The U.S. Patent and Trademark Office (USPTO) issued a further update on May 4, 2016 regarding Subject Matter Eligibility. The update is part of the USPTO's ongoing effort since 2014 to provide guidance on subject matter eligibility for patent applications under 35 U.S.C. § 101. The 2016 update is based on public comments on the 2015 Subject Matter Eligibility Update, and provides a memorandum to the Patent Examining Corps to "improve examiner correspondence regarding subject matter eligibility rejections," as well as additional Subject Matter Eligibility examples directed toward life sciences.
In the accompanying Federal Register notice, the USPTO explains that the memorandum is intended to provide guidance to examiners in formulating subject matter eligibility rejections, and evaluating applicant responses to them. While the eligibility examination procedures in the memorandum are substantially unchanged from last year, applicants are given some insight into the USPTO's approach.
In combination with the memorandum, the additional examples directed to nature-based products and application of natural laws provide some needed direction to applicants in life-sciences. While the USPTO notes that examiners should not use the examples as a basis for a subject matter eligibility rejection, applicants, may rely on an example as support for finding eligibility. Stakeholders are reminded that the USPTO guidance materials do not constitute substantive rulemaking and do not have the force and effect of law. Rather, they are intended to assist examiners and applicants in applying the eligibility guidance during prosecution of a patent application. The ultimate determinant of subject matter eligibility is the law and relevant court decisions.
The memorandum, "Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection," as well as the Subject Matter Eligibility Life Sciences Examples are accessible from the USPTO's website.