Ex parte SADOFF et al. - Page 4



              Appeal No. 1997-4275                                                                                          
              Application No. 08/253,217                                                                                    

                     The examiner urges that the use of two materials in combination would have been                        
              prima facie obvious where each is known to function for the same purpose.  (Answer, page                      
              17).  The examiner urges that (id.):                                                                          
                             each antibody is independently useful for the treatment of                                     
                             bacterial/LPS infection because Ziegler et al. outright show                                   
                             this treatment with anti-LPS antibody and Beutler et al. state                                 
                             that such treatment with anti-TNF antibody is an “obvious                                      
                             corollary” to their study.                                                                     
                     Thus, the examiner concludes (Answer, page 20):                                                        
                             We have two different active sites within the same pathway,                                    
                             and two different drugs/antibodies which act independently on                                  
                             each of the active sites of the pathway.  Absent contradictory                                 
                             evidence, it is concluded that the administration of these two                                 
                             antibodies would be expected to have additive or synergistic                                   
                             effects when combined for the treatment of sepsis.                                             
                     As the examiner realizes, the disclosure of Beutler is critical to the question of                     
              whether a prima facie case of obviousness of the claimed subject matter is established on                     
              this record.  The examiner has provided an in depth analysis of Beutler supported by                          
              sound scientific reasoning.  (Answer, pages 7-14).  However, in our opinion, the examiner                     
              has extended the teaching of Beutler in concluding that this reference suggests the use of                    
              an antibody to TNF for the treatment of sepsis in patients.  Beutler describes tests wherein                  
              mice are given a toxic dose of LPS in a single administration                                                 









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