955 F.3d 1358
Fed. Cir.2020Background
- CardioNet owns U.S. Patent No. 7,941,207, which claims a cardiac monitoring device that (a) detects beat-to-beat timing (R–R intervals), (b) detects premature ventricular beats, and (c) determines whether variability in beat timing indicates atrial fibrillation or atrial flutter while accounting for ventricular beats.
- The specification touts technical advantages: improved sensitivity and positive predictivity for AF/atrial flutter detection, ability to identify sustained episodes, suitability for ambulatory/real-time monitoring, and low computational requirements.
- InfoBionic moved to dismiss under Rule 12(b)(6), arguing the asserted claims are patent-ineligible under 35 U.S.C. § 101 as directed to an abstract idea (automating diagnostic reasoning about heartbeat variability).
- The district court held the claims abstract under Alice step one and dismissed. CardioNet appealed to the Federal Circuit.
- The Federal Circuit majority reversed: it concluded the claims are directed to a patent-eligible technological improvement in cardiac monitoring (so Alice step one fails for the defendant); it also held that Alice step one may be decided on the intrinsic record without requiring a prior-art/state-of-the-art remand. Judge Dyk concurred in the result but dissented in part, criticizing the majority’s dicta limiting the use of extrinsic evidence.
Issues
| Issue | CardioNet’s Argument | InfoBionic’s Argument | Held |
|---|---|---|---|
| Whether the asserted claims are directed to an abstract idea (Alice step 1) | Claims recite a specific device/process improving cardiac-monitoring accuracy and clinical usefulness | Claims merely automate diagnostic steps doctors have long performed (collect/analyze heartbeat data) | Reversed: claims are directed to a patent-eligible improvement to cardiac monitoring, not an abstract idea |
| Patent eligibility of dependent claims (claims 2,3,7,10–12,22) | Dependent claims add concrete technical features (weighting, QRS detector, non-linear functions, electrodes, data transmission) | Still generic data-processing/automation | Held eligible along with claim 1; dependent claims narrow technical features and thus are not abstract |
| Whether Alice step 1 resolution at Rule 12(b)(6) requires remand / examination of prior art or longstanding practices | Intrinsic record (claims + specification) does not show long-prevalent practice; no remand required | Argued claims automate longstanding medical practice; urged remand or consideration of extrinsic evidence | Majority: no remand needed; step one may be resolved on intrinsic evidence and does not require prior-art/state-of-art inquiry. Dissent: warns this dicta is inconsistent with precedent and that extrinsic evidence of longstanding practice can be relevant |
| Whether to proceed to Alice step two (inventive concept) | Not reached because claims pass step one | Would have argued lack of inventive concept if step one found abstract | Court did not reach step two after finding claims not directed to an abstract idea |
Key Cases Cited
- Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014) (established the two-step framework for § 101 abstract-idea analysis)
- Bilski v. Kappos, 561 U.S. 593 (2010) (identified ‘‘fundamental practices long prevalent’’ as paradigmatic abstract ideas)
- Diamond v. Diehr, 450 U.S. 175 (1981) (novelty/nonobviousness are separate from § 101 eligibility)
- McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016) (claims directed to a specific technological improvement are patent-eligible at step one)
- Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) (focus on whether claims improve computer capabilities or merely use computers as tools)
- Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253 (Fed. Cir. 2017) (claims to improved memory system held directed to technological improvement)
- Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) (eligibility can involve underlying factual issues; intrinsic evidence matters)
- Data Engine Techs. LLC v. Google LLC, 906 F.3d 999 (Fed. Cir. 2018) (if claims are not directed to an ineligible concept at step one, no need to reach step two)
- Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016) (do not oversimplify claims; consider claim focus/character as a whole)
- FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089 (Fed. Cir. 2016) (claims that merely collect/analyze information analogous to long-standing human practices can be abstract)