General Hospital Corporation v. Sienna Biopharmaceuticals
888 F.3d 1368
Fed. Cir.2018Background
- GHC (applicant of U.S. Appl. No. 13/789,575) and Sienna (owner of U.S. Pat. No. 8,821,941) were in an interference concerning methods of localized thermal damage to hair follicles using unassembled plasmonic nanoparticles. The Board declared the interference at GHC’s suggestion and identified Sienna’s claim 1 as the single count.
- Claim language at issue: Sienna claim 1 requires nanoparticle concentration of 10^9 to 10^23 particles/ml sufficient to induce thermal damage; GHC claim 65 recites “about 6.6 × 10^11 particles per ml.”
- The ’575 application discloses particle formulations by optical density (OD) rather than particles/ml; parties disputed the extinction coefficient to convert OD to particle concentration. The Board credited Sienna’s expert and used a coefficient of 4.2.
- With the Board’s construction of “about” as ±10%, the claimed range is 5.94×10^11 to 7.26×10^11 particles/ml; the Board found no disclosure in the ’575 application that clearly provides that value and held claims 65–67 lack written description under §112.
- GHC sought to add contingent claim 74 (limiting nanoparticles to Optical Density of 250 O.D. at ~810 nm). The Board denied the motion, finding GHC failed to show interference-in-fact/correspondence to Sienna’s claim and failed to establish patentability.
- The Federal Circuit: affirmed the Board’s written-description invalidity determination for claims 65–67, but vacated the denial of GHC’s motion to add claim 74 and remanded for further proceedings regarding that motion.
Issues
| Issue | Plaintiff's Argument (GHC) | Defendant's Argument (Sienna/Board) | Held |
|---|---|---|---|
| Proper construction of “about” in claim limitation | “About” can include ±20% (GHC relied on expert) | “About” means within 10% (per ’575 definition and Board) | The court upheld Board: “about” = within 10% (Board’s construction proper) |
| Written description sufficiency for claims 65–67 (claiming about 6.6×10^11 particles/ml) | The specification’s OD values (e.g., 250 OD → ~7.77×10^11) and ±10% disclosure support the claimed concentration | The specification discloses a broad range/values but not the claimed value; overlap is minimal and does not allow skilled artisan to ‘‘immediately discern’’ possession | Affirmed: substantial evidence supports Board that claims 65–67 lack written description under §112 |
| Denial of contingent motion to add claim 74 — patentability showing | GHC certified (per Standing Order) no known reason claim 74 is unpatentable; claim 74 narrows to a species (250 OD) within Sienna’s ranges | Board found GHC failed to show claim 74 patentable (insufficient supporting evidence) and failed to show interference/correspondence | Court: Board’s refusal to credit GHC’s Standing Order certification as to patentability was arbitrary and capricious; vacated denial and remanded to consider patentability substantively |
| Whether proposed claim 74 establishes interference/correspondence (obviousness/obvious selection) | Proposed claim 74 is a species within Sienna’s claim ranges; GHC presented sufficient evidence that the narrower claim would have been obvious from Sienna’s claim 1 | Board required additional evidence that a skilled artisan would have selected the narrow parameters; denied correspondence | Court: Under precedent, showing a claimed value falls within a disclosed range can satisfy the burden; GHC provided sufficient evidence that claim 74 corresponds/would be obvious; vacated Board’s correspondence finding and remanded |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.) (en banc) (written-description standard: inventor must show possession)
- Inphi Corp. v. Netlist, Inc., 805 F.3d 1350 (Fed. Cir.) (written-description factual inquiry reviewed for substantial evidence)
- Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320 (Fed. Cir.) (disclosure of broad range does not necessarily support a particular value without ‘‘blaze marks’')
- Eiselstein v. Frank, 52 F.3d 1035 (Fed. Cir.) (minor overlap between ranges does not establish equivalence)
- Veritas Techs. LLC v. Veeam Software Corp., 835 F.3d 1406 (Fed. Cir.) (standard of review for Board denial of motion to amend: arbitrary/capricious)
- Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731 (Fed. Cir.) (a claimed value within a prior-art range can establish a prima facie obviousness showing)
- Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 (Fed. Cir.) (prior art disclosing a concentration range expressly discloses particular concentrations within that range)
- In re Peterson, 315 F.3d 1325 (Fed. Cir.) (optimization within a disclosed range is often routine; motivates selection of particular values)