Appeal No. 2001-1970 Page 6
Application No. 08/260,190
cancer is associated with abnormal MN expression. Id., page 25. He concluded,
however, that the claims are not enabled throughout their full scope because the
specification “does not reasonably provide enablement for methods of treating
neoplastic diseases and/or pre-neoplastic disease associated with abnormal MN
gene expression, and of inhibiting the growth of a cancer cell that expresses MN
protein in vivo.” Id.
The examiner’s enablement analysis considered several of the Wands
factors. See the Examiner’s Answer, pages 4-12. In particular, the examiner
relied on the following findings:
• The nature of the invention was a “nucleic acid therapy method.”
Examiner’s Answer, pages 5-6.
• “At the time of filing the art recognized antisense therapy as in its
infancy and as highly unpredictable.” Id., page 6. More specifically,
“[d]etermining an effective antisense sequence, and transferring the
antisense sequence to adequate numbers of target cells in vivo and
getting specific binding between the antisense sequence and the
target mRNA in an amount sufficient to produce a beneficial effect in
any animal remain[ed] unpredictable at the time the invention was
made.” Id. The examiner cited several references discussing
various problems remaining to be overcome in the field of antisense
therapy. See id., pages 6-10.
• The breadth of the claims “encompasses a wide range of antisense
sequences, oligo structures, vector types, or compositions
employed as therapeutic agents in the claimed antisense therapy
methods to treat a wide range of different types of cancer
associated with MN expression, in any and/or all vertebrate animals
including humans.” Id., page 10.
• The specification provides working examples showing in vitro
inhibition of tumorigenic cell growth and inhibition of MN gene
expression. Id., page 11. However, the specification does not
“demonstrate a reasonable correlation between the in vitro data,
i.e., in vi[tro] inhibition of proliferation of a cultured tumorigenic
human cell line (CGL3 cells) by direct injection of plasmids
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007