Ex Parte Birnbaum

Board of Patent Appeals and Interferences

Aug 28, 2012

11523508 (B.P.A.I. Aug. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAY E. BIRNBAUM
__________

Appeal 2012-000115
Application 11/523,508
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and JEFFREY N. FREDMAN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
antifungal product, which the Examiner has rejected for anticipation and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm the
anticipation rejection.
STATEMENT OF THE CASE
The Specification discloses products “for treating subungual (under
the nail) infections, especially fungal infections” (Spec. 1). Specifically, “a
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solid or semisolid material having a fungicidal or fungistatic agent is placed
in contact with the nail bed and preferably forced under the nail plate” (id. at
7). “Anatomically, the ‘nail’ that is seen is technically the nail plate. . . . At
the distal end, between the nail plate and the skin, is the hyponychium . . . ,
which is a physical barrier sealing the distal margin of the nail bed where it
is coextensive with the nail plate.” (Id. at 5.)
Claims 1-5 are on appeal. Claim 1 is representative and reads as
follows:
1. A subunguicide comprising an antifungal agent and a non-soap
semisolid carrier formed into a bar and the a [sic] bar having Mohs hardness
less than 2.5 and being sufficiently cohesive to form shavings when
scratched with a nail of a patient, the shavings being configured to penetrate
past the hyponychium and rest in contact with the nail bed.

The claims stand rejected as follows:
• Claims 1-5 under 35 U.S.C. § 102(b) as anticipated by Mackles1
(Answer 5);
• Claims 1-4 under 35 U.S.C. § 103(a) as obvious based on Maibach2
(Answer 7); and
• Claim 5 under 35 U.S.C. § 103(a) as obvious based on Maibach and
the Academy of Dermatology paper3 (Answer 9).

1 Mackles et al., US 5,587,152, Dec. 24, 1996.
2 Mailbach et al., US 6,846,837 B2, Jan. 25, 2005.
3 International Study Measures Quality Of Life For Onychomycosis Patients,
American Academy of Dermatology (Sept. 22, 1999)
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I.
Issue
The Examiner has rejected claims 1-5 as anticipated by Mackles
(Answer 5). The Examiner finds that Mackles discloses semisolid deodorant
compositions that in some embodiments comprise triclosan, which is an
antifungal agent (id.). The Examiner acknowledges that “Mackles does not
test the hardness of its compositions” (id.) but concludes that this property
would be inherently present because Mackles’ composition “contain[s]
every chemical defined by the instant claims” (id.) and Appellant’s
Specification states that deodorants are a suitable semisolid carrier for
delivering a subunguicide in the manner recited in the claims (id. at 5-6).
Appellant contends that “the mere description of an antimicrobial in
Mackles fails to anticipate the claimed carrier of the antifungal agent”
(Appeal Br. 5). Appellant also contends that Mackles’ deodorant would not
form shavings, when scratched, that would penetrate past the hyponychium,
as claimed (id. at 5-6).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Mackles discloses a product that
meets all of the structural and functional limitations of claim 1?
Findings of Fact
1. The Specification states that “[s]emisolid carriers (such as used for
deodorants . . . ) can be formulated as desired to deliver the antifungal by
having the patient scratch the substance (whether or not in the geometry of a
bar)” (Spec. 7-8).
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2. The Specification states that “[a]dministration of a subunguicide in
the form of a semisolid (like a deodorant stick) . . . is shown in Fig. 2D,
wherein the patient scratches the surface of the solid or semisolid 231 with
sufficient force to propel shavings past the hyponychium and to rest in
contact with the nail bed” (id. at 12).
3. Mackles discloses “a clear solid topical deodorant composition”
(Mackles, col. 3, ll. 25-26).
4. Mackles discloses that the “compositions are transparent or
translucent, and are sufficiently hard to maintain their shape, without
cracking of shattering, when spread over the skin” (id. at col. 5, ll. 38-40).
5. Mackles discloses an embodiment that contains “0.25% by weight
of a topical antimicrobial agent” (id. at col. 4, ll. 38-39).
6. Mackles discloses a working example of a deodorant stick
containing 0.25% w/w triclosan (id. at col. 6, ll. 10-15).
7. The Examiner finds that triclosan is an antifungal agent (Answer
5). Appellant does not dispute this finding (see Appeal Br. 4-6).
Analysis
Mackles discloses a deodorant stick containing triclosan, an antifungal
agent. Mackles discloses that its solid deodorant compositions are
“sufficiently hard to maintain their shape, without cracking of shattering,
when spread over the skin” (FF 4), and Appellant’s Specification describes a
deodorant stick as a suitable carrier for administering an antifungal agent in
the manner recited in claim 1 (FFs 1, 2). The evidence of record therefore
provides a reasonable basis for concluding that Mackles’ antifungal-
containing deodorant stick inherently possesses the hardness and
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cohesiveness properties recited in claim 1. See In re Best, 562 F.2d 1252,
1254-55 (CCPA 1977):
[I]t is elementary that the mere recitation of a newly discovered
function or property, inherently possessed by things in the prior
art, does not cause a claim drawn to those things to distinguish
over the prior art. Additionally, where the Patent Office has
reason to believe that a functional limitation asserted to be
critical for establishing novelty in the claimed subject matter
may, in fact, be an inherent characteristic of the prior art, it
possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.
See also In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990): “[W]hen the PTO
shows sound basis for believing that the products of the applicant and the
prior art are the same, the applicant has the burden of showing that they are
not.”
Appellant argues “Claim 1 recites ‘an antifungal agent’ and the
Specification provides numerous examples with different chemical
compositions. The deodorant of Mackles cannot be chemically identical to
every antifungal agent.” (Appeal Br. 5.) Appellant also argues that “the
Specification explicitly recognizes different carriers for antifungal agents”
(id.), and concludes that “the mere description of an antimicrobial in
Mackles fails to anticipate the claimed carrier of the antifungal agent” (id.).
We disagree. Claim 1 reads on any product, in the shape of a bar and
having the recited properties, that comprises any antifungal agent and any
nonsoap semisolid carrier. Appellant has not disputed the Examiner’s
finding that triclosan is an antifungal agent, and the Specification itself
provides evidence that Mackles’ deodorant composition is a semisolid
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carrier having the recited properties. Claim 1 therefore encompasses the
product disclosed by Mackles.
Appellant also argues that “when scratched with a nail, the deodorant
of Mackles would not form shavings ‘configured to penetrate past the
hyponychium and rest in contact with the nail bed,’ as required by Claim
1” (Appeal Br. 5). Appellant argues that “the intended use set forth in the
claim of designing the carrier to have the antifungal agent which, upon being
scratched, forms shavings that penetrate past the hyponychium and rest in
contact with the nail bed is not even contemplated by the topical deodorant
of Mackles” (id. at 6).
This argument is also unpersuasive. Appellant points to no evidence
supporting the assertion that Mackles’ semisolid deodorant composition is
not configured to provide the property recited in claim 1, and, as the
Examiner has pointed out (Answer 5-6), Appellant’s Specification provides
evidence that Mackles’ composition is configured as required by the claim.
Appellant’s argument that Mackles does not disclose the intended use
recited in the claim is not germane to the question of whether Mackles
discloses the claimed product. See In re Schreiber, 128 F.3d 1473, 1477
(Fed. Cir. 1997) (“It is well settled that the recitation of a new intended use
for an old product does not make a claim to that old product patentable.”).
Conclusion of Law
The evidence of record supports the Examiner’s finding that Mackles
discloses a product that meets all of the structural and functional limitations
of claim 1. Claims 2-5 were not argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
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II.
Issue
The Examiner has rejected claims 1-4 as obvious based on Maibach
(Answer 7) and has rejected claim 5 as obvious based on Maibach and the
Academy of Dermatology paper (Answer 9). The Examiner finds that
Maibach discloses a composition comprising an antifungal agent and, “[i]n
some embodiments, the composition is a non-soap semisolid, such as a
lotion, paste, medicated plaster, skin patch, or gel” (id.at 7). The Examiner
reasons that the “recitation in instant claim 1 about the results of scratching
the composition is an intended use (scratching) of the composition, and is
given no weight in considering the validity of a claim to a composition of
matter” (id. at 8). The Examiner cites the Academy of Dermatology paper
for disclosing an anesthetic in a fungicidal composition (id. at 9), and
concludes that it would have been obvious to shape Maibach’s composition
into a bar (id. at 8), optionally with the addition of an anesthetic (id. at 9).
Appellant argues that Maibach states that its “formulation ‘may be in
any form suitable for application to the nail and surrounding tissues, and
may comprise, for example, a cream, lotion, solution, gel, ointment, paste,
plaster, paint, bioadhesive, or the like’” (Appeal Br. 7). Appellant argues
that this disclosure “only describes carriers that are applied to or spread over
the skin or nail surface,” not a bar having the hardness and cohesiveness
recited in claim 1 (id.).
We agree with Appellant that the Examiner has not shown that
Maibach, alone or combined with the Academy of Dermatology paper,
would have made obvious a product having the functional properties
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required by the claims. As Appellant has pointed out, Maibach suggests
several forms for its composition (see Maibach, col. 14, ll. 25-28), but those
forms do not include anything comparable to a stick or bar. The Examiner
has not pointed to evidence showing that any of the forms suggested by
Maibach would be “sufficiently cohesive to form shavings when scratched
with the nail of a patient, the shavings being configured to penetrate past the
hyponychium,” as required by claim 1.
We disagree with the Examiner’s conclusion that the quoted limitation
recites merely an intended use of the claimed product; the limitation recites a
structural property of the claimed product, even though the property is
defined by the results of a particular test. The Examiner has not
persuasively shown that any of the forms suggested by Maibach would
possess the recited property, nor has he provided any reason for concluding
that a form with the recited property would have been obvious based on
Maibach’s disclosure, alone or combined with the Academy of Dermatology
paper. The Examiner therefore has not shown a prima facie case of
obviousness.
SUMMARY
We affirm the rejection of claims 1-5 under 35 U.S.C. § 102(b). We
reverse the rejections of claims 1-5 under 35 U.S.C. § 103(a).
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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