[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Proposed Rules]
[Pages 74987-74997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25966]
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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 Duty To Disclose Information in Patent
Applications and Reexamination Proceedings
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 revisions to the materiality standard for the duty to
disclose information in patent applications and reexamination
proceedings (duty of disclosure) in light of a 2011 decision by the
U.S. Court of Appeals for the Federal Circuit (Federal Circuit). The
Office previously issued a notice of proposed rulemaking on July 21,
2011, and due to the passage of time since the comment period closed in
2011, the Office considers it appropriate to seek additional comments
from our stakeholders before issuing a final rulemaking. In the current
notice of proposed rulemaking, the Office is seeking public comments on
the rules of practice, as revised in response to the comments received
from our stakeholders.
DATES: Comment Deadline Date: The Office is soliciting comments from
the public on this proposed rule change. Written comments must be
received on or before December 27, 2016 to ensure consideration. No
public hearing will be held.
ADDRESSES: Comments concerning this notice should be sent by electronic
mail message over the Internet (email) addressed to
[email protected]. Comments may also be submitted by postal mail
addressed to: Mail Stop Comments--Patents, Commissioner for Patents,
P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of
Matthew
[[Page 74988]]
Sked, Legal Advisor, Office of Patent Legal Administration, Office of
the Associate Commissioner for Patent Examination Policy. Comments may
also be sent by email 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.
Although comments may be submitted by postal mail, the Office
prefers to receive comments via email to facilitate posting on the
Office's Internet Web site. Plain text is preferred, but comments may
also be submitted in ADOBE[supreg] portable document format or
MICROSOFT WORD[supreg] format. Comments not submitted electronically
should be submitted on paper in a format that facilitates convenient
scanning into ADOBE[supreg] portable document format.
The comments will be available for public inspection, upon request,
at the Office of the Commissioner for Patents, located in Madison East,
Tenth Floor, 600 Dulany Street, Alexandria, Virginia. Comments also
will be available for viewing via the Office's Internet Web site
(http://www.uspto.gov) and at http://www.regulations.gov. Because
comments will be made available for public inspection, 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: Matthew J. Sked, Legal Advisor ((571)
272-7627) or Nicole Dretar Haines, Senior Legal Advisor ((571) 272-
7717), Office of Patent Legal Administration, Office of the Deputy
Commissioner for Patent Examination Policy.
SUPPLEMENTARY INFORMATION:
Executive Summary:
Purpose: This notice proposes changes to the relevant rules of
practice to harmonize the materiality standard for the duty of
disclosure before the Office 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).
Summary of Major Provisions: The Office proposes to revise the
rules of practice to adopt the but-for standard for materiality
required to establish inequitable conduct set forth in the Federal
Circuit's decision in Therasense as the standard for materiality for
the duty to disclose information in patent applications and
reexamination proceedings. The Office also proposes to revise the rules
of practice to explicitly reference ``affirmative egregious
misconduct'' as set forth in the Federal Circuit's decision in
Therasense.
Costs and Benefits: This rulemaking is not economically significant
as that term is defined in Executive Order 12866 (Sept. 30, 1993).
Background
On May 25, 2011, the Federal Circuit issued the en banc Therasense
decision, modifying the standard for materiality required to establish
inequitable conduct before the courts. The Federal Circuit tightened
the materiality standard to ``reduce the number of inequitable conduct
cases before the courts and . . . cure the problem of overdisclosure of
marginally relevant prior art to the PTO.'' Therasense, 649 F.3d at
1291. In Therasense, the Federal Circuit held that ``the materiality
required to establish inequitable conduct is but-for materiality.'' Id.
The Federal Circuit 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.'' Id. The Federal Circuit further explained that
``in 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. at 1291-92. Examples of where
the Federal Circuit found information to be but-for material include
Transweb, LLC v. 3M Innovative Properties Co., 812 F.3d 1295 (Fed. Cir.
2016), and Apotex, Inc. v. UCB Inc., 763 F.3d 1354 (Fed. Cir. 2014).
In addition, the Federal Circuit recognized that the materiality
prong of inequitable conduct may also be satisfied in cases of
affirmative egregious misconduct. Id. at 1292. See also The Ohio Willow
Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1351 (Fed. Cir. 2013);
Intellect Wireless, Inc. v. HTC Corp., 732 F.3d 1339, 1344 (Fed. Cir.
2013). The Federal Circuit explained that ``[t]his exception to the
general rule of requiring but-for proof incorporates elements of the
early unclean hands cases before the Supreme Court, which dealt with
`deliberately planned and carefully executed scheme[s]' to defraud the
PTO and the courts.'' Therasense, 649 F.3d at 1292. The Federal Circuit
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. Further, the Federal Circuit
clarified that while the filing of an unmistakably false affidavit
would constitute affirmative egregious misconduct, ``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. at 1292-93. Rather, ``claims of inequitable conduct
that are based on such omissions require proof of but-for
materiality.'' Id. at 1293.
A notice of proposed rulemaking was previously published in the
Federal Register (76 FR 43631) on July 21, 2011. Comments were due on
September 19, 2011. The Office received 24 written comments in response
to the notice. In addition to considering the public comments, the
Office monitored further Federal Circuit decisions regarding the
application of the inequitable conduct standard. Based upon the passage
of time since the end of the comment period and the significant changes
to patent law as a result of the successful implementation of the
Leahy-Smith America Invents Act, the Office considered it appropriate
to obtain public comment on the proposed changes to the rules of
practice regarding the duty of disclosure. Therefore, the Office is
publishing the current notice of proposed rulemaking to provide the
public with an opportunity to comment on the proposed revisions, which
take into account the comments received in response to the 2011 notice
of proposed rulemaking.
Like the previously proposed rule, the currently proposed rule
would harmonize the materiality standard for the duty of disclosure
before the Office with the but-for materiality standard set forth in
Therasense for establishing inequitable conduct before the courts.
Specifically, the currently proposed rule would modify 37 CFR 1.56(a)
and 37 CFR 1.555(a) to recite that the materiality standard for the
duty of disclosure is but-for materiality, and would modify 37 CFR
1.56(b) and 37 CFR 1.555(b) to define the but-for materiality standard
as set forth in Therasense. Further, in view of the Federal Circuit's
recognition that affirmative egregious misconduct satisfies the
materiality prong of inequitable conduct, the currently proposed rule
would amend 37 CFR 1.56(a) and 37 CFR 1.555(a) to explicitly
incorporate affirmative egregious misconduct.
In the previous notice of proposed rulemaking, the Office proposed
only to
[[Page 74989]]
amend 37 CFR 1.56(b) and 37 CFR 1.555(b) by combining in the same
provision both an explicit reference to the Therasense materiality
standard and a definition of the materiality standard, which included
an explicit recitation of affirmative egregious misconduct. See
Revision of the Materiality to Patentability Standard for the Duty to
Disclose Information in Patent Applications, 76 FR 43631, 43634 (July
21, 2011). Prior to making a final decision on whether to modify the
previously proposed rule, the Office considered all public comments and
monitored the petition for certiorari to the Supreme Court in 1st
Media, LLC v. Electronic Arts, Inc., 694 F.3d 1367 (Fed. Cir. 2012),
cert. denied, 134 S.Ct. 418 (2013) and the further developments
regarding the application of the inequitable conduct standard by the
Federal Circuit. Accordingly, the Office has decided to modify the
previously proposed rule language to avoid potential confusion by
moving the language regarding affirmative egregious misconduct from the
definition of the materiality standard for disclosure of information in
37 CFR 1.56(b)(2) and 37 CFR 1.555(b)(2), as previously proposed, to 37
CFR 1.56(a) and 37 CFR 1.555(a), respectively. Therefore, in the
currently proposed rule, 37 CFR 1.56(b) and 37 CFR 1.555(b) would
define the but-for materiality standard as set forth in Therasense,
while 37 CFR 1.56(a) and 37 CFR 1.555(a) would incorporate affirmative
egregious misconduct.
In the previous notice of proposed rulemaking, the Office also
proposed to amend 37 CFR 1.56(b) and 37 CFR 1.555(b) to explicitly
reference the Therasense ruling. Comments received in response to the
previous notice of proposed rulemaking questioned explicitly
referencing the Therasense decision directly in the rules out of
concern that the rules could be affected as the Therasense ruling is
interpreted and applied, or if Therasense is overruled. While the
currently proposed rule removes the explicit reference to the
Therasense decision, explicitly referencing the court decision is not
necessary to link the materiality standard for the duty of disclosure
before the Office with the but-for materiality standard set forth in
Therasense for establishing inequitable conduct before the courts. The
recitation of but-for materiality in 37 CFR 1.56(a) and 1.555(a) and
the definition of but-for materiality in 37 CFR 1.56(b) and 1.555(b)
would establish that 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.
As discussed previously, Therasense was decided by the Federal
Circuit en banc. This precedential decision can only be overturned by
another en banc decision of the Federal Circuit or by a decision of the
Supreme Court. See, e.g., Nobelpharma AB v. Implant Innovations, Inc.,
141 F.3d 1059, 1068 n.5 (Fed. Cir. 1998) (Federal Circuit precedent may
not be changed by a panel.). The Office's explicit reference to and
definition of the but-for materiality standard set forth in Therasense
in currently proposed 37 CFR 1.56 and 37 CFR 1.555 would avoid
divergence between the Office's materiality standard for the duty of
disclosure and the but-for inequitable conduct materiality standard set
forth in Therasense. This approach should benefit the public by
providing a consistent materiality standard without the need for
continuous revisions to the rules as the Therasense standard is
interpreted or applied. In the event the Supreme Court, or Federal
Circuit acting en banc, chooses to revise the but-for materiality
standard in Therasense, the Office will reconsider the rules at that
time. Further, the Office will 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).
Historically, the Federal Circuit connected the materiality
standard for inequitable conduct with the Office's materiality standard
for the duty of disclosure. That is, the Federal Circuit has invoked
the materiality standard for the duty of disclosure to measure
materiality in cases raising claims of inequitable conduct. In doing
so, the Federal Circuit has utilized both the ``reasonable examiner''
standard set forth in the 1977 version of 37 CFR 1.56(b) and the prima
facie case of unpatentability standard set forth in the 1992 version of
37 CFR 1.56(b). 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., Ltd., 394 F.3d 1348, 1352-53 (Fed. Cir.
2005). In Therasense, the Federal Circuit eliminated what existed of
the historical connection between the two materiality standards and did
not indicate that the Office must apply the but-for standard for
materiality required to establish inequitable conduct under Therasense
as the standard for determining materiality under 37 CFR 1.56 or 37 CFR
1.555. Thus, while Therasense does not require the Office to harmonize
its materiality standard underlying the duty of disclosure and the
Federal Circuit's but-for materiality standard underlying the
inequitable conduct doctrine, there are important reasons to amend 37
CFR 1.56 and 37 CFR 1.555 to do so.
A unitary materiality standard is simpler for the patent system as
a whole. Under the single but-for standard of materiality, patent
applicants will not be put in the position of having to meet one
standard of materiality as set forth in Therasense in defending against
inequitable conduct allegations and a second, different materiality
standard when complying with the duty of disclosure before the Office.
Also, the Office expects that by adopting the Therasense but-for
standard for materiality in this currently proposed rule, the frequency
with which charges of inequitable conduct are raised against applicants
and practitioners for failing to disclosure material information to the
Office will be reduced.
Similarly, the Office expects that adopting the but-for materiality
standard would reduce the incentive to submit marginally relevant
information in information disclosure statements (IDSs). As such, this
currently proposed rule would further the Office's goal of enhancing
patent quality. The adoption of the but-for standard for materiality
should lead to more focused prior art submissions by applicants, which
in turn will assist examiners in more readily recognizing the most
relevant prior art.
At the same time, the Office also expects this currently proposed
rule would continue to encourage applicants to comply with their duty
of candor and good faith. The Office recognizes that it previously
considered, and rejected, a but-for standard for the duty of disclosure
in 1992 when it promulgated the prima facie case of unpatentability
standard that would be replaced under this proposed rule. Duty of
Disclosure, 57 FR 2021, 2024 (Jan. 17, 1992). The Office was concerned
about the types of potential misconduct that could occur unchecked
under a pure but-for standard. By including a provision for affirmative
egregious misconduct in the currently proposed rule, the Office's long-
standing concern would be mitigated. In Therasense, the Federal Circuit
stated, ``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.'' Id. at 1293.
[[Page 74990]]
Discussion of Specific Rules
The following is a description of the amendments PTO is proposing:
Section 1.56: Section 1.56(a) as proposed to be amended would
provide that the materiality standard for the duty of disclosure is
but-for materiality. Further, Sec. 1.56(a) as proposed would provide
that a patent will not be granted on an application in which
affirmative egregious misconduct was engaged in.
Section 1.56(b) as proposed to be amended would replace the prima
facie case of unpatentability materiality standard with the definition
of the but-for materiality standard. As proposed, Sec. 1.56(b) would
provide that information is but-for material to patentability if 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.
Previously proposed Sec. 1.56(b) included two discrete sentences.
The first sentence stated information is material to patentability if
it is material under the standard set forth in Therasense, and the
second sentence stated information is material to patentability under
Therasense if (1) the Office would not allow a claim if it were aware
of the information, or (2) the applicant engages in affirmative
egregious misconduct before the Office as to the information. See
Revision of the Materiality to Patentability Standard for the Duty to
Disclose Information in Patent Applications, 76 FR at 43634. The
explicit reference to the Therasense decision and the recitation of
affirmative egregious misconduct in previously proposed Sec. 1.56(b)
have not been retained in this currently proposed rule in view of
public comments received. Currently proposed Sec. 1.56(a) now recites
that the materiality standard for the duty of disclosure is but-for
materiality. Currently proposed Sec. 1.56(b) defines the but-for
materiality standard as set forth in Therasense.
As set forth above, 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. The Office has determined that
reciting ``but-for material[ity]'' and its definition as it is recited
in Therasense makes clear that the standard for materiality is the but-
for standard set forth in Therasense and its interpretations and
applications. Also, by moving the language regarding affirmative
egregious misconduct from previously proposed Sec. 1.56(b)(2) to Sec.
1.56(a), the Office has separated the definition of the materiality
standard for the duty to disclose information from the recitation of
affirmative egregious misconduct.
Additionally, the Office has modified the previously proposed rule
language to state that a claim is given its broadest reasonable
construction ``consistent with the specification.'' The Office did not
intend the previously proposed omission of this language that is
present in existing Sec. Sec. 1.56(b) and 1.555(b) as an indication
that claims would no longer be given their broadest reasonable
construction consistent the specification. While the Federal Circuit in
Therasense did not specifically state that the broadest reasonable
construction is a construction that is consistent with the
specification, the Federal Circuit referenced MPEP Sec. 2111 (8th ed.
2001) (Rev. 9, Aug. 2012) in establishing that a claim is given its
broadest reasonable construction. Therasense, 649 F.3d at 1292. MPEP
Sec. 2111 states that ``(d)uring patent examination, the pending
claims must be `given their broadest reasonable interpretation
consistent with the specification.''' See also Phillips v. AWH Corp.,
415 F.3d 1303, 1316 (Fed. Cir. 2005) (``The Patent and Trademark Office
(`PTO') determines the scope of claims in patent applications not
solely on the basis of the claim language, but upon giving claims their
broadest reasonable construction `in light of the specification as it
would be interpreted by one of ordinary skill in the art.' ''). In
addition, the Federal Circuit has indicated that the phrases ``broadest
reasonable interpretation'' and ``broadest reasonable interpretation
consistent with the specification'' have the same meaning as it would
be unreasonable to ignore any interpretive guidance afforded by the
written description. See In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997). Nevertheless, in order to make clear that any construction made
by the Office in the application of Sec. 1.56 must be consistent with
the specification, the currently proposed rules have been amended
accordingly.
Section 1.555: Section 1.555(a) as proposed to be amended would
provide that the materiality standard for the duty of disclosure in a
reexamination proceeding is but-for materiality. Further, Sec.
1.555(a) as proposed to be amended would provide that the duties of
candor, good faith, and disclosure have not been complied with if
affirmative egregious misconduct was engaged in by, or on behalf of,
the patent owner in the reexamination proceeding.
Section 1.555(b) as proposed to be amended would provide that
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. The
explicit reference to the Therasense decision and recitation of
affirmative egregious misconduct in previously proposed Sec. 1.555(b)
have not been retained in this currently proposed rule in view of
public comments received. Currently proposed Sec. 1.555(a) now recites
that the materiality standard for the duty of disclosure in a
reexamination proceeding is but-for materiality. Currently proposed
Sec. 1.555(b) defines the but-for materiality standard as set forth in
Therasense.
Additionally, Sec. 1.555(b) as proposed would provide that the
but-for materiality standard covers the disclosure of information as to
any matter that is proper for consideration in a reexamination
proceeding. Previously proposed Sec. 1.555(b) was silent as to the
types of information that are appropriate for consideration in a
reexamination proceeding, and existing Sec. 1.555(b) limits the types
of information that could be considered in reexamination to patents and
printed publications. In view of public comments received, this
currently proposed rule would amend Sec. 1.555(b) to again recite the
types of information that are appropriate for consideration in a
reexamination proceeding but, unlike the existing rule, this currently
proposed rule encompasses disclosure of information as to any matter
that is appropriate for consideration in a reexamination proceeding
(e.g., admissions by patent owner), as opposed to being limited to
patents and printed publications.
It is noted that Sec. 1.933 is also directed to the duty of
disclosure in inter partes reexamination proceedings; however, the
statement as to materiality of information in Sec. 1.933 incorporates
Sec. 1.555. Thus, Sec. 1.933 has not been amended in this currently
proposed rule.
Comments and Response to Comments
The Office published a notice on July 21, 2011, proposing to change
the rules of practice to revise the standard for materiality of the
duty to disclose information in patent applications and
[[Page 74991]]
reexamination proceedings in light of the decision of the Federal
Circuit in Therasense. See Revision of the Materiality to Patentability
Standard for the Duty to Disclose Information in Patent Applications,
76 FR at 43631. The Office received 24 written comments (from
intellectual property organizations, academic and research
institutions, companies, and individuals) in response to that notice.
The comments and the Office's responses to the comments follow:
A. Previously Proposed Sec. Sec. 1.56(b)(1) and 1.555(b)(1)
B. Cumulative Information
C. Affirmative Egregious Misconduct
D. Therasense Language
E. General Language Comments
F. Application of Rule Standards
G. General Comments
A. Previously Proposed Sec. Sec. 1.56(b)(1) and 1.555(b)(1)
Comment 1: Several comments suggested amending previously proposed
Sec. Sec. 1.56(b)(1) and 1.555(b)(1) to add the phrase ``consistent
with the specification'' following the phrase ``broadest reasonable
construction'' to ensure the Office would be giving a claim its
broadest reasonable construction consistent with the specification.
Response: As discussed in the preamble, the Office has modified the
previously proposed rule language to add ``consistent with the
specification'' after ``broadest reasonable construction.''
Comment 2: One comment suggested amending previously proposed
Sec. Sec. 1.56(b)(1) and 1.555(b)(1) to change the perspective from
the present to the time when information was withheld from the Office.
In particular, this comment suggested changing the phrase ``would not
allow a claim if it were aware of the information'' in proposed Sec.
1.56(b)(1) to ``would not have allowed a claim if it were aware of the
information,'' and changing the phrase ``would not find a claim
patentable if it were aware of the information'' in proposed Sec.
1.555(b)(1) to ``would not have found a claim patentable if it were
aware of the information.'' Another comment requested clarification
regarding whether proposed Sec. Sec. 1.56(b)(1) and 1.555(b)(1) would
apply to any application pending on, or applications filed after, the
effective date of any final rule.
Response: While the first comment suggested specific language found
in the Therasense holding be added to the rules, the Therasense holding
pertains to inequitable conduct analysis by the courts, which is
applied from a different perspective than the duty of disclosure
analysis by applicants. The duty of disclosure is a prospective
analysis, while inequitable conduct is a retrospective analysis. In
other words, an applicant determines materiality in the present, not
retroactively as a court would determine inequitable conduct.
Additionally, with respect to Office proceedings, Sec. Sec. 1.56(b)
and 1.555(b) as proposed in this rule would apply to any application or
reexamination proceeding pending on, filed on, or filed after the
effective date of any final rule.
Comment 3: Several comments requested clarification regarding
whether ``a claim'' in proposed Sec. Sec. 1.56(b)(1) and 1.555(b)(1)
is the finally allowed claim or any claim pending during prosecution,
such as restricted claims, withdrawn claims, amended claims, etc.
Response: Currently proposed Sec. 1.56(a) explicitly states
``[t]he duty to disclose information exists with respect to each
pending claim until the claim is cancelled or withdrawn from
consideration, or the application becomes abandoned.'' Similarly, Sec.
1.555(a) states ``[t]he duty to disclose the information exists with
respect to each claim pending in the reexamination proceeding until the
claim is cancelled.'' Therefore, the duty of disclosure pertains to all
claims while they are pending. The duty does not pertain to information
that is only material to claims that have been cancelled or withdrawn.
B. Cumulative Information
Comment 4: Several comments suggested the rules maintain the
language from existing Sec. Sec. 1.56(b) and 1.555(b), which provide
that information is material to patentability ``when it is not
cumulative to information already of record or being made of record.''
Response: Sections 1.56 and 1.555 in this currently proposed rule
do not include the language regarding cumulative information set forth
in existing Sec. Sec. 1.56 and 1.555. The Office, however, is not
requesting that applicants submit cumulative information. Information
that is merely cumulative to information already on the record would
not be material under the but-for standard.
Comment 5: One comment stated that non-disclosed cumulative
information may meet the but-for test in the situation where the Office
erred in allowing a claim over the originally cited art and the
applicant is in possession of art that is cumulative to the originally
cited art.
Response: The applicant is under a duty to refrain from filing and
prosecuting claims that are known to be unpatentable whether based on
information already of record and not recognized by the examiner or
cumulative information not submitted. See Sec. Sec. 11.18, 11.301, and
11.303. In such an instance, the applicant should amend the claims
accordingly.
C. Affirmative Egregious Misconduct
Comment 6: Several comments stated that combining the but-for test
of Sec. Sec. 1.56(b)(1) and 1.555(b)(1) and the affirmative egregious
misconduct test of Sec. Sec. 1.56(b)(2) and 1.555(b)(2) in the
previously proposed rules will lead to confusion because the but-for
test involves the materiality of information while the ``affirmative
egregious misconduct'' test is related to the nature of the conduct.
Several comments, in particular, suggested moving the ``affirmative
egregious misconduct'' exception into Sec. Sec. 1.56(a) and 1.555(a).
Response: In order to alleviate any potential confusion by
including affirmative egregious misconduct in Sec. Sec. 1.56(b) and
1.555(b), this currently proposed rule amends Sec. Sec. 1.56 and 1.555
by moving the language regarding affirmative egregious misconduct from
previously proposed Sec. Sec. 1.56(b)(2) and 1.555(b)(2) to Sec. Sec.
1.56(a) and 1.555(a), respectively. In particular, Sec. 1.56(a) as
currently proposed would provide that a patent will not be granted on
an application where any individual associated with the filing or
prosecution of the application engages in affirmative egregious
misconduct. Section 1.555(a) as currently proposed would provide that
the duties of candor, good faith, and disclosure have not been complied
with if any individual associated with the patent owner in a
reexamination proceeding engages in affirmative egregious misconduct.
Thus, Sec. Sec. 1.56(b) and 1.555(b), as currently proposed, are
limited to defining the but-for materiality standard for the duty to
disclose information.
Comment 7: Several comments stated that the phrase ``affirmative
egregious misconduct'' in previously proposed rules Sec. Sec.
1.56(b)(2) and 1.555(b)(2) is a vague and undefined term and,
therefore, should not be included in the rules. In addition, several
comments requested that the Office incorporate the definition of
affirmative egregious misconduct from Therasense directly into the
rule. Several comments requested guidance, such as examples, on what
sort of conduct constitutes affirmative egregious misconduct in
previously proposed Sec. Sec. 1.56(b) and 1.555(b). One other comment
suggested
[[Page 74992]]
clarifying affirmative egregious misconduct to prevent affirmative
egregious misconduct from ``swallowing'' the but-for rule and requiring
affirmative egregious misconduct to have a realistic potential to
impact patentability. Several comments also stated that it is unclear
how affirmative egregious misconduct relates to the Office's other
rules such as Sec. Sec. 1.56(a) and 10.23. (While Sec. 10.23 was in
effect at the time the comment was made, it has since been removed and
Sec. 11.804 was adopted. See Changes to Representation of Others
Before The United States Patent and Trademark Office, 78 FR 20188 (Apr.
3, 2013).) These comments are applicable to the currently proposed
rules as well.
Response: As discussed previously, the Office has retained and
moved the recitation of affirmative egregious misconduct to currently
proposed Sec. Sec. 1.56(a) and 1.555(a). Affirmative egregious
misconduct is recited in currently proposed Sec. 1.56(a) in addition
to the other forms of misconduct that would preclude a patent from
being granted. Similarly, affirmative egregious misconduct is recited
in currently proposed Sec. 1.555(a) in addition to the other forms of
misconduct engaged in by, or on behalf of, the patent owner in the
reexamination proceeding that would cause a violation of the duties of
candor, good faith, and disclosure. The discussion of affirmative
egregious misconduct in Therasense and subsequent cases, as well as the
lengthy jurisprudence of the unclean hands doctrine, offers guidance as
to the boundaries of affirmative egregious misconduct. Specifically, in
Therasense, the Federal Circuit likened affirmative egregious
misconduct to the doctrine of unclean hands that ``dealt with
`deliberately planned and carefully executed scheme[s]' to defraud the
PTO and the courts.'' Therasense, 649 F.3d at 1292. The Federal Circuit
also described several examples of behavior that would constitute
affirmative egregious misconduct including ``perjury, the manufacture
of false evidence, and the suppression of evidence,'' as well as filing
an ``unmistakably false affidavit.'' Id. at 1287, 1292. See also The
Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d at 1351 (finding that
misrepresenting evidence to the Board of Patent Appeals and
Interferences was ``tantamount to filing an unmistakably false
affidavit''); Intellect Wireless, Inc. v. HTC Corp., 732 F.3d at 1344
(stating ``the materiality prong of inequitable conduct is met when an
applicant files a false affidavit and fails to cure the misconduct'').
The Federal Circuit clarified, however, 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.'' Therasense, 649 F.3d at 1292-93. Further, the Federal
Circuit has provided additional guidance on the type of activity that
would not constitute affirmative egregious misconduct. See, e.g.,
Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221, 1235 (Fed. Cir. 2011)
(failing to update a Petition to Make Special ``is not the type of
unequivocal act, `such as filing an unmistakably false affidavit,' that
would rise to the level of `affirmative egregious misconduct.' '').
Comment 8: Several comments suggested that acts of ``affirmative
egregious misconduct'' in previously proposed Sec. Sec. 1.56(b) and
1.555(b) should not be limited solely to ``the applicant.''
Response: The Office does not interpret the Federal Circuit's use
of ``patentee'' in Therasense when describing affirmative egregious
misconduct as limiting the misconduct to only the applicant or patent
owner. All of the parties identified in Sec. Sec. 1.56(c) and 1.555(a)
are subject to the affirmative egregious misconduct provisions of
currently proposed Sec. Sec. 1.56(a) and 1.555(a), respectively.
Comment 9: One comment suggested striking previously proposed Sec.
1.555(b)(2), which was directed to affirmative egregious misconduct, as
unnecessary. The comment asserts that the previously proposed rule
invites potential third party abuse and confusion during reexamination
since third parties will see the rule as a license to argue a lack of
candor with respect to previous patent holder submissions to the
Office.
Response: While the currently proposed rule no longer includes
Sec. 1.555(b)(2), the recitation of affirmative egregious misconduct
has been moved to currently proposed Sec. 1.555(a). As proposed, this
rule would address a patent owner's duty of candor and good faith in
dealing with the Office, including the patent owner's duty of
disclosure. It would not establish an opportunity in a reexamination
proceeding for a third party to challenge the duty of candor and good
faith of a patentee. Conduct is not grounds on which reexamination may
be requested and is not appropriate to be raised during a reexamination
proceeding. See MPEP Sec. 2616. The conduct of the patent owner may be
raised by the patent owner during a supplemental examination
proceeding. If the conduct of the patent owner is raised by the patent
owner in the supplemental examination proceeding, it may be addressed
by the Office in the supplemental examination proceeding and in any
reexamination proceeding resulting from that supplemental examination
proceeding.
D. Therasense Language
Comment 10: Several comments stated that the previously proposed
rules should not explicitly reference Therasense. The comments
questioned whether an explicit reference would allow the rules to
change as the Therasense standard changes or lock the Office into the
standard set forth in the decision even if the standard is later
changed. Further, the comments asserted that an explicit reference
creates uncertainty in the rules since the rules will become a moving
target not subject to interpretation on their face and that a rule
cannot be understood on its face without need to interpret the
Therasense decision. The comments also asserted that tying the rule to
an evolving standard will cause currently pending applications to stand
as test cases until the standard is fully articulated. Finally, the
comments asserted that the incorporation by reference sets a standard
based on private litigation where the Office is not a party and grants
an administrative agency's rulemaking authority to the judicial branch,
which has different goals than the Office.
Response: The currently proposed rules no longer include the
language addressed by the comment. Notwithstanding the removal of an
explicit reference to Therasense in currently proposed Sec. Sec.
1.56(b) and 1.555(b), the recitation of the but-for materiality
standard for the duty to disclose information in currently proposed
Sec. Sec. 1.56(b) and 1.555(b) accomplishes what a reference to the
court decision would accomplish in adopting the but-for standard set
forth in Therasense. As discussed previously, the Office has determined
that to adopt the but-for standard of materiality set forth in
Therasense, Sec. 1.56 need not incorporate a specific reference to the
court decision that has created that standard. Accordingly, the
reference to the Therasense court decision in Sec. 1.56, as previously
proposed, has not been retained in the currently proposed rule.
The reference to the but-for standard should benefit the public by
providing a consistent materiality standard for the duty to disclose
information without the need for continuous revisions to the rules as
the but-for standard in Therasense is interpreted or applied. As
discussed previously, Therasense was decided by the Federal Circuit en
banc
[[Page 74993]]
and can only be overturned by another en banc decision of the Federal
Circuit or by a decision of the Supreme Court. In the event that the
Supreme Court, or Federal Circuit acting en banc, chooses to revise the
but-for materiality standard set forth in Therasense, the Office will
reconsider the rules at that time.
Finally, the Office is not conveying its rulemaking authority to
the judicial branch. Instead, the Office is exercising its rulemaking
authority to adopt a standard used by the Federal Circuit. By using its
rulemaking authority to adopt a common standard, the Office is
providing the public with a uniform materiality standard for the duty
to disclose information. If the Office should determine the uniform
standard no longer provides a benefit to the public, the Office retains
the ability to invoke its rulemaking authority and change the rules at
any time.
Comment 11: One comment stated that the previously proposed rules
incorporate two alternative statements within the rules. Specifically,
the previously proposed rules include a first sentence that states that
information is material to patentability if it is material under the
standard set forth in Therasense and a second sentence that states
information is material to patentability under Therasense if (1) the
Office would not allow a claim if it were aware of the information, or
(2) the applicant engages in affirmative egregious misconduct before
the Office as to the information. The comment questioned whether these
two sentences were equivalent and, if they were, whether they would
remain equivalent as the Therasense decision evolves in the Federal
Circuit.
Response: As discussed previously, this currently proposed rule
modifies previously proposed Sec. Sec. 1.56(b) and 1.555(b) to remove
the sentence that explicitly references the Therasense decision.
Sections 1.56(b) and 1.555(b) in this currently proposed rule would
define the but-for materiality standard for the duty to disclose
information as set forth in Therasense.
E. General Language Comments
Comment 12: One comment suggested that previously proposed rule
Sec. 1.555(b) should preserve the language that patents and printed
publications are the appropriate types of information for consideration
in reexamination.
Response: As discussed previously, unlike existing Sec. 1.555(b),
which limits the types of information that could be considered in
reexamination to patents and printed publications, the currently
proposed rule broadly recites that it is applicable to any matter
proper for consideration in a reexamination (e.g., admissions by patent
owner as well as patents and printed publications).
Comment 13: Several comments asserted the previously proposed rules
are difficult for applicants to apply and interpret prospectively.
Specifically, the comments assert that the proposed rules require the
applicant to make legal conclusions in determining how to comply with
the rule.
Response: As stated in the previous notice of proposed rulemaking,
the Office recognizes the tension in basing the disclosure requirement
on unpatentability. See Revision of the Materiality to Patentability
Standard for the Duty to Disclose Information in Patent Applications,
76 FR at 43633. However, since the existing provisions of Sec. Sec.
1.56(b) and 1.555(b) require applicants to determine if there is a
prima facie case of unpatentability, applicants are accustomed to
making such determinations when complying with the duty of disclosure.
Further, the but-for standard set forth in this currently proposed rule
should not be any more difficult for applicants to apply during
prosecution than the prima facie case of unpatentability standard that
would be replaced by this currently proposed rule. Both standards
require the applicant to reassess materiality as claims are amended,
cancelled, and added. Lastly, the Office believes the but-for standard,
as articulated by the Federal Circuit in Therasense, would also provide
applicants with guidance on what information the applicant is required
to submit to the Office.
F. Application of Rule Standards
Comment 14: Several comments addressed the scope of evidence to be
considered when materiality or egregious misconduct determinations are
made by the Office during application of these proposed rules,
including whether the Office would take into account rebuttal evidence
or whether the scope would be limited to the record before the Office.
Response: The Office would utilize all available evidence when
making determinations of materiality or affirmative egregious
misconduct, including rebuttal evidence. Limiting determinations of
materiality or affirmative egregious misconduct to the record before
the Office might promote fraud and bad faith in practicing before the
Office and may lead to erroneous decisions.
Comment 15: Several comments requested the Office to stay Office of
Enrollment and Discipline (OED) proceedings until a final court
resolution regarding inequitable conduct is obtained in the courts.
Response: This currently proposed rule would only modify the
materiality standard for the duty of disclosure required in Sec. Sec.
1.56 and 1.555. OED proceedings are governed by procedures outlined in
37 CFR part 11, and the timeline under which the OED must commence
disciplinary proceedings is subject to 35 U.S.C. 32 as amended by the
America Invents Act (AIA). See Public Law 112-29, section 3(k), 125
Stat. 340, section 3(k) (2011).
G. General Comments
Comment 16: One comment proposed the Office tailor the discipline
for failing to comply with the duty of disclosure to sanctions other
than rendering patents unenforceable.
Response: The Office does not render a patent unenforceable for an
applicant's failure to comply with the duty of disclosure. Rather, a
court may hold a patent unenforceable due to inequitable conduct.
Comment 17: Several comments suggested proposing rules for
materiality for each new post-issuance proceeding under the America
Invents Act (AIA), such as post grant review, inter partes review, and
covered business method patents review. The comment suggested that,
since each post-issuance proceeding is different, separate materiality
standards may be necessary.
Response: This comment is outside the scope of this rulemaking. The
Office, however, has adopted Sec. 42.11 to govern the duty of candor
owed to the Office in the new post-issuance proceedings under the AIA.
Additionally, the existing regulations at Sec. 42.51 require a party
to serve relevant information that is inconsistent with a position
advanced during the proceedings.
Comment 18: Several comments asserted the Office should not require
applicants to explain or clarify the relationship of the prior art to
the claimed invention as suggested by the Office in the previous notice
of proposed rulemaking. See Revision of the Materiality to
Patentability Standard for the Duty to Disclose Information in Patent
Applications, 76 FR at 43632. In addition, several comments suggested
that, if the Office requires such an explanation, applicants should be
given a safe harbor so that such explanation would not be regarded as
an act of affirmative egregious misconduct.
Response: The contemplated required explanation from the previous
notice of proposed rulemaking addressed by the comment is not included
in this currently proposed rulemaking.
[[Page 74994]]
Comment 19: Several comments stated that the proposed but-for
standard for materiality will not reduce the incentive to submit
marginally relevant information to the Office. In addition, one comment
asserted that the stated rationale for the but-for standard does not
justify the rule change since the 1992 version of the rule, which
contained a prima facie case of unpatentability standard, did not
contribute to the over-disclosure to the Office or the overuse of
inequitable conduct in litigation. This comment stated that, as long as
the penalty for inequitable conduct is the loss of enforceability of
the patent, applicants will continue to submit voluminous amounts of
information to the Office to avoid a finding of inequitable conduct.
Response: The Office appreciates that a patent may be found
unenforceable due to a finding of inequitable conduct. However, the
Office's proposed adoption of the but-for standard of materiality
articulated by the Federal Circuit in the Therasense decision, as well
as the Therasense decision itself, should incentivize applicants not to
submit marginally relevant information to the Office as this
information would not meet the articulated standard.
Comment 20: Several comments requested that the Office no longer
require the cross-citation of prior art found in related applications.
The comments also requested the Office to provide a safe harbor
provision under which information from related applications is not
material and need not be submitted or, in the alternative, the
definition of a related application is limited to ``family cases''
(i.e., those cases for which there is some chain of priority claim),
``similar claims cases'' (i.e., those cases under a common obligation
of assignment for which the claims are not patentably distinct), and
``team exception cases'' (i.e., those cases for which the provisions of
35 U.S.C. 102(b)(2)(c) apply (35 U.S.C. 103(c) for pre-AIA
applications)).
Response: An applicant is under a duty of disclosure to provide all
known material information to the Office no matter how the applicant
becomes aware of the information. An applicant is in the best position
to know of any material information, especially when an applicant
learns about the information from prosecution in related applications
such as in applications for which priority or benefit is claimed.
Having all material information in front of the examiner as early as
possible will expedite prosecution and improve examination quality. But
under the standard in this currently proposed rule, an applicant would
be under no duty to provide information from related applications
unless that information is but-for material.
Comment 21: Several comments requested the Office provide a
standard method of cross-citation for information in related cases so
examiners will automatically review the information in the
corresponding application without the applicant having to submit the
information in an IDS.
Response: The Office is currently exploring an initiative to
provide examiners with information (e.g., prior art, search reports,
etc.) from applicant's related applications as early as possible to
increase patent examination quality and efficiency. In the interim,
applicants must comply with the requirements of Sec. Sec. 1.97 and
1.98.
Comment 22: Several comments suggested incentivizing the filing of
non-material disclosures. Essentially, the comments believed that the
submission of a reference will be interpreted as an admission that it
meets that materiality standard and, therefore, applicants will not
submit non-material information. As an incentive to submit non-material
information, the comments suggested relaxing or eliminating any
burdens, such as waiving fees.
Response: The Office does not construe any submission of
information as an admission of materiality. Section 1.97(h)
specifically states, ``[t]he filing of an information disclosure
statement shall not be construed to be an admission that the
information cited in the statement is, or is considered to be, material
to patentability as defined in Sec. 1.56(b).'' Therefore, the proposal
to incentivize the submission of non-material information is not
necessary.
Comment 23: One comment stated that, while the Office will not
regard information disclosures as admissions of unpatentability for any
claims in the application under Sec. 1.97(h), the Office does not have
the authority to make this promise on behalf of the courts. The comment
asserted that the courts will inevitably hold that any disclosure of
prior art is an admission that some pending claim is unpatentable.
Response: The comment did not provide any support for the asserted
proposition that the courts treat the disclosure of prior art as an
admission that at least one pending claim is unpatentable, and the
Office is not aware of any court decision with such a holding.
Comment 24: Several comments requested the duty of disclosure end
upon payment of the issue fee rather than the patent grant.
Response: It is in the applicant's and the public's best interest
to have all material information known to the applicant considered by
the examiner before a patent is granted. This will result in a stronger
patent and avoid unnecessary post-grant proceedings and litigation.
Section 1.97(d) thus provides for information to be submitted to the
Office after a final action, notice of allowance, or action that
otherwise closes prosecution is mailed, provided the IDS is filed on or
before payment of the issue fee and is accompanied by the appropriate
fee and statement under Sec. 1.97(e). If the conditions of Sec.
1.97(d) cannot be met, an applicant must file a request for continued
examination (RCE) to have information considered by the examiner.
Further, once the issue fee has been paid, the applicant must comply
with Sec. 1.313(c) (i.e., file a petition to withdraw from issue for
consideration of an RCE) in order to have information considered by the
examiner. In order to alleviate the burden on applicants in this
situation, the Office has instituted the Quick Path Information
Disclosure Statement (QPIDS) pilot program. The QPIDS pilot program
eliminates the requirement for processing an RCE with an IDS after
payment of the issue fee where the IDS is accompanied by the
appropriate fee and statement under Sec. 1.97(e) and the examiner
determines that no item of information in the IDS necessitates
reopening prosecution. For more information visit the QPIDS Web site at
www.uspto.gov/patents/init_events/qpids.jsp.
Comment 25: Several comments proposed giving an applicant a ``safe
harbor'' so the duty of disclosure for the applicant ends when the
applicant provides the information to counsel.
Response: The purpose of the duty of disclosure requirement is to
ensure that all material information known by the applicant is provided
to the Office in the manner prescribed by Sec. Sec. 1.97(b)-(d) and
1.98. Ending that duty upon the submission of the documents to counsel
could potentially delay or prevent material information from being
filed with the Office, resulting in, for example, a reduction in patent
quality or a delay in the patent grant.
Comment 26: Several comments requested the Office abrogate the duty
of disclosure. The comments provided numerous reasons, such as
harmonization with the patent offices that do not have such a duty. In
the alternative, several comments suggested modifying the materiality
standard to include only information that is not available to the
public because most of the information submitted is readily searchable
public information.
[[Page 74995]]
Response: The public interest is best served, and the most
effective and highest quality patent examination occurs, when the
Office is aware of, and evaluates the teachings of, all information
material to patentability during examination. Since the applicant is in
the best position to be aware of material information in the art, it
serves the public interest to require that the applicant submit this
information to the Office during examination. Even if this information
is publicly available, there is no guarantee that the examiner will
find the information. Further, requiring the examiner to locate this
information when the applicant is already aware of it unnecessarily
expends government resources, increases search time, and could reduce
examination quality. It is also noted that limiting materiality to
information that is not available to the public would essentially
abrogate the duty of disclosure because most information that is not
available to the public is unlikely to meet the prior art requirements
of 35 U.S.C. 102, hence preventing pertinent prior art from being seen
by the examiner.
Comment 27: One comment asked the Office to clarify whether the new
rules create any duty to investigate.
Response: Sections 1.56 and 1.555 in the currently proposed rule
would not create any new or additional duty to investigate. However,
practitioners and non-practitioners are reminded of the duty under
Sec. 11.18(b)(2) to make an ``inquiry reasonable under the
circumstances'' when presenting any paper to the Office.
Rulemaking Considerations
A. Administrative Procedure Act
This currently proposed rule would harmonize the rules of practice
concerning the materiality standard for the duty of disclosure with the
but-for materiality standard for inequitable conduct set forth in
Therasense. The changes in this currently proposed rule would not alter
the substantive criteria of patentability. Therefore, the changes in
this currently proposed rule involve rules of agency practice and
procedure and/or interpretive rules. See Bachow Commc'ns, Inc. v.
F.C.C., 237 F.3d 683, 690 (D.C. Cir. 2001) (Rules governing an
application process are procedural under the Administrative Procedure
Act.); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir.
2001) (Rules for handling appeals were procedural where they did not
change the substantive standard for reviewing claims.); Nat'l Org. of
Veterans' Advocates, Inc. v. Sec'y of Veterans Affairs, 260 F.3d 1365,
1375 (Fed. Cir. 2001) (Rule that clarifies interpretation of a statute
is interpretive.).
Accordingly, prior notice and opportunity for public comment are
not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law). See
Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008)
(stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not
require notice and comment rulemaking for ```interpretative rules,
general statements of policy, or rules of agency organization,
procedure, or practice''' (quoting 5 U.S.C. 553(b)(3)(A))). The Office,
however, is publishing the currently proposed rule for comment to seek
the benefit of the public's views on the Office's proposed revision of
the materiality standard for the duty to disclose information to the
Office.
B. 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 for the duty of disclosure with the
but-for materiality standard for inequitable conduct set forth in
Therasense. The harmonized materiality standard should reduce the
incentives to submit marginally relevant information in information
disclosure statements (IDSs). The changes in this currently proposed
rule involve rules of agency practice and procedure and/or interpretive
rules and would not result in any additional fees or requirements on
patent applicants or patentees. Therefore, the changes proposed in this
rulemaking will not have a significant economic impact on a substantial
number of small entities.
C. Executive Order 12866 (Regulatory Planning and Review)
This rulemaking has been determined to be not significant for
purposes of Executive Order 12866 (Sept. 30, 1993).
D. 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 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 rulemaking
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.
E. Executive Order 13132 (Federalism)
This rulemaking does not contain policies with federalism
implications sufficient to warrant preparation of a Federalism
Assessment under Executive Order 13132 (Aug. 4, 1999).
F. Executive Order 13175 (Tribal Consultation)
This rulemaking 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).
G. Executive Order 13211 (Energy Effects)
This rulemaking is not a significant energy action under Executive
Order 13211 because this rulemaking 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).
H. Executive Order 12988 (Civil Justice Reform)
This rulemaking 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).
I. Executive Order 13045 (Protection of Children)
This rulemaking does not concern an environmental risk to health or
safety that may disproportionately affect children under Executive
Order 13045 (Apr. 21, 1997).
J. Executive Order 12630 (Taking of Private Property)
This rulemaking will not effect a taking of private property or
otherwise have taking implications under Executive Order 12630 (Mar.
15, 1988).
[[Page 74996]]
K. 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 PTO will submit a report
containing this final rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the Government Accountability Office. The changes in this notice do
not 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).
L. Unfunded Mandates Reform Act of 1995
The changes 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.
M. National Environmental Policy Act
This rulemaking 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.
N. 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 rulemaking does not contain provisions which
involve the use of technical standards.
O. Paperwork Reduction Act
The changes in this rulemaking 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 final
rule has been reviewed and approved by OMB under OMB control number
0651-0031. This rulemaking proposes to harmonize the standard for
materiality under Sec. Sec. 1.56 and 1.555 for the duty of disclosure
with the but-for standard for materiality for inequitable conduct set
forth in Therasense. This notice does not adopt 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, Biologics, 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
0
1. The authority citation for 37 CFR part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.
0
2. Section 1.56 is amended by revising paragraphs (a) and (b) to read
as follows:
Sec. 1.56 Duty to disclose information material to patentability.
(a) A patent by its very nature is affected with a public interest.
The public interest is best served, and the most effective patent
examination occurs when, at the time an application is being examined,
the Office is aware of and evaluates the teachings of all information
material to patentability. 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. The duty to disclose information exists
with respect to each pending claim until the claim is cancelled or
withdrawn from consideration or the application becomes abandoned.
Information material to the patentability of a claim that is cancelled
or withdrawn from consideration need not be submitted if the
information is not material to the patentability of any claim remaining
under consideration in the application. There is no duty to submit
information which is not material to the patentability of any existing
claim. The duty to disclose all information known to be material to
patentability is deemed to be satisfied if all information known to be
material to patentability of any claim issued in a patent was cited by
the Office or submitted to the Office in the manner prescribed by
Sec. Sec. 1.97(b) through (d) and 1.98. 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. The Office encourages applicants to
carefully examine:
(1) Prior art cited in search reports of a foreign patent office in
a counterpart application, and
(2) The closest information over which individuals associated with
the filing or prosecution of a patent application believe any pending
claim patentably defines, to make sure that any material information
contained therein is disclosed to the Office.
(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.
* * * * *
0
3. Section 1.555 is amended by revising paragraphs (a) and (b) to read
as follows:
Sec. 1.555 Information material to patentability in ex parte
reexamination and inter partes reexamination proceedings.
(a) A patent by its very nature is affected with a public interest.
The public interest is best served, and the most effective
reexamination occurs when, at the time a reexamination proceeding is
being conducted, the Office is aware of and evaluates the teachings of
all information material to patentability in a reexamination
proceeding. 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. The individuals who have
[[Page 74997]]
a duty to disclose to the Office all information known to them to be
material to patentability in a reexamination proceeding are the patent
owner, each attorney or agent who represents the patent owner, and
every other individual who is substantively involved on behalf of the
patent owner in a reexamination proceeding. The duty to disclose the
information exists with respect to each claim pending in the
reexamination proceeding until the claim is cancelled. Information
material to the patentability of a cancelled claim need not be
submitted if the information is not material to patentability of any
claim remaining under consideration in the reexamination proceeding.
The duty to disclose all information known to be material to
patentability in a reexamination proceeding is deemed to be satisfied
if all information known to be material to patentability of any claim
in the patent after issuance of the reexamination certificate was cited
by the Office or submitted to the Office in an information disclosure
statement. 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. Any information disclosure statement must be filed with the
items listed in Sec. 1.98(a) as applied to individuals associated with
the patent owner in a reexamination proceeding and should be filed
within two months of the date of the order for reexamination or as soon
thereafter as possible.
(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.
* * * * *
Dated: October 21, 2016.
Michelle K. Lee,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2016-25966 Filed 10-27-16; 8:45 am]
BILLING CODE 3510-16-P