USPTO Issues Interim Guidance on Patent Subject Matter Eligibility under 35 U.S.C. § 101

December 18, 2014

On December 16, 2014, the U.S. Patent and Trademark Office (USPTO) issued the “2014 Interim Guidance on Patent Subject Matter Eligibility” (“the Interim Eligibility Guidance”) for determining patent eligibility under 35 U.S.C. § 101, as well as Examples of Nature-Based Products.

The Interim Eligibility Guidance supersedes (replaces) Guidance issued March 4, 2014 on claims involving laws of nature, natural phenomena and natural products, which was issued in view of the U.S. Supreme Court’s Mayo and Myriad decisions, and supplements the Preliminary Examination Instructions issued June 25, 2014 , which was issued in view of the U.S. Supreme Court’s Alice v. CLS Bank decision.

The Interim Eligibility Guidance provides Examiners with a three-step process for analyzing patent eligibility. The first step (step 1) is to determine whether the claim is directed to a process, machine, manufacture or composition of matter. If yes, then the Examiner proceeds to the second step (step 2A) of determining if the claim is directed to a “judicial exception” of a law of nature, a natural phenomenon, or an abstract idea. If yes, then the Examiner proceeds to the third step (step 2B) to determine if the claim recites additional elements that amount to “significantly more” than the judicial exception.

The new three-step process differs from the March 2014 Guidance in certain respects. For example, the test for determining whether a claim is directed to the “product of nature” exception is separated from the analysis of whether the claim includes “significantly more” than the exception. Additionally, the application of the overall analysis is based on claims “directed to” judicial exceptions, rather than claims merely “involving” an exception. Further, the “markedly different” analysis, used to determine whether a judicial exception applies, now focuses on characteristics that may include a product’s structure, function, and/or other properties as compared to its naturally occurring counterpart in its natural state.

The Examples relating to Nature-Based Products apply the three-part test to ten exemplary fact patterns illustrating how Examiners should apply the three-part test.

These Examples are all within the chemical and biotechnology fields. They replace the Examples included in the Guidance issued March 4, 2014.

The USPTO has stated that new Abstract Idea Examples relating to Alice v. CLS Bank are “coming soon”.

The USPTO will consider written comments on the Interim Eligibility Guidance received by March 16, 2015. If you would like us to prepare and file any comments for you or your clients, then please let us know.

The Interim Eligibility Guidance can be found at the following web address:

The Examples of Nature-Based Products can be found at the following web address:

If you have any questions regarding the Interim Eligibility Guidance or the Examples of Nature-Based Products, please do not hesitate to contact us.