Q) Antisense Technology (10.03.14a)

by admin on April 8, 2010 · 6 comments

in Exam Questions

Test takers have noted that Question #14 from October 2003 (AM) patent bar exam is in the current exam database.


14. 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:
(A) appropriate because the claims are not commensurate in scope with the breadth of enablement inasmuch as the working examples in the application are narrow compared to the wide breadth of the claims, the unpredictability of the technology, the high quantity of experimentation needed to practice the technology in cells other than E. coli.
(B) appropriate because the claims are not commensurate in scope with the breadth of the enablement inasmuch no information is provided proving the technology is safe when applied to animal consumption.
(C) inappropriate because the claims are commensurate in scope with the breadth of enablement inasmuch as the specification discloses that the “the practices of this invention are generally applicable with respect to any organism containing genetic material capable of being expressed.”
(D) inappropriate because the claims are commensurate in scope with the breadth of enablement inasmuch as the claims are original, and therefore are self-supporting.
(E) inappropriate because the claims are commensurate in scope with the breadth of the enablement inasmuch as the inventor is not required to theorize or explain why the failures reported in the article occurred.


ANSWER: (A) is the most correct answer. 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  ineral 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 beeninterpreted 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.

{ 6 comments… read them below or add one }

1 SolNo Gravatar April 2, 2012 at 5:23 pm

I could not find the following in MEPE

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.

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2 MirandaNo Gravatar April 6, 2012 at 4:56 pm

I have a problem with this as well. John White of PLI states that claims can be self-enabling. anyone have any thoughts on this?

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3 TheGhostOfBilskiNo Gravatar April 6, 2012 at 6:05 pm

It seems “self-enabling” might be relevant in situations where a claim is later amended to include a limitation, and that limitation “in and of itself may enable one skilled in the art to make and use the claim containing that limitation even though that limitation may not be described in the original disclosure…”

From MPEP 2164:

The enablement requirement of 35 U.S.C. 112, first paragraph, is separate and distinct from the description requirement. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991) (“the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’”). See also MPEP § 2161. Therefore, the fact that an additional limitation to a claim may lack descriptive support in the disclosure as originally filed does not necessarily mean that the limitation is also not enabled. In other words, the statement of a new limitation in and of itself may enable one skilled in the art to make and use the claim containing that limitation even though that limitation may not be described in the original disclosure. Consequently, such limitations must be analyzed for both enablement and description using their separate and distinct criteria.
Furthermore, when the subject matter is not in the specification portion of the application as filed but is in the claims, the limitation in and of itself may enable one skilled in the art to make and use the claim containing
the limitation. When claimed subject matter is only presented in the claims and not in the specification portion of the application, the specification should be objected to for lacking the requisite support for the claimed subject matter using Form Paragraph 7.44. See MPEP § 2163.06. This is an objection to the specification only and enablement issues should be treated separately.

4 MirandaNo Gravatar April 6, 2012 at 6:16 pm

Ah, great answer, Ghost.

5 SolNo Gravatar April 6, 2012 at 6:56 pm

Good find, and I think claims can be self-enabling

If a limitation added later can be self-enabling,
then it should be the same case
An orginal limiation can be sel-enabling

Also in regard to WR, I think claims can provide WR to themselves as well.

Claims are part of specification

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6 SolNo Gravatar April 6, 2012 at 6:58 pm

Of course, I am talking about enabling or WR support CAN be found in claims themselves, but to decide if the support is enough, one still needs to stick the standard, to show possession and to make/use without undue expreimentation. All I am saying is that CLAIMS should not be excluded when analyzing patentability.

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