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.

The Memorandum

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.

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Photo of Fang Xie, Ph.D. Fang Xie, Ph.D.

Listed in IAM Strategy 300 – The World’s Leading IP Strategists, Fang Xie, Ph.D. focuses her practice on establishing, defending, licensing, sharing and monetizing intellectual property rights for life sciences companies. She has broad experience in worldwide patent portfolio development, intellectual property…

Listed in IAM Strategy 300 – The World’s Leading IP Strategists, Fang Xie, Ph.D. focuses her practice on establishing, defending, licensing, sharing and monetizing intellectual property rights for life sciences companies. She has broad experience in worldwide patent portfolio development, intellectual property due diligence, licensing and technology transfer, patentability and product clearance studies, validity/invalidity analyses, patent infringement evaluations, as well as intellectual property litigation and pre-litigation counseling.

Fang’s primary technical areas include biotechnology, synthetic biology and pharmaceuticals, with a focus on immunotherapy, antibody and biologics/biosimilars, nucleic acid synthesis, gene editing, protein and organism engineering, stem cell technology, biomarkers, diagnostics, small molecule drugs, regenerative medicine, analytical chemistry and cosmetics.