In Re: Ethicon, Inc.
844 F.3d 1344
| Fed. Cir. | 2017Background
- Ethicon owns U.S. Patent No. 7,591,844 claiming a balloon-expandable drug‑eluting stent coated with a PVDF:HFP copolymer (~85:15) processed below 60°C to provide an adherent, non‑cracking coating on expansion.
- Boston Scientific SCIMED and Abbott requested inter partes reexamination; the PTO merged the requests and the examiner rejected claims 1–17 and 19–23 as obvious over Tuch, Tu, Lo, and Le Morel (translation) among others.
- Tuch discloses drug‑containing polymer coatings for stents and warns that low‑elasticity coatings can crack during expansion; it lists many polymers (including VDF homopolymer) but not the specific 85:15 VDF:HFP copolymer.
- Tu discloses multilayered medical implants (e.g., grafts, valve leaflets) and lists VDF:HFP as a possible elastomer (without specifying monomer ratio and with higher curing temperatures in embodiments).
- Lo discloses VDF:HFP copolymers and reports that an ~85:15 ratio gives favorable mechanical properties for industrial coatings (nonmedical uses).
- The PTAB combined those teachings, discounted Ethicon’s objective‑indicia evidence (copying, commercial success, unexpected results), and affirmed the examiner’s obviousness rejection; the Federal Circuit (majority) affirmed.
Issues
| Issue | Ethicon's Argument | Director/PTAB's Argument | Held |
|---|---|---|---|
| Whether claims are obvious over Tuch in view of Tu and Lo | Tuch’s exhaustive lists do not suggest the omitted 85:15 VDF:HFP; Tu and Lo do not motivate selection for stents; combining is hindsight | Known polymers (Tu/Lo) have the properties Tuch sought (biocompatibility, elasticity); a skilled artisan would have been motivated to combine to solve Tuch’s cracking problem | Affirmed: substantial evidence supports PTAB that a skilled artisan would combine the references under KSR and the claims are obvious |
| Whether PTAB improperly relied on non‑analogous or stale art (Lo) | Lo is old and directed to industrial, nonmedical uses — not analogous; its age and field undermine reliance | Lo teaches relevant mechanical properties (elasticity/flexibility) of VDF:HFP; age is not dispositive absent evidence of long‑felt need or failure of others | Affirmed: Lo is reasonably pertinent; substantial evidence supports PTAB’s reliance |
| Whether Tu teaches away or is inapplicable because it is not about stents and requires high curing temps | Tu’s devices differ from stents and some embodiments require high cure temps, which contradict the ’844 temperature limitation | Tu discloses VDF:HFP as a useful elastomer and embodiments where elastomer contacts blood; curing requirements do not amount to teaching away | Affirmed: PTAB reasonably interpreted Tu and found no clear teaching away |
| Whether PTAB improperly discounted objective indicia (copying, commercial success, unexpected results) | Evidence (market acclaim, copying, comparative data in the patent) shows unexpected results and commercial impact tied to the claimed coating | Ethicon’s evidence lacked necessary comparative proof to the closest prior art and relied on conclusory testimony; successes could be due to unclaimed features (drug, stent design) | Affirmed: PTAB permissibly gave little weight to the proffered secondary considerations; substantial evidence supports that they did not overcome prima facie obviousness |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obviousness requires an expansive, flexible analysis; no need for explicit teaching, suggestion, or motivation when combination is predictable)
- Graham v. John Deere Co. of Kan. City, 383 U.S. 1 (1966) (obviousness is a legal conclusion grounded on underlying factual inquiries including objective indicia)
- In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003) (‘‘normal desire of scientists or artisans to improve’’ can supply motivation to combine known elements)
- Leo Pharma Prods., Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013) (broad prior‑art lists do not necessarily render an invention obvious to try when choices are numerous and undirected)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (substantial evidence standard for factual findings underlying obviousness review)
- W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540 (Fed. Cir. 1983) (warning against hindsight and using the invention to reconstruct obviousness analysis)