Ex Parte Hu et al - Page 4

                Appeal 2007-1148                                                                             
                Application 10/078,592                                                                       

                      mere disclosure that a protein is a protease without a more                            
                      specific recitation of what type of protease (i.e., what substrate                     
                      is cleaved) is insufficient to provide a substantial utility, as the                   
                      skilled  artisan  would  require  further  research  to  identify  or                  
                      reasonably confirm a real world context of use.                                        
                (Answer 4-5.)                                                                                
                      We agree with the Examiner’s reasoning.  Section 101 requires a                        
                utility that is both substantial and specific.  In re Fisher, 421 F.3d 1365,                 
                1371, 76 USPQ2d 1225, 1229 (Fed. Cir. 2005).  A substantial utility is one                   
                that “shows that an invention is useful to the public as disclosed in its                    
                current form, not that it may be useful at some future date after further                    
                research.  Simply put, to satisfy the ‘substantial’ utility requirement, an                  
                asserted use must show that th[e] claimed invention has a significant and                    
                presently available benefit to the public.”  Id., 76 USPQ2d at 1230.  A                      
                specific utility is “a use which is not so vague as to be meaningless.”  Id.  In             
                other words, “in addition to providing a ‘substantial’ utility, an asserted use              
                must show that th[e] claimed invention can be used to provide a well-                        
                defined and particular benefit to the public.”  Id.                                          
                      The instant Specification discloses that the amino acid sequence of                    
                SEQ ID NO:2 is similar to that of known proteases, including zinc-                           
                dependent metalloproteases, but it discloses no specific and substantial                     
                utility based on the expected protease activity.  Nor does the Specification                 
                disclose any specific and substantial utility for the protein of SEQ ID NO:2                 
                or the DNA encoding it based on other properties they are expected to have.                  
                The Specification contains only vague or generic assertions of utility.  We                  
                agree with the Examiner that the Specification does not “show that th[e]                     
                claimed invention has a significant and presently available benefit to the                   

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