EDWARDS et al. V. LEVEEN - Page 27





          Interference No. 104,290                                                           



                     It is our additional finding that LeVeen recognized the                 

          heat-sink problem in his grant request proposal. LX-1146 at 24.                    

          LeVeen stated in the proposal:                                                     

                     All of the tests to date have been ex-vivo,                             
                     and needless to say in-vivo testing must be                             
                     performed. We recognize the significant heat                            
                     sink afforded by flowing blood will alter the                           
                     in-vivo results somewhat, but we are optimis                            
                     tic that this system has potential of ablat                             
                     ing a large enough volume of tissue to be                               
                     clinically useful in a large number of                                  
                     patients.                                                               

          Thus, it can be seen that LeVeen recognized possible shortcomings                  

          in the tests as previously performed. LeVeen goes on to state in                   

          the potential pitfalls section of the proposal that dramatic                       

          heat-sink effects may result in insufficient heating in vivo.                      

          LX-1146 at 28.                                                                     

                     Lastly, as recognized in our discussion of the lack of                  

          any formal protocol for the demonstrations, explorations, or                       

          experiments conducted in June through October of 1993,.the only                    

          evidence that the experiments were regarded as successful are                      

          the non-contemporaneous conclusory statements of success found                     

          in the declarations. The declarations do not establish success                     

          by comparison to any formal oral or written protocol. LeVeen                       





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