Ex Parte Selzer

Board of Patent Appeals and Interferences

Feb 28, 2007

10312417 (B.P.A.I. Feb. 28, 2007)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TORSTEN SELZER
__________

Appeal 2006-0760
Application 10/312,417
Technology Center 1600
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ON BRIEF
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Before MILLS, GREEN, and LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This appeal involves claims to a dermal therapeutic system for
delivery of a COX-2 inhibitor. The Examiner has rejected the claims as
anticipated and obvious over prior art. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in-part and reverse-in-part.
DISCUSSION
Claims 13-27, which are all the pending claims, are on appeal (Br. 3).
The claims are subject to two prior art rejections (Id. at 4). In the first
rejection, claims 13-19 are rejected under 35 U.S.C. § 102. In the second
rejection, claims 20-27 are rejected under 35 U.S.C. § 103. We focus on
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Application No. 10/312,417

claim 13 as representative of the first grouping. For the second grouping,
the claims stand or fall together because Appellant has not provided separate
arguments for patentability of any of the claims. We select claim 20 as
representative claim of the second grouping. 37 C.F.R. § 41.37(c)(1)(vii).

13. A dermal therapeutic system comprising as an active
pharmaceutical ingredient for the treatment of symptoms associated
with irritation from degenerative joint disorders and for the treatment
of postoperative and menstrual pain at least one COX-2 inhibitor,
characterized in that the COX-2 inhibitor is a 3-aryl-4-(4-
methylsulfonylphenyl)-2(H5) furanone or a 4-[5-aryl-3-
(trifluoromethylpyrazol- 1-yl]benzenesulfonamide.
20. A dermal therapeutic system for the delivery of a medical
substance to the skin, which consists of:
a) a support layer, which is impermeable to the medical substance;
b) a reservoir or matrix layer that contains the medical substance
wherein said medical substances consists of:
1. at least one COX-2 inhibitor wherein said COX-2 inhibitor is
selected from the group consisting of 3-aryl-4-(4-
methylsulfonylphenyl)-2(H5) furanones and 4-[5-aryl-3-
(trifluoromethylpyrazol-1-yl]benzenesulfonamides; and
2. optionally, at least one compounds selected from the group
consisting of a plasticizers, tackifiers, stabilizers, fillers, carrier
and permeation enhancer(s);
wherein, said permeation enhancer(s), when present, is (are) a
compound selected from the group consisting of fatty alcohols, fatty
acids, polyoxyethylene fatty alcohols ethers, sorbitan monolaurate,
long-chain fatty acids with methyl, ethyl or isopropyl alcohols, esters
of fatty alcohols with acetic or lactic acid, and oleic acid
diethanolamine, and
wherein, when a reservoir layer is present, said reservoir layer
optionally contains a high viscosity liquid, a semisolid matrix, a
thixotropic matrix, and/or a gel former;
c) optionally, a control membrane;
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d) a contact adhesive layer for attachment of the dermal therapeutic
system to the skin and which is optionally identical to the layer
containing the medical substance; and
e) a protective layer.

Anticipation under 35 U.S.C. § 102(e)
Claims 13-19 stand rejected under 35 U.S.C. § 102(e) as anticipated
by Levin.
Levin1 describes “cetyl myristoleate (CMO) and CMO compounds in
combination with other compounds useful for treating inflammatory
disease.” (Levin at 2, ll. 8-10.) Cox-2 inhibitors are listed by Levin in a
group of others compounds which can be combined with CMO (id. at 3, ll.
27-33). Levin states that “[c]ompositions of the invention can be
administered by a variety methods which are well known in the art. Routes
of administration include, but are not limited to oral, topical, sublingual,
rectal, intranasal, intraocular, intravenous, intramuscular, transdermal, and
by inhalation.” (Id. at 11, ll. 14-17.)
The Examiner asserts that Levin teaches the limitations recited in
claim 13.
Levin teaches compositions comprising COX-2 inhibitors
(NSAIDS) including celecoxib [its chemical name “4-[5-aryl-3-
(trifluoromethylpyrazol-1-yl]benzenesulfonamides” is recited in
claim 13] and rofecoxib [its chemical name “3-aryl-4-(4-
methylsulfonylphenyl)-2(H5) furanones” is recited in claim 13]
formulated in transdermal bandages or patches for topical
administration. (abstract, page 7, lines 7-9, page 11, lines 14-17,
page 12, lines 9-1, page 21, claim 42).
(Answer 4.)

1 Levin, WO 01/41783 A1, published Jun. 14, 2001.
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Appellant argues that “Levin contains no examples which clearly,
unequivocally and simultaneously contain all of the requisite elements of the
Appellant’s claimed invention, i.e. (1) being a dermal system and (2)
containing” celecoxib and rofecoxib (Br. 5). He acknowledges that “specific
examples may not be necessary to establish anticipation,” but (citing In re
Petering, 301 F.2d 676, 133 USPQ 275, 278 (CCPA 1962) argues that “this
is generally limited to situations where the scope of the embodiments of the
inventions are so few in number such that one of ordinary skill in the art
could envisage every embodiment of the invention.” (Br. 5.) Because of the
generality of Levin’s disclosure, he urges that selection of two specific
COX-2 inhibitors for transdermal delivery as recited in claim 13 would have
required “one of ordinary skill in the art . . . to resort to the type of picking
and choosing which is precluded” in a rejection based on anticipation (Br.
7).
An anticipating “reference must describe and enable the claimed
invention, including all claim limitations, with sufficient clarity and detail to
establish that the subject matter already existed in the prior art and that its
existence was recognized by persons of ordinary skill in the field of the
invention.” Crown Operations International, Ltd. v. Solutia Inc., 289 F.3d
1367, 1375, 62 USPQ2d 1917, 1921 (Fed. Cir. 2002); In re Spada, 911 F.2d
705, 708, 15 USPQ2d 1655, 1657 (Fed. Cir. 1990) (“the reference must
describe the applicant's claimed invention sufficiently to have placed a
person of ordinary skill in the field of the invention in possession of it”).
Transdermal and topical delivery are listed by Levin among ten
different routes of administration for its compositions (at 11, pp. 15-17).
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However, topical administration is specifically disclosed by Levin for
tetracycline components, proteases, steroids, and topical antibiotics, but not
for Cox-2 inhibitors (Levin at 10, ll. 28-30; 20 (cl. 33); 21 (cl. 43); 23 (cl.
55)). In anticipation cases based on the disclosure of a genus, a “pattern of
preferences” had been found that narrowed the generic formula to limited
class of compounds which included anticipatory species. See In re Petering,
301 F.2d 676, 681, 133 USPQ 275, 279 (CCPA 1962); In re Schaumann,
572 F.2d 312, 315, 197 USPQ 5, 8 (CCPA 1978); Sanofi-Synthelabo v.
Apotex Inc., 470 F.3d 1368, 1377, 81 USPQ2d 1097, 1102-03 (Fed. Cir.
2006). In this case, there is no clear “pattern of preferences” that would
serve to narrow Levin’s generic disclosure to the specific embodiment in
which a Cox-2 inhibitor is administered by topical administration.2 The
Examiner has not provided sufficient evidence to establish that the skilled
worker would have recognized in Levin a “dermal therapeutic system” for
delivery of a Cox-2 inhibitor. Because the Examiner’s burden to establish a
case of prima facie anticipation has not been met, we reverse the rejection of
claims 13-19.

2 The Examiner presumed that Levin’s “topical” administration is a
disclosure of a dermal therapeutic system as required by claim 13.
Appellant do not challenge this presumption, and we adopt it here for the
purpose of this discussion.
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Obviousness under 35 U.S.C. § 103
Claims 20-27 stand rejected under 35 U.S.C. § 103(c) as obvious over
Levin in view of Lee. 3
Claim 20 is drawn to a dermal therapeutic system that consists of a) a
support layer which is impermeable to the Cox-2 inhibitor, celecoxib or
rofecoxib; b) a reservoir or matrix layer that contains the Cox-2 inhibitor; c)
optionally a control membrane; d) a contact adhesive layer to attach the
dermal therapeutic system to the skin; and e) a protective layer. According
to the Examiner, the only difference between the claimed subject matter and
Levin is that Levin does not describe the specific elements a) through e) of
the dermal therapeutic system recited in claim 20 (Answer 6). However, the
Examiner states that Lee teaches a drug delivery device for administering
NSAIDS that comprises the elements required by claim 20 (id.). The
Examiner concludes:
It would have been obvious to one of ordinary skill in the art to
formulate the COX-2 inhibitors including celecoxib and
rofecoxib (NSAIDS) in a transdermal delivery device taught by
Lee et al. because [the] transdermal device . . . delivers any
NSAIDS in general to treat pain and . . . [increase] compliance
for the user. One would have been motivated to formulate
COX-2 inhibitor in [a] transdermal delivery system taught by
Lee et al. in order to successfully treat patients suffering from
pain and to increase the compliance.
(Id.)
Appellant does not challenge the Examiner’s finding that Lee teaches
a dermal therapeutic system that contains the same elements which are
recited in claim 20. However, he argues that the phrase “consists of” recited

3 Lee et al. (Lee), U.S. Pat. No. 5,284,660, issued Feb. 8, 1994.
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in claim 20 excludes the presence of CMO (Br. 8-9). “Given that CMO is a
critical element of Levin's invention, there is no motivation or suggestion to
remove this critical element from Levin's composition nor is there any
reasonable expectation of success that Levin’s invention would be
practicable without the presence of CMO.” (Id. at 9.)
Appellant also argues that Example 3 of Levin is a “teaching away”
from using a Cox-2 inhibitor in the absence of CMO. He asserts that,
without CMO, it was necessary to increase the doses “to two to three times
the initial dose in order to maintain adequate symptomatic relief.” (Br. 10.)
At these dosages, side effects, including “dizziness, nausea and abdominal
pain” were observed. (Id.) The addition of CMO permitted the doses to be
decreased to their initial levels. (Id.)
Finally, Appellant asserts that Lee does not teach or suggest the use of
Cox-2 inhibitors alone for transdermal administration. Br. 10. “Lee offers
no additional insight into Levin’s problems with the use of COX-2 inhibitors
alone and are directed toward transdermal delivery of nicotine and
melatonin, two drugs which differ greatly both structurally and functionally
from the compounds used by Levin.” (Br. 10-11.)
After considering the record before, it is our opinion that there is
sufficient evidence to establish that the subject matter recited in claim 20 is
obvious. As indicated by the Examiner, Lee generally teaches that any
NSAID can be administered transdermally (Answer 5). Lee at col. 8, ll. 3.
Because celecoxib and rofecoxib are known NSAIDS, their administration
via a transdermal delivery device is merely following Lee’s suggestion.
While Lee does not explicitly disclose celecoxib and rofecoxib, a reference
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must be “considered in its entirety for what it fairly suggests to one skilled in
the art.” In re Hedges, 783 F.2d 1038, 1039, 228 USPQ 685, 687 (Fed. Cir.
1986). We find that Lee’s teaching that an NSAID can be administered by
its drug delivery device “fairly suggests” that any NSAID can be used,
including celecoxib and rofecoxib, which are known NSAIDS.
In reaching an obviousness determination, it is necessary to identify
the differences between the claimed invention and the prior art, and then to
determine whether these differences are obvious in view of the scope and
content of the prior art and the level of skill in the pertinent art. Graham v.
John Deere Co., 383 U.S. 1, 13-14, 148 USPQ 459, 465 (1966). Lee’s
broad disclosure of agents which can be administered by its transdermal
delivery device, including seven broad classes of agents (painkillers,
steroidal anti-inflammatory drugs, NSAIDS, cardiovascular drugs, beta
blockers, vasodilators and ACE inhibitors) and many additional examples of
specific agents (e.g., nicotine, caffeine, and melatonin) establish that
choosing a particular agent to administer by Lee’s device is within the level
of ordinary skill in the art. Because the only difference between the subject
matter of claims 20-27 and the prior art is the choice of a known NSAID,
celecoxib and rofecoxib, for Lee’s delivery device, its selection would have
been obvious to the person of ordinary skill in the art in view of Lee’s
explicit disclosure that its device is useful for administering NSAIDS.4
(Col. 7, l. 55 to col. 8, l. 3.) In the absence of secondary considerations,

4 This same reasoning appears applicable to the subject matter of claims 13-
19. Upon return of this application to the technology center, the Examiner
should consider whether it is appropriate to reject claims 13-19 under this
same grounds of rejection.
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patents are not granted for merely following the suggestion of the prior art in
a manner commensurate with the level of ordinary skill in the art.
Appellant argues that there was no motivation to have excluded CMO
from Levin’s delivery device (Br. 9). We are not persuaded. Appellant’s
own evidence establishes that both celecoxib and rofecoxib are administered
in the prior art alone, without CMO. (See Exhibits 1 and 2.) As pointed out
by the Examiner (Answer 9), Example 3, which Appellant relies on for his
“teaching away” theory, includes doxycycline in addition to a Cox-2 agent
(Levin at 14, ll. 20). Consequently, it is not clear whether the side effects
are due to the Cox-2 agent, its combination with doxycycline, or the
doxycycline alone.
Appellant also urges that Lee does not teach or suggest administering
Cox-2 inhibitors because its disclosure is directed to the delivery of nicotine
and melatonin, which differ “structurally and functionally” from Levin’s
compounds (Br. 10-11.) We disagree with Appellant’s characterization of
Lee’s disclosure. Lee’s specific working examples show delivery of
nicotine and melatonin (cols. 9 to 11), but its disclosure suggests numerous
other therapeutic agents (col. 7, l. 60 to col. 8, l. 22) that may be
administered in his transdermal delivery device. In evaluating the scope and
content of the prior art, “[a]ll the disclosures in a reference must be
evaluated . . . a reference is not limited to the disclosure of specific working
examples.” In re Mills, 470 F.2d 649, 651, 176 USPQ 196, 198 (CCPA
1972). The structural diversity of agents5 described by Lee as useful for

5 For example: nicotine, melatonin, steroids, and non-steroids. Col. 7, l. 62
to col. 8, l. 14.
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transdermal administration suggests, contrary to Appellant’s argument, that
the person of ordinary skill in the art would have reasonably believed that
transdermal delivery was not limited by a compound’s structure.
For the foregoing reasons, we affirm the rejection of claim 20 as
obvious over Levin in view of Lee. Because claims 21-27 were not
separately argued, they fall with claim 20.
OTHER ISSUES
PCT International Publication WO 00/00120 was cited in an
Information Disclosure Statement filed December 23, 2002. It is in the same
patent family as the Murdock6 patent, having a filing date of at least Jun. 29,
1999, which is earlier than the filing date of the instant application.
Murdock discloses a transdermal composition which comprises a non-
steroidal anti-inflammatory compound. Celecoxib and Vioxx® are
specifically mentioned (Col. 2, ll. 48-54; col. 8, ll. 44-47). In Example 73,
celecoxib is formulated with solvents and carriers as a gel for transdermal
use (Col. 31, ll. 40-45). The Examiner should consider whether this
example (and/or other disclosure in Murdock) anticipates and/or makes
obvious the subject matter of claim 13 (and other pending claims), alone, or
in combination with other prior art.
We also draw the Examiner’s to U.S. Pat. 5,466,8237 which discloses
celecoxib, a compound of Formula I (Col. 4, ll. 64-65). The patent discloses
that Formula I compounds can be administered topically (Col 47, l. 24). The
Examiner should consider whether this disclosure anticipates and/or makes

6 Murdock et al., U.S. Patent 6,479,074 B2, issued Nov. 12, 2002.
7 Talley et al. U.S. Patent 5,466,823, issued Nov. 14, 1995.
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obvious the subject matter of claim 13 (and other pending claims), alone, or
in combination with other prior art.

TIME PERIOD
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-IN-PART/REVERSED-IN-PART

DEMETRA J. MILLS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
LORA M. GREEN )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
RICHARD M. LEBOVITZ )
Administrative Patent Judge )

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Appeal No. 2006-0760
Application No. 10/312,417

WILLIAM F LAWRENCE
FROMMER LAWRENCE & HAUG
745 FIFTH AVENUE
NEW YORK, NY 10151

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