Ex Parte SAMARITANI et al - Page 9



                  Sucrose  (20273 - 14977)/20273 = 0.261 = 26.1%                                         
                  Mannitol (18919 - 14680)/18919 = 0.224 = 22.4%.9                                       
                        28. Counsel argues that the results of Tables 10-15                              
            "are surprising and unexpected."  Why?  In terms of the data in                              
            Table 10 and 11, we have not been told whether a 3-week period is                            
            practical shelf-life or whether r-hCG compositions are normally                              
            stored at 40°C or 50°C.  In other words:  "From a practical point                            
            of view, what would one skilled in the art understand to be the                              
            normal shelf-life needed for liquid r-hCG compositions?"                                     
            Additionally, we are in no position to determine, on this record,                            
            that any differences in results are not due to the difference in                             
            the ratio of r-hCG to sucrose v. the ratio of r-hCG to mannitol.                             
            The data in Tables 14 and 15 at the 3-week and 6-week periods                                
            shows the IU/ml figures to be similar (6757 v. 6977 and 14977 v.                             
            14680).  We have not been told whether a person having ordinary                              
            skill in the art would view these differences to have any                                    
            practical significance.                                                                      
                        29. We decline to find that the data in Tables 7                                 
            and 10-15 establish any superior, surprising or unexpected result                            
            for mannitol v. sucrose.                                                                     
                                 The prior art--PCT application                                          
                        30. According to the PCT application (page 1,                                    
            lines 8-11):                                                                                 

               Arguably, one might obtain counsel's percentages if the "base"                            
            is T = 4 weeks.                                                                              
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