U.S. Patent and Trademark Office Proposes to Redefine "Materiality" in its Duty of Disclosure Rules Consistent with Federal Circuit's Therasense Decision

July 25, 2011 – Firm News

On July 21, 2011, the USPTO published proposed rules §§ 1.56(b) and 1.555(b) to revise the materiality standard for the duty to disclose information to the USPTO in patent applications and reexamination proceedings in view of the Federal Circuit’s decision in Therasense, Inc. v. Becton, Dickinson & Co., ___ F.3d ___, 2011 WL 2028255 (Fed. Cir. 2011) (en banc).  The revision to section 1.56, which is substantively identical to the proposed new section 1.555(b) is as follows:

§ 1.56 Duty to disclose information material to patentability.

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(b) Information is material to patentability if it is material under the standard set forth in Therasense, Inc. v. Becton, Dickinson & Co., ___ F.3d ___ (Fed. Cir. 2011). Information is material to patentability under Therasense if:

     (1) The Office would not allow a claim if it were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction; or

     (2) The applicant engages in affirmative egregious misconduct.

The USPTO refers to the above as the “but-for-plus” standard, and it states this standard will “result in patent applicants providing the most relevant information and reduce the incentive for applicants to submit information disclosure statements containing only marginally relevant information out of an abundance of caution.”

The USPTO acknowledges that it rejected a “but-for” standard for materiality in 1992 when it promulgated the present version of rule 1.56. The USPTO distinguishes its prior rejection by the adoption of an “affirmative egregious misconduct” exception set forth in section (b)(2), which “addresses the Office’s long-standing concern about the types of unscrupulous conduct that could occur unchecked under a pure ‘but-for’ standard.”  The proposed rule changes do not define what constitutes “affirmative egregious misconduct.”  However, the USPTO confirmed that, consistent with Therasense, the proposal’s “affirmative egregious misconduct” exception set forth in section (b)(2) will not be met by “mere nondisclosure of information to the Office, or failure to mention information in an affidavit, declaration, or other statement to the Office.”

Although there will be no duty under proposed § 1.56 to submit information that is not material to patentability under the ‘‘but-for-plus” standard of Therasense and § 1.56(b), the USPTO is considering further incentives for applicants to assist the Office by explaining or clarifying the relationship of prior art to the claimed invention beyond that required under the Therasense materiality standard. Cf., the pre-March 1992 IDS rule 1.98.  The USPTO further stated that while it “recognizes the tension inherent in a disclosure standard based on unpatentability,” it “appreciates and expects that patent applicants are inclined to be forthcoming and submit information beyond that required by proposed Rule 56, in an effort to assist examiners in performing their duties.”  The USPTO further reminded applicants that under present rule § 1.97(h), the PTO “will not regard information disclosures as admissions of unpatentability for any claims in the application.”

The USPTO also acknowledged that Therasense could be reviewed by the U.S. Supreme Court, but due to the lengthy rule making process, it would proceed in parallel with any possible  Therasense certiorari petition.  The USPTO would consider delaying issuance of any final rule if a petition for certiorari were filed and the Supreme Court granted review of the case.

The USPTO is accepting written comments regarding this proposed rule change until September 19, 2011.

For more information on the underlying Therasense decision, please see: https://www.oblon.com/news/federal-circuit-changes-standards-make-it-more-difficult-prove-inequitable-conduct