Appeal No. 2006-0204 Page 2
Application No. 09/896,052
The examiner rejected claims 1-25, all the claims pending in the
application, as unpatentable under 35 U.S.C. §103(a). Claims 1 and 17 are
representative of the claims on appeal, and read as follows:
1. A texture masking oral dosage form comprising
a) a unitary soft core comprising a plurality of active agent particles having
an average size of greater than about 50 μm and
b) a brittle shell encasing the soft core, wherein the weight ratio of active
agent particles to shell being from about 1.0:0.5 to about 1.0 in the texture
masking oral dosage form.
17. A texture masking oral dosage form comprising
a) a unitary soft core comprising a plurality of active agent particles having
an average size of greater than about 50 μm and
b) a brittle shell encasing the soft core, wherein the weight ratio of active
agent particles to shell being from about 1.0:0.5 to about 1.0:15 and
wherein the soft core has a hardness of about 1 to about 8 kp/cm2 in the
texture masking oral dosage form.
The examiner relies upon the following references:
Lee 6,060,078 May 9, 2000
Friend et al. (friend) 6,139,865 Oct. 31, 2000
Background
“Chewable dosage forms are often employed in the administration of
active agents where it is impractical to provide a tablet for swallowing whole,
where it is desirable to make an active agent available topically in the mouth or
throat for both local effects or systemic absorption and to improve drug
administration in pediatric and geriatric patients.” Id., page 1. “It has been
observed that particles in chewable dosage forms leave a gritty sensation in the
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