Ex Parte BROWN et al

Board of Patent Appeals and Interferences

Sep 20, 2010

07937893 (B.P.A.I. Sep. 20, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL S. BROWN, JOSEPH L. GOLDSTEIN,
and YUVAL REISS
__________

Appeal 2009-0091091
Application 07/937,893
Technology Center 1600
__________

Before CAROL A. SPIEGEL, TONI R. SCHEINER, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL2
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 37, 39, 41, 42, 53, 54, 57, 58, and 60-62. We have jurisdiction under
35 U.S.C. § 6(b).

1 Heard September 16, 2010.
2 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.

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Application 07/937,893

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STATEMENT OF THE CASE
Claim 37, the only independent claim, is representative of the subject
matter on appeal:
37. An in vitro method for identifying a candidate substance having
the ability to inhibit a farnesyl transferase enzyme, comprising the steps of:

(a) obtaining an enzyme that is capable of transferring a farnesyl
moiety to a farnesyl acceptor substance;

(b) admixing a candidate substance with the enzyme and farnesyl
pyrophosphate in vitro;

(c) determining the ability of the farnesyl transferase enzyme to
transfer a farnesyl moiety to a farnesyl acceptor substrate in the
presence of the candidate substance and in the absence of the
candidate substance; and

(d) identifying a candidate substance having the ability to inhibit
the farnesyl transferase enzyme, wherein the identified
candidate substance has an IC50 of between 0.01 μM and 10
μM.

Claims 37, 39, 41, 42, 53, 54, 57, 58, and 60-62 stand rejected under
the doctrine of obviousness-type double patenting as unpatentable over
claim 6 of U.S. Patent 6,936,431 (‘431).3
In addition, claims 37, 39, 41, 42, 53, 54, 57, 58, and 60-62 stand
rejected under the doctrine of obviousness-type double patenting as
unpatentable over claims 18-34 of U.S. Patent 5,962,243 (‘243).4
We reverse.

3 U.S. Patent 6,936,431 B2, issued August 30, 2005 to Michael S. Brown,
Joseph L. Goldstein, and Yuval Reiss.
4 U.S. Patent 5,962,243, issued October 5, 1999 to Michael S. Brown,
Joseph L. Goldstein, and Guy L. James.
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Application 07/937,893

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FINDINGS OF FACT
Claim 6 of the ‘431 patent is as follows:
6. A method of determining the ability of a substance to inhibit
farnesyl transferase enzyme in cancer cells having a ras-related malignancy,
the method comprising:

(a) selecting a substance suspected of having the ability to inhibit
farnesyl transferse enzyme by a method that includes:

(i) obtaining an enzyme composition comprising a farnesyl
transferase enzyme that is capable of transferring a
farnesyl moiety to a farnesyl acceptor substance;

(ii) admixing the substance with the enzyme composition;

(iii) determining the ability of the farnesyl transferase enzyme
to transfer a farnesyl moiety to the farnesyl acceptor
substrate in the presence of the substance; and

(iv) selecting a substance found to have the ability to inhibit
the transfer of the moiety to the substrate; and

(b) determining the ability of the substance to inhibit farnesyl
transferase enzyme in malignant cells of a patient having a ras-
related cancer.

Claim 18 of the ‘243 patent is as follows:

18. A method of providing a farnesyl protein transferase inhibitor
comprising:

(a) obtaining a test composition comprising a compound suspected
of being a farnesyl protein transferse inhibitor;

(b) obtaining an enzyme composition comprising a farnesyl protein
transferase enzyme that is capable of transferring a farnesyl
moiety to a farnesyl acceptor substance wherein the farnesyl
protein transferase enzyme comprises a recombinant farnesyl
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protein transferase enzyme obtained by recombinant
expression;

(c) admixing farnesyl pyrophosphate, the enzyme composition and
the farnesyl acceptor substance with the test composition;

(d) determining the ability of the enzyme composition to transfer a
farnesyl moiety to the farnesyl acceptor substance in the
presence of the test composition, wherein the ability of the test
composition to inhibit the transfer of the farnesyl moiety to the
farnesyl acceptor substance confirms the identity of the test
composition to be a farnesyl protein transferase inhibitor; and

(e) providing the identified farnesyl protein transferase inhibitor.

Each of the appealed claims is narrower than claim 6 of the ‘431
patent, and narrower than claims 18-34 of the ‘243 patent, at least in part, in
that the final step of the appealed claims requires identifying a candidate
substance having the ability to inhibit the farnesyl transferase enzyme,
wherein the identified candidate substance has an IC50 that falls within a
defined range. None of the patented claims requires identifying a candidate
with any particular level of activity.
The present Specification discloses a number of exemplary peptides
incorporating a four amino acid farnesyl acceptor sequence “which have
been prepared, tested and shown to inhibit farnesyl transferase at an IC50 of
between 0.01 [μM] and 10 μM” (Spec. 15, 16).
DISCUSSION
Appellants contend that “claim 37 of the present application requires
‘identifying a candidate substance having the ability to inhibit the farnesyl
transferase enzyme, wherein the identified candidate substance has an IC50
of between 0.01 μM and 10 μM’” (App. Br. 7), while claim 6 of the ‘431
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Application 07/937,893

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patent and claims 18-34 of the ‘431 patent are “generic with respect to the
type of farnesyl transferase inhibitor that is identified and selected” (id. at 7,
11). Appellants contend that the patented claims “can be carried out using a
candidate substance that has an IC50 that is outside of the range of between
0.01 μM and 10 μM specified in claim 37 of the present application” (id. at
8).
In response, the Examiner argues:
[I]t would have been obvious to one of skill in the art of
medicinal chemistry to select that candidate which has a
maximum inhibiting activity[,] and to select any arbitrary range
of desired inhibiting activity in an assay to identify candidate
substances that are inhibitors does not lend unobviousness to
the assay.
(Ans. 5.)
Appellants reply that “[t]he Examiner has failed to come forward with
any evidence or argumentation that candidate substances having such an
IC50 were known or even possible, . . . [or] that the identification of such
candidate substances having such an activity is obvious” (Reply Br. 2).
Clearly, the patented claims would dominate the claims of the
invention, at least with respect to the class of inhibitor identified in the
method present method. But domination, “by itself, does not give rise to
‘double patenting’.” In re Kaplan, 789 F.2d 1574, 1577 (Fed. Cir. 1986);
see also In re Sarett, 327 F.2d 1005, 1007 (CCPA 1964). A proper
obviousness-type double patenting rejection “rest[s] on the fact that a patent
has been issued and later issuance of a second patent will continue
protection, beyond the date of expiration of the first patent, . . . of a mere
variation of that invention which would have been obvious to those of
ordinary skill in the relevant art[.]” Kaplan, 789 F.2d at 1579-80 (emphasis
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omitted). That being the case, “there must be some clear evidence to
establish why the variation would have been obvious” (id. at 1580).
The Examiner’s statement is essentially nothing more than an
assertion that the narrower claims of the application are dominated by the
generic claims of the patent. On this record, we are constrained to agree
with Appellants that the Examiner has not come forward with evidence that
the IC50 limitation in the present claims would have been an obvious
variation of the patented method.
SUMMARY
The rejection of claims 37, 39, 41, 42, 53, 54, 57, 58, and 60-62 under
the doctrine of obviousness-type double patenting as unpatentable over
claim 6 of U.S. Patent 6,936,431 is reversed.
The rejection of claims 37, 39, 41, 42, 53, 54, 57, 58, and 60-62 under
the doctrine of obviousness-type double patenting as unpatentable over
claims 18-34 of U.S. Patent 5,962,243 is reversed.

REVERSED

cdc

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