Appeal No. 2006-1565 Page 3
Application No. 09/757,610
13. The method of Claim 10 wherein the pathologically proliferating cells are
those causing restenosis.
Discussion
In its broadest aspect, the present invention is directed to a method of treating
patients suffering from conditions involving various kinds of pathologically proliferating
cells, wherein treatment comprises administering a therapeutically effective amount of an
inhibitor of glutathione-dependent formaldehyde dehydrogenase in an amount effective to
kill or reduce the proliferation rate of the pathologically proliferating cells.
Claims 8-14 stand rejected under 35 U.S.C. § 112, first paragraph, as the
specification “does not reasonably provide enablement for killing or reducing the growth
of pathologically proliferating mammalian cells in vivo” (Answer, page 3). According to
the examiner, “[t]he specification fails to provide information that would allow the skilled
artisan to practice the invention without undue experimentation” (id.), because
“[t]herapies involving cancer and pathologically proliferating cells are unpredictable” (id.
page 4), and “[t]he working examples lack sufficient data to understand if the clinical
results will invariably occur” (id.).
While “enablement requires that the specification teach those in the art to make
and use the invention without ‘undue experimentation,’ [the fact] [t]hat some
experimentation may be required is not fatal; the issue is whether the amount of
experimentation is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444
(Fed. Cir. 1991) (citation omitted, emphasis original). Whether the amount of
experimentation required is undue is determined by reference to the well-known Wands
factors. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
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