual block element components. More specifically, such an inquiry should focus on the diverse functions attributed to each block element as well as the teachings in the specification as to how such a component could be implemented. If based on such an analysis, the examiner can reasonably contend that more than routine experimentation would be required by one of ordinary skill in the art to implement such a component or components, that component or components should specifically be challenged by the examiner as part of a 35 U.S.C. 112, first paragraph rejection. Additionally, the examiner should determine whether certain of the hardware or software components depicted as block elements are themselves complex assemblages which have widely differing characteristics and which must be precisely coordinated with other complex assemblages. Under such circumstances, a reasonable basis may exist for challenging such a functional block diagram form of disclosure. See In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971) and In re Brown, supra. Moreover, even if the applicant has cited prior art patents or publications to demonstrate that particular block diagram hardware or software components are old, it should not always be considered as self-evident how such components are to be interconnected to function in a disclosed complex manner. See In re Scarbrough, 500 F.2d 560, 566, 182 USPQ 298, 301 (CCPA 1974) and In re Forman, 463 F.2d 1125, 1129, 175 USPQ 12, 16 (CCPA 1972). Furthermore, in complex systems including a digital computer, a microprocessor, or a complex control unit as one of many block diagram elements, timing between various system elements may be of the essence and without a timing chart relating the timed sequences for each element, an unreasonable amount of work may be required to come up with the detailed relationships an applicant alleges that he or she has solved. See In re Scarbrough, 500 F.2d at 566, 182 USPQ at 302.

For example, in a block diagram disclosure of a complex claimed system which includes a microprocessor and other system components controlled by the microprocessor, a mere reference to a prior art, commercially available microprocessor, without any description of the precise operations to be performed by the microprocessor, fails to disclose how such a microprocessor would be properly programmed to either perform any required calculations or to coordinate the other system components in the proper timed sequence to perform the functions disclosed and claimed. If, in such a system, a particular program is disclosed, such a program should be carefully reviewed to ensure that its scope is commensurate with the scope of the functions attributed to such a program in the claims. See In re Brown, 477 F.2d at 951, 177 USPQ at 695. If the disclosure fails to disclose any program and if more than routine experimentation would be required of one skilled in the art to generate such a program, the examiner clearly would have a reasonable basis for challenging the sufficiency of such a disclosure. The amount of experimentation that is considered routine will vary depending on the facts and circumstances of individual cases. No exact numerical standard has been fixed by the courts, but the “amount of required experimentation must, however, be reasonable.” White Consol. Indus., 713 F.2d at 791, 218 USPQ at 963. One court



apparently found that the amount of experimentation involved was reasonable where a skilled programmer was able to write a general computer program, implementing an embodiment form, within 4 hours. Hirschfield v. Banner, 462 F. Supp. 135, 142, 200 USPQ 276, 279 (D.D.C. 1978), aff’d, 615 F.2d 1368 (D.C. Cir. 1986), cert. denied, 450 U.S. 994 (1981). Another court found that, where the required period of experimentation for skilled programmers to develop a particular program would run to 1 to 2 man years, this would be “a clearly unreasonable requirement” (White Consol. Indus., 713 F.2d at 791, 218 USPQ at 963).

II.BLOCK ELEMENTS WITHIN A COMPUTER


The second category of block diagram cases occurs most frequently in pure data processing applications where the combination of block elements is totally within the confines of a computer, there being no interfacing with external apparatus other than normal input/output devices. In some instances, it has been found that particular kinds of block diagram disclosures were sufficient to meet the enabling requirement of 35 U.S.C. 112, first paragraph. See In re Knowlton, 481 F.2d 1357, 178 USPQ 486 (CCPA 1973), In re Comstock, 481 F.2d 905, 178 USPQ 616 (CCPA 1973). Most significantly, however, in both the Comstock and Knowlton cases, the decisions turned on the appellants’ disclosure of (A) a reference to and reliance on an identified prior art computer system and (B) an operative computer program for the referenced prior art computer system. Moreover, in Knowlton the disclosure was presented in such a detailed fashion that the individual program's steps were specifically interrelated with the operative structural elements in the referenced prior art computer system. The court in Knowlton indicated that the disclosure did not merely consist of a sketchy explanation of flow diagrams or a bare group of program listings together with a reference to a proprietary computer in which they might be run. The disclosure was characterized as going into considerable detail in explaining the interrelationships between the disclosed hardware and software elements. Under such circumstances, the Court considered the disclosure to be concise as well as full, clear, and exact to a sufficient degree to satisfy the literal language of 35 U.S.C. 112, first paragraph. It must be emphasized that because of the significance of the program listing and the reference to and reliance on an identified prior art computer system, absent either of these items, a block element disclosure within the confines of a computer should be scrutinized in precisely the same manner as the first category of block diagram cases discussed above.

Regardless of whether a disclosure involves block elements more comprehensive than a computer or block elements totally within the confines of a computer, USPTO personnel, when analyzing method claims, must recognize that the specification must be adequate to teach how to practice the claimed method. If such practice requires a particular apparatus, then the application must provide a sufficient disclosure of that apparatus if such is not already available. See In re Ghiron, 442 F.2d 985, 991, 169 USPQ 723, 727 (CCPA 1971) and In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402, 406 (CCPA 1976). When USPTO personnel question the adequacy of computer system or computer programming disclosures, the reasons for finding the specification to be nonenabling should be supported by the record as a whole. In this regard, it is also essential for USPTO personnel to reasonably challenge evidence submitted by the applicant. For example, in In re Naquin, supra, an affiant’s statement that the average computer programmer was familiar with the subroutine necessary for performing the claimed process, was held to be a statement of fact as it was unchallenged by USPTO personnel. In other words, unless USPTO personnel present a reasonable basis for challenging the disclosure in view of the record as a whole, a 35 U.S.C. 112, first paragraph rejection in a computer system or computer programming application may not be sustained on appeal. See In re Naquin, supra, and In re Morehouse, 545 F.2d 162, 165-66, 192 USPQ 29, 32 (CCPA 1976).

While no specific universally applicable rule exists for recognizing an insufficiently disclosed application involving computer programs, an examining guideline to generally follow is to challenge the sufficiency of such disclosures which fail to include either the computer program itself or a reasonably detailed flowchart which delineates the sequence of operations the program must perform. In programming applications where the software disclosure only includes a flowchart, as the complexity of functions and the generality of the individual components of the flowchart increase, the basis for challenging the sufficiency of



such a flowchart becomes more reasonable because the likelihood of more than routine experimentation being required to generate a working program from such a flowchart also increases.

As stated earlier, once USPTO personnel have advanced a reasonable basis or presented evidence to question the adequacy of a computer system or computer programming disclosure, the applicant must show that his or her specification would enable one of ordinary skill in the art to make and use the claimed invention without resorting to undue experimentation. In most cases, efforts to meet this burden involve submitting affidavits, referencing prior art patents or technical publications, presenting arguments of counsel, or combinations of these approaches.

III.AFFIDAVIT PRACTICE (37 CFR 1.132)

In computer cases, affidavits must be critically analyzed. Affidavit practice at the outset usually involves analyzing the skill level and/or qualifications of the affiant, which should be of the person of ordinary skill in the art (hereinafter “routineer”). When an affiant’s skill level is higher than that required by the routineer for a particular application, an examiner may challenge the affidavit since it would not be made by a routineer in the art, and therefore would not be probative as to the amount of experimentation required by a routineer in the art to implement the invention. An affiant having a skill level or qualifications above that of the routineer in the art would require less experimentation to implement the claimed invention than that for the routineer. Similarly, an affiant having a skill level or qualifications below that of the routineer in the art would require more experimentation to implement the claimed invention than that for the routineer in the art. In either situation, the standard of the routineer in the art would not have been met.

In computer systems or programming cases, the problems with a given affidavit, which relate to the sufficiency of disclosure issue, generally involve affiants submitting few facts to support their conclusions or opinions. Some affidavits may go so far as to present conclusions on the ultimate legal question of sufficiency. In re Brandstadter, 484 F.2d 1395,179 USPQ 286 (CCPA 1973), illustrates the extent of the inquiry into the factual basis underlying an affiant’s conclusions or opinions. In Brandstadter, the invention concerned a stored program controller (computer) programmed to control the storing, retrieving, and forwarding of messages in a communications system. The disclosure consisted of broadly defined block diagrams of the structure of the invention and no flowcharts or program listings of the programs of the controller. The Court quoted extensively from the Examiner’s Office Actions and Examiner’s Answer in its opinion where it was apparent that the Examiner consistently argued that the disclosure was merely a broad system diagram in the form of labelled block diagrams along with statements of a myriad of desired results. Various affidavits were presented in which the affiants stated that all or some of the system circuit elements in the block diagrams were either well-known in the art or “could be constructed” by the skilled design engineer, that the controller was “capable of being programmed” to perform the stated functions or results desired, and that the routineer in the art “could design or construct or was able to program” the system. The Court did consider the affiants’ statements as being some evidence on the ultimate legal question of enablement but concluded that the statements failed in their purpose since they recited conclusions or opinions with few facts to support or buttress these conclusions. With reference to the lack of a disclosed computer program or even a flowchart of the program to control the message switching system, the record contained no evidence as to the number of programmers needed, the number of man-hours and the level of skill of the programmers to produce the program required to practice the invention.


It should be noted also that it is not opinion evidence directed to the ultimate legal question of enablement, but rather factual evidence directed to the amount of time and effort and level of knowledge required for the practice of the invention from the disclosure alone which can be expected to rebut a prima facie case of nonenablement. See Hirschfield, 462 F. Supp. at 143, 200 USPQ at 281. It has also been held that where an inventor described the problem to be solved to an affiant, thus enabling the affiant to generate a computer program to solve the problem, such an affidavit failed to demonstrate that the application alone would have taught a person of ordinary skill in the art how to make and use the claimed invention. See In re Brown, 477 F.2d at 951, 177 USPQ at 695. The Court indicated that it was not factually



established that the applicant did not convey to the affiant vital and additional information in their several meetings in addition to that set out in the application. Also of significance for an affidavit to be relevant to the determination of enablement is that it must be probative of the level of skill of the routineer in the art as of the time the applicant filed his application. See In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402, 406 (CCPA 1976). In that case, each of the affiants stated what was known at the time he executed the affidavit, and not what was known at the time the applicant filed his application.

IV.REFERENCING PRIOR ART DOCUMENTS


The commercial availability of an identified prior art computer system is very pertinent to the issue of enablement. But in some cases, this approach may not be sufficient to meet the applicant’s burden. Merely citing extracts from technical publications in an affidavit in order to satisfy the enablement requirement is not sufficient if it is not made clear that a person skilled in the art would know which, or what parts, of the cited circuits could be used to construct the claimed device or how they could be interconnected to act in combination to produce the required results. See In re Forman, 463 F.2d 1125, 1129, 175 USPQ 12, 16 (CCPA 1972). This analysis would appear to be less critical where the circuits comprising applicant’s system are essentially standard components of an identified prior art computer system and a standard device attached thereto.

Prior art patents are often relied on by applicants to show the state of the art for purposes of enablement. However, these patents must have an issue date earlier than the effective filing date of the application under consideration. See In re Budnick, 537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976). An analogous point was made in In re Gunn, supra, where the court indicated that patents issued after the filing date of the application under examination are not evidence of subject matter known to any person skilled in the art since their subject matter may have been known only to the patentees and the Patent and Trademark Office.

Merely citing prior art patents to demonstrate that the challenged components are old may not be sufficient proof since, even if each of the enumerated devices or labelled blocks in a block diagram disclosure were old, per se, this would not make it self-evident how each would be interconnected to function in a disclosed complex combination manner. Therefore, the specification in effect must set forth the integration of the prior art; otherwise, it is likely that undue experimentation, or more than routine experimentation would be required to implement the claimed invention. See In re Scarbrough, 500 F.2d 560, 565, 182 USPQ 298, 301 (CCPA 1974). The court also noted that any cited patents which are used by the applicant to demonstrate that particular box diagram hardware or software components are old must be analyzed as to whether such patents are germane to the instant invention and as to whether such patents provide better detail of disclosure as to such components than an applicant’s own disclosure. Also, any patent or publication cited to provide evidence that a particular programming technique is well-known in the programming art does not demonstrate that one of ordinary skill in the art could make and use correspondingly disclosed programming techniques unless both programming techniques are of approximately the same degree of complexity. See In re Knowlton, 500 F.2d 566, 572, 183 USPQ 33, 37 (CCPA 1974).

V.ARGUMENTS OF COUNSEL

Arguments of counsel may be effective in establishing that an examiner has not properly met his or her burden or has otherwise erred in his or her position. However, it must be emphasized that arguments of counsel alone cannot take the place of evidence in the record once an examiner has advanced a reasonable basis for questioning the disclosure. See In re Budnick, 537 F.2d at 538, 190 USPQ at 424; In re Schulze, 346 F.2d 600, 145 USPQ 716 (CCPA 1965); In re Cole, 326 F.2d 769, 140 USPQ 230 (CCPA 1964). For example, in a case where the record consisted substantially of arguments and opinions of applicant’s attorney, the court indicated that factual affidavits could have provided important evidence on the issue of enablement. See In re Knowlton, 500 F.2d at 572, 183 USPQ at 37; In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).



2164.07Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101

The requirement of 35 U.S.C. 112, first paragraph as to how to use the invention is different from the utility requirement of 35 U.S.C. 101. The requirement of 35 U.S.C. 101 is that some specific, substantial, and credible use be set forth for the invention. On the other hand, 35 U.S.C. 112, first paragraph requires an indication of how the use (required by 35 U.S.C. 101) can be carried out, i.e., how the invention can be used.

If an applicant has disclosed a specific and substantial utility for an invention and provided a credible basis supporting that utility, that fact alone does not provide a basis for concluding that the claims comply with all the requirements of 35 U.S.C. 112, first paragraph. For example, if an applicant has claimed a process of treating a certain disease condition with a certain compound and provided a credible basis for asserting that the compound is useful in that regard, but to actually practice the invention as claimed a person skilled in the relevant art would have to engage in an undue amount of experimentation, the claim may be defective under 35 U.S.C. 112, but not 35 U.S.C. 101. To avoid confusion during examination, any rejection under 35 U.S.C. 112, first paragraph, based on grounds other than “lack of utility” should be imposed separately from any rejection imposed due to “lack of utility” under 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph.

I.WHEN UTILITY REQUIREMENT IS NOT SATISFIED

A.Not Useful or Operative

If a claim fails to meet the utility requirement of 35 U.S.C. 101 because it is shown to be nonuseful or inoperative, then it necessarily fails to meet the how- to-use aspect of the enablement requirement of 35 U.S.C. 112, first paragraph. As noted in In re Fouche, 439 F.2d 1237, 169 USPQ 429 (CCPA 1971), if “compositions are in fact useless, appellant’s specification cannot have taught how to use them.” 439 F.2d at 1243, 169 USPQ at 434. The examiner should make both rejections (i.e., a rejection under 35 U.S.C. 112, first paragraph and a rejection under 35 U.S.C. 101) where the subject matter of a claim has been shown to be nonuseful or inoperative.

The 35 U.S.C. 112, first paragraph, rejection should indicate that because the invention as claimed does not have utility, a person skilled in the art would not be able to use the invention as claimed, and as such, the claim is defective under 35 U.S.C. 112, first paragraph. A 35 U.S.C. 112, first paragraph, rejection should not be imposed or maintained unless an appropriate basis exists for imposing a rejection under 35 U.S.C. 101. In other words, Office personnel should not impose a 35 U.S.C. 112, first paragraph, rejection grounded on a “lack of utility” basis unless a 35 U.S.C. 101 rejection is proper. In particular, the factual showing needed to impose a rejection under 35 U.S.C. 101 must be provided if a 35 U.S.C. 112, first paragraph, rejection is to be imposed on “lack of utility” grounds. See MPEP § 2107 - § 2107.03 for a more detailed discussion of the utility requirements of 35 U.S.C. 101 and 112, first paragraph.

B.Burden on the Examiner

When the examiner concludes that an application is describing an invention that is nonuseful, inoperative, or contradicts known scientific principles, the burden is on the examiner to provide a reasonable basis to support this conclusion. Rejections based on 35 U.S.C. 112, first paragraph and 35 U.S.C. 101should be made.

Examiner Has Initial Burden To Show That One of Ordinary Skill in the Art Would Reasonably Doubt the Asserted Utility

The examiner has the initial burden of challenging an asserted utility. Only after the examiner has provided evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince one of ordinary skill in the art of the invention’s asserted utility. In re Swartz, 232 F.3d 862, 863, 56 USPQ2d 1703, 1704 (Fed. Cir. 2000); In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (citing In reBundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)).



C.Rebuttal by Applicant

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). There is no predetermined amount or character of evidence that must be provided by an applicant to support an asserted utility. Rather, the character and amount of evidence needed to support an asserted utility will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229, 231 (Bd. App. 1957)), and whether the asserted utility appears to contravene established scientific principles and beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not have to provide evidence sufficient to establish that an asserted utility is true “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Instead, evidence will be sufficient if, considered as a whole, it leads a person of ordinary skill in the art to conclude that the asserted utility is more likely than not true. See MPEP § 2107.02 for a more detailed discussion of consideration of a reply to a prima facie rejection for lack of utility and evaluation of evidence related to utility.

II.WHEN UTILITY REQUIREMENT IS SATISFIED


In some instances, the use will be provided, but the skilled artisan will not know how to effect that use. In such a case, no rejection will be made under 35 U.S.C. 101, but a rejection will be made under 35 U.S.C. 112, first paragraph. As pointed out in Mowryv. Whitney, 81 U.S. (14 Wall.) 620 (1871), an invention may in fact have great utility, i.e., may be “a highly useful invention,” but the specification may still fail to “enable any person skilled in the art or science” to use the invention. 81 U.S. (14 Wall.) at 644.

2164.08Enablement Commensurate inScope With the Claims [R-2]

All questions of enablement are evaluated against the claimed subject matter. The focus of the examination inquiry is whether everything within the scope of the claim is enabled. Accordingly, the first analytical step requires that the examiner determine exactly what subject matter is encompassed by the claims. See, e.g., AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003)(When a range is claimed, there must be reasonable enablement of the scope of the range. Here, the claims at issue encompassed amounts of silicon as high as 10% by weight, however the specification included statements clearly and strongly warning that a silicon content above 0.5% by weight in an aluminum coating causes coating problems. Such statements indicate that higher amounts will not work in the claimed invention.). The examiner should determine what each claim recites and what the subject matter is when the claim is considered as a whole, not when its parts are analyzed individually. No claim should be overlooked. With respect to dependent claims, 35 U.S.C. 112, fourth paragraph, should be followed. This paragraph states that “a claim in a dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers” and requires the dependent claim to further limit the subject matter claimed.

The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well-known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. Further the scope of enablement must only bear a “reasonable correlation” to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).

As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb



Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged “pioneer status” of invention irrelevant to enablement determination).

The determination of the propriety of a rejection based upon the scope of a claim relative to the scope of the enablement involves two stages of inquiry. The first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claimed invention without undue experimentation.


How a teaching is set forth, by specific example or broad terminology, is not important. In re Marzocchi, 439 F.2d 220, 223-24 169 USPQ 367, 370 (CCPA 1971). A rejection of a claim under 35 U.S.C. 112 as broader than the enabling disclosure is a first paragraph enablement rejection and not a second paragraph definiteness rejection. Claims are not rejected as broader than the enabling disclosure under 35 U.S.C. 112 for noninclusion of limitations dealing with factors which must be presumed to be within the level of ordinary skill in the art; the claims need not recite such factors where one of ordinary skill in the art to whom the specification and claims are directed would consider them obvious. In re Skrivan, 427 F.2d 801, 806, 166 USPQ 85, 88 (CCPA 1970). One does not look to the claims but to the specification to find out how to practice the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1558, 220 USPQ 303, 316-17 (Fed. Cir. 1983); In re Johnson, 558 F.2d 1008, 1017, 194 USPQ 187, 195 (CCPA 1977). In In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976), the court stated:

[T]o provide effective incentives, claims must adequately protect inventors. To demand that the first to disclose shall limit his claims to what he has found will work or to materials which meet the guidelines specified for “preferred” materials in a process such as the one herein involved would not serve the constitutional purpose of promoting progress in the useful arts.

When analyzing the enabled scope of a claim, the teachings of the specification must not be ignored because claims are to be given their broadest reasonable interpretation that is consistent with the specification. “That claims are interpreted in light of the specification does not mean that everything in the specification must be read into the claims.” Raytheon Co. v. Roper Corp., 724 F.2d 951, 957, 220 USPQ 592, 597 (Fed. Cir. 1983), cert. denied, 469 U.S. 835 (1984).

The record must be clear so that the public will have notice as to the patentee’s scope of protection when the patent issues. If a reasonable interpretation of the claim is broader than the description in the specification, it is necessary for the examiner to make sure the full scope of the claim is enabled. Limitations and examples in the specification do not generally limit what is covered by the claims.

The breadth of the claims was a factor considered in Amgen v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991). In the Amgen case, the patent claims were directed to a purified DNA sequence encoding polypeptides which are analogs of erythropoietin (EPO). The Court stated that:

Amgen has not enabled preparation of DNA sequences sufficient to support its all-encompassing claims. . . . [D]espite extensive statements in the specification concerning all the analogs of the EPO gene that can be made, there is little enabling disclosure of particular analogs and how to make them. Details for preparing only a few EPO analog genes are disclosed. . . . This disclosure might well justify a generic claim encompassing these and similar analogs, but it represents inadequate support for Amgen’s desire to claim all EPO gene analogs. There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them.

927 F.2d at 1213-14, 18 USPQ2d at 1027. However, 

when claims are directed to any purified and isolated DNA sequence encoding a specifically named protein where the protein has a specifically identified sequence, a rejection of the claims as broader than the enabling disclosure is generally not appropriate because one skilled in the art could readily determine any one of the claimed embodiments.

See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993) (The evidence did not show that a skilled artisan would have been able to carry out the steps required to practice the full scope of claims which encompass “any and alllive, non-pathogenic vaccines, and processes for making such vaccines, which elicit immunoprotective activity in any animal toward any RNA virus.” (original emphasis)); In re Goodman, 11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015 (Fed. Cir. 1993) (The



specification did not enable the broad scope of the claims for producing mammalian peptides in plant cells because the specification contained only an example of producing gamma-interferon in a dicot species, and there was evidence that extensive experimentation would have been required for encoding mammalian peptide into a monocot plant at the time of filing); In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (Where applicant claimed a composition suitable for the treatment of arthritis having a potency of “at least” a particular value, the court held that the claim was not commensurate in scope with the enabling disclosure because the disclosure was not enabling for compositions having a slightly higher potency. Simply because applicant was the first to achieve a composition beyond a particular threshold potency did not justify or support a claim that would dominate every composition that exceeded that threshold value.); In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (Given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims, a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate.).

If a rejection is made based on the view that the enablement is not commensurate in scope with the claim, the examiner should identify the subject matter that is considered to be enabled.

2164.08(a)Single Means Claim

A single means claim, i.e., where a means recitation does not appear in combination with another recited element of means, is subject to an undue breadth rejection under 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A single means claim which covered every conceivable means for achieving the stated purpose was held nonenabling for the scope of the claim because the specification disclosed at most only those means known to the inventor.). When claims depend on a recited property, a fact situation comparable to Hyatt is possible, where the claim covers every conceivable structure (means) for achieving the stated property (result) while the specification discloses at most only those known to the inventor.

2164.08(b)Inoperative Subject Matter

The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic examples do not make the disclosure nonenabling).

Although, typically, inoperative embodiments are excluded by language in a claim (e.g., preamble), the scope of the claim may still not be enabled where undue experimentation is involved in determining those embodiments that are operable. A disclosure of a large number of operable embodiments and the identification of a single inoperative embodiment did not render a claim broader than the enabled scope because undue experimentation was not involved in determining those embodiments that were operable. In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ 214, 218 (CCPA 1976). However, claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative. Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In reCook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971).

2164.08(c)Critical Feature Not Claimed

A feature which is taught as critical in a specification and is not recited in the claims should result in a rejection of such claim under the enablement provision section of 35 U.S.C. 112. See In re Mayhew, 527 F.2d 1229, 1233, 188 USPQ 356, 358 (CCPA 1976). In determining whether an unclaimed feature is critical, the entire disclosure must be considered. Features which are merely preferred are not to be considered critical. In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976).

Limiting an applicant to the preferred materials in the absence of limiting prior art would not serve the constitutional purpose of promoting the progress in the useful arts. Therefore, an enablement rejection based on the grounds that a disclosed critical limitation is missing from a claim should be made only when the language of the specification makes it clear that the limitation is critical for the invention to function as intended. Broad language in the disclosure, including the abstract, omitting an allegedly critical feature, tends to rebut the argument of criticality.


2165 The Best Mode Requirement[edit | edit source]

A third requirement of the first paragraph of 35 U.S.C. 112 is that:

The specification. . . shall set forth the best mode contemplated by the inventor of carrying out his invention.

“The best mode requirement creates a statutory bargained- for-exchange by which a patentee obtains the right to exclude others from practicing the claimed invention for a certain time period, and the public receives knowledge of the preferred embodiments for practicing the claimed invention.” Eli Lilly & Co. v. Barr Laboratories Inc., 251 F.3d 955, 963, 58 USPQ2d 1865, 1874 (Fed. Cir. 2001).

The best mode requirement is a safeguard against the desire on the part of some people to obtain patent protection without making a full disclosure as required by the statute. The requirement does not permit inventors to disclose only what they know to be their second-best embodiment, while retaining the best for themselves. In re Nelson, 280 F.2d 172, 126 USPQ 242 (CCPA 1960).

Determining compliance with the best mode requirement requires a two-prong inquiry. First, it must be determined whether, at the time the application was filed, the inventor possessed a best mode for practicing the invention. This is a subjective inquiry which focuses on the inventor’s state of mind at the time of filing. Second, if the inventor did possess a best mode, it must be determined whether the written description disclosed the best mode such that a person skilled in the art could practice it. This is an objective inquiry, focusing on the scope of the claimed invention and the level of skill in the art. Eli Lilly & Co. v. Barr Laboratories Inc., 251 F.3d 955, 963, 58 USPQ2d 1865, 1874 (Fed. Cir. 2001).

The failure to disclose a better method will not invalidate a patent if the inventor, at the time of filing the application, did not know of the better method ORdid not appreciate that it was the best method. All applicants are required to disclose for the claimed subject matter the best mode contemplated by the inventor even though applicant may not have been the discoverer of that mode. Benger Labs. Ltd. v. R.K. Laros Co., 209 F. Supp. 639, 135 USPQ 11 (E.D. Pa. 1962).

ACTIVE CONCEALMENT OR GROSSLY INEQUITABLE CONDUCT IS NOT REQUIRED TO ESTABLISH FAILURE TO DISCLOSE THE BEST MODE

Failure to disclose the best mode need not rise to the level of active concealment or grossly inequitable conduct in order to support a rejection or invalidate a patent. Where an inventor knows of a specific material that will make possible the successful reproduction of the effects claimed by the patent, but does not disclose it, speaking instead in terms of broad categories, the best mode requirement has not been satisfied. Union Carbide Corp. v. Borg-Warner, 550 F.2d 555, 193 USPQ 1 (6th Cir. 1977).

If the failure to set forth the best mode in a patent disclosure is the result of inequitable conduct (e.g., where the patent specification omitted crucial ingredients and disclosed a fictitious and inoperable slurry as Example 1), not only is that patent in danger of being held unenforceable, but other patents dealing with the same technology that are sought to be enforced in the same cause of action are subject to being held unenforceable. Consolidated Aluminum Corp. v. Foseco Inc., 910 F.2d 804, 15 USPQ2d 1481 (Fed. Cir. 1990).

2165.01 Considerations Relevant to BestMode[edit | edit source]

I.DETERMINE WHAT IS THE INVENTION

Determine what the invention is — the invention is defined in the claims. The specification need not set forth details not relating to the essence of the invention. In re Bosy, 360 F.2d 972, 149 USPQ 789 (CCPA 1966). See also Northern Telecom Ltd. v. Samsung Electronics Co., 215 F.3d 1281, 55 USPQ2d 1065 (Fed. Cir. 2000) (Unclaimed matter that is unrelated to the operation of the claimed invention does not trigger the best mode requirement); Eli Lilly & Co. v. Barr Laboratories Inc., 251 F.3d 955, 966, 58 USPQ2d 1865, 1877 (Fed. Cir. 2001) ("[P]atentee's failure to disclose an unclaimed preferred mode for accomplishing a routine detail does not violate the best mode requirement because one skilled in the art is aware of alternative means for accomplishing the routine detail that would still produce the best mode of the claimed invention.").

II.SPECIFIC EXAMPLE IS NOT REQUIRED

There is no statutory requirement for the disclosure of a specific example — a patent specification is not intended nor required to be a production specification. In re Gay, 309 F.2d 768, 135 USPQ 311 (CCPA 1962).

The absence of a specific working example is not necessarily evidence that the best mode has not been disclosed, nor is the presence of one evidence that it has. Best mode may be represented by a preferred range of conditions or group of reactants. In re Honn, 364 F.2d 454, 150 USPQ 652 (CCPA 1966).

III.DESIGNATION AS BEST MODE IS NOT REQUIRED

There is no requirement in the statute that applicants point out which of their embodiments they consider to be their best; that the disclosure includes the best mode contemplated by applicants is enough to satisfy the statute. Ernsthausen v. Nakayama, 1 USPQ2d 1539 (Bd. Pat. App. & Inter. 1985).

IV.UPDATING BEST MODE IS NOT REQUIRED

There is no requirement to update in the context of a foreign priority application under 35 U.S.C. 119, Standard Oil Co. v. Montedison, S.p.A., 494 F.Supp. 370, 206 USPQ 676 (D.Del. 1980) (better catalyst developed between Italian priority and U.S. filing dates), and continuing applications claiming the benefit of an earlier filing date under 35 U.S.C. 120, Transco Products, Inc. v. Performance Contracting Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994) (continuation under former 37 CFR 1.60); Sylgab Steel and Wire Corp. v. Imoco-Gateway Corp., 357 F.Supp. 657, 178 USPQ 22 (N.D. Ill. 1973) (continuation); Johns-Manville Corp. v. Guardian Industries Corp., 586 F.Supp. 1034, 221 USPQ 319 (E.D. Mich. 1983) (continuation and CIP). In the last cited case, the court stated that applicant would have been obliged to disclose an updated refinement if it were essential to the successful practice of the invention and it related to amendments to the CIP that were not present in the parent application. In Carter-Wallace, Inc. v. Riverton Labs., Inc., 433 F.2d 1034, 167 USPQ 656 (2d Cir. 1970), the court assumed, but did not decide, that an applicant must update the best mode when filing a CIP application.

V.DEFECT IN BEST MODE CANNOT BE CURED BY NEW MATTER

If the best mode contemplated by the inventor at the time of filing the application is not disclosed, such a defect cannot be cured by submitting an amendment seeking to put into the specification something required to be there when the patent application was originally filed. In re Hay, 534 F.2d 917, 189 USPQ 790 (CCPA 1976).

Any proposed amendment of this type (adding a specific mode of practicing the invention not described in the application as filed) should be treated as new matter. New matter under 35 U.S.C. 132 and 251 should be objected to and coupled with a requirement to cancel the new matter.

2165.02 Best Mode Requirement Compared to Enablement Requirement[edit | edit source]

The best mode requirement is a separate and distinct requirement from the enablement requirement of the first paragraph of 35 U.S.C. 112. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).

The best mode provision of 35 U.S.C. 112 is not directed to a situation where the application fails to set forth any mode — such failure is equivalent to nonenablement. In re Glass, 492 F.2d 1228, 181 USPQ 31 (CCPA 1974).

The enablement requirement looks to placing the subject matter of the claims generally in the possession of the public. If, however, the applicant develops specific instrumentalities or techniques which are recognized by the applicant at the time of filing as the best way of carrying out the invention, then the best mode requirement imposes an obligation to disclose that information to the public as well. Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 3 USPQ 2d 1737 (Fed. Cir.), cert. denied, 484 U.S. 954 (1987).

2165.03 Requirements for Rejection forLack of Best Mode[edit | edit source]

ASSUME BEST MODE IS DISCLOSED UNLESS THERE IS EVIDENCE TO THE CONTRARY

The examiner should assume that the best mode is disclosed in the application, unless evidence is presented that is inconsistent with that assumption. It is extremely rare that a best mode rejection properly would be made in ex parte prosecution. The information that is necessary to form the basis for a rejection based on the failure to set forth the best mode is rarely accessible to the examiner, but is generally uncovered during discovery procedures in interference, litigation, or other inter partes proceedings.

EXAMINER MUST DETERMINE WHETHER THE INVENTOR KNEW THAT ONE MODE WAS BETTER THAN ANOTHER, AND IF SO, WHETHER THE DISCLOSURE IS ADEQUATE TO ENABLE ONE OF ORDINARY SKILL IN THE ART TO PRACTICE THE BEST MODE

According to the approach used by the court in Chemcast Corp. v. Arco Industries, 913 F.2d 923, 16 USPQ2d 1033 (Fed. Cir. 1990), a proper best mode analysis has two components:

(A)Determine whether, at the time the application was filed, the inventor knew of a mode of practicing the claimed invention that the inventor considered to be better than any other.

The first component is a subjective inquiry because it focuses on the inventor’s state of mind at the time the application was filed. Unless the examiner has evidence that the inventors had information in their possession

(1)at the time the application was filed

(2)that a mode was considered to be better than any others by the inventors,

there is no reason to address the second component and there is no proper basis for a best mode rejection. If the facts satisfy the first component, then, and only then, is the following second component analyzed:

(B)Compare what was known in (A) with what was disclosed - is the disclosure adequate to enable one skilled in the art to practice the best mode?

Assessing the adequacy of the disclosure in this regard is largely an objective inquiry that depen