On the heels of the recent Federal Circuit en banc decision in Therasense, Inc. v. Becton, Dickinson & Co., — F.3d — (Fed. Cir. 2011), the U.S. Patent and Trademark Office (USPTO) is proposing to revise Applicants’ duty to disclose by limiting the scope of materiality. Particularly, the USPTO is proposing to adopt the “but-for-plus” standard for materiality.
The proposed new rule, 37 CFR §1.56(b), would read as follows:
Sec. 1.56 Duty to disclose information material to patentability.
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(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.
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The proposed new rule, 37 CFR §1.555 (b), would read as follows:
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(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.
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The most important element of the proposed rule change is the fact that simply failing to disclose information will not be considered material if the pending claim is itself allowable, without inclusion of the information. If Applicants go beyond simple omission, and engage in “affirmative acts of egregious misconduct,” those acts will be treated as material.
The USPTO explained that bringing its rules in line with the reasoning in Therasense will reduce the frequency with which applicants and practitioners are charged with inequitable conduct, reduce the number of submissions of marginally relevant prior art, and provide a simpler, unitary standard for the patent bar to implement, while at the same time continuing to prevent applicants from deceiving the USPTO and breaching their duty of candor and good faith.
The public is invited to submit comments to the proposed rule by September 19, 2011.