Ex parte PAVLAKIS et al. - Page 13

              Appeal No. 1995-2723                                                                                            
              Application 07/858,747                                                                                          

                      a few embodiments and do not demonstrate with reasonable specificity how to                             
                      make and use the other potential embodiments across the full scope of the                               
              claims.   See, e.g.  In re Goodman, 11 F.3d 1046, 1050-52, 29 USPQ2d 2010, 2013-                                
              2015  (Fed. Cir. 1993); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200,                                
              1212-14, 18 USPQ2d 1016, 1026-28  (Fed. Cir.),                                                                  
                      cert. denied, 502 U.S. 856 (1991);  In re Vaeck, 947 F.2d 488,  496, 20 USPQ2d                          
                      1438, 1445.  Enablement is lacking in those cases, the court has explained,                             
                      because the undescribed embodiments cannot be made based on the                                         
                      disclosure in the specification, without undue experimentation.  But the question                       
                      of undue experimentation is a matter of degree.  The fact that some                                     
              experimentation is necessary does not preclude enablement; what is required is that                             
              the amount of experimentation "must not be unduly extensive."  Atlas      Powder Co., v.  E.I.                  
              DuPont De Nemours & Co., 750 F.2d 1569, 1576,                                                                   
                      224 USPQ 409, 413  (Fed. Cir. 1984).  The Patent and Trademark Office Board                             
                      of Appeals summarized the point well when it stated:                                                    
                             The test is not merely quantitative, since a considerable amount of                              
                             experimentation is permissible, if it is merely routine, or if the                               
                             specification in question provides a reasonable amount of guidance                               
                             with respect to the direction in which the experimentation should                                
                             proceed to enable the determination of how to practice a desired                                 
                             embodiment of the invention claimed.  Ex parte Jackson, 217 USPQ                                 
                             804, 807 (Bd. App. 1982).                                                                        
                      In addition, the examiner should consider whether "the level of expression of said                      
              gene" would reasonably serve as a means of evaluating whether the effect of the  INS                            
              within the coding region of the mRNA has been reduced.  Both Schwartz and Wisdom                                
              would appear to suggest that the level of transcription of the mRNA would not necessarily                       
              reflect the "post transcription effect" called for by the claims.                                               


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