The US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) finding that a specification's disclosure of broad ranges failed to provide adequate written description for the claimed narrow range, but reversed the PTAB's denial of a motion to amend to add a new claim as being capricious and arbitrary. The General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., Case No. 17-1012 (Fed. Cir., May 4, 2018) (Moore, J).
Sienna Biopharmaceuticals is the owner of a patent directed to nanoparticles for hair removal, acne treatment and skin remodeling. At the request of General Hospital Corp. (GHC), the PTAB declared an interference between one of Sienna's patents and one of GHC's patent applications. Claim 1 of Sienna's patent, which constituted the sole count in the interference, is directed to a method of localizing thermal damage to a hair follicle by applying a composition containing unassembled plasmonic nanoparticles at a concentration of 109 to 1023 particles per ml. The corresponding claim in GHC's patent recited using a composition containing unassembled plasmonic nanoparticles at a concentration of about 6.6 × 1011 particles per ml for the same purpose.
Sienna asserted that the claims of GHC's patent application were unpatentable for failure to satisfy the written description requirement, arguing that the patent application only described formulations by reference to optical density (OD) rather than particles per ml (PPM). Relying on expert testimony, the PTAB determined that while OD units could be converted to PPM units, GHC's patent application failed to disclose formulations containing about 6.6 × 1011 PPM.
After the PTAB's finding, GHC moved to add a new claim reciting nanoparticles that have a "250 O.D. when measured at a wavelength of about 810 nm." The PTAB denied the motion, finding that GHC did not show interference-in-fact with Sienna's patent claim or correspondence to Count 1, and that GHC did not provide supporting evidence that this claim was patentable. GHC appealed.
On appeal, GHC asserted that the seven specific compositions disclosed in its application provided adequate support for the recited concentration. The Federal Circuit disagreed, finding that a disclosure of a broad range of values does not, by itself, provide written description support for a particular value within that range. The Court also rejected GHC's argument that an overlap between its disclosed range and Sienna's claimed range provided a basis to its claims.
As to GHC's new claim, the Federal Circuit reversed the PTAB, finding that the PTAB did not engage in a substantive analysis of the claim's patentability. The Court found that GHC had complied with the PTAB's standing order by making the requisite certifications, and the PTAB had not identified any credible basis to challenge GHC's certifications. The Court also found that the PTAB erred in determining no interference-in-fact, since GHC's claimed range was clearly within Sienna's patented range and the record did not indicate that GHC's claimed range would be unpredictable. The Court remanded the case to the PTAB for continued interference proceedings, depending on whether GHC's new claim would have been rendered obvious by Sienna's patent.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
