Guidelines for the Examination of Claims Directed to Species of Chemical Compositions Based Upon a Single Prior Art Reference

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The Patent and Trademark Office (PTO) is publishing the final version of guidelines to be used by Office personnel in reviewing a certain type of patent application for compliance with 35 U.S.C. 103. The guidelines are to be used when examining claims directed to a species or subgenus of chemical compositions when: (1) the claims have been rejected based upon a single prior art reference, and (2) the single prior art reference discloses a genus embracing the claimed species or subgenus but does not expressly describe the particular claimed species or subgenus. Because these guidelines govern internal practices, they are exempt from notice and comment rulemaking under 5 U.S.C. 553(b)(A).