On May 4, 2016, the USPTO issued a new set of guidelines relating to rejections under § 101. Entitled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection,” the memo follows the format of previous guidance – such as providing the proper analysis for rejections under § 101 and exhorting examiners to make a proper case of ineligibility by showing their work. (And, just as with previous guidance, the examining corps is supposed to receive guidance on this memo in the coming weeks.)
Along with this new memo, the USPTO also provided new examples relating to the life sciences. The examples provide further guidance relating to the “markedly different” and “significantly more” tests that have been found to provide enough substance for eligibility. The PTO was relatively generous in its examples. For example, the first example of the memo relates to vaccines for “Pigeon flu,” and provides seven example claims – five eligible under step 2A of the Mayo/Aliceframework (as being “markedly different”), one eligible under step 2B (as providing a device that constitutes “significantly more” than the exception), and one ineligible (as lacking “markedly different characteristics” or anything “significantly more” than the exceptions). The USPTO also updated its list of “Subject Matter Eligibility Court Decisions.” This list includes a few new cases that had not been issued at the time of the July 2015 memorandum.
But the memo goes a bit further than earlier guidance, seemingly illustrating a shift in the PTO’s thinking in response to the demands of its stakeholders.
In response to the July 2015 Update, members of the public submitted comments that an examiner’s mere “opinion” that a claim is drawn to an abstract idea was insufficient grounds for a rejection under § 101. For example, both AIPLA and FICPI urged the Office to require examiners to make a proper case of ineligibility instead of providing unsupported conclusions. In this most recent memo, the USPTO stated that examiners should not go beyond the concepts similar to those found ineligible by the courts in their rejections. The memo also urges examiners to be “familiar” with any decision they allege shows the claims to be ineligible.
If you receive a rejection that misapplies the law or merely concludes, without evidence, that claims are ineligible, there are a couple of avenues one can take. Contact the examiner and conduct an interview to discuss the cited case law so you have an opportunity to show why the case law is not relevant to your claims. And, refer back to the guidelines where it demands that examiners stick to what the courts have decided. This two‑pronged attack may provide the means to overcome a rejection under § 101.