Appeal No. 2001-1101 Page 7
Application No. 08/932,834
cover").
We now turn to a consideration of claim 14, cast in Markush format and reciting,
in the alternative, 15 prodrugs of lisofylline. The examiner argues that it would require
undue experimentation "to get lisofylline to actually work" (Paper No. 43, page 7, line 7).
It follows, according to the examiner, that applicants' specification does not teach any
person skilled in the art how to use the prodrugs recited in claim 14 without undue
experimentation. In other words, the examiner's argument centers on lisofylline. If
persons skilled in the art know how to use lisofylline, within the meaning of 35 U.S.C.
§ 112, first paragraph, the examiner would not deny that such persons would also know
how to use the 15 prodrugs recited in claim 14.
It is uncontroverted on this record that "lisofylline is the subject [of] FDA-
sanctioned Phase II and Phase III clinical trials." See the Paradise Declaration, filed
under the provisions of 37 CFR § 1.132, executed June 17, 1999, paragraph 3 and
Appendix E. As stated in In re Brana, 51 F.3d 1560, 1568, 34 USPQ2d 1436, 1442-43
(Fed. Cir. 1995), in the context of a PTO rejection under 35 U.S.C. § 112, first
paragraph,
Were we to require Phase II testing [FDA-sanctioned Phase II trials] in
order to prove utility, the associated costs would prevent many companies
from obtaining patent protection on promising new inventions, thereby
eliminating an incentive to pursue, through research and development,
potential cures in many crucial areas such as the treatment of cancer.
A fortiori, that lisofylline is the subject of FDA-sanctioned Phase II and Phase III clinical
trials establishes, on this record, that any person skilled in the art knows how to use
lisofylline within the meaning of 35 U.S.C. § 112, first paragraph. As stated in the
Paradise Declaration, paragraph 3., "[m]erely getting such trials approved require [sic]
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