In a post-Mayo v. Prometheus opinion addressing the subject matter eligibility of diagnostic methods based on underlying natural laws, the US Court of Appeals for the Federal Circuit affirmed the district court’s conclusion that the claims at issue were invalid as ineligible, notwithstanding  the Federal Circuit’s acknowledgement of the claims’ recitation of “certain concrete steps.” Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, Case No. 17-2508 (Fed. Cir. Feb. 6, 2019) (Lourie, J) (Newman, J, dissenting).

Athena is the exclusive licensee of a patent covering methods of diagnosing neurological disorders by detecting autoantibodies to a protein called muscle-specific tyrosine kinase (MuSK). Athena sued Mayo alleging infringement of the patent, and Mayo moved to dismiss, arguing that the asserted claims were invalid under 35 USC § 101. The district court granted Mayo’s motion, concluding that the asserted claims were invalid as directed to ineligible subject matter. More specifically, the district court found that the asserted claims were directed to a natural law and failed to recite an inventive concept. Athena appealed.

At the Federal Circuit, Athena argued that the claims were not directed to a natural law because they recited innovative, specific and concrete steps, but the Federal Circuit disagreed. The Court began by identifying the natural law as the correlation between the presence of naturally occurring MuSK autoantibodies and MuSK-related neurological diseases.

Proceeding to step one of the Alice inquiry, the Federal Circuit found the claims to be directed to an ineligible concept. While the Court conceded that the claims included certain concrete steps to observe the operation of the natural law, it determined that the claims as a whole were directed to the abstract idea, “because the claimed advance was only in the discovery of a natural law, and . . . the additional recited steps only apply conventional techniques to detect that natural law.” Moreover, the Court noted that the specification described the concrete steps as conventional.

Athena further argued that the claims required labeling with a human-made molecule, but the Federal Circuit reaffirmed that the use of a human-made molecule as part of conventional techniques to detect or observe a natural law may still leave the claim directed to the natural law. The Court distinguished the case at hand from its decision in Vanda (IP Update, Vol. 21, No. 5) on the basis that Vanda claimed a new treatment for an ailment using a natural law rather than the natural law itself.

At step two of the Alice inquiry, the Federal Circuit found that the claims did not include additional elements transforming the nature of the claim into a patent-eligible application, because the claims only required standard techniques applied in a conventional manner. The Court contrasted the claims at hand with those at issue in which required multiple freeze-thaw cycles, an unconventional step. Athena argued that the claimed steps were unconventional because, prior to Athena’s discovery of the correlation between the MuSK autoantibodies and the MuSK-related disease, the steps had not been applied to detect the MuSK autoantibodies. However, the Court explained that an unconventional concept at step two cannot be furnished by the unpatentable natural law itself—it must represent an inventive application beyond that discovery.

In dissent, Judge Newman stated that, in her view, the claims were directed to a multi-step method of diagnosis, not a law of nature. In Newman’s view, the majority erred in dissecting the claim into old and new elements and then removing the old elements from the claims for the purpose of the § 101 analysis.

According to Newman, under the proper procedural framework, where claims are considered as an ordered combination, the claimed method determines whether the correlation is present as part of a larger diagnostic method, but does not claim the concept of the correlation itself. Considering the claim as a whole, Newman would have found the claims subject matter eligible as directed to a method of diagnosing the MuSK-related disease using a human-made chemical-biochemical procedure, not a law of nature.

Turning to a policy issue, Newman argued that the public interest is poorly served by creating disincentives to the development of new diagnostic methods, a sentiment echoed in the majority opinion. As Newman observed, by their nature diagnostic methods are tightly bound to underlying natural laws and are hence especially susceptible to challenges based on subject matter eligibility.

Practice Note: In accordance with the distinction Judge Lourie made between the case at hand and Vanda, claims to methods of treatment may have a higher chance of withstanding scrutiny relative to diagnostic methods. In Vanda, the Federal Circuit concluded that a method of treatment by administering a drug at certain dosage ranges based on a patient’s genotype was not directed to a natural law.