Addressing the issue of whether method claims involving determination of risk of cardiovascular disease based on detection of a particular biomarker pass § 101 muster under the 2014 Supreme Court of the United States decision in Alice, the US Court of Appeals for the Federal Circuit upheld the district court’s finding that the claims were not patent eligible. The Cleveland Clinic Foundation v. True Health Diagnostics LLC, Case No. 16-1766 (Fed. Cir., June 16, 2017) (Reyna, J).

The patents at issue involve methods of detecting MPO, an enzyme released when arteries are damaged or inflamed, and evaluating the risk of cardiovascular disease based on the MPO levels. After Cleveland Clinic filed suit, True Health moved to dismiss on the grounds that the claims were directed to ineligible subject matter under § 101. The district court agreed and found all claims of the asserted diagnostic patents invalid. Cleveland Clinic appealed.

Cleveland Clinic argued that a motion to dismiss was an improper vehicle for assessing patent eligibility under § 101. Rather, the “district court should have undertaken claim construction and developed the factual and expert record before analyzing” validity under § 101. The Federal Circuit rejected this argument, noting that Cleveland Clinic “provided no proposed construction of any terms or proposed expert testimony that would change the § 101 analysis.” 

Turning to the merits of subject matter eligibility, the Federal Circuit first evaluated whether “the claims are directed to ineligible subject matter, such as a law of nature,” under Alice step one. The Court concluded that the claims are directed to a natural law because they involve detecting naturally occurring MPO and then “[employ] the natural relationship between those MPO values and predetermined or control values to predict a patient’s risk of developing or having cardiovascular disease.” 

Proceeding to Alice step two, the Federal Circuit examined “the elements of the claims to determine whether they contain an inventive concept sufficient to transform the claimed naturally occurring phenomena into a patent-eligible application.” In other words, having already identified the natural law—the presence of MPO in the body and its correlation with cardiovascular disease—in Alice step one, the Court focused on whether the claims added anything new sufficient to render the claims patentable. As part of that analysis, the Court distilled the claimed method to two steps: a “determining” step that involved analyzing MPO levels, followed by a “comparing” step that involved comparing MPO levels to statistically derived control or predetermined values. The Court concluded that both steps could be performed using known techniques, so the invention claimed reduced to the correlation between MPO and risk of cardiovascular disease. Accordingly, the Court concluded that the claimed method did “not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention.”  

Cleveland Clinic argued that its claims were analogous to those in CellzDirect and therefore were directed to patent-eligible subject matter. In CellzDirect, the Federal Circuit found that the challenged claims were valid under § 101 because they were “directed to a new and useful laboratory technique for preserving [liver cells]” (IP Update, Vol. 19, No. 8). The Court, however, disagreed with the analogy. In CellzDirect, “the inventors took the discovery that certain liver cells will survive multiple freeze-thaw cycles and applied that to improve existing methods for preserving liver cells.” The Court concluded that the claimed invention here was not directed to a new laboratory technique but rather “uses well known techniques to execute the claimed method.” 

Practice Note: Although the Federal Circuit determined that the claims in issue here were not patent eligible under § 101, it acknowledged a narrow path to § 101 eligibility under CellzDirect. Based on the Court’s reasoning, the claims could have survived the § 101 challenge had they required new and different methods of detecting MPO. When appropriate, patent owners should consider raising substantive claim construction arguments (in response to a motion to dismiss on §101 grounds) in order to try to establish that the challenged method requires new techniques.