The USPTO Changes Patent Eligibility Guidelines

May 14, 2019
Post by Patricia A. Sweeney - Of Counsel

The United States Patent Office has released updates to subject matter eligibility guidelines under 35 USC §101. Along with these updates, the Office has provided slides and a webinar reviewing the changes, using the same materials provided in training of patent examiners.

There are two parts to the analysis, Step 1, and Step 2A and 2B and it is Step 2 that has been changed. Step 1 remains the same, asking whether the patent claim is to a process, machine, manufacture or composition of matter. If the answer is no, the claim is not patent eligible. If the answer is yes, the analysis continues to Step 2.

Step 2A previously asked whether the claim is directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea. Step 2A has changed to a two-prong inquiry and added a different method to evaluate abstract ideas. New Prong One asks whether the claim recites an abstract idea, law of nature or natural phenomenon. If no, the claim is eligible. If yes, Prong Two asks whether the claim recites additional elements that integrate the abstract idea, law of nature or natural phenomenon into a practical application.

When evaluating an abstract idea in Prong One, examiners will no longer use a quick reference sheet. Rather, if a potential abstract idea is involved, the claim will be evaluated to determine if it relates to 1) mathematical concepts, 2) mental processes, or 3) “certain methods of organizing human activity”. In regard to the latter, specific examples of organizing human activity are provided and include fundamental economic principles or practices (such as hedging, insurance, mitigating risk); commercial or legal interactions (such as contracts, legal obligations, advertising, marketing or sales activities or behaviors; business relations); and managing personal behavior or relationships or interactions between people (examples including social activities, teaching and following rules or instructions). A claim falling into any of these three groups is not eligible. If the claim does not fall within one of these groups, but the examiner still wants to reject it under section 101, the examiner must obtain approval from the technology center director. Comments by Deputy Commissioner Barr are that this was an effort to obtain more consistent decisions.

In Prong Two there is a new procedure, in requiring the examiner to identify whether there are any additional elements recited in the claim beyond the judicial exception and evaluate those elements to decide if they “integrate the exception into a practical application of the exception”. The guidelines emphasize the elements must provide a “meaningful limit” and be more than artful claim drafting.

If the answer to Prong One and Prong Two is no, the examiner continues to Step 2B. This asks whether the claim recites additional elements that amount to significantly more than the judicial exception. If the answer is no, the claim is not eligible. The PTO points out in the training materials that much of this question will be decided in the Step 2A Prong Two evaluation by the examiner. However, the 2B evaluation is different from Prong Two in an important aspect. In 2B, the examiner now considers whether the additional claim elements represent only well understood, routine, or conventional activity and thus is not eligible – a point not considered in Prong Two. Thus, a claim may pass the test of Prong Two even if the additional elements would fail the routine and conventional activity test. In other words, at Prong Two the additional elements may be conventional, routine or well understood, yet provide a meaningful limit.In that case, the claim is patent eligible. If it is eligible, the evaluation ends at Prong Two and the question of whether the elements are well understood, routine and conventional need not be answered, as one does not proceed on to Step 2B.

The Patent Office is integrating several court cases, and memos including the Vanda Memo that found eligible applying or using a law of nature to affect a particular treatment or prophylaxis for a disease or medical condition. It is possible that by moving the analysis of whether additional elements are well understood, routine or conventional to later in the evaluation, more claims may be found eligible. However, the actual impact will not be known until examiners begin applying the new guidelines.

Patricia A. Sweeney is an Intellectual Property Attorney in the Biotechnology & Chemical Patent Practice Group at McKee, Voorhees & Sease, PLC. Pat was the first female patent attorney in the State of Iowa. For additional information please visit the MVS website or contact Pat directly via email at

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