Ex Parte LEE et al - Page 2




             Appeal No. 2005-2385                                                                                    
             Application No. 09/485,045                                                                              
             Tabibzadeh et al (‘751)   5,916,751   June 29, 1999                                                     
                                                                           (Filed Aug. 27 1997)                      
             Tabibzadeh et al. (Tabibzadeh) “Distinct Tumor Specific Expression of TGFB4 (ebaf), A                   
             Novel Human Gene of the TGF-β Superfamily,” Frontiers in Bioscience 2, Vol. 2, pp.                      
             a18-25, (1997)                                                                                          
             Kothapalli et al., (Kothapalli) “Detection of ebaf, a Novel Human Gene of the                           
             Transforming Growth Factor β Superfamily,” J. Clin. Invest., Vol. 99, No. 10, pp. 2342-                 
             2350 (1997)                                                                                             


             Grounds of Rejection                                                                                    
                    Claims 2, 4-11 and 53-55 stand rejected under 35 U.S.C. §101 for lack of utility.                
                    Claims 2, 4-11 and 53-55 stand rejected under 35 U.S.C. §112, first paragraph                    
             for lack of enablement.                                                                                 
                    We reverse these rejections.                                                                     


                                                   DISCUSSION                                                        
             Utility and Enablement                                                                                  
                    Claims 2, 4-11 and 53-55 stand rejected under 35 U.S.C. §101 for lack of utility.                
             Claims 2, 4-11 and 53-55 stand rejected under 35 U.S.C. §112, first paragraph for lack                  
             of enablement.                                                                                          
                    In support of the rejection for lack of utility, the examiner argues (Answer, pages              
             3-4)                                                                                                    
                    [t]he claimed invention is not supported by either a specific and substantial                    
                    asserted utility or a  well-established utility. ... While Appellant lists a                     
                    number of conditions for which the protein encoded by the GDF-16                                 
                    polynucleotide might be used (p. 5 and 6), the specification does not                            
                    disclose any activity known to be associated with it. ..... [N]o diseases or                     
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