In Re Bimeda: Limits on Negative Claim Limitations

Category: 112 - Written Description
By: Idlir Fida from Vancouver, Canada, Creative Commons
 By: Jesus Hernandez, Blog Editor/Contributor  
TitleIn re Bimeda Research & Dev. Ltd., 2012-1420 (Fed. Cir. July 25, 2013).
Issue"[T]he ’400 patent’s disclosure broadly described an invention that was free from anti-infectives, and also noted that Example 1 described an exemplary embodiment which did not include acriflavine as an ingredient. [The Patentee] therefore contended that an ordinary artisan, who would have been well aware that acriflavine could be used to prevent mastitis, would understand that its antiinfective-free invention could also be acriflavine- free." In re Bimeda, at *4 (text added).
Holding"[W]here 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. at *5 (affirming the PTAB holding, citing In re Ruschig, 379 F.2d 990 (CCPA 1967)).

Procedural History"Bimeda Research & Development Limited (“Bimeda”) appeals a decision by the United States Patent and Trademark Office (“PTO”) Board of Patent Appeals and Interferences, now known as the Patent Trial and Appeal Board (“Board”), in Ex Parte Bimeda Research & Devel- opment Limited, No. 2011-010507, 2011 WL 3754635 (B.P.A.I. Aug. 19, 2011) (“Board Opin.”), which affirmed an examiner’s rejection of certain claims introduced in the context of ex parte reexamination of Bimeda’s U.S. Patent No. 6,506,400 (issued Jan. 14, 2003) (“the ’400 patent”)." In re Bimeda, at *2.
Legal Reasoning (Clevenger and Prost)
Claim Feature at issue"Claim 32 recited the method of claim 1 wherein the teat seal canal had an 'an acriflavine-free' formulation. Acriflavine was a well-known antiseptic antiinfective agent which had long been used to treat mastitis." In re Bimeda, at *4.
Written Description Standard of Review“Written description under § 112, ¶ 1,3 is a question of fact, and on appeal from the Board, we review such questions 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 evidence 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 re Bimeda at *6.
No Substantial Evidence in the Disclosure of Specific Species Exclusions
Discussion in Summary of Invention“[T]he summary of the invention describes the invention’s ‘non-antibiotic approach’ to preventing mastitis, and explains how this approach achieves the benefit of ‘meeting consumer preferences for reducing the levels of antibiotics used in food production.’ ’400 patent at col.1 ll.35- 42." In re Bimeda, at *7.
Analysis of Example Embodiments, as a Whole
Example 1"[…] Example 1 described an exemplary embodiment which did not include acriflavine as an ingredient." In re Bimeda, at *4.
Example 2"[…] Example 2 of the patent utilizes a seal formulation made from liquid paraffin, Alugel 30 DF (aluminum stearate), and bismuth subnitrate, all mixed in a sterile bioprocess container or 'B.P.C.' […] Although this exemplary formulation does not expressly exclude any particular class of antiinfective, one nevertheless comes away with the clear understanding that it cannot include antibiotics because it is described as realizing results 'comparable with that achieved by prophylactic antibiotic treatment' and as 'very surprisingly offer[ing] a non-antibiotic approach' to mastitis prevention." In re Bimeda, at *7.
Examples 3-4“Examples 3 and 4 used the same seal formulation as Examples 1 and 2, so the observation that the exemplary seal is 'non-antibiotic' applies to those Examples as well. Id. at col.3 l.23, col.3 l.63.” In re Bimeda, at *7.
Examples 5-6“The fifth and final Example compares the invention with other formulations and concludes that ‘there was no significant difference between the antibiotic based treatments and the antibiotic-free treatment of the invention.’ Id. at col.5, ll.9–11.” In re Bimeda, at *7.
General Description of Invention in Disclosure“Importantly, the patent discloses that the invention presents ‘no risk of antibiotic residues after calving,’ id. at col.5, ll.16–17, which seemingly can only be true if the formulation excludes all antibiotics. The specification thus leaves no room for argument that the inventor possessed a formulation that excludes only acriflavine while permitting the use of antibiotics.” In re Bimeda, at *7.
“For the reasons set forth above, we affirm the Board’s decision that claims 32–36 of the ’400 patent lack written description support under § 112, ¶ 1.” In re Bimeda, at *8.
RADER, Chief Judge, concurring. In re Bimeda, Op. Rader, C.J., 1.
"[T]he Board discusses written description in the context of claiming the inclusion, not the exclusion, of a particular element. See J.A. 15 (noting that when a patentee claims a species, the broad naming of the genus in a specification is likely insufficient); J.A. 15–16 (citing In Re Ruschig, 379 F.2d 990 (CCPA 1967) for the proposition that the specification must provide “blaze marks” which guide the skilled worker from the broadly disclosed genus to the claimed species). Thus, the Board 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." In re Bimeda, Op. Rader, C.J., at *2.
Image Attribution Statement: "Wood Fence," by Idlir Fida. Available under a Creative Commons Attribution 3.0 license, Wikimedia Commons.
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