Appeal No. 2006-0299 Page 5
Application No. 09/964,412
complexity of cellular uptake of antisense oligonucleotides; physical barriers due
to internal structures of target RNAs and associations with cellular proteins; and
so-called non-antisense effects. Id., pages 6-8.
In addition, the examiner cites a number of references in support of his
assertion that the consensus in the art is that many “challenges [ ] remain before
the use of antisense becomes routine in a therapeutic setting” (id., page 9), and
that antisense therapy is still a long way from “effective and efficient clinical
translation” (id.).
Finally, the examiner appears to concede that “the type of experimentation
required to practice the invention” is of a “more or less standard nature” (id., page
11), but argues that “the type of experimentation . . . is outweighed by the sheer
quantity of experimentation . . . , the unpredictability of the art generally and the
claimed method in particular, and the lack of guidance in the specification
regarding the direction in which experimentation should proceed” (id.). The
examiner concludes that making and delivering an antisense compound “such
that one would be able to treat dementias of Alzheimer’s [disease] . . . [would
require] undue trial and error experimentation” (id., page 6), given the lack of
specific guidance in the specification.
“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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