Appeal 2007-3261
Application 09/854,802
the range of “3% to 20%” described by Bromet to achieve the slow-release
of melatonin. However, according to the Specification, when present in the
fast release cortex, it releases substantially all the melatonin within 10
minutes (Spec. 11). This is opposite to what would have been expected from
Bromet’s teaching: It would have been predicted that the addition of HPMC
to the cortex would lead to slow release, rather than fast release as shown in
the Specification. Thus, we agree with the Examiner that the formulation
art with respect to the release of melatonin was unpredictable.
Furthermore, as noted by the Examiner, the Specification provides no
guidance on what amounts of HPMC, lubricant, volume excipient, and
glidant to use in order to achieve the claimed release profiles for the slow
release nucleus and the fast release cortex (Answer 5). Particularly with
respect to the fast release cortex, the claim requires “melatonin, [HPMC], a
lubricant, a volume excipient and a glidant,” but the Specification does not
specifically identify these components in the fast release cortex, let alone
provide guidance on what amounts to use to achieve the recited release of
“within 10 minutes in an oscillating tray containing gastric/intestinal juice at
37°C.” This deficiency independently provides sufficient reason to question
the enablement for the entire scope of claim 16.
When, as here, the Examiner has set forth adequate doubt as to the
enablement of the claim, the burden shifts to the patent applicant to provide
rebuttal arguments or evidence. Appellant argues that it would only require
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