Ex Parte Hu et al - Page 6

                Appeal 2007-1148                                                                             
                Application 10/078,592                                                                       

                metalloprotease.  The same applies to Appellants’ reliance on Quesada (Br.                   
                6).  We have already concluded that the characterization of SEQ ID NO:2 as                   
                a metalloprotease, even if accurate, is insufficient to establish a patentable               
                utility for the claimed nucleic acids or the protein they encode.                            
                      Appellants also argue that the patentability of the claimed nucleic acids              
                is supported by Example 10 of the Revised Interim Utility Guideline Training                 
                Materials (Br. 7).  We disagree.  That example shows that a high degree of                   
                similarity to a protein with an established utility (e.g., a ligase enzyme) can              
                be sufficient to establish the likely activity of a claimed polypeptide or                   
                nucleic acid.  In this case, however, the characterization of SEQ ID NO:2 as a               
                “protease” or even a “zinc-dependent metalloprotease” does not suggest any                   
                specific and substantial utility to those skilled in the art.                                
                      Finally, Appellants argue that the claimed nucleic acids are useful for                
                “tracking [the] expression of the presently claimed sequence” (Br. 8), for                   
                identifying protein coding sequences of the genome (id. at 11), and for                      
                mapping human chromosomes (id. at 12).                                                       
                      These uses do not meet the requirements of § 101.  The Fisher court                    
                concluded that generic uses like those asserted by Appellants – assessing                    
                gene expression, mapping chromosomes, and identifying exons – are neither                    
                substantial nor specific.  Like in Fisher, these uses are “merely hypothetical               
                possibilities, objectives which the claimed [cDNAs], or any [cDNA] for that                  
                matter, could possibly achieve, but none for which they have been used in                    
                the real world.”  Fisher, 421 F.3d at 1373, 76 USPQ2d at 1231 (emphasis in                   
                original).  Therefore, they are not substantial utilities.                                   



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