Ex Parte Bunick et al - Page 4


                  Appeal No. 2006-0204                                                              Page 4                     
                  Application No. 09/896,052                                                                                   

                  improved organoleptic properties when chewed, such as taste” (Examiner’s                                     
                  Answer, page 3).  “The core may be in the form of a jelly . . . selected from a                              
                  group that includes pectin” and “[t]he outer layer may take a variety of forms,                              
                  including hard candy” (id.).  “Acetaminophen is listed as a possible active                                  
                  ingredient in the core” but Lee “does not teach the use of ibuprofen in the [ ]                              
                  dosage form” (id., page 4).                                                                                  
                          Friend is directed to microcapsule compositions “in which the taste of [a]                           
                  drug contained therein is tastemasked” (Friend, column 1, lines 14-17).  Friend’s                            
                  microcapsules range in size from approximately 30 μm to 800 μm (id., column 8,                               
                  lines 31-36); may contain drugs including acetaminophen and ibuprofen (id.,                                  
                  column 4, lines 34-35); and may be incorporated into chewable tablets (column                                
                  4, lines 56-60).  It is not entirely clear from the record, but it appears that the                          
                  examiner relies principally on those aspects of Friend’s disclosure that concern                             
                  the size of the microcapsules to make up any deficiencies in Lee (Examiner’s                                 
                  Answer, page 4).                                                                                             
                          According to the examiner, “[i]t would be obvious to one of ordinary skill in                        
                  the art to combine the teachings of Lee and Friend [ ] into the objects of the                               
                  present invention” (Examiner’s Answer, page 4) “to provide a pharmaceutical                                  
                  dosage form wherein the active ingredient is further taste-masked” (id.), because                            
                  both references “deal with the administration[ ] of drugs in pharmaceutical                                  
                  compositions with improved organoleptic properties” (id.).  The examiner asserts                             
                  that “[t]he adjustment and optimization of parameters such as hardness of the                                
                  soft core and the weight ratio of active agent particles are considered . . . to be                          





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