Ex parte Okabe et al.

Board of Patent Appeals and Interferences

Aug 29, 1997

07929044 (B.P.A.I. Aug. 29, 1997)

Application for patent filed August 13, 1992.1
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written
for publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 15
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte HIDEAKI OKABE, ICHIRO
TSUCHIDA and TAKANORI SAITO
_____________
Appeal No. 94-3575
Application 07/929,0441
______________
ON BRIEF
_______________
Before WINTERS and WILLIAM F. SMITH, Administrative Patent Judges
and McKELVEY, Senior Administrative Patent Judge.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner’s decision finally
rejecting claims 1 through 22, which are all of the claims in the
application.
Appeal No. 94-3575
Application 07/929,044
2
REPRESENTATIVE CLAIM
Claim 1, which is illustrative of the subject matter on
appeal reads as follows:
1. In a transdermal therapeutic adhesive composition
comprising an adhesive layer containing a pharmacologically
active agent and adapted to adhere the composition to the skin,
the improvement wherein the adhesion of the composition to the
skin is provided by a polymer having lipophilic monomer units and
hydrophilic monomer units in a weight ratio in the range from
98:2 to 0:100, wherein the composition has an adhesive strength
of at least 25 g/12 mm and wherein the composition comprises 5 to
100 weight parts of a C -C alcohol, 0 to 50 weight parts of a2 3
percutaneous absorption promoter and 10 to 40 weight parts of
water, respectively based on 100 weight parts of the polymer.
THE REFERENCES
The prior art references relied on by the examiner are:
Song et al. (Song) 4,789,547 Dec. 6, 1988
Petereit et al. (Petereit) 5,133,970 Jul. 28, 1992
Sablotsky et al. (Sablotsky) 5,186,938 Feb. 16, 1993
THE ISSUES
The issues presented for review are:
(1) Whether the examiner erred in finally rejecting claims 1
through 9, 11 through 19, 21, and 22 under 35 USC § 103 as
Appeal No. 94-3575
Application 07/929,044
3
unpatentable over the combined disclosures of Sablotsky and
Petereit; and
(2) Whether the examiner erred in finally rejecting claims
10 and 20 under 35 USC § 103 as unpatentable over the combined
disclosures of Sablotsky, Petereit, and Song.
DELIBERATIONS
Our deliberations in this matter have included evaluation
and review of the following materials:
(1) The instant specification, including all of the claims
on appeal;
(2) Appellants’ main Brief and Reply Brief before the Board;
(3) The Examiner’s Answer and the communication mailed by
the examiner September 13, 1994; and
(4) The above-cited references relied on by the examiner.
On consideration of the record, including the above-listed
materials, we reverse the examiner’s prior art rejections.
DISCUSSION
As recited in independent claim 1, appellants’ transdermal
therapeutic formulation contains 5 to 100 weight parts of a C -C2 3
Appeal No. 94-3575
Application 07/929,044
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alcohol based on 100 weight parts of polymer. In our judgment,
the prior art relied on by the examiner is insufficient to
support a conclusion of obviousness of claims containing that
limitation.
First, the examiner relies on Sablotsky’s disclosure of
“about 9% methanol” in column 6, lines 52 and 53. That
disclosure, however, relates to the amount of methanol in the
cross-linking agent, which is present in an amount of 0.2 to
about 1% by weight based on the total weight of Sablotsky’s first
component layer. See Sablotsky, column 6, lines 27 through 29.
The examiner’s reliance on this portion of Sablotsky is
misplaced, because Sablotsky does not disclose or suggest 5 to
100 weight parts of methanol based on 100 weight parts of polymer
as recited in independent claim 1. As correctly argued by
appellants in their Brief before the Board, page 5, footnote 1,
the amount of methanol disclosed by Sablotsky is well below the
amount of alcohol required by the appealed claims. Furthermore,
methanol is not a C -C alcohol.2 3
Second, the examiner relies on Sablotsky’s disclosure of a
sequence of steps for producing a bilayer transdermal dosage
system. Specifically, the examiner refers to column 10, lines 4
Appeal No. 94-3575
Application 07/929,044
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through 13, disclosing the use of ethanol. According to the
examiner, Sablotsky discloses removing 85 to 95% of the ethanol
(column 10, lines 11 through 13), and thus implies retaining 5 to
15% which meets the terms of the claims. See the Examiner’s
Answer, page 3, first paragraph, and page 5, lines 1 through 4.
As correctly pointed out by appellants, however, Sablotsky’s
multi-step method is not complete until the cross-linked adhesive
containing pharmaceutically active drug is transferred to a
coating station. There, Sablotsky discloses a heating means to
remove water and/or solvents which may have been included in the
mixing procedure; and
(11) after the heating is completed and the
solvents are removed, the first component
layer will be firmly adhered to the second
component layer and the system can be wound
into rolls for storage.
See Sablotsky, column 9, lines 20 through 27. Considering the
Sablotsky patent in its entirety, we agree with appellants that
(1) Sablotsky discloses removing ethanol in the coating station,
and (2) the examiner’s reliance on Sablotsky’s interim step of
removing only 85 to 95% ethanol (column 10, lines 11 through 13)
is misplaced. Appellants argue this point strenuously in their
Reply Brief, pages 1 and 2. In response, the examiner states
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Application 07/929,044
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only that “[t]he reply brief filed August 29, 1994 has been
entered and considered but no further response by the Examiner is
deemed necessary”.
The examiner does not rely on any disclosure in Petereit or
Song, and we find none, which would compensate for the above-
noted deficiencies in Sablotsky. Again, the combined disclosures
of Sablotsky, Petereit, and Song are insufficient to support a
conclusion of obviousness of claims requiring 5 to 100 weight
parts of a C -C alcohol based on 100 weight parts of the2 3
polymer.
We further note the examiner’s statement that “Sablotsky
does not disclose the presence of a lipophilic monomer unit”.
See the Examiner’s Answer, page 3, first paragraph. In this
regard, independent claim 1 recites “a polymer having lipophilic
monomer units and hydrophilic monomer units in a weight ratio in
the range from 98:2 to 0:100", i.e., claim 1 does not require
lipophilic monomer units. Furthermore, the examiner’s statement
is factually incorrect because Sablotsky discloses adhesives
containing about 5 to about 20% by weight of a C to C alkyl4 12
acrylate. See Sablotsky, column 5, lines 52 through 59. Compare
the instant specification, page 5, last paragraph, disclosing
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Application 07/929,044
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that preferred examples of the lipophilic monomer from which the
lipophilic monomer units are derived are acrylic ester monomers,
such as esters of acrylic acid or methacrylic acid with an
alcohol having 1 to 14 carbon atoms. The examiner’s position to
the contrary, notwithstanding, Sablotsky discloses lipophilic
monomer units.
The examiner’s rejections under 35 USC § 103 are reversed.
REVERSED
)
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
WILLIAM F. SMITH )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
Appeal No. 94-3575
Application 07/929,044
8
)
FRED E. McKELVEY, Senior )
Administrative Patent Judge )
MILLEN, WHITE, ZELANO & BRANIGAN
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