Ex parte PERGOLIZZI et al. - Page 13




          Appeal No. 95-3606                                                          
          Application 07/827,691                                                      
               genotype is characterized by an increased amount of                    
          unstable                                                                    
               DNA that maps to the repeat.  Most of this unstable DNA                
          and                                                                         
               indeed most of the repeat in normal X chromosomes is lost              
               during cloning and DNA amplification by PCR, thus, its                 
          exact                                                                       
               nature must remain speculative.                                        
               B.   Innis I and Innis II                                              
               Innis I teaches that DNA amplification by PCR is useful                
          to facilitate the cloning of DNA, characterization of both DNA              
          and RNA sequences, and the detection of pathogens and disease               
          states associated with the presence of particular DNA nucleic               
          acid segments (Innis I, col. 1, l. 9-17).  “PCR can be used in              
          conjunction with labeled probes and ‘dot-blot’ methodology to               
          detect the presence of a nucleic acid sequence initially                    
          present in extraordinarily small amounts” (Innis I, col. 1, l.              
          44-47).  When inefficient or no amplification occurs by PCR,                
          which unpredictably is often the case, extensive testing is                 
          often required to determine the source of the problem , e.g.,               
          the primers may be hybridizing to other regions of the target               
          sequence (Innis I, col. 2, l. 34-50).  It is Innis’s intent to              
          eliminate at least one potential problem, i.e., the formation               
          and presence of secondary structure in the target DNA molecule              
          which can greatly reduce the efficiency of amplification in                 

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