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2107    Guidelines for Examination of Applications for Compliance with the Utility Requirement

MPEP SECTION SUMMARY This section describes the principles behind rejections based on utility (whether or not an invention has any use) and obviousness based on one or more prior art references. In addition, there is a discussion on how to interpret claims within the scope of these utility or obviousness rejections.

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MPEP SECTION SUMMARY Useful inventions have a practical utility or specific utility without having to pursue further research to identify or reasonably confirm it. An applicant must identify why an invention is useful (unless it has a well-established utility), otherwise the claimed invention will be deficient under 35 U.S.C. 101 and 35 U.S.C. 112 first paragraph.

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35 U.S.C. 101 has been interpreted as imposing four purposes.

• First, 35 U.S.C. 101 limits an inventor to ONE patent for a claimed invention.
  • If more than one patent is sought, a patent applicant will receive a statutory double patenting rejection for claims included in more than one application that are directed to the same invention.
• Second, the inventor(s) must be the applicant in an application filed before September 16, 2012, (except as otherwise provided in pre-AIA 37 CFR 1.41(b)) and the inventor or each joint inventor must be identified in an application filed on or after September 16, 2012.
• Third, 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.
• Fourth, 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.

• The first is 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.
• 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

To satisfy 35 U.S.C. 101, an invention must be “useful.”

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.

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.”

B.Substantial Utility

“[A]n 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.”

The following are examples of situations that 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.

C.Research Tools

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.

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.

Courts have repeatedly found that the mere identification 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.

• 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.

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.
  
  

IV. RELATIONSHIP BETWEEN 35 U.S.C. 112(a) or Pre-AIA 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(a) or pre-AIA 35 U.S.C. 112, first paragraph.

It is important to recognize that 35 U.S.C. 112(a) or pre-AIA 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.

MPEP SECTION SUMMARY This section discusses procedural considerations related to rejections for lack of utility. It includes a discussion of inoperative inventions which includes those that do not operate to produce the results claimed by the patent applicant. In addition, it discusses credibility which must be believable to a person of ordinary skill in the art based on the totality of evidence and the reasoning provided. Lastly, it covers a prima facie showing, which must explain why a person of ordinary skill in the art would conclude it is more likely than not that asserted utility is not credible.

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-Inoperative inventions:

Inoperative inventions nclude those that do not operate to produce the results claimed by the patent applicant.

• Must be totally incapable of achieving a useful result.

An invention that performs crudely, or is not commercially successful, does not accomplish all its intended functions or only has partial success may still be useful.

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

• Where it is not apparent why the applicant believes the invention to be useful.
• Where an assertion of specific utility for the invention made by an applicant is not credible.

-Credibility:

Assertion of the utility must be credible (must be believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided).

Disclosure of utility:

• a claimed invention must have a specific and substantial utility
• this excludes such examples as using a complex invention for landfill (this is obviously not a good or valid use)
• an applicant need only provide one credible assertion of specific utility for each claimed invention to satisfy the utility requirement
• any rejection based on a lack of utility should include a detailed description as to why the claimed invention has no special or substantial utility
• the examiner should provide documented evidence regardless of the publication date
• an invention has a well established utility if a person of ordinary skill in the art can immediately appreciate why the invention is useful based on the characteristics of the invention
• the utility should be specific, substantial and credible
• where an asserted special and substantial utility is not credible, a prima facie showing of no specialization or substantial utility must establish that it is more likely than not that a person skilled in the art would not consider any special and substantial utility asserted by the applicant for the claimed invention as credible

-Prima facie showing:

A prima facie showing must explain why a person of ordinary skill in the art would conclude that it is more likely than not that an asserted utility is not credible.

To reject a claimed invention under 35 U.S.C. 101, the Office must:

• make a prima facie showing that the claimed invention lacks utility
• provide a sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie showing

An applicant may overcome a rejection by an examiner who established a prima facie showing of no specific and substantial credible utility for a claimed invention by:

• providing reasoning or arguments
• amending claims
• providing evidence in the form of a declaration under 37 C.F.R. 1.132
• providing evidence in the form of a printed publication rebutting the basis or logic of the prima facie showing
  
  

MPEP SECTION SUMMARY Any evidence of a 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. This section covers special considerations for asserted therapeutic or pharmacological utilities.

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Any evidence of a 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.

• Even the mere identification of a pharmacological activity of a compound that is relevant to an asserted pharmacological use provides an “immediate benefit to the public”.

The fact that there is no known cure for a disease cannot serve as the basis for a conclusion that such an invention lacks utility.

• The claimed invention just needs to be shown useful in treating a symptom of an incurable disease for it to have utility.

Evidence of structural similarity to a compound known to have a particular therapeutic or pharmacological utility is being supportive of an assertion of therapeutic utility for a new compound and establishes that compound as useful.

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.

-Analysis of compound(s):

Data generated using in vitro assays or testing in animal models is usually sufficient to establish a therapeutic or pharmacological utility for a compound, composition or process.

• Applicants are not required to provide data from human clinical trials to establish utility for an invention related to the treatment of human disorders.
• FDA approval is not a prerequisite for finding a compound useful within the meaning of the patent laws.

The requirements of 35 U.S.C. 101 for a “practical” utility is one that is safe or fully effective for human or animal consumption.

 

» 2111 Claim Interpretation; Broadest Reasonable Interpretation