Nevro Corp. v. Boston Scientific Corp.
955 F.3d 35
| Fed. Cir. | 2020Background
- Nevro sued Boston Scientific alleging infringement of 18 claims across seven patents directed to high-frequency, paresthesia-free spinal cord stimulation for pain relief.
- The patents include system/device claims (implantable signal generators/leads) and method claims (programming and delivering therapy signals at specific frequencies/amplitudes).
- District court (N.D. Cal.) held multiple asserted claims indefinite (including several reciting “paresthesia-free,” “configured to,” and means-plus-function language) and granted summary judgment of noninfringement on six claims.
- On appeal, Nevro challenged the district court’s indefiniteness rulings; Boston Scientific cross‑appealed certain terms the district court found definite.
- The Federal Circuit reviewed claim constructions and indefiniteness de novo (with standard subsidiary-fact review) and addressed four principal claim‑construction/indefiniteness issues: “paresthesia-free,” “configured to,” “means for generating,” and “therapy signal.”
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| “paresthesia‑free” (method vs system/device claims) | Nevro: term is definite; specification and examples enable skilled artisan to identify paresthesia‑free signals. | Boston Sci: system/device claims indefinite because infringement depends on patient response (case‑by‑case). | Court: term is definite for both method and system/device claims; construed as “does not produce a sensation usually described as tingling, pins and needles, or numbness.” |
| “configured to” | Nevro: means “designed to” (broader). | Boston Sci: ambiguous; if construed, should mean “requires no further configuration” or is indefinite. | Court: does not render claims indefinite; “configured to” means “programmed to” (setting generator parameters). |
| “means for generating” (§112 ¶6) | Nevro: corresponding structure disclosed as a signal/pulse generator. | Boston Sci: specification discloses only a generic signal generator; insufficient structure -> indefinite. | Court: means‑plus‑function valid; corresponding structure is “a signal/pulse generator configured to generate” the claimed signals. |
| “therapy signal” | Nevro: should be read as a spinal cord stimulation/modulation signal to treat pain. | Boston Sci: indefinite because spec doesn’t guarantee therapeutic result in every patient. | Court: not indefinite; term construed as “a spinal cord stimulation or modulation signal to treat pain.” |
Key Cases Cited
- Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) (announces the “reasonable certainty” standard for claim indefiniteness)
- Halliburton Energy Servs., Inc. v. M‑I LLC, 514 F.3d 1244 (Fed. Cir. 2008) (functional claim language and indefiniteness analysis)
- Enzo Biochem., Inc. v. Applera Corp., 599 F.3d 1325 (Fed. Cir. 2010) (functional limitations can be definite when specification supplies guidelines/examples)
- Aristocrat Techs. Australia Pty. Ltd. v. Int’l Game Tech., 521 F.3d 1328 (Fed. Cir. 2008) (algorithm disclosure required where function performed by general‑purpose computer)
- Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003) (variability of result does not alone render claim indefinite)
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318 (2015) (standard of review for district court subsidiary factual findings in claim construction)
- Cox Commc’ns v. Sprint Commc’n Co., 838 F.3d 1224 (Fed. Cir. 2016) (discusses functional claim language and definiteness)
- Star Sci., Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) (definiteness does not require infringer to be able to determine infringement ex ante)