Ex Parte Bracht et al

Board of Patent Appeals and Interferences

Jan 28, 2009

09959201 (B.P.A.I. Jan. 28, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte STEFAN BRACHT and MICHAEL HORSTMANN
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Appeal 2008-4546
Application 09/959,201
Technology Center 1600
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Decided: January 28, 2009
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Before TONI R. SCHEINER, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
transdermal therapeutic system. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 Oral Hearing held January 13, 2009.
Appeal 2008-4546
Application 09/959,201

STATEMENT OF THE CASE
Claims 20-34 are on appeal. Claims 35 and 36 are also pending but
have been withdrawn from consideration by the Examiner. We will focus on
claim 20, the broadest claim on appeal, which reads as follows:
20. A transdermal therapeutic system consisting essentially of:
a) a backing layer,
b) at least one active substance-containing polymer matrix
layer, which has or has not at the same time pressure sensitive adhesive
properties;
c) at least one permeation enhancer;
d) at least one basic auxiliary substance which is a basic
polymer; and
e) a pressure-sensitive adhesive layer on a skin-facing side of
the matrix layer in case the matrix layer does not have pressure-sensitive
adhesive properties;
wherein the active substance is at least one neuroleptic selected from
the group consisting of a pharmaceutically acceptable salt of fluphenazine, a
pharmaceutically acceptable salt of flupentixol and a pharmaceutically
acceptable salt of triflupromazine, wherein the permeation enhancer is
selected from the group consisting of saturated fatty acids, mono-unsaturated
fatty acids, saturated fatty alcohols and unsaturated fatty alcohols, each
having 6 to 18 carbon atoms, and
wherein said polymer matrix layer having pressure sensitive adhesive
properties and said pressure sensitive adhesive respectively are based on
polymers comprising pure hydrocarbons.
Claims 20-29 and 31-34 stand rejected under 35 U.S.C. § 103(a) as
obvious over Yamanaka (EP 0,452,837 A2, Oct. 23, 1991) in view of Lee
(US 5,882,676, Mar. 16, 1999) (Ans. 3).
Claim 30 stands rejected under 35 U.S.C. § 103(a) as obvious over
Yamanaka in view of Lee and Tsai (US 6,228,875 B1, May 8, 2001)
(Ans. 5).
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Appeal 2008-4546
Application 09/959,201

ISSUE
The Examiner relies on Yamanaka for disclosing “a medical adhesive
comprising a percutaneous absorption-promoting agent”; that the “adhesive
comprises a plaster layer [and] a backing layer”; that the “medical adhesive
may comprise psychotropic drugs, including fluphenazine hydrochloride and
flupenthixol hydrochloride”; that the “active ingredient . . . is incorporated
into a hydrophobic polymer layer”; that the “adhesive layer comprises
pressure-sensitive polymers, which are exemplified by acrylic-type
polymers, polyisobutylene gums, and polyisoprene gums . . . , as well as
copolymers of various acrylic monomers, including methacrylic acid and
dimethylaminoethyl methacrylate”; and that a “solubilizer may also be
incorporated into the plaster layer, which may be acidic or basic, and organic
or inorganic” (Ans. 3).
The Examiner relies on Lee for teaching “a transdermal device with
an active ingredient and a permeation enhancer, as well as . . . a backing
layer adjacent to one surface of the drug reservoir”; that “[f]luphenazine and
trifluorperazine are listed among suitable active agents in the transdermal
device”; and that “the matrix containing the drug is composed of a
hydrophobic polymer[,] one example of such a matrix [being] a system
comprising high molecular weight polyisobutylene, low molecular weight
polyisobutylene, and mineral oil” (Ans. 4). The Examiner concludes that
“[o]ne of ordinary skill in the art would be motivated to combine the
teachings of Yamanaka et al. and Lee et al. because . . . ‘[i]t is prima facie
obvious to combine two compositions, each of which is taught by the prior
art to be useful for the same purpose, in order to form a third composition
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Application 09/959,201

which is to be used for the very same purpose’” (id. at 5 (quoting In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980))).
Appellants contend that “Yamanaka fails to teach or suggest the
specific combination of ‘polymers comprising pure hydrocarbons’ and a
‘basic polymer’” (App. Br. 13). Appellants also contend that “Lee fails to
address the deficiencies of Yamanaka” (id. at 18).
The issue is whether the Examiner has set forth a prima facie case that
the applied references teach or suggest a transdermal therapeutic system
containing both a pressure-sensitive adhesive “based on polymers
comprising pure hydrocarbons” and a basic polymer.
FINDINGS OF FACT
1. Yamanaka discloses a medical adhesive comprising: (a) a
plaster layer containing a medicinal ingredient, a hydrophobic polymer, a
percutaneous absorption-promoting agent, water, and a hydrophilic polymer,
and (b) a porous base layer in contact with the plaster layer (Yamanaka 3:
36-46).
2. As the hydrophobic polymer, Yamanaka discloses “pressure-
sensitive adhesive polymers exemplified by acrylic-type polymers; gum-type
polymers such as silicone gums, polyisobutylene gums, polyisoprene gums
and styrene-butadiene (or-isoprene)-styrene block copolymer gums; poly
vinylalkyl ether-type polymers; vinyl-type polymers such as poly vinyl-
acetate and poly vinyl-propionate; and polyurethane elastic bodies” (id. at 6:
58 to 7: 4).
3. Yamanaka also discloses that pressure-sensitive adhesive acryl-
type copolymers are preferred and that “[e]xamples of the copolymerizable
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Application 09/959,201

monomers include functional monomers exemplified by . . . alkylaminoalkyl
group-containing acrylic-type monomers such as aminoethyl (meth)acrylate,
dimethylaminoethyl (meth)acrylate, diethylaminoethyl (meth)acrylate and
tert-butyl (meth)acrylate . . . .” (Id. at 7: 5-19.)
4. In addition, Yamanaka discloses that “a solubilizer may be
incorporated as an ingredient of the plaster layer. . . . As the solubilizers,
there can be mentioned acidic or basic inorganic or organic substances. . . .
Examples of the organic basic substances include amines such as
triethanolamine, diethanolamine, triisopropanolamine, diisopropanolamine,
etc., and amino acids such as L-arginine.” (Id. at 8: 57 to 9: 7.)
5. The present Specification teaches that an example of a basic
auxiliary substance is the polymer Eudragit E100, a poly(meth)acrylate
containing trialkylamino groups in its lateral chain (Spec. 4: 9-16 & 5: 18-
19).
ANALYSIS
The Examiner interprets “‘basic polymer’ . . . to simply mean a
polymer in combination with an alkaline substance” and “does not interpret
such a combination of materials to be patentably distinct from the disclosure
[in Yamanaka] of the incorporation of a basic solubilizer into the plaster”
(Ans. 9). We do not agree.
The Specification teaches that Eudragit E100 is an example of a basic
polymer (Finding of Fact 5). Therefore, we agree with Appellants that:
[T]he term “basic polymer” . . . refers to . . . a polymer that is
formed from basic groups such as amino residues. If a non-
basic polymer is mixed with a basic substance, it is still the
additional substance that is basic rather than the polymer. If a
non-basic polymer is dissolved or dispersed in an alkaline
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solution, the solution or dispersion may be basic. . . . However,
it is not the polymer as such that is basic. Hence, it would be
inaccurate to name these preparations a “basic polymer”.
(Reply Br. 5.)
CONCLUSION
The Examiner has not set forth a prima facie case that Yamanaka and
Lee teach or suggest a transdermal therapeutic system containing both a
basic polymer and a pressure-sensitive adhesive “based on polymers
comprising pure hydrocarbons.” We therefore reverse the obviousness
rejection of claims 20-29 and 31-34.
Claim 30 depends from claim 20. The Examiner relies on Tsai for
limitations recited in claim 30, and has not pointed to any disclosure in Tsai
would make up for the deficiency discussed above (Ans. 7). We therefore
also reverse the obviousness rejection of claim 30.

REVERSED

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