Ex Parte CHOUDARY et al - Page 3


                   Appeal No. 2004-2134                                                                Page 3                      
                   Application No. 09/425,075                                                                                      

                          Claims 36-39 and 42-501 stand rejected under 35 U.S.C. § 103(a) as                                       
                   being rendered obvious by the combination of Horwitz, Cregg, the Invitrogen                                     
                   Catalog and Robinson.  In addition, claims 36-39 and 41-502 stand rejected                                      
                   under 35 U.S.C. § 103(a) as being obvious over the previous combination of                                      
                   references as further combined with Vanderlaan.  After careful review of the                                    
                   record and consideration of the issues before us, we affirm both rejections.                                    
                                                        BACKGROUND                                                                 
                          The invention pertains to the production of functionally assembled antigen-                              
                   specific intact monoclonal antibodies produced by the transformation of the                                     
                   methylotropic yeast, Pichia pastoris, with immunoglobulin genes.  See                                           
                   Specification, page 1.  According to the specification,                                                         
                          [t]he method of the invention for production of functionally                                             
                          assembled antigen-specific intact monoclonal antibody, using                                             
                          transformation of P. pastoris, has a general utility and essentially                                     
                          any antibody can be produced or secreted by P. pastoris as long as                                       
                          the yeast expression vector carrying antibody genes can be                                               
                          appropriately assembled.                                                                                 
                   Id. at 6.                                                                                                       
                          More specifically,                                                                                       
                          a recombinant yeast expression vector (pPICZα) with dual                                                 
                          expression cassettes is constructed, each cassette carrying the                                          
                          inducible alcohol oxidase (AOX1) promoter, fused to the                                                  
                          Saccharomyces cerevisiae α-factor signal sequence.  P. pastoris is                                       
                                                                                                                                   
                   1 The Examiner’s Answer states that claims 36-40 and 42-49 stand rejected.  See Examiner’s                      
                   Answer, page 3.  The Appeal Brief, however, states that claims 36-39 and 42-50 stand rejected.                  
                   See Appeal Brief, page 5.  As claim 40 is not pending, the examiner’s statement appears to be a                 
                   typographical error, and we thus decide the appeal as it pertains to claim 36-39 and 42-50.                     
                   2 Again, the Examiner’s Answer states that the rejection is applied to claims 36-49, see                        
                   Examiner’s Answer, page 11, while the Appeal Brief states that it apples to claims 36-39 and 41-                
                   50.  For the reasons set forth in the previous footnote, we are again treating the examiner’s                   
                   statement as a typographical error.                                                                             





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