Thursday, July 25, 2013

CAFC cites Ruschig, mentions blaze marks, in affirming PTAB on written description rejection in Bimeda case

In the case IN RE BIMEDA RESEARCH & DEVELOPMENT LIMITED the Court of Appeals for the Federal Circuit [CAFC] affirmed PTAB.

From the case:

The Board affirmed the examiner’s rejection on two grounds. First, it agreed with the examiner’s finding that the disclosure failed to demonstrate possession of a formu- lation that specifically excluded the acriflavine species of antiinfectives. Board Opin. at *5. Citing In Re Ruschig et al., 379 F.2d 990 (CCPA 1967), the Board held that where the patent’s disclosure describes the exclusion of a broad genus, claims to embodiments which exclude particular species are only supported if the disclosure offers some guidance or “blaze marks” to guide the skilled artisan towards excluding that particular species. Id. In the case of the ’400 patent, the Board found that the disclosure lacked such guidance because it did not con- template the exclusion of any single specific antiinfective, much less acriflavine. Id. Rather, the Board found, the ’400 patent described inventions that were free of entire classes of agents such as antibiotics. Id.

Of the written description issue:

Written description under § 112, ¶ 1,3 is a question of fact, and on appeal from the Board, we review such ques- tions for substantial evidence. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); In re Gartside, 203 F.3d 1305, 1315 (Fed. Cir. 2000). Substantial evidence means “such relevant evi- dence as a reasonable mind might accept as adequate to support a conclusion.” Consol. Edison Co. v. Nat’l Labor Relations Bd., 305 U.S. 197, 229 (1938).

In this case, the Board found, inter alia, that claim 32 failed the written description requirement because the disclosure did not “describe[] a formulation excluding a specific species of the anti-infective genus, while permit- ting others to be present.” Board Opin. at *6. On appeal, Bimeda counters this finding by arguing that the disclosure broadly claims a teat seal formulation utilizing a physical barrier, yet does not expressly exclude any particular antiinfective agents. Bimeda interprets this as tacit indifference to the presence or absence of specific antiinfectives, and contends that the disclosure therefore supports a claim which excludes one particular antiinfec- tive (such as acriflavine) but permits the use of others (such as antibiotics).

The CAFC invoked the "substantial evidence" standard:

Substantial evidence supports the Board’s contrary interpretation because the disclosure is generally inconsistent with a formulation which, like claim 32, excludes acriflavine but could include antibiotics.


The ’400 patent’s disclosure is therefore inconsistent with a claim which “excludes acriflavine, but not the presence of other anti-infectives or antibiotics.”

The alternative grounds for rejection was not reached:

Because substantial evidence supports the Board’s finding that the patent’s disclosure does not convey possession of the literal scope of claim 32, we need not reach the merits of the Board’s alternative finding that the disclosure insufficiently led an artisan to target acriflavine for exclusion.


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