Ex parte SHIBLEY et al. - Page 8




              Appeal No. 1997-2512                                                                                           
              Application No. 08/118,905                                                                                     

              cavity.                                                                                                        
                      The examiner has not pointed to any evidence showing that Whittaker discloses the                      
              steps of penetrating the lower section of the sealed tube, followed by penetrating the upper                   
              section of the tube, to release the biological or pharmaceutical material to a mucosal                         
              membrane of an animal.  Nor has the examiner explained how these claim elements would                          

              be inherent in Whittaker’s delivery method.  Contrary to the examiner’s allegation, the                        
              dispensing method as described in Whittaker would not meet the claim elements in                               
              question here.  This is because claim 12 requires penetrating a lower section of the tube,                     
              followed by penetrating in the upper section to release the biological or pharmaceutical                       
              material to an animal.  In Whittaker, the coatings 15 and 17 are first removed.  But the                       
              removal of these coatings cannot reasonably be considered “penetrating” as required by                         
              the claims on appeal because there is nothing separate from the sealed tube entering into                      
              (or passing into or through) the sealed tube during the removal of these coatings.  We also                    
              note that the seal (column 2, lines 3-8 and column 2, line 48 to column 3, line 1) covering                    
              discharge opening 11 is apparently broken by the force of the ejecting medicinal fluid or                      
              fluffy preparation.  However, this breaking of the seal also cannot reasonably be                              
              considered to meet the limitation “penetrating” as recited in the claims on appeal because                     
              nothing separate from the sealed tube enters into the sealed tube during the breakage of                       

              the seal at discharge opening 11.  Additionally, there is no penetration at the other end by                   
              squeezing bulb 22 to compress internal air, which in turn acts on the piston plug 14,                          



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