MPEP 2106

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2106 Patent Subject Matter Eligibility

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.

C. Determine Whether the Claimed Invention Falls Within 35 U.S.C. 101 Judicial Exceptions – Laws of Nature, Natural Phenomena and Abstract Ideas

Determining whether the claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) does not end the analysis because claims directed to nothing more than abstract ideas (such as mathematical algorithms), natural phenomena, and laws of nature are not eligible for patent protection.

While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting, methods and products employing abstract ideas, natural phenomena, and laws of nature to perform a real-world function may well be. In evaluating whether a claim meets the requirements of section 101, the claim must be considered as a whole to determine whether it is for a particular application of an abstract idea, natural phenomenon, or law of nature, and not for the abstract idea, natural phenomenon, or law of nature itself.

1.Determine Whether the Claimed Invention Covers Either a 35 U.S.C. 101 Judicial Exception or a Practical Application of a 35 U.S.C. 101 Judicial Exception

USPTO personnel must ascertain the scope of the claim to determine whether it covers either a 35 U.S.C. 101 judicial exception or a practical application of a 35 U.S.C. 101 judicial exception. The conclusion that a particular claim includes a 35 U.S.C. 101 judicial exception does not end the inquiry because the practical application of a judicial exception may qualify for patent protection. “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Diehr, 450 U.S. at 187, 209 USPQ at 8 (emphasis in original); accord Flook, 437 U.S. at 590, 198 USPQ at 197; Benson, 409 U.S. at 67, 175 USPQ at 675. Thus, “[w]hile a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.” Diehr, 450 U.S. at 188, 209 USPQ at 8-9 (quoting Mackay, 306 U.S. at 94); see also Corning v. Burden, 56 U.S. (15 How.) 252, 268, 14 L.Ed. 683 (1854)(“It is for the discovery or invention of some practical method or means of producing a beneficial result or effect, that a patent is granted . . .”).

2.Determine Whether the Claimed Invention is a Practical Application of an Abstract Idea, Law of Nature, or Natural Phenomenon (35 U.S.C. 101 Judicial Exceptions)

For claims including such excluded subject matter to be eligible for patent protection, the claim must be for a practical application of the abstract idea, law of nature, or natural phenomenon. Diehr, 450 U.S. at 187, 209 USPQ at 8 (“application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”); Benson, 409 U.S. at 71, 175 USPQ at 676 (rejecting formula claim because it “has no substantial practical application”).

A claimed invention is directed to a practical application of a 35 U.S.C. 101 judicial exception when it:

(A)“transforms” an article or physical object to a different state or thing; or

(B)otherwise produces a useful, concrete and tangible result, based on the factors discussed below.

(1)Practical Application by Physical Transformation

USPTO personnel first shall review the claim and determine if it provides a transformation or reduction of an article to a different state or thing. If USPTO personnel find such a transformation or reduction, USPTO personnel shall end the inquiry and find that the claim meets the statutory requirement of 35 U.S.C. 101. If USPTO personnel do not find such a transformation or reduction, they must determine whether the claimed invention produces a useful, concrete, and tangible result.

(2)Practical Application That Produces a Useful, Concrete, and Tangible Result

For purposes of an eligibility analysis, a physical transformation “is not an invariable requirement, but merely one example of how a mathematical algorithm [or law of nature] may bring about a useful application.” AT&T, 172 F.3d at 1358-59, 50 USPQ2d at 1452. If USPTO personnel determine that the claim does not entail the transformation of an article, then USPTO personnel shall review the claim to determine it produces a useful, tangible, and concrete result. In making this determination, the focus is not on whether the steps taken to achieve a particular result are useful, tangible, and concrete, but rather on whether the final result achieved by the claimed invention is “useful, tangible, and concrete.” In other words, the claim must be examined to see if it includes anything more than a 35 U.S.C. 101 judicial exception. If the claim is directed to a practical application of a 35 U.S.C. 101 judicial exception, USPTO personnel must then determine whether the claim preempts the judicial exception. If USPTO personnel do not find such a practical application, then USPTO personnel have determined that the claim is nonstatutory.

In determining whether a claim provides a practical application of a 35 U.S.C. 101 judicial exception that produces a useful, tangible, and concrete result, USPTO personnel should consider and weigh the following factors:

a)“USEFUL RESULT”

For an invention to be “useful” it must satisfy the utility requirement of section 101. The USPTO’s official interpretation of the utility requirement provides that the utility of an invention has to be (i) specific, (ii) substantial and (iii) credible. MPEP § 2107 and Fisher, 421 F.3d at 1372, 76 USPQ2d at 1230 (citing the Utility Guidelines with approval for interpretation of “specific” and “substantial”). In addition, when the examiner has reason to believe that the claim is not for a practical application that produces a useful result, the claim should be rejected, thus requiring the applicant to distinguish the claim from the three 35 U.S.C. 101 judicial exceptions to patentable subject matter by specifically reciting in the claim the practical application. In such cases, statements in the specification describing a practical application may not be sufficient to satisfy the requirements for section 101with respect to the claimed invention. Likewise, a claim that can be read so broadly as to include statutory and nonstatutory subject matter must be amended to limit the claim to a practical application. In other words, if the specification discloses a practical application of a section 101 judicial exception, but the claim is broader than the disclosure such that it does not require a practical application, then the claim must be rejected.

b)“TANGIBLE RESULT”

The tangible requirement does not necessarily mean that a claim must either be tied to a particular machine or apparatus or must operate to change articles or materials to a different state or thing. However, the tangible requirement does require that the claim must recite more than a 35 U.S.C. 101 judicial exception, in that the process claim must set forth a practical application of that judicial exception to produce a real-world result. Benson, 409 U.S. at 71-72, 175 USPQ at 676-77 (invention ineligible because had “no substantial practical application.”). “[A]n application of a law of nature or mathematical formula to a … process may well be deserving of patent protection.” Diehr, 450 U.S. at 187, 209 USPQ at 8 (emphasis added); see also Corning, 56 U.S. (15 How.) at 268, 14 L.Ed. 683 (“It is for the discovery or invention of some practical method or means of producing a beneficial result or effect, that a patent is granted . . .”). In other words, the opposite meaning of “tangible” is “abstract.”

c)“CONCRETE RESULT”

Another consideration is whether the invention produces a “concrete” result. Usually, this question arises when a result cannot be assured. In other words, the process must have a result that can be substantially repeatable or the process must substantially produce the same result again. In re Swartz, 232 F.3d 862, 864, 56 USPQ2d 1703, 1704 (Fed. Cir. 2000) (where asserted result produced by the claimed invention is “irreproducible” claim should be rejected under section 101). The opposite of “concrete” is unrepeatable or unpredictable. Resolving this question is dependent on the level of skill in the art. For example, if the claimed invention is for a process which requires a particular skill, to determine whether that process is substantially repeatable will necessarily require a determination of the level of skill of the ordinary artisan in that field. An appropriate rejection under 35 U.S.C. 101 should be accompanied by a lack of enablement rejection under 35 U.S.C. 112, paragraph 1, where the invention cannot operate as intended without undue experimentation. See infra.

3.Determine Whether the Claimed Invention Preempts a 35 U.S.C. 101 Judicial Exception (Abstract Idea, Law of Nature, or Natural Phenomenon)

Even when a claim applies a mathematical formula, for example, as part of a seemingly patentable process, USPTO personnel must ensure that it does not in reality “seek[] patent protection for that formula in the abstract.” Diehr, 450 U.S. at 191, 209 USPQ at 10. “Phenomena of nature, though just discovered, mental processes, abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Benson, 409 U.S. at 67, 175 USPQ at 675. One may not patent a process that comprises every “substantial practical application” of an abstract idea, because such a patent “in practical effect would be a patent on the [abstract idea] itself.” Benson, 409 U.S. at 71-72, 175 USPQ at 676; cf. Diehr, 450 U.S. at 187, 209 USPQ at 8 (stressing that the patent applicants in that case did “not seek to pre- empt the use of [an] equation,” but instead sought only to “foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process”). “To hold otherwise would allow a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection.” Diehr, 450 U.S. at 192, 209 USPQ at 10. Thus, a claim that recites a computer that solely calculates a mathematical formula (see Benson) or a computer disk that solely stores a mathematical formula is not directed to the type of subject matter eligible for patent protection. If USPTO personnel determine that the claimed invention preempts a 35 U.S.C. 101 judicial exception, they must identify the abstraction, law of nature, or natural phenomenon and explain why the claim covers every substantial practical application thereof.

D.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 faciecase of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). If the record as a whole suggests that it is more likely than not that the claimed invention would be considered a practical application of an abstract idea, natural phenomenon, or law of nature, then USPTO personnel should not reject the claim.

After USPTO personnel identify and explain in the record the reasons why a claim is for an abstract idea 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. See, e.g., In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995); see generally MPEP § 2107 (Utility Guidelines).

For further discussion of case law defining the line between eligible and ineligible subject matter, as well as a summary of improper tests for subject matter eligibility, see Annex II and Annex III of Interim Guidelines for Examination of Patent Applications for Patent Subject Matter Eligibility, 1300 Off. Gaz. Pat. Office 142 (Nov. 22, 2005)(Patent Subject Matter Eligibility Interim Guidelines).

V.EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

A.Determine Whether the Claimed Invention Complies with 35 U.S.C. 112, Second Paragraph Requirements (MPEP § 2171)

The second paragraph of 35 U.S.C. 112 contains two separate and distinct requirements: (A) that the claim(s) set forth the subject matter applicants regard as the invention, and (B) 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 (see MPEP § 2171- § 2172.01).

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.

The scope of a “means” limitation is defined as the corresponding structure or material set forth in the written description and equivalents thereof. See MPEP § 2181 through § 2186. See MPEP § 2173 et seq. for a discussion of a variety of issues pertaining to the 35 U.S.C. 112, second paragraph requirement that the claims particularly point out and distinctly claim 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. Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1566-67, 43 USPQ2d 1398, 1404-05 (Fed. Cir. 1997); Hyatt v. Boone, 146 F.3d 1348, 1354, 47 USPQ2d 1128, 1132 (Fed. Cir. 1998). The claimed invention subject matter need not be described literally, i.e., using the same terms, in order for the disclosure to satisfy the description requirement. Software aspects of inventions , for example, may be described functionally. See Robotic Vision Sys. v. View Eng’g, Inc., 112 F.3d 1163, 1166, 42 USPQ2d 1619, 1622-23 (Fed. Cir. 1997); Fonar Corp. v. General Electric Co., 107 F.3d 1543, 1549, 41 USPQ2d 1801, 1805 (Fed. Cir. 1997); In re Hayes Microcomputer Prods., Inc., 982 F.2d 1527, 1537-38, 25 USPQ2d 1241, 1248-49 (Fed. Cir. 1992). See MPEP § 2163 for further guidance with respect to the evaluation of a patent application for compliance with the written description requirement.

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.

See MPEP § 2164 et seq. for detailed guidance with regard to the enablement requirement of 35 U.S.C. 112, first paragraph.

3.Best Mode (MPEP § 2165)

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.

See MPEP § 2165 et seq. for additional guidance. Deficiencies related to disclosure of the best mode for carrying out the claimed invention are not usually encountered during examination of an application because evidence to support such a deficiency is seldom in the record. Fonar, 107 F.3d at 1548-49, 41 USPQ2d at 1804-05.

VI.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. See MPEP § 2131 - § 2146 for specific guidance on patentability determinations under 35 U.S.C. § 102 and 103. 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.

VII.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 unpatentability. 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.

Guidelines Flowchart

2106.01Computer-Related Nonstatutory Subject Matter [R-5]

Descriptive material can be characterized as either “functional descriptive material” or “nonfunctional descriptive material.” In this context, “functional descriptive material” consists of data structures and computer programs which impart functionality when employed as a computer component. (The definition of “data structure” is “a physical or logical relationship among data elements, designed to support specific data manipulation functions.” The New IEEE Standard Dictionary of Electrical and Electronics Terms 308 (5th ed. 1993).) “Nonfunctional descriptive material” includes but is not limited to music, literary works, and a compilation or mere arrangement of data.

Both types of “descriptive material” are nonstatutory when claimed as descriptive material per se, 33 F.3d at 1360, 31 USPQ2d at 1759. When functional descriptive material is recorded on some computer- readable medium, it becomes structurally and functionally interrelated to the medium and will be statutory in most cases since use of technology permits the function of the descriptive material to be realized. Compare In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994)(discussing patentable weight of data structure limitations in the context of a statutory claim to a data structure stored on a computer readable medium that increases computer efficiency) and Warmerdam, 33 F.3d at 1360-61, 31 USPQ2d at 1759 (claim to computer having a specific data structure stored in memory held statutory product- by-process claim) with Warmerdam, 33 F.3d at 1361, 31 USPQ2d at 1760 (claim to a data structure per se held nonstatutory).

When nonfunctional descriptive material is recorded on some computer-readable medium, in a computer or on an electromagnetic carrier signal, it is not statutory since no requisite functionality is present to satisfy the practical application requirement. Merely claiming nonfunctional descriptive material, i.e., abstract ideas, stored on a computer-readable medium, in a computer, or on an electromagnetic carrier signal, does not make it statutory. See Diehr, 450 U.S. at 185-86, 209 USPQ at 8 (noting that the claims for an algorithm in Benson were unpatentable as abstract ideas because “[t]he sole practical application of the algorithm was in connection with the programming of a general purpose computer.”). Such a result would exalt form over substance. In re Sarkar, 588 F.2d 1330, 1333, 200 USPQ 132, 137 (CCPA 1978) (“[E]ach invention must be evaluated as claimed; yet semantogenic considerations preclude a determination based solely on words appearing in the claims. In the final analysis under § 101, the claimed invention, as a whole, must be evaluated for what it is.”) (quoted with approval in Abele, 684 F.2d at 907, 214 USPQ at 687). See also In re Johnson, 589 F.2d 1070, 1077, 200 USPQ 199, 206 (CCPA 1978) (“form of the claim is often an exercise in drafting”). Thus, nonstatutory music is not a computer component, and it does not become statutory by merely recording it on a compact disk. Protection for this type of work is provided under the copyright law.

When nonfunctional descriptive material is recorded on some computer-readable medium, in a computer or on an electromagnetic carrier signal, it is not statutory and should be rejected under 35 U.S.C. 101. In addition, USPTO personnel should inquire whether there should be a rejection under 35 U.S.C. 102 or 103. USPTO personnel should determine whether the claimed nonfunctional descriptive material be given patentable weight. USPTO personnel must consider all claim limitations when determining patentability of an invention over the prior art.

In re Gulack,

703 F.2d 1381, 1385, 217 USPQ 401, 403-04 (Fed. Cir. 1983). USPTO personnel may not disregard claim limitations comprised of printed matter.

See Gulack,

703 F.2d at 1384, 217 USPQ at 403;

2106.02 Mathematical Algorithms [R-5]

Claims to processes that do nothing more than solve mathematical problems or manipulate abstract ideas or concepts are complex to analyze and are addressed herein.

If the “acts” of a claimed process manipulate only numbers, abstract concepts or ideas, or signals representing any of the foregoing, the acts are not being applied to appropriate subject matter. Gottschalk v. Benson, 409 U.S. 63, 71 - 72, 175 USPQ 673, 676 (1972). Thus, a process consisting solely of mathematical operations, i.e., converting one set of numbers into another set of numbers, does not manipulate appropriate subject matter and thus cannot constitute a statutory process.

In practical terms, claims define nonstatutory processes if they:

– consist solely of mathematical operations without some claimed practical application (i.e., executing a “mathematical algorithm”); or

– simply manipulate abstract ideas, e.g., a bid (Schrader, 22 F.3d at 293-94, 30 USPQ2d at 1458- 59) or a bubble hierarchy (Warmerdam, 33 F.3d at 1360, 31 USPQ2d at 1759), without some claimed practical application.

Cf. Alappat, 33 F.3d at 1543 n.19, 31 USPQ2d at 1556 n.19 in which the Federal Circuit recognized the confusion:

The Supreme Court has not been clear . . . as to whether such subject matter is excluded from the scope of 101 because it represents laws of nature, natural phenomena, or abstract ideas. See Diehr, 450 U.S. at 186 (viewed mathematical algorithm as a law of nature); Gottschalk v. Benson, 409 U.S. 63, 71-72 (1972) (treated mathematical algorithm as an “idea”). The Supreme Court also has not been clear as to exactly what kind of mathematical subject matter may not be patented. The Supreme Court has used, among others, the terms “mathematical algorithm,” “mathematical formula,” and “mathematical equation” to describe types of mathematical subject matter not entitled to patent protection standing alone. The Supreme Court has not set forth, however, any consistent or clear explanation of what it intended by such terms or how these terms are related, if at all.

Certain mathematical algorithms have been held to be nonstatutory because they represent a mathematical definition of a law of nature or a natural phenomenon. For example, a mathematical algorithm representing the formula E = mc2 is a “law of nature” — it defines a “fundamental scientific truth” (i.e., the relationship between energy and mass). To comprehend how the law of nature relates to any object, one invariably has to perform certain steps (e.g., multiplying a number representing the mass of an object by the square of a number representing the speed of light). In such a case, a claimed process which consists solely of the steps that one must follow to solve.. the mathematical representation of E = mc2 is indistinguishable from the law of nature and would “preempt” the law of nature. A patent cannot be granted on such a process.

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