Appeal 2007-3261
Application 09/854,802
retardant formulations to increase its effectiveness (Spec. 3). The “subject
of this invention” are “new formulations for the controlled release of
melatonin able to ‘mimic’ the physiological melatonin pattern in the
peripheral blood” (Spec. 3). The pending claims are directed to a controlled
release melatonin tablet comprising a slow release nucleus and a fast release
cortex coating on the nucleus. Both the nucleus and cortex comprise
melatonin.
There are three rejections on review in this proceeding:
1) Claims 16-18 and 20-24 stand rejected under 35 U.S.C. § 112, first
paragraph, as lacking adequate written description (Answer 5);
2) Claims 16-18 and 20-24 stand rejected under 35 U.S.C. § 112, first
paragraph, as lacking enablement for the full scope of the claims (Answer
4); and
3) Claims 16-18 and 20-24 stand rejected under 35 U.S.C. § 112,
second paragraph, as being incomplete (Answer 6).
Within each rejection, the claims stand or fall together because
separate reasons for the patentability of any individual claim were not
provided. See 37 C.F.R. § 41.37(c)(1)(vii). We select claim 16, the only
independent claim on appeal, as representative of all the claims to decide the
issues in this proceeding. Claim 16 reads as follows:
A controlled release melatonin tablet which comprises:
(a) a slow release nucleus comprising melatonin,
hydroxypropyl methylcellulose, a lubricant, a volume excipient
and a glidant, wherein 95% of the melatonin is released within
5 hours in an oscillating tray containing gastric/intestinal juice
at 37°C;
(b) a fast release cortex coating on said nucleus which
comprises melatonin, hydroxypropyl methylcellulose, a
lubricant, a volume excipient and a glidant, wherein at least
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