Ex Parte Rajan

Patent Trial and Appeal Board

Feb 23, 2016

13205785 (P.T.A.B. Feb. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/205,785 08/09/2011
51957 7590 02/25/2016
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
Kothanda Raman T. Rajan
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.
18452CON (AP) 2550
EXAMINER
FAY,ZOHREHA
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
02/25/2016 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):
patents_ip@allergan.com
pair_allergan@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KOTHANDA RAMAN T. RAJAN1
Appeal2013-011056
Application 13/205,785
Technology Center 1600
Before DEMETRA J. MILLS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
STATEivIENT OF THE CASE
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Non-Final Rejection of claims 1-14 as unpatentable under
35 U.S.C. § 103(a) as being obvious over Babu et al. (US 2005/0085446
Al, April 25, 2005) ("Babu").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
1 Appellant states the real party-in-interest is Allergan, Inc. App. Br. 2.
Appeal2013-011056
Application 13/205,785
Appellant's invention is directed to gatitloxacin and prednisolone
topical ophthalmic pharmaceutical compositions for the prevention and
treatment of ophthalmic bacterial infections and inflammatory conditions
associated with pre-surgical and/or postsurgical ocular surgeries. Abstract.
REPRESENTATIVE CLAIM
Appellant argues the claims together. App. Br. 5-9. Claim 1 is
representative and recites:
1) A topical ophthalmic composition for treating or
preventing ophthalmic bacterial infections in a human patient
wherein the ophthalmic composition comprises:
gatifloxacin in a concentration of 0.01%to1.5% w/v;
prednisolone acetate in a concentration of 0.01 % w/v - 2.0%
w/v; and
a pH value in the range of 6.5 to 7.4 ..
App. Br. 16.
THE EXAMINER'S PRIMA F ACIE CASE OF OBVIOUSNESS
The Examiner finds Babu explicitly teaches the use of gatifloxacin
and prednisolone in an ophthalmic formulation for the treatment of
ophthalmic infection. Non-Final Act. 3 (citing Babu i-fi-f 17, 18, 41, and 43;
claims 1, 9, and 10). The Examiner concludes it would have been obvious to
use the claimed specific concentrations of prednisolone and gatifloxacin,
because Babu, teaches concentrations of fluoroquinolone active agents and
steroidal anti-inflammatory agents (including gatifloxacin and prednisolone)
that are encompassed within the scope of the claims. Id. (citing Babu i1 31;
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Application 13/205,785
claim 1 ). We agree with the Examiner's reasoning and conclude the
Examiner has established a prima facie case of obviousness.
ISSUE
Appellant argues Babu does not teach or suggest the limitations of the
claimed invention. App. Br. 5.
ANALYSIS
Appellant contends Babu does not expressly or impliedly disclose the
concentration range of gatifloxacin (0.01 % to 1.5% w/v) and prednisolone
acetate (0.01 % w/v - 2.0% w/v). App. Br. 5. Nor, Appellant argues, does
Babu disclose benzalkonium chloride in the amount of 0.005% w/v,
methylcellulose, sodium phosphate dibasic dehydrate, sodium phosphate
monobasic, edetate disodium, and IN hydrochloric acid. Id. Consequently,
asserts Appellant, Babu does not teach the present application. Id.
Specifically, Appellant argues that gatofloxacin is but one among
eleven fluoroquinolone compounds disclosed in Babu. Id. at. 6. Appellant
asserts that ciprofloxacin is the fluoroquinolone most emphasized by Babu;
most of Babu's examples, argues Appellant, recite results from experiments
using ciprofloxacin-based compositions. Id. (citing Babu i-f 41 ). According
to Appellant, one of skill in the art would therefore be prompted to choose
ciprofloxacin as a fluoroquinolone, rather than gatofloxacin. Id.
Appellant argues further that Babu provides no teaching, suggestion,
or motivation that would direct one of ordinary skill in the art to
preferentially select a pharmaceutical composition comprising a
fluoroquinolone and a steroid over a pharmaceutical composition comprising
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Application 13/205,785
a fluoroquinolone and a nonsteroidal anti-inflammatory agent. App. Br. 5.
According to Appellant, a skilled artisan could have picked either of these
two combinations to create a pharmaceutical composition for treating a
bacterial infection of the eye. Id. at 5---6.
Appellant also argues that Babu provides a list of steroid compositions
that may be used, including cortisone, hydrocortisone, corticosterone,
deoxycorticosterone, prednisolone, methyl prednisolone, meprednisone,
triamcinolone, paramethasone, flupredniso lone, betamethasone,
dexamethazone, fludrocortisone, and combinations thereof. App. Br. 7.
However, argues Appellant, Babu does not disclose that prednisolone has a
higher anti-inflammatory activity than hydrocortisone, nor does Babu
employ prednisolone in any examples. Id. Appellant points to the Non-
Final Office Action, which states: "Furthermore, one skilled in the art would
have been motivated to pick prednisolone based on the higher anti-
inflammatory activity over cortisone." Id. (quoting Non-Final Act. 3).
Appellant alleges that this conclusion is derived from Appellant's
Specification, which discloses: "Prednisolone acetate is a glucocorticoid and
has three to five times the anti-inflammatory potency of hydrocortisone." Id.
(quoting Spec. 5). Appellant suggests the Examiner's findings are taken
from Appellant's Specification and argues, therefore, that this constitutes an
impermissible use of hindsight analysis. Id. (citing In re Deuel, 51 F .3d
1551, 1558 (Fed. Cir. 1995).
Appellant also disputes the Examiner's finding that the combination
of gatifloxacin and prednisolone has been previously used in an ophthalmic
formulation. App. Br. 8 (see Non-Final Act. 3). Rather, Appellant contends,
the only data related to ocular use presented in Figures 1 and 2 of Babu
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which show data for a ciprofloxacin/hydrocortisone composition in an in
vitro tear tum-over experiment. Id.
Finally, argues Appellant, the claimed composition of 0.3%
gatifloxacin and 1 % prednisolone acetate is currently available under the
registered trademark Zypred® in Brazil and Mexico. Appellant points to
Table II of the Specification, which Appellant alleges shows that Zypred®
has a very good response among patients. Id. Appellant contends the data
presented in Table II demonstrates the superior properties of Zypred®,
which Appellant argues represent unexpected results as compared to the data
presented by Babu, which discloses only data with respect to in vitro tear
tum-over. Id.
The Examiner responds that picking individual species within a genus
is considered to be within the skill of artisan in the absence of evidence to
the contrary. Ans. 5. The Examiner finds claim 1 of Babu provides
motivation for a person skilled in the art to arrive at the claimed
concentrations, which encompass the claimed concentrations. Id.
The Examiner also finds there is no evidence of record to show that
the claimed combination at the specified concentrations is advantageous, or
provides unexpected results, compared to the other fluoroquinolone
antibiotics and steroids disclosed by Babu. Ans. 5.
The Examiner is not persuaded by Appellant's arguments with respect
to the unexpected results of the claimed combination, as demonstrated in
Table II of Appellant's Specification. The Examiner finds Table II presents
data from a survey of a doctors who administered the combination to their
patients. Id. The Examiner finds such survey is considered subjective and is
not supported by any comparative data. Id.
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Finally, with regard to Appellant's argument that the Examiner
impermissibly employed hindsight analysis in finding prednisolone acetate
is 3-5 times more potent as an anti-inflammatory than hydrocortisone, the
Examiner points out that, in the Non-Final Office Action, Appellant was
provided prior art for commercial prednisolone (Prednistab) showing the
higher anti-inflammatory activity of prednisolone over other corticoids,
including cortisone and hydrocortisone. Ans. 5 (citing Office Act. July 24,
2012; see Non-Patent Literature, July 24, 2012). The Examiner therefore
finds the higher anti-inflammatory activity of prednisolone was well-known
in the art at the time of Appellant's invention. Id.
We are not persuaded by Appellant's arguments. Claim 1 of Babu
recites:
1. An aqueous pharmaceutical composition comprising:
from 5 to 100 mg/mL of a fluoroquinolone active agent;
from 0 to 100 mg/mL of a steroidal or non-steroidal anti-
inflammatory agent; from 1 to 40% by weight of
cyclodextrin;
from 0.1 to 25 molar equivalents of a hydroxy acid; and
water to balance, said formulation having a pH between 4.5 and
7.
Moreover, dependent claim 9 of Babu teaches: "The composition
according to claim 1, wherein said fluoroquinolone is selected from the
group consisting of Gatifloxacin, Moxifloxacin, Sitafloxacin, Lomefloxacin,
Grepafloxacin, Gemifloxacin, Norfloxacin, Ofloxacin, Levofloxacin,
Trovafloxacin, Ciprofloxacin and combinations thereof."
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Furthermore dependent claim 10 recites: "The composition according
to claim 1, wherein said steroidal or non-steroidal anti-inflammatory
compound is a steroidal compound and is selected from the group consisting
of cortisone, hydrocortisone, corticosterone, deoxycorticosterone,
prednisolone, methylprednisolone, meprednisone, triamcinolone,
paramethasone, fluprednisolone, betamethasone, dexamethazone,
fludrocortisone, and combinations thereof."
We agree with the Examiner, therefore, that Babu teaches the
limitations of claim 1. Appellant argues that a person of ordinary skill in the
art would have no reason, upon reading the teachings of Babu, to select
gatifloxacin as the fluoroquinolone and prednisolone as the steroidal anti-
inflammatory agent and that, because ciprofloxacin is used as an exemplary
species, a person of ordinary skill would recognize that it is a constituent of
the preferred embodiment of Babu. See App. Br. 6. However, even if we
accept, arguendo, Appellant's argument that ciprofloxacin is a constituent of
a preferred embodiment, when conducting an obviousness analysis, "all
disclosures of the prior art, including unpreferred embodiments, must be
considered." Merck & Co., Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804,
807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA
1976)).
In the instant appeal, gatifloxacin is one of a limited number of
fluoroquinones (indeed, the first) specifically enumerated in claim 9.
Similarly, prednisolone is listed as one of a number of specifically-
enumerated acceptable anti-inflammatory compositions listed in claim 10.
"The combination of familiar elements according to known methods is likely
to be obvious when it does no more than yield predictable results." KSR
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Int'! Co. v. Teleflex inc., 550 U.S. 398, 416 (2007). Furthermore, "[i]fa
person of ordinary skill can implement a predictable variation, § 103 likely
bars its patentability." Id. at 417. We therefore agree with the Examiner's
conclusion that it would have been obvious to combine the potential
constituents recited in the claims of Babu to arrive at the claimed
composition
Appellant's argument that the Examiner impermissibly employed
hindsight fails in light of the Examiner's unrebutted provision of prior art in
the Non-Final Action that teaches that prednisolone has higher activity than
hydrocortisone.
Nor is Appellant's argument of unexpected results persuasive. Table
II of Appellant's Specification depicts the results of a customer satisfaction
survey directed to physicians who have used Appellant's claimed
composition. However, there is nothing in the survey to indicate that the
results obtained are or would be in any way different from any of the other
compositions taught by Babu, nor is there any clinical data citing the
comparative efficacy of Appellant's composition with respect to other
species taught by Babu.
We consequently agree with the Examiner's conclusion that the
claimed composition is obvious over Babu, and we affirm the Examiner's
rejection.
CONCLUSION
We agree with the Examiner's findings and conclusions establishing a
primafacie case of obviousness and we do not find Appellant's arguments
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to the contrary persuasive. We consequently atlirm the Examiner's rejection
of the claims.
DECISION
The Examiner's rejection of claims 1-14 as unpatentable under
35 U.S.C. § 103(a) is affirmed.
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). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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