In In re Bimeda Research & Development Ltd., No. 12-1420 (Fed. Cir. July 25, 2013), the Federal Circuit affirmed the Board's rejection of certain claims introduced during ex parte reexamination of U.S. Patent No. 6,506,400 ("the '400 patent") for not meeting the written description requirement.
The '400 patent is owned by Bimeda Research & Development Limited ("Bimeda") and concerns methods for preventing the onset of bovine mastitis, the inflammation of udder tissue in cows. Specifically, the '400 patent claims "prophylactic method[s] of controlling infection in a mammary gland by a mastitis-causing organism, comprising sealing a teat canal of a mammary gland with a seal formulation so as to provide a physical barrier in the teat canal." Slip op. at 3 (citation omitted). During ex parte reexamination of the '400 patent, Bimeda added new claims 18-39. The examiner allowed independent claims 18 and 26, which respectively recited that the seal formulation was free of antiinfective agents and had no bacterial action, and their dependent claims.
The examiner, however, rejected claims 32-39, which recited that the seal formulation was free of the antiinfective agent acriflavine. The examiner based the rejections on 35 U.S.C. § 112, ¶ 1, and the Board affirmed. The Board concluded that where a patent disclosure describes the exclusion of a broad genus, claims to embodiments that exclude particular species are only supported if the disclosure offers some guidance for excluding that particular species. Bimeda appealed the Board's decision to the Federal Circuit.
On appeal, Bimeda argued that the disclosure broadly claims a teat seal formulation utilizing a physical barrier but does not expressly exclude any particular antiinfective agents. The Court stated that Bimeda interprets this "as tacit indifference to the presence or absence of specific antiinfectives," and therefore supported a claim that excluded one particular antiinfective (acriflavine) while permitting the use of others (antibiotics). Id. at 6. The Federal Circuit instead found that substantial evidence supported the Board's contrary interpretation. The Court concluded that the disclosure was generally inconsistent with a formulation that excluded acriflavine but could include antibiotics. The Court stated that "the summary of the invention describes the invention's 'non-antibiotic approach' to preventing mastitis," and that "[t]he remainder of the disclosure similarly distinguishes the invention due to its ability to prevent mastitis without using antibiotics." Id. at 6-7. The Court thus concluded that substantial evidence supported the Board's finding that the '400 patent's disclosure did not convey possession of the literal scope of claim 32, and affirmed the Board's decision with regard to claims 32-39.
Chief Judge Rader wrote a separate concurring opinion to "highlight" the Board's "problematic alternative rationale." Rader Concurrence at 1. Chief Judge Rader opined that "[t]he repeated references to 'possession,' i.e. the traditional nomenclature for discussing written description, illustrate the weakness in using this framework for all written description cases." Id. According to Chief Judge Rader, "the Board refused to wrestle with the fact that the claim at issue (and the patent as a whole) focuses on negative claiming," and thus "places the patentee into a Catch-22: to satisfy written description, the patentee must show possession of something it specifically claims it does not possess." Id. at 2.
Judges: Rader (concurring), Clevenger (author), Prost
[Appealed from Board]
This article previously appeared in Last Month at the Federal Circuit, August 2013
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