In view of the U.S. Supreme Court’s decisions in Alice, Myriad, and Mayo, the United States Patent and Trademark Office (USPTO) has issued a series of guidance documents on patent subject matter eligibility under 35 U.S.C. § 101. These documents are collected on the Subject Matter Eligibility page of the USPTO website. The USPTO’s “May 2016 Subject Matter Eligibility Update” (88 Fed. Reg. 27381), announced the newest in this series of guidance, including new life science examples, a memorandum to the patent examining corps with instructions on formulating subject matter eligibility rejections, an index of eligibility examples, and an appendix of subject matter eligibility court decisions.

The new life science examples use hypothetical fact patterns to provide example subject matter eligibility analyses. The USPTO intends the examples to assist patent applicants and examiners by illustrating possibilities for drafting claims to satisfy 35 U.S.C. § 101. The examples include:

  • Vaccines
  • Diagnosing and treating julitis (an autoimmune disease)
  • Dietary sweeteners
  • Screening for gene alterations
  • Paper making machine
  • Hydrolysis of fat

Although these examples do not have the force of law, they reflect the USPTO’s current thinking and policy positions regarding the application of 35 U.S.C. § 101 to life science inventions. Applicants with pending applications, or applications in preparation, in the life sciences would be wise to consider these examples in preparing claims and office action responses.

Of general interest to those in the life science as well as in other fields, the examiner memorandum included with the USPTO’s new guidance is intended to improve the quality and consistency of subject matter eligibility determinations and rejections, for example by requiring examiners to more clearly explain their reasoning. The memorandum also requires examiners to carefully consider all of an applicant’s arguments and evidence rebutting the subject matter eligibility rejections, and to provide a reasoned rebuttal if the rejection is maintained. The memorandum should prove to be a useful tool during patent examination.

The impact of the USPTO’s new guidance should begin to be felt over the next few months, as the examiners receive formal training and begin applying the guidance in examination. In the meantime, the USPTO welcomes public comments on patent subject matter eligibility at The next few months may also bring additional developments on patent subject matter eligibility under 35 U.S.C. § 101, if the Supreme Court grants certiorari and revisits the issue in Ariosa v. Sequenom. In that case, Nutter attorneys Konstantin Linnik, Lana Gladstein, and Isaac Hubner filed an amicus brief on behalf of seven international biotech industry associations from Europe, Canada, Australia, and Japan. The amicus brief can be accessed here.