Ex parte LEE et al. - Page 4




               Appeal No. 95-2142                                                                                                  
               Application No. 07/996,423                                                                                          


                              The test of obviousness  vel non  is statutory.  It requires that one compare the                    
                              claim's "subject matter as a whole" with the prior art "to which said subject matter                 
                              pertains." 35 U.S.C. Section 103. The inquiry is thus highly fact-specific by design.                
                              This is so "whether the invention be a process for making or a process of using, or                  
                              some other process." [Citations omitted.]                                                            

                       Here the examiner has not compared the “subject matter as a whole,” including the starting poly             
               (ester-amide) composition, with the prior art.  It appears that the examiner has not evaluated, on this             
               record, whether the prior art would have suggested the specific poly (ester-amide) composition within the           
               scope of applicants’ claims.  Accordingly, we vacate the examiner’s rejection under 35 U.S.C. § 103 and             
               remand for further examination in light of Ochiai and the PTO Notice titled “Guidance on Treatment of               
               Product and Process Claims in light of  In re Ochiai, In re Brouwer and 35 U.S.C.§ 103(b)” published in             
               the Federal Register at _____ Fed. Reg. _____ and republished at 1184 Official Gaz. U.S. Pat. &                     
               Tradem’k Off. 86 (March 26, 1996).                                                                                  
               The rejection of claims 21 and 32 under 35 U.S.C. § 112, ¶ 2                                                        
                       The examiner also rejects claims 21 and 32 under 35 U.S.C. § 112, ¶ 2, as being indefinite.  The            
               examiner states:                                                                                                    
                              In claims 21 and 32 applicants have not specified how the melt-processable                           
                              poly(ester-amide) is prepared.  Note, that step (b) refers to heating the resulting                  
                              composition.  Note also that [sic, the] method should at least recite a positive,                    
                              active step  . . . . [Emphasis original.]                                                            

               Examiner’s Answer, p. 7.                                                                                            
                       A decision as to whether a claim is invalid under § 112, ¶ 2, requires a determination whether those        
               skilled in the art would understand what is claimed.  Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927             
               F.2d, 1200, 1217, 18 USPQ2d 1016, 1030  (Fed. Cir. 1991).  The legal standard for definiteness is                   
               whether a claim reasonably apprises those having ordinary skill in the art of its scope.  In re Warmerdam,          
               33 F.3d 1354, 1361, 31 USPQ2d 1754, 1759 (Fed. Cir. 1994).  We fail to see how the lack of a                        

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