On October 28, 2016, the United States Patent and Trademark Office (PTO) issued a notice of proposed rulemaking in the Federal Register proposing revisions to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings in light of Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).  The PTO had previously issued a notice of proposed rulemaking regarding the same rules in the Federal Register on July 21, 2011 after the Therasense decision.  However, given the passage of time and the significant changes to patent law as a result of the successful implementation of the Leahy-Smith America Invents Act (AIA), the PTO considered it appropriate to obtain public comment on the proposed changes to the duty of disclosure rules.

In the new notice, the PTO proposes to revise the rules to adopt the but-for standard for materiality required to establish inequitable conduct as set forth in the Federal Circuit’s decision in Therasense as the standard for materiality for the duty to disclose information in patent applications and reexamination proceedings.  The PTO also proposes to revise the rules to explicitly reference “affirmative egregious misconduct” as set forth in the Federal Circuit’s Therasense decision.

In particular, the PTO proposes the following changes to 37 C.F.R. § 1.56(a) and (b), where text to be deleted is indicated by strikethrough and text to be added is indicated by underlining:

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.  The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned.  Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application.  There is no duty to submit information which is not material to the patentability of any existing claim.  The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b)-(d)(b) through (d) and 1.98.  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.  The Office encourages applicants to carefully examine:
(1) Prior art cited in search reports of a foreign patent office in a counterpart application, and
(2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.
(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.
    (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.

Similar changes are proposed to 37 C.F.R. § 1.555(a) and (b).

The PTO notes in the new notice that the “proposed rule would harmonize the materiality standard for the duty of disclosure before the Office with the but-for materiality standard set forth in Therasense for establishing inequitable conduct before the courts.”  The PTO also notes that “[a] unitary materiality standard is simpler for the patent system as a whole.”  The PTO believes that by adopting the Therasense but-for standard for materiality as currently proposed, “the frequency with which charges of inequitable conduct are raised against applicants and practitioners for failing to disclosure material information to the Office will be reduced.”

Written comments concerning this notice must be received by the PTO on or before December 27, 2016 to ensure consideration, as set forth in the new Federal Register notice.