Appeal No. 2005-2207 Page 9
Application No. 09/548,933
especially as the examiner agrees that this type of channel “could be associated with [the]
etiology or development of migraine and epilepsy” (id., page 9).
Nor are we persuaded that appellant’s disclosed utility is insubstantial simply
because a direct association between the HAC3 channel and epilepsy or migraine is
“unsubstantiated” on the record (id.). As discussed above, there is evidence of record
that those of skill in the art at the time of the invention believed that members of the HAC
family of hyperpolarization-activated, cyclic nucleotide-gated channels were associated
with pacemaker currents in brain and heart tissue. See e.g., Santoro, page 725, and
Ludwig, page 590. Moreover, there is evidence of record that it was known in the art that
defects in pacemaker activity could lead to both inherited and acquired cardiac
arrhythmias, and that defects in pacemaker activity might also underlie various other
neurological diseases. See Santoro, page 717.
We recognize that the Fisher court wrote in terms of Fisher’s failure to “prove” or
“show” that the claimed ESTs could be used in any of the ways disclosed in the
specification. Nevertheless, we do not understand Fisher to relieve the PTO of its well-
established “initial burden of challenging a presumptively correct assertion of utility in the
disclosure.” In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995)
(citation omitted). “Only after the PTO provides evidence showing that one of ordinary
skill in the art would reasonably doubt the asserted utility does the burden shift to the
applicant to provide rebuttal evidence sufficient to convince such a person of the
invention’s asserted utility.” Id. In our view, the mere assertion that “a skilled practitioner
would not reasonably expect administration of [ ] modulators of HAC3 to have any effect
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