Ex Parte LEE - Page 16


                 Appeal No.  2004-1346                                                       Page 16                  
                 Application No.  08/971,338                                                                          
                 application” is acceptable.  Accordingly, we have considered Akhurst as                              
                 representative of the state of the art relating to transforming growth factors at the                
                 time the application was filed.                                                                      
                        In this regard, we note that appellant emphasizes that Akhurst                                
                 characterize the TGF-β superfamily “as ‘a large superfamily of related proteins,                     
                 each of which plays a pivotal role in embryonic processes’….”  See e.g., Brief,                      
                 page 8.  We note that the concept of a “pivotal role” appears to be a major                          
                 theme in appellant’s Brief.  See e.g., Brief, pages 8-10, wherein “pivotal role” is                  
                 mentioned no less than five times.  There is no doubt that the abstract (page                        
                 153) of Akhurst uses the term “pivotal role.”  However, what appellant fails to                      
                 point out or discuss is Akhurst’s statement (page 155), “[a]s yet there is no                        
                 definitive evidence that any of the TGFβs are endogenous regulators of                               
                 mammalian embryonic processes.”  Accordingly, as we understand the Akhurst                           
                 article, while members of the TGF-β superfamily may potentially play a role in                       
                 embryonic processes there is, at the time this invention was filed, no definitive                    
                 evidence to support this assertion.                                                                  
                        Thus, when Akhurst is considered as representative of the state of the art                    
                 at the time of appellant’s filing date, it appears that Akhurst would agree with                     
                 appellant’s disclosure (specification, page 14) that “[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                       










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