Ex Parte LEE - Page 18


                 Appeal No.  2004-1346                                                       Page 18                  
                 Application No.  08/971,338                                                                          
                           3.  Skeletal Development: Akhurst, page 159-161, wherein Akhurst                           
                               point out (page 161, endnotes omitted):                                                
                                      TGFβ1 expression is associated with more overtly                                
                                      differentiated cell types in areas of ossification,                             
                                      namely osteoblasts, osteocytes and osteoclasts….  It                            
                                      has been reported that TGFβ2 is also expressed in                               
                                      these cell types…, though this has been questioned                              
                                      by others….  Unlike TGFβ2 and β3, TGFβ1 is, thus,                               
                                      more likely to be involved in control of osteoblast/                            
                                      osteoclast function, including bone remodeling which                            
                                      continues in the adult, and is influenced by                                    
                                      osteotropic hormones.                                                           
                               Again, appellant has not identified on this record whether                             
                            GDF-1 exhibits TGFβ1, TGFβ2 or TGFβ3 activity.                                            
                 Accordingly, we agree with the examiner’s finding (Answer, page 17) that                             
                 Akhurst amply illustrates that embryogenesis is a highly diverse and complex                         
                 process including skeletal development, hematopoiesis, vascularization, and so                       
                 forth.  (See pages 157-164.)[.]  This is also acknowledged by the specification as                   
                 filed on page 2, lines 15-20.  As such, a disclosure that GDF-1 may be involved                      
                 in embryogenesis cannot be considered to convey to those of ordinary skill in the                    
                 art any specific or clear biological activity.  It provides no direction or guidance as              
                 to which aspect or to a particular activity.                                                         
                        Thus, we disagree with appellant’s intimation (Brief, page 8) that by                         
                 assigning GDF-1 to the TGF-β superfamily, GDF-1 can be imputed with the                              
                 same specific, substantial, and credible utility to the TGF-β family.  As set forth                  
                 above, different isoforms of the TGF-β family exhibit different activities.  On this                 
                 record, appellant failed to identify any evidence, and we find none, to support the                  
                 assertion that GDF-1 will share the activity of all isoforms of TGF-β.  Nor do we                    
                 find any evidence on this record that appellant’s specification identifies with any                  






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