# United States **Court of Appeals**  **for the Federal Circuit**

______________________

IN RE BIMEDA RESEARCH & DEVELOPMENT LIMITED

______________________

2012

- 1420

______________________ Appeal from the United State s Patent and Trademark Office, Board of Patent Appeals and Interferences No. 90/010,445

.

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Decided: July 25, 2013

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T ROY E. G RABOW , Finnegan, Henderson, Farabow

, Garrett & Dunner, LLP, of Washington, DC, argued for appellant. With him on the brief was S ARAH E. C RAVEN

. Of counsel was J ENNIFER R OBINSON

.

M EREDITH H. S CHOENFELD , Associate Solicitor, United States Patent and Trademark Office, of Alexandria, Virg inia, argued for appellee. With her on the brief w as R OBERT J. M C M ANUS , Associate Solicitor. Of counsel was N ATHAN K. K ELLEY , Deputy Solicitor.

______________________IN RE BIMEDA RESEARCH & DEVELOPMENT 2

Before R ADER , Chief Judge, C LEVENGER , and P ROST , Circuit Judges.
Opinion for the cou rt filed by Circuit Judge C LEVENGER Opinion concurring filed by Chief Judge R ADER 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 Res earch & Dev e lopment Limited , No. 2011

- 010507, 2011 WL 3754635 ( B.P.A.I. Aug. 19, 2011) (“ Board Opin. ”), which affirmed an examiner’s rejection of certain claim s 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 su mmary of the invention describes how the composition employs a physical barrier within the teat canal to block the introductio n of mastitis

- causing organisms without requiring the use of antiinfectives such as antibiotics : We have found that if a physical barrier is provi ded within the teat canal and/or the lower teat s inus during the dry period without the use of antibiotics, t he i ncidence of mammary disorders is substantially reduced.

. . . This non

- antibiotic a pproach to preventing new dry period infection in dairy cows has major potential for the dairy i ndustry as it results in the reduction of the inc idence of antibiotic con tamination in early season milk production. Thus the invention provides a quality improvement to dairy production and willIN 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.2 3– 42

. As originally issued

, claim 1 of the patent recite d 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 b y a masti tis

- 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

p atent 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 a ntibiotics and the antiseptic acrifla vine. 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 i nstance, 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 relev ant here.IN RE BIMEDA RESEARCH & DEVELOPMENT 4

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. Neve rtheless, the examiner rejected claim s 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 ap pealed 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 ant iinfective s, and also noted that E xample 1 described an exemplary embodiment which did not include acr iflavine 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 acriflavine

free.
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 antiinfec tives:
[T]he specific exclusion of acriflavine introduces a new concept, as [it] implies inclusion of one or more undisclosed antiinfectives other than acr iflavine. Such a concept is not supported in the di sclosure as originally filed. The original disclosure only contemplates the general concept of ant iinfective

- free formulations and does not conte m-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 disclo sure failed to demonstrate possession of a form ulation that specifically excluded the acriflavine species of antiinfective s

. Board Opin. at *5. C iting 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 pa rticular species are only supported if the disclosure offers some guidance or “blaze marks” to guide the skilled artis an to wards 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 co ntemplate the exclusion of a ny 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 cl aimed by claim 32

— namely, a formulation which excluded acriflavine but could include other ant iinfective agents. Board Opin. at *5 –6. T he 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 exclu ded a specific species of the antiinfective genus but permi tted the presence of others. Id

. at *6

. Accordingly, the Board affirmed the examiner’s reje ction. 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.IN RE BIMEDA RESEARCH & DEVELOPMENT 6

II
Written description under § 112, ¶ 1, 3 is a question of fact, and on appeal from the Board, we review such que stions 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 ev idence a s 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 permi tting others to be present.” Board Opin . at *6

. On appeal, Bimeda counters this finding by arguing that the discl osure 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 antiinfec tives , and contends that the disclosure therefore supports a claim which exclude s one particular antiinfe ctive (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 inco nsistent with a formulation which, like claim 32, excludes acriflavine but could include antibiotics

. As noted above,
t he summary of the inven tion 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 w ill 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 ac hieves the benefit of “meeting consumer preferences for reducing the levels of antib iotics used in food production. ” ’400 patent at col.1 ll. 35

- 42.

The remainder of the disclosure similarly disti nguishes the invention due to its ability to prevent masti tis without using antibiotics. For instance, E xample 2 of the patent utilizes a seal formulation made fro m liquid para ffin, Alugel 30 DF (aluminum stearate), and bismuth sub

nitrate, all mixed in a sterile bioprocess container or “B.P.C.” ’400 patent col .2 ll.61

- 64 (utilizing same form ulation as E xample 1)

. Although this exemplary formul ation does not expressly exclude a ny particular class of antiinfective, one nevertheless comes away with the clear understanding that it cannot include antibiotics because it is described as realiz ing 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 f ifth and final Example compares the invention with other fo rmulations and concludes that “there was no significant difference between the antibiotic based trea tments 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 antibiot ic 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

ac riflavine while permitting the use of antibiotics

. T he ’400 patent’s disclosure is therefore inconsistent with a claim which “excludes acriflavine, but not the presence of other anti

- infectives or antibiotics. ” BoardIN RE BIMEDA RESEARCH & DEVELOPMENT 8
Opin . at *5 (emphasis in original)

. Because substantial evidence supports the Board’s find ing that the patent’s disclosure does not convey possession of the literal scope of claim 32, w e need not reach the merits of the Board’s alternative finding that the disclosure insufficiently led

an ar tisan to target acriflavine for exclusion.

C ONCLUSION 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.

A FFIRMED

# United States **Court of Appeals**  **for the Federal Circuit**

______________________

IN RE BIMEDA RESEARCH & DEVELOPMENT LIMITED

______________________

2012

- 1420

______________________ Appeal from the United State s Patent and Trademark Office, Board of Patent Appeals and Interferences No. 90/010,445

.

______________________

R ADER , Chief Judge, concurring

. The undisputed claim construction in this case is a formulation which excludes a specific species of the ant iin fective 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 r ationale advanced by the Board of Patent Appeals and Interfer ences (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.IN RE : BIMEDA RESEARCH & DEVELOPMENT 2 “The name of the game is the claim.” In re Hiniker Co. , 150 F.3d 1362, 1369 (Fed. Cir. 1998) (quoting Giles Su therland 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 ) focuse s on negative claiming. That is, the claim at issue specifically excludes an el ement, 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 partic ular 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 p rovide “blaze marks” which guide the skilled worker from the broadly disclosed genus to the claimed species). Thus, the Board places the patentee into a C atch

- 22: to satisfy written description, the paten tee must show possession of som e thing it specifical ly claims it does not possess.
The adequacy of written description must be dete rmined on the facts of each case. In re Jolley , 308 F.3d 1317, 1323 (Fed. Cir. 2002). Here, the specification clea rly supports a formulation which excludes all antiinfe ctives. A criflavine 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.