Ex Parte Yu et al - Page 7


              Appeal No. 2006-0732                                                          Page 7                       
              Application No. 10/060,974                                                                                 

              process, or any association between the protein of SEQ ID NO:2 and any disease or                          
              disorder.  Thus, the specification’s disclosure is inadequate to allow those skilled in the                
              art to use the protein of SEQ ID NO:2 in a specific and substantial way.                                   
                     Appellants have pointed to no evidence outside of the specification, and publicly                   
              available before this application’s effective filing date, that would have allowed a person                
              skilled in the art to use the protein of SEQ ID NO:2 in a specific and substantial utility.                
              We therefore conclude that the mere identification of the protein encoded by the                           
              claimed nucleic acids as a sodium transporter does not satisfy the utility requirement of                  
              35 U.S.C. § 101.                                                                                           
                     Appellants also argue that the claimed polynucleotides are useful for “assessing                    
              gene expression patterns using high-throughput DNA chips” (Appeal Brief, page 14);                         
              that they are useful in mapping human chromosomes (id., page 16); and that they are                        
              “useful for functionally defining exon splice-junctions” (id., page 17).                                   
                     We find that none of these uses meet the requirements of § 101.  In this case, as                   
              in Fisher, the generic uses asserted by Appellants – assessing gene expression,                            
              mapping human chromosomes, and defining exon splice-junctions – 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.                                                                                                 
                     Nor are they specific utilities, because they could be asserted for any cDNA                        
              transcribed from any gene in the human genome.  Because nothing about Appellants’                          





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