Appeal No. 2003-1716 Page 9
Application No. 09/946,205
In particular, we invite attention to a comparison of instant claim 1 with claims 1
and 7 in the '579 patent:
Instant Claim 1
1. A tablet which comprises (i) carvedilol or a pharmaceutically acceptable salt
thereof, (ii) hydrochlorothiazide or a pharmaceutically acceptable salt thereof, and (iii) at
least one pharmaceutically acceptable additive.
Claims 1 and 7 in the '579 Patent
1. A process for producing a solid dosage form pharmaceutical combination
preparation containing carvedilol, or a pharmaceutically acceptable salt thereof, and
hydrochlorothiazide, or a pharmaceutically acceptable salt thereof, which comprises:
a) forming a press mass containing a carvedilol, or pharmaceutically acceptable
salt thereof, granulate and a hydrochlorothiazide carvedilol [sic] or pharmaceutically
acceptable salt thereof, granulate, the two granulates each having a granulate moisture
content between about 6% and about 20% and a bulk density between about 0.1 g/ml
and about 1.5 g/ml, the granuate moisture content and the bulk density of the two
granulates not varying from each other by more than about 30% and
b) compressing the press mass to form the solid dosage form pharmaceutical
combination preparation.
7. A pharmaceutically acceptable solid dosage form combination preparation
containing carvedilol, or a pharmaceutically acceptable salt thereof, and
hydrochlorothiazide, or a pharmaceutically acceptable salt thereof, prepared by a
process that comprises:
a) forming a press mass containing a carvedilol, or pharmaceutically acceptable
salt thereof, granulate and a hydrochlorothiazide carvedilol [sic] or pharmaceutically
acceptable salt thereof, granulate, the two granulates each having a granulate moisture
content between about 6% and about 20% and a bulk density between about 0.1 g/ml
and about 1.5 g/ml, the granuate moisture content and the bulk density of the two
granulates not varying from each other by more than about 30%; and
b) compressing the press mass to form the solid dosage form pharmaceutical
combination preparation.
Based on a perusal of the file wrapper in Application No. 09/447,872, now U.S.
Patent No. 6,403,579, it does not appear that the examiner entered a restriction
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