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

915 F.3d 743
CourtCourt of Appeals for the Federal Circuit
DecidedFebruary 6, 2019
Docket2017-2508
StatusPublished
Cited by48 cases

This text of 915 F.3d 743 (Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019).

Opinions

Dissenting opinion filed by Circuit Judge Newman.

Lourie, Circuit Judge.

*746Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V. (collectively, "Athena") appeal from the order of the United States District Court for the District of Massachusetts holding that claims 6-9 of U.S. Patent 7,267,820 (the " '820 patent") are invalid under 35 U.S.C. § 101 and dismissing Athena's complaint under Rule 12(b)(6). Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC , 275 F.Supp.3d 306 (D. Mass. 2017) (" Decision "). Because the district court correctly concluded that the claims at issue are directed to a natural law and lack an inventive concept, we affirm.

I. BACKGROUND

Athena Diagnostics is the exclusive licensee of the '820 patent, covering methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase ("MuSK"). '820 patent Abstract. Athena also markets a test called FMUSK that functions by evaluating those antibodies. After Mayo Collaborative Services, LLC ("Mayo") developed two competing tests that allegedly practice each step of one or more claims of the '820 patent, Athena accused Mayo of infringing its patent. Mayo moved to dismiss under Rule 12(b)(6), arguing that the asserted claims of the '820 patent were invalid under 35 U.S.C. § 101. The district court granted *747Mayo's motion, concluding that the claims were invalid under § 101 for claiming ineligible subject matter. This appeal solely concerns whether claims 6-9 are patent eligible under § 101.

A.

Myasthenia gravis ("MG") is a neurological disorder where patients experience muscle weakness and symptoms including drooping eyelids, double vision, and slurred speech. '820 patent col. 1 ll. 13-23. It was previously discovered that MG is an autoimmune disease caused by a patient generating antibodies against her own acetylcholine receptors. Id. col. 1 ll. 24-26. Antibodies which recognize a person's own proteins as foreign antigens are known as autoantibodies. Id. col. 1 ll. 42-45.

About 80% of patients with MG produce acetylcholine receptor autoantibodies. Id. col. 1 ll. 34-36. The other 20% do not, but they do experience the same MG symptoms. Id. col. 1 ll. 36-38. The named inventors of the '820 patent discovered that many of the 20% of MG patients without acetylcholine receptor autoantibodies instead generate autoantibodies to a membrane protein called MuSK. Id. col. 1 ll. 54-61. Prior to their discovery, no disease had been associated with MuSK. Id. col. 2 ll. 35-37.

Having discovered the association between MuSK autoantibodies and MG, the inventors of the '820 patent disclosed and claimed methods of diagnosing neurological disorders such as MG by detecting autoantibodies that bind to a MuSK epitope.1 Id. col. 2 ll. 61-65. Claim 1, not at issue in this appeal, is the only independent claim and reads as follows:

1. A method for diagnosing neurotransmission or developmental disorders related to [MuSK] in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of [MuSK].

Id. col. 12 ll. 31-35. Claim 7 is at issue and depends from claim 1. It recites:

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 [MuSK].

Id. col. 12 l. 62-col. 13 l. 5 (spacing added). Claim 8 depends from claim 7 and recites that the label is a radioactive label. Id. col. 13 ll. 6-7. Claim 9 depends from claim 8 and further recites that the radioactive label is 125I, a radioactive isotope of iodine. Id. col. 13 ll. 8-9. We focus on claim 9, the most specific one at issue, which requires: (1) contacting MuSK or an epitope thereof having a 125I label, with bodily fluid; (2) immunoprecipitating any antibody/MuSK complex; and (3) monitoring for the label on the complex, wherein the presence of the label indicates the presence of a MuSK-related disorder.

*748The specification of the '820 patent further explains what the steps of iodination and immunoprecipitation entail. First, MuSK is iodinated using radioactive 125I. Id. col. 10 ll. 50-52. Then iodinated MuSK is separated from any free 125I by gel filtration. Id. col. 10 ll. 55-56. Next, the 125I-labeled MuSK is added to a small volume of the patient's bodily fluid and left overnight. Id. col. 10 ll. 56-58.

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915 F.3d 743, Counsel Stack Legal Research, https://law.counselstack.com/opinion/athena-diagnostics-inc-v-mayo-collaborative-servs-llc-cafc-2019.