July 30, 2014

The USPTO Issues Guidelines for Subject Matter Eligibility Analysis: How the Supreme Court's Decisions in Pathology v. Myriad and Mayo v. Prometheus Could Change the Rules

2 min

On March 4th, 2014, the United States Patent and Trademark Office issued a guidance advising examiners and the public of the factors for determining whether an invention satisfies the provisions of 35 U.S.C. §101, as applied to patent eligibility in view of the U.S. Supreme Court's decisions in Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus). In this issue, we summarize and highlight key "take home" points of the guide. Next month, we will discuss the guide's potential implications for inventors and legal service providers.

The guide issued by the USPTO, Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products  (Guidance), contains four sections. The first section summarizes the overall process to be followed by examiners when assessing subject matter eligibility under 35 U.S.C. §101. The second section provides guidance on how to determine if a claim as a whole recites eligible subject matter and is "significantly different" from any of four judicial exemptions recited in the first section. The third section provides several example claims and analyses of their eligibility in view of the points raised in the first two sections. Finally, the fourth section provides examiners with language to be used when making a rejection in accordance with the Guidance.

Click here to read the full discussion on the impact that the Supreme Court's decisions may have on subject matter eligibility analysis.