On May 5, 2016, the United States Patent and Trademark Office issued six new examples that provide guidance to Examiners and patent applicants prosecuting claims directed to life sciences subject matter (Subject Matter Eligibility Examples: Life Sciences).  These examples analyze claims that are directed to several of the most contentious areas of patentable subject matter under 35 U.S.C. § 101, including vaccines, methods for diagnosing and treating, nature-based products including mixtures, methods for genetic screening, and machines and processes that are alleged to be founded on a natural law. 

Since the issuance of the U.S. Supreme Court’s rulings in Mayo Collaborative Services v. Prometheus Laboratories Inc. (diagnostic test was found to be patent ineligible subject matter) and Association of Molecular Pathology et al. v. Myriad Genetics Inc. (isolated human genes were found to be patent ineligible subject matter), applicants in the life sciences space have been struggling to find a clear definition of the space within which they can operate.

While the new examples address many concerns that patent applicants have raised, the impact of this guidance is unclear.  In a memorandum from Robert W. Bahr, Deputy Commissioner For Patent Examination Policy, dated May, 4, 2016, the Commissioner stated, “[e]xaminers are reminded that examples issued by the Office in conjunction with the Interim Eligibility Guidance are intended to show exemplary analyses only and should not be used as a basis for a subject matter eligibility rejection or relied upon in the same manner as a decision from a court…Additionally, while it would be acceptable for applicants to cite an example in support of an argument for finding eligibility in an appropriate factual situation, applicants should not be required to model their claims or responses after the examples to attain eligibility,” (Bahr Memorandum, May 4, 2016).

The new examples potentially leave open questions about the rationale for eligibility, and thus, could generate uncertainty about their applicability to an applicant’s claims. For instance, Example 29, directed to methods of diagnosing and treating a hypothetical illness, contains two claims:  one directed to a method of detecting a biomarker in a patient, and the second directed to a method of diagnosing an illness in a patient by detecting the biomarker.  They differ only in the preamble and the diagnosis claim has one additional step of diagnosing. The diagnosing claim is deemed ineligible even though it has one more step than the detecting claim.

Further, some of the examples appear to conflict with current Federal Circuit case law (see Ariosa v. Sequenom, which held methods of non-invasively measuring cell-free fetal DNA (cffDNA) in maternal plasma and serum to be patent ineligible subject matter). A petition for certiorari has been filed with the United States Supreme Court and a decision on whether the petition is accepted has not yet been made. More than 20 amicus briefs were filed on the issue of whether to accept the petition, which is an indication of the significance of this area of law.

Applicants and their representatives should carefully review these new examples to determine how these may be used at the patent office and what the implications for any issued claims may be, particularly in light of any new case law that is developed through the courts.