Ex Parte LEE et al - Page 4




             Appeal No. 2005-2385                                                                                    
             Application No. 09/485,045                                                                              
                    Appellants further argue, (Brief, pages 5-6 )                                                    
                    A number of scientific publications available as of the filing date of the                       
                    present application, describe specific expression of TGFβ family members,                        
                    for example the TGFβ-4 (endometrial bleeding associated factor; ‘ebaf’)                          
                    gene, in cell proliferative disorders, including endometrial bleeding and                        
                    adenocarcinoma of the colon, ovaries, and testes (see Kothapalli et al. J.                       
                    Clin.  Invest. 99,2342-2350 (May 15, 1997); and Tabibzadeh et al.,                               
                    Frontiers in BioScience 2, a18-25 (July 15, 1997)[)].  ... [T]he                                 
                    polynucleotide sequence of TGFβ-4 (ebaf), disclosed in US. Pat. No.                              
                    5,916,751 (The '751 Patent), contains a region of 303 nucleotides that is                        
                    92% homologous to SEQ ID NO: 1 of the subject application. ... Applicants                        
                    submit that one skilled in the art, viewing the subject application, and                         
                    having knowledge of the Kothapalli et al. and Tabibzadeh et al.                                  
                    references, would immediately appreciate that the polynucleotides of the                         
                    invention ...  are useful in the detection of TGFβ family members, such as                       
                    TGFβ-4 (ebaf), whose expression is correlated with cell proliferative                            
                    disorders.                                                                                       
                    We agree with appellants that one of ordinary skill in the art, viewing the subject              
             application and having knowledge of the ‘571 patent and Kothapalli and Tabibzadeh                       
             references, would appreciate that the claimed GDF-16 polynucleotide would have been                     
             useful in the detection of TGFβ family members, such as TGFβ-4 (ebaf), whose                            
             expression is correlated with cell proliferative disorders.                                             
                    An invention has a well-established utility if (i) a person of ordinary skill in the art         
             would immediately appreciate why the invention is useful based on the characteristics of                
             the invention (e.g., properties or applications of a product or process), and (ii) the utility          
             is specific, substantial, and credible. See, e.g., In re Folkers, 344 F.2d 970, 145 USPQ                
             390 (CCPA 1965). “[U]sefulness of a chemical compound is invariably a manifestation                     
             of a given property of that compound. ... [S]ome uses can be immediately inferred from                  
             a recital of certain properties. The question here is ...  whether knowledge of that                    
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