Ex parte SHIRAHASE et al. - Page 3




              Appeal No. 1997-0838                                                                                      
              Application 08/235,238                                                                                    
                     Humans produce five lactate dehydrogenase (LDH) isozymes, LDH , LDH , LDH ,1      2      3              
              LDH , and LDH , which catalyze the same reaction, but differ in certain of their physical4           5                                                                                         
              and/or chemical properties.  Each isozyme is composed of four subunits which may be                       
              heart muscle type (H), or skeletal muscle type (M), or both.  For example, LDH  is                        
                                                                                               1                        
              composed of four H subunits, LDH , LDH  and LDH  are composed of various2      3         4                                                    
              combinations of the H and M subunits, while LDH  is composed of four M subunits.                          
                                                                 5                                                      
              According to appellant,                                                                                   
                     Each of organs has its own composition of the isozymes.  For example,                              
                     LDH  is present in a myocardium in the largest amount. Since LDH1                                                           1                             
                     escapes from the myocardium into blood under a condition of a myocardial                           
                     infarction, a rise in serum LDH  level can be diagnostic for such a disease.                       
                                                     1                                                                  
                     (Specification, page 1).                                                                           
                     In its broadest aspect, the invention is directed to selective determination of LDH  in            
                                                                                                         1              
              human serum or plasma (using an assay for total LDH activity), wherein LDH , LDH , LDH2     3      4            
              and LDH , also present in the samples, are inhibited with a combination of "-chymotrypsin                 
                       5                                                                                                
              and a protein denaturing agent.                                                                           
                                                     Obviousness                                                        
                     Claims 1, 4 through 6, 10, 11, 13, 15 and 16 stand rejected as unpatentable over                   
              Iatron, Selmeci and Sanford.                                                                              
                     Iatron selectively measures residual LDH  activity in human serum using a protein                  
                                                                1                                                       
              denaturing agent (urea, thiourea, guanidine, etc.) in an alkaline buffer (pH 10-11) to                    

              inactivate LDH , LDH , LDH , and LDH .2      3     4           5                                                                 


                                                           3                                                            





Page:  Previous  1  2  3  4  5  6  7  8  9  10  Next 

Last modified: November 3, 2007