Ex parte KOSLEY JR. et al. - Page 13




          Appeal No. 1997-2167                                                        
          Application 08/137,444                                                      
          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                                                                        
          vivo studies were conducted on galanthamine n-butyl carbamate               
          in mice and yielded "promising results".                                    
               Additionally, the examiner has cited several other                     
          references in support of his rejection which acknowledge the                
          role of AChE inhibitors in treating Alzheimer's disease.  See               
          for example, Robinson et al. at page 1127 wherein the authors               


           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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