Based on recent statements made by the USPTO, it seems very likely that new Myriad Guidance may be issued soon that will supplant the current version which has been so controversial.  On September 17, 2014 the U.S. Patent and Trademark Office held the first bicoastal Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) meeting at the USPTO campus in Alexandria, Virginia and the San Jose University in San Jose, California.  While the meeting focused on several topics, of particular interest was the panel discussion of the Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (“Myriad Guidance”) that the USPTO issued on March 4, 2014.

The USPTO invited comments on the Myriad Guidance and received plenty of responses.  The good news is that June Cohan, from the USPTO Office of Patent Legal Administration, indicated during the meeting that the USPTO listened carefully to those comments and plans to address most of the key issues raised in a Revised Guidance document.  Although we will not know the actual content of the Revised Guidance until it is released in “a month or so,” Ms. Cohan stated that the USPTO agrees that patent eligibility under § 101 should be a “low hurdle” and both structural and functional differences should be considered when analyzing claims to so-called natural products.  Additionally, the USPTO plans to reduce the number of claims that must be analyzed by asking whether a claim is “directed to judicial exception(s)” instead of whether it “recites or involves judicial exception(s).” The USPTO also plans to simplify the current factors test and provide more and clearer examples in the Revised Guidance.

While we await the new Guidance, in some cases it may be wise to postpone responding to § 101 rejections.  Applicants also may consider speaking with the Examiner to discuss § 101 rejections in light of the Office’s apparent new position on patent eligibility or explain how their claims are patent eligible in writing.

This article was written by Sharla Flohr (Patent Agent) and Susan McBee (Principal), members of the Intellectual Property group at Miles & Stockbridge.

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