Ex parte SHIRAHASE et al. - Page 6




              Appeal No. 1997-0838                                                                                         
              Application 08/235,238                                                                                       
                     Examples 1-4 in the specification show the claimed process where it is                                
                     implied the LDH1 activity is preserved, however, it is not clearly shown what                         
                     the activity was before and after the inhibiting step.  Such a claimed                                
                     limitation must be specifically recited in the specification.  (Examiner’s                            
                     Answer, page 5).                                                                                      
                     This conclusory statement does not satisfy the examiner’s initial burden of                           
              establishing unpatentability.  In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369                         
              (CCPA 1971).  The specification need only teach how to make and use the claimed                              
              invention.  The examiner has not done the factual analysis necessary to establish that                       
              appellants’ specification does not meet this standard, especially in light of Examples 1, 2                  
              and 4, wherein LDH  retains 69% or more of its initial activity (i.e., wherein LDH  has a1                                                          1                       
              “residual activity” of 69% or more) in the presence of a protein denaturing reagent and "-                   
              chymotrypsin.                                                                                                
                     Accordingly, Rejection II of claims 10 and 11 as lacking enablement under 35                          
              U.S.C. § 112, first paragraph, is reversed.                                                                  
                                              Written Descriptive Support                                                  
                     An issue arising under the written description requirement of 35 U.S.C. § 112, first                  
              paragraph, is a question of fact.  Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19                       
              USPQ2d 1111, 1116 (Fed. Cir. 1991).  “[T]he ‘written description’ requirement most often                     
              comes into play where claims not presented in the application when filed are presented                       
              thereafter . . . The question raised by these situations is most often phrased as whether the                




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