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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.

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

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

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

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

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@@ Line 3: / Line 3: @@
 ==[[MPEP 2107|2107 Guidelines for Examination of Applications for Compliance with the Utility Requirement]]==
-<noinclude>__TOC__</noinclude>
+<noinclude><div class="noautonum">__TOC__</div></noinclude>
 EXAMINATION GUIDELINES FOR THE
@@ Line 13: / Line 13: @@
 requirement of 35 U.S.C. 101 and 112, first paragraph.
-'''(A)Read the claims and the supporting written
+'''(A) Read the claims and the supporting written  description:'''
-description.'''
-(1)Determine what the applicant has claimed,
+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
+(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
+(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. An invention has a well-
+based on lack of utility.
-established utility if (i) a person of ordinary skill in
-the art would immediately appreciate why the invention
+'''Criteria for a well-established utility:'''
-is useful based on the characteristics of the invention
+(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) the utility is specific, substantial,
+process), and
-and credible.
-'''(B)Review the claims and the supporting written
+(ii) Presence of specific, substantial and credible utility.
-description to determine if the applicant has asserted
-for the claimed invention any specific and substantial
-utility that is credible''':
-(1)If the applicant has asserted that the
-claimed invention is useful for any particular practical
-purpose (i.e., it has a “specific and substantial utility”)
-and the assertion would be considered credible by a
-person of ordinary skill in the art, do not impose a
-rejection based on lack of utility.
-(i)A claimed invention must have a specific
+'''(B) Determine if the applicant has asserted for the claimed invention any specific and substantial utility that is credible:'''
-and substantial utility. This requirement excludes
-“throw-away,” “insubstantial,” or “nonspecific” utilities,
+An assertion of the usefulness of the claimed invention which is
-such as the use of a complex invention as landfill,
+considered credible by a person of ordinary skill, eliminates the imposition of
-as a way of satisfying the utility requirement of
+rejection based on lack of utility.
-U.S.C. 101.
-(ii)Credibility is assessed from the perspective
+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
+the applicant’s assertions. An applicant need only provide
-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.
-(2)If no assertion of specific and substantial
+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
+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
+invention as claimed lacks utility.
-claims under 35 U.S.C. 112, first paragraph, on the
+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
+U.S.C. 101 rejection should incorporate by reference
-U.S.C. 101 rejection should incorporate by reference
+the grounds of the corresponding 35 U.S.C. 101 rejection.
-the grounds of the corresponding 35 U.S.C. 101rejection.
-(3)If the applicant has not asserted any specific
+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
@@ Line 88: / Line 87: @@
 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
+specific and substantial utility.
+The 35 U.S.C. 101 and
 rejections shift the burden of coming forward
 with evidence to the applicant to:
@@ Line 98: / Line 100: @@
 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
+at the time of filing.
+The examiner should
 review any subsequently submitted evidence of utility
 using the criteria outlined above. The examiner
@@ Line 109: / Line 113: @@
 claimed invention.
-(C)Any rejection based on lack of utility
+'''(C) Any rejection based on lack of utility should include a detailed explanation why the claimed invention has no specific and substantial credible 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
+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:
@@ Line 148: / Line 142: @@
 art.
-(2)Where the asserted specific and substantial
+'''(2)Where the asserted specific and substantial utility is not credible:'''
-utility is not credible, a prima facie showing of no
+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
+claimed invention.
+The prima facie showing must
 contain the following elements:
@@ Line 168: / Line 165: @@
 art.
-(3)Where no specific and substantial utility
+'''(3)Where no specific and substantial utility is disclosed or is well-established:'''
-is disclosed or is well-established, a prima facie
+a prima facie
 showing of no specific and substantial utility need
 only establish that applicant has not asserted a utility
@@ Line 175: / Line 173: @@
 known well-established utility.
-(D)A rejection based on lack of utility should
-not be maintained if an asserted utility for the claimed
+'''(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,
+invention would be considered specific, substantial, and credible by a person of ordinary skill in the art in
-and credible by a person of ordinary skill in the art in
+view of all evidence of record.'''
-view of all evidence of record.
 Office personnel are reminded that they must treat
@@ Line 186: / Line 183: @@
 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,
+doubt the credibility of such a statement.
-Office personnel must accept an opinion from a qualified
+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
@@ Line 200: / Line 198: @@
 in the form of a declaration under 37 CFR
 .132 or a patent or a printed publication that rebuts
-the basis or logic of the prima facie showing. If the
+the basis or logic of the prima facie showing.
-applicant responds to the prima facie rejection, the
+If the applicant responds to the prima facie rejection, the
 Office personnel should review the original disclosure,
 any evidence relied upon in establishing the
@@ Line 215: / Line 214: @@
 lack of utility be maintained.
-If the applicant satisfactorily rebuts a prima facierejection based on lack of utility under 35 U.S.C. 101,
+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.
-.01General Principles Governing
+===2107.01 General Principles Governing Utility Rejections [R-5]===
-Utility Rejections [R-5]
-U.S.C. 101. Inventions patentable
-Whoever invents or discovers any new and useful process,
+{{Statute|35 U.S.C. 101 Inventions patentable.}}
-machine, manufacture, or composition of matter, or any new and
+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.
-useful improvement thereof may obtain a patent therefor, subject
+|}
-to the conditions and requirements of this title.
-See MPEP § 2107 for guidelines for the examination
-of applications for compliance with the utility
-requirement of 35 U.S.C. 101.
-The Office must examine each application to
+'''As interpreted by the  Federal courts, 35 U.S.C. 101 has two purposes.'''
-ensure compliance with the “useful invention” or utility
-requirement of 35 U.S.C. 101. In discharging this
+- First,  35 U.S.C. 101 defines which categories of inventions
-obligation, however, Office personnel must keep in
-mind several general principles that control application
-of the utility requirement. As interpreted by the
-Federal courts, 35 U.S.C. 101 has two purposes. First,
-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. See Diamond v.
+or a process cannot be patented.
-Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980);
-Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981).
+- Second, 35 U.S.C. 101 serves to ensure that patents
-Second, 35 U.S.C. 101 serves to ensure that patents
 are granted on only those inventions that are “useful.”
-This second purpose has a Constitutional footing —
-Article I, Section 8 of the Constitution authorizes
-Congress to provide exclusive rights to inventors to
-promote the “useful arts.” See Carl Zeiss Stiftung v.
-Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094
-(Fed. Cir. 1991). Thus, to satisfy the requirements of
-U.S.C. 101, an applicant must claim an invention
-that is statutory subject matter and must show that the
-claimed invention is “useful” for some purpose either
-explicitly or implicitly. Application of this latter element
-of 35 U.S.C. 101 is the focus of these guidelines.
-Deficiencies under the “useful invention” requirement
-of 35 U.S.C. 101 will arise in one of two forms.
+'''Deficiencies under the “useful invention” requirement  of 35 U.S.C. 101 will arise in one of two forms.'''
-The first is where it is not apparent why the invention
-is “useful.” This can occur when an applicant fails to
+'''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. Brenner v. Manson, 383 U.S.
+field of the invention.
-, 148 USPQ 689 (1966); In re Fisher, 421 F.3d
-, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler,
+'''2- Where an assertion of specific and substantial utility for the invention made by an applicant is not credible.'''
-F.2d 1197, 26 USPQ2d 1600 (Fed. Cir.
-). The second type of deficiency arises in the rare
-instance where an assertion of specific and substantial
-utility for the invention made by an applicant is not
-credible.
-I.SPECIFIC AND SUBSTANTIAL REQUIREMENTS
+'''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
+used with reference to the utility requirement can
-reference to the utility requirement can
+be a difficult term  to define.
-be a difficult term
-to define. Brenner v. Manson, 383
+Where an applicant has set forth a specific and substantial
-U.S. 519, 529, 148 USPQ 689, 693 (1966) (simple
-everyday word like “useful” can be “pregnant with
-ambiguity when applied to
-the
-facts of life.”). 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
+utility was inaccurate.
+For example, in Nelsonv. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA
 ), the court reversed a finding by the Office that
 the applicant had not set forth a “practical” utility
@@ Line 301: / Line 271: @@
 asserted that the composition was “useful” in a particular
 pharmaceutical application and provided evidence
-to support that assertion. Courts have used the
+to support that assertion.
-labels “practical utility,” “substantial utility,” or “specific
+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
+invention” requirement of 35 U.S.C. 101.
-of Customs and Patent Appeals has stated:
+The Court of Customs and Patent Appeals has stated:
 Practical utility is a shorthand way of attributing “real-
@@ Line 312: / Line 285: @@
 manner which provides some immediate benefit to the
 public.
-Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881,
-(CCPA 1980).
 Practical considerations require the Office to rely
@@ Line 328: / Line 298: @@
 A “specific utility” is specific to the subject matter
 claimed and can “provide a well-defined and particular
-benefit to the public.” In re Fisher, 421 F.3d
+benefit to the public.
-, 1371, 76 USPQ2d 1225, 1230 (Fed. Cir.
-). This contrasts with a general utility that
+This contrasts with a general utility that
 would be applicable to the broad class of the invention.
 Office personnel should distinguish between situations
@@ Line 337: / Line 307: @@
 where the applicant merely indicates that the invention
 may prove useful without identifying with specificity
-why it is considered useful. For example,
+why it is considered useful.
-indicating that a compound may be useful in treating
+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. See, e.g.,
+define a specific utility for the compound.
-In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967);
-In re Joly, 376
-F.2d 906, 153 USPQ 45 (CCPA
-). Similarly, a claim to a polynucleotide whose
+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.
-See In re Fisher, 421 F.3d at 1374, 76 USPQ2d
-at 1232 (“Any EST [expressed sequence tag] transcribed
+A general statement of diagnostic utility,
-from any gene in the maize genome has the
-potential to perform any one of the alleged uses….
-Nothing about [applicant’s] seven alleged uses set the
-five claimed ESTs apart from the more than 32,000
-ESTs disclosed in the [ ] application or indeed from
-any EST derived from any organism. Accordingly, we
-conclude that [applicant] has only disclosed general
-uses for its claimed ESTs, not specific ones that satisfy
-§ 101.”). A general statement of diagnostic utility,
 such as diagnosing an unspecified disease, would
 ordinarily be insufficient absent a disclosure of what
@@ Line 378: / Line 332: @@
 a general statement that makes it clear that a “useful”
 invention may arise from what has been disclosed by
-the applicant. Knapp v. Anderson, 477 F.2d 588, 177
+the applicant.
-USPQ 688 (CCPA 1973).
 B.Substantial Utility
-“[A]n application must show that an invention is
+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
@@ Line 389: / Line 342: @@
 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
+available benefit to the public.”
-at 1371, 76 USPQ2d at 1230. The claims at issue in
+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
+are expressed in a cell.
-claimed ESTs can be used only to gain further information
-about the underlying genes and the proteins
+The court held that “the claimed ESTs can be used only to gain further information
-encoded for by those genes. The claimed ESTs themselves
+about the underlying genes and the proteins encoded for by those genes.
-are not an end of [applicant’s] research effort,
+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
+for a practical utility….
+Applicant does not identify
 the function for the underlying protein-encoding
 genes. Absent such identification, we hold that the
@@ Line 406: / Line 363: @@
 to the point of providing an immediate, well-
 defined, real world benefit to the public meriting the
-grant of a patent.” Id. at 1376, 76 USPQ2d at 1233-
+grant of a patent.”
-). Thus a “substantial utility” defines a “real
+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
@@ Line 420: / Line 379: @@
 would also define a “real world” context of use in
 identifying potential candidates for preventive measures
-or further monitoring. On the other hand, the
+or further monitoring.
-following are examples of situations that require or
+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,
@@ Line 449: / Line 409: @@
 services based on the claimed invention must be “currently
 available” to the public in order to satisfy the
-utility requirement. See, e.g., Brenner v. Manson,
+utility requirement.
-U.S. 519, 534-35, 148 USPQ 689, 695
-(1966).
 Rather, any reasonable use that an applicant
 has identified for the invention that can be viewed
-as
+as providing a public benefit should be accepted as
-providing a public benefit should be accepted as
 sufficient, at least with regard to defining a “substantial”
 utility.
@@ Line 472: / Line 422: @@
 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
+the setting in which the invention is to be used.
-example is inventions to be used in a research or laboratory
+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
+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
@@ Line 497: / Line 450: @@
 operate to produce the results claimed by the patent
 applicant) is not a “useful” invention in the meaning
-of the patent law. See, e.g., Newman v. Quigg,
+of the patent law.
-F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed.
+Wholly inoperative cases are rarest to find. A small degree  of utility is sufficient in an application. The claimed invention must
-Cir. 1989); In re Harwood, 390 F.2d 985, 989,
+only be capable of performing some beneficial function . An invention does not lack utility merely
-USPQ 673, 676 (CCPA 1968) (“An inoperative
-invention, of course, does not satisfy the requirement
-of 35 U.S.C. 101 that an invention be useful.”). However,
-as the Federal Circuit has stated, “[t]o violate
-[35
-U.S.C.] 101 the claimed device must be totally
-incapable of achieving a useful result.” Brooktree
-Corp. v. Advanced Micro Devices, Inc., 977 F.2d
-, 1571, 24 USPQ2d 1401, 1412 (Fed. Cir. 1992)
-(emphasis added). See also E.I. du Pont De Nemours
-and Co. v. Berkley and Co., 620 F.2d 1247, 1260 n.17,
-USPQ 1, 10 n.17 (8th Cir. 1980) (“A small degree
-of utility is sufficient . . . 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
+patent lacks perfection or performs crudely.
-commercially successful product is not required . . .
-Nor is it essential that the invention accomplish all its
+A commercially successful product is not required nor is it essential that the invention accomplish all its
-intended functions . . . or operate under all conditions
+intended functions or operate under all conditions. Partial success is sufficient to demonstrate patentable
-. . . partial success being sufficient to demonstrate patentable
+utility.
-utility . . . In short, the defense of non-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.
-See In re Brana, 51 F.3d 1560, 34 USPQ2d 1436
-(Fed. Cir. 1995); In re Gardner, 475 F.2d 1389,
-USPQ 396 (CCPA), reh’g denied, 480 F.2d 879
-(CCPA 1973); In re Marzocchi, 439 F.2d 220,
-USPQ 367 (CCPA 1971).
 Situations where an invention is found to be “inoperative”
@@ Line 543: / Line 475: @@
 “incredible in the light of the knowledge of the art, or
 factually misleading” when initially considered by the
-Office. In re Citron, 325 F.2d 248, 253, 139 USPQ
+Office.
-, 520 (CCPA 1963). Other cases suggest that on
+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. In re Sichert,
+were actually present in the invention.
-F.2d 1154, 196 USPQ 209 (CCPA 1977). However
-cast, the underlying finding by the court in these
+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
+work as the inventor claimed it did.
-many labels to describe a single problem (e.g., a false
+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
+based on the “utility” requirement.
-cases include: an invention asserted to change the
+Examples of such
+cases include:
+- an invention asserted to change the
 taste of food using a magnetic field (Fregeau v. Mossinghoff,
 F.2d 1034, 227 USPQ 848 (Fed. Cir.
-)), a perpetual motion machine (Newman v.
+)),
+- a perpetual motion machine (Newman v.
 Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir.
 )), a flying machine operating on “flapping or
 flutter function” (In re Houghton, 433 F.2d 820,
+USPQ 687 (CCPA 1970)),
-USPQ 687 (CCPA 1970)), a “cold fusion” process
-for producing energy (In re Swartz, 232 F.3d 862,
+- 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)),
-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
+(CCPA 1963)), and
+a method of controlling the aging
 process (In re Eltgroth, 419 F.2d 918, 164
 USPQ 221
-(CCPA 1970)). These examples are fact specific and
+(CCPA 1970)).
-should not be applied as a per se rule. Thus, in view of
-the rare nature of such cases, Office personnel should
-not label an asserted utility “incredible,” “speculative”
-or otherwise unless it is clear that a rejection
-based on “lack of utility” is proper.
-III.THERAPEUTIC OR PHARMACOLOGICAL
+'''III.THERAPEUTIC OR PHARMACOLOGICAL  UTILITY'''
-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. In re Chilowsky, 229 F.2d
+other field of technology.
-, 461-2, 108 USPQ 321, 325 (CCPA 1956)
-(“There appears to be no basis in the statutes or decisions
+Pharmacological or therapeutic inventions that provide
-for requiring any more conclusive evidence of
-operativeness in one type of case than another. The
-character and amount of evidence needed may vary,
-depending on whether the alleged operation described
-in the application appears to accord with or to contravene
-established scientific principles or to depend
-upon principles alleged but not generally recognized,
-but the degree of certainty as to the ultimate fact of
-operativeness or inoperativeness should be the same
-in all cases”); In re Gazave, 379 F.2d 973, 978, 154
-USPQ 92, 96 (CCPA 1967) (“Thus, in the usual case
-where the mode of operation alleged can be readily
-understood and conforms to the known laws of physics
-and chemistry, operativeness is not questioned,
-and no further evidence is required.”). As such, pharmacological
-or therapeutic inventions that provide
 any “immediate benefit to the public” satisfy
+U.S.C. 101.
-U.S.C. 101. The utility being asserted in Nelsonrelated to a compound with pharmacological utility.
-Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881,
+In order to determine the patentability of pharmacological or therapeutic invention,
-(CCPA 1980). Office personnel should rely on
+the Office Personnel are advised to rely on Nelson and other cases as providing general guidance when evaluating the utility of an invention.
-Nelson and other cases as providing general guidance
-when evaluating the utility of an invention that is
-based on any therapeutic, prophylactic, or pharmacological
-activities of that invention.
-Courts have repeatedly found that the mere identification
+The Court of Customs and Patent Appeals held in Nelson v. Bowler:
-of a pharmacological activity of a compound
-that is relevant to an asserted pharmacological use
-provides an “immediate benefit to the public” and
-thus satisfies the utility requirement. As the Court of
-Customs and Patent Appeals held in Nelson v. Bowler:
 Knowledge of the pharmacological activity of any compound
@@ Line 644: / Line 550: @@
 utility.
-Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881,
+{{Statute|Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980)}}
-(CCPA 1980).
 In Nelson v. Bowler, the court addressed the practical
 utility requirement in the context of an interference
-proceeding. Bowler challenged the patentability
+proceeding.
+Bowler challenged the patentability
 of the invention claimed by Nelson on the basis
-that
+that Nelson had failed to sufficiently and persuasively
-Nelson had failed to sufficiently and persuasively
 disclose in his application a practical utility for the
-invention. Nelson had developed and claimed a class
+invention.
+Nelson had developed and claimed a class
 of synthetic prostaglandins modeled on naturally
 occurring prostaglandins. Naturally occurring prostaglandins
@@ Line 661: / Line 569: @@
 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
+the ability to raise or lower blood pressure, etc.).
-support the utility he identified in his disclosure, Nelson
+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
+occurring prostaglandins.
-that
+The court concluded that
 Nelson had satisfied the practical utility requirement
 in identifying the synthetic prostaglandins as
@@ Line 675: / Line 585: @@
 basis for Nelson’s assertions that the compounds
 were pharmacologically active.
+|}
-In In re Jolles, 628 F.2d 1322, 206 USPQ 885
-(CCPA 1980), an inventor claimed protection for
-pharmaceutical compositions for treating
-leukemia.
-The active ingredient in the compositions
+{{Statute|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
@@ Line 696: / Line 601: @@
 that showed the relevant pharmacological
 activity.
+|}
-In Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739
+'''Utility of Therapeutic inventions at a very early stage of development'''
-(Fed. Cir. 1985), the Federal Circuit affirmed a finding
-by the Board of Patent Appeals and Interferences
-that a pharmacological utility had been disclosed in
-the application of one party to an interference proceeding.
-The invention that was the subject of the
-interference count was a chemical compound used for
-treating blood disorders. Cross had challenged the
-evidence in Iizuka’s specification that supported the
-claimed utility. However, the Federal Circuit relied
-extensively on Nelson v. Bowler in finding that
-Iizuka’s application had sufficiently disclosed a pharmacological
-utility for the compounds. It distinguished
-the case from cases where only a generalized
-“nebulous” expression, such as “biological properties,”
-had been disclosed in a specification. Such
-statements, the court held, “convey little explicit indication
-regarding the utility of a compound.” Cross,
-F.2d at 1048, 224 USPQ at 745 (citing In re Kirk,
-F.2d 936, 941, 153 USPQ 48, 52 (CCPA 1967)).
-Similarly, courts have found utility for therapeutic
+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.
-The Federal Circuit, in Cross v. Iizuka, 753 F.2d
-, 1051, 224 USPQ 739, 747-48 (Fed. Cir. 1985),
-commented on the significance of data from in vitrotesting that showed pharmacological activity:
-We perceive no insurmountable difficulty, under appropriate
+A successful vitro testing shall marshal resources and direct the expenditure
-circumstances, in finding that the first link in the
-screening chain, in vitro testing, may establish a practical
-utility for the compound in question. Successful in vitrotesting will 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
@@ Line 744: / Line 629: @@
 FDA approval, however, is not a prerequisite for finding a
 compound useful within the meaning of the patent laws.
-Scott [v. Finney], 34 F.3d 1058, 1063, 32 USPQ2d 1115,
+Usefulness in patent law, and in particular in the context of pharmaceutical inventions,
-[(Fed.Cir. 1994)]. 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. Were we to require Phase II testing in
+to humans.
-order to prove utility, the associated costs would prevent
+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
@@ Line 758: / Line 643: @@
 cancer.
-In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.
-Cir. 1995). Accordingly, Office personnel should not
-construe 35 U.S.C. 101, under the logic of “practical”
-utility or otherwise, to require that an applicant demonstrate
-that a therapeutic agent based on a claimed
-invention is a safe or fully effective drug for humans.
-See, e.g., In re Sichert, 566 F.2d 1154, 196 USPQ 209
-(CCPA 1977); In re Hartop, 311 F.2d 249, 135 USPQ
-(CCPA 1962); In re Anthony, 414 F.2d 1383,
-USPQ 594 (CCPA 1969); In re Watson, 517 F.2d
-, 186 USPQ 11 (CCPA 1975).
 These general principles are equally applicable to
@@ Line 780: / Line 653: @@
 under 35 U.S.C. 101.
- See MPEP § 2107.03 for special considerations for
-asserted therapeutic or pharmacological utilities.
 IV.RELATIONSHIP BETWEEN 35 U.S.C. 112,
@@ Line 788: / Line 659: @@
 A deficiency under the utility prong of 35 U.S.C.
 also creates a deficiency under 35 U.S.C. 112,
-first paragraph. See In re Brana, 51 F.3d 1560, 34
+first paragraph. If a claimed invention does not have
-USPQ2d 1436 (Fed. Cir. 1995); In re Jolles, 628 F.2d
+utility, the specification cannot enable one to use it.
-, 1326 n.10, 206 USPQ 885, 889 n.11 (CCPA
-); In re Fouche, 439 F.2d 1237, 1243, 169 USPQ
-, 434 (CCPA 1971) (“If such compositions are in
-fact useless, appellant’s specification cannot have
+Courts have also cast the
-taught how to use them.”). Courts have also cast the
 U.S.C. 101/35 U.S.C. 112 relationship such that 35
 U.S.C. 112 presupposes compliance with 35 U.S.C.
-. See In re Ziegler, 992
+.
-F.2d 1197, 1200-1201, 26
-USPQ2d 1600, 1603 (Fed. Cir. 1993) (“The how to
+If the application fails as a matter of
-use prong of section 112 incorporates as a matter of
+fact to satisfy 35 U.S.C. § 101, then the application
-law the requirement of 35 U.S.C. 101 that the specification
-disclose as a matter of fact a practical utility for
-the invention. ... 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. §
-.”); In re Kirk, 376 F.2d 936, 942, 153 USPQ 48,
+.
-(CCPA 1967) (“Necessarily, compliance with §
-requires a description of how to use presently useful
-inventions, otherwise an applicant would anomalously
+As such, a rejection properly imposed
-be required to teach how to use a useless
-invention.”). For example, the Federal Circuit noted,
-“[o]bviously, if a claimed invention does not have
-utility, the specification cannot enable one to use it.”
-In re Brana, 51
-F.3d 1560, 34 USPQ2d 1436 (Fed.
-Cir. 1995). 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,
@@ Line 831: / Line 682: @@
 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. 101should be accompanied by a rejection based on 35
+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
+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
+basis and conclusions set forth in the 35 U.S.C. 101rejection.
-U.S.C. 112, first paragraph, rejection
+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.
-, first paragraph. A 35
+, first paragraph.
-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
+U.S.C. 101. In other words, Office personnel
-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
@@ Line 860: / Line 715: @@
 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
+utility.
-fully supported by the disclosure (In re Vaeck,
+These matters include :
-F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir.
-)), whether the applicant has provided an
+- whether the claims are
-enabling disclosure of the claimed subject matter (In
+fully supported by the disclosure
-re Wright, 999 F.2d 1557, 1561-1562, 27 USPQ2d
-, 1513 (Fed. Cir. 1993)), whether the applicant
+- whether the applicant has provided an
-has provided an adequate written description of the
+enabling disclosure of the claimed subject matter
-invention and whether the applicant has disclosed the
-best mode of practicing the claimed invention (Chemcast
+- whether the applicant has provided an adequate written description of the
-Corp. v. Arco Indus. Corp., 913 F.2d 923, 927-
+invention and
-, 16 USPQ2d 1033, 1036-1037 (Fed. Cir. 1990)).
-See also Transco Products Inc. v. Performance Contracting
+- whether the applicant has disclosed the
-Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir.
+best mode of practicing the claimed invention
-); Glaxo Inc. v. Novopharm Ltd. 52 F.3d 1043,
+The fact that an
-USPQ2d 1565 (Fed. Cir. 1995). 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
+U.S.C. 112, first paragraph.
-U.S.C. 112, first paragraph. For example, if an
+For example, if an
 applicant has claimed a process of treating a certain
 disease condition with a certain compound and provided
@@ Line 891: / Line 746: @@
 art would have to engage in an undue amount of
 experimentation, the claim may be defective under
+U.S.C. 112, but not 35 U.S.C. 101.
-U.S.C. 112, but not 35 U.S.C. 101. To avoid confusion
-during examination, any rejection under
+To avoid confusion during examination, any rejection under
+U.S.C. 112, first paragraph, based on
-U.S.C. 112, first paragraph, based on
 grounds
 other than “lack of utility” should be imposed
@@ Line 902: / Line 756: @@
 paragraph.
+===2107.02 Procedural Considerations Related to Rejections for Lack of Utility [R-5]===
+I.THE CLAIMED INVENTION IS THE FOCUS
+OF THE UTILITY REQUIREMENT
-.02Procedural Considerations Related
-to Rejections for Lack of
-Utility [R-5]
-I.THE CLAIMED INVENTION IS THE FOCUS
-OF THE UTILITY REQUIREMENT
 The claimed invention is the focus of the assessment
@@ Line 918: / Line 765: @@
 requirement. Each claim (i.e., each “invention”),
 therefore, must be evaluated on its own merits for
-compliance with all statutory requirements. Generally
+compliance with all statutory requirements.
-speaking, however, a dependent claim will define an
+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
+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
@@ Line 940: / Line 790: @@
 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
@@ Line 950: / Line 802: @@
 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. See, e.g., Raytheon v.
+invention lacking in utility.
-Roper, 724 F.2d 951, 958, 220 USPQ 592, 598 (Fed.
-Cir. 1983), cert. denied, 469 U.S. 835 (1984) (“When
+'''Example:'''
-a properly claimed invention meets at least one stated
-objective, utility under 35 U.S.C. 101 is clearly
+- '''USPQ 665, 668 (CCPA 1964)''' :
-shown.”); In re Gottlieb, 328 F.2d 1016, 1019,
+"Having found
-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.”); In re Malachowski,
+as possibly useful.”;
-F.2d 1402, 189 USPQ 432 (CCPA 1976); Hoffman
-v. Klaus, 9 USPQ2d 1657 (Bd. Pat. App. & Inter.
-). Thus, if applicant makes one credible assertion
-of utility, utility for the claimed invention as a whole
-is established.
 Statements made by the applicant in the specification
@@ Line 973: / Line 818: @@
 before the Office cannot, standing alone, be the basis
 for a lack of utility rejection under 35 U.S.C. 101 or
-U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-
+U.S.C. 112.
-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553,
-USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not
-required that a particular characteristic set forth in the
+An applicant may include statements
-prosecution history be achieved in order to satisfy
-U.S.C. 101.). An applicant may include statements
 in the specification whose technical accuracy cannot
 be easily confirmed if those statements are not necessary
@@ Line 990: / Line 832: @@
 be especially careful not to read into a claim
 unclaimed results, limitations or embodiments of an
-invention. See Carl Zeiss Stiftung v. Renishaw PLC,
+invention. Doing so can inappropriately change the relationship
-F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In
-re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA
-). 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
+'''II.IS THERE AN ASSERTED OR WELL-ESTABLISHED
 UTILITY FOR THE
-CLAIMED INVENTION?
+CLAIMED INVENTION?'''
 Upon initial examination, the examiner should
 review the specification to determine if there are
-any
+any statements asserting that the claimed invention is
-statements asserting that the claimed invention is
 useful for any particular purpose. A complete disclosure
 should include a statement which identifies a
@@ Line 1,011: / Line 850: @@
+'''A.An Asserted Utility Must Be Specific and Substantial'''
-A.An Asserted Utility Must Be Specific and
-Substantial
 A statement of specific and substantial utility
@@ Line 1,031: / Line 865: @@
 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. 101and 35 U.S.C. 112, first paragraph. In such cases, the
+the claimed invention deficient under 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph.
-applicant has failed to identify a “specific and substantial
+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
@@ Line 1,038: / Line 874: @@
 composition with that activity is believed to be useful
 fails to set forth a “specific and substantial utility.”
-Brenner v. Manson, 383 US 519, 148 USPQ 689
-(1966) (general assertion of similarities to known
+'''USPQ2d 1600, 1604 (Fed. Cir. 1993):'''
-compounds known to be useful without sufficient corresponding
-explanation why claimed compounds are
+disclosure that composition is “plastic-like” and can form
-believed to be similarly useful insufficient under
-U.S.C. 101); In re Ziegler, 992 F.2d 1197, 1201,
-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
+utility for invention;
-USPQ 48 (CCPA 1967) (indication that compound is
+'''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). See also In re Joly,
+insufficient standing alone.
-F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v.
+A disclosure that identifies a particular biological activity of a
-Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165
-(CCPA 1973) (contrasting description of invention as
-sedative which did suggest specific utility to general
-suggestion of “pharmacological effects on the central
-nervous system” which did not). In contrast, 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
@@ Line 1,069: / Line 896: @@
 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
+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
@@ Line 1,078: / Line 907: @@
 of 35 U.S.C. 112, first paragraph.
-B.No Statement of Utility for the Claimed
+'''B.No Statement of Utility for the Claimed
 Invention in the Specification Does Not Per Se
-Negate Utility
+Negate Utility'''
 Occasionally, an applicant will not explicitly state
@@ Line 1,088: / Line 917: @@
 utility for the claimed invention in the specification,
 Office personnel should determine if the
-claimed invention has a well-established utility. An
+claimed invention has a well-established utility.
-invention has a well-established utility if (i) a person
-of ordinary skill in the art would immediately appreciate
+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,
+of a product or process), and
-substantial, and credible. If an invention has a well-
-established utility, rejections under 35 U.S.C. 101 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
 U.S.C. 112, first paragraph, based on lack of utility
-should not be imposed. In re Folkers, 344 F.2d 970,
+should not be imposed.
-USPQ 390 (CCPA 1965). For example, if an
+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
@@ Line 1,114: / Line 948: @@
 application under 35 U.S.C. 101 and under 35 U.S.C.
 , first paragraph, as failing to identify a specific
-and substantial utility for the claimed invention. The
+and substantial utility for the claimed invention.
-rejection should clearly indicate that the basis of the
+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. See
+utility can be found in the specification as filed.
-MPEP § 2701.
 If the applicant subsequently indicates why the
@@ Line 1,136: / Line 964: @@
-III.EVALUATING THE CREDIBILITY OF AN
+'''III.EVALUATING THE CREDIBILITY OF AN
-ASSERTED UTILITY
+ASSERTED UTILITY'''
-A.An Asserted Utility Creates a Presumption of
+'''A.An Asserted Utility Creates a Presumption of Utility'''
-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. See,
+satisfy the utility requirement of 35 U.S.C. 101.
-e.g., In re Jolles, 628 F.2d 1322, 206 USPQ 885
-(CCPA 1980); In re Irons, 340 F.2d 974, 144 USPQ
-(CCPA 1965); In re Langer, 503 F.2d 1380, 183
-USPQ 288 (CCPA 1974); In re Sichert, 566 F.2d
-, 1159, 196 USPQ 209, 212-13 (CCPA 1977). As
-the Court of Customs and Patent Appeals stated in In
-re Langer:
 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 mustbe taken as sufficient to satisfy the utility requirement of §
+in scope to the subject matter sought to be patented must
+be taken as sufficient to satisfy the utility requirement of §
 for the entire claimed subject matter unless there is a
 reason for one skilled in the art to question the objective
@@ Line 1,175: / Line 996: @@
 , 223, 169 USPQ 367, 369 (CCPA 1971), namely:
-[A] specification disclosure which contains a teaching of
+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
@@ Line 1,183: / Line 1,004: @@
 reason to doubt the objective truth of the statements contained
 therein which must be relied on for enabling support.
-(emphasis added).
 Thus, Langer and subsequent cases direct the
 Office to presume that a statement of utility made by
-an applicant is true. See In re Langer, 503 F.2d at
+an applicant is true.
-, 183 USPQ at 297; In re Malachowski, 530 F.2d
-, 1404, 189 USPQ 432, 435 (CCPA 1976); In re
+For obvious reasons of efficiency and in deference
-Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir.
-). 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,
@@ Line 1,210: / Line 1,029: @@
 Compliance with 35 U.S.C. 101 is a question of
-fact. Raytheon v. Roper, 724 F.2d 951, 956, 220
+fact. Thus, to overcome the presumption
-USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469
-U.S. 835 (1984). Thus, to overcome the presumption
 of truth that an assertion of utility by the applicant
 enjoys, Office personnel must establish that it is
@@ Line 1,315: / Line 1,132: @@
 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. See MPEP §
+asserted utility under 35 U.S.C. 101.
-.03 for additional guidance with regard to therapeutic
-or pharmacological utilities.
 IV.INITIAL BURDEN IS ON THE OFFICE
@@ Line 1,462: / Line 1,278: @@
-the rejection under 35 U.S.C. 101 “in view of the art
+the rejection under 35 U.S.C. 101 “in view of the art knowledge of the lack of a cure for cancer and the
-knowledge of the lack of a cure for cancer and the
 absence of any clinical data to substantiate the allegation.”
 F.2d at 252, 139 USPQ at 519 (emphasis in
@@ Line 1,627: / Line 1,442: @@
 more likely than not true.
-.03Special Considerations for Asserted
+===2107.03 Special Considerations for Asserted Therapeutic or Pharmacological Utilities===
-Therapeutic or Pharmacological
-Utilities
 The Federal courts have consistently reversed
@@ Line 1,648: / Line 1,462: @@
 to an asserted therapeutic use if there is a reasonable
 correlation between the activity in question
-and the asserted utility. Cross v. Iizuka, 753 F.2d 1040,
+and the asserted utility.
-USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d
-, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler,
+An applicant can establish this reasonable correlation by relying
-F.2d 853, 206 USPQ 881
+on
-(CCPA 1980). An applicant
-can establish this reasonable correlation by relying
+- statistically relevant data documenting the
-on statistically relevant data documenting the
+activity of a compound or composition,
-activity of a compound or composition, arguments or
-reasoning, documentary evidence (e.g., articles in scientific
+- arguments or
-journals), or any combination thereof. The
+reasoning,
-applicant does not have to prove that a correlation
+-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
@@ Line 1,665: / Line 1,483: @@
 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. Nelsonv. Bowler, 626 F.2d 853, 857, 206 USPQ 881, 884
+between the activity and the asserted use.
-(CCPA 1980).
 II.STRUCTURAL SIMILARITY TO COMPOUNDS
@@ Line 1,675: / Line 1,493: @@
 therapeutic or pharmacological utility as being supportive
 of an assertion of therapeutic utility for a
-new
+new compound.
-compound. In In re Jolles, 628 F.2d 1322, 206
+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
+a close structural relationship to daunorubicin and
-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
+was presented in conjunction with evidence demonstrating
-presented in conjunction with evidence demonstrating
 substantial activity of the claimed
-compounds
+compounds in animals customarily employed for
-in animals customarily employed for
+screening anticancer agents.
-screening anticancer agents. Such evidence should be
+Such evidence should be
 given appropriate weight in determining whether one
 skilled in the art would find the asserted utility credible.
@@ Line 1,714: / Line 1,526: @@
 combination thereof almost invariably will be sufficient
 to establish therapeutic or pharmacological utility
-for a compound, composition or process. A
+for a compound, composition or process.
-cursory review of cases involving therapeutic inventions
+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. 101based on inoperability. Most striking is the fact that in
+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. See, e.g., In re Brana, 51 F.3d
+rejection was reversed.
-, 34 USPQ 1436 (Fed. Cir. 1995); Cross v. Iizuka,
-F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re
-Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
-Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881,
-(CCPA 1980); In re Malachowski, 530 F.2d 1402,
-USPQ 432 (CCPA 1976); In re Gaubert, 530 F.2d
-, 189 USPQ 432 (CCPA 1975); In re Gazave,
-F.2d 973, 154 USPQ 92 (CCPA 1967); In re Hartop,
-F.2d 249, 135 USPQ 419 (CCPA 1962); In re
-Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961).
 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
+the court.
+In re Citron, 325 F.2d 248, 253, 139 USPQ
 , 520 (CCPA 1963) (therapeutic utility for an
 uncharacterized biological extract not supported or
-scientifically credible); In re Buting, 418 F.2d 540,
+scientifically credible);
+In re Buting, 418 F.2d 540,
 , 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,
+in treating disparate types of cancers);
+In re Novak,
 F.2d 924, 134 USPQ 335 (CCPA 1962) (claimed
 compounds did not have capacity to effect physiological
-activity upon which utility claim based). Contrast,
+activity upon which utility claim based).
+Contrast,
 however, In re Buting to In re Gardner, 475 F.2d
 , 177 USPQ 396 (CCPA 1973), reh'g denied,
+F.2d 879 (CCPA 1973), in which the court held
-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
@@ Line 1,763: / Line 1,576: @@
 data and the explanation would be viewed by one
 skilled in the art as being reasonably predictive of the
-asserted utility. See, e.g., Ex parte Maas, 9 USPQ2d
+asserted utility.
-(Bd. Pat. App. & Inter. 1987); Ex parte
-Balzarini, 21 USPQ2d 1892 (Bd. Pat. App. & Inter.
+Office personnel must be careful to evaluate all
-). 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,
@@ Line 1,800: / Line 1,612: @@
 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. In re Hartop, 311 F.2d 249, 135
+the asserted utility.
-USPQ 419 (CCPA 1962); In re Krimmel, 292 F.2d
-, 953, 130 USPQ 215, 219 (CCPA 1961); Ex parte
+Office personnel should be careful not to find
-Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.
-). 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. See In
+established prior to the filing of the application.
-re Chilowsky, 229 F.2d 457, 461, 108 USPQ 321,
-(CCPA 1956) (“The mere fact that something has
-not previously been done clearly is not, in itself, a sufficient
-basis for rejecting all applications purporting
-to disclose how to do it.”); In re Wooddy, 331 F.2d
-, 639, 141 USPQ 518, 520 (CCPA 1964) (“It
-appears that no one on earth is certain as of the
-present whether the process claimed will operate in
-the manner claimed. Yet absolute certainty is not
-required by the law. The mere fact that something has
-not previously been done clearly is not, in itself, a sufficient
-basis for rejecting all applications purporting
-to disclose how to do it.”).
 IV.HUMAN CLINICAL DATA
@@ Line 1,839: / Line 1,631: @@
 clinical trials to establish utility for an invention
 related to treatment of human disorders (see In re
-Isaacs, 347 F.2d 889, 146 USPQ 193 (CCPA 1963);
+Isaacs, even with respect to situations where no art-
-In re Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA
-)), even with respect to situations where no art-
 recognized animal models existed for the human disease
-encompassed by the claims. Ex parte Balzarini,
+encompassed by the claims.
-USPQ2d 1892 (Bd. Pat. App. & Inter. 1991)
-(human clinical data is not required to demonstrate
+Before a drug can enter human clinical trials, the sponsor, often the applicant,
-the utility of the claimed invention, even though those
-skilled in the art might not accept other evidence to
-establish the efficacy of the claimed therapeutic compositions
-and the operativeness of the claimed methods
-of treating humans). Before a drug can enterhuman 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
@@ Line 1,898: / Line 1,683: @@
 opposite conclusion. “FDA approval, however, is not
 a prerequisite for finding a compound useful within
-the meaning of the patent laws.” In re Brana, 51 F.3d
+the meaning of the patent laws.
-, 34
-USPQ2d 1436 (Fed. Cir. 1995) (citing Scottv. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120
-(Fed. Cir. 1994)).
@@ Line 1,912: / Line 1,692: @@
 as claimed, it is improper for Office personnel to
 request evidence of safety in the treatment of humans,
-or regarding the degree of effectiveness. See In re
+or regarding the degree of effectiveness.
-Sichert, 566 F.2d 1154, 196 USPQ 209 (CCPA 1977);
-In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA
-); In re Anthony, 414 F.2d 1383, 162 USPQ 594
-(CCPA 1969); In re Watson, 517 F.2d 465, 186 USPQ
-(CCPA 1975); In re Krimmel, 292 F.2d 948, 130
-USPQ 215 (CCPA 1961); Ex parte Jovanovics, 211
-USPQ 907 (Bd. Pat. App. & Inter. 1981).
 VI.TREATMENT OF SPECIFIC DISEASE
@@ Line 1,936: / Line 1,709: @@
 to the 1980’s, there were a number of cases where an
 asserted use in treating cancer in humans was viewed
-as “incredible.” In re Jolles, 628 F.2d 1322,
+as “incredible.”
-USPQ 885 (CCPA 1980); In re Buting, 418 F.2d
+The fact that there
-, 163 USPQ 689 (CCPA 1969); Ex parte Stevens,
-USPQ2d 1379 (Bd. Pat. App. & Inter. 1990); Ex
-parte Busse, 1 USPQ2d 1908 (Bd. Pat. App. & Inter.
-); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat.
-App. & Inter. 1986); Ex parte Jovanovics, 211 USPQ
-(Bd. Pat. App. & Inter. 1981). The fact that there
 is no known cure for a disease, however, cannot serve
 as the basis for a conclusion that such an invention
@@ Line 1,961: / Line 1,728: @@
 disease may require a significantly greater amount of
 evidentiary support to be considered credible by a
-person of ordinary skill in the art. In re Sichert, 566
+person of ordinary skill in the art.
-F.2d 1154, 196 USPQ 209 (CCPA 1977); In re Jolles,
-F.2d 1322, 206 USPQ 885 (CCPA 1980). See also
-Ex parte Ferguson, 117 USPQ 229 (Bd. Pat. App. &
-Inter. 1957).
 In these cases, it is important to note that the Food
@@ Line 1,972: / Line 1,735: @@
 used to treat life threatening and severely-debilitating
 illnesses, even where no alternative therapy exists.
-See 21 CFR 312.80-88 (1994). Implicit in these regulations
+Implicit in these regulations
 is the recognition that experts qualified to
 evaluate the effectiveness of therapeutics can and

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MPEP 2107: Difference between revisions

Latest revision as of 22:47, May 31, 2020

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

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

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

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

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