2014 Interim Guidance on Subject Matter Eligibility

The 2014 Interim Guidance on Patent Subject Matter Eligibility (2014 IEG) is for USPTO personnel to use when determining subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. The 2014 IEG supplements the June 25, 2014 Preliminary Examination Instructions issued in view of Alice Corp. and supersedes the March 4, 2014 Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products issued in view of Mayo and Myriad.

The July 2015 Update: Subject Matter Eligibility updates the 2014 IEG in response to public comments on the 2014 IEG.  The July 2015 Update includes a new set of examples and discussion of various issues raised by the public comments, and is intended to assist examiners in applying the 2014 IEG during the patent examination process.

The May 2016 Subject Matter Eligibility Update provides (i) a memorandum to the examining corps on best practices in formulating a subject matter eligibility rejection and evaluating the applicant’s response, (ii) additional subject matter eligibility examples in the life science area, and (iii) an open-ended comment period to allow ongoing comments on subject matter eligibility topics. The May 2016 Subject Matter Eligibility Update also announces the selection of subject matter eligibility rejections as a new case study under the Topic Submission for Case Studies Pilot Program.

UPCOMING ROUNDTABLES

The USPTO will be hosting two roundtables to facilitate discussion on patent subject matter eligibility. The first roundtable will be directed to receiving feedback from members of the public to improve the USPTO’s existing subject matter eligibility guidance and training examples. The second roundtable will be focused on receiving feedback regarding larger questions concerning the legal contours of eligible subject matter in the U.S. patent system.

MATERIALS

HOW TO COMMENT

The USPTO is interested in receiving public feedback on the May 2016 Subject Matter Eligibility Update, including the life sciences examples.

Any member of the public may submit written comments by electronic mail message over the Internet addressed to 2014_interim_guidance@uspto.gov. Electronic comments submitted in plain text are preferred, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. The comments will be available for public inspection here at this Web page. Because comments will be available for public inspection, information that is not desired to be made public, such as an address or a phone number, should not be included in the comments.

The comment period is open-ended, and comments will be accepted on an ongoing basis.