On January 4, 2019, the US Patent and Trademark Office (USPTO) announced revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 for computer-implemented inventions (Guidance). The Guidance takes effect Monday, January 7, 2019. The Guidance is important for medical patents that use algorithms for diagnosis and treatment decisions in personalized medicine.

Two Primary Changes to Improve Clarity

Two primary changes on how patent examiners should apply the first part of the two part U.S. Supreme Court’s Alice/Mayo test, are made to improve “clarity, consistency, and predictability of actions across the USPTO” (quoting Under Secretary of Commerce of Intellectual Property and Director of the USPTO Andrei Iancu Guidance Press Release):

1. The revised Guidance “extracts and synthesizes key concepts identified by the courts as abstract ideas to explain that the abstract idea exception includes certain groupings of subject matter: mathematical concepts, certain methods of organizing human activity, and mental processes”;
2. The revised Guidance “includes a two-prong inquiry for whether a claim is ‘directed to’ a judicial exception. In the first prong, examiners will evaluate whether the claim recites a judicial exception and if so, proceed to the second prong. In the second prong, examiners evaluate whether the claim recites additional elements that integrate the identified judicial exception into a practical application.”

Guidance Press Release

Public Comments Requested

The USPTO is seeking public comment on the Guidance documents. The public is invited to submit comments and suggestions for future guidance documents to Eligibility2019@USPTO.gov on or before March 8, 2019.