The specification of a patent application contains limited disclosure of using antisense technology in regulating three particular genes in E. coli cells. The specification contains three examples, each applying antisense technology to regulating one of the three particular genes in E. coli cells. Despite the limited disclosure, the specification states that the "the practices of this invention are generally applicable with respect to any organism containing genetic material capable of being expressed such as bacteria, yeast, and other cellular organisms." All of the original claims in the application are broadly directed to the application of antisense technology to any cell. No claim is directed to applying antisense technology to regulating any of the three particular genes in E. coli cells. The claims are rejected under 35 USC 112, first paragraph, for lack of enablement. In support of the rejection, a publication is cited that correctly notes antisense technology is highly unpredictable, requiring experimentation to ascertain whether the technology works in each type of cell. The publication cites the inventor's own articles (published after the application was filed) that include examples of the inventor's own failures to control the expressions of other genes in E. coli and other types of cells. In accordance with the patent laws, rules and procedures as related in the MPEP, the rejection is:

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35 U.S.C. § 112, first paragraph; MPEP §§ 2164.01 and 2164.06(b). MPEP § 2164.01 states "[t]he standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term 'undue experimentation,' it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation." See also the discussion of Enzo Biochem, Inc. v. Calgene, Inc., 52 USPQ2d 1129 (Fed. Cir. 1999) in MPEP § 2164.06(b). (B) is incorrect. MPEP § 2107.01, under the heading "III. Therapeutic Or Pharmacological Utility," states "[t]he Federal Circuit has reiterated that therapeutic utility sufficient under the patent laws is not to be confused with the requirements of the FDA with regard to safety and efficacy of drugs to marketed in the United States. . . In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). Accordingly, Office personnel should not construe 35 U.S.C. 101, under the logic of 'practical' utility or otherwise, to require that an applicant demonstrate that a therapeutic agent based on a claimed invention is a safe or fully effective drug for humans." (C) is incorrect. 35 U.S.C. § 112, first paragraph; MPEP § 2107.02. MPEP § 2107.02, under the heading "When Is An Asserted Utility Not Credible," states "Rejections under 35 U.S.C. 101 have been rarely sustained by federal courts. Generally speaking, in these rare cases, the 35 U.S.C. 101 rejection was sustained . . . because . . .[applicant] asserted a utility that . . . was wholly inconsistent with contemporary knowledge in the art. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967)." The disclosure in (C) is inconsistent with published information. (D) is incorrect. MPEP § 2107.01 under the heading "Relationship Between 35 U.S.C. 112, First Paragraph, and 35 U.S.C. 101," quotes In re Ziegler, 992 F.2d 1197, 1200- 1201, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993) as stating "The how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. 101 that the specification disclose as a matter of fact a practical utility for the invention. ... If the application fails as a matter of fact to satisfy 35 U.S.C. § 101, then the application also fails as a matter of law to enable one of ordinary skill in the art to use the invention under 35 U.S.C. § 112." Enablement for the claims in a utility application is found in the specification preceding the claims, as opposed to being in the claims. The claims do not provide their own enablement. 35 U.S.C. § 112, first paragraph. (E) is incorrect. MPEP 2107.01 states that the examiner "must treat as true a statement of fact made by an applicant in relation to an asserted utility, unless countervailing evidence can be provided that shows that one of ordinary skill in the art would have a legitimate basis to doubt the credibility of such a statement." Inasmuch as countervailing evidence has been produced, the lack of necessity to theorize or explain the failures does not alleviate the inventor from complying with 35 U.S.C. § 112, first paragraph to provide an enabling disclosure that is commensurate in scope with the claims.

The Specification of a Patent Application Contains Limited Disclosure of Using