Ex Parte USMAN et al - Page 7


                  Appeal No. 2002-1251                                                              Page 7                     
                  Application No. 08/459,340                                                                                   

                          Appellants argue that the examiner                                                                   
                          fails to provide any evidence whatsoever that the instant invention                                  
                          would not work for its intended purpose, other tha[n] alleging the                                   
                          unpredictability of in vivo efficacy based on the Antisense ’97                                      
                          article, or that ribozyme delivery is an unpredictable art based on                                  
                          the Branch article.  Appellants, however, have provided ample data                                   
                          and guidance in the specification and indicated teachings in the art                                 
                          that demonstrate the efficacy of modified enzymatic nucleic acid                                     
                          molecules both in vitro and in vivo. . . .  In the absence of any                                    
                          technical reasons and/or references to support its reasoning, the                                    
                          Office has failed to establish a prima facie case of lack of                                         
                          enablement.                                                                                          
                  Reply Brief, pages 12-13.                                                                                    
                          “When rejecting a claim under the enablement requirement of section 112,                             
                  the PTO bears an initial burden of setting forth a reasonable explanation as to                              
                  why it believes that the scope of protection provided by that claim is not                                   
                  adequately enabled by the description of the invention provided in the                                       
                  specification of the application; this includes, of course, providing sufficient                             
                  reasons for doubting any assertions in the specification as to the scope of                                  
                  enablement.  If the PTO meets this burden, the burden then shifts to the                                     
                  applicant to provide suitable proofs indicating that the specification is indeed                             
                  enabling.”  In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed.                                 
                  Cir. 1993).                                                                                                  
                          We agree with Appellants that the examiner has not met the burden of                                 
                  providing evidence to support a prima facie case of nonenablement.  The                                      
                  examiner provides no Wands-based analysis, based on the particular facts of the                              
                  application and claims under consideration, supporting a conclusion that undue                               
                  experimentation would have been required to use the claimed compositions                                     





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