Ex Parte SAMARITANI et al - Page 22



            an r-hCG/mannitol composition which has been stored for 1 week                               
            or 3 weeks.                                                                                  
                                                   c.                                                    
                  Tables 12 and 13 involve purity tests of the " subunit of                              
            r-hCG.  But, the claims are not limited to the " subunit of                                  
            r-hCG.  What significant fact are we to divine from data limited                             
            to the " subunit?  On this record, we are not told!                                          



                                                   d.                                                    
                  The data in Tables 14 and 15 are unexplained.  We recognize                            
            that there is data, but we have no idea of its significance to                               
            one of ordinary skill in the art.  Applicants have not                                       
            sufficiently explained the significance of the data.  See also                               
            n.6, supra, and Findings 23-27.                                                              
                  C.    Order                                                                            
                  Upon consideration of the appeal, and for the reasons given,                           
            it is                                                                                        
                        ORDERED that the rejection of claims 1-16 is affirmed.                           
                        FURTHER ORDERED that in view of the fact that we have                            
            relied on additional prior art and new rationale, the affirmance                             
            of the rejection is a new ground of rejection under 37 CFR                                   
            § 1.196(b).                                                                                  


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