BAI et al v. LAIKO et al - Page 32




                Interference No. 104,745                                                                                                 

                (Rebuttal Evidence)" (BX 2117), both of which are critical of Dr. Baldwin's rebuttal reasoning                           
                and conclusions.  We need not decide Laiko's motion to suppress the Fenn declaration, because,                           
                as explained below, the insufficiency of Dr. Baldwin's rebuttal testimony is apparent without                            
                considering the Fenn declaration, which therefore will not be considered.                                                
                        Dr. Baldwin contends that production of an analyte mass spectrum was essential to                                
                proving that bradykinin ions were generated and transported to the LC/MSD instrument, because                            
                        [t]he recognized standard in the field of mass spectrometry for verification of a                                
                        successful test of an "ionization apparatus for connection to a spectrometer" is the                             
                        successful production of an analyte ion mass spectrum.  Successful mass spectra                                  
                        have identifiable patterns of mass peaks.  Known analytes such as bradykinin and                                 
                        CZE peptide standard (as used by Bai and Laiko respectively), are used to test                                   
                        mass spectrometry ionization apparatus specifically because these peptides have                                  
                        easily recognized, well known, and well documented spectra with patterns of                                      
                        mass peaks that readily allow those skilled in the art to determine whether an                                   
                        experiment is successful or not.  Absent any mass spectrum, those of skill in the                                
                        art cannot say whether or not analyte ions have been successfully transported to                                 
                        the spectrometer.                                                                                                
                Baldwin Decl. (LX 1074) ¶  68.  (Laiko's emphasis.)   No documentary evidence is cited in                                
                support of these assertions.  Instead, Dr. Baldwin explains that the differences between the 1061                        
                m/z and 1900 m/z chromatograms fail to establish that bradykinin ions were detected for the                              
                following reasons: (1) "large variations in signal/noise can be encountered when the mass                                
                spectrometer settings are changed by large amounts, such as from 1061 m/z to 1900 m/z,                                   
                particularly for a quadrupole mass spectrometer," Baldwin Decl. (LX 1074) ¶ 71; and                                      


                (2) "nearby signal spikes may occur with selective ion monitoring and may be inadvertently                               
                introduced into the mass spectrometer, depending upon the specifications and the setting of the                          

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