The U.S. Patent and Trademark Office recently issued new guidelines to determine patent eligibility. For years after Alice,[i] Mayo,[ii] and Myriad,[iii] software and biotechnology patent applicants have had difficulty patenting many inventions, particularly in the trending “personalized medicine” field where patient genetics and proteomics are considered when selecting treatment regimens.
The new guidelines, issued in response to the Federal Circuit decision in Berkheimer v. HP Inc.,[iv] do not alter the fundamental analysis, which requires examiners to determine (1) if the claims recite or are otherwise directed to an abstract idea or natural phenomena; and (2) if the claim includes more than what is routine, conventional, or well-understood in the respective field. However, the new analysis requires examiners to provide citation to (1) the specification or evidence showing the applicant stated a specific element is routine, conventional, or well-understood; (2) a court decision finding the element routine, conventional, or well-understood; (3) or a publication- such as a review article, textbook, manual, etc.- that specifically describes the field and notes the element(s) are routine, conventional, or well-understood. Importantly, the guidelines note that this requirement is not met by simply showing the element(s) were known in the field, but requires a higher standard as stated by the Federal Circuit.[v]
Since the original Supreme Court decisions, elements of statutory requirements not related to patent eligibility have crept into the determination as to whether an invention is eligible for patenting, by including an analysis of the prior art through the routine, conventional, or well-understood guise. This has resulted in a heightened requirement, especially in the biotechnology field where novel testing methods have been scrutinized. However, the patent eligibility requirement was described as a “coarse eligibility filter”.[vi] The new guidelines assist in moving the eligibility requirement back toward that coarse filter. But the new guidelines still require a careful drafting of a new patent application to ensure that an invention comports with the eligibility standards of Mayo/Myriad/Alice and does not run afoul of the other statutory requirements for patentability, namely novelty and non-obviousness.
[i] Alice Corp. v. CLS Bank Int’l, 573 U.S. ___, 134 S.Ct. 2347 (2014).
[ii] Mayo Collaborative Svcs. V. Prometheus Labs., Inc., 566 U.S. 66,132 S.Ct. 1289 (2012).
[iii] Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 133 S.Ct. 2107 (2013).
[iv] 881 F.3d 1360 (Fed. Cir. 2018).
[v] Berkheimer, 881 F.3d at 1369.
[vi] Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067 (Fed. Cir. 2011).