Ex Parte LINNENBACH et al - Page 4


                Appeal No.2001-1258                                                   Page 4                  
                Application No. 08/413,805                                                                    

                extracellular domain of GA733-2.  Claim 4 is directed to a composition                        
                comprising a pharmaceutically effective amount of the polypeptide of SEQ ID                   
                NO: 2 in a pharmaceutically acceptable carrier.                                               
                      The examiner rejected the claims as obvious over the combined                           
                disclosures of Szala, Bumol, Hussey, and Johnson.  The examiner accurately                    
                characterized Szala as teaching the cloning and expression of full-length                     
                GA733-2, as well as the predicted functional domains of the protein (signal                   
                sequence, extracellular domain, transmembrane domain, and cytoplasmic                         
                domain).  Szala also teaches that the “cloning of cDNA for the tumor-associated               
                GA733-2 antigen . . . will facilitate the production of antigen needed for                    
                immunization strategies.”  Page 3542.  In addition, Szala teaches that expression             
                of the disclosed cDNA “will meet a critical need for tumor-associated antigen.                
                For instance, it will now be possible to compare recombinant tumor-associated                 
                antigen with internal image anti-idiotypic antibodies as agents for the                       
                immunotherapy of carcinoma.”  Page 3546.  The examiner acknowledged that                      
                Szala does not disclose a truncated GA733-2 variant consisting only of the signal             
                sequence and extracellular domain.                                                            
                      The examiner cites Bumol as disclosing vectors for producing the                        
                GA733-2 antigen in prokaryotic and eukaryotic host cells.1  The examiner points               
                in particular to the “prokaryotic expression vector pLKSA that contains the                   
                [GA733-2] coding sequence from which the DNA coding for the 49 C-terminal                     

                                                                                                              
                1 Bumol refers to the protein as the “KSA” antigen, but the examiner asserts, and Appellants do
                not dispute, that KSA and GA733-2 are alternative names for the same protein.                 





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