Ex parte CLARK et al. - Page 5




              Appeal No.  2001-2308                                                                                            
              Application 07/704,578                                                                                           

              Rejection 1                                                                                                      
                      Claims 28 and 29 stand rejected alternatively under 35 U.S.C. §102 or                                    
              35 U.S.C. §103 as anticipated by or obvious over Hirano, Weissenbach, or Zilberstein.                            
                      Under certain circumstances, the USPTO can require an applicant to prove that the                        
              prior art products do not necessarily or inherently possess the characteristics of his                           
              claimed product.  For example, where the claimed and prior art products are identical or                         
              substantially identical, or are produced by identical or substantially identical processes, the                  
              USPTO can require an applicant to prove that the prior art products do not necessarily or                        
              inherently possess the characteristics of his claimed product3.  However, the examiner                           
              bears the initial burden of providing facts and reasons to believe that the prior art products                   
              are identical or substantially identical to the claimed product.                                                 

                      Claim 28 requires a nonglycosylated protein in combination with a pharmaceutically                       
              acceptable vehicle.  In reviewing the Examiner’s Answer, nowhere do we find that the                             
              examiner has acknowledged and discussed this aspect of the invention.  Failure to                                
              consider the subject matter of the claim as a whole constitutes legal error.  Accordingly, all                   
              rejections of claim 28 are reversed.                                                                             
                      Claim 29 requires a product made by a specific process which is a non-                                   
              glycosylated protein having a specific amino acid sequence and is substantially free of                          
              other protein.  We find that the examiner has not provided adequate reasons to believe                           

                      3 In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977).                                    
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