Cleveland Clinic II – Why Can’t a Diagnostic Conclusion be a Practical Application of a Natural Law?

Because the Federal Circuit says it can’t, that’s why!  In Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017), the panel held patent-ineligible claims to a method of assessing a test subject’s risk of having cardiovascular disease (CVD) by comparing levels of a marker MPO in a sample from the subject with levels from control subjects diagnosed as not having the disease wherein elevated levels of MPO in the test subject over the control subjects’ MPO levels “is indicative of the extent of the test subject’s risk of having cardiovascular disease”. In that decision, the panel found that the method claims are directed to a patent-ineligible natural law ‘that blood MPO levels correlate with CVD, “holding that the claimed method ‘starts and ends’ with observation of ‘naturally occurring phenomena’, as in Ariosa….” The panel jumped right to Step 2B of the Mayo/Alice test and found that the claims “recited no further inventive concept sufficient to transform the nature of the claims into a patent eligible application of the natural law.”

In this case, “Cleveland Clinic II,” (Appeal 2018-1218 (Fed. Cir., April 1, 2019) the Clinic appealed the 101 rejection of claims that did not recite a diagnostic conclusion:

1. A method of detecting elevated MPO mass in a patient sample comprising;
2. obtaining a sample from a human patient having [CVD]; and
3. detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPRO in said plasma samples and said anti-MPO antibodies.

These claims were designed to track Example 29 – Claim 1 of the May 4, 2016 PTO Guidance on patent-eligible subject matter:

1. A method of detection JUL-1 [a marker for the autoimmune disease “julitis”], said method comprising:
   1. obtaining a plasma sample from a human patient; and
   2. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

The PTO advised that because this claim does not recite or describe any [ineligible concept] it is not directed to a natural law and is eligible under s. 101. The panel dismissed reliance on this guidance in view of its holding in Ariosa that “[t]he only remaining non-conventional element of each claim is the discovery that the protein is present in the bodily sample, and the discovery of a natural law cannot by itself provide the requisite inventive concept. The panel noted that “especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law [ed. note: consistently wrong].”

One problem with the panel’s heavy reliance on Ariosa, beyond discrediting Example 29, is that in Ariosa,  the cffDNA detected in the serum or plasma of a pregnant female was not recited to be correlated to any pathological condition, or even to a “normal level” of cffDNA, much less a correlated to a particular pathology, as in Cleveland Clinic I. The holding in Ariosa was that the mere discovery or detection of a natural product is patent-ineligible unless the “amplification and detection techniques” were unconventional enough to provide the “inventive concept” required by the Mayo/Alice test.

The Ariosa decision might have been tolerable, since the discovery of cffDNA in a pregnant females’ blood can be analogized to finding gold in a pine cone; it’s still gold, a natural element, although it was found in an unexpected place. What is much less tolerable is the Fed. Cir.’s ability to analytically jump from finding that a claim recites a natural phenomenon directly to the usually futile attempt to find a further inventive concept. Cleveland Clinic fell into this analytical trap by arguing that the in vivo correlation between blood levels and CVD is not a natural law because it can only be detected using certain techniques.  A better argument would have been that the use of “certain techniques” to evaluate the utility of the natural correlation evidenced that the claim was a practical application of the natural correlation. (However, Cleveland Clinic abandoned recitation of the practical medical application in the claims under review, and simply claimed a method of detecting elevated MPO.)

The PTO’s 2019 Revised Patent Eligibility Guidance flies in the face of this truncated analysis:

“[The Guidance] explains that a patent claim or patent application claim that recites a judicial exemption is not ‘directed to’ the judicial exception if the exception is integrated into a practical application of the judicial exception.”

While this Guidance might not have changed the outcome in this case – it was not cited – it surely would have changed the outcome in Cleveland Clinic I and similar decisions that depend on the recognition of the utility of naturally occurring correlations.

The early PTO Guidance (May 2016) that contained Example 29 was trying to work around its own conclusion that simple “If A, then B” diagnostic tests are not patent eligible. As I have argued in earlier posts, an in vivo correlation should not per se be patent eligible, e.g., “patients that are afflicted with CVD have high levels of MPO in their blood” –this is a natural phenomenon that has always existed without human intervention. However, the discovery that such a naturally occurring correlation exists and is a useful indicator or predictor of a pathological condition should be recognized as practical application of the in vivo correlation. Put another way, “comparing”, “indicative” and “determining” steps should not be ignored as routine or, worse, as mental steps, when the “practical application” analysis is being carried out.

The problem lies in the fact that the Fed. Cir. has so far failed to distinguish the claims at issue in Mayo from any of the diagnostic claims it has considered, unless there is an action step beyond the mental step of reaching a diagnostic conclusion. In other words, the Fed. Cir. should be adhering to Mayo by limiting the reach [of the claims] to a particular, inventive application of the law of nature. Remember, the correlation at the heart of Mayo identified as a natural phenomenon is the correlation between the drug’s metabolite levels and the “likely harm or ineffectiveness of the drugs.”  The S. Ct. held that the Mayo claims lacked the “additional features that provide practical assurance that the processes are genuine applications of [the natural phenomenon}.

The Supreme Court also took into account the fact that the prior art taught that “the levels in a patient’s blood of certain metabolites…were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective.” All the patent claims did was set forth “processes embodying researchers’ findings that identified these correlations with some precision.” In the present case, the inventors discovered the underlying correlation between MPO in the blood and CVD and then clinically arrived at MPO values that were informative/diagnostic. At least this distinction should be applied to the claims of Cleveland Clinic II.

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