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 (March 2014 Guidance). The March 2014 Guidance implemented a procedure to address changes in the law relating to subject matter eligibility under 35 U.S.C. § 101 in view of 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. 66, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012).
On April 16, 2014, the Office conducted a public session to provide information (https://www.uspto.gov/sites/default/files/patents/announce/myriad-mayo_bcp_20140416.pdf) and answer questions about the development and application of the March 2014 Guidance. The Office also held a public forum on May 9, 2014, discussed several example claims at the 2014 BIO International Convention on June 25, 2014, and invited members of the public to submit written comments on the March 2014 Guidance. The comments and feedback received from these outreach efforts, as well as the developing law regarding subject matter eligibility, were carefully considered by the Office and relied upon in formulating subsequent guidance documents.
Although the March 2014 Guidance is no longer in effect and has been superseded by subsequent guidance documents (available here: https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility), the comments and feedback received from the public in connection with the superseded guidance still provide relevant information about public viewpoints on subject matter eligibility.
Written Comments On The March 2014 Guidance
Members of the public were 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 public was 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.
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 March 2014 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)
Feedback on other past guidance documents, including comments on guidance issued after the In re Bilski and Bilski v. Kappos judicial decisions, may be viewed on our general Public Comments page, https://www.uspto.gov/patent/laws-and-regulations/comments-public-response-specific-requests-uspto.