Appeal No. 2006-0204 Page 6
Application No. 09/896,052
appellants that one skilled in the art would not have been led to incorporate
Friend’s microcapsules into the core of Lee’s oral dosage form, particularly as
Lee teaches that the “medicament . . . contained in the core[ ] [is] preferably . . .
a medicament which is unstable to heat” (Lee, column 2, lines 5-6).
Appellants also emphasize that “there is [no] disclosure or suggestion for
the claimed weight ratio of active agent particles to shell in any document cited
by the Examiner” (Appeal Brief, pages 6-7), “[y]et it is the combination of claimed
particle size of the active agent in the soft core and the claimed weight ratio of
active agent particles to brittle shell that help to provide the texture masking of
the present invention” (Reply Brief, page 2).
Nevertheless, Lee appears to be much more relevant to this issue than
the examiner appreciated, in that Lee’s dosage form provides texture masking in
addition to masking the taste of bitter medicaments. Specifically, Lee teaches
that “the conventional chewable tablet has problems . . . because of sandy taste
in granular chew and chalky taste in mouth” (Lee, column 1, lines 33-35), but the
“outer tasty chewable base” (i.e., the outer layer of the dosage form) imparts a
“better chewing property . . . [to] the conventional tablets” (id., column 3, lines
56-58).
Where the difference between the claimed invention and the prior art is
some range or other variable within the claims, appellants must show that the
particular range or variable is critical, ideally by showing that the claimed range
or variable achieves unexpected results relative to the prior art. In re Woodruff,
919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990). The
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