Ex Parte LEE - Page 22


                 Appeal No.  2004-1369                                                        Page 22                  
                 Application No.  08/966,233                                                                           
                        activin, has been shown to function as a nerve cell survival                                   
                        molecule.  …  Alternatively, if the target cells for GDF-1 in the                              
                        nervous system are the support cells, GDF-1 will likely prove to be                            
                        of therapeutic benefit in the treatment of disease processes leading                           
                        to demyelination.                                                                              
                               Many of the members of this superfamily, including GDF-1,                               
                        are also likely to be clinically useful for tissue repair and                                  
                        remodeling.  For example, the remarkable capacity of the bone                                  
                        morphogenetic proteins to induce new bone growth … has                                         
                        suggested their utility for the treatment of bone defects caused by                            
                        trauma, surgery, or degenerative diseases like osteoporosis….                                  
                               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.                                                                     
                        Consistent with the cited sections of appellant’s disclosure, the examiner                     
                 points out (Answer, page 8), “[t]he specification speculates on possible activities                   
                 of GDF-1[,] [n]one 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.”  Now, with                           
                 evidence from a reference published a decade after appellant’s effective filing                       
                 date, appellant asserts that their prediction was correct.  Specifically, the                         
                 “prediction” that a “second potential diagnostic use for GDF-1 is as an indicator                     
                 for the presence of developmental anomalies in prenatal screens for potential                         
                 birth defects … [and] may indicate the presence of structural defects in the                          
                 developing fetus.”  Specification, bridging paragraph, pages 12-13.  In our                           
                 opinion, appellant’s specification cannot be stretched this far.  As the examiner                     
                 explains (Answer, page 24), Rankin uses “information, materials, assays, and/or                       
                 techniques that were not known at the time of the invention and thus make clear                       
                 that one of ordinary skill in the art trying to determine what activity GDF-1 had at                  






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