Interference No. 102,572
analysis of the cultures noted by Mumford at CR-37, ¶ 10 and at CR-37-38, ¶ 12 are those
of the heavy chain or light chain transformed cells and are not of cotransformed cells.
SDS-PAGE of refractile body preparations does not and cannot identify and verify
the production of the intended product because the refractile body preparations made by
E.coli require lysis and solubilization to permit recovery and then refolding of the
recovered heavy and light chains. Cabilly et al. offered no evidence to identify and verify
the refolded product as the intended protein product of the count.
A demonstration of binding activity in an assay does not establish that all of the
steps of the process have been performed and that the intended product was produced.
No declarant asserted that a conclusion as to the chemical composition or structure could
be drawn from the binding activity data. Schendel v. Curtis, 83 F.3d 1399, 1403-1404, 38
USPQ2d 1743, 1747 (Fed. Cir. 1996); Colbert, 21 USPQ2d at 1071. Because the
intended product has not been identified and verified there can be no appreciation of the
existence or operability of the intended product.
While the question of utility is actually moot, we add the following comments for
completeness. Herein, the count does not set forth a particular utility for the intended
product of the count. Evidence of substantial utility for any purpose is sufficient to prove
27(...continued)
entry): “[T]he gels are shown on [the] following pages. No real strong product bands could
be seen on either gel. It is possible that trace metal contamination would have occurred in
the new fermentors due to condensation pick-up during sterilization.”
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