Ex Parte Padilla et al

Patent Trial and Appeal Board

Aug 16, 2016

13462375 (P.T.A.B. Aug. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/462,375 05/02/2012
27805 7590
THOMPSON HINE L.L.P.
10050 Innovation Drive
Suite 400
DAYTON, OH 45342-4934
08/18/2016
FIRST NAMED INVENTOR
Angel Padilla
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.
078807.36 7827
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
08/18/2016 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):
ipdocket@thompsonhine.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANGEL PADILLA and GEORGE BAKLA YAN
Appeal2015-003480
Application 13/462,375 1
Technology Center 1600
Before ERIC B. GRIMES, ELIZABETH A. LA VIER, and RY ANH. FLAX,
Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
Pursuant to 35 U.S.C. § 134(a), Appellants seek reversal of the
Examiner's rejections of claims 59----67. We have jurisdiction under 35
U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
1 Appellants state the real party in interest is Bausch & Lomb Pharma
Holdings Corporation. Appeal Br. 3.
Appeal2015-003480
Application 13/462,375
BACKGROUND
The Specification relates to compositions ofbepotastine2 and its
pharmaceutically acceptable salts, and uses thereof. See Spec. 1. Claim 59,
the only independent claim, is representative:
59. A method of treating at least one of rhinitis, mucosal
inflammation associated with rhinitis, sinusitis, rhinosinusitis,
and symptoms associated with rhinitis, mucosal inflammation
associated with rhinitis, sinusitis, and/or rhinosinusitis in a
patient in need of such treatment, the method comprising
nasally administering a pharmaceutical composition consisting
of a pharmaceutically acceptable salt ofbepotastine at a
concentration ranging from 2.00% w/v to 8.00% w/v with at
least one pharmaceutically compatible excipient in aqueous
solution to the patient in need thereof, in a dose regimen
effective to treat at least one of rhinitis, mucosal inflammation
associated with rhinitis, sinusitis, rhinosinusitis, and symptoms
associated with rhinitis, mucosal inflammation associated with
rhinitis, sinusitis, and/ or rhinosinusitis.
Corrected Claims Appendix 1. 3
2 Appellants provide the chemical name for bepotastine as ( + )-(S )-4-[ 4-[ ( 4-
chlorophenyl)(2-pyridyl)methoxy ]piperidino ]butyric acid. Spec. 1.
3 In response to a Notification of Non-Compliant Appeal Brief, mailed
August 22, 2014, Appellants subsequently filed a corrected version of the
Claims Appendix, on August 28, 2014.
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Appeal2015-003480
Application 13/462,375
REJECTIONS MAINTAINED ON APPEAL
1. Claims 59---62 and 65 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Ha,4 Torkildsen,5 and Williams. 6 Ans. 2.
2. Claims 63, 64, and 66 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Ha, Torkildsen, Williams, Astelin,7 Bountra,8
and Guo. 9 Ans. 6-7.
3. Claims 59, 63, and 67 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Ha, Torkildsen, Williams, Astelin, Bountra, Guo,
Mehta, 10 and Dow. 11 Ans. 11-12.
4. Claims 59---67 stand provisionally rejected under the judicially
created doctrine of obviousness-type double patenting as unpatentable
4 Ha et al., WO 2008/123701 Al, published Oct. 16, 2008.
5 G. Torkildsen et al., Bepotastine Besilate Opthalmic Solution for the Relief
of Nonocular Symptoms Provoked by Conjunctiva! Allergen Challenge, 105
ANN. ALLERGY ASTHMAIMMUNOL. 57---64 (2010).
6 Jon I. Williams et al., Non-Clinical Pharmacology, Pharmacokinetics, and
Safety Findings for the Antihistamine Bepotastine Besilate, 26 CURRENT
MED. RES. & OP. 2329-38 (2010).
7 Meda Pharmaceuticals Inc., Astelin® Nasal Spray (product information)
(2009).
8 Bountra et al., WO 2010/026129 Al, published Mar. 11, 2010.
9 Yang Guo et al., The Effect of Formulation Variables and Breathing
Patterns on the Site of Nasal Deposition in an Anatomically Correct Model,
22 PHARM. RES. 22:11, 1871-78 (2005).
10 Mehta et al., Novel Nasal In Situ Gelling System for Treatment of
Sinusitis' INDIAN J. PHARM. SCI. 71: 6, 721-22 (2009).
11 The Dow Chemical Company, Methocel Cellulose Ethers Technical
Handbook (2002).
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Appeal2015-003480
Application 13/462,375
over claims 69-78 of copending Application No. 13/462,466 in view
of Preswetoff-Morath. 12 Ans. 25.
DISCUSSION
A. Statutory Obviousness Rejections
Ha teaches treating or preventing a histamine-mediated or allergic
disease with a pharmaceutical composition comprising a crystalline
bepotastine metal salt hydrate and a carrier, where the composition may be
administered orally, nasally, or via other routes. Non-Final Action 6 (citing
Ha 5:33-38, 6: 1-3, 6: 13-15, claims 10-12).
Appellants first argue the Examiner erred in applying Ha to the
present claims because Ha's "bepotastine metal complex has a different
chemical structure and formula than Appellants' pharmaceutically
acceptable salt ofbepotastine." Appeal Br. 10. Appellants' position thus
focuses on the lack of identity between described compounds; instead of on
the scope of claim 59. See id.; see also Reply Br. 2--4. But claim 59 broadly
encompasses any "pharmaceutically acceptable salt of bepotastine." And as
the Examiner points out, the Specification defines the term
"pharmaceutically acceptable salt" to include "salts derived from a variety of
organic and inorganic counter ions," including calcium and strontium. Ans.
14--15 (citing Spec. 13). Calcium and strontium are the two options for
metal ions in the salts of Ha's invention. Ha 2:35-3:4. Appellants stress the
"chemical differences between a hydrate (Ha) and a salt (Appellants),"
Reply Br. 2, but do not persuasively rebut the Examiner's position that "the
12 Preswetoff-Morath et al., US 2009/0324699 Al, published Dec. 31, 2009.
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Application 13/462,375
bepotastine metal salt hydrate is a pharmaceutically acceptable salt of
bepotastine," Ans. 14, within the broadest reasonable interpretation of claim
59, see id. at 15. In essence, Appellants have not explained convincingly
why a hydrated salt is not a pharmaceutically acceptable salt, as understood
in context of the claimed invention.
Appellants also argue that Ha teaches away from the present
invention. See Appeal Br. 10. Specifically, Appellants assert that "Ha
distinguished and touted superiority of its compound compared to the
compound used in Appellants' treatment method." Id. Indeed, Ha points to
bepotastine besylate13 as a prior art compound, prone to "slow racemization"
under high moisture conditions. See Ha 1:28-33. But "[a] known or
obvious composition does not become patentable simply because it has been
described as somewhat inferior to some other product for the same use." In
re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Accordingly, we do not agree
with Appellants that Ha's discussion of certain comparative shortcomings of
bepotastine besylate amounts to a teaching away. 14 When considering
§ 103, the prior art must be considered for all of its teachings, including
unpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d
804, 807 (Fed. Cir. 1989) (citation omitted). Likewise we are unpersuaded
by Appellants' suggestion, see Appeal Br. 11-12, that Ha teaches away from
13 Ha uses "benzensulfonic acid" rather than "besylate," Ha 1 :29, but these
terms are interchangeable, see Appeal Br. 11. "Besilate" is an alternate
spelling of "besylate." See id. Bepotastine besilate is recited specifically in
dependent claim 65.
14 Consequently, even if Ha's bepotastine metal salt hydrates fell outside the
scope of claim 59, Ha's background disclosure ofbepotastine besylate
would still render obvious the present claims.
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Application 13/462,375
nasal administration because of Ha's preference for an oral formulation.
Similarly, Appellants' assertion that Ha lacks clinical efficacy data, see id. at
12, does not mean that one of ordinary skill in the art would not have
considered it, see Ans. 19.
Finally, Appellants argue that the other references fail to cure Ha's
deficiencies. See Appeal Br. 12-14. As we are unpersuaded that Ha is
deficient, as described above, we are unpersuaded by these arguments as
well.
As we are unpersuaded by Appellants' arguments, we affirm the
Examiner's rejection of claim 59. Claims 60-67, which are not argued
separately, 15 fall with claim 59.
B. Provisional Obviousness Type Double Patenting: Claims 59-67
Appellants do not separately argue this rejection, and have not
identified an error in it. Accordingly, we affirm the provisional rejection of
claims 59----67 on the ground of nonstatutory obviousness-type double
patenting for the reasons presented by the Examiner. See Non-Final Action
4--5; Ans. 25-26.
CONCLUSION
The rejections of claims 59----67 are affirmed for the reasons of record
and as explained herein.
15 Appellants mention different sets of claims in reference to the groups in
which the Examiner rejected them, but do not substantively argue the claims
separately.
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Appeal2015-003480
Application 13/462,375
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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