Ex parte DUBOIS - Page 5




                 Appeal No. 1997-0138                                                                                                                   
                 Application No. 08/383,912                                                                                                             


                 supplied no evidence to demonstrate that the resulting                                                                                 
                 pharmaceutical composition would be free of any volatile                                                                               
                 solvent .  Nor has the examiner supplied any evidence1                                                                                                                         
                 regarding the claimed process for preparing the same.                                                                                  
                          The examiner argues that the pharmaceutical composition                                                                       
                 resulting from the combined teachings of Kelly and Evans                                                                               
                 "would inherently be free of solvent" because "the organic                                                                             
                 solvent is typically evaporated from the composition in                                                                                
                 liposome formation."  See Answer, pages 4 and 5.  However, the                                                                         
                 examiner has not supplied any factual basis to support the                                                                             
                 determination that the typical volatile organic solvent                                                                                
                 evaporation technique would  necessarily remove any and all                                                                            
                 volatile solvents present in the pharmaceutical composition.                                                                           
                 See Ex parte Levy, 17 USPQ2d 1461, 1463-64 (Bd. Pat. App. &                                                                            
                 Int. 1990).  It is well settled that   inherency cannot be                                                                             
                 established by probabilities or possibilities.  See In re                                                                              
                 Oelrich, 666 F.2d 578, 581, 212 USPQ 323, 326 (CCPA 1981); In                                                                          
                 re Rijckaert, 9 F.3d 1531, 1534,                                                                                                       
                 28 USPQ2d 1955, 1957 (Fed. Cir. 1993).                                                                                                 

                          1Evans prepares liposomes in a volatile organic solvent                                                                       
                 (chloroform).  See column 5, example 6.                                                                                                
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