United States Court of Appeals 

for the Federal Circuit ______________________ 

IN RE BIMEDA RESEARCH &

DEVELOPMENT LIMITED

______________________ 

2012-1420

______________________ 

Appeal from the United States Patent and Trademark 

Office, Board of Patent Appeals and Interferences No. 

90/010,445. 

______________________ 

Decided: July 25, 2013 

______________________ 

TROY E. GRABOW, Finnegan, Henderson, Farabow, 

Garrett & Dunner, LLP, of Washington, DC, argued for 

appellant. With him on the brief was SARAH E. CRAVEN. 

Of counsel was JENNIFER ROBINSON. 

MEREDITH H. SCHOENFELD, Associate Solicitor, United 

States Patent and Trademark Office, of Alexandria, 

Virginia, argued for appellee. With her on the brief was

ROBERT J. MCMANUS, Associate Solicitor. Of counsel was 

NATHAN K. KELLEY, Deputy Solicitor. 

______________________ 
2 IN RE BIMEDA RESEARCH & DEVELOPMENT

Before RADER, Chief Judge, CLEVENGER, and PROST,

Circuit Judges.

Opinion for the court filed by Circuit Judge CLEVENGER

Opinion concurring filed by Chief Judge RADER

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 & Development 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”). 

For the reasons set forth below, we affirm. 

I 

The ’400 patent concerns methods for preventing the 

onset of bovine mastitis, i.e., the inflammation of udder 

tissue in cows. The patent is entitled “Antiinfective free

intramammary veterinary composition,” and the summary of the invention describes how the composition 

employs a physical barrier within the teat canal to block 

the introduction of mastitis-causing organisms without 

requiring the use of antiinfectives such as antibiotics: 

We have found that if a physical barrier is provided within the teat canal and/or the lower teat sinus during the dry period without the use of 

antibiotics, the incidence of mammary disorders is 

substantially reduced. . . . This non-antibiotic approach to preventing new dry period infection in 

dairy cows has major potential for the dairy industry as it results in the reduction of the incidence of antibiotic contamination in early season 

milk production. Thus the invention provides a 

quality improvement to dairy production and will 
 IN RE BIMEDA RESEARCH & DEVELOPMENT 3

facilitate farmers meeting consumer preferences 

for reducing the level of antibiotics used in food 

production.

’400 patent col.1 ll.23–42. 

As originally issued, claim 1 of the patent recited a 

method for sealing the teat canal of a cow’s mammary 

gland with a seal formulation so as to provide a physical 

barrier that blocks mastitis-causing organisms from 

reaching the canal:

A prophylactic method 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.

’400 patent col.5 l.52–col.6 l.2. 

The PTO ordered ex parte reexamination of the ’400 

patent on March 13, 2009, to reevaluate patentability in 

light of prior art teachings of teat seal formulations 

utilizing a physical barrier in conjunction with certain 

antiinfective agents such as antibiotics and the antiseptic 

acriflavine.1 In response, Bimeda cancelled claims 1–8 

and added new claims 18–39.2 

Three of Bimeda’s new claims were independent: 

claims 18, 26, and 32. Claim 18 recited the method of 

claim 1 “wherein the seal formulation is free of an agent 

1 The class of antiinfectives covers all agents capable 

of fighting infections, but can be divided into subclasses 

such as antiseptics and antibiotics based upon, for instance, how the agents fight infections or what types of 

infections the agents are capable of preventing. 

2 Bimeda originally added and then cancelled new 

claims 9–17, for reasons not relevant here. 

 
4 IN RE BIMEDA RESEARCH & DEVELOPMENT

that is antiinfective . . . .” Claim 26 recited the same 

method using a seal formulation that “has no bacterial 

action.” The examiner allowed these two claims along 

with their related dependent claims. 

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. Nevertheless, the examiner rejected claims 32–39 under 

§ 112, ¶ 1, reasoning that “acriflavine” was not mentioned 

anywhere in the original disclosure of the ’400 patent and 

so therefore the disclosure did not demonstrate possession 

of an acriflavine-free composition. Board Opin. at *2.

Bimeda appealed the rejection of claims 32–39 to the 

Board. It argued that that the ’400 patent’s disclosure 

broadly described an invention that was free from antiinfectives, and also noted that Example 1 described an 

exemplary embodiment which did not include acriflavine 

as an ingredient. It 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 acriflavinefree. 

In response to the appeal, the examiner reiterated the

original basis for rejection and further argued that the 

’400 patent’s disclosure failed to describe formulations 

which (like claim 32) could exclude acriflavine but include 

other antiinfectives: 

[T]he specific exclusion of acriflavine introduces a 

new concept, as [it] implies inclusion of one or 

more undisclosed antiinfectives other than acriflavine. Such a concept is not supported in the disclosure as originally filed. The original disclosure 

only contemplates the general concept of antiinfective-free formulations and does not contem-
 IN RE BIMEDA RESEARCH & DEVELOPMENT 5

plate inclusion or exclusion of particular species of 

antiinfectives from the formulations.

Board Opin. at *5–6.

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 formulation 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 contemplate 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. 

Second, the Board agreed with the examiner that the 

disclosure failed to convey the full scope of what was 

affirmatively claimed by claim 32—namely, a formulation 

which excluded acriflavine but could include other antiinfective agents. Board Opin. at *5–6. The Board believed that Example 1 of the patent was consistent with 

this finding because it contained no antiinfectives at all, 

and therefore did not disclose a formulation which excluded a specific species of the antiinfective genus but permitted the presence of others. Id. at *6. 

Accordingly, the Board affirmed the examiner’s rejection. Board Opin. at *6. Bimeda sought rehearing before 

the Board, which was denied, and then timely appealed to 

this court. We have jurisdiction under 

28 U.S.C. § 1295(a)(4)(A) and 35 U.S.C. § 141.
6 IN RE BIMEDA RESEARCH & DEVELOPMENT

II

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 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 permitting 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 antiinfective (such as acriflavine) but permits the use of others 

(such as antibiotics). 

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. As noted above, 

the summary of the invention describes the invention’s 

3 Paragraph 1 of 35 U.S.C. § 112 was replaced with 

newly designated § 112(a) when § 4(c) of the Leahy-Smith 

America Invents Act (“AIA”), Pub. L. No. 112-29, took 

effect on September 16, 2012. Because this case was filed 

before that date, we will refer to the pre-AIA version of 

§ 112.

 
 IN RE BIMEDA RESEARCH & DEVELOPMENT 7

“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. 

The remainder of the disclosure similarly distinguishes the invention due to its ability to prevent mastitis 

without using antibiotics. For instance, 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.” ’400 patent col.2 ll.61-64 (utilizing same formulation as Example 1). 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. Id. at col.3 ll.16–19. 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. 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. 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. 

The ’400 patent’s disclosure is therefore inconsistent 

with a claim which “excludes acriflavine, but not the 

presence of other anti-infectives or antibiotics.” Board 
8 IN RE BIMEDA RESEARCH & DEVELOPMENT

Opin. at *5 (emphasis in original). 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. 

CONCLUSION

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. 

AFFIRMED
United States Court of Appeals 

for the Federal Circuit ______________________ 

IN RE BIMEDA RESEARCH &

DEVELOPMENT LIMITED

______________________ 

2012-1420

______________________ 

Appeal from the United States Patent and Trademark 

Office, Board of Patent Appeals and Interferences No. 

90/010,445. 

______________________ 

RADER, Chief Judge, concurring. 

The undisputed claim construction in this case is a 

formulation which excludes a specific species of the antiinfective genus but permits the presence of other species. 

As the specification does not sufficiently disclose this 

dual-natured formulation, I join my colleagues. I write 

separately to highlight the problematic alternative rationale advanced by the Board of Patent Appeals and 

Interferences (Board).

The Board stated that the patentee did not show 

possession of a formulation that specifically excluded 

acriflavine as a species of antiinfectives. J.A. 14–15. The 

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.
2 IN RE: BIMEDA RESEARCH & DEVELOPMENT

“The name of the game is the claim.” In re Hiniker 

Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998) (quoting Giles 

Sutherland Rich, Extent of Protection and Interpretation 

of Claims-American Perspectives, 21 Int’l Rev. Indus. 

Prop. & Copyright L. 497, 499 (1990)). Here, the Board 

refused to wrestle with the fact that the claim at issue

(and the patent as a whole) focuses on negative claiming. 

That is, the claim at issue specifically excludes an element, acriflavine, from the claimed formulation. J.A. 9. 

Yet the 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.

The adequacy of written description must be determined on the facts of each case. In re Jolley, 308 F.3d 

1317, 1323 (Fed. Cir. 2002). Here, the specification clearly supports a formulation which excludes all antiinfectives. Acriflavine was a well-known species of 

antiinfective that had been used in teat seals to treat 

bovine mastitis for over 75 years. J.A. 15; 2418–53. Some 

of the Board’s analysis of possession ignored these facts 

and ignored the nature of the claims.