Appeal No. 1997-4344
Application 08/380,218
Sellassie et al are made of only two layers, one layer
comprising the active ingredient + antiadherents + binders and
one layer comprising a material that provides the necessary
release characteristics.
The examiner also makes the assertion that the process of Ghebre-Sellassie and
that of the present invention are “in fact the same.” (Examiner's Answer, page 3). We
disagree. Example 1 of Ghebre-Sellassie states in relevant part that “the layering solution
was sprayed on the fluidizing bed of lactose granules until the desired drug loading was
achieved.” Example 1 of the present specification indicates that a similar process was
used but that the amount of the active agent and delayed-release film material were
“maintained under constant control.” When Example 1 of the present specification is read
in the context of the remaining portions of the specification, e.g., page 4, lines 1-11, the
“constant control” must include forming alternating microlayers of the active agent in the
delayed-release film material. In other words, it appears that according to the present
invention, the apparatus used in the process of Example 1 would be controlled so that a
first layer of active agent is sprayed onto the inert granules followed by a first layer of the
delayed-release film material with the spraying steps being alternated until a sufficient
number of alternating microlayers of the two materials is achieved. No such control is
found in Ghebre-Sellassie. If there is a “layering” taking place in Example 1 of Ghebre-
Sellassie, it is that multiple layers of the same composition are applied to the inert
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