Ex Parte FISCHETTI - Page 6


                 Appeal No.  2001-2524                                                        Page 6                  
                 Application No.  08/369,295                                                                          
                        We find no analysis of the Wands factors by the examiner.  Instead, we                        
                 find only the examiner’s unsupported conclusions as to why the specification                         
                 does not enable the claimed invention.  According to the examiner (Answer,                           
                 page 6), “any peptides of five or more amino acids may prove to be antigenic                         
                 when conjugated to a carrier protein but whether such an antigen will or will not                    
                 be protective is not predictive from the fact that it is antigenic since such findings               
                 are empirical … based on trial and experimentation….”  In addition, with regard                      
                 to the carrier portion of the antigen conjugate, the examiner finds (Answer, page                    
                 8), “the specification does not provide sufficient guidance as to which natural                      
                 carriers would be effective in providing a conjugate that would be effectively                       
                 immunogenic and/or immunoprotective.”  The examiner, however, failed to                              
                 provide a factual basis for his concerns.  In the absence of a fact-based                            
                 statement of a rejection based upon the relevant legal standards, the examiner                       
                 has not sustained his initial burden of establishing a prima facie case of non-                      
                 enablement.                                                                                          
                        As set forth in In re Moore, 439 F.2d 1232, 1235, 169 USPQ 236, 238                           
                 (CCPA 1971), before issues related to the patentability of the claimed subject                       
                 matter can begin to be considered, the examiner must determine what is being                         
                 claimed.                                                                                             
                                      [T]he claims must be analyzed first in order to                                 
                               determine exactly what subject matter they                                             
                               encompass….                                                                            
                                      The first inquiry therefore is merely to                                        
                               determine whether the claims do, in fact, set out and                                  
                               circumscribe a particular area with a reasonable                                       
                               degree of precision and particularity.  It is here where                               
                               the definiteness of the language employed must be                                      






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