Ex Parte Muller et al

Board of Patent Appeals and Interferences

Mar 29, 2011

10856192 (B.P.A.I. Mar. 29, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHRISTOPHER A. MULLER, JANET K. CHEETHAM,
TERESA H. KUAN, and DAVID F. POWER
__________

Appeal 2011-001915
Application 10/856,192
Technology Center 1600
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-16. We have jurisdiction under 35 U.S.C.
§ 6(b).
STATEMENT OF THE CASE
Claims 1 and 2 are representative of the claims on appeal, and read as
follows:
1. An aqueous topical ophthalmic composition comprising from 0.35%
to 0.45% ketorolac tromethamine.
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Application 10/856,192

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2. The aqueous topical ophthalmic composition of claim 1 comprising
0.4% ketorolac tromethamine.

In addition, each of claims 4-6 and 9-16 are drawn to compositions
and methods requiring 0.4% ketorolac tromethamine.
The following ground of rejection is before us for review:
Claims 1-16 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by Fu.1
We affirm as to claims 1, 3, 7, and 8, but reverse as to claims 2, 4-6,
and 9-16.
ISSUE
Have Appellants presented evidence of unexpected results, that when
weighed with the evidence of obviousness, is sufficient to demonstrate the
unobviousness of a 0.4% ketorolac composition?

FINDINGS OF FACT
FF The Examiner’s statement of the rejection may be found at pages 3-4
of the Answer. We adopt the Examiner’s findings of fact and conclusion
regarding the prima facie case of obviousness as our own.
PRINCIPLES OF LAW
One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of “unexpected results,” i.e.,
to show that the claimed invention exhibits some superior
property or advantage that a person of ordinary skill in the
relevant art would have found surprising or unexpected. The

1 Fu et al., US 5,414,011, issued May 9, 1995.
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basic principle behind this rule is straightforward-that which
would have been surprising to a person of ordinary skill in a
particular art would not have been obvious.

In re Soni, 54 F.3d 746, 750 (Fed. Cir.1997).
“When prima facie obviousness is established and evidence is
submitted in rebuttal, the decision-maker must start over.” In re Rinehart,
531 F.2d 1048, 1052 (CCPA 1976); In re Hedges, 783 F.2d 1038, 1039
(Fed. Cir. 1986) (“If a prima facie case is made in the first instance, and if
the applicant comes forward with reasonable rebuttal, whether buttressed by
experiment, prior art references, or argument, the entire merits of the matter
are to be reweighed”).
In addition, “when unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991). A showing of unexpected results must also be commensurate in
scope with the breadth of the claims. In re Grasselli, 713 F.2d 731, 743
(Fed. Cir. 1983).

ANALYSIS
Appellants do not argue the prima facie case, but assert that “a 0.4%
ketorolac composition provides unexpected results . . . over the 0.5%, 0.25%
and 0.10% w/v ketorolac formulations as taught in Fu” (App. Br. 3). As
Appellants do not argue the broader claims, of which claim 1 is
representative, we conclude that the Examiner has set forth a prima facie
case of obviousness as to those claims, which has not been rebutted, and thus
affirm the rejection of those claims, that is, claims 1, 3, 7, and 8.
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Application 10/856,192

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As to the 0.4 % ketorolac composition, Appellants cite the Sandoval
paper to demonstrate that the 0.4% solution is just as effective as the 0.5%
solution, but has significantly less side effects (id. at 4). With respect to the
0.25% and 0.1% ketorolac compositions taught by Fu, Appellants cite the
Declaration of Mayssa Attar (Attar Declaration), attached to the Appeal
Brief as Exhibit B. The Declaration states that based on their
pharmacokinetic data and mathematical models using that data, a 0.1%
ketorolac composition would have to be administered 15 times a day, and a
0.25% ketorolac composition would have to be administered 7 times a day,
to provide an equivalent amount of ketorolac as the 0.4% ketorolac
composition provides when administered 4 times a day (Attar Declaration,
¶¶5-7; see also App. Br. 4-5).
In response to the above data, the Examiner concludes that it would
have been well within the level of skill of the ordinary artisan to administer a
higher concentration of an active agent less frequently. The Examiner also
asserts that the “data are not commensurate in scope with the claimed
language. Such data are done at one concentration, however the independent
claims are not limited to one concentration” (Ans. 5).
The Examiner’s response, however, does not address why the
ordinary artisan would have expected the lower concentration compositions
taught by Fu have to be administered more frequently than would be
suggested by just the difference in concentrations. That is, why a 0.25%
ketorolac composition would have to be administered 7 times a day to
deliver the same amount of active as a 0.4% ketorolac composition, and why
a 0.1% ketorolac composition would have to be administered 15 times a day
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to deliver the same amount of active as a 0.4% ketorolac composition
administered 4 times a day. The Examiner also does not address the
statements in the declaration that that administration 7 or 15 times a day
would not be acceptable for treating ocular inflammation in a patient (see
(Attar Declaration, ¶¶10, 12). Moreover, the Examiner did not address the
evidence in the Sandoval paper, or provide any evidence or persuasive
reason to expect a 0.4% ketorolac composition to provide the same
effectiveness, but fewer side effects, compared to a 0.5% solution. As to the
Examiner’s statement that the claims are not commensurate in scope, claims
2, 4-6, and 9-16 are limited to a 0.4% ketorolac composition.

CONCLUSION OF LAW
We conclude that Appellants have presented evidence of unexpected
results, that when weighed with the evidence of obviousness, is sufficient to
demonstrate the unobviousness of a 0.4% ketorolac composition.
Thus, as to the rejection of claims 1-16 under 35 U.S.C. § 103(a) as
being rendered obvious by Fu, we affirm the rejection as to claims 1, 3, 7,
and 8, but reverse as to claims 2, 4-6, and 9-16.

Appeal 2011-001915
Application 10/856,192

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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-IN-PART

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