Mayo Wins in Another s. 101 Appeal – Discovery of a Useful Natural Correlation is not Patent Eligible

By now, once you see the claim, I would not be surprised if any of my loyal readers could not predict how it would fare at the Fed. Circuit. However, this is a worthwhile decision to review, particularly since the dissent by Judge Newman brings the analytical flaws in the majority’s opinion into such sharp focus. A representative doomed claim is below, compressed for readability:

7. A method for diagnosing neurotransmission or developmental disorders related to [the marker protein MuSK] in a mammal comprising:

contacting MuSK… having a suitable label thereon with [a] bodily fluid,

immunoprecipitating any antibody/MuSK complex… from the,

bodily fluid and

monitoring for said label on any of said antibody/MuSK complex…,

wherein the presence of said label is indicative of said mammal suffering from said… disorder related to [MuSK].

The claim is the result of the discovery that 20% of myasthenia gravis (“MG”) patients do not express autoantibodies to the acetyl choline receptor, but do generate autoantibodies against MuSK, a membrane protein. “Prior to this discovery, no disease had been associated with MuSK.” Slip op. at 4.

So, this is an example of an “If A, then B” diagnostic claim, with some wrinkles. The user does not simply measure the level of a biomarker, following the administration of a drug known to yield the biomarker, as in the 6-TP metabolite used as the marker in Mayo. In this claim, a hypothetical user would need to obtain the labeled MuSK protein (e.g., radiolabeled), add it to the test fluid, so that any antibody/MuSK complex is immunoprecipitated, measure the level of the label, and conclude that the patient does or does not have MG. This looks a lot like the hand of man at work, but these steps did not impress the majority of Judges Lourie and Prost. Perhaps they have become “strict constructivists” of the Mayo/Alice Rule.

If you have been watching the legal walls close in on diagnostic assays, you know how this appeal is going to be decided. The lower court concluded that the claim is “directed to” a law of nature, that the lower court identified as “the interaction between the labeled MuSK and the autoantibodies that bind to it – “an interaction that occurs naturally.” Then the lower court jumped straight to Step 2 of the Mayo/Alice analysis and determined that the claims lack an inventive concept, since the recited steps involved only standard steps in the art.”

The majority spends the next nine pages affirming the lower court’s reasoning. Of course, Athena argued that the claims are not a law of nature, but are “directed to a new laboratory technique that makes use of man-made molecules.” The majority first identified the natural law as “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.”

But isn’t that the problem with the majority’s analysis. As Judge Newman’s dissent points out, the claim is not directed to a bodily fluid containing autoantibodies that bind to MuSK, the claim is directed to a diagnostic method based on the discovery of the presence of such antibodies and their utility in diagnosing MS. Footnote 3 of the Majority’s opinion is intriguing, since it is a dismissal of the lower court’s holding that the “focus of the claims was the binding of MuSK to MuSK antibodies in bodily fluid [sic].” The footnote states that “Our cases have not described a claim to the binding of two molecules during a sequence of chemical manipulations (here, after MuSK labeling and before immunoprecipitation) as a claim to a natural law, even if such binding occurs according to natural laws.” In other words, the majority must disregard the detection step, that involves the binding of labeled MuSK to autoantibodies in the sample, in order to broadly focus on a correlation that exists in nature apart from any human interaction.

Once we get that little point-of-order out of the way, the majority strips the manipulative and measurement steps away from the correlation and laboriously finds them to be conventional, etc. The majority is assisted, as was the majority in Cleveland Clinic by the fact that the specification had lots of that “well-known to the art” language that is treated like an admission. The CellzDirect claims were distinguished as more than a simple observation or detection of the ability of hepatocytes to survive multiple freeze/thaw cycles, but as effectively “harness[ing] a natural law to produce a technologic improvement that was patent eligible.”

Note that this language seems to be an attempt to track the PTO Guidance on the patent-eligibility of claims that are based on abstract ideas. If the claim recites an abstract idea, it need not be analyzed under Step 2 of Mayo/Alice if it is directed to a technological improvement. Unfortunately, the Guidance said little about natural laws, and the use of the term “technological improvement” may have been intended to distance software and computer system claims from medical advances.

Cleveland Clinic was discussed as reiterating that “claims that merely recite observing naturally occurring biological correlations, ‘with no meaningful non-routine steps in between’ are directed to a natural law… As the claims only covered the correlation between MPO and cardiovascular disease, an ineligible discovery, together with ‘well known techniques to execute the claimed method’, we held that the claims were directed to a natural law.” But can’t “discoveries”, which are specifically named in section 101, be patent-eligible if they are embedded in enough concrete steps to be valuable tools?

The answer to that question is “No!” The legal sin is that “[t]he claims… involve both the discovery of a natural law and certain concrete steps to observe its operation.” Page 12 of the Slip opinion end with a statement that is close to an insult: “The ‘820 patent thus describes the claimed invention principally as a discovery of a natural law, not as an improvement in the underlying immunoassay technology.” Of course, that’s not what the inventors were attempting to claim, and Judges Lourie and Prost should know better than to try to crib language from the computer system/software side of Alice and her children.

Athena urged the panel to consider that the assay employs a man-made molecule, labeled MuSK, to no avail. Mayo argued that the claims in Prometheus v Mayo involved a man-made drug – conveniently not noting that it was both a known drug and that it was administered to a patient to yield a known metabolite biomarker. Ariosa was used as an example of using man-made primers, but they were pretty much called natural products by the Fed. Cir. in Ambry as were the DNA probes by the S. Ct. in Myriad. The majorities shaky conclusion was: “We this reaffirm that use of a man-made molecule in a method claim employing standard techniques to detect of observe a natural law may still leave the claim directed to a natural law.” What does that even mean? What if the man-made molecule is a patentable new drug? Any use of that drug is patentable, right?

Predictable, the panel endorses the deadly language in Genetic Techs. v Meriel, that “[t]he inventive concept necessary at step 2… cannot be furnished by the unpatentable law of nature itself.” In other words, the discovery of the utility of a natural correlation cannot provide the inventive step required when the claim recites the use of the natural correlation in a diagnostic claim. The level of analysis by the majority hits a new low when Athena’s argument that the labeled MuSK should rise to the level of an inventive concept by concluding that “appending labeling techniques to a natural law does not provide an inventive concept where, as here, the specification describes 125-I labeling as a standard practice in a well-known assay.” But the claimed assay for MuSK antibodies was found to be novel and unobvious.

I meant to spend time on Judge Newman’s dissent, and it deserves our attention for clearly describing a sensible “road not taken” that might have led us out of the last almost five years of a doctrinal mine field. Of course, I have liberally borrowed from her concerns as noted above but, hopefully tomorrow I can present them to you in a more ordered form.

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