Appeal No. 1997-2801
Application 08/364,072
Rasmusson describes a method of treating patients with benign prostate
hypertrophy by administering a therapeutically effective amount of a 17$-N-
(monosubstituted)-carbamoyl-4-aza-5"-androst-1-en-3-one compound represented by
formula I disclosed by Rasmusson. The compounds described by Rasmusson includes
those recited in claim 1 on appeal. For example, Rasmusson discloses that the
compound 17$-(N-tert-butylcarbamoyl)-4-aza-5"-androst-1-en-3-one, which is the
compound recited in claim 4 on appeal. Rasmusson, col. 2, line 14, to col. 3, line 29; col.
5, lines 67-68. Rasmusson also indicates that the compound can be administered orally at
a daily dosage of from 50 to 2,000 mg and that an effective amount of the drug is ordinarily
from about 1 mg to about 50 mg/kg of body weight per day, preferably from about 1 mg to
7 mg/kg of body weight per day which are well below the toxic dose of the compound.
Rasmusson, col. 6, line 64, to col. 7, lines 12.
Benign prostate hypertrophy (nodular hyperplasia of prostate) is defined as
glandular and stromal hyperplasia which occurs very commonly in the middle and lateral
lobes of older men, forming nodules that may increasingly obstruct the urethra. Stedman,
pages 676 and 677. (Hyperplasia is defined as an increase in the number of cells in a
tissue or organ, excluding tumor formation, whereby the bulk of the part or organ is
increased. Stedman, page 675.)
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