Court Opinion

ID: 1035238
Source: CourtListenerOpinion
Date Created: 2013-07-25 15:20:23.493283+00
Date Added: 2024-06-11T15:27:43.522421
License: Public Domain

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 & 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”).
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 sum-
mary 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 provid-
      ed within the teat canal and/or the lower teat si-
      nus during the dry period without the use of
      antibiotics, the incidence of mammary disorders is
      substantially reduced. . . . This non-antibiotic ap-
      proach to preventing new dry period infection in
      dairy cows has major potential for the dairy in-
      dustry as it results in the reduction of the inci-
      dence 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 in-
stance, how the agents fight infections or what types of
infections the agents are capable of preventing.
    2Bimeda 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. Never-
theless, 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 anti-
infectives, 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 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 antiinfectives:
    [T]he specific exclusion of acriflavine introduces a
    new concept, as [it] implies inclusion of one or
    more undisclosed antiinfectives other than acri-
    flavine. Such a concept is not supported in the dis-
    closure as originally filed. The original disclosure
    only contemplates the general concept of anti-
    infective-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 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 par-
ticular 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.
     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 anti-
infective agents. Board Opin. at *5–6. The Board be-
lieved 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 exclud-
ed a specific species of the antiinfective genus but permit-
ted the presence of others. Id. at *6.
     Accordingly, the Board affirmed the examiner’s rejec-
tion. 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 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 disclo-
sure 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).
    Substantial evidence supports the Board’s contrary
interpretation because the disclosure is generally incon-
sistent 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 “meet-
ing consumer preferences for reducing the levels of antibi-
otics used in food production.” ’400 patent at col.1 ll.35-
42.
     The remainder of the disclosure similarly distin-
guishes 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 paraf-
fin, 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 formu-
lation as Example 1). Although this exemplary formula-
tion 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 treat-
ments 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 anti-
infective 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 ra-
tionale 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 ele-
ment, 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 patent-
ee must show possession of something it specifically
claims it does not possess.
    The adequacy of written description must be deter-
mined on the facts of each case. In re Jolley, 308 F.3d
1317, 1323 (Fed. Cir. 2002). Here, the specification clear-
ly supports a formulation which excludes all antiinfec-
tives.     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.