Ex Parte B. Santos et al - Page 5


                 Appeal No.  2006-0251                                                           Page 5                   
                 Application No.  10/017,697                                                                              
                         While White discloses both liquid (column 7, line 47 – column 8, line 12),                       
                 and soft gelatin capsule (column 8, line 13 – line 10, line 3) formulations4, White                      
                 discloses (column 1, lines 26-29, emphasis added), “[s]oft gelatin capsules are a                        
                 preferred dosage form for accurately dispensing liquids, offering a simple means                         
                 of masking the unpleasant taste and aromas of many pharmaceutically                                      
                 acceptable actives.”  We find, and the examiner identifies, no teaching in White                         
                 of a taste-masked liquid pharmaceutical composition.  Accordingly, it appears the                        
                 examiner is relying on the principles of inherency to reach appellants’ claim the                        
                 limitation that the final form of the taste-masked pharmaceutical composition is a                       
                 liquid.                                                                                                  
                         However, as set forth in In re Robertson, 169 F.3d 743, 745, 49 USPQ2d                           
                 1949, 1950-51 (Fed. Cir. 1999) (citations omitted) “[t]o establish inherency, the                        
                 extrinsic evidence ‘must make clear that the missing descriptive matter is                               
                 necessarily present in the thing described in the reference, and that it would be                        
                 so recognized by persons of ordinary skill.  Inherency, however, may not be                              
                 established by probabilities or possibilities.  The mere fact that a certain thing                       
                 may result from a given set of circumstances is not sufficient.’”  As we                                 
                 understand the examiner’s reasoning at page 10 of the Answer, since White                                
                 discloses a composition that comprises pyrrolidone and a high MW polyethylene                            
                 glycol, White’s composition will, like appellants’ composition, result in a taste-                       


                                                                                                                          
                 4 In this regard, we note that White exemplifies several liquid pharmaceutical formulations that         
                 are “suitable for oral administration, and encapsulation within soft gelatin shells.”  See Examples      
                 I, III-V, VII, and VIII.  Example VIII, however, is the only example that contains a drug,               
                 polyethylene glycol, polyvinylpyrrolidone, and a tri ester.  Accordingly, we find White’s Example        
                 VIII to be the closest to appellants’ claimed invention.                                                 





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