[author: Anthony D. Sabatelli*]
[Ed. On May 9, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4. According to the Office's Guidance webpage, the forum was intended to provide an opportunity for stakeholders to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination. Our coverage of the forum can be found here. Dr. Anthony D. Sabatelli of Dilworth IP LLC, who appeared in the forum's first group of presenters, allowed Patent Docs to republish the following article on the forum.]
It has now been a week since the U.S. Patent and Trademark Office held its public forum on the March 4th Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance. I was invited to present at this Forum, where I provided comments before the USPTO on the necessity for the Guidance, how the Guidance can be improved, and also provided cautions to prevent its misapplication. I had previously written about the Guidance in an earlier article on this site (see "How to Patent Grapefruit Juice: the New USPTO Guidance for Patent Eligible Subject Matter is Both Sticky and Sour").
Now that the dust has settled and the press and others have been publishing their commentary, I would like to share some thoughts from the perspective as both a speaker and attendee. According to the USPTO, there were about 80 attendees at the forum and an additional 400 hundred viewing via a live webcast. A copy of the agenda and the presentations (including my own) are available on the USPTO's webpage devoted to the Guidance.
USPTO Deputy Director Michelle Lee provided welcoming remarks. Andrew Hirshfeld, Deputy Commissioner for Patent Examination Policy, provided a high level overview of the Guidance and the USPTO's rationale for issuing it. This was followed by an in-depth review by Raul Tamayo, Senior Legal Advisor for the Office of Patent Legal Administration. The USPTO presentations were followed by three groups of invited public presentations, including Q&A, an open public forum period, and closing remarks by Commissioner Hirshfeld. I presented during the first group of the invited presentations. The entire program ran about four hours.
The USPTO speakers emphasized that it was necessary to issue the Guidance as reasonably soon as possible and pointed out that this supplanted the interim memo of June 14, 2013, that was issued the day after the Myriad decision came down from the Supreme Court. Commissioner Hirshfeld also explained that the process for informing and training the examining corps on this topic is iterative and that the work product will continue to evolve.
Most of the commentary from the invited speakers, as well as the general public, was critical of the Guidance. A common theme expressed was that the Guidance is not workable and is not helpful for practitioners to give advice to their clients. In fact, several comments suggested withdrawal and there was even a point blank request from one speaker to do so. Commissioner Hirshfeld stated that the USPTO was "unlikely to withdraw the guidelines," indicating it would "not be productive to do so." However, he invited further comments and suggestions from the public, and pointed out that the USPTO would be accepting written comments through June 30th.
In my presentation, one of the concerns I had raised is that the Guidance seems to be confusing the § 101 threshold inquiry of patent eligibility with the subsequent patentability determination (i.e., the determinations for § 102 novelty, § 103 obviousness, etc.). I discussed how the Guidance factor analysis could be misapplied by bringing in these patentability determinations under the guise of the threshold § 101 inquiry. I suggested the need for appropriate oversight, examiner training, and applicant recourse, to prevent such misapplication. Other presenters commented that the Guidance failed to give consideration to the function of claimed subject matter by putting the emphasis solely on structural differences. Other concerns were raised with respect to diagnostics and natural-product derived pharmaceuticals.
It became very clear from the forum that the USPTO realized it should have sought public input on the Guidance before issuing it. Commissioner Hirshfeld acknowledged this oversight and continues to actively seek further commentary and recommendations from the public. I would therefore urge anyone with a strong opinion on the Guidance, whether positive or negative, to provide their written feedback to the USPTO. Comments can be submitted via the USPTO's webpage (cited above). The deadline for doing so is June 30, 2014. In view of the public forum and the request for additional public comments, it is my hope the USPTO will next issue a "revised draft Guidance" for further public comment before finalizing.
* Dr. Sabatelli is a Partner with Dilworth IP.