Appeal No. 2006-3379 Page 2
Application No. 10/393,549
5-chloro-1H-indole-2-carboxylic acid [(1S)-benzyl-(2R)- hydroxy-3-((3R,4S)-dihydroxy-
pyrrolidin-1-yl-)-3-oxpropyl] amide referred to as “Drug A.” Id., page 1, lines 13-24.
Drug A is a “sparingly soluble” drug which has low bioavailability when administered
orally. Id., page 1, line 28-page 2, line 2. The instant application provides
pharmaceutical compositions in which Drug A is combined with a concentration-
enhancing polymer that increases the concentration of Drug A in blood. Id., page 2,
lines 5-31. The pharmaceutical composition can be in the form of an amorphous
dispersion. Id., page 2, lines 5-31; page 3, lines 29-34.
Claim status
Claims 74-78, 80, and 84-88 are pending. There are two grounds of rejection:
1) Claims 74-77 and 84-88 stand rejected under 35 U.S.C. § 102(b); and 2) Claims 78
and 80 stand rejected under 35 U.S.C. § 103(a). Answer, pages 3-4. The claims within
each grouping stand or fall together because Appellants have not provided separate
reasons for patentability for any individual claims. 37 C.F.R. § 41.37(c)(1)(vii). We
select claims 74 and 78 as representative of each group of claims on appeal.
74. A process for forming a pharmaceutical composition, comprising the steps of:
(a) forming solid amorphous dispersion particles each comprising a
sparingly soluble drug and a concentration enhancing polymer, wherein at
least a major portion of said drug is amorphous;
(b) blending said solid amorphous dispersion particles and matrix material
to form a blend;
(c) feeding said blend to a melt-congeal process to form a molten mixture
comprising said solid amorphous dispersion particles and said matrix
material; and
(d) cooling said molten mixture and forming solid particles each
comprising said solid amorphous dispersion particles trapped within said
matrix material.
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