The Federal Circuit’s Hands are Tied as Diagnostic Methods take Another Step Away from Eligibility – And the Court Isn’t Happy About It

February 14, 2019
News | Patents

Applicants and patentees have been struggling to certain patent diagnostic methods following Supreme Court precedent in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) which held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not patent-eligible subject matter. Similarly, the claims at issue in this appeal were directed to methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle specific tyrosine kinase (“MuSK”), although the claims further recited what would appear to be the concrete steps of mixing a manmade 125 I labeled MuSK protein with a bodily fluid, immunoprecipitating any resulting antibody/MuSK complex; and monitoring for the label on the complex. Claim 7, which depended from claim 1, was the primary claim at issue. Both appear below.

1. A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).

7. A method according to claim 1, comprising contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to muscle specific tyrosine kinase (MuSK).

The Federal Circuit concluded that the claims were directed to a natural law although they were recognized to include the above specific concrete steps. In her dissent Judge Newman noted the labeled MuSK was unknown, the reaction between the antibody and the labeled MuSK protein was unknown, the antibody/MuSK complex formed was unknown, and the immunoprecipitation of this complex was unknown. However, while admitting unhappiness with their own decision, the majority said that Supreme Court precedent left them no alternative. In footnote 4, writing for the majority, Judge Lourie stated:

The dissent states much that one can agree with from the standpoint of policy, and history, including that “the public interest is poorly served by adding disincentive to the development of new diagnostic methods.” Dissent at 12. We would add further that, in our view, providing patent protection to novel and non-obvious diagnostic methods would promote the progress of science and useful arts. But, whether or not we as individual judges might agree or not that these claims only recite a natural law, cf. Berkheimer v. HP Inc., 890 F.3d 1369, 1374 (Fed. Cir. 2018) (Lourie, J., concurring in the denial of rehearing en banc) (discussing traditional laws of nature such as “Ohm’s Law, Boyle’s Law, [and] the equivalence of matter and energy”), the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature, see 566 U.S. at 77, and “[p]urely ‘conventional or obvious’ ‘[pre]-solution activity’ is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law,” id. at 79 (second alteration in original) (quoting Flook, 437 U.S. at 590). We have since confirmed that applying somewhat specific yet conventional techniques (such as the polymerase chain reaction) to detect a newly discovered natural law does not confer eligibility under § 101. Ariosa, 788 F.3d at 1377; see also Cleveland Clinic, 859 F.3d at 1356, 1362 (addressing other conventional techniques such as flow cytometry). Our precedent leaves no room for a different outcome here.

The Federal Circuit thus – reluctantly, it appears – concluded that the recited steps only apply conventional techniques to detect that natural law and are not an improvement in the underlying immunoassay technology. In finding the techniques conventional although unknown, the court relied on statements within the specification that “[t]he actual steps of detecting autoantibodies in a sample of bodily fluids may be performed in accordance with immunological assay techniques known per se in the art,” and that “[i]odination and immunoprecipitation” are identified as “standard techniques in the art.”

As to the use of a man-made molecule in the methods claimed, the Federal Circuit found that if it amounts to only a routine step in a conventional method for observing a natural law, the claim may still be directed to a natural law. The court noted the specification described 125I labeling as a standard practice in a well-known assay. Although the man-made molecule was novel and likely unobvious based on its unknown utility and absence of motivation to prepare it, these issues were not addressed and apparently not relevant to a determination as to what is a routine step.

Judge Newman stated in her dissent that in finding the separate steps conventional, the court deviated from the requirement under Diamond v. Diehr, 450 U.S. 175 (1981), that in determining eligibility under § 101, claims must be considered as a whole and “It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis.” The majority appears to have wished it could agree – but that is small comfort to applicants and patentees, at the present time.


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