Ex Parte Starling et al - Page 6


                Appeal No. 2005-2121                                                                                 Page 6                    
                Application No. 09/745,605                                                                                                     

                page 14).  The examiner concludes that “[s]ignificant further research would have to be                                        
                conducted to identify such a nexus” (id.).  In other words, the examiner finds that the                                        
                claimed invention does not provide a well-defined, particular benefit to the public.                                           
                         A substantial utility is one that makes the invention useful to the public in its current                             
                form, not potentially useful in the future after further research.  See Fisher, 421 F.3d at                                    
                1371, 76 USPQ2d at 1230.  As the examiner has pointed out, the specification provides                                          
                no guidance on the meaning of an increase or decrease in APEX-1 expression or activity,                                        
                other than a hypothetical association with inflammation, cancer and/or immune disorders.                                       
                Thus, we agree with the examiner that the specification fails to disclose a substantial                                        
                utility that satisfies the requirements of 35 U.S.C. § 101.                                                                    
                         To the extent appellants argue that “credible utility is established at the very least                                
                by the use of the claimed compounds as molecular weight markers,” (Brief, page 8) we                                           
                disagree.  A utility that could be asserted for any expressed human gene is not a                                              
                “specific” utility that will satisfy § 101.  See Fisher, 421 F.3d at 1370, 76 USPQ2d at 1230                                   
                (a specific utility requires “that [the] claimed invention can be used to provide a well-                                      
                defined and particular benefit to the public”) and id. at 1374, 76 USPQ2d at 1232 (“Any                                        
                EST transcribed from any gene in the maize genome has the potential to perform any one                                         
                of the alleged uses . . . Nothing about Fisher’s seven alleged uses set the five claimed                                       
                ESTs apart from the more than 32,000 ESTs disclosed in the ‘643 application or indeed                                          
                from any EST derived from any organism.  Accordingly, we conclude that Fisher has only                                         
                disclosed general uses for its claimed ESTs, not specific ones that satisfy § 101”).                                           
                         Any expressed human gene could be used as a molecular weight marker – just                                            
                as any expressed gene “can be used to map the location of [its] corresponding gene[ ]                                          





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