• Feb 6 2019
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  • Category: CAFC Updates

Athena Diagnostics, Inc. and others appeal from an order of the District Court holding that certain claims of U.S. Patent 7,267,820 (covering methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle specific tyrosine kinase or “MuSK”) are invalid under 35 U.S.C. § 101 and dismissing  Athena’s complaint.  In conducting the first step of the Mayo/Alice test, the CAFC identifies the relevant natural law as being the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like Myasthenia gravis or “MG” and notes that claiming 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. With respect to the second step of the Mayo/Alice test, the CAFC finds that the recited steps were conventional both as an ordered combination and individually and notes that to supply an inventive concept the sequence of claimed steps must do more than adapt a conventional assay to a newly discovered natural law. Because the district court correctly concluded that the claims at issue recite only a natural law together with conventional steps to detect that law, they are ineligible under § 101, the CAFC affirms.  Judge Newman dissents, arguing that the CAFC’s decisions on the patent-ineligibility of diagnostic methods are not consistent, and the majority’s decision enlarges the inconsistencies and exacerbate the judge-made disincentives to development of new diagnostic methods, with no public benefit.  Judge Newman believes that the claims recite a manmade reaction sequence employing new components in a new combination to perform a new diagnostic procedure and that diagnostic claims should be evaluated for novelty and unobviousness, specificity and enablement, with no regard as to whether the diagnosed event occurs in the human body or in an extraneous device.

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