Ex parte LUDWIG et al. - Page 5




              Appeal No. 1997-0160                                                                                         
              Application No. 08/073,985                                                                                   


                     Mullis describes a process for amplifying a target nucleic acid sequence in a                         
              nucleic acid sample and then detecting the amplified target sequence (c. 2, ll. 46-50;                       
              c. 7, ll. 17-24), wherein the sample acid can be single or double stranded DNA or RNA, a                     
              DNA-RNA hybrid or mixtures thereof (c. 7, ll. 39-47), including DNA or RNA from any                          
              source, including bacteria (c. 7, l. 66 - c. 8, l. 2).  For example, a single stranded nucleic               
              acid sample containing a target sequence to be amplified (1) is hybridized with a primer                     
              complementary to the target sequence and (2) contacted with a polymerization agent, e.g.,                    
              a polymerase, and the four deoxyribonucleotides to synthesize a primer extension (i.e.,                      
              elongation) product, (3) the complementary strands of nucleic acid are separated and (4)                     
              the steps of strand separation and extension product synthesis are repeated until the                        
              desired quantity of the target nucleic acid sequence is produced (c. 6, ll. 56-58; c. 9, l. 5 -              
              c. 10, l. 44).  To ascertain whether a test sample contains the target sequence or not, the                  
              test sample is treated with primer, polymerase and deoxyribonucleotides as above,                            
              resulting in amplification of the target sequence if present, (5) a labeled probe capable of                 
              hybridizing to the target sequence is added and (6) if hybridization of labeled probe is                     
              detected, then the test sample contained the target sequence (c. 2, l. 63 - c. 3, l. 29).                    
              According to Mullis,                                                                                         
                            [t]he present process is expected to be useful in detecting, in a                              
                     patient DNA sample, a specific sequence associated with an infectious                                 
                     disease such as, e.g., Chlamydia using a biotinylated hybridization probe                             
                     spanning the desired amplified sequence ... (c. 31, ll. 33-37).                                       

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