Appeal No. 2003-0569 Page 3
Application No. 09/381,044
OPINION
All of the claims require the presence of at least one excipient selected from a group of
various matrices including hydrophilic matrices. The specification identifies hydroxypropyl
methyl cellulose as a usable hydrophilic matrix material (specification, p. 4, ll. 22-23). The
rejections over Norling alone and Norling in view of Kwan are based on the fact that Norling
suggests compositions including hydroxypropyl methyl cellulose as a binding agent (Answer, p.
4). The Examiner equates the binder of Norling with the required matrix excipient of the claims.
Appellants argue that there is a difference between a matrix excipient and a binder and
cite the fact that Appellants’ specification lists binders as separate optional ingredients as
evidence of this. According to Appellants, matrices form an extended network within which the
active ingredient is slowly released whereas a binder is present in smaller amounts and acts
simply to hold the ingredients together (Brief, p. 6).
The Examiner argues in response that Appellants have provided no evidence to support
the contention that binders are present in smaller amounts. The Examiner also states that
hydroxypropyl methyl cellulose is well known in the pharmaceutical art as a matrix excipient,
and absent evidence to the contrary, the hydroxypropyl methyl cellulose would perform the same
function whether included as a matrix excipient or a binder (Answer, p. 7).
The Examiner provides no technical reasoning nor evidence indicating that use of
hydroxypropyl methyl cellulose as a binding agent inherently results in a matrix or that use as a
binder would have suggested use as a matrix. On the other hand, the fact that Appellants’
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Last modified: November 3, 2007