Appeal No. 2001-1970 Page 8
Application No. 08/260,190
the references cited by the examiner focus on optimization of antisense therapy
to the point that it would be ready for clinical application. This standard,
Appellants argue, is higher than what is required for enablement. See the
Appeal Brief, pages 26-27. Appellants point to the approval of clinical trials using
antisense oligonucleotides as evidence of enablement. See id., pages 29-30.
In support of each of the above arguments, Appellants cite declaratory
evidence they submitted during prosecution. See the declaration submitted
under 37 CFR § 1.132 by Dieter Cotter Gruenert (Paper No. 27, filed July 17,
1997), Appendix II to the Appeal Brief. The examiner disputes the probative
value of the declaration, because “[s]ections 3, 4, 5, 6, and 8 as to the in vitro
data . . . do not provide factual evidence to indicate that antisense nucleic acid
therapy to treat all tumor bearing vertebrate animals . . . is reasonabl[y] predictive
at the time the invention was made, nor do the sections provide factual evidence
to demonstrate an extrapolation from the guidance and/or in vitro data disclosed
in the as-filed application to the entire scope of the claimed invention.”
Examiner’s Answer, pages 24-25.
“When rejecting a claim under the enablement requirement of section 112,
the PTO bears an initial burden of setting forth a reasonable explanation as to
why it believes that the scope of protection provided by that claim is not
adequately enabled by the description of the invention provided in the
specification of the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement. If the PTO meets this burden, the burden then shifts to the
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