Appeal No. 2001-1970 Page 7
Application No. 08/260,190
expressing the antisense nucleic acids molecules of SEQ ID NO:3
of SEQ ID NO:4, and the [claimed method].” Id., page 5.
• Finally, the examiner found that the specification “failed to address”
many of the issues that have hampered development of antisense
therapeutic methods, including “stability of antisense nucleic acids
in an in vivo environment . . .; the ability of a chosen antisense
nucleic acid to reach and enter the target cell in vivo; . . . and
specificity of an administered nucleic acid . . . to generate a
desired therapeutic effect.” Id., pages 11-12.
The examiner concluded that “the specification is non-enabling in view of
the complex and unpredictabl[e] nature of the subject matter, the lack of
description and working examples which are correlating to the full scope of the
claimed subject matter, the lack of guidance provided as to the selection of
essential combination of parameters which would result in an effective
therapeutic composition, and the amount of undue experimentation required to
practice the full scope of the claimed invention.” Examiner’s Answer, page 12.
Appellants argue that the examiner has not made out a prima facie case
of nonenablement, for several reasons. Appellants argue that the claims are
relatively narrow, since the claims are limited to antisense sequences that are
complementary to part of SEQ ID NO:5, and the specification provides an in vitro
screening method that would enable those skilled in the art to select
therapeutically useful antisense oligonucleotides. See the Appeal Brief, pages
24-25.
Appellants also argue that methods of administering therapeutic
oligonucleotides were known in the art, as were methods for determining
appropriate dosages. See the Appeal Brief, pages 17-18. Appellants argue that
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