Appeal No. 2004-0394 Page 3
Application No. 09/915,467
DISCUSSION
According to appellant (Request, page 2), “[i]t is undisputed that the prior art
acknowledges a long-felt need for the problem of teratogen-related birth defects.”
Nevertheless, appellant asserts (Request, page 3), “[d]espite a panoply of proposed
solutions, as recently as 2001 the art had failed to solve this problem. This failure to
solve the long-felt need is shown both by [pregnancy] data collected by the
manufacturer of ACCUTANEŽ isotretinoin, and by the United States Food & Drug
Administration’s interpretation of this data.” According to appellant (Request, page 4),
“[t]he reason for these pregnancies, despite ostensibly clear admonitions to avoid
pregnancy, is unclear.” However, appellant notes that Woodcock (Appendix to Brief)
asserts “exclusive reliance on ‘human memory’ is not an adequate precaution for
managing severe risks.” Id. According to appellant (id.),
The Food & Drug Administration thus concluded that “additional
systematized measures to manage risk and fully inform patients and
families should be instituted, given the devastating impact of potential side
effects.” … Notably, the FDA advanced this position in 2001 – clearly
showing that the long-felt need remained unsatisfied at that time.”
Accordingly, appellant asserts (Request, bridging paragraph, pages 4-5,
footnotes omitted), since Abrams, Elsayed and PDR “were followed temporally by …
WOODCOCK … and by Roche Pharmaceuticals, Inc., APPENDIX I … the long-felt need
remained unfulfilled as recently as several months before Appellant filed the immediate
application.” In support of this assertion appellant states (Request, page 5, fn. 5):
Notably, ABRAMS, ELSAYED, and THE PHYSICIANS DESK REFERENCE each
preceded ROCHE PHARMACEUTICALS, INC., APPENDIX I (2001), and thus by
definition lacked knowledge of the data presented there. Thus, an earlier
allegation of solving the long-felt need (if such an allegation in fact were
shown in the record) would appear baseless, directly contradicted by the
subsequent 2001 data, and thus unsustainable as a matter of law.
I. Appellant’s implied satisfaction of a long-felt need unsupported by evidence:
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