Ex Parte LEE - Page 18


                 Appeal No.  2004-1369                                                        Page 18                  
                 Application No.  08/966,233                                                                           
                            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 20) 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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