The USPTO just issued a May 2016 Subject Matter Eligibility Update providing further guidance to examiners and practitioners in determining subject matter eligibility under 35 U.S.C. § 101, more specifically to clarify the scope of judicial exceptions to subject matter eligibility. Subject matter involving an abstract idea, law of nature, natural phenomena, or natural products is considered ineligible for patent protection and is thus called a “judicial exception.” However, claims that include limitations involving these exceptions are not a priori unpatentable; instead they require heightened scrutiny by the examiner to determine whether the claim as a whole “adds meaningful limits on the use of the exception” that make the claim patentable.
In the Life Sciences area, new and detailed examples illustrating the scope of eligible subject matter (i.e. claims reciting “abstract ideas” or products of nature) were provided for vaccines, diagnostic methods, chemical compositions (dietary sweeteners), methods of screening for gene alterations, and hydrolysis of fat.
Particularly relevant are the new guidelines clarifying the eligibility of certain diagnostic claims. In the past, a claim that includes the steps of first diagnosing a disease, typically by identifying the presence of a biomarker in a patient sample, and a second step of treating the disease with a particular treatment, such as administering an antibiotic, antiviral agent, or other medicine or treatment regimen, was typically rejected as being unpatentable subject matter under Section 101. However, under the May 2016 guidelines Examiners are instructed to recognize that this type of claim is patent eligible, because the recitation of a particular treatment of the diagnosed disease is now recognized as an additional element in “a claim as a whole that adds meaningful limits on the use of the exception (the correlation and critical thinking step). The totality of these steps including the recitation of a particular treatment ….. integrate the exception into the diagnostic and treatment process, and amount to more than merely diagnosing a patient with …[a disease] and instructing a doctor to generically “treat it. BWSM patent attorneys have typically drafted diagnostic claims that include such a particular treatment step in view of previous case law, particularly the Mayo Collaborative Services v. Prometheus Laboratories decision. 566 U.S. ___, 132 S.Ct. 1289 (2012).
The new guidelines also offer several examples of patent eligible vaccines. For example, the guidelines emphasize the subject matter eligibility of a vaccine that includes a live attenuated virus that has a different structural characteristic (such as a change in the nucleotide sequence of its polymerase gene due to the mutation) than the naturally occurring virus, which has resulted in the live attenuated virus having a different functional characteristic (reduced virulence), if no mutations of this gene are known to occur in nature. In another example, the novel inclusion of an antigen, such as a certain Peptide, in a pharmaceutically acceptable carrier such as a cream, emulsion, gel, liposome, nanoparticle, or ointment, is patentable subject matter even without considering whether the antigen has been modified over its naturally occurring state. The reason given is, ”The cream’s changed form and adherence are marked differences in structural and physical characteristics as compared to the natural counterparts [such as oil and water] , and therefore the cream is not a “product of nature” exception. Thus, the claim is not directed to an exception…, and qualifies as eligible subject matter.”
Testing for Gene Mutations
The new guidelines further include examples of controversial claims for testing of gene mutations, modeled after the technology in U.S. Patent 5,753,441, regarding BRACA1 gene screening. In this case, actual claim 1 was directed to screening patients for alterations in the BRCA1 gene by comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences. Because only routine methods well known and used in the art were recited in actual claim 1, it was held to be ineligible by the Federal Circuit as directed to an abstract idea without additional elements that amount to significantly more than the abstract idea in Association for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012) (“Myriad CAFC”), aff’d in part and rev’d in part on other grounds, Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). (It is noted that claims 7 and 8 of the same patent were held ineligible in University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014)).
In the guidelines, similar hypothetical claims for gene screening were considered eligible if they recite specific and unconventional ways of gathering data that amount to significantly more than the abstract idea. The guidelines further explain that just because a technique has been discussed in several widely-read scientific journals, mere knowledge of this technique does not make its use routine or conventional in this field. Instead, the evaluation turns on whether the use of a method (such as to detect DNA hybridization) was actually routinely or conventionally used by scientists at the time the invention was made and the application was filed. Thus the use of unconventional methods can make an otherwise abstract idea patent eligible subject matter under section 101.
The May 2016 guidelines are already helping to overcome improper rejections by Examiners of pending diagnostic claims that properly recite both diagnosis of a disease and a particular treatment, and they will assist in continuing to draft and prosecute claims in the Life Sciences.