Ex Parte Harland et al - Page 4


                 Appeal No.  2007-0079                                                        Page 4                  
                 Application No.  10/159,749                                                                          
                 artisan conclude that there is an existing correlation between the claimed                           
                 structure (any deletion mutant) and the function of providing bone morphogen                         
                 antagonizing and binding activity.”                                                                  
                        In support of his position, the examiner finds (Id.), Skolnick teaches that                   
                 “binding and receptor function cannot be reliably predicted from protein sequence                    
                 homology. . . .”  In addition, the examiner finds that Vukicevic teaches that the                    
                 OP-1 family of TGF-beta “induces metanephrogenesis whereas closely related                           
                 TGF-beta family members-BMP-2 and TGF-beta1-have no effect on                                        
                 metanephrogenesis under identical conditions. . . .”  Id.  Similarly, the examiner                   
                 finds that Tischer teaches that VEGF a member of the PDGF family exhibits                            
                 different activity than PDGF; and that Kopchick teach that a 198 amino acid                          
                 vertebrate growth hormone “becomes an antagonist (inhibitor of growth) when a                        
                 single amino acid is changed. . . .  Even 99% homology does not allow                                
                 predictability in this instance.”  Answer, page 7.  Based on this evidence the                       
                 examiner concludes (Id.),                                                                            
                        [g]iven the unpredictability of homology comparisons, and the fact                            
                        that the specification fails to provide objective evidence that any                           
                        deletion mutant, comprising only 8 contiguous amino acids or                                  
                        otherwise, would provide for binding and antagonism of bone                                   
                        morphogen growth, it cannot be established that a representative                              
                        number of species have been disclosed to support the genus                                    
                        claim[ed].  There is no correlation or nexus provided between                                 
                        possession of any deletion mutant and the functional features of                              
                        bone morphogen antagonizing activity and binding such that it is                              
                        clearly conveyed that possession of any deletion mutant would                                 
                        reliably and predictably possess these functional features.                                   
                        We are not persuaded by the examiner’s argument.  First, unlike the                           
                 situation in Vukicevic and Tischer, the claims before us on appeal are directed to                   






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