Ex Parte Goldenberg - Page 6


                Appeal No. 2006-0656                                                                                  Page 6                    
                Application No. 10/086,637                                                                                                      

                         Nor do we find anything in Goldenberg or Barbet which would have led one                                               
                skilled in the art to use a divalent fragment with a molecular weight of 85,000 daltons or                                      
                less.  As appellant points out, Goldenberg “is concerned with . . . a method of reducing                                        
                background radiation so as to obtain an accurate reading of the radiation associated                                            
                with the primary antibody that binds the tumor antigen” (Appeal Brief, page 8), and “it                                         
                doesn’t really matter what type of antibody is used as the primary antibody” (id., page                                         
                9).  Barbet, on the other hand, does suggest that dual specificity conjugates comprising                                        
                various combinations of antibody fragments are preferable to conjugates comprising                                              
                whole antibodies, but all of Barbet’s dual specificity conjugates are trivalent (at least),                                     
                with two or more binding sites for antigen, and one or more for hapten, and are                                                 
                considerably larger than the divalent fragments required by the present claims (Barbet,                                         
                columns 4 and 5, and Example 1).  Moreover, “clearance of [ ] excess dual specificity                                           
                conjugate” is not an issue in Barbet’s method because clearance “is not required prior                                          
                [to] injection of the [affinity enhancement probe]” (id., column 9, lines 4-6).                                                 
                         Much has been said on both sides about the propriety of combining Goldenberg                                           
                and Barbet, but the bottom line is, quite simply, neither reference describes or suggests                                       
                the use of an antibody fragment that has two binding sites and a molecular weight of                                            
                85,000 daltons or less.  Horowitz, cited with respect to claim 190 as evidence that                                             
                brachytherapy via endoscope or catheter is conventional, does nothing to remedy this                                            
                deficiency.                                                                                                                     
                         “[T]he examiner bears the initial burden of presenting a prima facie case of                                           
                obviousness.  Only if that burden is met, does the burden of coming forward with                                                
                evidence or argument shift to the applicant.”  In re Rijckaert, 9 F.3d 1531, 1532, 28                                           





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