On March 4, 2014, the Office published a guidance memorandum titled Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (Guidance). The Guidance implements a new procedure to address changes in the law relating to subject matter eligibility under 35 U.S.C. § 101 in view of recent court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012).
The Office completed a first round of training for the examiners in Technology Centers most likely to be impacted by the Guidance (TC 1600 and 1700).
During the May 9 forum (see below), the Office noted that it would be updating the Guidance, and invited the public to submit any comments they wished considered for the update to be submitted on or before June 30, 2014. In response to several requests from our stakeholders for additional time to submit comments, the Office has extended the period for submission of public comments until July 31, 2014.
On June 25, 2014, the Office discussed several sample claims at the 2014 BIO International Convention.
The Office will issue an update to the Guidance once it has carefully considered all feedback and the developing law regarding subject matter eligibility.
Written Comments - Due July 31, 2014
Members of the public are invited to submit written comments that present their interpretation of the impact of relevant Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination of claims reciting or involving laws of nature, natural phenomena, and natural products. The Office would like for members of the public who believe that the Supreme Court decisions could be implemented in an alternative manner from the approach taken in the Guidance to submit written comments presenting their alternative approach and the legal rationale for the alternative. The public is also invited to suggest additional examples for use by the Office to create a more complete picture of the impact of Supreme Court precedent on subject matter eligibility, and to provide comments on the subject matter eligibility of particular claims, including the sample claims discussed at the 2014 BIO International Convention.
Comments received will be posted for public viewing. Accordingly, information that the submitter does not desire to make public, such as an address or phone number, should not be included in the comments.
Forum on May 9, 2014
The Office hosted a forum on Friday, May 9, 2014, to receive public feedback from organizations and individuals on the Guidance. The forum was open for any member of the public to participate. The forum provided an opportunity for participants 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.
Forum Presentations (in the order of presentation)
- Biotechnology Industry Organization (BIO)
- Suzannah Sundby
- Anthony D. Sabatelli, Ph.D.
- Kenneth H. Sonnenfeld, Ph.D.
- Courtenay C. Brinckerhoff
- Leslie Fischer, Ph.D.
- Warren D Woessner, Ph.D.
- American Intellectual Property Law Association (AIPLA)
- Duane C. Marks
- American Bar Association, Section of Intellectual Property Law (ABA-IPL)