Ex Parte Harland et al - Page 3


                 Appeal No.  2007-0079                                                        Page 3                  
                 Application No.  10/159,749                                                                          
                 page 4.  For clarity, claim 1 of Harland is reproduced below with underlining to                     
                 illustrate where the claim differs from claim 1 before us on appeal:                                 
                        1. A method for reducing morphogen-dependent bone formation of a cell                         
                           comprising an extracellular surface in contact with a medium, said                         
                           method comprising the step of:                                                             
                               contacting said medium with an antagonist of a bone morphogenic                        
                           protein (BMP) selected from the group consisting of human BMP2 and                         
                           human BMP4, said antagonist produced exogenously from said cell                            
                           and comprising SEQ ID NO:[ ]2, 4, 6, 8 or 9 or a deletion mutant of a                      
                           sequence selected from the group consisting of SEQ ID NO:[]2 or 8                          
                           wherein said deletion mutant encodes a polypeptide that retains at                         
                           least residues 64-179 of SEQ [I]D NO:[ ]2 or residues 28-176 of SEQ                        
                           ID NO:[ ]8 and is sufficient to specifically bind and antagonize said                      
                           BMP, under conditions whereby said morphogen-dependent bone                                
                           formation is reduced; and                                                                  
                               measuring a resultant reduction of said morphogen-dependent                            
                           bone formation.                                                                            
                                                                                                                     
                        According to the examiner (Answer, page 4), “deletion mutants other than                      
                 those having residues 64-179 of SEQ ID NO:[ ]2 and 28-176 of SEQ ID NO:[ ]8,                         
                 have not been shown to exhibit binding and/or bone morphogen antagonizing                            
                 activity.”  From this, the examiner asserts (Id.), “[t]he claims thus encompass a                    
                 substantial number of variants for which requisite activity for either function is not               
                 established, while both are required.”  While the examiner recognizes that pages                     
                 11 and 12 of appellants’ specification identify “particular deletion mutants[ ]1 that                
                 exhibit shared structure and function,” the examiner finds “the specification fails                  
                 to exemplify any other deletion mutants which exhibit binding and bone                               
                 morphogen antagonizing function.”  Answer, page 6.  Therefore, the examiner                          
                 concludes (Id.), “the artisan cannot conclude that a representative number of                        
                 species within the full scope of the genus have been provided.  Nor can the                          
                                                                                                                      
                 1 Specifically, this portion of appellants’ specification refers to SEQ ID NO: 2, residues 24-182 of 
                 SEQ ID NO: 2, residues 54-180 of SEQ ID NO: 2, SEQ ID NO: 8 and residues 12-181 of SEQ ID            
                 NO: 8.                                                                                               




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