Ex Parte Ousler et al

Patent Trial and Appeal Board

Apr 22, 2016

12154665 (P.T.A.B. Apr. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/154,665 05/23/2008
58249 7590 04/26/2016
COOLEYLLP
ATTN: Patent Group
1299 Pennsylvania Avenue, NW
Suite 700
Washington, DC 20004
FIRST NAMED INVENTOR
George W. Ouster III
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.
ACEX-004002US
322412-2012
9329
EXAMINER
FAY,ZOHREHA
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
04/26/2016 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):
zpatdcdocketing@cooley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE W. OUSLER III,
MATTHEW J. CHAPIN, and MARK B. ABELSON1
Appeal2013-008675
Application 12/154,665
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Aciex Therapeutics, Inc. App.
Br. 1.
Appeal2013-008675
Application 12/154,665
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 43, 49-54, and 60 as unpatentable
under 35 U.S.C. § 103(a) as being obvious over the combination of Sawa et
al. (US 2007/0287749 Al, December 13, 2007) ("Sawa"), Friedlaender et al.
(US 2007/0166402 Al, July 19, 2007) ("Friedlaender"), and Waterbury (US
4,454,151, June 12, 1984) ("Waterbury").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to compositions for treating and/ or
preventing signs and symptoms associated with dry eye and/or ocular
irritation, and methods of use thereof. Abstract. Such compositions are
provided in ophthalmic formulations that are comfortable upon instillation in
the eye. Id.
REPRESENTATIVE CLAIM
Appellants argue all claims on appeal together. App. Br. 7-9.
Independent claim 43 is representative of the claims on appeal, and recites:
43. An ophthalmic formulation consisting of a combination of:
1) a tear substitute component having has a viscosity ranging
from about 60-115 cpi; and
2) about 0.15% to about 0.32% ketorolac tromethamine
(wt/vol), wherein the combination is an aqueous solution
formulated for instilling into a human eye and is effective to
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Application 12/154,665
increase tear film break up time and ocular protection index,
and decrease ocular discomfort, thereby, treating or
preventing at least one sign and symptom of dry eye, wherein
the ophthalmic formulation does not produce an anesthetic
effect.
App. Br. 11.
ISSUE
Appellants argue the Examiner erred in finding the combination of
Sawa, Friedlaender, and Waterbury teaches or suggests the two limitations
of claim 43. App. Br. 7.
ANALYSIS
Appellants argue the combined cited prior art references neither teach
nor suggest the limitations of claim 43 reciting (1) the amount of ketorolac
(0.15% to 0.32%) and (2) the viscosity of the formulation (about 60-115
cpi). 1A .. pp. Br. 7. Appellants contend neither Sav,ra nor Friedlaender teach
any specific descriptions with respect to either the amounts of ketorolac that
are effective for ophthalmic use or the viscosity of the ophthalmic solution.
Appellants admit Waterbury provides a description of both parameters, but
fails to describe or suggest the specific parameters required by claim 43. Id.
According to Appellants, Waterbury does not describe an ophthalmic
solution ofketorolac within the claimed range of0.15% to 0.32%. App. Br.
8. Rather, Appellants argue, Waterbury teaches only exemplary solutions
with specific amounts of ketorolac, viz., 0.001 %, 0.003%, 0.01 %, 0.03%,
0.1 %, and 0.5%. Id. Furthermore, argue Appellants, Waterbury fails to
provide a reasonable expectation of success that 0.15% to 0.32% ketorolac
would be effective to inhibit ocular inflammation, which is the only effect
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Application 12/154,665
tested in Waterbury. Id. Appellants point to the examples of Waterbury,
which show that, in only one of three experiments designed to test this
efficacy, was a 0.1 % ketorolac solution's efficacy comparable to the
industry standard 0.5% solution. Id.
Appellants point next to the results provided in their Specification,
which, they argue, provides evidence that a 0.125% ketorolac solution is not
effective to decrease the ocular irritation associated with dry eye, as
demonstrated by its poor performance in the controlled adverse environment
("CAE") model. App. Br. 8 (citing Spec. 38, 11. 21-24. Therefore,
Appellants argue, a person of ordinary skill, combining the teachings of
Sawa and Waterbury, would at most arrive at a 0.1 % ketorolac formulation
ineffective for treating dry eye. Id.
Appellants argue further that Waterbury provides no teaching or
suggestion to alter the viscosity of its ketorolac formulations from 1 to the
60 to 100 cpi range, as required by claim 43. App. Br. 9. Appellants
contend the Examiner's finding that "[t]he use of different viscosity agents
in order to obtain the desired viscosity is shown by Sawa" is unsupported by
evidence and conclusory. Id. (quoting Final Act. 5). Appellants therefore
argue that the Examiner has failed to articulate any reasoning with some
rational underpinning to support the legal conclusion of obviousness. Id.
(citing KSR Int'! v. Teleflex Inc., 550 U.S. 398, 418 (2007).
The Examiner responds that Waterbury teaches a range of specific
concentrations of ketorolac tromethamine from 0.005%-----0.5% (w/vol),
which encompasses the range recited in claim 43. Ans. 6. With respect to
Appellants' argument concerning the advantages of the claimed specific
concentrations, the Examiner finds there is no evidence of record
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Application 12/154,665
demonstrating the advantages of choosing the claimed range from the range
of concentrations taught by Waterbury for the treatment of ocular irritation.
Id. The Examiner further finds the methods of inducing and measuring
ocular irritation disclosed in Appellants' Specification are significantly
different from those taught in the examples of Waterbury and that, therefore,
the results disclosed by the Specification are not comparable to the teachings
of Waterbury. Id. The Examiner finds further that the composition taught
by Waterbury is effective in reducing inflammatory conditions associated
with the dry eye. Id.
The Examiner further finds Sawa and Friedlaender teach the use of
different viscosity agents in order to obtain a desired viscosity. Ans. 6. The
Examiner finds Sawa teaches the use of the anti-inflammatory agent,
bromfenac, which is functionally equivalent to ketorolac tromethamine in
combination with the claimed tear substitutes in an ophthalmic formulation
for the treatment of dry eye syndrome. Ans. 7. The Examiner also finds
Sawa teaches the use of secondary non-steroidal anti-inflammatory agents,
including ketorolac, can be added to its bromfenac compositions.
The Examiner finds Friedlaender teaches the use of ketorolac
tromethamine in combination with the claimed tear substitutes, such as
hydroxypropylmethyl cellulose for the treatment of dry eye. Ans. 7.
The Examiner finds Waterbury teaches the use of ketorolac
tromethamine encompassing the claimed range concentrations for the
treatment of ophthalmic inflammatory conditions. Ans. 7. The Examiner
finds Waterbury teaches, in one exemplary study, that the efficacy of a
0.1 % solution was comparable to the efficacy of 0.5% ketorolac
tromethamine. Id.
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Application 12/154,665
The Examiner notes that Appellants have claimed a concentration
range within the scope of concentrations taught by Waterbury and claims the
use of the claimed composition for the treatment of the same disorder as
taught by the Friedlaender and Sawa. Ans. 7.
The Examiner finds a person of ordinary skill in the art would realize,
from the teachings of Sawa and Friedlaender, that it was well-known in the
art of formulating ophthalmic solutions to add viscosity agents to a ketorolac
tromethamine composition to adjust the viscosity of the composition to the
claimed range. Ans. 7. The Examiner therefore concludes that it would
have been obvious to, and well within the skill of, a person skilled in the art
to add the claimed viscosity agents to a ketorolac tromethamine-based
ophthalmic solution. Id.
We are not persuaded by Appellants' arguments. Appellants'
invention is directed to an ophthalmic formulation designed for "treating or
preventing at least one sign and symptom of dry eye." Claim 43. Sawa
teaches the use ofbromfenac, a non-steroidal anti-inflammatory agent, in
solution, for the treatment of, inter alia, dry eye. Sawa i-fi-13--4, 135. Sawa
also teaches the use of additional non-steroidal anti-inflammatory agents,
including ketorolac. Sawa i-f 112. It was therefore known in the prior art
that non-steroidal anti-inflammatory agents, including ketorolac, can be
effective in the treatment of dry eye.
Friedlaender teaches a composition for treatment of eye irritation
caused by foreign debris. Friedlander i18. Friedlaender also teaches
embodiments of the composition containing ketorolac tromethamine and an
artificial tear solution. Id. at i-fi-f 14--15.
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Waterbury teaches the use of ketorolac in the treatment of
inflammation of the ocular surface and describes effective results at the
specific concentrations of 0.02%, 0.1 %, 0.25%, and 0.3%, which include
concentrations falling within the range of "about 0.15% to about 0.32%"
recited in claim 43.
Finally, Sawa teaches the use of viscosity-increasing agents as
additives to compositions for the treatment of dry eye. Sawa i-fi-f 112-114.
Friedlaender similarly teaches the use of such agents. Friedlaender i-f 18.
Although neither reference explicitly teaches the range of viscosities recited
in clam 43 (60-115 cpi), we agree with the Examiner that, because the
references teach the use of viscosity modifying agents was well-known in
the art of ocular treatment compositions at the time of invention, a person of
ordinary skill in that art would have known how to adjust the concentrations
those agents to achieve the viscosities recited in claim 43.
We consequently agree with the Examiner's conclusion that it would
have been obvious to combine the teachings of the cited prior art references
to arrive at Appellants claimed invention. See KSR Int'! Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007) ("The combination of familiar elements according
to known methods is likely to be obvious when it does no more than yield
predictable results"). We therefore affirm the Examiner's rejection of the
claims.
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Application 12/154,665
DECISION
The Examiner's rejection of claims 43, 49-54, and 60 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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