Ex parte KAY et al. - Page 2


             Appeal No. 2001-0980                                                                             
             Application 08/953,146                                                                           

                   Claim 1 is representative of the subject matter on appeal and reads as follows:            
                   1.     An alkanol free anhydrous glycol based oral analgesic composition                   
                   comprising an analgesia producing amount of benzocaine, a glycol solvent                   
                   system for the benzocaine in an amount sufficient to dissolve the benzocaine               
                   comprising polyethylene glycol, having a molecular weight of about 400 to 600              
                   and a preservative agent in an amount sufficient to protect against                        
                   microbiological degradation consisting essentially of a combination of about               
                   0.05% to about 0.2% by weight of methylparaben and about 0.25% to about                    
                   0.5% by weight of phenylcarbinol each based on the weight of the total                     
                   composition.                                                                               
                   The references relied upon by the examiner are:                                            
                   Singleton et al. (Singleton)           5,547,657          Aug. 20, 1996                    
                   Reuter et al. (Reuter)                5,446,063          Aug. 29, 1995                    
                   Di Colo et al.1 (Di Colo), “A Study of Drug-Vehicle Interactions in Anhydrous              
                   Polyethylene Glycol Ointments” Chem. Abstracts, Vol. 99, No. 163959, Sept.                 
                   1983                                                                                       
                   Yamahira2, (Sumitomo) “Preservative for interferon formulations.” Chem.                    
                   Abstracts, Vol. 102 No. 32270 Mar. 28, 1993                                                
                   Remington’s Pharmaceutical Sciences, Mack Publishing Co., pg. 1891, 15th                   
                   edition, 1975                                                                              
             Claims 1 through 4, 6 through 10, and 12 stand rejected under 35 U.S.C. § 103(a).  As            
             evidence of obviousness, the examiner relies upon Singleton, Di Colo, Remington,                 
             Reuter, and Sumitomo.  We reverse.                                                               







                                                                                                              
             1 We have obtained a copy of the full text Di Colo document and have considered the full text document in
             reaching this decision.                                                                          
             2 The document which is the subject of this abstract is a Japanese published examined patent application.
             We have obtained a copy of that document as well as a translation thereof.  Our consideration of the
             issues raised in this appeal have been based upon the translation.                               

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