By Kevin E. Noonan --
The U.S. Patent and Trademark Office issued a notice in the Federal Register today (76 Fed. Reg. 43631) proposing to change the Office's definition of materiality in Rule 56 and Rule 555(b) to be consistent with the materiality standard enunciated by the Federal Circuit in Therasense, Inc. v. Becton, Dickinson & Co. on May 25. While stating that the Office does not believe the change is mandatory, the notice cites the following reasons for the proposed change:
The materiality standard set forth in Therasense should reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, consequently reducing the incentive to submit information disclosure statements containing marginally relevant information and enabling applicants to be more forthcoming and helpful to the Office. At the same time, it should also continue to prevent fraud on the Office and other egregious forms of misconduct. Additionally, harmonization of the materiality standards is simpler for the patent system as a whole.
The proposed change will amend 37 C.F.R. §§ 1.56 and 1.555(b) to require "but for" materiality as defined by Therasense. The notice explains that:
"[w]hen 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.'' Therasense, 2011 WL 2028255, at *11. Said differently, the Court explained: ''[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[,] * * * apply[ing] the preponderance of the evidence standard and giv[ing] claims their broadest reasonable construction.'' Id. The Court also recognized that ''affirmative acts of egregious misconduct,'' Id. at *12, before the PTO are unacceptable: ''Although but-for materiality generally must be proved to satisfy the materiality prong of inequitable conduct, this court recognizes an exception in cases of affirmative egregious misconduct.'' Id. The Court reasoned that ''a patentee is unlikely to go to great lengths to deceive the PTO with a falsehood unless it believes that the falsehood will affect issuance of the patent.'' Id. The Court clarified that ''neither mere nondisclosure of prior art references to the PTO nor failure to mention prior art references in an affidavit constitutes affirmative egregious misconduct.'' Id. Lastly, the Court identified the submission of an unmistakably false affidavit as an example of affirmative egregious misconduct. Id.
The Office acknowledges that this test is not as inclusive as the current Rule 56, but the notice states that "[w]hile not as inclusive as current § 1.56(b), the Office expects that the 'but-for-plus' standard from Therasense will result in patent applicants providing the most relevant information and reduce the incentive for applicants to submit information disclosure statements containing only marginally relevant information out of an abundance of caution," and further that:
The Court stated that its "but-for-plus" standard, "[b]y creating an exception to punish affirmative egregious acts without penalizing the failure to disclose information that would not have changed the issuance decision, * * * strikes a necessary balance between encouraging honesty before the PTO and preventing unfounded accusations of inequitable conduct." Therasense, 2011 WL 2028255, at *12.
Thus, according to the Office, it expects that the "'but-for-plus' standard will reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, thereby reducing the incentive for applicants to submit marginally relevant information to the Office," and "[a]t the same time, it will continue to prevent applicants from deceiving the Office and breaching their duty of candor and good faith."
The notice also expresses the Office's opinion that a "unitary materiality standard" will be simpler for the patent bar to implement, because "patent applicants will not be put in the position of having to meet one standard for materiality as defined in Therasense in defending against inequitable conduct allegations and a second, different materiality standard to fulfill the duty to disclose before the Office."
Under the proposed rule, "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." Further, "[a]s stated 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." The notice also states that the Office "appreciates and expects that patent applicants are inclined to be forthcoming and submit information beyond that required by proposed Rule 56, in an effort to assist examiners in performing their duties."
Although the Office is proposing to revise §§ 1.56(b) and 1.555(b) to match the ''but-for-plus'' materiality standard announced in Therasense, the Office recognizes that Therasense could be reviewed by the U.S. Supreme Court. Because the rulemaking 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.
Finally, the notice contains suggestions that the Office is considering other "ways to encourage applicants to submit information beyond that required under the Therasense materiality standard."
The following is the text of the proposed revised rules:
§ 1.56 Duty to disclose information material to patentability.
* * *
(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.
§ 1.555 Information material to patentability in ex parte reexamination and inter partes reexamination proceedings.
* * *
(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 find a claim patentable 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 patent owner engages in affirmative egregious misconduct before the Office as to the information.
Comments must be submitted by September 19, 2011 to [email protected] or by mail addressed to: Mail Stop Comments- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Hiram H. Bernstein, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy.
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