On May 5th, the US Patent and Trademark Office published an update to the Interim Guidance titled “May 2016 Subject Matter Eligibility Update” to provide its examining corps with additional guidelines for determining subject matter eligibility under 35 USC §101.

The publication includes a memorandum, “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection,” which “seeks to improve examiner correspondence with regard to subject matter eligibility rejections.” It was issued in response to public comments.

The update also includes additional Subject Matter Eligibility Examples for the life sciences.  These Examples include nature based products, diagnostics and treatments, and abstract ideas. Notably, in light of last year’s controversial Federal Circuit Sequenom decision, one example recites “specific and unconventional ways of gathering data that amount to significantly more than the abstract idea.” In Sequenom, the court ruled that claims directed to a naturally occurring phenomenon were not patent eligible if they recited methods that were “conventional, routine and well understood applications in the art.”

This latest guidance follows an update from July 2015, which was issued in response to public comment on the 2014 Interim Patent Eligibility Guidance. That first guidance, published in the wake of the Alice Corp., Myriad, and Mayo Supreme Court decisions, offered additional guidelines on the patent eligibility of claims directed toward the judicial exceptions – including laws of nature, natural phenomena, or abstract ideas.

However, this latest PTO update is not likely to be the last word.  Back in March, Sequenom petitioned the Supreme Court for review of the decision, and twenty amicus briefs are now on file.  It is likely the Court will take on the case and rule on the patent eligibility of diagnostic claims, thereby necessitating a further PTO update.

The latest materials, inluding those from the May update, can be accessed from the USPTO website:



– Jessica Miles and Anthony D. Sabatelli, PhD, JD

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