Ex Parte QUAN et al - Page 5


                 Appeal No.  2003-1679                                                        Page 5                  
                 Application No.  08/993,010                                                                          
                 with infectivity.  (Figura, page 298, right column; Figure 5 and accompanying                        
                 legend).”                                                                                            
                        Figura characterizes H. pylori Type I strains as expressing VacA and                          
                 CagA, and Type II strains as being VacA- and CagA-negative.  See Figura,                             
                 Abstract.  Consistent with appellants’ analysis (Brief, page 11), Figura teaches                     
                 (page 298, second column, last paragraph, endnotes omitted), Western blots                           
                        are not quantitative and sometimes difficult to interpret.  In Fig. 5,                        
                        for example, disparate immune responses to CagA and VacA can                                  
                        be observed (lanes 3 to 5).  These proteins are expressed together                            
                        in more than 70% of H. pylori isolates.  Surprisingly, out of the                             
                        hundreds of Western blots we have performed, VacA immune                                      
                        recognition was observed in only about 15% of cases in which                                  
                        serum samples reacted with CagA, and in about 5% of cases which                               
                        were seronegative for CagA.  Although the results of Xiang et al.                             
                        explain the existence of strains expressing only VacA (in about 10%                           
                        of isolates), the examples shown in Fig. 5 indicate that more                                 
                        studies are needed to clarify the situation in vivo.                                          
                        We remind the examiner, that in order to establish a prima facie case of                      
                 obviousness, there must be both some suggestion or motivation to modify the                          
                 references or combine reference teachings and a reasonable expectation of                            
                 success.  In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438, 1442 (Fed. Cir.                            
                 1991).  On this record, while Figura refers to Xiang to “explain the existence of                    
                 strains expressing only VacA,” Figura expressly states that “more studies are                        
                 needed to clarify the situation in vivo.”  In this regard, notwithstanding the                       
                 examiner’s position to the contrary (Answer, page 16, paragraph 15), appellants’                     
                 claimed invention is directed to a method of detecting Helicobacter pylori                           
                 antibodies associated with infection in a human subject comprising, inter alia,                      
                 correlating the presence of antibodies that bind to specific antibodies to either                    







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