In General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., Case No. 2017-1012 (Fed. Cir. May 4, 2018), the Federal Circuit affirmed the PTAB's August 2016 decision that General Hospital Corporation's (GHC) claims involved in an interference proceeding (that GHC requested) failed to meet the written description requirement. But the court also vacated the PTAB's denial of GHC's contingent motion to add a new claim as arbitrary and capricious because the PTAB did not follow its own Standing Order. The court therefore remanded the case to the PTAB to decide remaining issues in the interference.
The interfering subject matter concerns a method for applying a composition containing nanoparticles to damage and/or remove hair follicles. One step in GHC's independent claims recites a specific concentration of nanoparticles, "about 6.6 x 1011 particles per ml of the composition." Sienna argued that claims reciting this specific concentration were unpatentable for failure to meet the written description requirement of 35 U.S.C. § 112, and the PTAB agreed. The PTAB further denied GHC's contingent motion to amend its application to add a new claim. As a result of these decisions, GHC had no claims pending and the PTAB therefore terminated the interference.
In determining that GHC had not met the written description requirement, the PTAB construed the term "about" to include a 10% variation, as Sienna argued and its expert testified. GHC's specification did not describe the concentration as recited in its claims, in "particles per ml"; rather it described the concentration in terms of optical density. GHC identified several optical density values in its specification that when converted to "particles per ml" offer a broad range of values and several discrete values within that range, but none identical to or within 10% of the concentration recited in the claims. Based on these facts, the PTAB concluded GHC's specification did not describe the claimed feature.
The Federal Circuit affirmed this portion of the PTAB's decision as supported by substantial evidence. The court reiterated that the disclosure of a broad range of values does not by itself provide written description support for a particular value within that range: "One cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention." Slip Op. at 5 (citing Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000)). Further, the court explained that the range of "about 45-55%...is not the same as a very different 10% range, viz., 50-60%." Slip Op. at 7 (citing Eiselstein v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995)). Noting that the overlap in this case was even less significant, the court concluded that substantial evidence supported the PTAB's decision.
The Federal Circuit determined that the PTAB acted arbitrarily and capriciously in denying GHC's contingent motion to amend its application to add a new claim more narrowly reciting optical density that falls within the range recited in Sienna's claims. According to the Board, GHC's motion did not show the proposed claim interfered-in-fact with a Sienna claim and did not provide evidence supporting a conclusion that the claim would be patentable to GHC. But the court found that the PTAB did not engage in a substantive patentability analysis, remarking that the PTAB did not follow its own Standing Order for conducting interferences and ignored precedent that selecting a value from a known range will generally be obvious, absent a sufficient showing to the contrary. The Standing Order simply instructs the movant to certify that it is not aware of any reason why the proposed claim is unpatentable. GHC certified as much and there was no evidence the certification was inconsistent with the file history. Based on these facts, GHC's motion was not deficient under the Standing Order. The court therefore vacated the PTAB's decision and remanded for continued interference proceedings.
This blog post was written by Marshall Gerstein summer law
clerk
Fabrice Guyot-Sionnest.
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