Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Massachusetts holding claims directed to methods for diagnosing neurological disorders invalid for lack of subject matter eligibility under 35 U.S.C. § 101. Athena Diagnostics, Inc. v. Mayo Collaborative Servs , LLC, 2019 U.S. App. LEXIS 3645 (Fed. Cir. 2019).  The patent at issue is directed to detecting neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK).

The Federal Circuit applied the two-part Alice/Mayo test set for the by the Supreme Court, and first analyzed whether the claims are “directed to a law of nature.”  The Federal Circuit agreed with Defendant that the 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 like MG [Myasthenia gravis].”  In doing so, the Federal Circuit rejected Plaintiff’s argument that the claims do not preempt a natural law because they use man-made molecules to attach to the MuSK and perform a new laboratory technique.  The Federal Circuit noted that the claims at issue involve the discovery of a natural law, and certain concrete steps to observe it.

Before proceeding to step two of the Alice/Mayo test, the Federal Circuit noted the difference between claims that recite a natural law and conventional means for detecting it (such as the claims at issue), and applications of natural laws such as the method of treatment by administering drug at certain dosage ranges based on a patient’s genotype.  (citing Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1133-36 (Fed. Cir. 2018)).  The court further stated that “[c]laiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself.  But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law.”

At step two of the Alice/Mayo test, the Plaintiff argued that the claims provide an inventive concept: “an innovative sequence of steps involving man-made molecules.”  Defendant argued that the claims lack inventive concept because the specification describes the steps for detecting MuSK antibodies as standard techniques in the art.  The Federal Circuit agreed with Defendant and stated that even if the steps had not previously been used to detect MuSK antibodies, “we cannot hold that performing standard techniques in a standard way to observe a newly discovered natural law provides an inventive concept.”

Judge Newman wrote a lengthy dissent, contending that the Federal Circuit’s Section 101 eligibility jurisprudence was inconsistent.  She believed the claims at issue satisfied the first Alice step, directed to a multi-step method of diagnosis, not a law of nature.  Judge Newman also argued that Section 101 does not exclude new methods of diagnosing human ailments.

There continues to be uncertainty regarding subject matter eligibility for method claims related to diagnosis and testing, but it is clear that the inclusion of man-made molecules in diagnostic tests or of standard test procedures to observe a new phenomenon, are not sufficient to render diagnostic method claims patent eligible.