Appeal No. 1997-4344
Application 08/380,218
Applicant's [sic] main argument is that the reference does
not disclose multiple alternating layers of drugs and delyaed
[sic] release film material. The Examiner agrees with the
statement that the reference shows only one functional layer.
This is the layer that is applied on top of the inert core which is
layered with the micronized drug. Ghebre-Sellassie et al.
disclose that the drug is layered onto the core using a binder
such as polyvinylpyrrolidone. The term “layered” implies layers
of the drug. The drug is able to be layered due to the
presence of the binder (polyvinylpyrrolidone). If there were no
binder between the drug layers, there could be no “layers”
since one drug layer would not stick to the other drug layer.
This is what the term “layering” means to one skilled in the art
of manufacturing pharmaceutical dosage formst [sic].
We agree with appellants that Ghebre-Sellassie does not teach or suggest forming
a pharmaceutical dosage form containing multiple alternating microlayers as required by
the claims on appeal. The examiner's reading of the reference simply has no factual basis.
Keeping in mind, Ghebre-Sellassie is the only evidence of obviousness relied upon by the
examiner, it is not clear on what basis the examiner has concluded that “the term 'layered'
implies layers of the drug” (emphasis added). We agree with the following statement at
page 8 of the Appeal Brief:
Consequently, the Examiner's observations in the final
Official Action does not reflect the specification or the claims
of U.S. Patent No. 5,084,287, since Appellants could not find
any reasonable reference in the patent to indicate that either
the drug and polyvinylpyrrolidone or the only two types of layers
are multiple and alternated many times as in the instant
invention. On the contrary, the micropellets of Ghebre-
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