Ex Parte SAMARITANI et al - Page 21



            compositions differs.  See Findings 16 and 25.  There is no                                  
            testimony before us which explains why data based on the                                     
            compositions would be accepted by those skilled in the art in the                            
            face of the different ratios.                                                                
                                                   b.                                                    
                  We do not know whether the data set out in Tables 10 and 11                            
            would be accepted by a person skilled in the art as showing that                             
            use of sucrose is not as good as use of mannitol.  We cannot                                 
            overemphasize the fact that one relying on data to establish has                             
            a burden of establishing that unexpected results are actually                                
            obtained and the significance of those results to one having                                 
            ordinary skill in the art.  Cf. In re Klosak, 455 F.2d 1077,                                 
            1080, 173 USPQ 14, 16 (CCPA 1972) (inventor must show that the                               
            results claimed to obtained with a claimed invention are actually                            
            obtained with the invention).                                                                
                  Assuming that the different ratios of hCG to sucrose or                                
            mannitol have no practical effect on other testing described in                              
            the specification, then we note that in the case of Compositions                             
            1 and 2, after 1 week at 50°C the stability data (90.0) for                                  
            r-hCG/sucrose would appear to be higher (and therefore presumably                            
            better) than the data (89.5) for r-hCG/mannitol (see Finding 18).                            
            A similar observation can be made with respect to Compositions 3                             
            and 4 when tested at 40°C for 3 weeks (see Finding 19).  Even if                             
            we were inclined to give the term "stable" in the preamble of                                
            claim 1 some claim limiting significance, it would not exclude                               

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