Just When You Thought Things Couldn’t Get Worse Via The Application Of 101

Application of 101On Friday, in Cleveland Clinic Foundation v. True Health Diagnostics, Appeal no. 2016-1766 (Fed. Cir., June 16, 2017), a Fed. Cir. panels of Judges Lourie, Reyna and Wallach (Reyna writing) held that claims to a method of assessing a test subject’s risk of having atherosclerotic cardiovascular disease by comparing the levels of myeloperoxidase (MPO) in a sample from the test subject with predetermined levels of control subjects. In other words, the claims were drawn to a way to correlate MPO levels with the risk of developing cardiovascular disease. 

This is a simple “If A, then B” claims that corresponds closely to the homocysteine level-based cobalamin assay declared to be no more than a natural phenomenon by Justice Breyer, in dictum, in his dissent in Metabolite Labs some years ago. I hoped against all odds, even after Ariosa – which only involved the detection of cffDNA in maternal blood without claiming a specific correlation—that the “Breyer dissent” would not lead the way to the end of claiming diagnostic methods, but that turkey has finally found its roost.

If you have been following the expansion of patent-ineligible subject matter by application of the “Mayo/Alice test” you could write this decision without further information from me. (There was one group of diagnosis then treating claims that was not challenged.) The Fed. Cir. agreed with the district court that the testing patents’ claims were directed to a natural phenomenon under Alice step one because the claims were directed to the correlation between MPO in the blood and the risk of cardiovascular disease. Thus, the claims were directed to ineligible subject matter: “Because the testing patents are based on ‘the relation [between cardiovascular disease and heightened MPO levels that] exists in principle apart from human action’ they are directed to a patent ineligible law of nature.”

By now, you know that “If A, then B” claims are not going to escape the net of Alice step one. It was noted that the inventors did not invent the MPO assay methods and that the statistical methods used to generate the risk/no risk curve were routine. Even the “comparing step”, which led to the diagnosis was referred to as “a bare mental process.” Indeed, the court wrote that “just like Ariosa, the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between—the presence of MPO in a bodily sample is correlated to its relationship to cardiovascular disease. The claims are therefore directed to a natural law….The process steps here merely tell those ‘interested in the subject about the correlations that the researchers discovered.”’

But isn’t that what patents are supposed to do? The s.101 discussion ends by citing Mayo, and says “Likewise, while Cleveland Clinic argues that its discovery of the relationship between MPO and cardiovascular health was groundbreaking, ‘even such valuable contributions can fall short of statutorily patentable subject matter.”’ I have not yet heard a better argument for Congress amending s. 101.

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2 Responses to Just When You Thought Things Couldn’t Get Worse Via The Application Of 101

  1. george liu says:

    How could we help our clients for such inventions? I would appreciate it if anyone can offer some meaningful advice on how to draft claims that will pass this absurd reasoning.

  2. Paul Cole says:

    Could anyone explain how the subject matter claimed clearly is sufficiently transformational to fall within the “process” category of Section 101?

    The specification was apparently written before Mayo and the representative claim is in the broadest and most general terms without reciting specific steps and reagents.

    Very notably the method of treatment claims apparently were unchallenged, and as patients found by the test constitute a new patient group and treatment of them is transformational the decision not to challenge appears correct.

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