BAI et al v. LAIKO et al - Page 43




                Interference No. 104,745                                                                                                      

                reasonable expectation that the recited biological process would achieve the particular recited                               
                biological result:                                                                                                            
                         The above statement in Burroughs . . .  was not dealing with whether an inventor                                     
                         had a reasonable expectation of producing the claimed device or composition, but                                     
                         instead whether the inventor had a reasonable expectation that the device or                                         
                         composition, once completed, would work for its intended purpose.  Here, in                                          
                         contrast, we are focusing on whether the inventors had a reasonable expectation                                      
                         that they would produce the claimed invention. Here, in contrast, we are focusing                                    
                         on whether the inventors had a reasonable expectation that they would produce                                        
                         the claimed invention.  Burroughs concerned six patents directed toward                                              
                         administering a drug, AZT, to AIDS patients.  It was undisputed that the inventors                                   
                         had already synthesized the AZT.  The claims of the first five patents recited                                       
                         various permutations of administering the AZT to patients, without reciting                                          
                         details of how the human body would react to the drug.  See id. at 1225 n.3, 32                                      
                         USPQ2d at 1917 n.3.  As to the claims of these five patents, we held, as quoted                                      
                         above, that the developers of AZT had sufficiently established conception of the                                     
                         limitations of the claims (i.e., the drug itself and the intention to administer it to                               
                         humans), and that it was immaterial that the inventors lacked a “reasonable                                          
                         expectation” as to how non-claimed aspects of the drug would work (i.e., the                                         
                         particular effect of the drug on the body).  Id. at 1228, 32 USPQ2d at 1920.                                         
                         However, as to the claims of the sixth patent, which recited details of an                                           
                         anticipated immune response to the drug (i.e., “a method of increasing the number                                    
                         of T-lymphocytes in a human infected with the [HIV] virus ....”), we held that this                                  
                         claim was not conceived in advance of further studies because of uncertainty as to                                   
                         whether administering AZT actually would promote T-lymphoctye production,                                            
                         i.e., the claimed intended use.  Id. at 1231-32, 32 USPQ2d at 1923.  Thus, the                                       
                         inventors in Burroughs lacked a “definite and permanent idea” as to whether this                                     
                         recited claim limitation of the sixth patent would be met by administering the                                       
                         drug.  Id. at 1230, 32 USPQ2d at 1923.  In the present case, like the claims of the                                  
                         sixth patent discussed in Burroughs, Hitzeman claimed the specific result of a                                       
                         biological process.  Because Hitzeman failed to show that he had a reasonable                                        
                         expectation that the claimed result of the biological process would occur, his                                       
                         conception argument cannot prevail.                                                                                  
                Hitzeman, 243 F.3d at 1358, 58 USPQ2d at 1170.  The count before us is not directed to a                                      
                biological process, let alone a biological process for achieving a specific biological result.  Nor                           
                does the count specify that the analyte ions are to take a specific form.  Thus, Burroughs rather                             

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