Ex Parte CARMAN - Page 7



                    Appeal No. 1997-2510                                                                                                    
                    Application No. 07/868,539                                                                                              

                            By addressing the written description and enablement provisions of 35                                           
                    U.S.C. § 112, first paragraph together, the examiner failed to focus on the                                             
                    requirements of either provision.  Thus, the rejection is not susceptible to a                                          
                    meaningful review.  Accordingly, we vacate the examiner’s rejection and remand                                          
                    the application.  Upon receipt of the application, the examiner should step back                                        
                    and reconsider the issue of written description separately from the issue of                                            
                    enablement.  If, the examiner believes that a rejection under the written                                               
                    description provision or the enablement provision is necessary, the examiner                                            
                    should issue an appropriate office action, that clearly sets forth the factual basis                                    
                    for the rejection.  In the event the examiner finds that a rejection under the                                          
                    written description provision and the enablement provision is required, the                                             
                    examiner should issue an appropriate Office Action, separately addressing, and                                          
                    clearly setting forth the factual basis for each rejection.                                                             
                            While we take no position on the merits of the examiner’s rejection.  We                                        
                    offer the following guidance, and make the following observations, to assist the                                        
                    examiner’s in his reconsideration of this record.                                                                       
                    A.  Written Description:                                                                                                
                        As set forth in Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323, 56                                        
                    USPQ2d 1481, 1483 (Fed. Cir. 2000) the written description “inquiry is a factual                                        
                    one and must be assessed on a case-by-case basis.”  Furthermore, “the PTO                                               
                    has the initial burden of presenting evidence or reasons why persons skilled in                                         
                    the art would not recognize in the disclosure a description of the invention                                            


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