Appeal No. 2006-3379 Page 4
Application No. 10/393,549
lyophilization, by extended mechanical processing . . . , or in a twin-screw extruder or in
a ball mill, or by solvent processing.” Id., page 20, lines 30-36.
The solid amorphous dispersion particles are blended with a matrix material in
step (b) which is fed to melt-congeal process in step (c) to form a molten mixture.
Examples of matrix materials include citric acid, sugar, lipid, or wax. Id., page 35,
line 35-page 36, line 2; page 36, lines 30-page 37, line 1. According to the
specification, the melt-congeal process can be performed according to prior art
methods. Id., page 36, lines 9-19. When the molten mixture resulting from the melt-
congeal process is cooled, it forms (d) “solid amorphous dispersion particles trapped
within said matrix material.”
Kigoshi
Kigoshi teaches a solid dispersion of a “slightly soluble” xanthine derivative.
Kigoshi, page 2, lines 21-22. The xanthine derivative is blended with a polymer. The
“solid dispersion . . . can be prepared by a co-grinding method, a solvent method, a
melting method, a heat-melt-kneading method, or the like.” Id., page 4, lines 16-17.
Examples of polymers include rubber compounds, gelatin, polysaccharides, cellulose
derivatives, polyvinyl derivatives, and methacrylate copolymers. Id., page 3,
line 55-page 4, line 9. Dosage forms of the solid dispersion can further comprise
additives, “such as a coloring agent, a corrigent, an excipient, a disintegrator, a
lubricant, and a surfactant.” Id., page 5, lines 37-38.
The Examiner argues that Kigoshi discloses a solid dispersion comprising
“polymer and additives such as surfactant, coloring agent, starch, dextrin, triethyl citrate,
polyethylene glycol, triacetin, sucrose-fatty acid esters, lactose, amino acids,
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