Ex Parte GLASSMAN et al - Page 2




            Appeal No. 1997-1842                                                                              
            Application 08/068,878                                                                            



                   1.  A method for the chronic treatment for a period of at least two and one-half           
            years of urinary symptoms associated with benign prostatic hyperplasia comprising                 
            administering to a male human patient in need of such treatment a therapeutically                 
            effective amount of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-                    
            furanyl)carbonyl]piperazine or a pharmaceutically acceptable salt thereof.                        
                   2.  A method for the chronic treatment of urinary symptoms associated with                 
            benign prostatic hyperplasia comprising administering to a male human patient in need             
            of such treatment a therapeutically-effective amount of 1-(4-amino-6,7-dimethoxy-2-               
            quinazolinyl)-4-[(tetrahydro-2-furanyl)-carbonyl]piperazine monohydrochloride dihydrate.          
                   7.  The method of Claim 1 wherein said therapeutically effective amount of                 
            1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-tetrahydrofuroyl)piperazine or a                    
            pharmaceutically acceptable salt thereof is administered in the form of a soft elastic            
            gelatin capsule formulation in unit dosage form comprising between 1 mg and 20 mg                 
            of active ingredient.                                                                             

                   The references relied upon by the examiner are:                                            
            Lepor et al. (Lepor et al. 1988), “Laboratory Assessment of Terazosin and Alpha-1                 
            Blockade in Prostatic Hyperplasia,” Urology, Supp. to Vol. 32 (6), pp. 21-26 (Dec.                
            1988).                                                                                            
            Lepor, (Lepor 1989), “Role of Alpha-Adrenergic Blockers in the Treatment of Benign                
            Prostatic Hyperplasia,” The Prostate, Supp. 3, pp. 75-84 (1990), Proc. of the Urological          
            Assoc., Dallas, TX, May 6, 1989.                                                                  
            Lepor et al. (Lepor et al. 1989), “The Safety and Efficacy of Terazosin for the                   
            Treatment of Benign Prostatic Hyperplasia,” Int. J. Clin. Pharmacol. Ther. Toxicol.,              
            27 (8), pp. 392-97 (Aug. 1989).                                                                   
            Dunzendorfer, “Effects of Terazosin in the Treatment of Benign Prostatic Hyperplasia,”            
            Arzneimittelforschung, 39 (1), pp. 1289-91 (Oct. 1989).                                           
            Fabricius et al. (Fabricius), “Efficacy of Once-A-Day Terazosin in Benign Prostatic               
            Hyperplasia: A Randomized, Double-Blind Placebo-Controlled Clinical Trial,” The                   
            Prostate, Supp. 3, pp. 85-93 (1990).                                                              

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