Ex Parte Gerber - Page 2

              Appeal 2007-2371                                                                      
              Application 10/426,654                                                                

              cell-mediated immune response at the portal of entry.  This is best done with         
              an adjuvant and delivery system that targets vaccine antigens to . . . the            
              mucous membranes” (Specification 1, citation omitted).                                
                    Thus, compared to an injected vaccine, orally administering a vaccine           
              against a gut pathogen “may engender a stronger immune response against               
              such pathogens by eliciting the production of secretory immunoglobulin A              
              antibodies at the mucosal site. . .  Likewise, administration of vaccine              
              against an upper respiratory pathogen may be most effective if delivered to           
              the mucosal-associated lymphoid tissue in the oral cavity or nasal passages”          
              (id. at 1-2, citation omitted).                                                       
                    The Specification discloses “an adjuvant composition that includes              
              lecithin and a polymer that is preferably an acrylic polymer or copolymer.            
              The preferred acrylic polymer is a polyacrylic acid polymer.  The lecithin            
              and polymer form a matrix or net-like structure which is effective in                 
              trapping or encapsulating vaccine antigen” (id. at 6).  The Specification             
              states that “the strong mucoadhesive and adsorptive properties of the                 
              polymer and lecithin combination enhances the adsorption of vaccine                   
              antigen onto mucosal surfaces” (id. at 6).                                            
                                           DISCUSSION                                               
              1.  CLAIMS                                                                            
                    Claims 1-9 and 20-22 are pending and on appeal.  Claim 1 is                     
              representative and reads as follows:                                                  
                    1.  A method for delivering a vaccine to a human or an                          
                    animal mucosally comprising:                                                    
                    formulating a vaccine comprising an antigen and an adjuvant                     
                    comprising lecithin and an acrylic polymer combined together                    


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