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Athena v. Mayo

Representative Claim(s)

6. [A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) wherein said method comprises the steps of: a) contacting said bodily fluid with muscle specific tyrosine kinase (MuSK) or an antigenic determinant thereof; and b) detecting any antibody-antigen complexes formed between said receptor tyrosine kinase or an antigenic fragment thereof and antibodies present in said bodily fluid, wherein the presence of said complexes is indicative of said mammal suffering from said neurotransmission or developmental disorders) 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), wherein said antibody-antigen complex is detected using an anti-IgG antibody tagged or labeled with a reporter molecule] 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 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)] 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:

Appeal from decision of the District Court

Exception Category: Law of Nature

“Athena argues that claims 7–9 are not directed to a natural law at step one because they recite innovative, specific, and concrete steps that do not preempt a natural law. Rather, Athena contends that the claims are directed to a new laboratory technique that makes use of man-made molecules.”

“As an initial matter, we must identify what the relevant natural law is. Here, it is the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG. This correlation exists in nature apart from any human action. There can thus be no dispute that it is an ineligible natural law.”

“As in Cleveland Clinic and Ariosa, we conclude that claims 7–9 are directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law.”

“Athena argues that the claims at issue, like the claims in CellzDirect, are directed to an innovative laboratory technique, not a law of nature. However, Athena does not point to any innovation other than its discovery of the natural law. CellzDirect did not suggest that appending standard techniques to detect a natural law rendered claims not directed to a natural law; rather, we expressly distinguished the eligible claims in that case from ineligible claims that “amounted to nothing more than observing or identifying the ineligible concept itself.”

“Athena argues that the claims at issue differ from prior diagnostic claims we have held ineligible under § 101 because they require labeling MuSK with a manmade substance. We disagree. As Mayo argues, the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.”

Significantly More: No

“We agree with Mayo that the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only require standard techniques to be applied in a standard way.”

“Athena also argues that the claimed steps were unconventional because they had not been applied to detect MuSK autoantibodies prior to Athena’s discovery of the correlation between MuSK autoantibodies and MG. Even accepting that fact, we cannot hold that performing standard techniques in a standard way to observe a newly discovered natural law provides an inventive concept. … Rather, to supply an inventive concept the sequence of claimed steps must do more than adapt a conventional assay to a newly discovered natural law; it must represent an inventive application beyond the discovery of the natural law itself.”

“For the same reasons that we have concluded that attaching a label to MuSK did not make the claims directed to an eligible concept at step one, we conclude that appending labeling techniques to a natural law does not provide an inventive concept where, as here, the specification describes 125I labeling as a standard practice in a well-known assay.”

Judge Newman dissented

“The ’820 inventors did not patent their scientific discovery of MuSK autoantibodies. Rather, they applied this discovery to create a new method of diagnosis, for a previously undiagnosable neurological condition.”

“Claims 7–9 require specific steps by which the diagnostic method is performed. The panel majority ignores these steps, and instead holds that ‘claims 7–9 are directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law.’ [Citation omitted.] This analysis of patent-eligibility is incorrect, for the claim is for a multi-step method of diagnosing neurotransmission disorders related to muscle specific tyrosine kinase, by detecting autoantibodies using a series of chemical and biological steps as set forth in the claims.”

“After eliminating the “conventional” procedures, my colleagues rule that this new method is a ‘law of nature.’ However, these inventors are not claiming the scientific fact of a newly described autoantibody; they are claiming a new multi-step diagnostic method. This is not a law of nature, but a manmade reaction sequence employing new components in a new combination to perform a new diagnostic procedure.”

“The majority does not distinguish between the question of whether the claimed method as a whole is eligible, and the question of whether the separate steps use conventional procedures. Instead, my colleagues hold that since the separate procedures are conventional, it is irrelevant that the method as a whole is a new method. The majority misconstrues the claims, in holding that claims 7–9 are directed to the ‘concept’ of ‘the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG.’ [Citation omitted.] The claimed method determines whether this correlation is present, for diagnostic purposes, but the concept itself is not claimed.”

Judge Newman also discussed the negative policy implications of too narrow a reading of section 101.