Padilla, Angel et al.

Patent Trials and Appeals Board

Jan 9, 2020

13462375 - (D) (P.T.A.B. Jan. 9, 2020)

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.
13/462,375 05/02/2012 Angel Padilla 078807.36 7827
27805 7590 01/09/2020
THOMPSON HINE L.L.P.
10050 INNOVATION DRIVE
SUITE 400
DAYTON, OH 45342-4934
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
01/09/2020 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 BAKLAYAN
____________

Appeal 2019-002793
Application 13/462,3751
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
RYAN H. FLAX, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from Examiner’s
decision to reject claims 59–64 and 67–69. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 This Application was before the Board in Appeal 2015-003480, Decision
Affirming the rejection of claims 59–67 entered August 18, 2016.
2 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Bausch &
Lomb Pharma Holdings Corp” (Appellant’s October 22, 2018 Appeal Brief
(Appeal Br.) 2).
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STATEMENT OF THE CASE
Appellant’s disclosure relates to compositions comprising bepotastine,
and pharmaceutically acceptable salts thereof, for nasal administration 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, or rhinosinusitis (see e.g.,
Spec.3 1 and 4). Appellant’s independent claims, claims 59, 68, and 69, are
reproduced below:
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 nasal spray composition
comprising
bepotastine besilate or bepotastine benzoate at a concentration
ranging from 2.00% w/v to 8.00% w/v 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, where the bepotastine besilate or
bepotastine benzoate does not include calcium or strontium, and
where the pharmaceutical nasal spray composition comprises:
at least one buffer;
at least one tonicity agent;
at least one chelating agent;
at least one preservative; and
one of either
at least one suspending agent, or

3 Appellant’s May 22, 2012 Substitute Specification.
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at least one viscosity agent and at least one taste-
masking agent.
(Appeal Br. 9.)
68. 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 nasal spray composition
comprising a pharmaceutically acceptable salt of bepotastine at
a concentration ranging from 2.00% w/v to 8.00% w/v 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, where
the pharmaceutically acceptable salt of bepotastine does not
include calcium or strontium, and where the pharmaceutical
nasal spray composition comprises:
at least one buffer;
at least one tonicity agent;
at least one chelating agent;
at least one preservative; and
hydroxypropylmethyl cellulose (HPMC).
(Id. at 10–11.)
69. 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 nasal spray composition
comprising
bepotastine besilate or bepotastine benzoate at a concentration
ranging from 2.00% w/v to 8.00% w/v in aqueous solution to
the patient in need thereof, in a dose regimen effective to treat
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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, where the bepotastine besilate or
bepotastine benzoate does not include calcium or strontium, and
where the pharmaceutical nasal spray composition comprises:
at least one buffer;
at least one tonicity agent;
at least one chelating agent;
at least one preservative; and
hydroxypropylmethyl cellulose (HPMC).
(Id. at 11.)

Grounds of rejection before this Panel for review:4
Claims 59–64 and 67 stand provisionally rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 69–78 of copending Application No. 13/462,466 in view of
Preswetoff-Morath5.
Claims 59–62 stand provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 59, 60, 62,
63, 66–68, and 71 of copending Application No. 13/505,426.

4 Appellant’s claim 65 is cancelled and, therefore, was not included in our
deliberations (cf. Examiner’s December 20, 2018 Answer (Ans.) 4-6).
5 Preswetoff-Morath et al., US 2009/0324699 Al, published Dec. 31, 2009.
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Claims 59–62 and 696 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ha,7 Ophthalmology,8 Bepreve,9
Astelin,10 and Williams.11
Claims 63 and 64 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ha, Ophthalmology, Bepreve, Astelin,
Williams, Bountra,12 and Guo.13

6 Examiner makes clear that Appellant’s claim 69 was addressed in
Examiner’s May 11, 2018 Final Office Action (Final Act.) but inadvertently
omitted in the statement of this rejection (see Ans. 7). Therefore, we include
claim 69 as part of this rejection.
7 Ha et al., WO 2008/123701 A1, published Oct. 16, 2008.
8 Nasal spray tested against seasonal allergic rhinitis, Ophthalmology
Times (Aug. 4, 2010), available at
http://ophthalmologytimes.modernmedicine.com.
9 ISTA Pharmaceuticals, Inc., BepreveTM Ophthalmic Solution (Highlights
of Prescribing Information) (Aug. 2009).
10 Meda Pharmaceuticals Inc., Astelin® Nasal Spray (product information)
(Jan. 2009).
11 Williams et al., Non-clinical pharmacology, pharmacokinetics, and safety
findings for the antihistamine bepotastine besilate, 26 Current Medical
Research & Opinion 2329–2338 (2010).
12 Bountra et al., WO 2010/026129 A1, published Mar. 11, 2010.
13 Guo et al., The Effect of Formulation Variables and Breathing Patterns on
the Site of Nasal Deposition in an Anatomically Correct Model, 22
Pharmaceutical Research 1871–1878 (2005).
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Claims 59, 63, and 67–6914 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ha, Bepreve, Astelin, Williams,
Ophthalmology, Bountra, Guo, Mehta,15 and Dow.16

Nonstatutory Double Patenting:
“Appellant affirms that the need for a terminal disclaimer will be
assessed if and when the ’466 and [’426] applications issue and/or the scope
of otherwise allowable subject matter in this application is known” (Appeal
Br. 4; see also Ans. 19). In sum, Appellant waived any appeal of these
rejections. Therefore, they are summarily affirmed. See MANUAL OF
PATENT EXAMINING PROCEDURE § 1205.02 (“If a ground of rejection
stated by the examiner is not addressed in the appellant's brief, that ground
of rejection will be summarily sustained by the Board.”).

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?

14 We acknowledge and agree with Appellant’s contention that although
“[t]he Office Action does not affirmatively reject claim 69, . . . Appellant
believes this oversight to be a typographical error, in which this rejection
actually pertains to claims 59, 63, and 67–69” (Appeal Br. 4: n. 1).
Therefore, we include claim 69 as part of this rejection.
15 Mehta et al., Novel Nasal in situ Gelling System for Treatment of Sinusitis,
71 Indian J. Pharm. Sci. 721–722 (2009).
16 The Dow Chemical Company, Methocel Cellulose Ethers Technical
Handbook (2002).
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FACTUAL FINDINGS (FF)
FF 1. Ha discloses a crystalline bepotastine metal salt hydrate of the
following formula:

wherein M is calcium or strontium (Ha 2: 37–3: 4; see generally Ans. 7).
FF 2. Ha “provides a pharmaceutical composition for treating or
preventing a histamine-mediated disease or an allergic disease, which
comprises the crystalline bepotastine metal salt hydrate of formula (I) as an
active ingredient and a pharmaceutically acceptable carrier” (Ha 5: 33–36;
see Ans. 7).
FF 3. Ha discloses “various pharmaceutical composition[s] comprising a
specific amount of active ingredient, together with or without additives such
as said carriers, diluents or excipients, . . . prepared in accordance with any
of the conventional procedures” (Ha 6: 13–15; see also id. at 15: 30–32
(Ha’s “pharmaceutical composition . . ., wherein [the] crystalline bepotastine
metal salt hydrate is present in an amount ranging from 0.1 to 95% by
weight based on the total weight of the composition”); see Ans. 7–8).
FF 4. Ha’s “pharmaceutical composition . . . is useful for the treating or
preventing allergic rhinitis, urticaria, pruritus, nasal obstruction, dermatitis
or eczema” (Ha 5: 37–39; see Ans. 7).
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FF 5. Ha’s “pharmaceutical composition . . . may be administered via the
various routes including oral, nasal, ocular, rectal, and injectable route,
preferably the oral route” (Ha 6: 1–3; see Ans. 7).
FF 6. Ha discloses that at
pH 6.8 simulating the juice of [the] intestinal region that is
responsible [for] the absorption of bepotastine [in the
gastrointestinal tract], the solubility . . . of bepotastine calcium
salt hydrate . . . was at least 2 times higher than that
of . . . bepotastine benzenesulfonic acid salt.
(Ha 12: 32–13: 2.)
FF 7. Examiner finds that “Ha does not explicitly teach a composition
comprising a salt of bepotastine with a pharmaceutically acceptable
suspending agent further comprising at least one buffer, at least one tonicity
agent, at least one chelating agent, and at least one preservative” or “nasal
spray” (Ans. 8).
FF 8. Ophthalmology discloses “a phase I/II clinical study of bepotastine
besilate nasal spray for the treatment of symptoms associated with seasonal
allergic rhinitis” and reports than an “eye-drop formulation of bepotastine
1.5% (Bepreve) was approved by the FDA in September 2009 for the
treatment of ocular itching associated with allergic conjunctivitis”
(Ophthalmology; see Ans. 8).
FF 9. Bepreve discloses an ophthalmic solution comprising bepotastine
besilate, benzalkonium chloride, monobasic sodium phosphate dihydrate,
sodium chloride, sodium hydroxide to adjust pH, and water for injection
(Bepreve 9; see Ans. 8 (Examiner finds that “[m]onobasic sodium phosphate
dihydrate reads on a buffer” and “[s]odium [c]hloride reads on a tonicity
agent”)).
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FF 10. Astelin discloses a nasal spray comprising azelastine hydrochloride
in an aqueous solution at pH 6.8 ± 0.3, benzalkonium chloride, edetate
disodium, hypromellose, citric acid, dibasic sodium phosphate, sodium
chloride, and purified water (Astelin 1; see Ans. 8–9 (Examiner finds that
“[b]enzalkonium chloride reads on a preservative,” “[e]detate disodium
reads on a chelating agent,” “[h]ypromellose reads on a suspending agent,”
“[c]itric acid and dibasic sodium phosphate read on a buffer,” and [s]odium
chloride reads on a tonicity agent”)).
FF 11. Astelin discloses that its nasal spray composition is useful
for the treatment of the symptoms of seasonal allergic rhinitis
such as rhinorrhea, sneezing, and nasal pruritus in adults and
children 5 years and older, and for the treatment of the
symptoms of vasomotor rhinitis, such as rhinorrhea, nasal
congestion and postnasal drip in adults and children 12 years
and older.
(Astelin 2; see Ans. 8.)
FF 12. Williams’ Figure 1 is reproduced below:

William’s Figure 1 provides the chemical structure of bepotastine besilate
(Williams 2330).
FF 13. Williams discloses “[a]n oral table formulation of bepotastine
besilate . . . for the treatment of allergic rhinitis, . . . urticarial and itching
associated with skin diseases (eczema/dermatitis, prurigo, and pruritus
cutaneous)” and “[a]n ophthalmic formulation of [1.5%] bepotastine
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besilate . . . for the treatment of ocular itching associated with allergic
conjunctivitis” (Williams 2330; see Ans. 10).
FF 14. Examiner finds that the combination of Ha, Ophthalmology,
Bepreve, Astelin, and Williams does “not teach a composition wherein the
composition consists of dibasic sodium phosphate heptahydrate, sodium
chloride, edetate disodium, benzalkonium chloride, a blend of
microcrystalline cellulose and carboxy methyl cellulose (AVICEL®); and
polyoxyethylene (20) sorbitan monooleate (polysorbate 80) or
hydroxypropylmethylcellulose (HPMC) 15 LV, citric acid monohydrate, and
a taste-masking agent” (Ans. 12–13).
FF 15. Bountra “relates to the use of a urea compound in the treatment of
rhinitis, to aqueous pharmaceutical compositions containing said compound,
in particular to compositions suitable for intranasal administration”
(Bountra, Abstract; see Ans. 13).
FF 16. Bountra’s “[a]queous pharmaceutical . . . intranasal compositions,
may include one or more pharmaceutically acceptable excipients selected
from the group consisting of suspending agents, thickening agents,
preservatives, wetting agents and isotonicity adjusting agents” (Bountra 5:
19–22; see Ans. 13).
FF 17. Bountra discloses that
The suspending agent, if included, will typically be present in
an amount of between about 0.1 and 5% (w/w), such as
between about 1.5% and 2.5% (w/w), based on the total weight
of the composition. Examples of suspending agents include
Avicel®, carboxymethylcellulose, veegum, tragacanth,
bentonite, methylcellulose and polyethylene glycols, e.g.
microcrystalline cellulose or carboxy methylcellulose sodium.
(Bountra 5: 29–33; see Ans. 13.)
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FF 18. Bountra discloses that its compositions “may be protected from
microbial or fungal contamination and growth by inclusion of a
preservative,” wherein “[e]xamples of pharmaceutically acceptable anti-
microbial agents or preservatives may include . . . benzalkonium
chloride . . . [and] chelating agents such as disodium
ethylenediaminetetraacetate (EDTA),” which “may be present in an amount
of between about 0.001 and 1% (w/w), such as about 0.015% (w/w), based
on the total weight of the composition” (Bountra 6: 5–17; see Ans. 13).
FF 19. Bountra discloses that its compositions “may include a
pharmaceutically acceptable wetting agent . . . such as polyoxyethylene (20)
sorbitan monooleate (Polysorbate 80) . . . in an amount of between about
0.001 and 1.0% . . . based on the total weight of the composition” (Bountra
6: 26–33; see Ans. 13).
FF 20. Bountra discloses that the isotonicity of its compositions may be
adjusted with an isotonicity adjusting agent, such as sodium chloride “in an
amount of between about 0.1 and 10% (w/w) . . . based on the total weight
of the composition” “to achieve isotonicity with body fluids e.g. fluids of the
nasal cavity” (Bountra 7: 5–9; see Ans. 13).
FF 21. Bountra discloses that its compositions “may be buffered by the
addition of suitable buffering agents such as sodium citrate, citric acid,
phosphates such as disodium phosphate (for example the dodecahydrate,
heptahydrate, dihydrate and anhydrous forms) or sodium phosphate and
mixtures thereof” (Bountra 7: 11–16; see Ans. 13).
FF 22. Bountra discloses that its compositions may also include “taste-
masking agents (such as menthol)” (Bountra 7: 18–20; see Ans. 13).
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FF 23. Guo discloses that “[n]asal sprays with a low viscosity provided
greater surface coverage of the nasal mucosa than higher viscosity
formulations” and that commonly used viscosity-enhancing polymers added
to commercial nasal formulations to increase the retention time of
medications in the nasal cavity, prevent dripping, and enhance the physical
stability of suspended drugs include hydroxypropyl methylcellulose
(HPMC) (Guo, Abstract; id. at 1871; see Ans. 14).
FF 24. Examiner finds that the combination of Ha, Bepreve, Astelin,
Williams, Ophthalmology, Bountra, and Guo does “not teach administering
a composition comprising HPMC or that HPMC is HMPC E15 LV” (Ans.
17–18).
FF 25. Mehta discloses that “[p]oloxamers in combination with HPMC are
suitable to develop stable, safe in situ temperature-based mucoadhesive
gelling systems with prolonged nasal residence time” (Mehta, Abstract; see
also id. at Results and Discussion (Mehta discloses that “[a]mong the
various polymers tried, only HPMC E-15 was able to form a consistent gel
at low concentration of Poloxamers”); see Ans. 18).
FF 26. Examiner finds that Mehta does “not teach [that its] HPMC E-15 is
HPMC E-15 LV” (Ans. 18).
FF 27. Examiner finds that “Methocel® is a trademark for hydroxypropyl
methylcellulose, CAS 9904-65-3” (Ans. 18 (citing Dow 10)).
FF 28. Dow discloses that “[b]ecause the viscosity of a solution depends on
the concentration of METHOCEL, this wide range of product viscosity
allows you to obtain the viscosity you want in a formulation, while using a
concentration that gives the desired level of other performance properties”
(Dow 1; see Ans. 18).
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FF 29. Dow discloses that “[s]everal different suffixes are . . . used to
identify special products,” wherein “LV refers to special ‘low viscosity’
products” (Dow 1; see Ans. 18).
FF 30. Williams discloses that the pH range of the anterior of the nose is
5.17–8.13 and the pH range of the posterior of the nose 5.20–8.00
(Williams).
FF 31. Williams discloses that “[n]asal anterior pH can be decreased when
buffers of 0.13 M and above are used. Mildly acidic solutions produce an
increase in pH presumably due to reflux bicarbonate secretion. Posterior
nasal pH was not altered by administration of any buffer except the 0.13 M
buffer at pH 5.8,” which “produced a rise in posterior pH” (Williams).
ANALYSIS
The rejection over the combination of Ha, Ophthalmology, Bepreve, Astelin,
and Williams:
Based on the combination of Ha, Ophthalmology, Bepreve, Astelin,
and Williams, Examiner concludes that, at the time Appellant’s invention
was made, it would have been prima facie obvious to treat allergic rhinitis
with a nasal spray composition comprising bepotastine besilate,
preservative, chelating agent, buffer, and tonicity agent (see Ans. 9; see also
FF 1–12). Although Examiner finds that “Ha does not teach a
pharmaceutical composition wherein the amount of bepotastine besilate is in
the amount of 2–8% w/v,” Examiner reasons that it would have been prima
facie obvious to optimize the amount of bepotastine besilate in a nasal spray
composition using, as a starting point, the 1.5% bepotastine besilate
concentration disclosed by Ophthalmology for a nasal composition (Ans.
10).

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Claim 59:
Ophthalmology and Williams both disclose formulations comprising
bepotastine besilate for the treatment of allergic rhinitis (see FF 8 and 13).
More specifically, after the publication date of Ha, Ophthalmology disclosed
“a phase I/II clinical study of bepotastine besilate nasal spray for the
treatment of symptoms associated with seasonal allergic rhinitis” (FF 8).
Therefore, we are not persuaded by Appellant’s contention “that one of
ordinary skill in the art would not select bepotastine besilate . . . over the
crystalline metal salt hydrate described in Ha in a method of treatment”
(Appeal Br. 5; see also id. at 6–7 (Appellant contends that “Examiner cannot
simply ignore all the negative consequences of placing bepotastine
besilate . . . in an aqueous formulation when these negative consequences are
explicitly provided in the cited reference”)).
We recognize Appellant’s contentions regarding the solubility of
bepotastine besilate and crystalline bepotastine metal salt hydrate at different
pHs (see Appeal Br. 5–6) and Williams’ disclosure of the pH ranges for the
anterior and posterior portions of a nose (FF 31). Given, however,
Ophthalmology’s disclosure of “a phase I/II clinical study of bepotastine
besilate nasal spray for the treatment of symptoms associated with seasonal
allergic rhinitis” (FF 8), we are not persuaded by the assertions of
Appellant’s counsel that “Ha teaches one of ordinary skill in the art that
solubility would decrease upon administering the pharmaceutical nasal spray
composition, resulting in undesirable outcomes, e.g., difficulty controlling
the dose” and, therefore, “one of ordinary skill in the art would not select
bepotastine besilate . . . as the active ingredient in a nasal spray formulation
in light of Ha’s disclosure” (Appeal Br. 5; see also id. at 6–7 (Appellant’s
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counsel makes similar assertions regarding the moisture conditions of the
nose and racemization of the active ingredients)). In re Pearson, 494 F.2d
1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the
place of evidence.”).
Examiner’s conclusion of obviousness is based upon the combination
of Ha, Ophthalmology, Bepreve, Astelin, and Williams (see Ans. 6–12).
Appellant does not address the disclosures of Ophthalmology, Bepreve,
Astelin, or Williams (see Appeal Br. 4–7). Therefore, we are not persuaded
by Appellant’s contention of a rejection of “Appellant’s claims based on the
teachings of Ha,” alone, which fails to account for the disclosures of
Ophthalmology, Bepreve, Astelin, and Williams as relied upon by Examiner.

Claim 69:
Examiner failed to establish that any of Ha, Ophthalmology, Bepreve,
Astelin, or Williams, alone or in combination, suggest a composition
comprising HPMC (see FF 1–13; see generally Appeal Br. 7).
Therefore, the rejection of claim 69 over the combination of Ha,
Ophthalmology, Bepreve, Astelin, and Williams is reversed.

The rejection over the combination of Ha, Ophthalmology, Bepreve, Astelin,
Williams, Bountra, and Guo:
Based on the combination of Ha, Ophthalmology, Bepreve, Astelin,
Williams, Bountra, and Guo, Examiner concludes that, at the time
Appellant’s invention was made, it would have been prima facie
obvious to one of ordinary skill in the art to modify the method
of treating rhinitis comprising nasally administering a nasal
spray composition comprising bepotastine besilate, a
suspending agent, a buffer, a tonicity agent, a chelating agent
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and a preservative taught by the combination of Ha, Astelin®,
Bepreve®, Williams, and Ophthalmology Times to administer a
composition consisting of Avicel® CL-611 as the suspending
agent; disodium phosphate heptahydrate and citric acid as the
buffering agents; sodium chloride as the isotonicity adjusting
agent; benzalkonium chloride as the preservatives and EDTA as
the chelating agent; a taste masking agent; and polyoxyethylene
(20) sorbitan monooleate (Polysorbate 80) as the wetting agents
in view of the teachings of Bepreve®, Astelin® Product
Information; Bountra, and Guo.
(Ans. 15.) We find no error in Examiner’s prima facie case of obviousness.
Appellant does not address this rejection or, otherwise, address a
rejection of claims 63 and 64 (cf. Appeal Br. 4–8). Therefore, we are
compelled to affirm the rejection of these claims.

The rejection over the combination of Ha, Bepreve, Astelin, Williams,
Ophthalmology, Bountra, Guo, Mehta, and Dow:
Based on the combination of Ha, Bepreve, Astelin, Williams,
Ophthalmology, Bountra, Guo, Mehta, and Dow, Examiner concludes that,
at the time Appellant’s invention was made, it would have been prima facie
obvious to one of ordinary skill in the art to modify the method
of treating rhinitis comprising administering bepotastine
besilate via nasal administration taught by the combination of
Ha, Bepreve®, Astelin®, Williams, Ophthalmology Times,
Bountra and Guo, to include HPMC E-15 in the intranasal
composition in view of the teachings of Mehta.
(Ans. 18.)

Claim 59:
For the foregoing reasons, we are not persuaded by Appellant’s
contention that the “[r]ejection of claim 59 under Section 103 is clearly
erroneous” (Appeal Br. 7; see generally id. at 4–7).
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Claim 68:
Guo discloses that “[n]asal sprays with a low viscosity provided
greater surface coverage of the nasal mucosa than higher viscosity
formulations” and that commonly used viscosity-enhancing polymers added
to commercial nasal formulations to increase the retention time of
medications in the nasal cavity, prevent dripping, and enhance the physical
stability of suspended drugs include hydroxypropyl methylcellulose
(HPMC) (FF 23). In addition, Mehta discloses that “[p]oloxamers in
combination with HPMC are suitable to develop stable, safe in situ
temperature-based mucoadhesive gelling systems with prolonged nasal
residence time.” (FF 25.)
Appellant’s claim 68 does not exclude poloxamers from its
formulation (see id. at 10–11). Therefore, we are not persuaded by
Appellant’s contention that
Mehta teaches only that a combination of poloxamers and
HPMC provides the disclosed benefits. However, claim 68
does not recite poloxamers, making Mehta’s disclosure of
absolutely no relevance to Appellant’s claimed method. For at
least this additional reason, claim 68 is patentable over the cited
references.
(Id. at 7.)
Therefore, in sum, we are not persuaded by Appellant’s contention
that Appellant’s “[c]laim 68 is patentable over the cited references for at
least the same deficiencies of Ha noted above” or that claim 68 “recites a
unique combination of features neither taught nor reasonably suggested
by . . . [Ha],” which fails to account for the combined disclosures of Ha,
Ophthalmology, Bepreve, Astelin, Williams, Bountra, Guo, Mehta, and Dow
(Appeal Br. 7; cf. Ans. 17–19; FF 1–23).
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Claim 69:
For the foregoing reasons, we are not persuaded by Appellant’s
contention that “[c]laim 69 is patentable over the cited references for at least
the same deficiencies of Ha and Mehta noted above and because this claim
recites a unique combination of features neither taught nor reasonably
suggested by the cited references” (Appeal. Br. 7).

CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to the rejection of claim 59 under 35
U.S.C. § 103(a) as unpatentable over the combination of Ha,
Ophthalmology, Bepreve, Astelin, and Williams. Therefore, this rejection is
affirmed. Claims 60–62 are not separately argued and fall with claim 59.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to the rejection of claim 69
under 35 U.S.C. § 103(a) as unpatentable over the combination of Ha,
Ophthalmology, Bepreve, Astelin, and Williams. Therefore, this rejection is
reversed.
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to the rejection of claims 63 and 64
under 35 U.S.C. § 103(a) as unpatentable over the combination of Ha,
Ophthalmology, Bepreve, Astelin, Williams, Bountra, and Guo. Therefore,
this rejeciton is affirmed.
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to the rejection of claims 59, 68, and
Appeal 2019-002793
Application 13/462,375

19
69 under 35 U.S.C. § 103(a) as unpatentable over the combination of Ha,
Bepreve, Astelin, Williams, Ophthalmology, Bountra, Guo, Mehta, and
Dow. Therefore, this rejection is affirmed. Claims 63 and 67 are not
separately argued and fall with claim 68.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
59–62, 69 103 Ha, Ophthalmology,
Bepreve, Astelin,
Williams
59–62 69
63, 64 103 Ha, Ophthalmology,
Bepreve, Astelin,
Williams, Bountra,
Guo
63, 64
59, 63, 67, 68, 69 103 Ha, Bepreve,
Astelin, Williams,
Ophthalmology,
Bountra, Guo,
Mehta, Dow
59, 63,
67–69

59–64, 67 Nonstatutory
Double Patenting
13/462,466,
Preswetoff-Morath
59–64, 67
59–62 Nonstatutory
Double Patenting
13/505,426
59–62
Overall
Outcome
59–64,
67–69

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