Appeal No. 2006-2861
Application No. 10/007,272
BACKGROUND
“5,6-Dichloro-2-(isopropylamino)-1-(β-L-ribofuranosyl)-1H-
benzimidazole (1263W94) is a benzimidazole derivative useful in medical
therapy.” (Specification 1.) The specification describes anhydrous
crystalline forms and solvates of this compound, pharmaceutical
formulations comprising these crystalline forms and solvates, and their use
in therapy. (Id.)
For example, the specification describes a crystalline form, designated
Form II, “defined by the X-ray powder diffraction pattern illustrated in
Figure 2” of the application. (Id. at 3.) The specification states that
“Form II may be produced by crystallization or recrystallization of the
amorphous compound . . . from mixtures of methanol and water or methanol
and toluene. The initial product of the recrystallization is a methanol solvate
which on drying loses methanol to produce Form II.” (Id.)
The specification states that the crystalline forms and solvates can be
used “for the treatment . . . of viral diseases such as herpes virus infections.”
(Id. at 15-16.) The crystalline forms and solvates are preferably
administered “as a pharmaceutical formulation,” which is generally
“prepared by uniformly and intimately bringing in to association the active
ingredient with liquid carriers or finely divided solid carriers or both.” (Id.
at 17.) The active ingredient may be included “as a solution or a suspension
in an aqueous liquid or a non-aqueous liquid.” (Id.) The “preparation of
dosage forms as solutions of the anhydrous crystalline forms or solvates
substantially completely dissolved in a solvent . . . will preclude the
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