Appeal No. 2001-0545 Page 5
Application No. 08/442,423
Id. at 5-6. The rejection contends that there “is no evidence that the rat is an art
recognized or a correlatable model for the treatment of diseases and conditions
that are affected by angiogenesis.” Id. at 7.
In addition, according to the rejection, the specification only provides one
example of ligand administration, but does not enable other methods of
administration, nor the amounts that would be required to inhibit angiogenesis.
See id. at 6. The examiner concludes:
Therefore, given the unpredictability recognized in the art in
the delivery of genes and antisense oligonucleotides for therapies
and the lack of evidence in a correlatable animal model, the
specification does not provide sufficient guidance to the artisan to
implement the claimed invention with a predictable degree of
success. The determination of routes of delivery and amounts of
ligand to inhibit angiogenesis to a useful degree would require an
inventive step on the part of the artisan. Given the arguments
presented here, the instant claims are an invitation to invent.
Id., page 8.
Appellants argue that enablement rejection is improper. We agree.
The burden is on the examiner to set forth a prima facie case of
unpatentability. See In re Glaug, 283 F.3d 1335, 1338, 62 USPQ2d 1151, 1152
(Fed. Cir. 2002). Facts that should be considered in determining whether a
specification is enabling, or if it would require an undue amount of
experimentation to practice the invention include: (1) the quantity of
experimentation necessary to practice the invention, (2) the amount of direction
or guidance presented, (3) the presence or absence of working examples, (4) the
nature of the invention, (5) the state of the prior art, (6) the relative skill of those
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