915 F.3d 743
Fed. Cir.2019Background
- Athena owned U.S. Patent No. 7,267,820, claiming methods to diagnose MuSK‑related neurological disorders by detecting autoantibodies to MuSK; Athena markets a MuSK antibody test.
- Asserted claims (6–9) recite immunoassay steps: contacting labeled MuSK (or epitope) with bodily fluid, immunoprecipitating antibody/MuSK complexes, and detecting label (claims 7–9 use 125I; claim 6 describes an ELISA‑style labeled secondary antibody).
- The specification acknowledges iodination, immunoprecipitation, radioimmunoassays, and ELISA as conventional, "known per se in the art."
- Mayo developed competing tests; Mayo moved to dismiss under Rule 12(b)(6), arguing claims 6–9 are patent‑ineligible under 35 U.S.C. § 101.
- The district court held claims 6–9 invalid under § 101 as directed to a natural law (the correlation between MuSK autoantibodies and disease) and applying only conventional techniques; this appeal followed.
Issues
| Issue | Plaintiff's Argument (Athena) | Defendant's Argument (Mayo) | Held |
|---|---|---|---|
| Whether claims 7–9 are "directed to" a natural law at step one of Mayo/Alice | Claims recite specific, innovative, concrete laboratory steps using man‑made labeled MuSK and so are directed to a laboratory technique, not a natural law | Claims are directed to the natural law — the correlation between MuSK autoantibodies and disease; remaining steps are conventional assay techniques | Claims 7–9 are directed to a natural law (the correlation) because the claims chiefly claim the discovery and use conventional detection steps |
| Whether the claims supply an ‘‘inventive concept’’ at step two | The claimed sequence of steps, use of labeled MuSK, and application to an unmet diagnostic need supply an inventive concept; factual disputes exist about whether steps were routine | The specification admits the assay steps (iodination, immunoprecipitation, ELISA/radioimmunoassay) are conventional; no inventive concept — routine application of standard techniques | No inventive concept: the non‑natural‑law elements are conventional individually and as an ordered combination; § 101 invalidity affirmed |
| Whether the district court erred by refusing to consider Athena’s expert declaration (conversion to summary judgment) | Expert showed iodination/immunoprecipitation were non‑routine as applied, creating factual disputes precluding dismissal | The expert declaration was outside the pleadings and inconsistent with the patent specification; district court properly declined to convert the motion | District court did not abuse discretion; expert evidence not considered and dismissal on § 101 was appropriate |
| Whether claim 6 (ELISA variant) requires remand for separate analysis | Claim 6 involves a different labeling technique and was not separately argued below, so it merits separate review | Athena failed to present claim‑6‑specific arguments below; claim 6 was properly treated as represented by claims 7–9 | Athena waived distinct claim‑6 arguments; even on merits claim 6 would be ineligible (ELISA described as conventional) |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (2012) (establishes two‑step test for laws of nature/diagnostic claims)
- Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014) (applies Mayo two‑step framework to abstract ideas)
- Diamond v. Diehr, 450 U.S. 175 (1981) (claim must be considered as a whole; applications of laws of nature can be patentable)
- Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) (step‑one directed‑to inquiry can find claims not directed to abstract ideas if they improve technology)
- Elec. Power Grp. v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016) (focus on claim as a whole in directed‑to analysis)
- Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016) (multi‑step process that yields a technological improvement may be eligible)
- BASCOM Glob. Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016) (inventive concept can lie in a non‑conventional ordered combination)
- Ariosa Diagnostics v. Sequenom, 788 F.3d 1371 (Fed. Cir. 2015) (diagnostic claim applying conventional techniques to a newly discovered natural correlation held ineligible)
- Cleveland Clinic Found. v. True Health Diagnostics, 859 F.3d 1352 (Fed. Cir. 2017) (claims that merely observe a natural correlation using well‑known techniques are ineligible)
- Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) (distinguishes patent‑eligible man‑made compositions from natural products)
- In re BRCA1‑ & BRCA2‑Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014) (diagnostic claims applying routine techniques to natural correlations held ineligible)
- Vanda Pharm. Inc. v. West‑Ward Pharm. Int’l, 887 F.3d 1117 (Fed. Cir. 2018) (example where application of natural law in a treatment regimen was found eligible)