Ex parte BOZYCZKO-COYNE et al. - Page 6




               Appeal No. 1997-3275                                                                                               
               Application No. 07/963,329                                                                                         

               determining whether undue experimentation is required to practice the claimed invention                            
               throughout its full scope are listed in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400,                             
               1404 (Fed. Cir. 1988).  These factors 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.                                                                              
                      On the record before us, the examiner has failed to provide the factual evidence or                         
               reasoning which would reasonably support a conclusion that the present disclosure in                               
               support of the claimed invention was not enabling through out the scope of the claimed                             
               subject matter.  Even if we assume, for purposes of argument, that the area of endeavor is                         
               highly unpredictable, the examiner's speculation concerning dosages, routes of                                     
               administration, and effectiveness are not supported by evidence which would reasonably                             
               establish that one skilled in this art could not practice the invention, given the disclosure                      
               provided by the specification, without undue experimentation.   More is required than                              
               merely providing alternative explanations for the results described and direction provided                         
               by the specification.  The examiner must establish that one skilled in this art would not                          
               accept the disclosure as enabling for the claimed invention.                                                       






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