Ex parte RASMUSSEN et al. - Page 3


                  Appeal No.  1998-1719                                                                                      
                  Application No.  08/442,603                                                                                
                         In the Final Office Action4 (page 4), the examiner finds that the combination                       

                  of Martin in view of Levinson and Clark teach the pGB20 plasmid.  The examiner                             
                  relies (Answer, pages 4-5) upon Martin to teach the glucocerebrosidase gene.  The                          
                  examiner states (Answer, bridging paragraph, pages 6-7) that:                                              
                         Appellants argue that the glucocerebrosidase gene of Martin et al. is                               
                         not the functional equivalent of applicant’s gene segment.  This is not                             
                         persuasive because applicants have failed to show that the                                          
                         glucocerebrosidase gene of appellants is different in an unobvious                                  
                         manner from the gene of Martin et al.  Appellants argue that their                                  
                         original gene segment was extensively modified but fail to show how                                 
                         the modified segment (included within the claimed plasmids) differs                                 
                         from the gene segment of Martin et al. … Martin et al. state on page                                
                         100 that “the cDNA for human glucocerebrosidase was obtained from                                   
                         plasmid pUC19/GC … This cDNA contained 5’ and 3’ untranslated                                       
                         sequences as well as the complete coding region for                                                 
                         glucocerebrosidase.” … The nucleotide sequence of pUC19/GC is                                       
                         not given so it is not clear that the Eco RI – Xba I fragment of the                                
                         cDNA insert of this plasmid contains the complete 5’ and 3’ non-                                    
                         coding regions of the human GCR gene but merely that at least some                                  
                         of these sequences are present.                                                                     
                         Appellants’ specification (page 18, lines 5-26) discloses:                                          
                         To optimize expression of GCR in mammalian cells, we further                                        
                         modified the GCR.D21 … the modifications were made using                                            
                         oligonucleotide directed mutagenesis … to alter the nucleotide                                      
                         sequence near the GCR translation start to match the consensus                                      
                         sequence (CCACCATGG) for optimal translation in mammalian cells                                     
                         … and to delete the excess sequence 3’ of the gcr.D21C stop codon.                                  
                         … A bicistronic gcr-dhfr expression vector for CHO cells was                                        
                         constructed as shown in Fig. 7 … This vector, pGB20, contained                                      
                         gcr.D21C ….                                                                                         
                         Appellants’ figure 6 illustrates the modifications made to obtain gcr.D21C,                         
                  including the oligonucleotide directed mutagenesis of the GCR translation start to                         
                  match the consensus sequence described on page 18 of the specification.  Figure                            
                                                                                                                             
                  4 Paper No. 13, mailed October 4, 1995.                                                                    

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