Ex Parte GLASSMAN et al - Page 12




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



            peak and mean urinary flow rates improved by 49% and 36%, respectively.  Page 1290,               
            column 1, last paragraph, through the column 2, second paragraph.                                 
                   21.  Dunzendorfer concluded that terazosin taken once-a-day offers benefits in             
            treating the symptoms of patients with BPH.  Page 1291, column 1, third paragraph.                
                   22.  None of the references explicitly describe the administration of terazosin in         
            the treatment of BPH for a period of at least two and one-half years.                             
                   23.  Fabricius shows that when BPH patients taking terazosin stop taking                   
            terazosin, the beneficial effects of terazosin in the relief of symptoms of BPH were not          
            sustained.                                                                                        
                   24.  Fabricius reported the results of a randomized, placebo-controlled, double-           
            blind study, where 10 mg/day of terazosin was given to fifty-seven patients with BPH.             
            After a four-week placebo lead-in and a 24-week treatment period (the single-blind                
            phase) with terazosin, thirty patients who responded to terazosin were randomly                   
            assigned either to be given terazosin or a placebo for twelve weeks (double-blind                 
            phase).   Fabricius, page 86, line 14, to page 87, line 6.                                        
                   25.  During the single-blind treatment period, the peak urine flow rate increased          
            54%, after terazosin treatment.  The mean flow rate increased 55%.  The mean                      
            obstructive symptom score and irritative symptom source improved 68% and 34%,                     
            respectively.  Fabricius, Table 1, and the accompanying text.                                     


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