Appeal No. 2006-0275 Page 4
Application No. 09/964,667
All of the pending claims stand rejected under 35 U.S.C. § 112, first
paragraph, for lack of enablement. The examiner concedes that “antisense may
be used in treatment of disease” (Answer, page 14), but argues that the
specification “provides only general guidance for the various antisense based
nucleic acid compounds used in the claimed method” (id. page 4), even though
“[t]he art of nucleic acid based therapies is [ ] unpredictable” (id., page 6).
Moreover, the examiner argues that “the specification has not even shown any
particular cancer disease that has as its causation, an overexpression of AD7c-
NTP” (id., page 7). Along the same lines, the examiner argues that the
specification “does not identify any particular cancer where the inhibition of
[AD7c-NTP] activity or expression is ameliorative” (id., page 10).
“When rejecting a claim under the enablement requirement of section
112,” it is well settled that “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.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510,
1513 (Fed. Cir. 1993).
“Although the statute does not say so, enablement requires that the
specification teach those in the art to make and use the invention without ‘undue
experimentation.’ In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.
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