Appeal No. 2001-0544 Page 5
Application No. 08/195,048
teach a successful assay method which provides for the
immobilization of an anti-hCG antibody prior to contact with the
sample, and specifically teaches that such a method is highly
sensitive and extremely simple to carry out. Although neither
McClune [‘999] or Katz et al. specifically teach washing of the
antibody-analyte complex prior to incubation with enzyme-labeled
antibody, such a step would have been obvious to one of ordinary
skill in the art, since such modification of assay methods by
inclusion of additional wash steps is well-known and conventional.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
met, does the burden of coming forward with evidence or argument shift to the
applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993). “The test of obviousness vel non is statutory. It requires that one
compare the claim’s ‘subject matter as a whole’ with the prior art ‘to which said
subject matter pertains.” In re Ochiai, 71 F.3d 1565, 1569, 37 USPQ2d 1127,
1132 (Fed. Cir. 1995) (quoting 35 U.S.C. § 103).
In this case, the examiner has not carried the burden of showing prima
facie obviousness of the claimed subject matter as a whole. Specifically, in the
claimed method, after the solid support is contacted with a sample, it is washed
with a solution containing phenol or a derivative of phenol substituted with a C1 to
C3 alkyl group, chlorine, and/or bromine. The examiner has not explained why
the cited references would have made it obvious to carry out such a washing
step.
Every claim limitation is material and must be considered in the
obviousness analysis. See In re Angstadt, 537 F.2d 498, 581, 190 USPQ 214,
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