On October 28, the U.S. Patent and Trademark Office published a notice of proposed rulemaking in the Federal Register (81 Fed. Reg. 9451), proposing revisions to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings. The Office previously issued a notice of proposed rulemaking regarding the same rules in July 2011 following the Federal Circuit's decision in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc), but indicated in the latest notice that given the passage of time since the comment period closed on the prior notice, the Office felt it was appropriate to seek additional comments from stakeholders before issuing a final rulemaking.
In its latest notice, the Office points out that the Therasense decision does not require the Office to harmonize its materiality standard underlying the duty of disclosure with the Federal Circuit's but-for materiality standard underlying the inequitable conduct doctrine. However, the Office asserts that "[a] unitary materiality standard is simpler for the patent system as a whole." The Office also believes that by adopting the Therasense but-for standard for materiality in the proposed rules changes, "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." The Office further believes that adopting the but-for materiality standard will "reduce the incentive to submit marginally relevant information in information disclosure statements (IDSs)."
In the notice, the Office proposes changes to the rules of practice to harmonize the materiality standard for the duty of disclosure before the Office with the but-for materiality standard for establishing inequitable conduct before the courts in light of the Federal Circuit's decision in Therasense. The Office is also proposing changes to the rules of practice to explicitly reference "affirmative egregious misconduct" as set forth in Therasense. In particular, the Office proposes the following changes to 37 C.F.R. § 1.56(a) and (b) (wherein 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 being proposed to 37 C.F.R. § 1.555(a) and (b).
In response to its July 2011 notice, the Office received 24 comments. As indicated in the latest notice, several of these comments motivated the Office to make further changes to the proposed rules. In particular, the Office notes that to avoid potential confusion, the language regarding affirmative egregious misconduct was moved from the definition of the materiality standard for disclosure of information as previously proposed, to 37 C.F.R. § 1.56(a) and 37 C.F.R. § 1.555(a). In addition, the explicit reference to the Therasense decision was removed from the previously proposed rules. The Office further modified the previously proposed rules to state that a claim is given its broadest reasonable construction "consistent with the specification." Finally, the Office is no longer requiring applicants to explain or clarify the relationship of the prior art to the claimed invention as proposed in the prior notice of proposed rulemaking.
In addressing the comments to the prior notice, the Office also notes that "[t]he duty does not pertain to information that is only material to claims that have been cancelled or withdrawn." With regard to the language regarding cumulative information set forth in existing 37 C.F.R. §§ 1.56 and 1.555 (which has been removed from the proposed changes to the rules in the latest notice), the Office contends that "[i]nformation that is merely cumulative to information already on the record would not be material under the but-for standard," and therefore the Office "is not requesting that applicants submit cumulative information."
The Office did not, however, change the rules such that the duty of disclosure would end upon payment of the issue fee rather than the patent grant as proposed in several comments. Nor did the Office change the rules to abrogate the duty of disclosure as also proposed in several comments.
Written comments regarding the notice of proposed rulemaking can be sent by e-mail to: AC58.comments@uspto.gov; by regular mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Matthew Sked, Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal. Written comments must be submitted by December 27, 2016 to be considered.
