Padilla, Angel et al.

Patent Trials and Appeals Board

May 19, 2020

2019005504 (P.T.A.B. May. 19, 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.
13/462,466 05/02/2012 Angel Padilla 078807.37 2562
27805 7590 05/19/2020
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
05/19/2020 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 2019-005504
Application 13/462,446
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), Appellant1 appeals2 from Examiner’s
decision to reject claims 69–76 and 78–88 (Appeal Br. 2). We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 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 Holding Corp., of Rochester, NY” (Appellant’s December 20,
2018 Appeal Brief (Appeal Br.) 2).
2 Appellant identifies Application 13/462,375 (Appeal 2019-002793), now
abandoned, as “potentially related” to the present Appeal. A Decision on
Appeal was entered into the record of Appeal 2019-002793 January 9, 2020
affirming rejections under 35 U.S.C. § 103 and nonstatutory double
patenting.
Appeal 2019-005504
Application 13/462,446

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STATEMENT OF THE CASE
Appellant’s disclosure relates to methods of using “compositions
comprising bepotastine as a free base, pharmaceutically acceptable salt,
solvate, or physiologically functional derivative thereof, and at least one
corticosteroid as a free form, pharmaceutically acceptable salt, solvate, or
physiologically functional derivative thereof, the composition which is
effective for suppressing nasal inflammatory conditions” (Spec.3 1).
Appellant’s independent claims 69, 79, 86, and 88 are reproduced below:
69. A method of treating at least one of rhinitis, mucosal
inflammation associated with rhinitis, sinusitis, rhinosinusitis,
and runny nose and stuffy nose symptoms associated with
rhinitis, mucosal inflammation associated with rhinitis,
sinusitis, or rhinosinusitis in a patient in need of such treatment,
the method comprising:
nasally administering a pharmaceutical composition, the
composition consisting essentially of:
a corticosteroid, the corticosteroid formulated with a
sufficient concentration of a suspending agent excipient to
result in a corticosteroid suspension, the corticosteroid as a free
form, pharmaceutically acceptable salt, or solvate;
bepotastine as a free base, pharmaceutically acceptable
salt, or solvate at a concentration ranging from 0.5% w/v to
8.00% w/v in aqueous solution;
at least one pharmaceutically compatible buffer;
at least one tonicity agent;
at least one chelating agent; and one of either
a blend of microcrystalline cellulose and carboxymethyl
cellulose with polyoxyethylene (20) sorbitan monooleate
(polysorbate 80) or hydroxypropylmethylcellulose (HPMC)

3 Appellant’s May 2, 2012 Specification.
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E15 LV with citric acid monohydrate and a taste-masking
agent;
the composition administered 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 runny nose and stuffy nose symptoms associated with
rhinitis, mucosal inflammation associated with rhinitis,
sinusitis, or rhinosinusitis.
(Appeal Br. 9 (emphasis added).)
79. A method to treat at least one of rhinitis, mucosal
inflammation associated with rhinitis, sinusitis, rhinosinusitis,
and runny nose and stuffy nose symptoms associated with
rhinitis, mucosal inflammation associated with rhinitis,
sinusitis, or rhinosinusitis, the method comprising:
nasally administering to a patient in need thereof a
composition consisting essentially of:
bepotastine besilate;
a corticosteroid, the corticosteroid formulated with a
sufficient concentration of a suspending agent excipient to
result in a corticosteroid suspension, the corticosteroid as a free
form, pharmaceutically acceptable salt, solvate, or
physiologically functional derivative thereof;
dibasic sodium phosphate heptahydrate;
sodium chloride, edetate disodium;
benzalkonium chloride; and one of either:
a blend of microcrystalline cellulose and carboxymethyl
cellulose and/or polyoxyethylene (20) sorbitan monooleate
(polysorbate 80), or
hydroxypropylmethyl cellulose (HPMC), citric acid
monohydrate, and
taste-masking agent;
under conditions to treat at least one of rhinitis, mucosal
inflammation associated with rhinitis, sinusitis, rhinosinusitis,
and runny nose and stuffy nose symptoms associated with
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rhinitis, mucosal inflammation associated with rhinitis,
sinusitis, or rhinosinusitis.
(Id. at 11 (emphasis added).)
86. A method of treating at least one of rhinitis, mucosal
inflammation associated with rhinitis, sinusitis, rhinosinusitis,
and runny nose and stuffy nose symptoms associated with
rhinitis, mucosal inflammation associated with rhinitis,
sinusitis, or rhinosinusitis in a patient in need of such treatment,
the method comprising nasally administering 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 runny nose and stuffy nose
symptoms associated with rhinitis, mucosal inflammation
associated with rhinitis, sinusitis, or rhinosinusitis, a
pharmaceutical composition consisting of
a corticosteroid, the corticosteroid formulated with a
sufficient concentration of a suspending agent excipient to
result in a corticosteroid suspension, the corticosteroid as a free
form, pharmaceutically acceptable salt, solvate,
bepotastine as a free base, pharmaceutically acceptable
salt, solvate at a concentration ranging from 0.5% w/v to 8.00%
w/v in aqueous solution;
dibasic sodium phosphate heptahydrate at a concentration
of 0.10% w/v to 1.00% w/v;
sodium chloride at a concentration of 0.9% w/v with
0.5% bepotastine, 0.4% w/v with 2.00%-3.00% bepotastine,
0.3% w/v with 4.00% bepotastine, 0.2% w/v with 6.00%
bepotastine, 0.1 % w/v with 8.00% bepotastine;
edetate disodium at a concentration of 0.005% w/v to
0.100% w/v;
benzalkonium chloride at a concentration of 0.002% w/v to
0.200% w/v; and one of either:
a blend of microcrystalline cellulose and carboxymethyl
cellulose at a concentration of 0.5% w/v to 2.5% w/v and
polyoxyethylene (20) sorbitan monooleate (polysorbate 80) at a
concentration of 0.005% w/v to 0.050% w/v, or
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hydroxypropylmethylcellulose (HPMC) E15 LV at a
concentration of 0.01 % w/v to 1.00% w/v, citric acid
monohydrate at a concentration of 0.10% w/v to 1.00% w/v,
and a taste-masking agent at a concentration of 0.01 % w/v to
1.00% w/v.
(Id. at 12–13 (emphasis added).)
88. A method of treating at least one of rhinitis, mucosal
inflammation associated with rhinitis, sinusitis, rhinosinusitis,
and runny nose and stuffy nose symptoms associated with
rhinitis, mucosal inflammation associated with rhinitis,
sinusitis, or rhinosinusitis in a patient in need of such treatment,
the method comprising
nasally administering a pharmaceutical
composition consisting essentially of
a corticosteroid as a free form, pharmaceutically
acceptable salt, or solvate in suspension;
bepotastine as a free base, pharmaceutically
acceptable salt, solvate at a concentration ranging from
0.5% w/v to 8.00% w/v in aqueous solution; and
at least one of (a) a blend of microcrystalline
cellulose and carboxymethyl cellulose, (b)
polyoxyethylene (20) sorbitan monooleate (polysorbate
80), and (c) hydroxypropyl methyl cellulose (HPMC)
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 runny nose and stuffy
nose symptoms associated with rhinitis, mucosal inflammation
associated with rhinitis, sinusitis, or rhinosinusitis.
(Id. at 13–14 (emphasis added).)

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Grounds of rejection before this Panel for review:4
Claims 69–73, 76, 78, and 88 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Pipkin.5
Claims 79–85 and 88 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pipkin, Flonase,6 and Bepreve.7
Claims 74, 75, 86, and 87 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pipkin, Flonase, Bepreve, and
Bountra.8
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
The rejection of claims 69–73, 76, 78, and 88:
Examiner concludes that, at the time Appellant’s invention was made,
it would have been prima facie obvious in view of Pipkin (Ans.9 4–8; see
also Final Act.10 4–9). We are not persuaded.

4 Application 13/462,375 abandoned March 17, 2020. Thus, the provisional
nonstatutory obviousness-type double patenting rejection over this
Application is moot and will not be discussed further.
5 Pipkin et al., US 2009/0312724 A1, published Dec. 17, 2009.
6 FLONASE®, Nasal Spray, 50 mcg, Prescribing Informaiton, 1–13
(GlaxoSmithKline, March 2004).
7 ISTA Pharmaceuticals, Inc., Bepreve™ Ophthalmic Solution (Highlights
of Prescribing Information) (Aug. 2009).
8 Bountra et al., WO 2010/026129 Al, published Mar. 11, 2010.
9 Examiner’s March 8, 2019 Answer.
10 Examiner’s June 22, 2018 Final Office Action.
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The transitional phrase “consisting essentially of,” as set forth in
Appellant’s independent claims 6911 and 88, limits the scope of the nasally
administered pharmaceutical composition to the specified materials “and
those that do not materially affect the basic and novel characteristic(s)” of
that composition. See In re Herz, 537 F.2d 549, 551–52 (CCPA 1976).
As Appellant explains, on this record, “[t]he composition of [Pipkin’s]
invention is a corticosteroid solution comprising a corticosteroid and SAE-
CD” (Appeal Br. 6 (citing Pipkin ¶ 82)). Pipkin discloses:
By including SAE-CD in a liquid composition containing
corticosteroid, the corticosteroid is dissolved. The
corticosteroid exhibits greater stability in the presence of SAE-
CD than it does in its absence. When a second active agent is
present, the second active agent can also exhibit greater stability
in the presence of SAE-CD than it does in its absence.
(Pipkin ¶ 83; see also Appeal Br. 6.) Thus, as Appellant explains, “the
presence of SAE-CD[, in Pipkin’s composition,] materially affects the
behavior of the corticosteroid in the formulation” (Appeal Br. 6). We agree.
For the foregoing reasons, we are not persuaded by Examiner’s
assertion that “SAE-CD is an excipient (e.g. solubilizer)” and “it is unclear
how the inclusion of other excipient agents would materially change the
characteristics of [Appellant’s] invention” (Ans. 17; see also Final Act. 5).
For the foregoing reasons, the rejection of claims 69–73, 76, 78, and
88 is reversed.

11 Appellant’s claims 70–73, 76, 78 depend directly or indirectly from claim
69 (see Appeal Br. 9–11).
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The rejection of claims 79–85 and 88:
Examiner finds that “Pipkin suggests all the limitations of claims 79,
80, and 88 . . ., except wherein the composition comprises bepotastine
besilate and fluticasone propionate, dibasic sodium phosphate heptahydrate,
sodium chloride, edetate disodium, benzalkonium, and a blend of
microcrystalline cellulose and carboxymethyl cellulose” (Ans. 9 and 10; see
also Final Act. 10). To make up for these deficiencies in Pipkin, Examiner
relies on Flonase to disclose “a fluticasone propionate nasal spray
comprising microcrystalline cellulose, carboxymethylcellulose sodium,
benzalkonium chloride, and polysorbate” and Bepreve to disclose “a
composition comprising bepotastine besilate, benzalkonium chloride,
sodium chloride, and monobasic sodium phosphate dehydrate” (Ans. 10–11
(citing Flonase 1 and Bepreve 9); see also Final Act. 11 (citing Flonase 1
and Bepreve 9)).
Thus, based on the combination of Pipkin, Flonase, and Bepreve,
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 select sodium
chloride, edetate disodium, benzalkonium, and a blend of
microcrystalline cellulose and carboxymethyl cellulose to
formulate a composition consisting of fluticasone propionate
and bepotastine besilate based on the fact that these are known
components useful in formulating commercially available
compositions of fluticasone propionate and/or bepotastine
besilate . . . [and] formulate the composition rendered obvious
by the prior art formulated in any of the administration devices
disclosed based on the fact that these are methods known in the
art that are suitable for administering a composition for the
treatment of allergic rhinitis, resulting in the practice of the
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method of claims 81-85 with a reasonable expectation of
success.
(Ans. 11–12; see also Final Act. 11–12.) We are not persuaded.
The transitional phrase “consisting essentially of,” as set forth in
Appellant’s independent claims 7912 and 88, limits the scope of the nasally
administered pharmaceutical composition to the specified materials “and
those that do not materially affect the basic and novel characteristic(s)” of
that composition. See Herz, 537 F.2d at 551–52. As discussed above, the
presence of SAE-CD, in Pipkin’s composition, is evidenced to materially
affect the behavior of the corticosteroid in the formulation and Examiner
failed to establish that Flonase or Bepreve, either alone or in combination,
cure this deficiency in Pipkin (see Appeal Br. 7 (Appellant contends that
“neither Flonase nor Bepreve, either alone or in combination, cure the noted
deficiencies of Pipkin”).

The rejection of claims 74, 75, 86, and 87:
Examiner finds that the combination of Pipkin, Flonase, and Bepreve,
as discussed above, suggests all the limitations of the rejected claims with
the exception of “the claimed amount of the claimed components” and relies
on Bountra to make up for this deficiency (Ans. 12–13; see also Final Act.
12–13). According to Examiner, “[t]he amount of the agents present is
clearly a result effective parameter that a person of ordinary skill in the art
would routinely optimize” (Ans. 13; see also Final Act. 13). We are not
persuaded.

12 Appellant’s claims 80–85 depend directly or indirectly from claim 79 (see
Appeal Br. 9–11).
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Appellant’s claims 74 and 75 depend from Appellant’s independent
claim 69. The transitional phrase “consisting essentially of,” as set forth in
Appellant’s independent claim 69 and, thus, its dependent claims 74 and 75,
limits the scope of the nasally administered pharmaceutical composition to
the specified materials “and those that do not materially affect the basic and
novel characteristic(s)” of that composition. See Herz, 537 F.2d at 551–52.
As discussed above, the presence of SAE-CD, in Pipkin’s composition, is
evidenced to materially affect the behavior of the corticosteroid in the
formulation and Examiner failed to establish that Flonase, Bepreve, or
Bountra, either alone or in combination, cure this deficiency in Pipkin (see
Appeal Br. 7 (Appellant contends that “none of Flonase, Bepreve, and
Bountra, either alone or in combination, cure the noted deficiencies of
Pipkin”).
Appellant “additionally note[s] the use of the transitional phrase
‘consisting of,’ and the lack of SAE-CD listed in . . . claim [86]. Thus,
claim 86 clearly excludes SAE-CD” (Appeal Br. 7). We agree. Because
Appellant’s claim 87 depends from claim 86, the rejection of claim 87
suffers from the same deficiency as the rejection of Appellant’s claim 86.
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 69–73, 76, 78, and 88 under 35 U.S.C.
§ 103(a) as unpatentable over Pipkin is reversed.
The rejection of claims 79–85 and 88 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pipkin, Flonase, and Bepreve is
reversed.
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The rejection of claims 74, 75, 86, and 87 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pipkin, Flonase, Bepreve, and Bountra
is reversed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
69–73, 76,
78, 88
103 Pipkin 69–73,
76, 78, 88
79–85, 88 103 Pipkin, Flonase,
Bepreve
79–85, 88
74, 75, 86,
87
103 Pipkin, Flonase,
Bepreve, Bountra
74, 75,
86, 87
Overall
Outcome
69–76,
78–88

REVERSED