Ex Parte Gellman et al

Patent Trial and Appeal Board

Nov 24, 2014

10933987 (P.T.A.B. Nov. 24, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SAMUEL H. GELLMAN, MICHAEL A. GELMAN,
BERNARD WEISBLUM, and DAVID M. LYNN1
__________

Appeal 2012-006337
Application 10/933,987
Technology Center 1600
__________

Before LORA M. GREEN, MELANIE L. McCOLLUM, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1, 4–7, and 29–37 are on appeal (App. Br. 1).2 We will focus
on claims 30 and 4, which are set forth in the Claims Appendix to the
Appeal Brief (App. Br. A-2 to A-5).

1 Appellants identify the real party in interest as Wisconsin Alumni Research
Foundation (App. Br. 1).
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Claims 1, 5–7, and 29–37 stand rejected under 35 U.S.C. § 103(a) as
obvious over Overberger3 in view of Yamada4 and Strobridge5 (Ans. 5).
Claim 4 stands rejected under 35 U.S.C. § 103(a) as obvious over
Overberger in view of Yamada, Strobridge, and Panarin6 (Ans. 7).
The Examiner relies on Overberger for teaching “p-alkyl styrenes,
including octyl-styrene, and their use as oral products, such as a chewing
gum base” (id. at 5). The Examiner finds that “copolymerization with other
monomers, including styrene derivatives, is taught . . . as a means to vary the
desired polymer properties” (id.). However, the Examiner finds that
“Overberger does not teach the co-polymerization of p-methylamine
styrenes” (id.).
The Examiner relies on Yamada for teaching “the antimicrobial
effects of poly(benzyalonium salts)” (id.). The Examiner finds that, “[t]o
make the activated salt, N,N-dimethylbenzylamine monomers are first
polymerized and then the polymerized resin is activated via an acetone bath
and 1-bromonododceane [sic], then converted to the chloride salt by washing
with sodium hydroxide, water, hydrochloric acid, and water, successively”
(id.). However, the Examiner finds that Yamada “does not teach the co-
polymerization with an alkyl-styrene” (id.).

2 Claim 28 is also pending but has been withdrawn from consideration (App.
Br. 1).
3 Overberger, US 2,802,812, Aug. 13, 1957.
4 Yamada et al., US 5,683,709, Nov. 4, 1997.
5 Strobridge, US 5,015,464, May 14, 1991.
6 E. F. Panarin et al., Synthesis and Antimicrobial Properties of Polymers
Containing Quaternary Ammonium Groups, 5 PHARMACEUTICAL
CHEMISTRY JOURNAL 406–408 (1971).
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The Examiner relies on Strobridge for teaching that “antimicrobial
gums are known to have antiplaque effect and are administered with known
to be pharmaceutically acceptable carriers for oral administration, such as
sorbitol and mannitol” (id.). However, the Examiner finds that Strobridge
“does not teach the specific polymer gum bases used for antiplaque effects”
(id.).
The Examiner concludes:
It would have been obvious to one of ordinary skill in the
art when making the gum formulations of Overberger to include
an antimicrobial monomers which provide the copolymer
system with antimicrobial properties, as taught by Yamada . . .
based on the teaching of St[ro]bridge, which suggests
antimicrobial gums were known in the art and the skilled
artisan would understand that the addition of an antimicrobial
monomer to the gum base would provide an antimicrobial
effect, thereby acting as an antiplaque.
Further, in order to make the antimicrobial product, the
skilled artisan would first copolymerize the base, then activate
the N,N-dimethylbenzylamine, such as practiced by Yamada et
al. Thus, the intermediate product made obvious in solution
appears to read on the instantly claimed product.
(Id. at 5–6.)
In rejecting claim 4, the Examiner additionally relies on Panarin for
teaching “the ability to modify the molecular weight of polymers by
modifying the amount of initiator to produce variations of the primary
polymer containing quaternary ammonium groups” and for teaching
“varying the molecular weight of polymers containing quaternary
ammonium groups as a way to optimize the antimicrobial effect desired” (id.
at 7). The Examiner concludes that it would have been obvious “to adjust
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the molecular weight of the copolymer product made obvious by
Overberger, Yamada et al, and St[ro]bridge as a means of adjust[ing] the
antimicrobial effect of the resulting gum, as taught Panarin” (id.).
ISSUE
With regard to both grounds of rejection, the issue is: Has the
Examiner set forth a prima facie case that it would have been obvious to
include monomers having an N,N-dimethylbenzylamine in Overberger’s
p-alkyl styrene polymers?
ANALYSIS
Overberger discloses “p-alkyl styrenes [that] are valuable in the
preparation of polymers including homo polymers, heteropolymers, and
copolymers of use in the production of coatings, adhesives, chewing gum
base compositions and the like” (Overberger, col. 6, ll. 46–51). Overberger
also discloses that “the p-alkyl styrenes may be copolymerized with various
other polymerizable materials particularly those containing a CH=CH2
group” (id. at col. 6, ll. 57–60). In addition, Overberger lists styrene and its
derivatives as “illustrative of such copolymerizing materials” (id. at col. 6,
ll. 60–63). Overberger also discloses that the “proportions used in making
the copolymers may vary widely depending on the properties desired” (id. at
col. 6, ll. 64–66). However, Overberger does not provide additional
guidance as to the type or amount of copolymerization materials that may be
included in chewing gum base.
Strobridge discloses chewing gum incorporating an “antiplaque
effective amount of eucalyptol, menthol, methyl salicylate and thymol”
(Strobridge, col. 1, l. 67, to col. 2, l. 4). In discussing the prior art,
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Strobridge states that the “essential oils used in . . . two proposed gums . . .
are not strongly antimicrobial and hence not exceptionally effective against
plaque” (id. at col. 1, ll. 47–52). Thus, the Examiner relies on Strobridge for
generally teaching the incorporation of an antimicrobial in chewing gum as
an antiplaque agent (Ans. 5). However, Strobridge does not disclose
copolymerizing antiplaque agents with other monomers to form the chewing
gum base.
Yamada “relates to the use of poly(benzalkonium salt) in aqueous
drug compositions to inhibit microbial growth” (Yamada, col. 1, ll. 5–7). In
particular, Yamada discloses an insoluble resin containing repeating units of
the formula [CH2–CH(Ar)]–, wherein Ar is a group of the formula
–Phe–CH2–N+(CH3)2R X–, and wherein R is a long chain alkyl (id. at col. 2,
ll. 28–36). Yamada also discloses forming this resin from “an ion-exchange
resin containing N,N-dimethylbenzylamine functionality” (id. at col. 3,
ll. 16–17, & col. 4, ll. 8–24). However, we agree with Appellants that the
Examiner has not adequately explained why it would have been obvious to
include monomers having an N,N-dimethylbenzylamine in Overberger’s
p-alkyl styrene polymers.
Yamada states that “benzalkonium chloride (BAC), a benzyl
quaternary ammonium compound having a higher aliphatic chain, is widely
used as an anti-microbial agent [in ophthalmic drug formulations] because of
its relatively low toxicity to humans” (id. at col. 1, ll. 18–22). However,
Yamada states that “benzalkonium chloride often irritates the eye at
concentrations higher than about 0.02 weight %” and that “[s]ome patients
are sensitive to benzalkonium chloride at concentrations as low as about
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0.01% when the formulation containing BAC is used chronically” (id. at
col. 1, ll. 22–27). Thus, Yamada discloses “a package containing an
aqueous drug composition, containing an insoluble resin comprising
benzalkonium units in an amount sufficient to inhibit growth of microbes in
said aqueous drug solution” (id. at col. 2, ll. 19–22).
We understand the Examiner’s position that Yamada’s benzalkonium
units are antimicrobial and therefore would act as an antiplaque agent
(Ans. 5–6). However, even if we agree that it would have been obvious to
include Yamada’s benzalkonium units in chewing gum, the Examiner has
not adequately explained why it would have been obvious to copolymerize
benzalkonium monomers with Overberger’s p-alkyl styrenes to form a
chewing gum base.
CONCLUSION
The Examiner has not set forth a prima facie case that it would have
been obvious to include monomers having an N,N-dimethylbenzylamine in
Overberger’s p-alkyl styrene polymers. We therefore reverse the
obviousness rejections.

REVERSED

cdc