Ex Parte YOSHII et al - Page 9


                 Appeal No.  2001-1907                                                        Page 9                    
                 Application No.  08/694,315                                                                            

                        Appellants argue that “[n]one of the references disclose any . . . activity of                  
                 histamine-activated immunoglobulin that is virtually histamine free, nor could it                      
                 have been expected from the disclosure of any of the references, alone or in                           
                 combination.  We agree.                                                                                
                        The burden is on the examiner to make a prima facie case of                                     
                 obviousness, and the examiner may meet this burden by demonstrating that the                           
                 prior art would lead the ordinary artisan to combine the relevant teachings of the                     
                 references to arrive at the claimed invention.  See In re Fine, 837 F.2d 1071,                         
                 1074, 5 USPQ2d 1596, 1598-99 (Fed. Cir. 1988).  The findings of fact underlying                        
                 the obviousness rejection, as well as the conclusions of law, must be made in                          
                 accordance with the Administrative Procedure Act, 5 U.S.C. 706 (A), (E) (1994).                        
                 See Zurko v. Dickinson, 527 U.S. 150, 158, 119 S.Ct. 1816, 1821, 50 USPQ2d                             
                 1930, 1934 (1999).  Findings of fact underlying the obviousness rejection, upon                        
                 review by the Court of Appeals for the Federal Circuit, must be supported by                           
                 substantial evidence within the record.  See In re Gartside, 203 F.3d 1305, 1315,                      
                 53 USPQ2d 1769, 1775 (Fed. Cir. 2000).  In addition, in order for meaningful                           
                 appellate review to occur, the examiner must present a full and reasoned                               
                 explanation of the rejection.  See, e.g., In re Lee, 277 F.3d 1338, 1342, 61                           
                 USPQ2d 1430, 1432 (Fed. Cir. 2002).  The obviousness rejection and the                                 
                 obviousness-type double-patenting rejection of record do not meet the above                            
                 criteria.                                                                                              
                        The claims are drawn to activated immunoglobulin in which the histamine                         
                 is removed from the mixture, wherein the amount of histamine after its removal is                      





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