Ex parte PERGOLIZZI et al. - Page 8




          Appeal No. 95-3606                                                          
          Application 07/827,691                                                      
               “useful,” in the sense that a patent can be granted on                 
          it,                                                                         
               unless substantial or practical utility for the invention              
               has been discovered and disclosed where such utility                   
          would                                                                       
               not be obvious.  Brenner v. Manson, 383 U.S. 519, ....,                
          148       USPQ      689 (1966).                                             
               Unlike the language of method Claim 41 and all claims                  
          dependent thereon, the language of kit Claim 42 and all claims              
          dependent thereon reasonably may be interpreted consistent                  
          with the teaching in the specification, appellants’ arguments,              
          and the art made of record in this application to include                   
          materials for use in methods which cannot be used to reliably               
          determine whether an individual carries a mutation for Fragile              
          X.  For example,                                                            
          see the results reported in applicants’ Fig. 1, explained in                
          Example 1 as follows (Spec., Example 1, p. 23, l. 12-24).                   
               DNA isolated from: (1) a normal individual (lanes 1);                  
               (2) a fragile X carrier male (lanes 2); (3) a male                     
               afflicted with the fragile X syndrome (lanes 3); and                   
               (4) a female fragile X carrier (lanes 4) were subjected                
               to PCR in the presence of different proportions of                     
               7-deaza-2'-dGTP to dGTP (100:0; 75:25; 50:50).  The                    
               PCR products were analyzed by blot hybridization using                 
               a probe B (described above) complementary to the CGG                   
               repeat region of the FMR-1 locus.  Figure 1 shows the                  
               results of this analysis.  Note that the high molecular                
               weight bands were detected only in the presence of 100%                
               7-deaza-2'-dGTP, 0% dGTP.  In other words, the fully                   
               mutated fragile X gene was only detected when the PCR                  
               reaction mixture was substantially free of dGTP.                       

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