Ex parte RAMANTHAN et al. - Page 4




                Appeal No. 1997-0711                                                                                                           
                Application No. 08/271,539                                                                                                     


                         [p]referably, the immunogenicity of the polypeptides is increased by                                                  
                         combination with an adjuvant and/or by conversion to a larger form prior to                                           
                         immunization (p. 11, ll. 28-30)                                                                                       
                or                                                                                                                             
                         [t]he immunogenicity of the polypeptides can also be enhanced by cross-                                               
                         linking or by coupling to an immunogenic carrier molecule .... Cross-linking                                          
                         or conjugation to a carrier molecule may be required because small                                                    
                         polypeptides sometimes act as haptens (molecules which are capable of                                                 
                         specifically binding to an antibody but incapable of eliciting antibody                                               
                         production, i.e., they are not immunogenic).  Conjugation of such                                                     
                         polypeptides to an immunogenic carrier molecule renders the fragments                                                 
                         immunogenic through what is commonly known as the "carrier effect."                                                   
                [P. 12, ll. 11-22.]                                                                                                            
                Production of the desired antibodies is determined using a two-part screening procedure,                                       
                i.e., (1) an ELISA analysis using the immunizing polypeptide and IL-4 as antigens and (2) a                                    
                radioligand receptor binding analysis which measures the inhibition of the specific binding                                    
                   125                                                                                                                         
                of I-IL-4 to cellular receptors (specification, p. 16, ll. 21-26).                                                             
                         The specification exemplifies immunizing rabbits by intradermal administration of a                                   
                combination of polypeptide No. 7 (i.e., amino acid residues 61 to 82 of IL-4), pertussis                                       
                vaccine and Freund's complete adjuvant (p. 21) and ELISA and radioligand analyses of                                           
                the obtained antiserum (i.e., antiserum 343-6 IgG fraction) (pp. 22-24).                                                       
                                                                 OPINION                                                                       
                         All of the appealed claims require a method comprising administration of "a                                           
                polypeptide consisting of amino acid residues 61 to 82 of IL-4" (emphasis added).  The                                         


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