On March 4th the US Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC §101. The guidelines were issued in light of the Supreme Court’s decisions in Myriad, Prometheus, and related cases. See, “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.” The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.

The Guidance has not been particularly well received. Since March, the USPTO has held a Public Forum, at which I had testified, and put out a call for further public comments that were published last month. Most recently on September 17th, the USPTO held a Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting at which it provided an update on the status of the Guidance. At this meeting, Ms. June Cohan, Legal Advisor with the USPTO’s Office of Patent Legal Administration indicated that it intended to release a revised Guidance in about a month. I will keep you apprised if and when the revised Guidance is issued. Further commentary from the September meeting can be found in this review piece posted on Patent Docs: USPTO Expected to Issue Revised Myriad-Mayo Guidance in October.


– Anthony D. Sabatelli, PhD, JD
Check out Anthony’s bio page


This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. The opinions expressed in this article are those of the author only and are not necessarily shared by Dilworth IP, its other attorneys, agents, or staff, or its clients.