On October 28, 2016, the United States Patent and Trademark
Office ("PTO") again proposed revisions to the
materiality standard for the duty to disclose information in patent
applications and reexamination proceedings. Revision of the
Duty to Disclose Information in Patent Applications and
Reexamination Proceedings, 81 Fed. Reg. 74,987 (proposed Oct.
28, 2016) (to be codified at 37 C.F.R. pt. 1) (hereinafter 2016
Proposed Revisions). The PTO sought to "harmonize the
materiality standard for the duty of disclosure before the [PTO]
with the but-for materiality standard for establishing inequitable
conduct before the courts in light of the Federal Circuit's
decision in Therasense, Inc. v. Becton, Dickinson &
Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc)."
Id. at 74988.
The PTO had previously proposed revisions to a similar effect on
July 21, 2011 and received 24 written public comments. See
Revision of the Materiality to Patentability Standard for the Duty
to Disclose Information in Patent Applications, 76 Fed. Reg.
43,631 (proposed July 21, 2011) (hereinafter 2011 Proposed
Revisions). However, the passage of time and the intervening
implementation of the America Invents Act prompted the PTO to
solicit further comments on the subject. See 2016 Proposed
Revisions at 74,988.
In Therasense, the Federal Circuit held that ''the
materiality required to establish inequitable conduct is but-for
materiality.'' Therasense, 649 F.3d at 1291. The
Federal Circuit clarified 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." Id. "[I]n assessing . . . whether
the PTO would have allowed the claim if it had been aware of the
undisclosed reference[,] . . . the court should apply the
preponderance of the evidence standard and give claims their
broadest reasonable construction." Id. at
1291–92. In addition, to deal with "'deliberately
planned and carefully executed schemes' to defraud the PTO and
the courts," the Federal Circuit recognized an
"affirmative egregious misconduct" exception to the
general rule of requiring but-for materiality. Id. at
1292.
Although Therasense does not require the PTO to revise its
materiality standard, the PTO saw important reasons to do so.
2016 Proposed Revisions at 74,989. The PTO expected that
the adoption of the but-for materiality standard in
Therasense would reduce the number of inequitable conduct
charges in front of the PTO and "reduce the incentive to
submit marginally relevant information in information disclosure
statements." Id. The PTO "also expect[ed] this
currently proposed rule would continue to encourage applicants to
comply with their duty of candor and good faith." Id.
In particular, the PTO differentiated a pure but-for
standard it rejected in 1992 from the currently proposed rule which
includes the affirmative egregious misconduct exception. See
id.
Specifically, the PTO now proposes to revise 37 C.F.R. § 1.56
to read as follows (with proposed revisions underlined):
§ 1.56 Duty to disclose information material to
patentability.
(a) . . . Each individual associated
with the filing and prosecution of a patent application has a duty
of candor and good faith in dealing with the Office, which includes
a duty to disclose to the Office all information known to that
individual to be material to patentability under the but-for
materiality standard as defined in paragraph (b) of this
section. . . . However, no patent will be granted on an application
in connection with which affirmative egregious misconduct was
engaged in, fraud on the Office was practiced or attempted, or
the duty of disclosure was violated through bad faith or
intentional misconduct. . . .
(b) Information is but-for material to patentability if the
Office would not allow a claim if the Office were aware of the
information, applying the preponderance of the evidence standard
and giving the claim its broadest reasonable construction
consistent with the specification.
The PTO also proposes to revise 37 C.F.R. § 1.555 to read
as follows (with proposed revisions underlined):
§ 1.555 Information material to patentability in ex
parte reexamination and inter partes reexamination
proceedings.
(a) . . . Each individual associated
with the patent owner in a reexamination proceeding has a duty of
candor and good faith in dealing with the Office, which includes a
duty to disclose to the Office all information known to that
individual to be material to patentability in a reexamination
proceeding under the but-for materiality standard as defined in
paragraph (b) of this section. . . . However, the duties of
candor, good faith, and disclosure have not been complied with if
affirmative egregious misconduct was engaged in, any fraud
on the Office was practiced or attempted, or the duty of disclosure
was violated through bad faith or intentional misconduct by, or on
behalf of, the patent owner in the reexamination proceeding. . .
.
(b) Information is but-for material to patentability if, for any
matter proper for consideration in reexamination, the Office would
not find a claim patentable if the Office were aware of the
information, applying the preponderance of the evidence standard
and giving the claim its broadest reasonable construction
consistent with the specification.
Note that 37 C.F.R. § 1.933, which is also directed to the
duty of disclosure in inter partes reexamination proceedings, has
not been amended herein because the statement as to materiality of
information in § 1.933 incorporates § 1.555.
These revisions differ from the PTO's 2011 Proposed
Revisions in several aspects:
First, in response to public comments raising potential confusion
issues, the PTO moved the language regarding affirmative egregious
misconduct from the definition of the materiality standard to
§ 1.56(a) and § 1.555(a). 2016 Proposed
Revisions at 74,991; see also 2011 Proposed Revisions
at 43,634.
Second, the currently proposed rule no longer explicitly refers to
the Therasense decision in view of the public comments received.
Id. at 74,989. However, the PTO did not intend to de-link
the proposed rules with the Therasense decision despite
this language change. Indeed, the PTO stated that "an explicit
reference to the Therasense decision is not necessary to
link the materiality standard for the duty of disclosure to the
but-for materiality standard for inequitable conduct set forth in
Therasense." Id. at 74,990. From the
PTO's perspective, "the materiality standard for the duty
of disclosure in this currently proposed rule is the same as
the but-for materiality standard set forth in Therasense and its
interpretations and applications." Id. at 74,989
(emphasis added). The PTO also relied on "Therasense
and subsequent cases, as well as the lengthy jurisprudence of the
unclean hands doctrine . . . [for] guidance as to the boundaries of
affirmative egregious misconduct." Id. at 74,992. The PTO
favored this approach because it "provid[es] a consistent
materiality standard without the need for continuous revisions to
the rules as the Therasense standard is interpreted or
applied." Id. at 74,989. The PTO promised to reconsider the
rules "[i]n the event the Supreme Court, or Federal Circuit
acting en banc, [chose] to revise the but-for materiality
standard in Therasense," and to "keep the public
informed of its understanding of how the Federal Circuit interprets
the standard through future revisions to the Manual of Patent
Examining Procedure (MPEP)." Id.
Third, unlike the existing rule and the 2011 Proposed
Revisions, § 1.555(b) as proposed does not limit the
types of information that could be considered in a reexamination
proceeding to patents and printed publications. Id. at
74,990. Rather, "the currently proposed rule encompasses
disclosure of information as to any matter that is proper for
consideration in a reexamination proceeding (e.g., admissions by
patent owner)." Id.
Fourth, the PTO took a step back from its previous proposal
considering incentivizing applicants "to assist the [PTO] by
explaining/clarifying the relationship of prior art to the claimed
invention." 2011 Proposed Revisions at 43,632.
Several public comments argued that "the [PTO] should not
require applicants to explain or clarify the relationship of the
prior art to the claimed invention," and that "if the
[PTO] requires such an explanation, applicants should be given a
safe harbor . . . ." 2016 Proposed Revisions at
74,993. In response, the currently proposed rulemaking no longer
includes the contemplated required explanation from the previous
notice of proposed rulemaking. Id.
Finally, the PTO fixed an unintended omission by modifying the
previously proposed rule language to state that a claim is given
its broadest reasonable construction ''consistent with the
specification.'' Id. at 74,990.
Although no public hearing will be held, the PTO is accepting
public comments on the proposed rulemaking until December 27,
2016.
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