Appeal No. 1996-1815
Application 07/690,841
Brown et al. (Brown), “Murine Monoclonal Antibodies,” Antibodies: A Practical Approach,
Vol. 1, (1988), pp. 81-104.
DISCUSSION
All of the claims stand rejected under 35 U.S.C. § 103. In regard to claims
1 through 8, 10 , 11, 14 and 18 through 23, the examiner relies upon Jastreboff and Brown
as evidence of obviousness. In regard to claims 15 through 17, the examiner relies upon
those two references and Navalgund. We reverse.
By now it is well settled that the initial burden of establishing unpatentability rests on
the examiner. In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir.
1992). Here, all the claims require the presence or use of a monoclonal antibody specific
for an antigenic determinant of thymidylate synthase wherein the monoclonal antibody has
sufficient binding affinity to detect thymidylate synthase in a Western blot assay.
Jastreboff describes the isolation of monoclonal antibodies which bind to
thymidylate synthase. However, the examiner agrees with appellants that the monoclonal
antibodies isolated in Jastreboff do not have sufficient binding affinity to detect thymidylate
synthase in a Western blot assay. Rather, we understand the examiner's position to be
that it would have been obvious to one of ordinary skill in the art to make other monoclonal
antibodies using the procedures set forth in Jastreboff with the reasonable expectation that
subsequent runs would produce monoclonal antibodies as required by the claims on
appeal. As set forth at page 9 of the Examiner's Answer, “the binding characteristics
required for use in Western blots are not unusual or rare, as evidenced by the large
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