PTO to Match Materiality Standard to Therasense

Yesterday, the PTO published a Federal Register notice that it plans to conform its materiality standard for complying with the duty of disclosure to that set forth by the Federal Circuit in Therasense.

The PTO indicated in the notice that it believes having one standard for both patent prosecution and patent litigation will make it easier for applicants and attorneys to comply.  The new standard will require applicants to submit information and references that are clearly material to the patentability of patent claims, but should keep them from dumping references of marginal importance.

The PTO had previously rejected a pure “but for” standard in 1992 in crafting new rules.  Now, the PTO believes that the court granted a safety net from the straight “but for” test.  The PTO characterizes the Federal Circuit’s test as “but for plus”.  Information is material if the patent claims would not have issued “but for” the withholding of the information from the PTO.  Information is also material if the conduct constitutes “affirmative egregious misconduct.”

Specifically, the PTO proposes to amend 37 C.F.R. § 1.56 as follows:

(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 before the Office as to the information.

 The PTO has set a deadline of September 19 for comments to this proposed rule change.  The agency acknowledges that the Supreme Court may still weigh in on the case.  In the event that that happens, it may consider delaying publication of the final rule.  Given how long the rule-making process takes, however, the PTO decided to move ahead simultaneously with Supreme Court consideration.

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3 Responses to “PTO to Match Materiality Standard to Therasense”

  1. TJ Says:

    Doesn’t the Therasense decision eliminate any legitimate reason for the America Invents Act’s removal of language that guards against “intent to deceive?” For anyone not familiar with this part of America Invents, see Section 20. There are seven places where phrases like “intent to deceive” have been removed from the law. This removal was over-reaching to begin with, but in light of Therasense, isn’t the only real benefit now for the person who really does intend to deceive?

    • Matt Osenga Says:


      I’m not sure I really understand your comment. In any event, I think you are referring to the provisions regarding correction of inventorship and re-issue applications under current law. I’m not sure how or why the “without deceptive intent” requirements for making these corrections will work. I don’t know whether Therasense will play a role in these instances or not.


  2. General Global Week in Review 8 August 2011 from IP Think Tank Says:

    [...] to match materiality standard to Therasense (Inventive Step) (IP [...]

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