Appeal No. 2001-1431
Application No. 07/968,553
The examiner has not adequately explained why a person of skill in the art
would have been motivated to combine the positive and negative calibrators,
used by Ellis in an immunoassay, with the flow cytometry technique disclosed by
Schwartz. The references are directed to different problems encountered when
using different techniques. There is simply nothing in the cited references that
bridges the gap between their respective teachings. There is no suggestion, for
example, that the reproducibility problem addressed by Schwartz could also be
solved by the use of Ellis’ calibrators.
The examiner asserted that those skilled in the art would have appreciated
the applicability of Ellis’ calibrators to Schwartz’s method because
both radioimmunoassay and flow cytometry are directed toward the
detection and/or quantitation of an analyte, both use a labeling
system for the detection of said analyte and both use some type of
standards or controls to aid in the detection of the analyte,
therefore, the principle of negative/positive controls found to be
effective in one type of detection assay should also be expected to
provide the same function in a similar type of detection assay.
Examiner’s Answer, pages 7-8. While this rationale may be enough to establish
a reasonable expectation of success, it does not establish adequate motivation to
combine the references. First, we disagree that Schwartz “use[s] some type of
standards or controls to aid in the detection of the analyte,” as the examiner
characterizes it. Schwartz’s use of standards is not intended to aid in
determining whether a given measurement corresponds to a positive result, but
only to ensuring that measurements taken at different times, using different
machines, are reproducible.
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