Ex Parte HOLMGREN et al - Page 12




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

              which was CFA/I positive evoked partial protection against challenge with CFA                                
              homologous as well as CFA-heterologous ETEC strains.    Because Svennerholm                                  
              suggests that colicin treatment is an alternative method to mild formalin treatment to                       
              inactivate ETEC bacteria, it would have been obvious to one of ordinary skill in the art                     
              at the time of the present invention to substitute mild formalin treatment for the colicin                   
              treatment to inactivate CFA positive ETEC cells with an expectation of success that it                       
              would provide for a protective oral vaccine.   We also find Evans 1, 2, Soderlind and                        
              Gregory to be cumulative and supportive of the efficacy of formalin treated ETEC                             
              vaccines.                                                                                                    
                     Where the prior art, as here, gives reason or motivation to make the claimed                          
              invention, the burden then falls on an appellants to rebut that prima facie case.  Such                      
              rebuttal or argument can consist of any other argument or presentation of evidence that                      
              is pertinent.  In re Dillon, 919 F.2d 688, 692-93, 16 USPQ2d 1897, 1901 (Fed. Cir.                           
              1990) (en banc),  cert. denied,  500 U.S. 904 (1991).                                                        
                    In response to the examiner=s arguments, appellants argue (Brief, pages 7-8)                          
              that ASvennerholm clearly indicate that efficacious anti-ETEC vaccines were still                            
              theoretical. ... [A]ccordingly, one of ordinary skill in the art would have recognized that                  
              success could only be measured by clinical data which had not yet been acquired at the                       
              date of publication.  Thus, appellants argue that Svennerholm provides no reasonable                         
              expectation of success of obtaining an efficacious ETEC vaccine.   Brief, page 8.                            
                     In response, it is the position of the examiner that (Answer, pages 5-6)                              

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