Ex parte RHODES - Page 6




              Appeal No.  1997-3019                                                                                       
              Application No. 08/404,122                                                                                  

                     [Lipkowitz] teach[es] that the generation of aldehyde moieties on cell surface                       
                     structures by treatment with neuraminidase and galactose oxidase induce[s]                           
                     marked proliferation of lymphocytes (p 2702, column 1). [Lipkowitz] also                             
                     teach[es] that oxidized macrophages are potent stimulators of T cells and                            
                     that oxidized B and T cells can also stimulate T cell  proliferation provided                        
                     macrophages or macrophage-dependent soluble mediators are present in                                 
                     the cell culture medium (p 2702 column 2).                                                           
                     Rhodes teaches that T cells may be activated by generating aldehydes (via                            
                     oxidation) on membrane glycoproteins by means of galactose oxidase                                   
                     reacting with the galactosyl or N-acetylgalactosaminyl residues exposed                              
                     after neuraminidase treatment.  These aldehydes then react covalently with                           
                     ligands on class II positive accessory cells to form Schiff bases and the                            
                     result is a vigorous T cell proliferative response (p 1482, column 2,                                
                     paragraph 2).                                                                                        
                     [Gao] teach[es] that Schiff base-forming ligands play an essential role in the                       
                                                             +                                                            
                     inductive interaction between Class II  antigen presenting cells and T helper                        
                     cells (p 2889 column 2, last paragraph).                                                             
                     [Roitt] teach[es] that T helper cells recognize antigen processed by antigen                         
                     presenting cells and provide help to B cells which then secrete antibody                             
                     (Figure 8.8).                                                                                        
                     Ada teach[es] that the activation of antigen presenting cells, T cells and B                         
                     cells are all requirements of a vaccine (p 525, column 1).                                           
                     It would have been obvious to one of ordinary skill in the art to include                            
                     galactose oxidase in the neuraminidase adjuvant composition taught by                                
                     [Knop] because neuraminidase and galactose oxidase result in biochemical                             
                     changes of membrane glycoproteins which, in turn, result in inducing the                             
                     activation of T cells and the interaction between antigen presenting cells and                       
                     T helper cells, as taught by [Lipkowitz] and Rhodes and [Gao].  Furthermore,                         
                     the activation of these cells is important in the production of antibodies and                       
                     is a requirement of a vaccine as taught by Roitt and Ada.  Therefore, one of                         
                     ordinary skill in the art would expect that the combination of neuraminidase                         
                     and galactose oxidase would act as an adjuvant in a vaccine formulation by                           
                     enhancing the interactions between  antigen presenting cells and T cells and                         
                     potentiating the immune response . . .                                                               

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