Appeal No. 2006-3379 Page 6
Application No. 10/393,549
proper weight to the limitation in claim 74 of “solid particles each comprising said solid
amorphous dispersion particles trapped within said matrix material.” Although it is
expressly recited in the claim, we do not find that the Examiner addressed it in her
Answer. Appellants’ reference to “raisin bread” is shorthand for this limitation. See
above. Thus, the Examiner was incorrect to conclude that “the ‘raisin bread’ analogy is
not set forth in the claims.” Answer, page 7.
To anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg. Corp. v.
Cleveland Golf Co., 242 F.3d 1376, 1383, 58 USPQ2d 1286, 1291 (Fed. Cir. 2001).
It is the Examiner’s burden to come forward with evidence to establish that the prior art
reference meets this requirement. On the record before us, we find no evidence put
forward by the Examiner that Kigoshi’s process of forming a solid dispersion with a
drug, polymer, and excipient by melting or heat-melt-kneading methods (Kigoshi,
page 4, lines 16-17) would result in solid amorphous particles “trapped” in a matrix
material as required by claim 74.
Furthermore, claim 74 requires that the amorphous dispersion particles are
blended with a matrix material and then fed to a melt-congeal process to form a molten
mixture. The Examiner asserts that Kigoshi’s process in which an amorphous
dispersion is formed by heat melting meets this requirement. Answer, pages 7-8. We
agree that if Kigoshi’s heat melting process could form dispersion particles of the drug
and polymer, while at the same time forming a molten mixture that would cool to form
“solid amorphous dispersion particles trapped” in the matrix material, it would be
anticipatory to the claimed method. However, the Examiner has provided no evidence
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