Obtaining patent protection in the US for inventions based on natural products has become challenging in recent years, particularly in view of various Supreme Court decisions, such as Mayo and Myriad.

In 2014 and 2015 the USPTO issued guidance on what constitutes patent eligible subject matter in the US and the latest update provides additional examples that are likely to be of interest to companies working in field of life sciences, specifically in the areas of diagnostic methods and biomarker detection.

The new examples provide some useful insights into how changes in language may influence the eligibility of diagnostic method claims and therefore provide a useful tool for both applicants and examiners working in this area.

Of course, the new examples are illustrative and are not the only acceptable form of diagnostic method claims. Certainly, the new examples are not intended to be used as the basis for the rejection of existing claims. However, when dealing with difficult patent eligibility objections, I have found it useful to highlight the similarities between pending claims and examples in the guidance materials.

Whilst the new examples should not be used as an exclusive reference when drafting or amending diagnostic method claims, they certainly offer welcome assistance in this difficult area of patent law.


“The May 2016 Subject Matter Eligibility Update provides (i) a memorandum to the examining corps on best practices in formulating a subject matter eligibility rejection and evaluating the applicant’s response, (ii) additional subject matter eligibility examples in the life science area, and (iii) an open-ended comment period to allow ongoing comments on subject matter eligibility topics. The May 2016 Subject Matter Eligibility Update also announces the selection of subject matter eligibility rejections as a new case study under the Topic Submission for Case Studies Pilot Program.”