The USPTO announced on July 21, 2011, that it plans to "revise the standard for materiality" for the duty of disclosure in view of the Federal Circuit's decision in Therasense, Inc. v. Becton, Dickinson & Co. In particular, the USPTO plans to "match" the materiality standard the court announced in the context of its inequitable conduct decision. The USPTO acknowledges that the Supreme Court may take up Therasense for review, but has decided to move forward for the time being. The USPTO will accept written comments on its proposal until September 19, 2011.

The Proposed Rule Changes

The USPTO proposes to revise Rule 56 to provide that information is material to patentability if it falls under the "but-for-plus" test of Therasense. According to the USPTO, information is material under that test 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 before the Office as to the information.

Parallel amendments would be made to Rule 555 (pertaining to reexamination proceedings).

The USPTO states that, as set forth in Therasense, "neither mere nondisclosure of information to the Office nor failure to mention information in an affidavit, declaration, or other statement to the Office constitutes affirmative egregious misconduct."

Importantly, the USPTO indicates that it will not regard IDS submissions as "admissions of unpatentability for any claims," although it notes that there will not be a duty to submit information that is not material under the "but-for-plus'" standard.

Voluntary Harmonization For Appropriate Incentivization

The USPTO emphasizes that its proposed changes to Rule 56 (and Rule 555) are voluntary and not required by Therasense, because the USPTO's materiality standard and the court's inequitable conduct standard are "not inseparably tied." Nevertheless, the USPTO notes the following benefits of adopting the "but-for-plus" standard:

  • it incentivizes applicants to provide the most relevant information while reducing incentives to submit only marginally relevant information out of an abundance of caution.
  • it may reduce the frequency of inequitable conduct charges, thereby reducing the incentive for applicants to submit marginally relevant information.
  • it will prevent applicants from deceiving the USPTO and breaching their duty of candor and good faith.
  • a unitary materiality standard will be simpler for the patent bar to implement.

With regard to the possibility for Supreme Court review, the USPTO states:

Because the rule making process is lengthy and because the Office prefers to receive and consider public comments before issuing a final rule, the Office is proceeding in parallel with the possibility of a Therasense certiorari petition. Should a petition for certiorari be filed and the Supreme Court grant review of the case, the Office will consider delaying issuance of a final rule until the Supreme Court has issued its decision.

With regard to other possible changes, the USPTO indicates:

[T]he Office is considering further actions that may provide an incentive for applicants to assist the Office by explaining/clarifying the relationship of prior art to the claimed invention. . . . The Office believes it is worthwhile to explore ways to encourage applicants to submit information, beyond that required under the Therasense materiality standard, that would be helpful and useful in advancing examination.

In the wake of Therasense, I wondered if the USPTO might propose a requirement to explain cited references (perhaps similar to the current requirement for Accelerated Examination applications). It is interesting to see this possibility mentioned here, and encouraging to note that the USPTO may be considering how to incentivize voluntary submissions rather than imposing mandatory requirements.