Ex Parte DEE et al - Page 5


                Appeal No.  2002-1644                                                   Page 5                
                Application No.  08/602,498                                                                   
                explains (id., paragraph 7), “[a]lthough this product performed satisfactorily in             
                laboratory tests, I did not know how it would perform in actual use on dairy                  
                animals.  As a result, a quantity of DX-206 was provided to Dr. Gardner on                    
                January 31, 1995 for field testing by his clients in their herds.”  Dee emphasizes            
                (id., paragraph 8), “[a]t the time it was sent to Dr. Gardner, the DX-206                     
                formulation was not a commercial product.  It had undergone no field testing,                 
                and had not been subjected to protocol testing using control animals to                       
                determine its efficacy in a more quantitative way.”  In addition, Dee declares (id.,          
                paragraph 10):                                                                                
                      The DX-206 formulation was changed based on the results of Dr.                          
                      Gardner’s field testing.  For example, in October 1995, based on                        
                      complaints from some of Dr. Gardner’s clients that DX-206 did not                       
                      work well in teat dip sprayers, more water was added to the                             
                      formulation to make the product easier to spray.  Wintergreen was                       
                      also added at this time to improve the odor of the product.                             
                      The Gardner Declaration confirms the statements made by Dee.                            
                According to Gardner (id., paragraph 8), “[a]lthough DX-206 had performed well                
                in laboratory tests, such performance was not indicative of how the product                   
                would perform in the field, under extreme conditions and with actual dairy                    
                animals.”  In addition Gardner declares (id., paragraph 16):                                  
                      Before DX-206 was field tested by certain of my clients under my                        
                      supervision, I did not know whether it would work for its intended                      
                      purpose.  In fact, although many of my clients were quite satisfied                     
                      with the DX-206 formulation, others … decided not to use DX-206                         
                      based on their experience in the field test.                                            
                Gardner also declares (id., pagaraph 9), “varying amounts of DX-206 [were sold]               
                to my herd health clients, asking them to try the product for test purposes.”                 








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