Appeal No. 2001-1431
Application No. 07/968,553
The examiner finds this deficiency to be remedied by Ellis, who teaches
“an immunoassay method . . . in which positive and negative calibration
standards are used to determine the cut-off point between positive and negative
samples.” Id. The examiner concludes that “[i]t would have been obvious to one
of ordinary skill in the art at the time the invention was made to use the cut-off
determination of Ellis et al for determining the median channel of the standard
microbeads in the method of Schwartz because Ellis et al teach using positive
and negative calibrators [to] achieve a rapid, accurate cut-off for qualitative
determinations of disease in samples.” Id.
“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 going 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 is “whether the teachings of the prior art, taken
as a whole, would have made obvious the claimed invention.” In re Gorman, 933
F.2d 982, 986, 18 USPQ2d 1885, 1888 (Fed. Cir. 1991).
Prima facie obviousness based on a combination of references requires
that the prior art provide “a reason, suggestion, or motivation to lead an inventor
to combine those references.” Pro-Mold and Tool Co. v. Great Lakes Plastics
Inc., 75 F.3d 1568, 1573, 37 USPQ2d 1626, 1629 (Fed. Cir. 1996).
[E]vidence of a suggestion, teaching, or motivation to combine may
flow from the prior art references themselves, the knowledge of one
of ordinary skill in the art, or, in some cases, from the nature of the
problem to be solved. . . . The range of sources available, however,
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