USPTO Again Proposes To Revise Duty Of Disclosure In View Of Therasense

31 October 2016 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

More than five years after the Federal Circuit’s en banc decision in Therasense and its first proposed rulemaking under that decision, the USPTO has issued a new proposed rulemaking to adapt its duty of disclosure rule (37 CFR § 1.56) to the court’s decision. As set forth in the October 28, 2016 Federal Register Notice, the revised rule would adopt a “but-for” materiality test designed to be consistent with Therasense.

The Therasense Decision

The Federal Circuit decision in Therasense addressed the standards for establishing inequitable conduct, including the underlying requirements of intent to decieve and materiality of the withheld or misrepresented information. With regard to materiality, the court determined that the standard needed to be “adjusted” in order to “reduce the number of inequitable conduct cases before the courts” and address “the problem of over-disclosure of marginally relevant prior art to the PTO.” Thus, the court adopted a “but-for” test for materiality:

This court holds that, as a general matter, the materiality required to establish inequitable conduct is but-for materiality. When an applicant fails to disclose prior art to the PTO, that prior art is but-for material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.

The court also provided this additional guidance:

[I]n assessing the materiality of a withheld reference, the court must determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference. In making this patentability determination, the court should apply the preponderance of the evidence standard and give claims their broadest reasonable construction.

The court also held that inequitable conduct could be found without but-for materiality in cases of “affirmative acts of egregious misconduct.”

The Proposed Changes To Rule 56

As set forth in the Federal Register Notice, the USPTO is proposing to revise 37 CFR § 1.56 to “harmonize” the rule with the court’s “but-for” test for materiality:

§ 1.56 Duty to disclose information material to patentability.

(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability under the but-for materiality standard as defined in paragraph (b) of this section. …. However, no patent will be granted on an application in connection with which affirmative egregious misconduct was engaged in, fraud on the Office was practiced or attempted, or the duty of disclosure was violated through bad faith or intentional misconduct. ….
(b) Information is but-for material to patentability if the Office would not allow a claim if the Office were aware of the information, applying the  preponderance of the evidence standard and giving the claim its broadest reasonable construction consistent with the specification.
(b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
   (1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
   (2) It refutes, or is inconsistent with, a position the applicant takes in:
          (i) Opposing an argument of unpatentability relied on by the Office, or
          (ii) Asserting an argument of patentability.
A prima facie case of unpatentability is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard, giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability. ….

Parallel changes are proposed for 37 CFR § 1.555, which applies to reexamination proceedings and, indirectly, to post-grant proceedings.

Why Change Rule 56?

According to the Federal Register Notice, the USPTO believes these changes to Rule 56 will “harmonize the materiality standard for the duty of disclosure before the Office with the … standard … for establishing inequitable conduct before the courts,” and also reflect the court’s “recognition that affirmative egregious misconduct satisfies the materiality prong of inequitable conduct.” The USPTO notes that having a “unitary materiality standard [will be] simpler for the patent system as a whole,” and is expected to reduce “the frequency with which charges of inequitable conduct are raised against applicants and practitioners for failing to disclosure material information to the Office.”

Consistent with the Federal Circuit’s comments, the USPTO “expects that adopting the but-for materiality standard [will] reduce the incentive to submit marginally relevant information in [IDSs]” and thereby “further the Office’s goal of enhancing patent quality.” In this regard, the Federal Register Notice explains that “adoption of the but-for standard for materiality should lead to more focused prior art submissions by applicants, which in turn will assist examiners in more readily recognizing the most relevant prior art.” On the other hand, the USPTO believes that the revised rule still will “encourage applicants to comply with their duty of candor and good faith,” and address USTPO concerns regarding affirmative misconduct.

Written Comment Period

The Federal Register Notice responds to the written comments submitted in response to the July 2011 proposed rulemaking on Therasense and opens a new written comment period that expires December 27,2016. The USPTO prefers written comments sent by email to

Will this revised version of Rule 56 change applicant behavior and reduce IDS submissions, or have applicants already altered their practices in view of Therasense?

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