In the Cleveland Clinic Foundation v. True Health Diagnostics LLC, [2016-1766](June 16, 2017), the Federal Circuit affirmed that the asserted claims of U.S. Patent Nos. 7,223,552; 7,459,286; and 8,349,581 are not directed to patent-eligible subject matter, and that Cleveland Clinic failed to state a claim of contributory or induced infringement of U.S. Patent No. 9,170,260.
The patents were all directed to methods for detecting the risk of cardiovascular disease in a patient. The district court next found the three testing patents patent ineligible under the two-step framework for analyzing patent subject matter eligibility under §101 articulated in Alice. More specifically, the district court found that the testing patents’ claims were directed to a law of nature under Alice step one because the claims were directed to the correlation between MPO in the blood and the risk of cardiovascular disease. Under Alice step two, the district court found there was no saving inventive concept, employing well-known methods to detect MPO, comparing MPO levels with a control value in what could be a bare mental process, and ultimately, instructing a user to apply a natural law.
The district court further found that True Health’s testing service was not a “material or apparatus” that could form the basis for a contributory infringement claim. The district court further found that the Cleveland Clinic did not allege facts sufficient to show the specific intent to induce third parties to infringe.
The Federal Circuit affirmed the propriety of deciding §101 rejections at the motion to dismiss stage, before claim construction or significant discovery has commenced. On the merits, the Federal Circuit agreed that the claims of the testing patents were directed to multistep methods for observing the law of nature that MPO correlates to cardiovascular disease. Because this relationship exists in principle apart from human action, the claims are directed to a patent ineligible law of nature. The Federal Circuit found the case similar to Ariosa. At step two of the Alice inquiry, the Federal Circuit agreed that the practice of the method claims does not result in an inventive concept that transforms the natural phenomena of MPO being associated with cardiovascular risk into a patentable invention.
On the issue of contributory infringement, the Federal Circuit said that a party that provides a service, but no “material or apparatus,” cannot be liable for contributory infringement. Because the defendant was merely providing testing services, the Federal Circuit agreed that the claim should be dismissed. On the issue of inducement, the Federal Circuit observed that the mere knowledge of possible infringement by others does not amount to inducement; and that specific intent and action to induce infringement must be proven. The Federal Circuit found that merely providing test reports to physicians falls short of showing the specific intent and action to induce infringement of the ’260 patent.