Ex Parte Armstrong

Patent Trial and Appeal Board

Dec 20, 2016

12834198 (P.T.A.B. Dec. 20, 2016)

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.
12/834,198 07/12/2010 David Nigel Armstrong 036411-000001 8028
24239 7590 12/22/2016
MOORE & VAN AT .TEN PLLC
P.O. BOX 13706
3015 Carrington Mill Boulevard, Suite 400
Research Triangle Park, NC 27709
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
12/22/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
iplaw @ mvalaw. com
u sptomail @ m valaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID NIGEL ARMSTRONG1
Appeal 2015-000966
Application 12/834,198
Technology Center 1600
Before ERIC B. GRIMES, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
treatment method, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Metronidazole ... is a synthetic antibacterial and antiprotozoan
antibiotic .... The antibiotic has been used for many years in its oral or
intravenous form, to treat inflammatory conditions.” (Spec. 1:12—14.) The
1 Appellant identifies the Real Party in Interest as S.L.A. Pharma AG.
(Appeal Br. 3.)
Appeal 2015-000966
Application 12/834,198
Specification also states that “the oral form is used to treat inflammatory
conditions of the perianal region or anal canal such as . . . post-surgical
wounds.” {Id. at 1:16—18.) The Specification states that “there is no
disclosure of the direct application of metronidazole into the rectum or distal
colon (as for example a suppository, foam or enema) in the treatment of
inflammatory disease.” {Id. at 2:8—10.)
Claims 1—11, 17—20, 22, 24, and 26—32 are on appeal. Claim 1 is the
only independent claim and reads as follows:
1. A method of relieving pain or promoting wound healing in a patient
following a surgical operation to the colon, rectum, anorectum or perianal
region of patient, said method comprising:
applying directly to the colon, rectum, anorectum or perianal region of
patient affected by the surgical operation a topical composition, wherein the
topical composition consists essentially of metronidazole in a therapeutically
effective concentration of 10 wt % in a pharmacologically acceptable non-
aqueous vehicle, wherein metronidazole is the sole active agent in said
topical composition for relieving pain or promoting wound healing in the
patient.
DISCUSSION
The Examiner has rejected claims 1—11, 17—20, 22, 24, and 26—30
under 35 U.S.C. § 103(a) as obvious based on Urbanek2 and Wenshan3
(Ans. 2.) The Examiner has rejected claims 31 and 32 under 35 U.S.C.
§ 103(a) as obvious based on Urbanek, Wenshan, and Romer4 (Ans. 4). The
same issue is dispositive for both rejections.
2 Urbanek et al., Vulval Crohn’s disease: difficulties in diagnosis, 21
Clinical and Experimental Dermatology 211—214 (1996).
3 Wenshan, CN 1291484, published Apr. 18, 2001.
4 Romer et al., US 4,784,994, issued Nov. 15, 1988.
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Appeal 2015-000966
Application 12/834,198
The Examiner finds that Urbanek teaches topical treatment of a
patient with Crohn’s disease using metronidazole. {Id. at 2.) The Examiner
finds that “[t]he limitations wherein the topical medicament is applied to
reduce anorectal operation is rendered obvious over the prior art because the
condition of treating Crohn’s disease of the anorectum and perianal region
with metronidazole is known.” {Id.)
The Examiner finds that Wenshan teaches a topical formulation of
metronidazole and Vaseline {id. at 3), and concludes that it would have been
obvious “to incorporate the metronidazole into Vaseline and further in the
amount of about 10%” because Urbanek and Wenshan both teach topical
metronidazole formulations and determining the optimum dosage would
have been within the level of skill in the art. {id. at 3 4.)
Appellant argues, among other things, that claim 1 is directed to “the
use of a topical composition that consists essentially of metronidazole in a
very specific concentration of 10% and as the sole active agent in the
treatment of pain and healing after a surgical procedure.” (Appeal Br. 9.)
Appellant argues that, “[ijmportantly, the composition is applied to a
specific area on the body to relieve the symptoms of pain related to the
surgery and to help with healing. None of the cited references alone or in
combination teach such a composition or method of using such a
composition.” {Id.)
We agree with Appellant that the Examiner has not shown that a
method meeting all of the limitations of claim 1 would have been obvious
based on the cited references. Urbanek states that “Crohn’s disease is a
chronic inflammatory condition of the gastrointestinal system (GIT) of
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Appeal 2015-000966
Application 12/834,198
unknown aetiology.” (Urbanek 211, left col.) Urbanek describes a patient
with Crohn’s disease presenting with oedema and erythema who was treated
with topical metronidazole (id.), but does not describe treatment of a patient
with metronidazole following a surgical operation.
Wenshan describes a “medicine used for treating prostatic disease
[that] contains green chiretta, furantantin, metronidazole and vaseline” and is
applied to the prostate gland. (Wenshan, abstract.) Wenshan mentions
metronidazole’s use as anti-parisitic noting that it has “strong disinfecting
action on trichomonad and amebic protozoacide,” but it does not describe
treatment of a patient with metronidazole following a surgical operation.
(Wenshan 1.) Thus, neither Urbanek nor Wenshan disclose topically
treating, or provide any reason to topically treat, a patient following a
surgical operation, with 10% metronidazole.
The Examiner has not provided evidence or sound technical reasoning
to support the conclusion that topical treatment following a surgical
operation would have been obvious based on the prior art description of a
topical treatment for Crohn’s disease. The rejection based on Urbanek,
Wenshan, and Romer relies on the same reasoning for combining Urbanek
and Wenshan. For the reasons discussed above, we conclude that the
Examiner has not shown that Urbanek and Wenshan would have made
obvious the method of claim 1. We therefore reverse both of the rejections
on appeal.
REVERSED
4