Appeal No. 2005-1746 Page 5
Application No. 09/963,738
According to one preferred process for preparing this base
material for dry direct tableting obtained by impregnating low-
substituted hydroxypropyl cellulose with a sugar or a sugar alcohol
and then drying it, a wet granular material is prepared by dry-
blending low-substituted hydroxypropyl cellulose with a sugar or
sugar alcohol and then adding water to the resulting blend while
agitating it, or by adding an aqueous solution of a sugar or a sugar
alcohol to low-substituted hydroxypropyl cellulose while agitating it.
Thereafter, the resulting granular material is dried in the usual
manner, and may be pulverized and classified as required. Thus,
the desired base material for dry direct tableting comprising low-
substituted hydroxypropyl cellulose impregnated with a sugar or a
sugar alcohol can be obtained. In addition to the above-described
agitation granulation process, this base material may also be
prepared by fluidized bed granulation, spray drying and other
suitable processes.
Id. at 6-7 (emphasis added).
Shimizu teaches that
The solid preparation of the present invention can be
produced in accordance with a conventional method in the fields of
pharmaceutics. Such methods include, for instance, a method
which comprises blending, if necessary after addition of water, a
pharmaceutically active ingredient, a water-soluble sugar alcohol
and low-substituted hydroxypropylcellulose having hydroxypropyl
group contents of 7.0 to 9.9 percent by weight, and molding, if
necessary followed by drying.
Id. at 14. Moreover, in Working Example 1, a fluidized bed granulator is used, in
which granulation is carried out while spraying distilled water. See id. at 17.
Thus, the composition taught by Shimizu appears to be the same as that
of the composition of claim 1, and the burden is shifted to appellant to
demonstrate that they are different. See In re Best, 562 F.2d 1252, 1255, 195
USPQ 430, 433-34 (Fed. Cir. 1977). Arguments of counsel cannot take the
place of evidence in the record. See in re Scarbrough, 500 F.2d 560, 566, 182
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