17 F.4th 155
Fed. Cir.2021Background
- The ’706 patent (University of Strathclyde) claims disinfecting air/surfaces by exposing Gram-positive bacteria (e.g., MRSA) to visible light without a photosensitizer, where part of the light is 400–420 nm (optimum 405 nm).
- Inventors’ data showed strong MRSA inactivation at 405 nm with lower energy doses than broad-spectrum visible light.
- Ashkenazi: experiments showing P. acnes inactivation by 407–420 nm blue light, but all cultures were grown in media containing photosensitizers (riboflavin and/or ALA).
- Nitzan: MRSA experiments without ALA/photosensitizer showed no inactivation at tested doses (up to 50 J/cm²); earlier Nitzan 1999 reported similar failures.
- PTO Board held claims obvious over Ashkenazi in view of Nitzan (and Jones for dependent claims), finding the combination taught photosensitizer-free inactivation and that a skilled artisan would have had a reasonable expectation of success. The Federal Circuit reversed, holding those findings unsupported by substantial evidence.
Issues
| Issue | Strathclyde's Argument | Clear‑Vu's Argument | Held |
|---|---|---|---|
| Whether prior art discloses inactivation by 400–420 nm light without a photosensitizer | Ashkenazi used riboflavin in all P. acnes cultures; Nitzan’s non‑ALA MRSA showed no inactivation—combination does not teach photosensitizer‑free inactivation | Combine Ashkenazi’s illumination parameters with Nitzan’s riboflavin‑free MRSA to yield photosensitizer‑free inactivation | Reversed: no substantial evidence. Neither reference discloses or suggests inactivation without a photosensitizer and Board gave no rational basis for omitting a photosensitizer when combining references |
| Whether a skilled artisan would have had a reasonable expectation of success in achieving such inactivation | Prior art (Nitzan, Nitzan 1999) shows failure; no data indicating success at higher doses; expert testimony supported lack of expected effect | MRSA produces endogenous porphyrins; Ashkenazi teaches porphyrin‑mediated photoeradication and that increasing dose/illumination can increase effect | Reversed: no substantial evidence. The record showed failures and absence of promising data; finding of reasonable expectation was hindsight |
| Whether the Board properly weighed expert evidence | Board improperly dismissed Strathclyde’s expert (Goodrich) though he analyzed Nitzan data and supported opinions | Board credited its expert (Sulzinski) and relied on combination rationale | Court found the Board’s reason for discounting Goodrich unsupported; inconsistent credibility findings undermined Board’s conclusions |
Key Cases Cited
- Pers. Web Techs. v. Apple, Inc., 848 F.3d 987 (Fed. Cir. 2017) (review: legal questions de novo, factual findings for substantial evidence)
- OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019) (reasonable‑expectation‑of‑success requires data or other reliable indicators; failures can negate expectation)
- PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186 (Fed. Cir. 2014) (all claim limitations must be found in prior art for obviousness)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (substantial evidence standard and agency fact‑finding review)
- In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (obviousness legal standard and factfinding)
- Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012) (inventor’s results cannot be used as hindsight to establish obviousness)
- Hoffmann‑La Roche Inc. v. Apotex Inc., 748 F.3d 1326 (Fed. Cir. 2014) (conclusive proof of efficacy not required; but reasonable expectation must be supported)