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Athena Diagnostics, Inc. v. Mayo Collaborative Services, et al.

Representative Claim(s)

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).

6. A method according to claim 3 [reciting use of a labeled antibody] whereby the intensity of the signal from the anti-human IgG antibody is indicative of the relative amount of the anti-MuSK autoantibody in the bodily fluid when compared to a positive and negative control reading.

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).

8. A method according to claim 7 wherein said label is a radioactive label.

9. A method according to claim 8 wherein said label is 125I.


Defendants’ Motion to Dismiss for lack of eligible subject matter

Exception Category: Law of Nature

“For the 20% of Myasthenia Gravis patients who do not have the AChR autoantibodies, the ‘820 patent inventors discovered that they had IgG antibodies that attack the N-terminal domains of muscle specific tyrosine kinase (“MuSK”), a receptor that is located on the surface of neuromuscular junctions.”

“While 125I-MuSK and the antibody/MuSK complexes are not found in nature, this does not transform the patent at issue here to a patent eligible concept. Contrary to Plaintiffs’ argument, the ‘820 patent is not a composition patent directed at the creation of the 125I-MuSK auto-antibody complex. Rather, the patent is directed at a method for the diagnosis of a disease. … Although the patented method uses man-made 125I-MuSK, the use of a man-made complex does not transform the subject matter of the patent. The focus of the claims of the invention is the interaction of the 125I-MuSK and the bodily fluid, an interaction which is naturally occurring. The purpose of the patent is to detect whether any antibody-antigen complexes are formed between the 125I-MuSK receptor and the antibodies “present in said bodily fluid.’ ”

“Plaintiffs’ argument that the patent is transformed by the use of a man-made molecule is unavailing. The stated purpose of the patent is to diagnose Myasthenia Gravis, and the method is directed to a patent ineligible law of nature under § 101.”

Significantly More: No

“Defendants argue that Plaintiffs’ patent fails step two of § 101 analysis because it uses well-known techniques for identifying the presence of autoantibodies to MuSK and therefore does not contain an ‘inventive concept.’ … Defendants cite to [two references disclosed in the patent specification that] …date from 1976 and 1985, and according to Defendants the publications describe ‘(1) the introduction of a 125I-labeled antigen (AChR) into a bodily fluid sample, (2) immunoprecipitation, and (3) detecting the radioactive label.’ ”

“Plaintiffs argue that at the time the invention was made, the step of ‘detecting’ autoantibodies was neither well understood nor routine, and that the step of contacting MuSK or a MuSK epitope with a suitable label was novel. Pls.’ Memo. … Plaintiffs admit that the specification states ‘[i]odination and immunoprecipitation are standard techniques in the art,’ but Plaintiffs argue that none of those steps are routine when applied to proteins. According to Plaintiffs, proteins are complex, and getting known iodination methods to work with proteins is not routine.”

“Plaintiffs’ argument is unavailing. … None of the complexity to which Plaintiffs cite is described or claimed in the patent.  While Plaintiffs argue that ‘Production of ‘MuSK or an epitope or antigenic determinant thereof having a suitable label thereon’ required several steps that were neither well-known, not standard, nor conventional for MuSK,’ [citation omitted], this statement directly contradicts the language in the specification. In the specification, the inventors simply state that the ‘suitable label” is 125I or the like, and that iodination of the label is a standard technique in the art.’ ”

The Plaintiff also argued that the use of a man-made molecule necessarily made the claims patent-eligible. The Court rejected this, noting that the specification and the claims were directed to “a process for detecting autoantibodies, not a process for creating the 125I–MuSK.”