Ex Parte HOLLIS et al - Page 9


                 Appeal No. 2003-0847                                                      Page 9                   
                 Application No. 08/744,685                                                                         

                 recombinant proteins in general, nor that its is an issue with respect to the                      
                 claimed homologous recombination insertional expression vector.                                    
                       Third, the rejection is concerned with the difficulties that may be                          
                 associated with immunoglobulin gene expression.  The rejection, does not                           
                 however, address why it would require an undue amount of experimentation to                        
                 express immunoglobulin genes in the claimed homologous recombination                               
                 insertional vectors, especially as the specification exemplifies the expression of a               
                 recombinant antibody.  Moreover, a claim may encompass inoperative                                 
                 embodiments and still meet the enablement requirement of 35 U.S.C. § 112, first                    
                 paragraph.  See Atlas Powder Co. v. E.I. Du Pont De Nemours & Co., 750 F.2d                        
                 1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984), In re Angstadt, 537 F.2d 498,                      
                 504, 190 USPQ 214, 218 (CCPA 1976), In re Cook, 439 F.2d 730, 732, 169                             
                 USPQ 298, 300 (CCPA 1971).                                                                         
                       Finally, the rejection is concerned with the breadth of the claims and that                  
                 the claims encompass expression in any mammalian cell, and are not limited to                      
                 NS/O cells.  That concern is not understood, however, as the claim requires that                   
                 the recombinant gene be capable of being expressed in NS/O cells.  That the                        
                 recombinant gene may or may not be capable of being expressed in other cell                        
                 types by the claimed homologous recombination insertional vector is irrelevant.                    
                 Moreover, the fact that aberrant glycosylation of recombinant proteins may be a                    
                 problem in NS/O cells, and such glycosylation may affect the structure, stability                  
                 and solubility of any expressed protein, also does not render the claims non-                      







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