Appeal No. 2006-0275 Page 6
Application No. 09/964,667
to internal structures of target RNAs and associations with cellular proteins; and
so-called non-antisense effects. Id., pages 6-8.
The examiner concedes that the resolution of these problems involves
experimentation of a “more or less standard (albeit empirical and unpredictable)
nature” (id., page 12), 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.).
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, to the extent 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, we do not agree
that that is sufficient to establish that those skilled in the field 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).
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