Ex Parte Breitenbach et al

Patent Trial and Appeal Board

Aug 30, 2013

10523908 (P.T.A.B. Aug. 30, 2013)

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.
10/523,908 01/28/2005 Armin Breitenbach 6102-000075/US/NP 9463
28997 7590 08/30/2013
HARNESS, DICKEY, & PIERCE, P.L.C
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
08/30/2013 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 ARMIN BREITENBACH and HANS-MICHAEL WOLFF
__________

Appeal 2012-001100
Application 10/523,908
Technology Center 1600
__________

Before LORA M. GREEN, ERICA A. FRANKLIN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This appeal1 under 35 U.S.C. § 134 involves claims related to a
transdermal therapeutic system. The Examiner entered rejections under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellants identify the Real Party in Interest as UCB Pharma GmbH.
(App. Br. 3.)
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STATEMENT OF THE CASE
Claims 28-36 and 41 are on appeal. Claim 28 is the only independent
claim on appeal. The dependent claims have not been argued separately and
therefore stand or fall together with the independent claim from which they
depend. 37 C.F.R. § 41.37(c)(1)(vii). Claim 28 is representative and reads
as follows:
28. A transdermal therapeutic system comprising a drug-
containing adhesive matrix, wherein the drug-containing
adhesive matrix comprises:
rotigotine free-base and
hot-meltable adhesive,
wherein the drug-containing adhesive matrix exhibits at
160°C a dynamic viscosity of not more than 100 Pa·s.

The claims stand rejected as follows:
I. Claims 28-32, 34-36 and 41 under 35 U.S.C. § 103(a) over the
combination of Ulman et al. (US 5,658,975, issued Aug. 19, 1997)
and Müller (US 6,620,429 B1, issued Sep. 16, 2003).
II. Claims 28 and 33 under 35 U.S.C. § 103(a) over the combination
of Ulman, Müller, and Noel (US Re. 36,754, issued Jun. 27, 2000).

The Examiner has also provisionally rejected claims 28-36 and 41
under the judicially-created doctrine of obviousness-type double patenting as
being unpatentable over claims 1-23 of co-pending Application No.
10/630,633 (see, e.g., App. Br 20). Appellants have not traversed the merits
of this rejection. We therefore summarily affirm it. See MANUAL OF PATENT
EXAMINING PROCEDURE § 1205.02 (“If a ground of rejection stated by the
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examiner is not addressed in the appellant’s brief, that ground of rejection
will be summarily sustained by the Board.”).

OPINION
REJECTION I.—OBVIOUSNESS OVER ULMAN AND MÜLLER
Issue
The Examiner rejected claims 28-32, 34-36 and 41 under 35 U.S.C. §
103(a) over the combination of Ulman and Müller. The Examiner finds that
“Ulman explains that a transdermal therapeutic system in the form of a hot-
melt adhesive and a softener is beneficial because, ‘. . . the amount of drug
released can be increased or controlled’” (Ans. 10, quoting Ulman at col. 1,
line 67 - col. 2, line 1.) “Ulman differs from the instant application in that it
does not disclose the rotigotine in base form . . .” (id. at 7). The Examiner
cites to Müller “for the limited teaching of rotigotine in a transdermal
formulation; i.e., transdermal delivery of rotigotine was known in the art at
the time the instant application was filed” (id. at 10).
The issue presented is: Does the evidence of record support the
Examiner’s finding that the combined cited prior art renders claim 28
obvious?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF1. The Specification discloses “a transdermal therapeutic system
(TTS) which contains a rotigotine-containing adhesive layer and is
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characterized by the fact that the adhesive layer contains a hot-meltable
contact adhesive” (Specification, abstract).
FF2. The Specification discloses as follows:
Suitable silicones include all of the silicone adhesives
employed in adhesive-patch technology. . . . The particularly
preferred adhesives include condensates or mixtures of silicone
resins and polyorganosiloxanes . . . .
(Id. at 15.)
FF3. The Specification discloses that
[T]he inventors were surprised to find that the Rotigotine, being
susceptible to oxidation, remains stable in the hot-melt process
even when heated to temperatures around 160° C. While at
higher temperatures in an oxygen-containing atmosphere,
Rotigotine tends to decompose in oxidative fashion, it is
amazingly stable in the hot adhesive melt and is present in the
matrix at a purity level that is routinely better than 98% and
generally over 99%.

(Id. at 8.)
FF4. The “hot-melt process” is described in the Specification as
follows: “The Rotigotine is introduced in a solvent-free melt that is
preferably heated to 100-170° C, desirably to 120-160° C and ideally to 130-
150° C, and then processed and cooled within 5 minutes, preferably within 3
minutes and ideally within a maximum of 1 minute after the admixture of
the Rotigotine” (id. at 11).
FF5. Ulman discloses that
The hot-melt silicone pressure sensitive adhesives of the
instant invention are comprised of a silicone pressure sensitive
adhesive selected from the group consisting of a mixture of (i) a
silicone resin and (ii) a silicone fluid and a condensed product
of (i) and (ii); the silicone pressure sensitive adhesive exhibiting
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tackiness and adhesiveness; the silicone pressure sensitive
adhesive being blended with (iii) from about 1 to 20 weight
percent, based on the total weight of (i) and (ii), of a siloxylated
polyether wax.

(Ulman, col. 2, ll. 18-26).
FF6. “Component (i) of the instant invention may be further
described as being a soluble, hydroxyl-functional organopolysiloxane resin .
. . .” (id. at col. 2, ll. 43-44).
FF7. Müller discloses transdermal therapeutic systems containing
active substances in their free base form (see, e.g., Müller at col. 1, ll. 20-
28). Rotigotine ((-)-5,6,7,8-tetrahydro-6-[propyl[2-(2-thienyl)-ethyl]amino
]-1-naphthol hydrochloride) is disclosed as an example and prepared as a
patch matrix (id. at col. 3 and 4, Example 1 and 2).
Principles of Law
“[A] patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007).
However, a prima facie conclusion of obviousness may be supported by a
showing that a combination of familiar elements according to known
methods yields no more than predictable results. Id. at 401; citing United
States v. Adams, 383 U.S. 39, 50-52 (1966). Furthermore, the Supreme
Court has emphasized that “the [obviousness] analysis need not seek out
precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” Id. at 418. “If a person of
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ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
We adopt the Examiner’s fact finding and rationale as our own. The
evidence on this record supports the Examiner’s finding that the
combination of references teaches all elements of the claims. The Examiner
has presented a sound rationale as to why a person of ordinary skill in the art
would have modified the hot-melt silicone pressure sensitive adhesives of
Ulman with the teachings of Müller, disclosing a transdermal system
comprising rotigotine free-base, to arrive at the claim composition. Having
done so, the burden shifted to Appellants to provide evidence that the
claimed combination of known elements would do more than yield
predictable results, KSR, 550 U.S. at 416 (2007), or that the compositions in
the prior art did not possess the claimed properties. Appellants have not met
this burden, as is further explained herein below.
Appellants’ Dynamic Viscosity Limitation
Appellants contend that “Ulman and Muller, singly or in combination,
do not teach (1) the adhesive matrix exhibiting at 160°C a dynamic viscosity
of not more than 100 Pa·s” (App. Br. 10). The Examiner, however, finds
that Ulman’s composition to be the same or substantially the same as the
adhesive matrix set forth in the claims, and thus would possess the same or
substantially the same properties (see Ans. 10). We do not find any
evidence of record to support a finding that any addition of rotigotine free-
base, the element for which Müller is relied upon, to Ulman’s composition
would alter the properties of Ulman’s composition.
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Appellants’ Teaching Away Argument
One “may rebut a prima facie case of obviousness by showing that the
prior art teaches away from the claimed invention in any material respect.”
In re Peterson, 315 F.3d 1325, 1331 (Fed. Cir. 2003); citing In re Geisler,
116 F.3d 1465, 1469 (Fed. Cir. 1997). However, for a reference to teach
away, it must state more than a general preference for an alternative
invention. It must ‘“criticize, discredit, or otherwise discourage”’
investigation into the invention claimed. DePuy Spine, Inc. v. Medtronic
Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009), quoting In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Here, Appellants argue that
“Ulman’s express utility to ‘increase’ hydrophilic drugs” amounts to a
teaching away (App. Br. 13). Appellants further argue that “[b]ased on this
motivation, one of ordinary skill in the art would follow Ulman for improved
hydrophilic drug performance and would consider Ulman unfit for use with
rotigotine free-base” due to the lipophilic nature of rotigotine free-base (id.).
We are not persuaded. As noted by the Examiner, “while the Ulman
composition may teach hydrophilic drugs as a preferred embodiment, the
reference does not implicitly or explicitly suggest that hydrophilic drugs are
used with the disclosed composition exclusively” (Ans. 14). Ulman is silent
with respect to lipophilic drugs. However, silence as to a feature of the
claims is not a teaching away. DyStar Textilfarben GmbH v. C.H. Patrick
Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006) (“We will not read into a
reference a teaching away from a process where no such language exists.”).
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Appellants’ Drug Concentration Argument
Appellants argue that “[d]rug concentration is a critical factor in a
TTS system because high level of drug concentration is needed for adequate
delivery. However, no method was known to attain this goal when
rotigotine is used.” (App. Br. 12.) We are not persuaded. We note that
claim 28 does not include a recitation of a drug concentration.
Appellants’ No Reasonable Expectation Of Success Argument
Appellants argue that there is no reasonable expectation of success
because 1) “a solvent-based system described in Müller was not expected to
be useful for making the claimed TTS system because the solvent-based
system can be charged with a low-level of rotigotine” (App. Br. 16) and 2)
“the assertion that ‘[U]lman does not preclude use of lipophilic drugs in the
disclosed adhesive composition’ does not amount to a reasonable
expectation that rotigotine free-base would be successful in the hydrophilic
composition of Ulman’” (id. at 17).
We are not persuaded. As noted by the Examiner, “the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art” (Ans. 12-13, citing In re Keller, 642 F.2d 413, 425
(CCPA 1981)). The Examiner finds “that a person of ordinary skill in the art
knowing the benefits of Ulman’s hot-melt adhesive would be motivated to
add rotigotine to such an adhesive so that the amount of rotigotine released
in a transdermal formulation may be increased or controlled” (id. at 13). We
find no evidence of record suggesting that a person of ordinary skill in the
art would have expected the device suggested by the combination of
references incapable of operating in the manner set forth by the Examiner.
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Unexpected Results
A case of prima facie obviousness can be rebutted with a showing of
unexpected results. In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). Here,
Appellants contend that “rotigotine was known to be susceptible to
oxidation” and “[t]herefore, it was surprising to find that rotigotine remains
stable even when heated to temperatures around 160°C” (App. Br. 18; see
also, App. Br. 11-12 (“Rotigotine is known to be lipophilic and thermally
unstable at temperatures above 25°C and prone to oxidative damage at those
temperatures. Based on this, one would expect that hot-melt process for
preparing a hot-melt TTS of rotigotine to fail, because the rotigotine active
would be destroyed in the process of making the TTS.”)).
As noted by the Examiner, “Appellants have not provided any data or
evidence to substantiate their claims” (Ans. 12). “It is well settled that
unexpected results must be established by factual evidence. Mere argument
or conclusory statements in the specification does not suffice.” In re De
Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984); see also In re Wood, 582 F.2d
638, 642 (CCPA 1978) (“Mere lawyer’s arguments and conclusory
statements in the specification, unsupported by objective evidence, are
insufficient to establish unexpected results.”); In re Lindner, 457 F.2d 506,
508 (CCPA 1972) (“[M]ere conclusory statements in the specification . . .
are entitled to little weight when the Patent Office questions the efficacy of
those statements.”). We likewise find the unsupported statements in the
Specification to be insufficiently supported by evidence.
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Conclusion of Law
The evidence of record supports the Examiner’s finding that the
combined cited prior art renders claim 28 obvious. Claims 29-32, 34-36 and
41 fall with claim 28. 37 C.F.R. § 41.37(c)(1)(vii).

REJECTION II.—OBVIOUSNESS OVER ULMAN, MÜLLER AND
NOEL
Appellants argue that claims 28 and 33 are non-obvious over the
combination of Ulman, Müller, and Noel without providing additional
argument or evidence (see App. Br. 19-20). Thus, for the same reasons
discussed in the section above, Appellants’ arguments do not persuade us
that the Examiner has erred in concluding that claims 28 and 33 are obvious
over Ulman, Müller, and Noel.
SUMMARY
We affirm all rejections on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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