Ex Parte Libin

Board of Patent Appeals and Interferences

May 30, 2008

09224781 (B.P.A.I. May. 30, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BARRY M. LIBIN
__________

Appeal 2008-2034
Application 09/224,781
Technology Center 3700
__________

Decided: May 30, 2008
__________

Before, TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation and obviousness. We have jurisdiction under 35
U.S.C. § 6(b).

Appeal 2008-2034
Application 09/224,781

The following claims are representative.
23. A method of treating fungal infections, said method comprising
contacting fungal disease sites with an amount of a composition which
consists essentially of triclosan which is effective to alleviate the
symptoms of said fungal infection.
24. A method of treating fungal infections as defined in claim 23
wherein the triclosan is combined in a liquid formulation with a solubilizer.
25. A method of treating fungal infections as defined in claim 23
wherein the triclosan is in a semi-solid formulation.
26. A method of treating fungal infections said method comprising
contacting fungal disease sites with an amount of a composition which
comprises triclosan and a cationic antimicrobial agent in amounts which are
effective to alleviate the symptoms of said fungal infections.

References Cited by the Examiner:
Libin 5,236,699 Aug. 17, 1993
Takaoka GB 2160099 Dec. 18, 1985
Forward EP 0670711 B1 Feb. 17, 1999

Grounds of Rejection
1. Claims 23-25 stand rejected under 35 U.S.C. § 102(b), as
anticipated by Forward.
2. Claims 23-25 stand rejected under 35 U.S.C. § 102(b), as
anticipated by Takaoka.
3. Claims 23-30 stand rejected under 35 U.S.C. 103(a) as being
unpatentable over Libin in view of Forward.
2
Appeal 2008-2034
Application 09/224,781

DISCUSSION
Background
“The present invention comprises a method for the prevention or
treatment of mucositis, herpetic infections and fungal infections which
comprises applying to the affected area an effective amount of a composition
which comprises triclosan alone or in combination with a cationic
antimicrobial compound.” (Spec. 4.) Fungal infections treated “may
include fungal infections of the head (tinea capitis), body infections (tinea
corporis), ‘athletes foot’ (tinea pedis) as well as groin and buttocks
infections (tinea crusis). The composite has also been found to be effective
against superficial candidiasis (moniliasis) and cutaneous candidiasis.”
(Spec. 3.)

1. Claims 23-25 stand rejected under 35 U.S.C. § 102(b), as
anticipated by Forward.

Claim interpretation
“A determination of anticipation … involves two steps. First is
construing the claim, … followed by a comparison of the construed
claim to the prior art. This comparison process involves fact-finding,
and is for the fact-finder in the first instance.” Key Pharms. v. Hercon
Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998). Accordingly, our
analysis begins by construing the claimed invention, followed by a
comparison of the construed claim to the prior art.
3
Appeal 2008-2034
Application 09/224,781

The transitional phrase "consisting essentially of" limits the
scope of a claim to the specified materials or steps "and those that do
not materially affect the basic and novel characteristic(s)" of the
claimed invention. In re Herz, 537 F.2d 549, 551-52 (CCPA 1976).
However, absent a clear indication in the Specification or claims of
what the basic and novel characteristics of the claimed composition actually
are, the term “consisting essentially of” is construed as equivalent to
“comprising.” PPG Industries v. Guardian Industries, 156 F.3d 1351, 1354
(Fed. Cir. 1998).
Appellant has not defined in the Specification the scope of the
invention proscribed by the claim term “consisting essentially of.”
Therefore, we construe the term “consisting essentially of” in the claims as
equivalent to the term “comprising.” The use of the transitional phrase
"comprising" itself indicates that the elements or steps following the
transition may be supplemented by additional elements or steps and still fall
within the scope of the claim. Scanner Technologies Corp. v. ICOS Vision
Systems Corp., 365 F.3d 1299, 1303 (Fed. Cir. 2004). Thus, the methods of
claims 23-25 include contacting fungal disease sites with a composition
including triclosan, which may include other additional ingredients. In view
of the above, we address the prior art rejections before us.
According to the Examiner, Forward discloses the treatment of fungal
infections, including oral Candida, with a combination of triclosan and nisin.
(Ans. 3.) The compositions may be in mouthwash (liquid) or gel (semisolid)
form. (Ans. 3.)
Appellant contends that the
4
Appeal 2008-2034
Application 09/224,781

rejection is in error because the cited reference requires the
presence of additional active materials that are excluded by the
terms of claims 23-25. The amended claims, which include the
recitation ‘consisting essentially of’, exclude the use of the
polypeptide antibiotic nisin which is an essential component of
the '711 compositions. …
. . . Nisin is a polypeptide antibiotic according to the '711
[Forward] patent and therefore would have a profound and
material effect on the properties of the compositions of the '711
[Forward] patent. The phrase ‘consisting essentially of,’ when
used with triclosan, excludes other active materials because the
specification and claims clearly contemplate the use of triclosan
alone as the sole antifungal agent. Pages 9-11 of the original
specification disclosed a number of compositions with triclosan
as the sole active ingredient.

(Br. 3-4.)

The Examiner responds that “there is no evidence of record to support
appellant's allegation that nisin has a ‘profound and material effect on the
properties’ on the prior art compositions.” (Ans. 6.)
Notwithstanding the Examiner’s response to Appellant’s arguments,
this case is one which turns primarily on claim interpretation. As discussed
herein, Appellant has not defined in the Specification the scope of the
invention proscribed by the claim term “consisting essentially of.”
Therefore, we construe the term “consisting essentially of” in claim 23 as
equivalent to the term “comprising.” As such, claim 23 does not exclude
contacting fungal diseases with a composition comprising triclosan and other
ingredients, such as nisin. Further, we agree with the Examiner that there is
no evidence of record showing that nisin has a material effect on triclosan.
Thus, we find that Forward anticipates claim 23.
5
Appeal 2008-2034
Application 09/224,781

We remind Appellant that it is his burden to precisely define the
invention, not the PTO’s. In re Morris, 127 F.3d 1048, 1056 (Fed. Cir.
1997). Appellant always has the opportunity to amend the claims during
prosecution, and broad interpretation by the Examiner reduces the possibility
that the claim, once issued, will be interpreted more broadly than is justified.
In re Prater, 415 F.2d 1393, 1404-05 (CCPA 1969).
Appellant contends that claim 24 is not anticipated by Forward
because it does not disclose the use of a solubilizer. (Br. 4). However, the
Examiner finds that Forward uses water alone (working examples 1-8) or in
combination with ethanol (working examples 9-13 and 16) as a solvent
(solubilizer), and that the surfactants disclosed by Forward at page 3, lines
15-29 would have a solubilizing function as well. (Ans. 7.) We agree with
the Examiner that Forward discloses the use of a solubilizer and find claim
24 anticipated by Forward.
Appellant also argues that claim 25 is not anticipated by Forward
because that patent does not disclose a semi-solid composition. (Br. 4.) The
Examiner finds that the gels disclosed at page 1, lines 53, and the toothpastes
prepared in working examples 1-8, of Forward are semisolids. (Ans. 7.) We
agree with this finding of the Examiner and thus conclude claim 25 is
anticipated by Forward.
The anticipation rejection of claims 23-25 based on Forward is
affirmed.

2. Claims 23-25 stand rejected under 35 U.S.C. § 102(b), as
anticipated by Takaoka. We select claim 23 as representative of the
6
Appeal 2008-2034
Application 09/224,781

rejection before us since Appellant has not separately argued the individual
claims. 37 C.F.R. 41.37(c)(1)(vii).1
The Examiner contends that Takaoka “discloses the use of triclosan,
either in solution with alcohol or water, or as an ointment, to treat athlete's
foot fungus (see page 1, lines 35-38).” (Ans. 4.)
Appellant contends that all of the disclosed compositions employ urea
as well as triclosan, and that the claim language “consisting essentially of”
excludes the presence of urea. (Br. 5.)
Again we are not persuaded by Appellant’s arguments in view of the
claim interpretation discussed herein.
Therefore, we construe the term “consisting essentially of” in claim
23 as equivalent to the term “comprising.” As such, claim 23 does not
exclude contacting fungal disease sites with a composition comprising
triclosan and other ingredients, such as urea. Thus we find that Takaoka
anticipates claim 23, and the rejection is affirmed.

3. Claims 23-30 stand rejected under 35 U.S.C. 103(a) as being
unpatentable over Libin in view of Forward. We select claims 23 and 26 as
representative of the rejection before us since Appellant has not separately
argued the other individual claims. 37 C.F.R. 41.37(c)(1)(vii).
The Examiner finds that Libin
discloses mouthrinses comprising a combination of triclosan
and cetylpyridinium chloride, which are used to inhibit plaque
formation and to treat periodontitis (column 4, lines 57-60). It

1 We note that arguments presented on page 6 of the Brief relate to the
Forward reference not the Takaoka reference, and therefore, we do not
address them in the rejection over Takaoka.
7
Appeal 2008-2034
Application 09/224,781

differs from the instant claims in its silence regarding the
treatment of fungal infections.

Triclosan and cetylpyridinium chloride are both known to be
active against the oral fungus Candida. See [Forward]. … The
reference also recognizes that these agents are equally useful
for inhibiting plaque (paragraph 0043). It differs from the
instant claims insofar as it does not specify the use of the two
agents together.

(Ans. 4.) See, e.g. pending claims 26-28.

The Examiner concludes that

[i]t would have been obvious to have administered mouthrinses
comprising triclosan and cetylpyridinium chloride to oral
Candida patients, motivated by the desire to inhibit plaque as
taught by the primary reference, while simultaneously treating
the Candida infection as taught by the secondary reference.

(Ans. 5.)
Appellant puts forth the same arguments with respect to Forward
discussed above, namely that the claims exclude the use of nisin. (Br. 7.)
Appellant also argues that Libin does not explicitly mention or suggest the
treatment of a fungal disease. (Br. 7.)
We are not persuaded by Appellant’s arguments. We have found
herein that claim 23, as interpreted, does not exclude ingredients such as
nisin. Furthermore, while Libin does not explicitly disclose the use of
triclosan for the treatment of fungal disease, Forward discloses that an oral
hygiene composition comprising triclosan, as in Libin, is useful for the
treatment of fungal infections. (Forward, p. 2. ¶ 008.) Thus, a person of
ordinary skill in the art would have recognized that the Libin composition
8
Appeal 2008-2034
Application 09/224,781

including triclosan, would also useful for the treatment of fungal infections
in view of the disclosure of Forward. (Ans. 9-10.)
Appellant also argues that claim 26 is not obvious in view of the cited
references. (Br. 7.) When determining whether a claim is obvious, an
examiner must make “a searching comparison of the claimed invention –
including all its limitations – with the teaching of the prior art.” In re
Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995) (emphasis added). Thus,
“obviousness requires a suggestion of all limitations in a claim.” CFMT,
Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In
re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Libin discloses the use of triclosan in combination with a cationic
agent such as cetyl pyridinium choloride in a mouthrinse, as claimed.
(Libin, abstract.) Forward discloses mouthwashes for the treatment of oral
fungal infections including cetyl pyridinium chloride or triclosan. (Forward,
p. 2. ¶ 008.) In view of the above, we find the Examiner has provided
sufficient evidence in the prior art of each of the claimed limitations and an
adequate reason to combine the teachings of the prior art mouthrinses. As
discussed herein, we do not find the pending claims exclude the inclusion of
a nisin compound. In view of the above, the obviousness rejection is
affirmed.

SUMMARY
The rejections of the claims for anticipation and obviousness are
affirmed.
No time period for any subsequent action in connection with this
appeal may be extended under CFR § 1.136(a).
9
Appeal 2008-2034
Application 09/224,781

AFFIRMED
lp

JAMES V COSTIGAN
HEDMAN GIBSON & COSTIGAN
1185 AVENUE OF THE AMERICAS
NEW YORK NY 10036
10