Appeal No. 2006-3379 Page 8
Application No. 10/393,549
Claim construction
Claim 78 is drawn to a method of forming a pharmaceutical composition.
It comprises three steps: (a) forming a solution of a sparingly soluble drug, a
polymer, and a solvent; (b) spray drying the solution to form droplets which
solidify into amorphous dispersion particles; and (c) “further drying said solid
amorphous dispersion particles in a separate drying apparatus, thereby removing
residual solvent to less than 1 wt% of said composition.” The additional drying is
required to occur in a “separate drying apparatus,” but it does not otherwise
specify the characteristics of the drying apparatus or the nature of the drying
process. Consequently, we construe this limitation to include any apparatus in
which spray-dried particles are subjected to additional drying, including the
apparatus in which the spray drying was accomplished.
Kigoshi
Kigoshi has been described above for teaching a solid dispersion
comprising a slightly soluble drug. It describes a solvent method of producing a
solid dispersion “using, for example, a fluidized-bed granulator, an agitating
granulator, a spray-dry granulator, or a vacuum-dry granulator.” Kigoshi, page 4,
lines 37-38. For performing spray-drying, “a granulator may be used which is
further equipped with a vacuum-drying unit or microwave drying unit.” Id., page
4, lines 58-59.
The Examiner states that Kigoshi describes the claimed process, but does
not specifically disclose the claimed droplet size. Answer, page 5. However, she
argues that Kigoshi’s spray drying process would result in particles having the
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