Earlier this month, the U.S. Patent & Trademark Office (“USPTO”) issued updated guidance to its examining corps concerning subject matter eligibility rejections and responses under 35 U.S.C. § 101. The 2016 Guidance, available here, instructs examiners to articulate detailed explanations and provides various examples of eligible and non-eligible life science claims. The 2016 Guidance follows 2014’s Interim Guidance and 2015’s Updated Guidance and is intended to further refine examiners’ consideration of subject matter eligibility issues under § 101.

Those operating in life sciences industries may find the 2016 Guidance of particular interest, as it supplements the twenty-seven examples set forth in the 2014 Interim Guidance and 2015 Updated Guidance with six new examples for determining subject matter eligibility in the life sciences area. The examples include patent eligible and ineligible claims concerning: vaccines; diagnostics and treatments using a hypothetical disease; hypothetical nature-based products including mixtures; screening for gene alterations; and others.

The 2014 Interim Guidance and 2015 Updated Guidance directed examiners to follow a two-part analysis based on Alice Corp. v. CLS Bank, 573 U.S. __ (2014): (1) is the claim directed to a law of nature, a natural phenomenon, or an abstract idea; and, if so, (2) is any element, or are a combination of elements, in the claim sufficient to ensure that the claim amounts to significantly more than the judicial exception?

The 2016 Guidance are intended to clarify how examiners should evaluate these two steps. For example, when the first step indicates that “the claim recites a law of nature or natural phenomenon, the rejection should identify the law of nature or natural phenomenon as it is recited (i.e., set forth or described) in the claim and explain using a reasoned rationale why it is considered a law of nature or natural phenomenon.” In contrast, when the first step indicates that “the claim recites an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim, and explain why it corresponds to a concept that the courts have identified as an abstract idea.” (The 2016 Guidance is accompanied by a list of relevant court decisions.) The 2016 Guidance also provides direction for use when the first step indicates that the claim is directed to a product of nature.

With respect to the second step of the analysis, the 2016 Guidance includes instruction concerning the consideration of the combination of additional elements in the claim (“particularly critical”), notes that whether “claim limitations are well-understood, routine, conventional activities” should not require a prior art search “because lack of novelty…does not necessarily” supply an answer, and provides commentary concerning “claim limitations that recite a generic computer component performing generic computer functions at a high level of generality.”

The 2016 Guidance also addresses consideration of an applicant’s claim amendment and/or argument in response to a subject matter eligibility rejection.

The 2016 Guidance are one of the more recent data points populating the subject matter eligibility landscape. David Kappos, former Director of the USPTO, recently called for abolition of § 101 at the Federal Circuit Judicial Conference. Several recent district court decisions have declined to grant fee awards after asserted claims were found invalid for lack of patentable subject matter. See, e.g., YYZ LLC v. Pegasystems Inc., D. Del. Case No. 1-13-cv-00581 (May 2, 2016 Order); Clarilogic, Inc. v. FormFree Holdings Corporation et al,, S.D. Cal. Case No. 3-15-cv-00041 (Apr. 27, 2016 Order). And, in March, Sequenom, Inc. filed a Petition for Writ of Certiorari asking the Supreme Court to review the Federal Circuit’s ruling in Ariosa Diagnostics, Inc. v. Sequenom, Inc. (finding ineligible claims in the medical diagnostics field directed to detecting fetal abnormalities using paternally-inherited DNA). We anticipate that the subject matter eligibility landscape will continue to evolve as these and other data points are considered by practitioners, the courts, the USPTO, and others.