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Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC

No § 101 Fact-Finding Necessary Where Allegations in Pleadings are Incompatible with Patent

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, __ F.3d __, 2019 WL 453489 (Fed. Cir. Feb. 6, 2019) (Newman (dissenting), LOURIE, Stoll) (D. Mass.: Talwani) (3 of 5 stars)

Fed Cir affirms § 101 dismissal of Athena’s patent complaint. Athena is the exclusive licensee of a patent relating to detection of neurological disorders by detecting antibodies to muscle-specific tyrosine kinase (“MuSK”). Applying the Alice/Mayo framework, at step one Athena’s claims are directed to a natural law, namely “the correlation between the presence of naturally occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases[.]” Op. at 9–10. The opinion discusses how Athena’s claims are “directed to” that law, and not to any technological process employing it, thus distinguishing CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016), and Enfish, 822 F.3d 1327 (Fed. Cir. 2016), and noting that Athena’s “claimed advance was only in the discovery of a natural law[.]” Op. at 12. Athena’s contention that the claims are directed to an innovative laboratory technique was unsupported by any identification of what that laboratory innovation was. And though the claims were specific and concrete (thus leaving room for “other ways of interrogating the correlation between MuSK autoantibodies and MuSK-related disorders without practicing the claim’s concrete steps,” this lack of total preemption was insufficient to save the claims at step one. That the claims required labeling MuSK with a manmade substance also was not decisive. Vanda, 887 F.3d 1117 (Fed. Cir. 2018), is also not contradictory because that case claimed a “new treatment for an ailment, albeit using a natural law,” which was different than claiming the law itself.

At step two, Athena’s claims recited no more than conventional implementation of the natural law. That this was the first time those steps had been applied to MuSK autoantibodies did not alter the outcome. And the use of the manmade label for MuSK was conventional.

Aatrix, 882 F.3d 1121 (Fed. Cir. 2018), did not require pre-dismissal fact-finding. The opinion notes that Athena’s complaint contained no factual allegations contradicting the indications in the patent itself that the technique at issue used anything other than standard implementation steps. The district court did not abuse its discretion in declining to consider an expert declaration Athena had submitted, nor in deciding not to convert Mayo’s Rule 12 motion into a motion for summary judgment. The opinion notes, “the district court did not need to consider the allegations in the expert declaration because they were not consistent with the complaint read in light of the ’820 patent,” and describes how the complaint makes various assertions not reflected in the claims.

The district court did not err in dismissing as to claim 6 of the patent, even though Athena’s arguments had focused only on claims 7–9. “[W]e agree with Mayo that Athena waived its arguments specific to claim 6 by not making them before the district court.” Op. at 21.

Dissent: Judge Newman would have treated Athena’s claims as a “multi-step method of diagnosis, not a law of nature,” and thus would have reversed. She criticizes the majority for applying Alice and Mayo’s restrictions on subject matter eligibility too broadly.

KEYWORDS: SUBJECT-MATTER ELIGIBILITY; MOTION TO DISMISS; FACT FINDING; SECTION 101