Appeal No. 2004-2035
Application 09/978,763
coating material is not identified for the Comparative Examples, no delivery rate of Taxol®
stated in µg/day is disclosed for either of the Comparative Examples, and the stents used in these
examples are a balloon expandable NIR® patterned stent in the Examples and an undescribed
coil stent in the Comparative Examples. Appellants have presented no scientific explanation or
objective evidence explaining the practical significance of the PLA/PCL copolymer/paclitaxel
matrix coatings vis-ŕ-vis the unidentified polymeric/Taxol® coatings of the third party stents,
and certainly not with the polyvinyl aromatic/different drug coatings taught by Berg, which does
not disclose either paclitaxel or Taxol®. In these respects, we found above that Berg clearly
teaches that the delivery rate of the polymer/drug matrix depends on the polymer and the drug,
and all that appealed claim 75 requires is a delivery rate over at least seven days of a drug in an
amount that prevents or inhibits undesired cellular proliferation.
Accordingly, on this record we are of the opinion that the evidence in the specification as
relied on by appellants in the brief and reply brief, is entitled to little, if any, weight. See
Lindner, 457 F.2d at 508, 173 USPQ at 358 (“The affidavit and specification do contain
allegations that synergistic results are obtained with all the claimed compositions, but those
statements are not supported by any factual evidence other than that limited amount of evidence
discussed above. This court has said . . . that mere lawyers’ arguments unsupported by factual
evidence are insufficient to establish unexpected results. [Citations omitted.] Likewise, mere
conclusory statements in the specification and affidavits are entitled to little weight when the
Patent Office questions the efficacy of those statements. [Citations omitted]”).
Accordingly, based on our consideration of the totality of the record before us, we have
weighed the evidence of obviousness found in Berg with appellants’ countervailing evidence of
and argument for nonobviousness and conclude that the claimed invention encompassed by
appealed claims 75, 76, 78, 80 through 82, 84 through 87 and 90 through 94 would have been
obvious as a matter of law under 35 U.S.C. § 103(a).
As the examiner points out (answer, page 7), appellants have not separately argued in the
brief the grounds of rejection under § 103(a) of claim 77 over the combined teachings of Berg
and Hunter and of claim 83 over Berg alone, and we find no argument in these respects in the
reply brief. Accordingly, we summarily conclude that the claimed invention encompassed by
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