Ex parte Gleave

Informative decision only: persuasive authority, not binding precedent. In a written description rejection under the first paragraph of 35 U.S.C. § 112, it is the examiner's "initial burden [to] present[] evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims," and the Board will reverse where the examiner has not done so. Where the examiner meets that burden, as with claims defined only by function (a "composition" effective to inhibit IGFBP-5 expression) for which the specification describes only antisense oligonucleotides, the rejection is affirmed. No prior Board precedent is named as affected; the Board applies In re Wertheim's allocation of the initial burden to the examiner in written description rejections. For an examiner, a conclusory assertion that the specification discloses only two target sequences will not carry the burden. The examiner must explain why skilled artisans would not expect the disclosed mouse and human sequences to be representative of, or structurally similar to, other mammalian IGFBP-5 DNA. For applicants, the decision shows that pointing to the examiner's failure to carry the burden can win reversal for the antisense claims, but purely functional genus claims to any "composition" that inhibits IGFBP-5 remain vulnerable under University of Rochester v. G.D. Searle and University of California v. Eli Lilly. The Board relied on Federal Circuit and CCPA authority: In re Wertheim (CCPA 1976), Vas-Cath, University of Rochester, Eli Lilly, and Enzo Biochem. LEGAL TEST OR STANDARD: Written description is a question of fact decided case by case (Vas-Cath). The requirement is met when the specification sets forth enough detail to allow a person of ordinary skill to understand what is claimed and to recognize that the inventor invented what is claimed (University of Rochester). The examiner has the initial burden to present evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims (Wertheim). A definition by function alone does not suffice for a genus of genetic material (Eli Lilly), and the standard applies to method claims as well as product claims (University of Rochester). TRIGGERING FACTS: Claims 1-3, 4, 6, 9, 10, 13, 16, 17, 20, 22, 23 and 38 required antisense oligonucleotides inhibiting IGFBP-5 expression. The specification gave mouse and human IGFBP-5 DNA sequences and several antisense sequences, and the examiner said it described only two target sequences. The examiner did not explain why other mammalian DNA would not be similar, so those claims were reversed. Claims 8, 12, 15, 19, 39 and 40 required merely a composition effective to inhibit IGFBP-5 expression, and the specification disclosed only antisense oligonucleotides, with no description of which other compositions have the function, so those claims were affirmed. KEY QUOTE: "Again, it is the examiner's "initial burden [to] present[] evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims" (Wertheim, 541 F.2d at 263, 191 USPQ at 97)." (Appeal No. 2005-2447, p. 12) PRIOR PRECEDENT AFFECTED: No prior Board precedential or informative decision is directly affected. The Board follows In re Wertheim, 541 F.2d 257 (CCPA 1976), University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004), and University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997), and relies on Vas-Cath and Enzo Biochem. PRACTICE TIP: On appeal from a written description rejection, check first whether the examiner offered evidence or reasons why skilled artisans would not recognize the claimed invention in the disclosure, and argue failure of that initial burden under Wertheim. Do not rely on that argument for claims that define a genus only by function, such as any composition effective to inhibit expression, without describing which members have the function.