Appeal No. 1997-2510 Application No. 07/868,539 effectiveness of a prosthetic device is more properly left to the Food and Drug Administration (FDA).”). Upon further prosecution, the examiner should clarify this issue. V. Antisense References: The examiner refers (Answer, pages 16-17) to the Infectious Disease Weekly, the Genesis Report-RX, Gura, Wagner, and Stull to support his arguments. The examiner, however, has failed to explain the nexus between these references, which discuss antisense technology, and the claimed invention. In this regard, we note appellant’s statement (Brief, page 5) that “the [m]olecules constructed according to the claimed method of the present invention are NOT designed to interact (i.e., specifically hybridize) with the DNA and/or RNA of the host or virus.” Upon further prosecution, the examiner should address appellant’s comment, and explain the nexus between the claimed invention and any reference relied upon by the examiner. THE REJECTION UNDER 35 U.S.C. § 112, SECOND PARAGRAPH: As set forth in Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1217, 18 USPQ2d 1016, 1030 (Fed. Cir. 1991): The statute requires that “[t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” A decision as to whether a claim is invalid under this provision requires a determination whether those skilled in the art would understand what is claimed. See Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624, 225 USPQ 634, 641 (Fed. Cir. 1985) (Claims must “reasonably apprise those skilled in the art” as to their scope and be “as precise as the subject matter permits.”). 12Page: Previous 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 NextLast modified: November 3, 2007