Ex Parte 5676968 et al

Patent Trial and Appeal Board

Feb 4, 2015

90012693 (P.T.A.B. Feb. 4, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
90/012,693 09/20/2012 5676968 5028-0031 1489
7590 02/05/2015
MILLEN WHITE ZELANO & BRANIGAN
ARLINGTON COURTHOUSE PLAZA I
SUITE 1400
2200 CLARENDON BLVD.
ARLINGTON, VA 22201
EXAMINER
RAILEY, JOHNNY F
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
02/05/2015 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte BAYER SCHERING PHARMA AKTIENGESELLSCHAFT1
Appellant
__________

Appeal 2015-001301
Reexamination Control No. 90/012,693
Patent US 5,676,968
Technology Center 3900
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. §§ 134(b) and 306 from the
Examiner’s rejections of claims 1–10 for obviousness. We have jurisdiction
under 35 U.S.C. §§ 6(b)(2) and 306.
We affirm.
STATEMENT OF THE CASE
A request for ex parte reexamination of the ’968 Patent2 was filed on
September 20, 2012. The request for ex parte reexamination was assigned
Reexamination Control No. 90/012,693.

1 Appellant asserts that Bayer Intellectual Property GmbH is the Real Party
in Interest (Br. 1).
2 Lipp et al., US 5,676,968, issued Oct. 14, 1997.
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Background
The ’968 Patent is directed to “transdermal therapeutic systems, which
make available active ingredients to the organism through the skin and are
characterized in that crystallization inhibitors are contained in the active
ingredient-containing matrix.” (See ’968 Patent, col. 1, ll. 6–10). The ’968
Patent asserts that “[h]igh concentrations of dissolved active ingredient in
the matrix of transdermal therapeutic systems generally make possible a
high flow of active ingredients through the skin” (id. at col. 1, ll. 19–21).
The ’968 Patent also asserts that “[a] problem of such supersaturated
solutions is the insufficient storage stability. Since easily crystallizing
compounds are involved in the incorporated active ingredients,
crystallization processes must be expected during the storage” (id. at col. 1,
ll. 26–30). The ’968 Patent further asserts that “[i]n addition, crystal growth
leads to the reduction of the crystal surface, by which the rate of solution is
reduced during the administration” (id. at col. 1, ll. 42–44).
In an attempt to “prevent crystallization processes in transdermal
therapeutic systems and to be able to administer the therapeutically desired
dose continuously,” the ’968 Patent discloses that “crystallization inhibitors
are added [to the matrix] according to the invention” (id. at col. 1, ll. 45–48).
The crystallization inhibitors “are therefore particularly suitable to make the
active ingredient continuously bioavailable in humans in therapeutically
relevant doses” (id. at col. 1, ll. 57–59). The ’968 Patent further discloses
that “especially the polyyinylpyrrolidones, their copolymers with vinyl
acetate and highly dispersed silicon dioxide are distinguished by a high
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crystallization-inhibitory potency” (id. at col. 2, ll. 15–18).
Claims on Appeal
Claims 1–10 are on appeal and can be found in the Claims Appendix
of Appellant’s brief. Independent Claim 1 is representative, and reads as
follows:
1. A transdermal therapeutic system, comprising:
a) a top coating which is impermeable to water,
penetration enhancer and active ingredient, and
b) an adhesive matrix, adhered to the top coating
comprising
bl) an active ingredient,
b2) 0.1 to 40% by weight relative to the total
weight of the matrix of a vinylpyrrolidone-vinylacetate
copolymer as crystallization inhibitor, and
b3) a skin contact adhesive.
The Rejection
The Examiner rejected claims 1–10 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Suzuki,3 Hoffmann,4 Blank,5
Ogasawara,6 and Khanna.7

3 Suzuki et al., US 5,413,776, issued May 9, 1995.
4 Hoffmann et al., CA 2,027,053, issued Apr. 7, 1991.
5 Blank, US 5,232,703, issued Aug. 3, 1993.
6 Ogasawara, JP 54-89017, published July 14, 1979.
7 Khanna, US 5,122,543, issued June 16, 1992.
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FINDINGS OF FACT
We adopt the Examiner’s findings of fact as set forth in the Answer.
For emphasis, we highlight the following:
FF1. The Examiner finds:
Suzuki teaches a transdermal therapeutic system
comprising an impermeable substrate with an adhesive matrix.
The adhesive matrix comprises a high concentration of a
hydrophilic drug along with a mixture of a copolymer of N-
vinyl-2-pyrrolidone (VP) and (meth)acrylic acid ester and a
homopolymer of N-vinyl-2-pyrrolidone (PVP). See Column 2,
line 47 through Column 3, line 53. The presence of the PVP
provides for an increased effect of keeping the hydrophilic drug
soluble in the adhesive layer with improved drug releasability
to the skin, while not reducing adhesiveness of the transdermal
therapeutic system. Transdermal delivery of specific drugs or
active constituents includes hydrophilic compounds, taught by
Suzuki at column 5, lines 24-32. Column 5, at lines 39-40,
shows that the drug can be present in an amount of 5 to 30 wt %
in the adhesive layer. At Column 6, lines 30-31, the substrate
layer can be 500 µm or less, preferably 5 to 100 µm. The size
of the substrate can be 10 cm x 10 cm, or 100cm2. See column
9, line 42. There can be a strippable liner covering the adhesive
layer. See column 7, lines 7-9 and column 9, line 61.
(Ans. 2).
FF2. The Examiner finds:
Hoffmann teaches a transdermal therapeutic system
comprising an impermeable material backing layer (a “plaster”)
and a pressure-sensitive adhesive of at least one homopolymer
and/or copolymer of a derivative of acrylic or methacrylic acid.
Included is an active substance, such as estrogen, and a
substance to prevent the crystallization of the active substance.
See page 5, beginning at the last paragraph through page 7,
second paragraph. The substance to prevent crystallization is
typically at 0.1 to 20%-wt. See page 6, last paragraph through
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page 7, first paragraph. The crystallization inhibitor can be
polyvinylpyrrolidone (PVP). See page 12, line 15. A
removable protective layer covering the adhesive film is taught
on page 6, lines 6-7. The adhesive film may have a thickness of
from 0.01 to 0.30 mm. See page 12, lines 17-19. The substrate,
or plaster, is typically 1 to 50 cm2. See page 16, lines 19-20.
(Id. at 2–3).
FF3. The Examiner finds:
Blank teaches a transdermal therapeutic system for the
delivery of estradiol by incorporating uncrosslinked, water-
insoluble vinylpyrrolidone copolymers in the compositions.
See column 2, lines 55-62. This composition can be cast onto a
suitable substrate and affixed to the skin. See column 6, lines
1-9. The vinylpyrrolidone copolymer can be vinylpyrrolidone
and vinyl acetate. See column 5, lines 20-24. The
compositions allow for the slow release of the drug when
applied to topically to the skin. See column 4, lines 23-33.
Blank does not make any examples with an adhesive matrix and
provides only examples of gel emulsions, none of which
contain vinylpyrrolidone/vinyl acetate copolymers.
(Id. at 3).
FF4. The Examiner finds that “Ogasawara teaches that ointment
preparations comprising vinylpyrrolidone-vinyl acetate copolymer
(PVP-VA) incorporated therein prevented aggregation and crystal
formation of an active constituent. See the translation at page 4, lines
6-29; page 6, lines 1-8 and page 7, lines 6-13” (id.).
FF5. The Examiner finds:
Khanna teaches that in oral formulations, PVP or
PVP/VA prevents the formation of hydrate crystals and inhibits
the formation of disadvantageous or unsuitable crystalline
forms. Suitable protective colloids are poly-N-vinyl
pyrrolidone and a vinylpyrrolidone/vinyl acetate copolymer.
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See column 3, lines 46-55; column 4, lines 13-18 and 26-29.
The vinylpyrrolidone/vinyl acetate copolymer was well-known
and available in the art as Kollidon® VA 64 (BASF). See
column 4, lines 37-42. Example 1 in column 6 uses Kollidon®
VA 64 (BASF) with an active ingredient.
(Id.).
ANALYSIS
Based on the cited teachings of the prior art (FF1–5), we determine
that the Examiner has made a prima facie showing that “it would have been
obvious to use the vinylpyrrolidone-vinylacetate (VP/VA) copolymer as a
crystallization inhibitor in a transdermal therapeutic system” (Ans. 3). We
have considered Appellant’s arguments, but are not persuaded otherwise.
As an initial matter, Appellant argues that “the grounds upon which
the requester requested reexamination in the first place were improper” and
that “substantively, all of the references relied on by the requester to allege
obviousness were of record during the prosecution of the parent application,
except Blank” (Br. 3). We are not persuaded. Appellant acknowledges that
Blank, which forms part of the basis for the obviousness rejection, was not
considered during the original prosecution. Appellant does not present any

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basis to conclude that the reference is cumulative to other prior art of
record.8
Appellant argues that Suzuki teaches away from a transdermal
therapeutic system (TTS) containing a crystallization inhibitor. Appellant
asserts that “[i]nstead Suzuki teaches to use the drug in an amount such that
it will not crystallize (see col. 5, lines 33-40)” (Br. 4–5). We are not
persuaded. We note that none of the claims, except claim 6, requires any
particular amount for the active ingredient. Moreover, the amount recited in
claim 6 (“0.1 to 10% by weight relative to the total weight of the matrix”) is
less than or within the general amounts taught by Suzuki to avoid
crystallization (FF1). Furthermore, Suzuki clearly teaches a drug delivery
device wherein PVP is added as a “drug dissolution aid” or “drug dissolution

8 Moreover, to the extent that Appellant intends to assert through this
argument that a substantial new question of patentability (SNQ) was not
raised for this ex parte reexamination proceeding, we note that Appellant has
not followed the appropriate procedure for raising that issue before the
Board, as set forth in 75 Fed. Reg. 36357–58 (June 25, 2010). According to
the Federal Register Notice:
In order to preserve the right to have the BPAI [now
PTAB] review of the SNQ issue, a patent owner must first
request reconsideration of the SNQ issue by the examiner.
Accordingly, for ex parte reexamination proceedings ordered
on or after June 25, 2010, the patent owner may seek a final
agency decision from the BPAI on the SNQ issue only if the
patent owner first requests reconsideration before the examiner
(e.g., in a patent owner’s statement under 37 CFR 1.530 or in a
patent owner’s response under 37 CFR 1.111) and then seeks
review of the examiner’s SNQ determination before the BPAI.

Id.
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auxiliary agent” (Ans. 7; FF1). Suzuki at most suggests that keeping the
active ingredient within certain levels will not require further crystallization
inhibitors, but does not criticize, discredit, or otherwise discourage the use of
crystallization inhibitors within the composition. We therefore do not
consider Suzuki to teach away from the claimed invention. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of
more than one alternative does not constitute a teaching away from any of
these alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed . . . .”).
Appellant argues that “Hoffmann provides no teaching related to a
vinylpyrrolidone-vinylacetate copolymer or the use of such a copolymer as a
crystallization inhibitor” (Br. 5). We disagree. Hoffman specifically teaches
that polyvinylpyrrolidone can serve as a crystallization inhibitor (FF2).
Based on the teachings of the other cited references (i.e., Blank, Ogasawara,
and Khanna) (FF3–5), the skilled artisan would have found it obvious to
copolymerize vinylpyrrolidone with vinyl acetate in order to improve upon
the crystallization inhibition properties. We thus consider the claimed
invention to be merely the “combination of known elements according to
their established functions,” without any showing that the combination
“yields more than predictable results.” Wm. Wrigley Jr. Co. v. Cadbury
Adams USA LLC, 683 F.3d 1356, 1362 (Fed. Cir. 2012) (citing Merck & Co.
v. Biocraft Labs., Inc., 874 F.2d 804, 808 (Fed.Cir.1989)).
We are also not persuaded by Appellant’s arguments that Blank,
Ogasawara, and Khanna do “not disclose a TTS of the type in Suzuki,
Hoffmann or the claimed invention” (Br. 5–7). It is sufficient for
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consideration of a reference that it is “reasonably pertinent to the particular
problem with which the inventor is involved.” In re Klein, 647 F.3d 1343,
1348 (Fed. Cir. 2011) (citation and internal quotation marks omitted). The
standard is met if the reference “is one which, because of the matter with
which it deals, logically would have commended itself to an inventor's
attention in considering his problem.” Id. (citation and internal quotation
marks omitted). In this case, there is nothing to suggest that the skilled
artisan would not have considered these references’ teachings of utilizing a
VP/VA copolymer to be reasonably pertinent to preventing crystallization of
the active ingredient in a TTS, such as that taught by Suzuki, Hoffmann, or
the claimed invention. Indeed, Hoffmann specifically teaches that
crystallization inhibition of the active ingredient utilizing PVP can be
important for a TTS (FF2). We therefore consider Blank, Ogasawara, and
Khanna to be analogous art and relevant to the obviousness inquiry.
In sum, the Examiner’s explanation provides sufficient factual basis
and technical reasoning to support a determination that the combination of
Suzuki, Hoffmann, Blank, Ogasawara, and Khanna renders obvious claims
1–10. Appellant has not rebutted the Examiner’s prima facie showing.
SUMMARY
We affirm the rejection of claims 1–10 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Suzuki, Hoffmann, Blank, Ogasawara,
and Khanna.

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TIME PERIOD FOR RESPONSE
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED

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