As we previously reported, the Court of Appeals for the Federal Circuit released in May 2011 its long-awaited decision in Therasense, Inc. v. Becton Dickinson and Co., in which it raised the standard for proving inequitable conduct and rendering a patent unenforceable.  The defense of inequitable conduct applies to both utility and design patents.  Last year, we reported on a design patent litigation where this defense was raised.

The Therasense decision redefined the type of information that can potentially support a defense of inequitable conduct if it is withheld, misleading, or incorrect -- i.e., what constitutes “material” information.  Under the new standard, information is material only “if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.”  The Federal Circuit refers to this as the “but for” standard.

Last week, in response to the Therasense decision, the USPTO published proposed changes to the materiality standard of  37 CFR § 1.56, which governs Applicants’ duty of disclosure during the prosecution of a design patent.  The proposed rule, which defines materiality using a so-called “but for-plus” test, is shown below in its entirety.

§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.

Part (b)(1) above is straight forward and corresponds to the “but for” test adopted by the Therasense decision.  Part (b)(2) raises some questions.  It embodies the “plus” aspect of the proposed “but for-plus” materiality standard.  While the Therasense decision provides support for findings of inequitable conduct in cases of affirmative egregious misconduct, the USPTO had historically treated intentional misrepresentations, false and misleading statements under a different rule than Rule 56.  Affirmative egregious misconduct in the form of false statements or misrepresentations, especially in affidavits or declarations were considered to be inherently material. But such materiality was a result of a violation of the duty of candor and good faith. Whereas the duty of disclosure was confined to acts of omission and given separate treatment under Rule 56.  The USPTO is soliciting comments on its proposal on or before September 19, 2011.  We will keep track of this process and report on our blog so as to keep design patent applicants informed.