[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Proposed Rules]
[Pages 43631-43634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18408]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No. PTO-P-2011-0030]
RIN 0651-AC58
Revision of the Materiality to Patentability Standard for the
Duty To Disclose Information in Patent Applications
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The United States Patent and Trademark Office (Office or PTO)
is proposing 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 (Federal Circuit or Court) 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. While Therasense does not require the Office to
harmonize the materiality standards underlying the duty of disclosure
and the inequitable conduct doctrine, the Office believes that there
are important reasons to do so. The materiality standard set forth in
Therasense 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. Additionally, harmonization of the materiality
standards is simpler for the patent system as a whole.
DATES: The Office solicits comments from the public on this proposed
rule change. Written comments must be received on or before September
19, 2011 to ensure consideration. No public hearing will be held.
ADDRESSES: Comments concerning this notice should be sent by electronic
mail message over the Internet addressed to [email protected].
Comments may also be submitted by mail addressed to: Mail Stop
Comments-Patents, Commissioner for Patents, P.O. Box 1450, Alexandria,
VA 22313-1450, marked to the attention of Hiram H. Bernstein, Senior
Legal Advisor, Office of Patent Legal Administration, Office of the
Associate Commissioner for Patent Examination Policy. Although comments
may be submitted by mail, the Office prefers to receive comments via
the Internet.
Comments may also be sent by electronic mail message over the
Internet via the Federal eRulemaking Portal. See the Federal
eRulemaking Portal Web site (http://www.regulations.gov) for additional
instructions on providing comments via the Federal eRulemaking Portal.
The comments will be available for public inspection at the Office of
the Commissioner for Patents, located in Madison East, Tenth Floor, 600
Dulany Street, Alexandria, Virginia, and will be available via the
Internet (http://www.uspto.gov). Because comments will be made
available for public inspection,
[[Page 43632]]
information that the submitter does not desire to make public, such as
an address or phone number, should not be included in the comments.
FOR FURTHER INFORMATION CONTACT: Hiram H. Bernstein, Senior Legal
Advisor; Kenneth M. Schor, Senior Legal Advisor; or Nicole D. Haines,
Legal Advisor, Office of Patent Legal Administration, Office of the
Associate Commissioner for Patent Examination Policy, by telephone at
(571) 272-7707, (571) 272-7710, or (571) 272-7717, respectively, or by
mail addressed to: Mail Stop Comments-Patents, Commissioner for
Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the
attention of Hiram H. Bernstein.
SUPPLEMENTARY INFORMATION: The Office is proposing to revise the
materiality standard for the duty to disclose information to the Office
in patent applications and reexamination proceedings set forth in
Sec. Sec. 1.56(b) and 1.555(b) in light of the Federal Circuit's
decision in Therasense, Inc. v. Becton, Dickinson & Co., ------ F.3d --
----, 2011 WL 2028255 (Fed. Cir. 2011) (en banc). Specifically, the
Office is proposing to adopt the standard for materiality required to
establish inequitable conduct as defined in Therasense as the standard
for materiality under Sec. Sec. 1.56(b) and 1.555(b).
In Therasense, the Court defined materiality using a ``but-for-
plus'' standard. As the general rule, the Court explained 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.'' Therasense, 2011 WL 2028255, at
*11. Said differently, the Court explained: ``[I]n assessing the
materiality of a withheld reference, the court must determine whether
the PTO 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.'' Id. The Court also recognized that ``affirmative acts
of egregious misconduct,'' Id. at *12, before the PTO are unacceptable:
``Although but-for materiality generally must be proved to satisfy the
materiality prong of inequitable conduct, this court recognizes an
exception in cases of affirmative egregious misconduct.'' Id. The Court
reasoned that ``a patentee is unlikely to go to great lengths to
deceive the PTO with a falsehood unless it believes that the falsehood
will affect issuance of the patent.'' Id. The Court clarified that
``neither mere nondisclosure of prior art references to the PTO nor
failure to mention prior art references in an affidavit constitutes
affirmative egregious misconduct.'' Id. Lastly, the Court identified
the submission of an unmistakably false affidavit as an example of
affirmative egregious misconduct. Id.
Historically, the Federal Circuit connected the materiality
standard for inequitable conduct with the PTO's materiality standard
for the duty of disclosure. That is, the Court has invoked the
materiality standard for the duty of disclosure to measure materiality
in cases raising claims of inequitable conduct. In doing so, the Court
has utilized both the ``reasonable examiner'' standard set forth in the
1977 version of Sec. 1.56(b) and current Sec. 1.56(b) promulgated in
1992. See, e.g., Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d
1350, 1363 (Fed. Cir. 1984); Bruno Indep. Living Aids, Inc. v. Acorn
Mobility Servs., Inc., 394 F.3d 1348, 1352-53 (Fed. Cir. 2005). While
the Therasense Court severed what existed of the historical connection
between the two materiality standards, as most recently articulated in
Digital Control Inc. v. Charles Mach. Works, 437 F.3d 1309, 1315-16
(Fed. Cir. 2006) (identifying the PTO's current standard as one of many
standards the courts could apply), it did not indicate that the Office
must apply the standard for materiality required to establish
inequitable conduct under Therasense as the standard for determining
materiality under Sec. 1.56(b) or Sec. 1.555(b). As the dissent in
Therasense noted, ``the scope of the court-made [inequitable conduct]
doctrine is not inseparably tied to the breadth of the PTO's disclosure
rules.'' Therasense, 2011 WL 2028255, at *33. The Office, however,
believes that there are important reasons to amend Sec. 1.56(b) and
Sec. 1.555(b) so that the PTO's materiality standard for the duty of
disclosure matches the materiality standard for inequitable conduct.
While not as inclusive as current Sec. 1.56(b), the Office expects
that the ``but-for-plus'' standard from Therasense will result in
patent applicants providing the most relevant information and reduce
the incentive for applicants to submit information disclosure
statements containing only marginally relevant information out of an
abundance of caution. The Court stated that its ``but-for-plus''
standard, ``[b]y creating an exception to punish affirmative egregious
acts without penalizing the failure to disclose information that would
not have changed the issuance decision, * * * strikes a necessary
balance between encouraging honesty before the PTO and preventing
unfounded accusations of inequitable conduct.'' Therasense, 2011 WL
2028255, at *12. Thus, the Office expects that the ``but-for-plus''
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 to the Office. At the same time, it will continue to
prevent applicants from deceiving the Office and breaching their duty
of candor and good faith.
The Office also believes that a unitary materiality standard is
simpler for the patent bar to implement. Under the single ``but-for-
plus'' standard of materiality, patent applicants will not be put in
the position of having to meet one standard for materiality as defined
in Therasense in defending against inequitable conduct allegations and
a second, different materiality standard to fulfill the duty to
disclose before the Office.
The Office recognizes that it previously considered, and rejected,
a ``but-for'' standard for the duty of disclosure in 1992 when it
promulgated current Sec. 1.56(b). Duty of Disclosure, 57 FR 2021, 2024
(Jan. 17, 1992). The affirmative egregious misconduct exception set
forth in Therasense addresses the Office's long-standing concern about
the types of unscrupulous conduct that could occur unchecked under a
pure ``but-for'' standard.
Although the Office is proposing to revise Sec. Sec. 1.56(b) and
1.555(b) to match the ``but-for-plus'' materiality standard announced
in Therasense, the Office recognizes that Therasense could be reviewed
by the U.S. Supreme Court. Because the rule making process is lengthy
and because the Office prefers to receive and consider public comments
before issuing a final rule, the Office is proceeding in parallel with
the possibility of a Therasense certiorari petition. Should a petition
for certiorari be filed and the Supreme Court grant review of the case,
the Office will consider delaying issuance of a final rule until the
Supreme Court has issued its decision.
Additionally, the Office is considering further actions that may
provide an incentive for applicants to assist the Office by explaining/
clarifying the relationship of prior art to the claimed invention.
While this form of information would not implicate the standard of
materiality as that term has been defined in Therasense, and therefore
would not be required under the proposed changes to Sec. 1.56, the
[[Page 43633]]
Office believes it is worthwhile to explore ways to encourage
applicants to submit information, beyond that required under the
Therasense materiality standard, that would be helpful and useful in
advancing examination.
Discussion of Specific Rules
Title 37 of the Code of Federal Regulations, Part 1, is proposed to
be amended as follows:
Section 1.56: Section 1.56(b) as proposed to be amended would
provide 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 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. As stated in Therasense, neither mere nondisclosure of
information to the Office nor failure to mention information in an
affidavit, declaration, or other statement to the Office constitutes
affirmative egregious misconduct. Therasense, 2011 WL 2028255, at *12.
The Office notes that, under the ``but-for-plus'' standard of
Therasense, information is not material if the pending claim is
allowable, applying the preponderance of the evidence standard and
giving the claim its broadest reasonable construction, and the
applicant does not engage in affirmative egregious misconduct before
the Office as to the information. The Office recognizes the tension
inherent in a disclosure standard based on unpatentability, but
appreciates and expects that patent applicants are inclined to be
forthcoming and submit information beyond that required by proposed
Rule 56, in an effort to assist examiners in performing their duties.
The Office wishes to facilitate and encourage such efforts by
applicants. While applicants should avoid drafting claims that are
unpatentable in the face of the prior art they disclose, the Office
will not regard information disclosures as admissions of
unpatentability for any claims in the application. See Sec. 1.97(h).
In addition, there is no duty under Sec. 1.56 to submit information
that is not material under the ``but-for-plus'' standard of Therasense
and Sec. 1.56(b).
Section 1.555: Section 1.555(b) as proposed to be amended would
provide 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 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. Again as stated in Therasense, neither mere nondisclosure
of information to the Office nor failure to mention information in an
affidavit, declaration, or other statement to the Office constitutes
affirmative egregious misconduct. Therasense, 2011 WL 2028255, at *12.
Section 1.933 is directed to the duty of disclosure in inter partes
reexamination proceedings; however, the statement as to materiality of
information simply incorporates Sec. 1.555. Thus, no revision is
proposed for Sec. 1.933.
Rule Making Considerations
A. Regulatory Flexibility Act: For the reasons set forth herein,
the Deputy General Counsel for General Law of the United States Patent
and Trademark Office has certified to the Chief Counsel for Advocacy of
the Small Business Administration that changes proposed in this notice
will not have a significant economic impact on a substantial number of
small entities. See 5 U.S.C. 605(b).
This notice proposes to harmonize the standard for materiality
under Sec. Sec. 1.56 and 1.555 with the standard for materiality
required to establish inequitable conduct. Additionally, the single
harmonized materiality standard should reduce the incentives to submit
information of marginal relevance. This notice does not propose any
additional fees or requirements on patent applicants or patentees.
Therefore, the changes proposed in this notice will not have a
significant economic impact on a substantial number of small entities.
B. Executive Order 12866 (Regulatory Planning and Review): This
rule making has been determined to be not significant for purposes of
Executive Order 12866 (Sept. 30, 1993).
C. Executive Order 13563 (Improving Regulation and Regulatory
Review): The Office has complied with Executive Order 13563.
Specifically, the Office has, to the extent feasible: (1) Used the best
available techniques to quantify costs and benefits, and has considered
values such as equity, fairness and distributive impacts; (2) involved
the public in an open exchange of information and perspectives among
experts in relevant disciplines, affected stakeholders in the private
sector and the public as a whole, and provided on-line access to the
rule making docket; (3) attempted to promote coordination,
simplification and harmonization across government agencies and
identified goals designed to promote innovation; (4) considered
approaches that reduce burdens and maintain flexibility and freedom of
choice for the public; and (5) ensured the objectivity of scientific
and technological information and processes, to the extent applicable.
D. Executive Order 13132 (Federalism): This rule making does not
contain policies with federalism implications sufficient to warrant
preparation of a Federalism Assessment under Executive Order 13132
(Aug. 4, 1999).
E. Executive Order 13175 (Tribal Consultation): This rule making
will not: (1) Have substantial direct effects on one or more Indian
tribes; (2) impose substantial direct compliance costs on Indian tribal
governments; or (3) preempt tribal law. Therefore, a tribal summary
impact statement is not required under Executive Order 13175 (Nov. 6,
2000).
F. Executive Order 13211 (Energy Effects): This rule making is not
a significant energy action under Executive Order 13211 because this
rule making is not likely to have a significant adverse effect on the
supply, distribution, or use of energy. Therefore, a Statement of
Energy Effects is not required under Executive Order 13211 (May 18,
2001).
G. Executive Order 12988 (Civil Justice Reform): This rule making
meets applicable standards to minimize litigation, eliminate ambiguity,
and reduce burden as set forth in sections 3(a) and 3(b)(2) of
Executive Order 12988 (Feb. 5, 1996).
H. Executive Order 13045 (Protection of Children): This rule making
does not concern an environmental risk to health or safety that may
disproportionately affect children under Executive Order 13045 (Apr.
21, 1997).
I. Executive Order 12630 (Taking of Private Property): This rule
making will not effect a taking of private property or otherwise have
taking implications under Executive Order 12630 (Mar. 15, 1988).
J. Congressional Review Act: Under the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the
United States Patent and Trademark Office will submit a report
containing the final rule and other required information to the U.S.
Senate, the U.S. House of
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Representatives and the Comptroller General of the Government
Accountability Office. The changes in this notice are not expected to
result in an annual effect on the economy of 100 million dollars or
more, a major increase in costs or prices, or significant adverse
effects on competition, employment, investment, productivity,
innovation, or the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.
Therefore, this notice is not expected to result in a ``major rule'' as
defined in 5 U.S.C. 804(2).
K. Unfunded Mandates Reform Act of 1995: The changes proposed in
this notice do not involve a Federal intergovernmental mandate that
will result in the expenditure by State, local, and tribal governments,
in the aggregate, of 100 million dollars (as adjusted) or more in any
one year, or a Federal private sector mandate that will result in the
expenditure by the private sector of 100 million dollars (as adjusted)
or more in any one year, and will not significantly or uniquely affect
small governments. Therefore, no actions are necessary under the
provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C.
1501 et seq.
L. National Environmental Policy Act: This rule making will not
have any effect on the quality of environment and is thus categorically
excluded from review under the National Environmental Policy Act of
1969. See 42 U.S.C. 4321 et seq.
M. National Technology Transfer and Advancement Act: The
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because
this rule making does not contain provisions which involve the use of
technical standards.
N. Paperwork Reduction Act: The changes in this rule making involve
information collection requirements which are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.). The collection of information
involved in this notice has been reviewed and approved by OMB under OMB
control number 0651-0031. This rule making proposes to harmonize the
standard for materiality under Sec. Sec. 1.56 and 1.555 with the
standard for materiality required to establish inequitable conduct.
This notice does not propose any additional fees or information
collection requirements on patent applicants or patentees.
Notwithstanding any other provision of law, no person is required
to respond to nor shall a person be subject to a penalty for failure to
comply with a collection of information subject to the requirements of
the Paperwork Reduction Act unless that collection of information
displays a currently valid OMB control number.
List of Subjects in 37 CFR Part 1
Administrative practice and procedure, Courts, Freedom of
Information, Inventions and patents, Reporting and record keeping
requirements, Small businesses.
For the reasons set forth in the preamble, 37 CFR Part 1 is
proposed to be amended as follows:
PART 1--RULES OF PRACTICE IN PATENT CASES
1. The authority citation for 37 CFR Part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2).
2. Section 1.56 is amended by revising paragraph (b) to read as
follows:
Sec. 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.
* * * * *
3. Section 1.555 is amended by revising paragraph (b) to read as
follows:
Sec. 1.555 Information material to patentability in ex parte
reexamination and inter partes reexamination proceedings.
* * * * *
(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.
* * * * *
Dated: July 15, 2011.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2011-18408 Filed 7-20-11; 8:45 am]
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