Ex Parte TULLY et al - Page 8


                  Appeal No. 2003-0835                                                           Page 8                    
                  Application No. 09/419,371                                                                               

                  members, and the rejection of claims 9-20 and 39-50 under 36 U.S.C. § 112, first                         
                  paragraph, as lacking adequate written description, is reversed.                                         
                  3.     Rejection under 35 U.S.C. § 112, first paragraph, lack of enablement                              
                         Claims 9-20 and 39-50 stand rejected under 35 U.S.C. § 112, first                                 
                  paragraph, on the grounds that the specification, “while being enabling for                              
                  assessing the effect of a drug on particular species of dCREB2 activators and                            
                  repressors as disclosed in the specification, see in particular pp. 2-12, etc., does                     
                  not reasonably provide enablement for the claimed invention as drawn to a                                
                  genus and subfamily of molecules.  The specification does not enable any                                 
                  person skilled in the art to which it pertains, or with which it is most nearly                          
                  connected, to make and use the invention commensurate in scope with these                                
                  claims.”  Paper No. 10, page 5.                                                                          
                         According to the rejection,                                                                       
                         the specification fails to teach a mammalian assay for assessing                                  
                         the effect of a drug on long term memory formation, a mammalian                                   
                         method for screening a pharmaceutical agent for its ability to                                    
                         modulate long term memory and fails to teach a mammalian assay                                    
                         for determining the relative levels of mammalian dCREB2,                                          
                         activators, repressors, CREB/CREM/ATF-1 subfamily members,                                        
                         activator isoforms, repressor isoforms and antagonists.  The                                      
                         specification only discloses Drosophila activators as set forth, see                              
                         in particular dCREB2a, dCREB2b, dCREB2c, etc.  One skilled in                                     
                         the art recognizes that although different species often possess                                  
                         homologous proteins, the skilled artisan is unable to predict with                                
                         any measure of certainty the function of structurally divergent                                   
                         molecules [citing Skolnick4, abstract and Box 2].  Thus, for those                                
                         divergent peptide structures between Drosophila as disclosed and                                  
                         mammalian as claimed, the skilled artisan would be required to                                    
                         perform further undue experimentation to discover those peptides                                  
                                                                                                                           
                  4 Skolnick et al. (Skolnick), “From genes to protein structure and function: novel applications of       
                  computational approaches in the genomic era,” TIBTECH, Vol. 18, pp. 34-39 (2000).                        





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