As an introduction to this topic, please reread my post of July 5, 2017 about The Cleveland Clinic v. True Health Diagnostics, subtitled “Time to Redefine ‘Inventive Concept'”? The claim were directed to diagnosing the presence of cardiovascular disease (CAD) by measuring the blood level of the MPO enzyme in a patient and comparing it to the level in a control subject diagnosed as not having the disease. The panel found that the method failed to pass Step 2 of the Alice/Mayo test. I wrote:
“The part of the decision that set off some legal alarm bells, at least for me, was the panel’s trivializing the techniques used to establish he controls and the relationship between the MPOP level in a patient vs. the control level in a patient population not having CAD. The panel wrote:
‘[T]he claims instruct that MPO levels be detected or determined using any of these known techniques. The claims of the testing patent also contain a comparing step where MPO levels are compared to statistically derived control or predetermined values. Here too, the Cleveland Clinic does not purport to drive new statistical methods to arrive at the predetermined or control levels of MPO that would indicate a patient’s risk of [CAD].’”
In a talk I recently gave on the dire fate of diagnostic methods in the hands of the courts and PTAB, I argued that, in view of the columns of selection criteria and statistical analysis required to carry out the claimed diagnosis, that Cleveland Clinic might have “purported” more than they did about the inventive concept(s) required to reach the diagnostic conclusion.
I am not claiming any influence over the able litigators at Jones Day, but this is the central approach that they took in the Petition for Cert. that they filed on January 16, 2008:
“[T]he Federal Circuit ignored a crucial point: while the patents employed conventional techniques, the inventors adapted those techniques for an entirely new purpose not known in the prior art, and, in fact, taught away from by the prior art. …[the Federal Circuit] ignored the inventor’s important and previously unknown discovery that those techniques could be adapted in a new way to provide medically-relevant data that was predictive of the risk of CVD….This case raises the issue whether the discovery of a new application of known techniques resulting in a novel and non-obvious method for diagnosing the risk of heart disease is patent eligible subject matter under Section 101.”
Since 2014, the walls have been closing in on diagnostic methods. Ariosa adapted the PTO’s implicit finding that the discovery of the significance of a naturally occurring correlation could not provide the inventive concept required by the Mayo/Alice test. At the end of the Mayo decision, Judge Breyer rejected the Government’s argument that “virtually any step beyond a statement of a law of nature itself should transform an unpatentable law of nature into a potentially patentable invention [under 101].”
The question remaining is what sort of additional steps – if any – should be recognized as accomplishing the transformation. Cleveland Clinic is trying to get the Supreme Court to answer this question for diagnostic tests. Since the question of the patent-eligibility of diagnostic tests was raised (and ducked) in Mayo, Cleveland Clinic may have a better than zero chance of saving patents in this increasingly important area of personalized medicine.