Ex Parte Polonsky et al - Page 15


                     Appeal No.  2005-0258                                                                          Page 15                        
                     Application No.  09/768,877                                                                                                   
                     specification and figures, it would be clear to one of skill in the art that the                                              
                     [a]ppellants had possession of the claimed invention at the time of filing sufficient                                         
                     to practice the invention.”  To the contrary, as we understand it, appellants had                                             
                     possession of the structurally-distinct calpains 10a-10h as diagrammatically                                                  
                     illustrated in figures 1A-1H (SEQ ID NOs:2, 4, 6, 8, 10, 12, 14 and 16), and the                                              
                     mouse calpain 10 set forth in SEQ ID NO:18.  See specification page 8.  As the                                                
                     examiner points out (Answer, page 8), “[t]he genus of polypeptides …                                                          
                     [encompassed by] the claimed method is a large and structurally variable genus.”                                              
                     The specification fails to provide any correlation between the structures of these                                            
                     structurally-distinct calpains and any functional activity.  Accordingly, it is our                                           
                     opinion that the application does not describe structural features common to                                                  
                     members of the genus, either expressly or via a known correlation between                                                     
                     structure and function.  The evidence of record supports the examiner’s position                                              
                     that the description of calpain 10 polypeptides is inadequate to describe the full                                            
                     genus of calpain 10 polypeptides encompassed by claim 51.                                                                     
                              While the inventions at issue in Lilly and Enzo were DNA constructs per                                              
                     se, the holdings of those cases are also applicable to the instant claim.  Claim 51                                           
                     is directed to a method, rather than a product, but carrying out the claimed                                                  
                     method requires the use of a calpain 10 polypeptide.  In our opinion, the instant                                             
                     specification does not provide an adequate description of the genus of calpain 10                                             
                     polypeptides encompassed by the method of claim 51, per Lilly, by describing                                                  
                     “structural features common to the members of the genus, which features                                                       
                     constitute a substantial portion of the genus.”  Nor does the specification                                                   







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