Ex Parte Walke et al - Page 6

               Appeal  2007-3881                                                                           
               Application  09/833,782                                                                     

               NO: 2 is a neurolysin.  The Examiner does not dispute that the GenBank                      
               entry’s amino acid sequence is identical to SEQ ID NO: 2 or that the                        
               researchers who deposited the GenBank entry annotated it as human                           
               neurolysin.  We therefore agree with Appellants that the GenBank entry is                   
               persuasive evidence that SEQ ID NO: 2 is the human neurolysin sequence.                     
                      The Examiner has conceded that “the utility of animal neurolysins                    
               was already known before the instant application was filed” (Answer 18).                    
               Kato provides evidence supporting the Examiner’s statement.2  Kato                          
               provides a thorough discussion of research on neurolysin (also known as                     
               endopeptidase 24.16, oligopeptidase M, and MOP) (Kato, paragraph                            
               bridging 15313 and 15314).  Kato states that neurolysin and endopeptidase                   
               24.15 are “the two best characterized” mammalian metalloendopeptidases                      
               (id. at 15313, right-hand column) and that neurolysin inactivates neurotensin               
               and has been shown to “have a relatively broad substrate-specificity and                    
               tissue distribution” (id. at 15314, left-hand column).                                      
                      It is true, as the Examiner points out, that Appellants have pointed to              
               no experimental data, in the instant Specification or elsewhere, that shows                 
               definitively that the protein of SEQ ID NO: 2 has the activity of neurolysin.               
               However, a patent applicant need not provide definitive experimental data in                
               order to show that a claimed invention has patentable utility.  Rather, the                 
               Examiner bears the burden of showing a reasonable basis for doubting the                    

                                                                                                          
               2 The Examiner states that “nowhere in [Kato] one can find the word                         
               ‘neurolysin,’” but Kato states that “[t]he enzyme, termed neurolysin or                     
               endopeptidase 24.16, was shown to be distinct from EP 24.15 (TOP) . . .”                    
               (Kato at 15314, middle of left-hand column).                                                
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