Ex Parte Pena et al

Board of Patent Appeals and Interferences

Mar 25, 2008

09634399 (B.P.A.I. Mar. 25, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte LORRAINE ELISABETH PENA and MAW-SHENG WU
____________

Appeal 2007-2919
Application 09/634,399
Technology Center 1600
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Decided: March 25, 2008
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and DEMETRA J.
MILLS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 1, 5-8, 10, 13-22,
30, 35, 62, 66, 68, 70-76, 111, 112, 115, 116, and 123-134, the only claims
pending in this application. We have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2007-2919
Application 09/634,399

INTRODUCTION
The claims are directed to a composition in the form of a single-phase
gel (claims 1, 5-8, 10, 13-22, 30, 35, 62, 66, 68, 70-76, and 123-134) and a
method of using the single phase gel (claim 111, 112, 115, and 116). Claims
1, 20, and 112 are illustrative:
1. A composition in the form of a single-phase gel comprising from
about 5% to about 8% minoxidil, a crosslinked copolymer of acrylic acid as
a thickening agent, and a pharmaceutically acceptable solvent, wherein said
minoxidil is present at a concentration which is less than its solubility limit
in said composition.

20. [A composition of claim 1, further comprising a neutralizing
agent], wherein said neutralizing agent is 2-amino-2-methyl-1-propanol.

112. A method [comprising topically administering a composition
according to claim 1 to a region of hair loss on a patient], wherein said hair
loss is selected from the group consisting of androgenic alopecia, frontal hair
loss, bitemporal recession, vertex balding, mid-anterior balding, alopecia
areata, anagen hair loss, diffuse alopecia, and telogen effluvium.

The Examiner relies on the following prior art references to show
unpatentability:
Pena US 5,225,189 Jul. 6, 1993
Samour US 5,620,980 Apr. 15, 1997
Anton US 5,798,426 Aug. 25, 1998
Preuilh US 6,106,848 Aug. 22, 2000

Grollier GB 2 194 887 A Mar. 23, 1988
Ewers DE 196 13 698 A1 Jan. 1, 1997

We note that the Examiner failed to list Anton, Grolier, and Samour in
the Examiner’s statement of the “Evidence Relied Upon” (Ans. 2-3
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(emphasis removed)). We find these omissions to be an inadvertent
typographical error.
The rejections as presented by the Examiner are as follows:
1. Claims 1, 5-8, 10, 13-19, 21, 22, 30, 35, 62, 66, 68, 70-75, 111, 115, 123-
131, and 133 stand rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Preuilh, Ewers, and Pena.
2. Claims 76, 112, 116, 132, and 134 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Preuilh, Ewers, Pena, and
Samour.
3. Claims 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Preuilh, Ewers, Pena, Anton, and Grollier.
We reverse.

DISCUSSION
1. Claims 1, 5-8, 10, 13-19, 21, 22, 30, 35, 62, 66, 68, 70-75, 111, 115, 123-
131, and 133 stand rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Preuilh, Ewers, and Pena.
The claims are directed to a composition or method of topically
administering a single-phase gel composition comprising, inter alia, a
crosslinked copolymer of acrylic acid.
Pena teaches single-phase gel compositions comprising carbomers
such as “Carbopol ® 934P” (Pena, col. 2, ll. 37-46). Appellants assert that
“Carbopol® 910 and 934 are crosslinked homopolymers of acrylic acid”
which are distinct from the claimed composition that requires “a crosslinked
copolymer of acrylic acid” (App. Br. 6). The Examiner asserts, however,
that a person of ordinary skill in the art would have recognized that Pemulen
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Application 09/634,399

TR1 as taught by Preuilh would have been useful as a thickener in the
preparation of a single-phase gel,
because 1) emulsifying agents are known to modify the
viscosity of the composition, and thus function as thickeners,
(see instant specification [(Spec. 8: 5-7)] wherein, “thickening
agent” is taught as an agent which may act as viscosity
modifying agent, emulsifying agents, gelling agent, stabilizing
agent), and 2) Preuilh teaches that Pemulen TR1 is compatible
with minoxidil, and results in stable [oil-in-water emulsion]
compositions.

(Ans. 11).
Appellants disagree. According to Appellants, Preuilh teaches that
“such crosslinked copolymers of acrylic acid are useful as emulsifying
agents. Preuilh does NOT teach or suggest the use of crosslinked
copolymers of acrylic acid to thicken or gel the disclosed emulsions” (App.
Br. 7). In this regard, Appellants direct attention to paragraph 10 of the
Second Pena Declaration and assert that a person of ordinary skill in the art
at the time the invention was made “would find no motivation in either . . .
[Preuilh or Pena] to utilize a crosslinked copolymer of acrylic acid as a
thickening or gelling agent, because there is no need for an emulsifying
agent in a single-phase gel” (App. Br. 9; Second Pena Declaration ¶ 10).
Further, while Appellants’ Specification refers to thickening agents as
including emulsifying agents, the Examiner fails to recognize that
Appellants’ Specification is drawn to both gels, including single-phase gels,
and emulsions (Spec. 4-5). In this regard, the Examiner has failed to
identify a teaching in the prior art that would suggest the use of an
emulsifying agent, such as Pemulen TR1, in a single-phase gel. The prior
art of record teaches that Pemulen TR1 is an effective emulsifying agent for
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Application 09/634,399

use in emulsions (Preuilh, col. 2, ll. 4-63; App. Br. 6; First Pena Declaration
¶¶ 7-9; and Second Pena Declaration ¶¶ 8-10). The evidence of record does
not teach the use of a crosslinked copolymer of acrylic acid in a single phase
gel. The Examiner’s recognition that Pemulen TR1 is compatible with
minoxidil and results in stable oil-in-water emulsion compositions (Ans. 11)
is not sufficient to bridge this evidentiary gap. Ewer fails to make up for this
deficiency in the combination of Preuilh and Pena.
Accordingly, we reverse the rejection of claims 1, 5-8, 10, 13-19, 21,
22, 30, 35, 62, 66, 68, 70-75, 111, 115, 123-131, and 133 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Preuilh, Ewers, and Pena.

2. Claims 76, 112, 116, 132, and 134 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Preuilh, Ewers, Pena, and
Samour.
The claims are directed to a composition or method of topically
administering a single-phase gel composition comprising, inter alia, a
crosslinked copolymer of acrylic acid. The Examiner relies on the
combination of Preuilh, Ewers, and Pena as discussed above. The Examiner
recognizes, however, that the combination of Preuilh, Ewers, and Pena does
not teach the “preferred percent weights of polyols as about 53% as in
claims 76, and 131, and modes of hair loss as recited in claims 112, 116,
[and] 134” (Ans. 7). To make up for this deficiency the Examiner relies on
Samour to teach “a method for treating hair loss, specifically androgenic
alopecia” comprising the topical application of a composition comprising
minoxidil and a composition comprising, inter alia, “0-90% lower alcohol
[and] 0-98% lower glycol” (id.). Samour does not, however, make up for
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the deficiencies in the combination of Preuilh, Ewers, and Pena discussed
above.
Accordingly, we reverse the rejection of claims 76, 112, 116, 132, and
134 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Preuilh, Ewers, Pena, and Samour.

3. Claim 20 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Preuilh, Ewers, Pena, Anton, and Grollier.
Claim 20 depends from and further limits claim 1 to further comprise
a neutralizing agent that is 2-amino-2-methyl-1-propanol.
The Examiner relies on the combination of Preuilh, Ewers, and Pena as
discussed above. The Examiner recognizes, however, that the combination
of Preuilh, Ewers, and Pena fails to teach a composition comprising a
neutralizing agent that is 2-amino-2-methyl-1-propanol. To make up for this
deficiency the Examiner relies on Grollier to teach “compositions suitable
for inducing and stimulating hair growth or for decreasing loss of hair,
which comprises minoxidil . . . and 2-amino-2-methyl-l-propanol” (Ans. 8).
The Examiner relies on Anton to teach that amino methyl propanol is useful
in neutralizing the acrylic polymer in acrylic polymer compounds and
aqueous compositions thereof (Ans. 8). Neither Grollier nor Anton,
however, make up for the deficiencies in the combination of Preuilh, Ewers,
and Pena discussed above
Accordingly, we reverse the rejection of claim 20 under 35 U.S.C. §
103(a) as unpatentable over the combination of Preuilh, Ewers, Pena, Anton,
and Grollier.
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CONCLUSION
In summary, we reverse the rejections of record.

REVERSED

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