Ex Parte Bissery

Board of Patent Appeals and Interferences

Dec 16, 2010

10422823 (B.P.A.I. Dec. 16, 2010)

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.
10/422,823 04/25/2003 Marie-Christine Bissery 3806.0281-08 7896
22852 7590 12/16/2010
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON, DC 20001-4413
EXAMINER
MARX, IRENE
ART UNIT PAPER NUMBER
1651
MAIL DATE DELIVERY MODE
12/16/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARIE-CHRISTINE BISSERY
__________

Appeal 2010-000599
Application 10/422,823
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of treating leukemia with a combination of docetaxel and a vinca
alkaloid. The Patent Examiner rejected the claims on the ground of
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-000599
Application 10/422,823

2
STATEMENT OF THE CASE
Claims 45, 47, 48, 55, 56 and 58-60, which are all the pending claims,
are on appeal. Claim 45 is representative and reads as follows:
45. A method of treating a leukemia in a human patient comprising
administering an effective amount of a combination of docetaxel and a
vinca alkaloid to the patient, wherein the combination of docetaxel
and the vinca alkaloid has greater anticancer activity against said
leukemia in the human patient than the optimum dose of docetaxel
alone against said leukemia in the human patient or the optimum dose
of the vinca alkaloid alone against said leukemia in the human patient.

The Examiner rejected the claims under 35 U.S.C. § 103(a) as
unpatentable over Bissery (1992)2 and Bissery (1991).3

OBVIOUSNESS
The Issue
The Examiner’s position is that Bissery (1992) described the
successful treatment of leukemia in mice with a combination of docetaxel
and vincristine, a vinca alkaloid. (Ans. 3.) The Examiner found that the
mouse was a known model for cancer therapy, as shown for example by
Bissery (1991), which also disclosed that docetaxel was useful for treating
two types of leukemia. (Id.) Given those facts, the Examiner concluded that
it would have been obvious to use the combination of docetaxel and
vincristine or other vinca alkaloids for treating leukemia in humans “with a

2 M.C. Bissery et al., In vivo evaluation of Taxotere (RP56976, NSC628503)
in combination with cisplatinum, doxorubicin, or vincristine, Abstract no.
2645 in 33 PROC. AMER. ASSOC. CANCER RES. 443 (1992).
3 Marie-Christine Bissery et al., Experimental Antitumor Activity of
Taxotere (RP 56976, NSC 628503), a Taxol Analogue, 51 CANCER RES.
4845-4852 (1991).
Appeal 2010-000599
Application 10/422,823

3
reasonable expectation of success . . . for the expected benefit of
successfully treating leukemia effectively.” (Id.)
Appellant contends that the claims recite that the combination of
docetaxel and a vinca alkaloid has greater anticancer activity than either
agent alone, but the references cited by the Examiner “fail to teach or
suggest these unexpected results.” (App. Br. 10.) Appellant points to the
Bissery (1992) disclosure that “‘[a]t the maximum tolerated dose, the
combinations tested [including the combination of docetaxel and vincristine,
a vinca alkaloid] were as active as the most active agent in the
combination’).” (Id.) Appellant concludes “[t]hus, the prior art does not
lead one skilled in the art to expect the novel and non-obvious results of the
instant invention.” (Id.)
The issue with respect to this rejection is whether a person of ordinary
skill in the art would have reasonably expected the combination of docetaxel
and vincristine to have a greater anticancer activity than the optimum dose
of either drug alone.

Findings of Fact
We adopt the Examiner’s findings concerning the scope and content
of the prior art references.

Principles of Law
Obviousness requires finding that the prior art provided a reason for
carrying out a claimed process, and provided a reasonable expectation of
success in achieving the claimed beneficial result. In re Dow Chemical Co.,
Appeal 2010-000599
Application 10/422,823

4
837 F.2d 469, 473 (Fed. Cir. 1988). “The expectation of success must be
founded in the prior art, not in the applicant’s disclosure.” Id.

Analysis
We agree with the Examiner that the prior art suggested treating
leukemia in humans with a combination of docetaxel and a vinca alkaloid.
We also agree that there would have been a reasonable expectation of
successfully treating the cancer with the combination.
The claims on appeal, however, define a method in which the
combination has greater anticancer activity than the optimum dose of either
drug alone. We agree with Appellant that the prior art does not provide an
expectation of that result because Bissery (1992) states that the combination
was only as effective as the most active drug in the combination. Because
the prior art does not provide a reasonable expectation of achieving the
claimed result, we reverse. See Dow Chemical, 837 F.2d at 473. The
evidence supports finding that the expected result would have been the one
reported by Bissery (1992). Thus, the cited references would not have led
those skilled in the art to expect the superior result that Appellant claims.

CONCLUSION
The evidence does not support finding that a person of ordinary skill
in the art would have reasonably expected the combination of docetaxel and
vincristine to have a greater anticancer activity than the optimum dose of
either drug alone.

Appeal 2010-000599
Application 10/422,823

5
SUMMARY
We reverse the rejection of claims 45, 47, 48, 55, 56 and 58-60 under
35 U.S.C. § 103(a) as unpatentable over Bissery (1992) and Bissery (1991).

REVERSED

lp

FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON DC 20001-4413