Following the recent Supreme Court decisions in Alice Corp., Myriad, and Mayo which invalidated an array of claims under 35 U.S.C. § 101, patent subject matter eligibility has become a closely watched and debated issue. In its most recent attempt to decipher these decisions and apply them in patent examination, on May 4, 2016, the U.S. Patent and Trademark Office (“USPTO”) issued a Subject Matter Eligibility Update (“May 2016 Update”) May 4, 2016. The May 2016 Update provides a memorandum to the Patent Examining Corps on best practices in formulating a subject matter eligibility rejection and evaluating the applicant’s response, along with additional subject matter eligibility examples in the life sciences area.
In formulating a § 101 rejection, examiners should, according to the memorandum:
(1) identify the judicial exception (i.e., abstract idea, law of nature, or natural product) by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception;
(2) identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception; and
(3) explain the reason(s) that the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception.