Ex parte PAVLAKIS et al. - Page 7

              Appeal No. 1995-2723                                                                                            
              Application 07/858,747                                                                                          

                      disruption of the initiation codon by a single point mutation altering mRNA                             
                      stability which results in rapid turnover of the mRNA as taught by Wisdom et                            
                      al, further in view of . . . methods for producing several single base                                  
                      substitution mutations introduced within a DNA template region as a way of                              
                      generating a high frequency of desired nucleotide changes of a genotype as                              
                      taught by Kunkel and analyzing the frequency of at least some codon pairs                               
                      (encoding the same amino acid) as disclosed by Hatfield et al. to create a                              
                      method for reducing the effect of inhibitory/instability sequences within the                           
                      coding region of a mRNA as a whole for the expected advantages of                                       
                      increasing the stability and/or utilization of a mRNA produced which would                              
                      otherwise not be expressed or which would be poorly expressed to achieve                                
                      higher levels of expression.                                                                            
                      The examiner bears the initial burden of presenting a prima facie case of                               
              obviousness.  In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444                                          
              (Fed. Cir. 1992).   On the record before us, we conclude that the examiner has made out a                       
              prima facie case of unpatentability of the claimed subject matter.  Both Schwartz and                           

              Wisdom are concerned with the identification of those regions of a gene which                                   

              express an unstable mRNA which contribute to that instability.  Both make use of                                
              mutational means which would be expected to effect the expression of the INS region and                         
              both study the effects of such mutations to determine the effect on the mRNA stability and                      
              expression.  It appears to us that Schwartz teaches everything except the multiple point                        
              mutation of the INS sequence.   The use of a particular mutation process would reasonably                       
              appear to be an arbitrary matter of designer choice.  The examiner has cited references                         
              which suggest that this mutagenesis method is known to those skilled in this art.  In                           
              addition we note page 32, lines 10-25 of the specification where the appellants indicated                       
              that the particular mutagenesis process used in the claimed invention is known in the art.                      


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