Ex parte SHIRAHASE et al. - Page 7




              Appeal No. 1997-0838                                                                                         
              Application 08/235,238                                                                                       
              application provides ‘adequate support’ for the claim(s) at issue.”  Id., 935 F.2d at 1560,                  
              1111 USPQ at 1114.                                                                                           
                     As the result of amendment, claims 10 and 11 require “preserving more than 50%                        
              of LDH  activity” during the process of the invention. Appellants argue that this limitation is              
                     1                                                                                                     
              adequately supported inasmuch as the invention “provid[es] an LDH  assay which is useful                     
                                                                                       1                                   
              for clinical examinations,” while prior art methods are described in the specification as                    
              “unsatisfactory for clinical examinations because more than 50 percent LDH  may be                           
                                                                                               1                           
              inactivated during the inhibition of the other enzymes.”  Brief, page 24.                                    
                     In context, and under the heading “Description of the Related Art,” the portion of the                
              specification cited by appellants reads as follows:                                                          

                     In a most common LDH isozyme assay, LDH , LDH , LDH , LDH  and then1      2      3      4                                
                     LDH  are fractionated in the order of electrophoretic mobility.  An                                   
                          5                                                                                                
                     immunological LDH assay is also known.  In other LDH assay . . . a                                    
                     coenzyme derivative . . . is used.  In addition, LDH assays wherein a sample                          
                     is treated under an alkaline condition are described . . .                                            
                     The above-mentioned electrophoretic or immunological assay is unsuitable                              
                     for clinical autoanalysis because of complicated process and long operation                           
                     time.  In addition, the LDH isozymes may be insufficiently fractionated by the                        
                     electrophoretic method.                                                                               
                     [I]t is impossible to assay the LDH isozyme fractions by the method wherein                           
                     the coenzyme derivative is used . . .                                                                 
                     In the method comprising the alkaline treatment of the sample, more than 50                           
                     % of LDH  may be inactivated during the inhibition of the other isozymes.  In                         
                                1                                                                                          
                     addition, the process is complicated and takes a long time.                                           
                     Thus, the above-mentioned conventional LDH assays are unsatisfactory for                              
                     a clinical examination.  (pages 1 and 2, emphasis added).                                             

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