Appeal No. 2006-0299 Page 4
Application No. 09/964,412
All of the pending claims stand rejected under 35 U.S.C. § 112, first
paragraph, for lack of enablement. The examiner acknowledges that “the
specification shows that the recombinant over-expression of AD7c-NTP in cells in
culture produces phenotypes associated with Alzheimer’s disease
neurodegeneration” (Answer, page 4). However, the examiner notes that the
specification “does not provide any examples of inhibiting AD7c-NTP in cells in
culture or in an animal . . . via the administration of antisense based nucleic acid
compounds” (id., page 6), even though “[t]he art of nucleic acid based therapies
[is] [ ] unpredictable” (id.).
“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).
The examiner cites a number of references as evidence of “the
unpredictability and the problems faced in the antisense art” (Answer, page 7).
The problems or challenges enumerated by the examiner are essentially these:
identification of an appropriate target in the disease process; identification of an
antisense molecule that can interfere with the disease process through specific
recognition and affinity; delivery of antisense oligonucleotides to the brain; the
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 Next
Last modified: November 3, 2007