Alice: ‘This is impossible’ (Alice in Wonderland 2010): Alice (Corp. Pty. Ltd. v. CLS Bank Int’l,), aid’s in striking yet another blow against the pursuit of diagnostic test method

| June 26, 2017

Cleveland Clinic Foundation v. True Health Diagnostics LLC

June 16, 2017

Before Lourie, Reyna and Wallach.  Opinion by Reyna.


The CAFC affirmed the invalidly of method claims in three diagnostic test patents held by Cleveland Clinic Foundation (hereon – Cleveland Clinic), and further affirmed that True Health Diagnostics LLC (hereon – True Health) was not liable for contributory or induced infringement of a fourth patent directed to methods of treating patients diagnosed by the diagnostic tests.

This CAFC decision strikes another blow against the patent eligibility of diagnostic methods, while further highlighting the difficulty of enforcing method treatments based on such diagnostic tests (i.e., personalized medicine).


Patent eligibility

The diagnostic testing patents held by Cleveland Clinic at issue were U.S. Patent No. 7,223,552, U.S. Patent No. 7,459,286, and U.S. Patent No. 8,349,581. The patents are directed towards methods of determining a patients risk of developing atherosclerotic cardiovascular disease by determining the levels of myelopoxidase (MPO) activity, MPO mass or both in a bodily sample (for instance, blood), and comparing the predetermined levels of MPO activity, MPO mass or both. In comparing the samples, the results are indicative of the patient’s risk of developing atherosclerotic cardiovascular disease. The district court analyzed claims 21 and 22 of the ‘286 patent, claim 5 of the ‘581 patent and claims 11, 14 and 15 of the ‘552 patent, holding the patents ineligible under §101.

Cleveland Clinic initially challenged the districts courts analysis of only analyzing certain claims of each of the patents for patentable eligibility under §101. Cleveland Clinic argued that the unexamined dependent claims provide sufficient inventive concepts over the representative claims that were examined. The CAFC disagreed. The CAFC held that each limitation Cleveland Clinic raised merely recited known methods of detecting MPO and the like, and so are substantively similar and linked to the same ‘law of natures’ as the representative claims.

Next, the CAFC applied the two-step Alice framework to determine whether the claims were directed to ineligible subject matter.

Applying step one of the Alice analysis, the courts found the testing patents were directed to methods for observing the ‘law of nature’ that MPO correlates to cardiovascular disease.

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.’

Applying step two of the Alice analysis, the court held that the claims do not recite the use of any new detection or analytical techniques, and so did not contain an inventive concept sufficient to transform the claimed naturally occurring phenomena into a patent-eligible application.

The court held that the claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. That ‘Mayo and Ariosa make clear that transforming claims that are directed to a law of nature requires more than simply stating the law of nature while adding the words “apply it.”’ The process steps here merely tell those “interested in the subject about the correlations that the researchers discovered.” Mayo, 566 U.S. at 78.

The court did not deny that the discovery of the relationship was not ‘groundbreaking’ but continued that “even such valuable contributions can fall short of statutory patentable subject matter, as it does here.”

Thus, the CAFC affirmed the district court’s findings that the testing patents are directed to patent-ineligible subject matter under §101.

Patent Infringement

The final issue involved a fourth Patent by Cleveland Clinic, U.S. Patent No. 9,170,260. Independent claim 1 recites:

Claim 1. A method for administering a lipid lowering agent to a human patient based on elevated levels of myeloperoxidase (MPO) mass and/or activity comprising:

(a) performing an enzyme linked immunosorbent assay (ELISA) comprising contacting a serum or plasma sample with an anti-MPO antibody and a peroxidase activity assay to determine MPO activity in the serum or plasma sample;

(b) selecting a patient who has elevated levels of MPO mass and/or activity compared to levels of MPO mass and/or activity in apparently healthy control subjects; and

(c) administering a lipid lowering agent to the selected human patient.

The CAFC upheld the district courts finding to grant True Health’s motion to dismiss, finding no basis to support claims of contributory infringement or induced infringement. The CAFC agreed that Cleveland Clinic had failed to assert facts that could support True Health’s liability for contributory infringement or induced infringement.

Contributory infringement occurs if a party sells, or offers to sell, a material or apparatus for use in practicing a patented process, and that “material or apparatus” is material to practicing the invention, it has no substantial non-infringing uses, and it is known by the party “to be especially made or especially adapted for use in an infringement of such patent.” True Health provides MPO testing services. The only “material or apparatus” that Cleveland Clinic claims True Health sells are lab reports documenting the results of True Health’s testing services. As to contributory infringement, the courts agreed that True Health’s lab reports do not qualify as a “material or apparatus” that could support liability under 35 USC § 271(c).

As to induced infringement, “Whoever actively induces infringement of a patent shall be liable as an infringer. However, knowledge of the acts alleged to constitute infringement is not enough.” Thus, the mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven.

The court held that it is undisputed that True Health does not sell or prescribe lipid lowering drugs to patients. Cleveland Clinic argued that True Health’s lab reports were sufficient to create the reasonable inference that a doctor who ordered such a report would rely on the results and would administer a lipid lowering agent where the results indicated the patient had a cardiovascular disease risk. The court noted ‘Cleveland Clinic alleges no facts that suggest any connection between True Health and doctors that may prescribe lipid lowering drugs.’

Thus, the CAFC agreed that Cleveland Clinic “falls short of showing ‘specific intent and action’ on behalf of True Health to induce infringement of the ’260 patent.”


While Akamai and Eli Lilly and Company, provided some avenues for establishing induced infringement when there is no single party who would be liable for direct infringement, it may still be difficult to establish such for diagnostic companies when they do not preform the treatments steps nor direct a third party to do so.

Full Opinion

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