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BIO Submits Joint Supplemental Comments on the USPTO March Guidance

October 22, 2014
Last week BIO, alongside a number of member companies and private individuals, submitted supplemental comments to the U.S. Patent and Trademark Office concerning their March 2014 Guidance on patent subject matter eligibility.

In July, BIO and international bio-industry associations had submitted comments to the USPTO expressing concern about the Guidance, and its impact on the patent eligibility of biotechnology inventions.

Since July, USPTO staff has indicated a final revision to the Guidance would be released this Fall. These may include parameters which could narrow the range of claims that would undergo a 101 analysis, and possibly a unified 101 analytical framework for patent subject matter eligibility.

Supreme CourtIn their most recent comments, BIO urged the USPTO to include additional caselaw into their considerations, and scrutinize the claims at issue in cases considered by the Courts.

The Supreme Court has not overruled a number of cases, such as Parke-Davis, Merck v Olin Mathieson, In re Kratz, In re Bergstrom, and they as such remain good law until stated otherwise by the Court. Rather than focusing on selected Supreme Court cases, the UPSTO needs to draw from all available precedent.

Furthermore, BIO asked that the USPTO be consciously aware of the different SCOTUS approaches to patent eligibility regarding different cases. The Supreme Court’s Alice opinion, for example, provided guidance as to how to analyze process claims based on abstract ideas, but its mode of analysis does not necessarily apply to compositions or manufactures with their own line of case law. “Inventive concept/significantly more” cases, such as Myriad, J.E.M. Ag-Supply, Chakarabrty, Funk Bros undergo a significantly different analysis that “process” cases, like Benson, Flook, Diehr, and BilskiUS Patent Application

Should the USPTO decide to implement a unified eligibility analysis framework for all claims types, as it has hinted, it would have to be sufficiently flexible to account for the Court’s varied guidance for finding claims eligible under its body of precedent.

BIO urges the USPTO to reissue the revised Guidance in draft form, and allow the patent community and public to comment on any significant proposed changes to the patent eligibility criteria. A group of higher education associations, including the Association of American Universities (AAU) and the American Council on Education (ACE) also called on the USPTO to open the final version of the Guidance for comments.