Appeal No. 2001-0941 Page 3
Application No. 08/890,705
Hypericum extract, dissolution regulator for sustained release, binder, filler,
glidant, and lubricant (also referred to as “lubricant/glidant”). See, e.g., page 3,
lines 1-6.
The specification discloses that “methods of forming the tablets of the
invention generally excludes [sic] the typical wet granulation methods. . . . The
nature of the supplement is such that conventional processing by wet
compression or wet granulation did not work for reasons not previously known to
the inventors. Initial efforts at wet granulation produced a tar-like product.” Page
8. Subsequent refinement of the wet granulation method, as well as tableting by
“planetary mixing,” produced better results but only with manual control of the
process. See id., pages 8-9.
The specification discloses that a “dry granulation” process was necessary
“to enable the supplement materials to be tableted with consistency.” Page 9. In
the disclosed method, all of the ingredients except for part of the glidant and/or
lubricant are “blended into a first composition and compressed into a pre-tablet or
slug. The slug is ground (and usually screened), the remaining glidant and/or
lubricant from the final formulation is added to form a second composition, and
then the second composition is compressed into a tablet.” Id.
The specification also states that such dry granulation processes had
“previously been used where the components of the tablet are sensitive to
moisture (as by degradation) or are unable to withstand the elevated
temperatures of drying.” Id. However, “[t]he components of the present tablet
are neither degraded by moisture nor sensitive to drying temperatures, so dry
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