Appeal 2007-3261
Application 09/854,802
Written description rejection
The Examiner contends that the claims do not comply with the written
description requirement.
First, the Examiner asserts that since 95% of the melatonin was
released “within the 5th hour” and not “within five hours” the Specification
does not describe the limitation in claim 16 that “wherein 95% of the
melatonin is released within 5 hours” (Answer 6). The same assertion is
made for the limitation wherein 95% of the melatonin is released within 10
minutes.
Secondly, the Examiner asserts that
the Appellant has amended the claims to indicate that the fast
release cortex also contains a lubricant, volume excipient and
glidant. However, the Specification does not appear to indicate
that the “cortex” contains lubricant or a glidant. The only
example set forth contains, in addition to melatonin and HPMC,
lactose, a bulking agent, i.e. volume, titanium bioxide, a
pigment, and ethyl alcohol and water, solvents, which
presumably are evaporated away in order to form the cortex
(See Pg. 8, lines 15-23).
(Answer 6.)
We find that the Specification adequately describes the claim
limitations “wherein 95% of the melatonin is released within 5 hours” and
“wherein at least 95% of the melatonin is released within 10 minutes.” The
Specification expressly describes the release of melatonin within the recited
times (Spec. 4: 1-7; 5: 29-32; 12: 1-5). In addition, as argued by Appellants,
“[t]he specification is addressed to one of ordinary skill in the art of
controlled release pharmaceuticals and it is well known that all
measurements of controlled released products are based on a cumulative
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