Appeal No. 2006-0204 Page 3
Application No. 09/896,052
mouth that can be unpleasant, i.e., unpleasant mouthfeel. The term mouthfeel
relates to the type of sensation or touch that a dosage form produces in the
mouth . . . and is not concerned with the chemical stimulation of olfactory nerves
or taste buds.” Id. “In general, a gritty texture is undesirable. A smooth texture
is preferred.” Id.
The present invention is directed to “an oral dosage form for delivering
active agents” (id., page 3), “that masks the grittiness of the active agents
contained therein” (id.). The dosage form has “a soft core with [ ] active agent
particles, which have an average size of greater than about 50 μm, and a brittle
shell encasing the soft core, [ ] the weight ratio of drug particles to shell being
from about 1.0:0.5 to about 1.0:15” (id.). “The active agent can be in the form of
a fine powder, granule, or large crystal, and has an average particle size from
about 20 to about 1000 μm, also from about 150 μm to about 500 μm. Typically,
the active agent used in the present invention has an average size of greater
than 50 μm” (id., page 7).
According to appellants, “the brittle [shell] of the present [dosage form] not
only stabilizes the soft core, but it also provides a masking agent for the gritty
texture of the active agent upon chewing” (id., page 3).
Discussion
The examiner rejected claims 1-25 under 35 U.S.C. § 103(a) as being
unpatentable over the combined teachings of Lee and Friend. According to the
examiner, “Lee teaches a chewable pharmaceutical dosage form comprising [ ] a
core containing an active ingredient, and an outer layer” which “demonstrates
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