Ex parte MEDFORD et al. - Page 4


                 Appeal No.  1997-4380                                                                                    
                 Application No.  08/147,878                                                                              
                 further reference appellants’ Brief3, and appellants’ Reply Brief4 for the appellants’                   

                 arguments in favor of patentability.                                                                     
                 THE REJECTION UNDER 35 U.S.C. § 112, FIRST PARAGRAPH:                                                    
                         It is well settled that the examiner bears the initial burden of providing                       
                 reasons why a supporting disclosure does not enable a claim.  In re Marzocchi, 439                       
                 F.2d 220, 223, 169 USPQ 367, 370 (CCPA 1971).  See also, In re Wands, 858                                
                 F.2d 731, 737, 8 USPQ2d 1400, 1404, (Fed. Cir. 1988):                                                    
                                Factors to be considered in determining whether a                                         
                                disclosure would require undue experimentation have                                       
                                been summarized by the board in In re Forman, [230                                        
                                USPQ 546, 547 (BdPatAppInt 1986)].  They include (1)                                      
                                the quantity of experimentation necessary, (2) the                                        
                                amount of direction or guidance presented, (3) the                                        
                                presence or absence of working examples, (4) the                                          
                                nature of the invention, (5) the state of the prior art, (6)                              
                                the relative skill of those in the art, (7) the predictability                            
                                or unpredictability of the art, and (8) the breadth of the                                
                                claims. (footnote omitted).                                                               
                         In this case the examiner failed to analyze the claimed invention with                           
                 reference to the factors set forth in Wands.  Instead the examiner merely makes a                        
                 series of conclusions:                                                                                   
                                The specification does not adequately teach how to deliver the                            
                         claimed oligonucleotides (oligos) in vivo. [Answer, page 5]…. The                                
                         specification does not adequately teach how to use the claimed                                   
                         methods in vivo because it does not disclose what happens when the                               
                         oligos are administered. [Answer, page 6]…. The specification does                               
                         not explain how to use the claimed methods for diagnosis.  [Answer,                              
                         page 7].                                                                                         


                                                                                                                          
                 3 Paper No. 22, received March 31, 1997.                                                                 
                 4 Paper No. 25, received August 28, 1997.                                                                

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