In view of this year’s Federal Circuit en banc decision in Therasense, Inc. v. Becton, Dickinson & Co., 2011 WL 2028255 (Fed. Cir. May 25, 2011) (en banc), the United States Patent and Trademark Office (USPTO) recently proposed revising the materiality standard for the duty of disclosure to match that of the inequitable conduct doctrine, as articulated in that decision.
The Therasense Court limited materiality to a “but-for-plus” standard. In doing so, the Court explained that “[w]hen an applicant fails to disclose prior art to the [USPTO], 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.” Id. at *11. The Court therefore held that inequitable conduct during prosecution cannot be found unless the alleged misconduct was a “but-for” cause for the patent’s issuance. In addition, the Court recognized an exception in cases of affirmative egregious misconduct before the USPTO. Id. at *12. The Court, however, clarified that “neither mere nondisclosure of prior art references to the [USPTO] nor failure to mention prior art references in an affidavit” would rise to such misconduct. Id. In contrast, submission of an unmistakably false affidavit would be considered affirmative egregious misconduct. Id.
Although the USPTO does not consider Therasense to require it to harmonize the materiality standards underlying the duty of disclosure and the inequitable conduct doctrine, the USPTO believes there are important reasons to do so. In particular, the USPTO believes that adopting the Therasense materiality 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 out of an abundance of caution. A harmonized standard will also avoid forcing applicants to meet one standard when defending against inequitable conduct allegations and a second, different standard to fulfill the duty of disclosure before the USPTO.
Thus, the USPTO has proposed to rewrite 37 C.F.R. § 1.56(b) to clarify that “information is material to patentability if it is material under the standard set forth in Therasense, and that information is material to patentability under Therasense if: (1) The [USPTO] 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 [USPTO] as to the information.” Revision of the Materiality to Patentability Standard for the Duty to Disclose Information in Patent Applications, 76 Fed. Reg. 43633 (July 21, 2011). The USPTO also plans to similarly revise 37 C.F.R. § 1.555(b), which relates to reexamination proceedings before the USPTO. See id. As alluded to above, the new rules ensure that a failure to disclose information cannot be considered material to patentability so long as the subject claims are still allowable.