Ex parte KOSLEY JR. et al. - Page 13




          Appeal No. 1997-2188                                                        
          Application 08/137,440                                                      
          acknowledges on page 673 that:                                              
               One of the more promising palliative approaches relates                
               to potentiating the activity of the central cholinergic                
               system. A decrease in central nervous system cholinergic               
               markers is the most consistent and well-documented                     
               neurochemical change in Alzheimer's disease. Accordingly,              
               several pharmacological strategies to enhance central                  
               cholinergic function are being explored: muscarinic                    
               agonists, acetylcholine releasing agents and                           
               cholinesterase inhibitors. [cites to the bibliography                  
               omitted]                                                               
          Thereafter in the paragraph bridging pages 673 and 674, the                 
          authors observe that:                                                       
               Galanthamine (1, scheme 1), a long-acting, centrally-                  
               active competitive cholinesterase inhibitor, has shown                 
               considerable promise.  This natural product, an alkaloid               
               of the Amaryllidaceae family, is hydrolysis-resistant,                 
               only moderately toxic, and more readily absorbed than                  
               physostigmine.  The animal data suggest that this                      
               compound might be effective in treating the central                    
               cholinergic deficits in Alzheimer's disease. A recent                  
               clinical trial found that 1 was a well-tolerated drug                  
               during long term treatment. [cites to the bibliography                 
               omitted]3                                                              
          On page 674 the parent compound 1 and nine other galanthamine               
          derivatives are set forth.  On page 679 in Table III, the                   
          IC 's for seven galanthamine derivatives is set forth and in                
            50                                                                        

           Whether or not the results of the clinical trial have3                                                                      
          been published and whether, if published, the results are                   
          prior art having a bearing on the patentability of the                      
          appealed claims is an issue the examiner and appellants should              
          investigate upon return of this application to the examining                
          group.                                                                      
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