Ex parte KOSLEY JR. et al. - Page 12




          Appeal No. 1997-2182                                                        
          Application 08/137,443                                                      
               treatment. [cites to the bibliography omitted]4                        
          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               
          acknowledge the therapeutic effect of AChE inhibitors for                   
          treating Alzheimer's disease.  The examiner has also cited                  
          Sarter et al. as evidence that there was a recognition in the               
          art at the time appellants made their invention that the high               
          number of failures in clinical trials for drugs ("recognition               
          enhancers") screened and then tested on an animal model was                 
          directly correlated to the lack of sufficient attention to the              
          specific psychological mechanisms underlying behavioral                     

           Whether or not the results of the clinical trial have4                                                                      
          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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