Ex Parte HOLMGREN et al - Page 13




              Appeal No. 1999-2634                                                                                         
              Application No. 08/108,606                                                                                   

                     Svennerholm does more than invite experimentation but teaches the                                     
                     administration of oral vaccines for protection against enterotoxin-                                   
                     producing E. coli.   Evans et al and Svennerholm et al teach the                                      
                     administration of an oral ETEC vaccine, it is maintained that the                                     
                     combination of this art is appropriate despite the fact that the vaccines of                          
                     Meyers, Soderlind and Gregory are administered parenterally because the                               
                     ordinary artisan would have had a reasonable expectation of success                                   
                     using the teachings of Myers, Soderlind and Gregory in the method of                                  
                     Evans et al in light of Svennerholm et al because Myers, Soderlind and                                
                     Gregory are analogous art as they focus on vaccines against enterotoxin-                              
                     producing E. coli and each reference defines conditions which provide                                 
                     insight to the nature of the antigens of enterotoxin-producing E. coli which                          
                     would result in the ordinary artisan having a reasonable expectation of                               
                     success of attaining a vaccine which is optimized against E. coli infection.                          
                     We agree with the examiner that Soderlind, alone or in combination with Evans 1                       
              and 2, Soderlind, Gregory and Myers provide the requisite reason, suggestion or                              
              motivation to substitute mild-formalin treated bacteria for colicin treated bacteria for                     
              preparation of an ETEC vaccine, and the reasonable expectation of success.   The                             
              reasonable expectation of success is particularly supported by Evans 1 disclosure of a                       
              successful whole cell ETEC vaccine and evidence of record that mild formalin treatment                       
              also provides for a whole cell vaccine.                                                                      

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