Athena Diagnostics v. Mayo – Finessing the Correlations Trap?
In The Cleveland Clinic Foundation v. True Health Diagnostics, the Fed. Cir. panel held that a claim to a diagnostic method for determining a test subject’s risk for atherosclerotic cardiovascular disease (CD) by comparing MPO levels in the bodily fluid of a test subject to levels of MPO in control subjects is a patent-ineligible attempt to claim a law of nature:
“The method then employs the natural relationship between those MPO values and predetermined control values to predict a patient’s risk of developing or having CD. Thus, just like Ariosa, the method starts and ends with naturally phenomena with no meaningful non-routine steps in between–the presence of MPO in a bodily sample is correlated to its relationship to CD. The claims are therefore directed to a natural law.”
Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, Civil Action No: 15-cv-40075-IT (D. Mass., August 25, 2016) is an older district court decision that follows the Mayo/Alice test to the same conclusion but contains some interesting language by Judge Talwani. The claims were directed to a method of diagnosing Myasthenia Gravis, a neurodegenerative affliction, by determining if the subject has IgG autoantibodies that bind to muscle-specific tyrosine kinase (MuSk). (U.S. Pat. No. 7,267,820).
The decision reproduces two dependent claims that describe different assay techniques, but only discusses one of them. Claim 7 (discussed) recites that labeled MuSK is contacted with a bodily fluid, immunoprecipitating any antitbody-MuSk complexes and monitoring for any label on any antibody-MuSK complexes, wherein the presence of the label provides diagnosis of MG. (I have simplified the claim language for readability.)
Claim 2 is more complex, and is directed to adding MuSK to a sample of bodily fluid and then detecting any binary complexes that have formed between the native antibodies and the MuSK, wherein the presence of the complexes is indicative of MG. The detection step in this case can be carried out by contacting the complexes with a second antibody comprising a detectable label, thus forming a tertiary complex.
Now the argumentation gets interesting, since both claims use either a chemically modified MuSK or a labelled IgG antibody that will bind to the complex recited in claim 2. (See claim 3.) Again, the plaintiffs argument seems directed only to claim 7:
“Those antibody-MuSK complexes are created in the laboratory and result from the use of a non-naturally occurring laboratory-created molecule, [I-125 labelled MuSK], and therefore the antibody/MuSK complexes formed and detected in [claim 9, that depends from claim 7 via claim 8] are not found in nature.”
The judge rejects this argument, stating:
“While [I-125]-MuSK and the antibody- [labelled]MuSK complexes are not found in nature, this does not transform the patent at issue here to a patent eligible concept [sic]. Contrary to Plaintiff’s argument the ‘820 patent is not a composition patent directed at the creation of the [I-125]-MuSK autoantibody complex [emphasis supplied]. Rather the patent is directed for the diagnosis of a disease….Counter to Plaintiff’s argument, because the patent focuses on [a naturally occurring interaction], it is directed to a patent-ineligible concept.”
I will spare you the rest of the argumentation, because now we are in Stage 2 of the Mayo/Alice test, and we know how that usually turns out. However, the judge denied the motion to dismiss on the ground that further fact-finding was needed before the Stage 2, inventive concept, question could be decided.
But considering the judge’s comment about composition claims, there are a number of composition claims that can be extracted from method claims that recite the use of man-made complexes. The labeled MuSK claim may well be novel and unobvious. Even if MuSK had previously been isolated, it may be unexpected that MuSK can be labeled without reducing its ability to bind to the autoantibodies. And what about the detection of the unlabeled MuSK-antibody complexes using a labeled anti-IgG antibody, a step that necessarily forms a tertiary complex. How can either the binary or tertiary “tagged” complexes be natural products, particularly noting that they are formed in in vitro. If the inventors discovered that IgG autoantibodies existed in the blood, why not claim an isolated purified preparation of the autoantibodies?
Questions like this have never been resolved by the Fed. Cir. and won’t be resolved in this case either. Following Bergy II, in which the CCPA found that a purified cultured microorganism was patentable because the inventors had brought it out of the jungle of nature and put it to practical use, even composition claims to the isolated non-labeled complexes may be patent-eligible. The Pandora’s Box that unleashed the misery of s. 101 rejections on the life sciences may well contain a grain of Hope.