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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).

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.

Posture:

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.’ ”

Significantly More: Not Decided

“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.’ ”

“The court cannot determine at this junction whether Plaintiffs’ patented method uses standard techniques in the art, or whether it is sufficiently inventive to be patentable under the second step of Mayo. While it may later be established that the Plaintiffs’ process is not deserving of patent protection because the techniques are standard in the art and therefore fail to provide an inventive concept, the court cannot resolve these factual determinations at the motion to dismiss stage.”