Athena III – Should the Discovery of a Naturally-Occurring Correlation Encompass Recognition of its Practical Utility?

The origin of the idea that natural phenomena, like the law of gravity, cannot be patented, even by their discoverer, is well-settled law. In Gottschalk v. Benson, the Supreme Court stated, in dictum: “Phenomena of nature, though just discovered, mental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” The Court went on to quote from Funk Bros.: “He who discovers a hitherto unknown phenomenon of nature has not claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.” The Court concluded that, in Funk Bros., “we dealt with a ‘product’ claim while the present case deals with a ‘process’. But the think the same principle applies.”

In the legal eyes of the Federal Circuit, discovery of a natural correlation, such that the presence of autoantibodies to MuSK in a patient’s blood can be correlated to a diagnosis of MG, a neurological condition, encompasses the recognition by the researcher that an assay to detect these autoantibodies would be likely to be indicative of MG, if the “newly discovered” autoantibodies could be detected and if the detection using any available techniques, such as ELISA, yielded an accurate diagnosis. (This is beginning to feel like the hindsight reconstruction of the claimed diagnostic test that would be prohibited in an obviousness analysis.) But not all natural correlations are useful, e.g., can be turned into useful diagnostic procedures using conventional analytical and statistical tools.

For example, as reported at the Colgate website, gum disease seemed to correlate with Alzheimer’s disease in a study of 20 deceased patients. The report continues:

“Because [the study was small] the association between [AD] and gum disease in this study could have occurred by chance. It is also possible that people with [AD] have worse oral hygiene than do people without dementia. Therefore, the bacteria [from plaque] found in the brain tissue may be the result of [AD], not the cause.”

In other words, to be patent-eligible, a natural phenomenon must be useful, not just “newly discovered.” (One can consider that the claims in both Prometheus v. Mayo and Cleveland Clinic were refinements of natural correlations that were well-known to the art – in Athena, the inventors discovered the correlation.)  Panels of Fed. Cir. judges have uniformly held that a natural phenomenon recited in a claim embraces the utility requirements of s. 101. No one would disagree that the natural correlation per se is not novel, but once the mental step of establishing that the correlation is indeed useful – that is has been applied to a useful end–is subsumed into the analysis of whether or not the correlation in the claim renders it “directed to” a natural phenomenon, there is nothing left but to examine the recited assay techniques for the elusive inventive step in Step 2B of the Mayo/Alice test.

The Fed. Cir. panels that have been invalidating diagnostic claims under s. 101 have given no weight to the manipulative steps that are required to carry out the claimed diagnostic test when they conduct the step 1 analysis to determine whether or not the claims are directed to a naturally-occurring correlation. Once the panel finds that the claim is directed to a natural phenomenon, the panel jumps right to Step 2 and look for an additional inventive step in the claim. Of course, it is never found in claims that don’t recite treating the diagnosed condition.

This compression of the Mayo/Alice test is at the heart of Judge Newman’s decision in Athena v. Mayo:

“The panel majority contravenes the requirements of precedent [e.g., Diehr], now holding that all of the steps of claims 7-9—that is radioactive labelling, complexing, precipitating and monitoring – are removed from consideration in the Section 1 analysis because they use conventional procedures; the majority holds that ‘[t]he ‘820 patent thus describes the claimed invention principally as a discovery of a natural law, not as an improvement in the underlying immunoassay technology.’…However, that is not the claimed invention….Applying the Mayo/Alice protocol of two-step claim analysis, claims 7-9 of the ‘820 patent are patent eligible under Step 1, for this method of diagnosing [MG] is not a law of nature, but a man-made chemical-biomedical procedure.”

Section 101 jurisprudence could have taken a different tack. In Genetic Technologies Ltd. v. Merial LLC, decided in April of 2016, the panel confronted a claim that “encompasses methods of detecting a coding region allele by amplifying and analyzing any linked non-coding region, which could be found within the same gene, or within an intergenic region.” The panel did not dispute that the method has advantages over prior art methods involving direct analysis of a coding region. The claim is question also recited in vitro manipulative steps such as the use of PCR to amplify the DNA and analyzing the amplified DNA sequence to detect the target allele.

Nonetheless, the panel, citing Ariosa, stated that:

“So too in the present case: the patent claim focuses on a newly discovered fact about human biology (the linkage of coding and non-coding regions of DNA), involves no creation or alteration of DNA sequences, and does not purport to identify novel detection techniques….The claim is directed to a natural law—the principle that certain non-coding and coding sequences are in linkage equilibrium with one another.”

This leads straight to Step 2 of the Mayo/Alice test and you know how that came out—the panel found that the manipulative steps of amplifying and analyzing DNA in general were well-understood routine and conventional. GTG argued that “’no one had before analyzed man-made non-coding DNA in order to detect a coding region allele’ and that this additional feature, at least provides sufficient inventive concept to pass step two of the Mayo/Alice test.” The panel disregarded this “mental process step” on the basis that it is “a routine comparison that can be performed by the human mind” – confusing a mental process step with an attempt to claim a process that can be performed entirely in the human mind, as in Cybersource v. Retail Decisions.

Also, the Meriel panel, ignored the hand of man steps that could have stopped the Mayo/Alice inquiry at Step 1. All of GTG’s arguments that sensibly could be applied to the Step 1 analysis were framed (or re-framed) as Step 2 arguments, including the diagnostic utility itself. “The question…[at Step 2] is whether the claims do significantly more than simply describe [a] natural relation…The inventive concept necessary at step 2 of the Mayo/Alice analysis cannot be furnished by the unpatentable law of nature…itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered law of nature…must provide something inventive, beyond ‘well understood…activity.” In other words, why can’t the discovery of a law of nature that leads to a useful diagnostic test meet the “inventive step” or practical application requirement of Step 1? Put another way, shouldn’t the inventive step requirement of step 2 be moved into step 1, so that it is attached to the claim as a whole and not to the manipulative/analytic steps that are evaluated in step 2?

If Judge Newman were on the panel, she would, probably, to no avail, argue that this method is patentable under Step 1 of the Mayo/Alice test “for this method [of detecting a coding region allele] is not a law of nature, but a man-made chemical biomedical procedure.” The point being that the “hand of man” steps in a diagnostic claim should be sufficient to halt the Mayo/Alice test at step 1. In effect, all diagnostic claims would be patent eligible. As stated by Judge Newman:

“Section 101 does not turn on whether any claim steps are ‘standard techniques.’  The appropriate analysis of the role of conventional process steps in claims to a new method is under Sections 102 and 103, not Section 101.”

If the Meriel panel had taken this tack in April of 2016, think of the millions of dollars of legal fees that would have been saved, not to mention the toll on inventors and their employers. In early 2019, the PTO released Guidance designed to circumvent “abstract idea” rejections using the “Newman approach, and generally stated that the Guidance would be applied to test other judicial exceptions.  I have not tried to analyze the support that Judge Newman’s position would have if Athena is reheard en banc, but I still consider her to be the RBG of the Federal Circuit. Unfortunately, she is also becoming the “great dissenter” in Section 101 appeals.

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