PITHA V. MULLER et al. - Page 27




                 Interference 102,413                                                                                   Page 27                        
                 Pitha v. Muller                                                                                                                       
                          Pitha directed us to pages Sz-34 and Sz-36 to establish                                                                      
                 that a portion of the product from Sz-8 was solubilized in                                                                            
                 water with a drug.  We have not been directed to evidence                                                                             
                 which establishes a description of Sz-8 product or that the                                                                           
                 Sz-8 product contained cyclodextrin derivatives.  Thus, the                                                                           
                 products Sz-34 and Sz-36, both of which incorporate Sz-8, do                                                                          
                 not describe an embodiment which falls within the scope of the                                                                        
                 count.                                                                                                                                
                                   b.  The product Sz-11 and products including Sz-11                                                                  
                          In Sz-11 (PR 182, PX-19-20), the experiment took place no                                                                    
                 later than July 2, 1981, which is the date indicated on the                                                                           
                 subsequently occurring page PX-19-38.  The reaction product of                                                                        
                 BCD and 1,4 butanediol diglycidyl ether was said to be formed                                                                         
                 during the experiment.  The substance formed was described as                                                                         
                 white and foam like with no homogenous composition of product.                                                                        
                 There is no indication whether crystals were formed.  There                                                                           
                 was no indication whether the product of Sz-11 contained more                                                                         
                 than one cyclodextrin derivative.  The solubility of the                                                                              
                 substance in water at room temperature is reported to be                                                                              
                 3.60g/100ml.  Dr. Szente states the solubility was improperly                                                                         
                 recorded. 40                                                                                                                          


                          40PR page 182, lines 14-15.                                                                                                  





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