Ex Parte Studin et al

Board of Patent Appeals and Interferences

Jan 17, 2012

11788959 (B.P.A.I. Jan. 17, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/788,959 04/23/2007 Joel Studin SDF 07-7 7301
7590 01/18/2012
Stuart D. Frenkel
Frenkel & Associates
Suite 330
3975 University Drive
Fairfax, VA 22030
EXAMINER
SCHUBERG, LAURA J
ART UNIT PAPER NUMBER
1657
MAIL DATE DELIVERY MODE
01/18/2012 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 STUDIN and ROBERT GIULIANO
____________

Appeal 2011-004682
Application 11/788,959
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 21-30 and 33-40
(App. Br. 2). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method of treating insect bites. Claims
21, 22, and 33 are representative and are reproduced in the “Claims
Appendix” of Appellants’ Brief (App. Br. 16-17).
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Claims 21-25 and 27-30 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Gendimenico,1 Kidd,2 Rubin,3 and
Palma.4
Claims 21-30 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Kennedy,5 Kidd, Rubin, and Palma.
Claims 33-40 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Kennedy, Kidd, Rubin, Palma, and Hahn. 6
We affirm the rejection of claims 21-25 and 27-30 over the
combination of Gendimenico, Kidd, Rubin, and Palma.
We affirm the rejection of claims 21 and 24-30 over the combination
of Kennedy, Kidd, Rubin, and Palma.
We affirm the rejection of claims 33-40 over the combination of
Kennedy, Kidd, Rubin, Palma, and Hahn.
We reverse the rejection of claims 22 and 23 over the combination of
Kennedy, Kidd, Rubin, and Palma.

The combination of Gendimenico, Kidd, Rubin, and Palma:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?

1 Gendimenico, US 2003/0104016 A1, published June 5, 2003.
2 Kidd, JR. et al., US 2004/0223946 A1, published November 11, 2004.
3 Rubin, US 5,543,149, issued August 6, 1996.
4 Palma, US 2004/0067922 A1, published April 8, 2004.
5 Kennedy, US 2002/0192304 A1, published December 19, 2002.
6 Hahn et al., US 5,716,625, issued February 10, 1998.
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FACTUAL FINDINGS (FF)
FF 1. We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 5-8 and 13-18), and repeat the following findings for
reference purposes.
FF 2. Gendimenico suggests a method and composition for the treatment
of insect bites (Ans. 6).
FF 3. Gendimenico suggests ingredients for the insect bite composition
include a protease (trypsin), a steroid (hydrocortisone), and an antipruritic
(antihistamine) (Ans. 5-6).
FF 4. The Examiner finds that “Gendimenico does not combine all the
ingredients in one embodiment” (Ans. 6).
FF 5. Gendimenico suggests a composition comprising “[h]ydrocortisone
at a concentration of 0.1 wt%” (Ans. 5).
FF 6. Kidd suggests:
[A] treatment for insect bites wherein the medicament can
include any of the available medicaments or agents for the skin
conditions that occur as a result of insect bites. The
medicament can also comprise any suitable anti-inflammatory
or anesthetic, anti-pruritic agent, other active agents, or other
treatment agents for insect bites as well . . . . Suitable agents
include, but are not limited to, known agents such as anti-
pruritic agents such as antihistamines, analgesics, anesthetics,
and counter-irritants (all of which may generally be referred to
as anti-itch agents). Mixtures of any two or more of these can
also be used as desired.

(Ans. 6.)
FF 7. The Examiner relies on Rubin to suggest that the proteolytic enzyme
papain is known in the art to be useful in the treatment of insect bites (Ans.
6).
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FF 8. The Examiner relies on Palma to suggest that compositions
comprising a proteolytic enzyme and steroid (corticosteroids) were known in
the art (id.; see also App. Br. 8; Reply Br. 4).

ANALYSIS
Claim 21:
While Appellants recognize that Gendimenico suggests “the use of
hydrocortisone with totarol in a composition . . . Appellants respectfully
point out that totarol is not a steroid, a proteolytic enzyme or an antipruritic
agent” (App. Br. 6; Reply Br. 2).7 Appellants also acknowledge the
Examiner’s finding that Gendimenico does not exemplify a composition
wherein all the ingredients effective to treat an insect bite, e.g., a protease, a
steroid (hydrocortisone), and an antipruritic (antihistamine) are included in a
single composition (id.; Reply Br. 2; FF 4). Therefore, Appellants contend
that Gendimenico fails to suggest the subject matter of Appellants’ claim 21
(App. Br. 6). We are not persuaded (see FF 6).
We are not persuaded by Appellants’ contention that “Kidd’s
teachings . . . are simply too vague for teaching a person of ordinary skill in
the art to come up with the Applicant’s [sic] claimed invention directed to a
specific combination of ingredients” (App. Br. 7; see also Reply Br. 3; Cf.
FF 6). Appellants’ claim 21 is open to include any number of ingredients in
addition to a steroid, a proteolytic enzyme, and at least one antipruritic (e.g.,
antihistamine) (see FF 1 at Ans. 14; Cf. Reply Br. 2). Therefore,

7 We recognize Exhibit B of Appellants’ Brief, relied upon to establish that
“[t]otarol is a naturally occurring plant extract with antibacterial activities”
(App. Br. 4).
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notwithstanding Appellants’ contentions to the contrary, the combination of
Gendimenico with Kidd fairly suggests a method of treating insect bites with
a composition comprising applying onto skin that has been affected by an
insect bite, a composition comprising a steroid, a proteolytic enzyme, and at
least one antipruritic.
We are therefore not persuaded by Appellants’ contention that “[t]he
Examiner has failed to show that even if Rubin suggests that papain is well
known in the art of treating insect bites, how combining Rubin with
Gendimenico would lead one of ordinary skill in the art to the present
invention” set forth in claim 22 (Reply Br. 3; see also App. Br. 8; Cf. FF 1-
3, 6, and 7).
Palma establishes that compositions comprising a proteolytic enzyme
and a steroid are known in the art. Therefore, in view of the combination as
a whole, we are similarly not persuaded by Appellants’ contention that since
“Palma is directed to a pharmaceutical composition for treating phimosis”
“there is no valid reason to combine a steroid, proteolytic enzyme and an
antipruritic agent in a composition for treating insect bites, in light of the
disclosure of Palma” (Reply Br. 4 (emphasis removed); see also App. Br. 8-
9; Cf. 1-3, 6, and 8).

Claim 22:
We are not persuaded by Appellants’ contention that “[t]he Examiner
has not indicated anywhere in the references the specific ranges of the
dependent claims, see e.g., dependent claim 22 wherein said composition
comprises about 0.1-5.0 wt% of a steroid” (App. Br. 10; see FF 5).
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CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claims 21 and 22 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Gendimenico, Kidd, Rubin, and
Palma is affirmed. Because they are not separately argued claims 24, 25,
and 27-30 fall together with claim 21. Claim 23 falls together with claim 22.
37 C.F.R. § 41.37(c)(1)(vii).
The combination of Kennedy, Kidd, Rubin, and Palma:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 9. We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 8-10 and 18), and repeat the following findings for
reference purposes.
FF 10. We incorporate FFs 1 and 6-8 herein by reference.
FF 11. Kennedy suggests a method and composition for the treatment of
insect bites (Ans. 8).
FF 12. Kennedy suggests ingredients for the insect bite composition include
a protease (papain), a steroid (hydrocortisone), and an antipruritic
(antihistamine) (id.).
FF 13. The Examiner finds that “Kennedy does not combine all the
ingredients in one embodiment” and Kennedy does not suggest a steroid
concentration of “about 0.1-5.0 wt%” (id.).
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FF 14. Palma teaches a composition comprising corticosteroids and/or
hormone steroids at a concentration of 0.025-5 wt% for topical treatment of
phimosis (Palma, Abstract; Ans. 9).
ANALYSIS
Claim 21:
Appellants recognize that Kennedy suggests a composition for the
treatment of insect bites that “includes papain and may include additional
ingredients, such as hydrocortisone and antihistamines (antipruritic)” (App.
Br. 10; see also Reply Br. 5-6). Nevertheless, Appellants contend that since
Kennedy fails to exemplify a composition that comprises papain,
hydrocortisone and antihistamines in the same composition, Kennedy fails to
suggest the invention of claim 22 (App. Br. 10; Reply Br. 6 see FF 13). We
are not persuaded (see FF 6).
Notwithstanding Appellants’ contentions to the contrary, the
combination of Kennedy with Kidd fairly suggests a method of treating
insect bites with a composition comprising applying onto skin that has been
affected by an insect bite, a composition comprising a steroid, a proteolytic
enzyme, and at least one antipruritic (antihistamine). For the reasons set
forth above, we are not persuaded by Appellants’ contentions regarding
Kidd, Rubin, and Palma as they apply in combination with Kennedy with
respect to claim 21 (App. Br. 11-12; Reply Br. 6-7).

Claim 22:
Appellants contend that the combination of references fails to suggest
a method of treating insect bites with a composition comprising about 0.1-
5.0 wt% of a steroid as required by Appellants’ claim 22 (App. Br. 12; Reply
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Br. 7). We agree. While Palma suggest a composition comprising
corticosteroids and/or hormone steroids at a concentration of 0.025-5 wt%
for the treatment of phimosis, the Examiner fails to establish an evidentiary
basis to support a conclusion that a person of ordinary skill in this art would
have appreciated from the references relied upon that the same steroid
concentration effective in treating phimosis would also be effective in
treating insect bites.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness with regard to claim 21. Therefore, the rejection of claim 21
under 35 U.S.C. § 103(a) as unpatentable over the combination of Kennedy,
Kidd, Rubin, and Palma is affirmed. Because they are not separately argued
claims 24-30 fall together with claim 21. 37 C.F.R. § 41.37(c)(1)(vii).
The preponderance of evidence on this record fails to support a
conclusion of obviousness with regard to claims 22 and 23. Therefore, the
rejection of claims 22 and 23 under 35 U.S.C. § 103(a) as unpatentable over
the combination of Kennedy, Kidd, Rubin, and Palma is reversed.

The combination of Kennedy, Kidd, Rubin, Palma, and Hahn:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 15. We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 11-12 and 18-19), and repeat the following findings for
reference purposes.
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FF 16. We incorporate FFs 9-13 herein by reference.
FF 17. The Examiner finds that the combination of Kennedy, Kidd, Rubin
and Palma fails to suggest a composition comprising “strontium cations”
(Ans. 11).
FF 18. Hahn suggests a method of treating insect bites with a composition
that comprises strontium cation and a steroid (Ans. 11-12).
FF 19. The Examiner finds Hahn’s suggestion that “strontium cation may
act to inhibit or modify the action of skin cell proteases” does not teach
away from a composition comprising strontium cation and papain because
papain is not a skin cell protease (Ans. 19).
ANALYSIS
For the reasons set forth above, we are not persuaded by Appellants’
contentions regarding the combination of Kennedy, Kidd, Rubin, and Palma
(App. Br. 13-14; Reply Br. 8).
We are not persuaded by Appellants’ contention that Hahn teaches
away from its combination with a proteolytic enzyme (App. Br. 15; Cf. FF
19). While Appellants agree with the Examiner’s finding that papain is not a
skin protease, Appellants contend that “skin proteases include cysteine
proteases of which papain is a distinct and well known member” (Reply Br.
8). Therefore, Appellants’ content that “a person of ordinary skill in the art
would know that an inhibitor of skin proteases, which includes cysteine
protease, would also inhibit other cysteine proteases because all cysteine
proteases share the same catalytic/proteolytic mechanism” (Reply Br. 9).
We are not persuaded.
Appellants fail to establish that Hahn’s suggestion that “strontium
cation may act to inhibit or modify the action of skin cell proteases”
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(1) contemplates all skin cell proteases, including cysteine proteases, (2)
establishes that strontium cation does inhibit or modify the action of skin
cell proteases, and/or (3) establishes that strontium cation does inhibit or
modify the action of papain in a manner that would render it useless in a
composition suggested by the combination of references relied upon by the
Examiner (see FF 19 (emphasis added)). Accordingly we are not persuaded
by the evidence relied upon by Appellants to establish that papain is a
cysteine protease (Reply Br. Exhibits B and C).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness with regard to claim 33. The rejection of claim 33 under 35
U.S.C. § 103(a) as unpatentable over the combination of Kennedy, Kidd,
Rubin, Palma, and Hahn is affirmed. Because they are not separately argued
claims 34-40 fall together with claim 33. 37 C.F.R. § 41.37(c)(1)(vii).

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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