Ex Parte Studin

Board of Patent Appeals and Interferences

Sep 22, 2010

10829316 (B.P.A.I. Sep. 22, 2010)

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.
10/829,316 04/21/2004 Joel R. Studin SDF 04-14 5671
7590 09/22/2010
Stuart D. Frenkel
Suite 330
3975 University Drive
Fairfax, VA 22030
EXAMINER
SHEIKH, HUMERA N
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
09/22/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOEL R. STUDIN
__________

Appeal 2009-0136241
Application 10/829,316
Technology Center 1600
__________

Before CAROL A. SPIEGEL, TONI R. SCHEINER, and STEPHEN WALSH,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL2
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-16 and 30-32 on the ground of obviousness. We have jurisdiction
under 35 U.S.C. § 6(b).

1 Heard September 16, 2010.
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-013624
Application 10/829,316

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STATEMENT OF THE CASE
Claims 1, 30 and 31 are representative of the subject matter on appeal:
1. A method of treating healed wounds so as to reduce scarring
and/or improve the appearance of scars comprises; applying onto a healed
wound a composition comprising a fluid, film-forming carrier, and
subsequently hardening the carrier into a tangible membrane juxtaposed to
the healed wound thereby reducing scarring or improving the appearance
thereof.

30. A method of treating healed wounds so as to reduce scarring
and/or improve the appearance of scars comprises: applying onto a healed
wound a topical composition comprising collagenase.

31. The method of claim 30, wherein said topical composition
comprises collagenase contained within a fluid, film-forming carrier,
subsequent to applying said composition onto said healed wound, hardening
said carrier into a tanglible membrane juxtaposed to the healed wound.

Claims 1-16 and 30-32 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Youssefyeh3 and Lee.4
In addition, claims 1-16 and 30-32 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Mantelle5 and Lee.
We reverse.
FINDINGS OF FACT
1. Youssefyeh discloses a method and topical composition for
“reducing inflammation that triggers the onset of rheumatic diseases,
eczema, urticaria, psoriasis, erythema multiforme and lichen planus;

3 U.S. Patent 5,968,519, issued October 19, 1999 to Youssefyeh et al.
4 U.S. Patent 5,552,162, issued September 3, 1996 to Lee.
5 U.S. Patent 5,446,070, issued August 29, 1995 to Mantelle.
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3
inflammation of the gums, and chronic localized body pain derived from
acute injury” (Youssefyeh, col. 1, ll. 13-16).
2. Youssefyeh’s topical composition comprises “finely divided
powder of safflower seed” in “a water-penetrable bag or container to be used
in water, ointments, creams, lotions, solutions, dressings and patches, slow-
release preparations and film-forming preparations” (Youssefyeh, col. 13, ll.
64-65; col. 14, ll. 22-25). The composition may further comprise anti-
inflammatory analgesics and corticosteroids (id. at col. 14, ll. 28-40).
3. Mantelle discloses “a method for the topical administration of
an anesthetic agent or a combination of anesthetic agents to prevent or
ameliorate pain” (Mantelle, col. 1, ll. 24-27). In addition, Mantelle discloses
that any one of thousands of pharmaceutically active agents, including
collagenase, can be substituted for the anesthetic agent (id., at col. 23, ll. 33-
36; col. 38, l. 4).
4. Mantelle teaches that “the incorporation of one or more
anesthetic agents in a solvent for the anesthetic agent into a flexible, finite,
pharmaceutically acceptable carrier, permits an exceptionally high loading
of anesthetic agent in the carrier, permitting more rapid delivery of the
anesthetic agent to the tissue” (Mantelle, col. 3, ll. 47-52).
5. According to Mantelle, “finite carriers” are “non-spreading
substances which retain their form, e.g. patches, dressings and bandages”
(Mantelle, col. 1, ll. 54-56).
6. Lee discloses “a method for improving the size and appearance
of a scar by stimulating collagenase activity in the scar[,]” particularly “scars
associated with a fibromatosis, keloid, or a hypertrophic wound healing
disorder” (Lee, col. 6, ll. 11-16).
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7. Lee’s method is “based upon creating a set of conditions which
are effective in bringing about an increase in the activity of the protease
enzymes which occur naturally in human fibroblast scar tissue” (Lee, col. 8,
ll. 6-9). Specifically, Lee’s method stimulates endogenous collagenase
activity “by elevating the surface temperature of the scar from about 0.5°C
to about 5°C . . . by covering the scar with a thermal insulating material”
such as a hydrogel (id. at col. 6, ll. 22-33).
DISCUSSION
Obviousness over Youssefyeh and Lee
The Examiner finds that Youssefyeh “explicitly teaches methods for
treating inflammatory dermal conditions, both acute and chronic” (Ans. 5),
thus, “[t]he methods of treatment and conditions to be treated as taught by
Youssefyeh would include application upon healed wounds so as to reduce
scarring and/or improve the appearance thereof” (id. at 6). In addition, the
Examiner finds that “collagenase is provided in [Lee’s] composition in order
for the effective breakdown and degradation of collagen” (id.). Based at
least in part on these findings, the Examiner concludes that “[i]t would have
been obvious to one of ordinary skill in the art . . . to provide for methods for
treating scars, such as hypertrophic scars such as taught by Lee within the
methods of Youssefyeh” (id.).
Appellant contends that “the treatment of inflammation and pain
associated with inflammatory dermatoses, gingivitis and acute injury, as
taught and disclosed in Youssefyeh et al., is not the same as treating healed
wounds so as to reduce scarring and/or improve the appearance of scars, as
presently claimed” (App. Br. 4-5 (emphasis omitted)). Appellant contends
“[t]here is simply no indication whatsoever in Youssefyeh et al. that the
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composition disclosed therein can be used to treat healed wounds to reduce
scarring or improve the appearance of scars” (id. at 7 (emphasis omitted)),
thus “[t]here is simply no reason to combine elements of the composition
disclosed in Youssefyeh . . . with elements of . . . Lee” (id. (emphasis
omitted)). Moreover, with respect to claims 30-32, Appellant contends
“there is no mention or suggestion whatsoever in Lee of including
collagenase in a composition for treating and/or reducing scarring, as
presently claimed” (id. at 9).
Given these conflicting positions, the principle issue raised by this
appeal is whether the Examiner’s conclusion is based on an interpretation of
the references that is not supported by the record. If so, the succeeding issue
is whether the Examiner has otherwise established that it would have been
obvious for one of ordinary skill in the art to apply a fluid, film-forming
carrier to a healed wound, or to apply collagenase to a healed wound, with or
without a film-forming carrier.
We agree with Appellant that the Examiner’s conclusion is based on
at least two findings not supported by the record. Specifically, the Examiner
has not provided any evidence to support the finding that any of the
conditions and/or inflamed lesions treated by Youssefyeh would have been
considered a “healed wound.” Nor does the evidence of record support the
Examiner’s finding that Lee discloses applying collagenase to a healed
wound. Rather, Lee discloses stimulating the activity of the collagenase
“which occur[s] naturally in human fibroblast scar tissue” (FF7). In any
case, the mere assertion that it would have been obvious “to provide for
methods for treating scars . . . such as taught by Lee within the methods of
Youssefyeh” (Ans. 6) does not explain how or why one of ordinary skill in
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the art would have combined aspects of the references in the manner
required by the claims.
Thus, the Examiner has not established that it would have been
obvious to apply a fluid, film-forming carrier to a healed wound to form a
tangible membrane juxtaposed to the wound. Nor has the Examiner
established that it would have been obvious to apply collagenase to a healed
wound, with or without a film-forming carrier.

Obviousness over Mantelle and Lee
The Examiner finds that Mantelle “teaches flexible, finite,
bioadhesive compositions and methods for topical application comprising a
therapeutically effective amount of a pharmaceutical agent(s), [including
collagenase,] a pharmaceutically acceptable carrier and a solvent for the
pharmaceutical agent(s) in the carrier” (Ans. 12). The Examiner finds that
Mantelle “does not explicitly teach treatment of ‘healed wounds’ . . . [but]
nonetheless explicitly teaches compositions that are topically applied on the
skin for effective treatment of pain” (Ans. 12). The Examiner finds that Lee
teaches “a method for improving the size and appearance of a scar
associated with fibromatosis, a keloid or a hypertrophic wound healing
disorder that comprises stimulating collagenase activity in the scar . . . [by]
covering the scar with a hydrogel or thermally insulating material that
elevates the surface temperature of the scar” (id. at 13). The Examiner
concludes that “[i]t would have been obvious to one of ordinary skill in the
art . . . to provide for methods for treating scars . . . such as taught by Lee
within the methods of Mantelle” (id.).
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Appellant contends “there is no mention or suggestion whatsoever in
Mantelle that the composition disclosed therein can be used for treating a
healed wound so as to reduce and/or improve the appearance of scarring”
(App. Br. 11 (emphasis omitted)), while “Lee does not teach or suggest the
use of a fluid, film-forming carrier and hardening the carrier into a tangible
membrane juxtaposed to the healed wound” (id. (emphasis omitted)).
Appellant contends “[t]here is simply no reason to combine the elements of
the composition disclosed in Mantelle with elements of the composition
disclosed in Lee” (id. at 12 (emphasis omitted)).
The issue raised by this appeal is whether the Examiner has
established that it would have been obvious for one of ordinary skill in the
art to apply a fluid, film-forming carrier to a healed wound, or to apply
collagenase to a healed wound, with or without a film-forming carrier, given
the teachings of Mantelle and Lee.
Mantelle, which is primarily directed to topical administration of
anesthetic agents to prevent or ameliorate pain (FF3), is no more relevant to
the claimed invention than Youssefyeh, discussed above. Moreover, the
Examiner has not established that Mantelle discloses administering the agent
in the form of a fluid, film-forming carrier, and subsequently hardening the
carrier in to a tangible membrane (FF4). Again, the mere assertion that it
would have been obvious “to provide for methods for treating scars . . . such
as taught by Lee within the methods of Mantelle” (Ans. 13) does not explain
how or why one of ordinary skill in the art would have combined aspects of
the references in the manner required by the claims.

Appeal 2009-013624
Application 10/829,316

8
SUMMARY
The rejection of claims 1-16 and 30-32 under 35 U.S.C. § 103(a) as
unpatentable over Youssefyeh and Lee is reversed.
The rejection of claims 1-16 and 30-32 under 35 U.S.C. § 103(a) as
unpatentable over Mantelle and Lee is reversed.

REVERSED

dm

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