Appeal No. 2004-2035
Application 09/978,763
stent of Palmaz coated with at least “a polyvinyl aromatic coating containing the substantially
water-insoluble drug,” with the closest prior art of Berg, which is a coil stent of Wiktor coated
with the same drug containing polyvinyl aromatic coating, wherein the difference is solely the
patterned stent vis-à-vis the coil stent, and appellants do not contend otherwise. See generally,
In re Baxter Travenol Labs., 952 F.2d 388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991)
(“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown
to be unexpected compared to the closest prior art. [Citation omitted.]”); In re Burckel, 592 F.2d
1175, 1179, 201 USPQ 67, 71 (CCPA 1979) (the claimed subject matter must be compared with
the closest prior art in a manner which addresses the thrust of the rejection); In re Dunn, 349
F.2d 433, 439, 146 USPQ 479, 483 (CCPA 1965) (“[W]e do not feel it an unreasonable burden
on appellants to require comparative examples relied on for non-obviousness to be truly
comparative. The cause and effect sought to be proven is lost here in the welter of unfixed
variables.”).
Thus, at best, appellants are left with relying on the comparisons in the specification as
indirect evidence of nonobviousness, and therefore, have the further burden of presenting
analysis based on established scientific principles demonstrating how such evidence indirectly
distinguishes the claimed patterned stents over the teachings of Berg. See, e.g., In re Best,
562 F.2d 1252, 1254, 195 USPQ 430, 432 (CCPA 1977) (“[I]ndirect comparisons, based on
established scientific principles, can validly be applied to distinguish a claimed chemical process
or product from that disclosed in the prior art.”); In re Blondel, 499 F.2d 1311, 1317, 182 USPQ
294, 297-98 (CCPA 1974) (“Appellants’ brief goes through a detailed, step-by-step analysis of
the evidence in support of the conclusion to be drawn from the indirect comparison . . . ,”
establishing that the indirect evidence provided a reliable indication of the performance of the
closest claimed and prior art compounds).
On this record, and in the absence of an explanation or evidence establishing the practical
significance of the evidence relied on with respect to the ground of rejection, including analysis
establishing that the indirect evidence is reliable, we find that appellants have not carried the
burden of demonstrating any difference between the claimed stents and those of Berg based
solely on the type of stent that is coated. It is readily apparent that there are substantial
differences between the specification Examples and Comparative Examples in that the polymeric
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