Appeal 2007-3261
Application 09/854,802
“a minimum amount of experimentation . . . to make useful compositions
within the scope of the claims” (Sub. App. Br. 51). Appellant also argues:
These claims are specific to a particular material [melatonin]
and from this perspective are quite narrow. The recitation of the
other ingredients is made in terms that are specific of to
materials or classes of materials that are well known and are
exemplified in the specification. The art of making controlled
release formulations for oral administration to humans has
generated many thousands of patents in recent years and there
are many textbooks and courses that have been devoted to this
subject. Since the present claims deal with only one substance,
this variable is not present in the appealed claims.
(Sub. App. Br. 6.)
We do not find Appellant’s argument sufficient to rebut the rejection
for lack of enablement. We acknowledge that controlled release formations
were known in the art prior to the application filing date. However, with
respect to a controlled release tablet comprising melatonin – the same active
pharmacological agent recited in claim 16 – Bromet’s teaching about the
amounts of HPMC utilized in a slow- or sustained-released composition
would have lead persons of skill in the art to reasonably doubt the scope of
enablement for claim 16. Appellant has not responded to this issue nor
explained how the Specification provides guidance on a fast release cortex
comprising “melatonin, [HPMC], a lubricant, a volume excipient and a
glidant” as recited in claim 16. Because the Examiner’s reasons for
doubting the scope of enablement remain unrebutted, we affirm the rejection
of claims 16-18 and 20-24 under § 112, first paragraph, for lack of
enablement.
1 This is a reference to the Substitute Appeal Brief, date stamped March 2,
2006.
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