Ex Parte HOLLIS et al - Page 2


                 Appeal No. 2003-1594                                                          Page 2                    
                 Application No.  08/970,266                                                                             

                            (b) culturing the said cells under conditions suitable for glutamine                         
                                synthetase selection and recombinant antibody gene expression.                           
                     11. A method for expressing a recombinant gene in a murine host cell                                
                            comprising the following steps:                                                              
                            a) inserting said recombinant gene into a murine immunoglobulin                              
                                gamma 2A locus present in said murine host, wherein said                                 
                                recombinant gene comprises a nucleic acid encoding for a                                 
                                recombinant protein and a promoter transcriptionally coupled to                          
                                said nucleic acid providing for expression in said murine host,                          
                                provided that said recombinant gene is capable of being expressed                        
                                is [sic] said murine host, and                                                           
                            b) culturing said host under conditions suitable for expression of said                      
                                recombinant gene.                                                                        
                        The examiner relies upon the following references:                                               
                 Fell et al. (Fell A)               5,204,244                  Apr. 20, 1993                           
                 Hollis et al. (Hollis)              WO 95/17516                 Jun. 29, 1995                           
                 Yuriko Yamawaki-Kataoka et al. (Yamawaki-Kataoka), ”The complete nucleotide                             
                 sequence of mouse immunoglobulin K2a gene and evolution of heavy chain                                  
                 genes:  further evidence for intervening sequence-mediated domain transfer,”                            
                 Nucleic Acids Research, Vol. 9, No. 6, pp. 1365-1381 (1981)                                             
                 Galfre et al. (Galfre), ”Preparation of Monoclonal Antibodies:  Strategies and                          
                 Procedures,” Methods in Enzymology, Vol. 73, pp. 3-48 (1981)                                            
                 Sambrook, Molecular Cloning A Laboratory Manual, 2nd Edition, pp. 16.8-16.15                            
                 (1989)                                                                                                  
                 Fell et al. (Fell B), “Homologous recombination in hybridoma cells:  Heavy chain                        
                 chimeric antibody produced by gene targeting,” Proc. Natl. Acad. Sci. USA, Vol.                         
                 86, pp. 8507-8511(1989)                                                                                 
                        Claim 13 stands rejected under 35 U.S.C. § 112, first paragraph, as                              
                 containing subject matter that was not described in the specification in such a                         
                 way as to reasonably convey to one skilled in the relevant art that the inventors,                      
                 at the time of filing, had possession of the claimed invention.  Claim 13 stands                        





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