Appeal No. 1997-4344
Application 08/380,218
active agent and (2) delayed-release film material. As seen from claim 1, the coated
microgranules are to have a specified final particle size.
As explained at page 4, lines 1-11 of the specification:
Thus produced is a programmed-release ambroxol·HCl
pharmaceutical dosage form, comprising a plurality of inert
core microgranules of a variety of particle sizes ranging from
0.3 to 1.2 mm, such inert core microgranules being coated
with alternating microlayers of (1) micronized ambroxol
hydrochloride active agent and (2) delayed-release film
material, such coated microgranules including an external
microlayer of delayed-release film material, and such coated
microgranules having particle sizes ranging from 0.6 to
1.5 mm.
Claim 11 on appeal is directed to the method for producing the claimed dosage form
having the specified alternating microlayers.
Ghebre-Sellassie describes a pharmaceutical dosage form in which a drug is
coated on a core material. While Ghebre-Sellassie does not appear to directly disclose or
suggest the use of ambroxol·HCl as the active agent, appellants have not made this
argument in support of patentability. Rather, appellants' position is that the pharma-
ceutical dosage form of Ghebre-Sellassie does not have multiple alternating microlayers of
(1) micronized active agent and (2) delayed-release film material. In response, the
examiner states at page 3 of the Examiner's Answer:
3
Page: Previous 1 2 3 4 5 6 7 Next
Last modified: November 3, 2007