Appeal No. 2006-0299 Page 7
Application No. 09/964,412
We have no reason to doubt the examiner’s assessment of the state of the
art in general, and we think it is fair to say that the evidence of record shows that,
at the time of the invention, those of skill in the art recognized that considerable
experimentation would be needed before antisense therapy would be ready for
broad clinical application. Nevertheless, that showing alone is not enough to
establish that those skilled in the art of antisense therapy would have considered
the experimentation required to practice the claimed invention to be undue - what
is considered undue is relative, it varies from one field to another. See, e.g.,
Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (factors relating to undue
experimentation include quantity of experimentation necessary, nature of the
invention, and relative skill of those in the art).
In this case, the examiner focuses on sources of “unpredictability and [ ]
problems [ ] in the antisense art” in general (Answer, page 7), rather than the
claimed method in particular. As discussed above, the examiner acknowledges
that “the specification shows that recombinant over-expression of AD7c-NTP in
cells in culture produces phenotypes associated with Alzheimer’s disease
neurodegeneration” (id., page 4), and does not appear to question appellants’
identification of AD7c-NTP as an appropriate target in the disease process.
Rather, the examiner’s concerns stem from the “unpredictability of the art
generally” and the “sheer quantity of experimentation” required to practice the
claimed invention, even though the nature of that experimentation is conceded to
be “more or less standard” (id., page 11) in the field of antisense therapy.
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