Appeal No. 1997-4138
Application No. 08/384,681
dots thereon which contain an insolubilized binding partner of the component to be
determined.
DISCUSSION
The rejections under 35 U.S.C. § 103
In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of
presenting a prima facie case of obviousness. In re Oetiker, 977 F.2d 1443, 1445, 24
USPQ2d 1443, 1444 (Fed. Cir. 1992). Only if that burden is met, does the burden of
coming forward with evidence or argument shift to the applicants. Id. In order to meet that
burden the examiner must provide a reason, based on the prior art, or knowledge
generally available in the art as to why it would have been obvious to one of ordinary skill in
the art to arrive at the claimed invention. Ashland Oil, Inc. v. Delta Resins & Refractories,
Inc., 776 F.2d 281, 297 n.24, 227 USPQ 657, 667 n.24 (Fed. Cir. 1985), cert. denied, 475
U.S. 1017 (1986).
Claims 27 - 31, 33 - 44, 46 - 52, 54-55, and 62 - 63:
On the record before us, the examiner has not met the initial burden of establishing
why the prior art relied on would have led one of ordinary skill in this art to modify the assay
of Fish, Wada, Gordon, or Towbin in a manner to arrive at the presently claimed assay kit
(Claim 27) or assay (Claim 46), both of which require the presence or use of "a working
reagent conjugate of predetermined concentration of at least about 15 micrograms per ml
5
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