On February 6, 2019, the Federal Circuit decided Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, affirming a District Court for the District of Massachusetts decision that the claims at issue were patent ineligible for being directed to a natural law.

As summarized in a prior post, Athena Diagnostics (“Athena”) sued Mayo Collaborative Services (“Mayo”) for infringing U.S. Patent No. 7,267,820 (the ’820 patent). The asserted claims are directed to methods of diagnosing neurological disorders by detecting autoantibodies using labeled antigens. The claim at issue, Claim 7, concludes with the following wherein clause:

wherein the presence of said label [used to detect the autoantibody] is indicative of said mammal is suffering [sic] from said neurotransmission or developmental disorder related to [MuSK].

The district court found that the claims were unpatentable under 35 U.S.C. § 101, concluding that the claim recited a patent ineligible “natural law.” The Federal Circuit affirmed the decision. The Federal Circuit based its determination of patent ineligibility on the wherein clause reproduced above, concluding that the clause recites the “natural law” of a correlation between the presence of autoantibodies and a neurological disease. The Federal Circuit’s analysis raises at least two interesting issues with respect to the patentability of diagnostic methods under § 101.

First Issue – the “Wherein” Clause

The Federal Circuit noted that the district court concluded that the claim was directed to an ineligible “natural law” because the claim focused on a naturally occurring interaction between the labeled MuSK protein and the autoantibody. The Federal Circuit declined to follow the district court’s reasoning, stating that prior cases have not described interactions of two molecules as a claim directed to an ineligible “natural law,” even if such binding occurs according to natural laws. However, the Federal Circuit also declined to decide whether the district court’s rationale was correct since it found the claim ineligible based on the wherein clause instead. See Opinion at footnote 3.

The Federal Circuit’s reliance on the wherein clause to find the claim directed to ineligible subject matter raises the issue of whether the claim would have been found patent eligible if the wherein clause was missing from the claim. It could be argued that the wherein clause does not provide any patentable weight to the claim since it arguably does not change how the claimed method is performed, and was therefore unnecessary. Based on the Federal Circuit’s apparent reluctance to adopt the district court’s reasoning, it is possible that the claim would have been found patent eligible without the wherein clause.

It is worth noting, however, that the Federal Circuit’s opinion states that the determination of what a claim is directed to is “based on both the written description and the claims.” Thus, a court may look beyond what is recited in the claims to determine patent eligibility. This could lead a court to find claims ineligible based on statements in the patent specification despite the lack of this type of wherein clause in the claims. This is in contrast to the most recent guidelines from the US Patent and Trademark Office (“PTO”), which require a patent examiner to review what is recited in the claim to determine what the claim is directed to: “If the claim does not recite a judicial exception, it is not directed to a judicial exception … and is patent eligible.” 2019 Revised Patent Subject Matter Eligibility Guidance, Federal Register (2019) 84(4):50 at p. 54 (emphasis added, herein after “PTO Guidance”).

Second Issue – “Well-understood, Routine, Conventional Steps”

In its opinion, the Federal Circuit stated that the steps to detect the autoantibodies recited in the claim – the steps of contacting a sample with labeled peptide, immunoprecipitating, and monitoring – are steps that were routine and conventional. The court concluded that the claims were therefore “directed to a natural law because they recite only the natural law together with standard techniques for observing it.” It is important to note that determining whether that the recited steps were routine and conventional was carried out under Step 1 of the Alice/Mayo analysis. Consideration of whether the recited steps are well-understood, routine and conventional is more often found in Step 2 of the analysis, where a court considers if the claim recites “something more” that transforms the judicial exception into a patent-eligible subject matter.

The court’s consideration of whether the additional claim steps were routine and conventional in the Step 1 of the Alice/Mayo analysis contrasts with the PTO Guidance on Step 1 (referred to as “Step 2A” in the PTO Guidance). In the PTO Guidance, if a claim recites a judicial exception (e.g., a natural law or abstract idea), the claim is evaluated as a whole to determine whether it integrates the judicial exception into a practical application and is thus patent eligible. The PTO Guidance directs examiners to give weight to all additional elements recited in the claim, whether or not they are conventional. The PTO Guidance expressly states that this analysis “specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity,” which is instead to be considered only as step 2 of the Alice/Mayo analysis (referred to as “Step 2B” in the PTO Guidance). PTO Guidance at p. 55 (emphasis added).

There is an obvious tension between the standards set forth by the court in Athena v. Mayo and the process described in the recent PTO Guidance. These tensions may affect strategies for pursuing patents at the PTO, and are likely to play out as the PTO continues to integrate court decisions with its guidelines.

Written by: Robert J. Hilton, Ph.D. & Brenden S. Gingrich, Ph.D.