Title 35 of United States Code section 101 (35 U.S.C. 101) states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, ….”
Thus, 35 U.S.C. 101 serves to ensure that patents are granted on only those inventions that are "useful." Further, Article I, Section 8 of the Constitution authorizes Congress to provide exclusive rights to inventors to promote the "useful arts."
Figure 1: United States Capitol That Houses Congress That Has to Promote The Useful Arts.
Specific and Substantial Utility
According to the manual for patent examining procedure (MPEP) of the United States Patent and Trademark Office (USPTO) 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, that being the properties or applications of a product or process, and
(ii) the utility is specific, substantial, and credible.
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 a landfill, as a way of satisfying the utility requirement of 35 U.S.C. 101.
An applicant in a patent application need only provide one credible assertion of specific and substantial utility for each claimed invention to satisfy the utility requirement.
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, then the claim(s) is to be rejected. The claim(s) are to be rejected under 35 U.S.C. 101 on the grounds that the invention as claimed lacks utility. The claim(s) are also to be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, the first paragraph, on the basis that the disclosure fails to teach how to use the invention as claimed.
Figure
2: No Assertion of Specific and Substantial
Utility Claims to be Rejected.
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. A distinction should be made 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.
Figure 3: Polynucleotide Use Disclosed as Gene Probe or Chromosome Marker Not Considered Specific.
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 an insufficient disclosure of what condition can be diagnosed. This is insufficient to define a specific utility for the invention. Contrast the situation where an applicant discloses a specific biological activity and reasonably correlates that activity to a disease condition. This is sufficient to identify a specific utility for the invention.
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. 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.
Figure 4: Must Show Invention Has a Significant Presently Available Benefit to The Public.
A substantial utility defines a real-world use. If the carrying out of further research is required to identify or reasonably confirm a real-world use, it is a not substantial utility. An assay is a process of analyzing a substance to determine its composition or quality. 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 that has a stated correlation to a predisposition to the onset of a particular disease condition would also define a real-world context of use. It identifies potential candidates for preventive measures or further monitoring.
Figure 5: Assay Measures Material Correlated to a Predisposition to the Onset of Disease Defines Real-World Context of Use.
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 a substantial utility:
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. (United States Patent and Trademark Office agency of Department of Commerce, 2020)
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United States Patent and Trademark Office agency of Department of Commerce. (2020, 06 25). 2107 Guidelines for Examination of Applications for Compliance with the Utility Requirement [R-11.2013]. Retrieved 09 16, 2022, from uspto.gov: https://www.uspto.gov/web/offices/pac/mpep/s2107.html
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