Appeal No. 2002-1251 Page 6
Application No. 08/459,340
As discussed above, the specification describes the claimed composition
in the manner required by 35 U.S.C. § 112. The rejection for inadequate written
description is therefore reversed.
2. Enablement
The examiner also rejected all of the claims on the basis of lack of
enablement. The examiner asserts that
[o]ne skilled in the art would not accept on its face based on the
limited guidance provided in the specification, the ability to deliver
the claimed ribozymes via a composition in vivo such that target
can be cleaved and further provide some effect within a whole
organism. Note Branch who teach[es] that delivery of ribozymes in
vivo is a highly unpredictable endeavor. The specification as filed
fails to teach with particularity formulations of ribozymes which
would necessarily be expected to deliver any ribozymes to a whole
organism such that [the] target can be cleaved in the appropriate
cells etc… and further where secondary effects might be provided
such as for treatment as implied by the pharmaceutical language.
Essentially no general guidelines to date are known for [the]
successful delivery of ribozymes. Only limited examples are
known. To date, undue trial and error experimentation depending
on the target would have to be engaged [in] in order to practice the
invention as claimed.
Examiner’s Answer, pages 3-4.
Thus, the examiner does not seem to seriously dispute that the
specification teaches those skilled in the art how to make compositions
comprising a nucleozyme and a pharmaceutically acceptable carrier. We
understand the examiner’s position to be that the specification does not
adequately teach how to use such compositions because it does not disclose
how to administer the claimed composition so as to produce a therapeutically
beneficial effect.
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