Ex Parte MITCHELL - Page 4


                  Appeal No. 1999-1427                                                                                     
                  Application No. 08/372,429                                                                               

                  mouse, a model which is not receptive to infection by the pathogen, to protectivity                      
                  in any mammalian host against any pathogen.”  Id.                                                        
                         “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.”  In re Wright, 999 F.2d 1557, 1561,  27 USPQ2d 1510, 1513 (Fed.                             
                  Cir. 1993).  “[A] specification disclosure which contains a teaching of the manner                       
                  and process of making and using the invention in terms which correspond in                               
                  scope to those used in describing and defining the subject matter sought to be                           
                  patented must be taken as in compliance with the enabling requirement of the                             
                  first paragraph of § 112 unless there is reason to doubt the objective truth of the                      
                  statements contained therein which must be relied on for enabling support.”  In re                       
                  Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971), emphasis in                                 
                  original.                                                                                                
                         In this case, the specification contains a working example (pages 29-34)                          
                  that appears to teach the “process of making and using the invention in terms                            
                  which correspond in scope to those used in describing and defining the subject                           
                  matter sought to be patented.”  Marzocchi, 439 F.2d at 223, 169 USPQ at 369.                             
                  That is, the working example teaches a method of inducing a mucosal immune                               
                  response by mucosal administration of antigen-encoding DNA complexed with a                              

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