Appeal No. 2003-0736 Page 6
Application No. 09/720,007
record to support this assertion. Even assuming that the examiner is correct,
however, the evidence of record does not provide the reasonable expectation of
success that is necessary for a prima facie case of obviousness. The examiner’s
position, basically, is that pain is pain; since “the actives were known to be useful
for treating pain from a wide variety of sources,” Examiner’s Answer, page 4,
they would be expected to be useful in treating pain from any source. This
position is not supported by the evidence. Wetzel, for example, states that “[i]t is
unclear whether gabapentin is more effective for a specific type of pain.” Page
1083.
In fact, the evidence shows that GABA analogs were expected not to be
useful against some types of pain. After testing gabapentin in two rat pain
models, Field concluded that gabapentin was effective in blocking hyperalgesia
but was not effective against transient pain.1 Field concluded that the data
indicate that gabapentin does not possess an antinociceptive effect
in transient models of pain. The ability of gabapentin to block
inflammatory- and neuropathy-induced hyperalgesia indicates that
this class of compounds is effective only in sensitized pain models.
Therefore, we suggest that gabapentin and (S)-(+)-3-isobutylgaba
should be referred to as antihypersensitive agents rather than
analgesics. As such they are not expected to abolish physiological
pain but should reduce abnormal hypersensitivity induced by
chronic pain.
Page 1520 (emphasis added).
Thus, we agree with Appellant that the cited references would not have
provided a skilled artisan with a reasonable expectation of success. At best, the
1 Hyperalgesia refers to “extreme sensitiveness to painful stimuli,” while pain in general is referred
to as “nociception.” See Stedman’s Medical Dictionary, pp. 732 and 1031 (attached).
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