Ex Parte LEE - Page 13


                 Appeal No.  2004-1346                                                       Page 13                  
                 Application No.  08/971,338                                                                          
                        for purification of GDF-1 proteins (claims 24-30) also lacks                                  
                        patentable utility.                                                                           
                 According to the examiner (Answer, page 8),                                                          
                        [t]he specification speculates on possible activities of GDF-1.  None                         
                        of the particular activities disclosed for other TGF-β superfamily                            
                        members have been demonstrated for this protein in the                                        
                        specification and none were known at the time of the invention.                               
                        None of the uses set forth in the specification could be practiced at                         
                        the time of the invention without undue experimentation.  Providing                           
                        a laundry list of potential uses [as set forth in appellant’s                                 
                        specification], some of which are diametrically opposed to each                               
                        other, is not deemed to be enabling.                                                          
                 To emphasize the “laundry list” of potential uses set forth in appellant’s                           
                 specification the examiner reproduces portions of appellant’s disclosure found at                    
                 pages 1, 2, 12-15, and 20 into the answer.  See Answer, pages 8-13.  For                             
                 example, the portions of appellant’s specification reproduced by the examiner                        
                 identify several potential uses for GDF-1 including, inter alia, “as a specific                      
                 marker for the presence of tumors arising from cell types that normally express                      
                 GDF-1” (specification, page 12; Answer, page 10); “as an indicator for the                           
                 presence of developmental anomalies in prenatal screens for potential birth                          
                 defects” (id.); and “in prenatal screens for genetic diseases that either directly                   
                 correlate with the expression or function of GDF-1 or are closely linked to the                      
                 GDF-1 gene” (specification, page 13; Answer, page 11).  Nevertheless, despite                        
                 the assertion of “potential uses for GDF-1” appellant admits (specification, page                    
                 14; Answer, page 12), “[a] determination of the specific clinical settings in which                  
                 GDF-1 will be used as a diagnostic or as a therapeutic tool await further                            
                 characterization of the expression patterns and biological properties of GDF-1                       
                 both under normal physiological conditions and during disease states.”                               






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