927 F.3d 1333
Fed. Cir.2019Background
- Athena Diagnostics (and co-appellants) appealed invalidation under 35 U.S.C. § 101 of claims in U.S. Patent No. 7,267,820 that diagnose myasthenia gravis (MG) by detecting MuSK autoantibodies using labeled immunoassay steps (claims 7–9).
- The district court found the claims patent-ineligible as directed to a natural law with only conventional assay steps; the Federal Circuit panel affirmed.
- The panel and multiple concurring judges applied the Supreme Court’s two-step Mayo/Alice framework: (1) determine whether claims are directed to a natural law; (2) if so, ask whether additional claim elements supply an "inventive concept."
- The majority concluded the claims are directed to the natural-law correlation (MuSK autoantibodies ↔ MG) and the recited steps are conventional, so no inventive concept under Mayo.
- Several judges (dissenters and concurrences) criticized Mayo’s application, arguing it (a) collapses § 101 into novelty/inventiveness inquiries better suited to §§ 102/103/112, (b) creates a de facto per se rule excluding diagnostics, and (c) conflicts with Diehr and Myriad.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether claims reciting detection of MuSK autoantibodies for diagnosing MG are directed to a patent-ineligible natural law | Athena: claims are specific, concrete methods applying a discovery (new correlation) and thus are patent-eligible under § 101 | Mayo/Mayo-derived precedent: the correlation is a natural law; the claimed assay steps are conventional and do not transform the claim into patent-eligible subject matter | Court: claims are directed to a natural law (the correlation) and additional steps are conventional — ineligible under § 101 (Mayo controlling) |
| Whether conventional detection steps can supply an "inventive concept" under Mayo step two | Athena: the combination of steps and the novel discovery of the correlation supply patentable subject matter; discovery of a new natural phenomenon can supply inventiveness | Mayo view: novelty of the natural law itself does not supply the required inventive concept when the claim adds only routine techniques | Court: conventional assay steps cannot supply the inventive concept; novelty of the natural law alone is insufficient |
| Proper role of other Patent Act provisions (§§ 102, 103, 112) in screening overbroad claims | Athena: novelty/nonobviousness/utilization considerations should control claims that are specific and narrow | Mayo/majority: §§ 102/103/112 cannot adequately prevent patents that would preempt natural laws; § 101 serves a distinct preemption screen | Court: follows Mayo — § 101 must be applied at threshold to prevent preemption even if other sections overlap |
| Whether Federal Circuit should rehear en banc / reform § 101 application to diagnostics | Dissenters: en banc review needed because Mayo has been overapplied and has produced a per se exclusion of diagnostics that harms innovation; propose narrower rule allowing specific diagnostic claims | Majority concurrences: bound by Supreme Court precedent (Mayo/Alice) and cannot meaningfully distinguish this case; call on Supreme Court or Congress to act | Petition for rehearing en banc denied; no change to precedent from this court |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (2012) (establishes two-step § 101 framework and rejects claims that add only conventional steps to a natural law)
- Diamond v. Diehr, 450 U.S. 175 (1981) (holdings emphasize evaluating claims as a whole and that application of a law of nature can be patent-eligible)
- Parker v. Flook, 437 U.S. 584 (1978) (introduced ‘‘inventive concept’’ scrutiny and treated algorithmic elements as prior art for § 101 analysis)
- Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014) (applies Mayo two-step framework to abstract ideas and reaffirms search for transformative additional elements)
- Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) (distinguishes naturally occurring DNA from patent-eligible applications of genetic knowledge)
- Gottschalk v. Benson, 409 U.S. 63 (1972) (early statement of judicial exceptions to § 101 for abstract ideas)
- Bilski v. Kappos, 561 U.S. 593 (2010) (reaffirms limits on patenting abstract ideas and the need to avoid monopolizing fundamental building blocks)
- Brenner v. Manson, 383 U.S. 519 (1966) (utility requirement and caution against granting patents for speculative or broadly preemptive discoveries)