Ex Parte Weibel et al

Patent Trial and Appeal Board

Nov 7, 2018

13913912 (P.T.A.B. Nov. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/913,912 06/10/2013
97568 7590 11/09/2018
Cantor Colburn-WARF
20 Church Street
22nd Floor
Hartford, CT 06103-3207
FIRST NAMED INVENTOR
Douglas Benjamin Weibel
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
WIS0009US2 7910
EXAMINER
CARTER, KENDRA D
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
11/09/2018 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):
usptopatentmail @cantorcolburn.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DOUGLAS BENJAMIN WEIBEL, YE JIN EUN,
MARIE HAZEL FOSS, and KATHERINE ANN HURLEY
Appeal2017-010258
Application 13/913 ,912
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
method of treating a subject in need of treatment for a bacterial infection
with an antimicrobial compound. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify the Real Party in Interest as the Wisconsin Alumni
Research Foundation (see App. Br. 2).
2 We have considered and herein refer to the Specification of June 10, 2013
("Spec."); Final Office Action ofNov. 4, 2016 ("Final Action"); Appeal
Brief of Mar. 7, 2017 ("App. Br."); Examiner's Answer of June 2, 2017
("Ans."), and Reply Brief of July 27, 2017 ("Reply Br.").
Appeal2017-010258
Application 13/913,912
Statement of the Case
Background
"An effective strategy for combating slow-growing bacteria is to
target the lipid membrane." (Spec. ,r 5). "Peripheral and integral membrane
proteins participate in various essential cellular processes ... Compounds
that perturb these processes disrupt growth and the maintenance of cell
homeostasis and may serve as potent therapeutic antimicrobial agents"
(Spec. ,r 5).
The Claims
Claims 10, 11, 13-20 and 22 are on appeal. Claim 10 is
representative and reads as follows:
10. A method of treating a subject in need of treatment for a
bacterial infection comprising administering to the subject a
pharmaceutical composition comprising an antimicrobial
compound of Formula I, or a pharmaceutically acceptable salt
thereof, and a pharmaceutically acceptable excipient, wherein
the antimicrobial compound of Formula I is:
Ci-(2-1'JII-C(R._2)(1l3)(1l4) (I)
wherein
Cl
Cl
Ci is
OH
'/~\.
(2 is ~
Jl2 and Jl3 are hydrogen, and
ll 4 is C6-C8 alkyl optionally substituted with hydroxy,
or
ll2 is hydrogen, and ll3 and ll4 in -C(ll2)(1l3)(1l4) together
with the carbon (-C) form a C6-C7 cycloalkyl ring structure.
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Appeal2017-010258
Application 13/913,912
The Rejection3
The Examiner rejected claims 10, 11, 13-20 and 22 under 35 U.S.C.
§ I03(a) as obvious over Amuro4 (Final Act. 5-8).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that the prior art
renders the claims obvious?
Findings of Fact (FF)
1. Amuro teaches "an object of the present invention is to provide
a novel antibacterial agent capable of exhibiting excellent antibacterial
effects against various bacteria" (Amuro ,r 4).
2. Amuro teaches a structure as reproduced below:
N
"X2 and X12 are each independently a halogen atom ... a chlorine atom";
"X1, X3, X4, X11, X13, and X14 are each ... a hydrogen atom"; and "Y is an
amino group"(Amuro ,r,r 18-21 ).
3 The Examiner withdrew the rejection under 35 U.S.C. § 112, first
paragraph for new matter (see Ans. 2).
4 Amuro, JP 2007-223916 Al, published Sept. 6, 2007 (We rely on a
machine translation of Amuro that was entered into the file on Mar. 23,
2015).
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Appeal2017-010258
Application 13/913,912
3. Amuro teaches that the amino group Y may be as reproduced
below:
R3 and Ri are each independently a hydrogen atom or a
substituted or unsubstituted alkyl group, an alkenyl group or
alkynyl group. R3 and Ri total number of carbon atoms of, in
the range of 1 to 5. If the total of the number of carbon atoms is
more than 5, it becomes difficult to obtain a good anti-microbial
activity.
(Amuro ,r,r 23-24).
4. Amuro teaches a compound, b-6, that is reproduced below:
Compound b-6 has chlorines at the X2 and X12 positions and five carbon
isopentyl groups at the R3 and Ri positions of the amino group Y relative to
the general compound structure disclosed by Amuro (Amuro, table 2).
Principles of Law
A prima facie case for obviousness requires "a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
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Appeal2017-010258
Application 13/913,912
Analysis
Appellants contend
Amuro clearly discourages one from preparing compounds in
which R3 + R4 has more than 5 carbon atoms. Amuro, in
translation, does not appear to refer to "good antimicrobial
activity", rather referring to "it becomes difficult to obtain
satisfactory antibiotic activity." In view of the disclosure of
compounds with satisfactory antimicrobial activity, why would
one be motivated to try compounds Amuro clearly stated have
less than satisfactory activity? Appellants submit that Amuro
provides a clear teaching away from the claimed compounds.
(App. Br. 7).
The Examiner responds
Amuro teaches in paragraph 24 that "If the total of the number
of carbon atoms is more than 5, it becomes difficult to obtain a
good anti-microbial activity". The Examiner is reading, "good
anti-microbial activity" subjectively and one skilled in the art
would still be motivated to try a homologue of a 5 carbon alkyl
chain ... with an expectation that it still had activity. The
Examiner does not read "difficulty to obtain good anti-
microbial activity" as not having activity at all, because Amuro
et al. does not teach that anything over 5 carbons does not have
activity, which is a true "teaching away" or clear teaching that
the compounds do not have activity.
(Ans. 3--4).
We agree with Appellants because claim 10 requires at least 6 carbons
at the R4 position of Formula I and Amuro teaches that "[i]f the total of the
number of carbon atoms is more than 5, it becomes difficult to obtain a good
anti-microbial activity" (FF 3). Amuro's teaching undercuts the Examiner's
obviousness rationale based on the selection of homo logs having similar
properties because Amuro teaches that compounds with more than 5 carbon
atoms would not be expected to have good anti-microbial activity.
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Appeal2017-010258
Application 13/913,912
Under the lead compound analysis rubric, we must first "determine[]
whether a chemist of ordinary skill would have selected the asserted prior art
compounds as lead compounds, or starting points, for further development
efforts." Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1291 (Fed. Cir.
2012). "The second inquiry in the analysis is whether the prior art would
have supplied one of ordinary skill in the art with a reason or motivation to
modify a lead compound to make the claimed compound with a reasonable
expectation of success." Id. at 1292.
In this case, while Amuro might reasonably provide several lead
compounds as starting points, Amuro would not have supplied the ordinary
artisan with a reason to modify any of these lead compounds to make the
claimed compound because Amuro teaches that compounds with more than
5 carbons are less likely to have "good anti-microbial activity" (FF 3).
We also agree with Appellants that Amuro teaches away from the
claimed structure "A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant." In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994). While we can agree with the Examiner that
Amuro teaches antibacterial compounds with up to 5 carbons at the R3 and
Ri positions of the amino group Y relative to the general compound
structure disclosed by Amuro (FF 1-3), Amuro specifically teaches "[i]f the
total of the number of carbon atoms is more than 5, it becomes difficult to
obtain a good anti-microbial activity" (FF 3). This is not a situation where
the prior art could not have synthesized the claimed compound based on
Amuro, but rather a situation where Amuro discourages the use of more than
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Appeal2017-010258
Application 13/913,912
5 carbon atoms at these positions (FF 3), and the Examiner has advanced no
persuasive positive reason to do so. We therefore agree with Appellants that
"Amuro clearly teaches away from the presently claimed compounds as they
are of the type expected to have less than satisfactory antimicrobial activity"
(App. Br. 7).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner's conclusion that the prior art renders the claims obvious.
SUMMARY
In summary, we reverse the rejection of claims 10, 11, 13-20 and 22
under 35 U.S.C. § 103(a) as obvious over Amuro.
REVERSED
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