Appeal 2007-3261
Application 09/854,802
melatonin, lubricant, volume excipient and glidant. As such, . . . undue
experimentation [would be required] in order to make and/or use the
invention commensurate in scope with the claims, i.e. determining what
combination of HPMC, melatonin, lubricants, volume excipients and
glidants would result in the release profile claimed” (Answer 5).
In our opinion, the Examiner has set forth a reasonable basis to doubt
the enablement provided for claim 16. In particular, the Examiner cites the
Bromet patent (US 5,879,710, issued Mar. 9, 1999) as evidence of
unpredictability. Bromet describes a melatonin tablet comprising sustained-
and rapid-release layers (Bromet, at cols. 5-6). The sustained-release layer
(A) is for slow release of the melatonin (Bromet, at col. 3, ll. 60-65) and
comprises HPMC (col. 5, ll. 1-5 and 63 (“methocel”)) like the corresponding
slow release nucleus of the claimed invention (Spec. 4: 8-10). At column 5,
lines 1-5, referred to in the Answer, among the list of ingredients in the
sustained-release layer (beginning at col. 4, l. 50), Bromet describes HPMC
(“methocel”) as a retardant present “at a weight concentration of 3% to 20%,
and preferably 5 to 15%.” Thus, Bromet’s disclosure would have led
persons of skill in the art to reasonably expect that 3% to 20% HPMC in a
tablet would result in the sustained release of melatonin.
Bromet’s rapid-release layer, however, does not contain HPMC in
contrast to the fast release cortex of the claimed invention, which serves the
same function to release melatonin rapidly upon administration (Bromet, at
col. 3, l. 66 to col. 4, l. 2; Spec. 4: 1-4 and 10-12). Instead, it contains
disintegrant to enhance release (Bromet, at col. 5, ll. 38-44).
In the only example provided in the instant Specification, the fast
release cortex layer contains 8.8% HPMC (Spec. 8: 19) – which falls within
5
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