The U.S. Patent and Trademark Office (USPTO) has announced its plan to “revise the standard for materiality for the duty to disclose information in patent applications and reexamination proceedings in light of the decision by the U.S. Court of Appeals for the Federal Circuit in Therasense, Inc. v. Becton, Dickinson & Co. Specifically, the Office is proposing to revise the materiality standard for the duty to disclose to match the materiality standard, as defined in Therasense, for the inequitable conduct doctrine.” Comments are requested by September 19, 2011.
According to USPTO, this standard “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.”
In Therasense, the court made it more difficult to challenge the validity of a patent by claiming that the applicant failed to disclose prior art to USPTO. The court adopted a “but-for-plus standard” as to the prior art’s materiality, stating, “When an applicant fails to disclose prior art to the [USPTO], that prior art is but-for material if the [USPTO] would not have allowed a claim had it been aware of the undisclosed prior art.” In other words, “In assessing the materiality of a withheld reference, the court must determine whether the [USPTO] 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.” The court excluded affirmative, egregious misconduct from the but-for materiality rule. See Federal Register, July 21, 2011.