Changes To Eliminate Unnecessary Regulations, 2759-2762 [2018-00769]
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This draft guidance is
not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
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(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). Any
collection of information, including a
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III. Electronic Access
Persons with access to the internet
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https://www.fda.gov/Safety/Recalls/
default.htm or https://
www.regulations.gov.
Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00918 Filed 1–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF COMMERCE
United States Patent and Trademark
Office
37 CFR Parts 1 and 42
[Docket No.: PTO–P–2017–0034]
RIN 0651–AD25
Changes To Eliminate Unnecessary
Regulations
United States Patent and
Trademark Office, Commerce.
ACTION: Notice of proposed rulemaking.
AGENCY:
The United States Patent and
Trademark Office (USPTO or Office)
proposes to remove its regulations
governing reservation clauses, petitions
from the refusal of a primary examiner
to admit an amendment, the publication
of amendments to the regulations, and
limits that the Director can impose on
the number of inter partes reviews and
post-grant reviews heard by the Patent
Trial and Appeal Board. These
regulations are unnecessary or
superfluous and in some cases have
expired, and their removal will help
streamline USPTO’s body of regulations
without reducing the availability of
services for the public. This proposed
rule arises out of the USPTO’s work
during FY 2017 to identify and propose
regulations for removal, modification,
and streamlining because they are
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SUMMARY:
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outdated, unnecessary, ineffective,
costly, or unduly burdensome on the
agency or the private sector. The
revisions proposed herein would put
into effect the work the USPTO has
done, in part through its participation in
the Regulatory Reform Task Force
established by the Department of
Commerce pursuant to Executive Order
13777, to review and identify
regulations that are candidates for
removal.
DATES: Written comments must be
received on or before February 20, 2018.
ADDRESSES: Comments on the changes
set forth in this proposed rulemaking
should be sent by electronic mail
message to: AD25.comments@uspto.gov.
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
Raul Tamayo, Senior Legal Advisor,
Office of Patent Legal Administration.
Comments concerning ideas to improve,
revise, and streamline other USPTO
regulations, not discussed in this
proposed rulemaking, should be
submitted to: RegulatoryReformGroup@
uspto.gov.
Comments may also be submitted via
the Federal eRulemaking Portal at
https://www.regulations.gov. See the
Federal eRulemaking Portal website 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 by
electronic mail message over the
internet because the Office may easily
share such comments with the public.
Electronic comments are preferred to be
submitted in plain text, but also may be
submitted in ADOBE® portable
document format or MICROSOFT
WORD® format. Comments not
submitted electronically should be
submitted on paper in a format that
facilitates convenient digital scanning
into ADOBE® portable document
format.
The comments will be available for
public inspection at the Office of the
Commissioner for Patents, currently
located in Madison East, 600 Dulany
Street, Alexandria, Virginia. Comments
also will be available for viewing via the
Office’s internet website (https://
www.uspto.gov) and at https://
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.
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Raul
Tamayo, Senior Legal Advisor, Office of
Patent Legal Administration, at (571)
272–7728, for questions regarding the
changes to 37 CFR 1.79 and/or 1.127;
Susan L. C. Mitchell, Lead
Administrative Patent Judge, Patent
Trial and Appeal Board, at (571) 272–
8715, for questions regarding the
changes to 37 CFR part 42; and Nicolas
Oettinger, Senior Counsel for Regulatory
and Legislative Affairs, Office of the
General Counsel, at (571) 272–7832, for
questions regarding the change to 37
CFR 1.351 and general questions
regarding regulatory reform.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
In accordance with Executive Order
13777, ‘‘Enforcing the Regulatory
Reform Agenda,’’ the Department of
Commerce established a Regulatory
Reform Task Force (Task Force),
comprising, among others, agency
officials from the National Oceanic and
Atmospheric Administration, the
Bureau of Industry and Security, and
the USPTO, and charged the Task Force
with evaluating existing regulations and
identifying those that should be
repealed, replaced, or modified because
they are potentially outdated,
unnecessary, ineffective, costly, or
unduly burdensome to both government
and private sector operations.
To support its regulatory reform
efforts on the Task Force, the USPTO
assembled a Working Group on
Regulatory Reform (Working Group),
consisting of subject matter experts from
each of the business units that
implement the USPTO’s regulations, to
consider, review, and recommend ways
that the regulations could be improved,
revised, and streamlined. In considering
the revisions, the USPTO, through its
Working Group, incorporated into its
analyses all presidential directives
relating to regulatory reform. The
Working Group reviewed existing
regulations, both discretionary and
required by statute or judicial order. The
USPTO also solicited comments from
stakeholders through a web page
established to provide information on
the USPTO’s regulatory reform efforts,
and through the Department’s Federal
Register Notice titled ‘‘Impact of Federal
Regulations on Domestic
Manufacturing’’ (82 FR 12786, Mar. 7,
2017), which addressed the impact of
regulatory burdens on domestic
manufacturing. These efforts led to the
development of candidate regulations
for removal based on the USPTO’s
assessment that these regulations were
not needed and/or that elimination
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could improve the USPTO’s body of
regulations. To facilitate review and
public comment, the USPTO
consolidates and proposes in this rule
revisions to patent regulations in Part 1
and Patent Trial and Appeal Board
regulations in Part 42. Other proposals
to remove regulations on other subject
areas may be published separately.
II. Regulations Proposed for Removal
This proposed rulemaking would
remove regulations concerning
reservation clauses, petitions from the
refusal of a primary examiner to admit
an amendment, and publication of
amendments to the regulations in 37
CFR part 1. This proposed rulemaking
would also remove regulations
concerning limits that the Director can
impose on the number of inter partes
reviews and post-grant reviews in 37
CFR part 42.
In particular, this proposed
rulemaking would remove 37 CFR 1.79.
Section 1.79 prohibits reservation
clauses, i.e., it prohibits a pending
patent application from containing a
reservation for a future patent
application of subject matter disclosed
but not claimed in the pending
application. An applicant’s ability to
claim benefit of a prior application is
affirmatively provided elsewhere in
statute and regulation (as described
below), and the explicit prohibition of
§ 1.79 on reservation clauses (which do
not confer this benefit) dates from a time
when the mechanism for properly
claiming benefit of a prior application
was less clear and less fully developed
in USPTO’s regulations and guidance.
The proposed removal of § 1.79 is not an
endorsement of reservation clauses nor
an invitation for applicants to include
reservation clauses in applications. The
Office does not expect the use of
reservation clauses to significantly
increase once the proposed rulemaking
is made final, because such reservation
clauses provide no legal benefit,
regardless of § 1.79. For example, the
inclusion of a reservation clause in a
pending application would not change
any of the requirements for a future
application to benefit from the earlier
filing date of the pending application.
The authority for the future application
to benefit from the earlier filing date of
the pending application would stem, as
it does now, from the fulfillment of
requirements set forth in statutory and
regulatory provisions in which a
reservation clause plays no role, e.g., 35
U.S.C. 120 and 37 CFR 1.78. Nor would
the inclusion of a reservation clause
protect against rejections for statutory or
nonstatutory double patenting. In view
of the fact that the inclusion of a
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reservation clause provides no legal
benefit, and given that the affirmative
ability to claim benefit of a prior
application is more fully and
completely described elsewhere in
USPTO’s regulations and guidance
(unlike when § 1.79 was first adopted),
the prohibition of reservation clauses in
§ 1.79 is unnecessary.
Section 1.79 also permits a patent
application disclosing unclaimed
subject matter to contain a reference to
a later filed application of the same
applicant or owned by a common
assignee disclosing and claiming that
subject matter. This provision of § 1.79
is duplicative and therefore
unnecessary. 37 CFR 1.78 provides for
cross-references to other applications,
including cross-references to
applications for which a benefit is not
claimed, which encompasses the later
filed applications identified in § 1.79.
Thus, once the proposed rulemaking is
made final, applicants will continue to
be able to include in a pending
application a reference to a later filed
application as currently provided for in
§ 1.79.
This proposed rulemaking would
remove § 1.127, which also is
duplicative. Section 1.127 indicates that
a petition to the Director under 37 CFR
1.181 may be filed upon a refusal by a
primary examiner to admit an
amendment, in whole or in part. Section
1.127 is unnecessary. The language of
§ 1.181 makes clear that a refusal by a
primary examiner to admit an
amendment is petitionable under
§ 1.181. The Manual of Patent
Examining Procedure (9th ed. 2014)
(Rev. Nov. 2015) also makes this fact
clear in its discussion at section
1002.02(c). Thus, once the proposed
rulemaking is made final, applicants
will continue to be able to petition
under § 1.181 the refusal by a primary
examiner to admit an amendment, in
whole or in part.
This proposed rulemaking
additionally would remove 37 CFR
1.351. Section 1.351 states that all
amendments to the regulations in 37
CFR part 1 will be published in the
Official Gazette and in the Federal
Register. Section 1.351 is unnecessary.
In accordance with the requirements of
the Administrative Procedure Act (APA)
and guidance from the Office of
Management and Budget (OMB), the
Office publishes any amendments to 37
CFR part 1 in the Federal Register. The
APA generally requires the Office to
give public notice of any regulatory
change, and OMB’s guidance with
respect to rulemaking makes clear that
publication in the Federal Register is
the required means for giving public
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notice. Furthermore, the Office intends
to continue publishing all amendments
to the regulations in 37 CFR part 1 in
the Official Gazette. Thus, once the
proposed rulemaking is made final, the
Office will continue the practice of
publishing all amendments to the
regulations in 37 CFR part 1 in the
Federal Register, as required by OMB,
and in the Official Gazette.
Finally, this proposed rulemaking
would remove 37 CFR 42.102(b) and
42.202(b), both of which are now out of
date. Section 42.102(b) provides that the
Director may impose a limit on the
number of inter partes reviews that may
be instituted during each of the first four
one-year periods that the Leahy-Smith
America Invents Act (AIA) is in effect.
Section 42.202(b) has a similar
provision for post-grant reviews. Neither
rule remains necessary because the
fourth anniversary of the effective date
of the AIA has passed.
The regulations proposed in this rule
for removal achieve the objective of
making the USPTO’s regulations more
streamlined and less burdensome, while
enabling the USPTO to fulfill its
mission goals. The USPTO’s analysis
shows that removal of these regulations
is not expected to substantially reduce
the burden on the impacted community;
however, the regulations are
nonetheless being eliminated because
they are ‘‘outdated, unnecessary, or
ineffective’’ regulations encompassed by
the directives in Executive Order 13777.
III. Discussion of Proposed Rules
Changes
Part 1
Section 1.79: Section 1.79 is removed
and reserved.
Section 1.127: Section 1.127 is
removed and reserved.
Section 1.351: Section 1.351 is
removed and reserved.
Part 42
Section 42.102(b): Section 42.102(b) is
removed and reserved.
Section 42.202(b): Section 42.202(b) is
removed and reserved.
Rulemaking Considerations
A. Administrative Procedure Act: The
changes in this proposed rulemaking
involve rules of agency practice and
procedure, and/or interpretive rules. See
Perez v. Mortg. Bankers Ass’n, 135 S. Ct.
1199, 1204 (2015) (Interpretive rules
‘‘advise the public of the agency’s
construction of the statutes and rules
which it administers.’’ (citation and
internal quotation marks omitted)); Nat’l
Org. of Veterans’ Advocates v. Sec’y of
Veterans Affairs, 260 F.3d 1365, 1375
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(Fed. Cir. 2001) (Rule that clarifies
interpretation of a statute is
interpretive.); Bachow Commc’ns Inc. v.
FCC, 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.).
Accordingly, prior notice and
opportunity for public comment for the
changes in this proposed rulemaking are
not required pursuant to 5 U.S.C. 553(b)
or (c), or any other law. See Perez, 135
S. Ct. at 1206 (Notice-and-comment
procedures are required neither when
an agency ‘‘issue[s] an initial
interpretive rule’’ nor ‘‘when it amends
or repeals that interpretive rule.’’);
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)(A))). The Office, however, is
publishing these proposed changes for
comment as it seeks the benefit of the
public’s views on the Office’s proposed
implementation of the proposed rule
changes.
B. Regulatory Flexibility Act: For the
reasons set forth herein, Senior Counsel
for Regulatory and Legislative Affairs,
Office of General Law, of the USPTO,
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 proposed rule would remove the
provisions at 37 CFR 1.79, concerning
the prohibition of reservation clauses,
§ 1.127, concerning petitions from
refusal to admit amendment, and
§ 1.351, concerning the publication of
amendments to rules. These regulations
are removed because they are not
necessary. This rule would also remove
37 CFR 42.102(b) and 42.202(b), which
provide that the Director may impose a
limit on the number of inter partes
reviews and post-grant reviews that may
be instituted during each of the first four
one-year periods that the AIA is in
effect. These regulations are no longer
necessary because the fourth
anniversary of the effective date of the
AIA has passed.
Removing these regulations achieves
the objective of making the USPTO’s
regulations more effective and more
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streamlined, while enabling the USPTO
to fulfill its mission goals. The removal
of these regulations is not expected to
substantively impact parties as parties
would either continue to be able to take
the same action under a different
regulatory provision, or the rights or
obligations of the parties would not be
changed in any way. For these reasons,
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.
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 and
applicable: (1) Made a reasoned
determination that the benefits justify
the costs of the rule; (2) tailored the rule
to impose the least burden on society
consistent with obtaining the regulatory
objectives; (3) selected a regulatory
approach that maximizes net benefits;
(4) specified performance objectives; (5)
identified and assessed available
alternatives; (6) 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; (7) attempted to
promote coordination, simplification,
and harmonization across government
agencies and identified goals designed
to promote innovation; (8) considered
approaches that reduce burdens and
maintain flexibility and freedom of
choice for the public; and (9) ensured
the objectivity of scientific and
technological information and
processes.
E. Executive Order 13771 (Reducing
Regulation and Controlling Regulatory
Costs): This proposed rule is expected to
be an Executive Order 13771
deregulatory action.
F. 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).
G. 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
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required under Executive Order 13175
(Nov. 6, 2000).
H. 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).
I. 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).
J. 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).
K. Executive Order 12630 (Taking of
Private Property): This rulemaking will
not affect a taking of private property or
otherwise have taking implications
under Executive Order 12630 (Mar. 15,
1988).
L. 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 USPTO will
submit a report containing the final rule
and other required information to the
United States Senate, the United States
House of 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 foreignbased 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).
M. Unfunded Mandates Reform Act of
1995: The changes set forth 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
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necessary under the provisions of the
Unfunded Mandates Reform Act of
1995. See 2 U.S.C. 1501 et seq.
N. National Environmental Policy
Act: This rulemaking will not have any
effect on the quality of the environment
and is thus categorically excluded from
review under the National
Environmental Policy Act of 1969. See
42 U.S.C. 4321 et seq.
O. 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 that involve the
use of technical standards.
P. Paperwork Reduction Act: The
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.) requires that the
Office consider the impact of paperwork
and other information collection
burdens imposed on the public. This
rulemaking does not involve an
information collection that is subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3549).
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.
37 CFR Part 1
Administrative practice and
procedure, Courts, Freedom of
Information, Inventions and patents,
Reporting and recordkeeping
requirements, Small businesses.
PART 1—RULES OF PRACTICE IN
PATENT CASES
1. The authority citation for part 1
continues to read as follows:
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■
Authority: 35 U.S.C. 2(b)(2).
[Removed and reserved]
2. Section 1.79 is removed and
reserved.
■
[Removed and reserved]
3. Section 1.127 is removed and
reserved.
■
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PART 42—TRIAL PRACTICE BEFORE
THE PATENT TRIAL AND APPEAL
BOARD
5. The authority citation for part 42
continues to read as follows:
■
Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41,
135, 311, 312, 316, 321–326 and Public Law
112–29, 125 Stat. 284; and Pub. L. 112–274,
126 Stat. 2456.
§ 42.102
[Amended]
6. Amend § 42.102 by removing and
reserving paragraph (b).
■
§ 42.202
[Amended]
7. Amend § 42.202 by removing and
reserving paragraph (b).
■
Dated: January 11, 2018.
Joseph Matal,
Associate Solicitor, performing the functions
and duties of the Under Secretary of
Commerce for Intellectual Property and
Director of the United States Patent and
Trademark Office.
[FR Doc. 2018–00769 Filed 1–18–18; 8:45 am]
BILLING CODE 3510–16–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 1
RIN 2900–AP90
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Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) proposes to amend its
regulations to clarify that a valid
consent authorizing the Department to
release the patient’s confidential VA
medical records to a health information
exchange (HIE) community partner may
be established not only by VA’s physical
possession of the written consent form,
but also by the HIE community partner’s
written (electronic) attestation that the
patient has, in fact, provided such
consent. This proposed rule would be a
reinterpretation of an existing, longstanding regulation and is necessary to
facilitate modern requirements for the
sharing of patient records with
community health care providers,
health plans, governmental agencies,
and other entities participating in
electronic HIEs. This revision would
ensure that more community health care
providers and other HIE community
partners can deliver informed medical
SUMMARY:
37 CFR Part 42
Administrative practice and
procedure, Inventions and patents.
For the reasons stated in the
preamble, the Office proposes to amend
parts 1 and 42 of title 37 as follows:
§ 1.127
[Removed and reserved]
4. Section 1.351 is removed and
reserved.
■
Consent for Release of VA Medical
Records
List of Subjects
§ 1.79
§ 1.351
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care to patients by having access to the
patient’s VA medical records at the
point of care.
DATES: Comment Date: Comments must
be received on or before March 20, 2018.
ADDRESSES: Written comments may be
submitted through
www.Regulations.gov; by mail or handdelivery to Director, Regulation Policy
and Management (00REG), Department
of Veterans Affairs, 810 Vermont
Avenue NW, Room 1063B, Washington,
DC 20420; or by fax to (202) 273–9026.
Comments should indicate that they are
submitted in response to ‘‘RIN 2900–
AP90 Consent for Release of VA
Medical Records.’’ Copies of comments
received will be available for public
inspection in the Office of Regulation
Policy and Management, Room 1063B,
between the hours of 8:00 a.m. and 4:30
p.m., Monday through Friday (except
holidays). Please call (202) 461–4902 for
an appointment. (This is not a toll-free
number.) In addition, during the
comment period, comments may be
viewed online through the Federal
Docket Management System (FDMS) at
www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Stephania Griffin, Director, Veterans
Health Administration Information
Access and Privacy Office, Department
of Veterans Affairs, 810 Vermont
Avenue NW, Washington, DC 20420;
Stephania.griffin@va.gov, (704) 245–
2492 (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: Under 38
U.S.C. 7332, VA must keep confidential
all records of identity, diagnosis,
prognosis, or treatment of a patient in
connection with any program or activity
carried out by VA related to drug abuse,
alcoholism or alcohol abuse, infection
with human immunodeficiency virus, or
sickle cell anemia, and must obtain
patients’ written consent before VA may
disclose the protected information
unless authorized by the statute. This
requirement applies to communications
between VA and community health care
providers for the purposes of treatment,
except in certain situations, for instance
in medical emergencies and when the
records are sent to a non-Department
entity that provides hospital care to
patients as authorized by the Secretary.
38 U.S.C. 7332(b)(2)(A) and (H); Public
Law 115–26 (April 19, 2017). Although
section 7332 does not explicitly require
that the written consent physically be in
VA’s possession at the time of the
disclosure, VA had interpreted the
statute to require such possession, and
therefore applied 38 CFR 1.475
consistent with that interpretation. VA
has reexamined that statutory
interpretation in light of contemporary
E:\FR\FM\19JAP1.SGM
19JAP1
Agencies
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Proposed Rules]
[Pages 2759-2762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00769]
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DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
37 CFR Parts 1 and 42
[Docket No.: PTO-P-2017-0034]
RIN 0651-AD25
Changes To Eliminate Unnecessary Regulations
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 (USPTO or
Office) proposes to remove its regulations governing reservation
clauses, petitions from the refusal of a primary examiner to admit an
amendment, the publication of amendments to the regulations, and limits
that the Director can impose on the number of inter partes reviews and
post-grant reviews heard by the Patent Trial and Appeal Board. These
regulations are unnecessary or superfluous and in some cases have
expired, and their removal will help streamline USPTO's body of
regulations without reducing the availability of services for the
public. This proposed rule arises out of the USPTO's work during FY
2017 to identify and propose regulations for removal, modification, and
streamlining because they are outdated, unnecessary, ineffective,
costly, or unduly burdensome on the agency or the private sector. The
revisions proposed herein would put into effect the work the USPTO has
done, in part through its participation in the Regulatory Reform Task
Force established by the Department of Commerce pursuant to Executive
Order 13777, to review and identify regulations that are candidates for
removal.
DATES: Written comments must be received on or before February 20,
2018.
ADDRESSES: Comments on the changes set forth in this proposed
rulemaking should be sent by electronic mail message 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
Raul Tamayo, Senior Legal Advisor, Office of Patent Legal
Administration. Comments concerning ideas to improve, revise, and
streamline other USPTO regulations, not discussed in this proposed
rulemaking, should be submitted to: [email protected].
Comments may also be submitted via the Federal eRulemaking Portal
at https://www.regulations.gov. See the Federal eRulemaking Portal
website 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 by electronic mail
message over the internet because the Office may easily share such
comments with the public. Electronic comments are preferred to be
submitted in plain text, but also may 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 digital scanning into ADOBE[supreg] portable
document format.
The comments will be available for public inspection at the Office
of the Commissioner for Patents, currently located in Madison East, 600
Dulany Street, Alexandria, Virginia. Comments also will be available
for viewing via the Office's internet website (https://www.uspto.gov)
and at https://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: Raul Tamayo, Senior Legal Advisor,
Office of Patent Legal Administration, at (571) 272-7728, for questions
regarding the changes to 37 CFR 1.79 and/or 1.127; Susan L. C.
Mitchell, Lead Administrative Patent Judge, Patent Trial and Appeal
Board, at (571) 272-8715, for questions regarding the changes to 37 CFR
part 42; and Nicolas Oettinger, Senior Counsel for Regulatory and
Legislative Affairs, Office of the General Counsel, at (571) 272-7832,
for questions regarding the change to 37 CFR 1.351 and general
questions regarding regulatory reform.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with Executive Order 13777, ``Enforcing the
Regulatory Reform Agenda,'' the Department of Commerce established a
Regulatory Reform Task Force (Task Force), comprising, among others,
agency officials from the National Oceanic and Atmospheric
Administration, the Bureau of Industry and Security, and the USPTO, and
charged the Task Force with evaluating existing regulations and
identifying those that should be repealed, replaced, or modified
because they are potentially outdated, unnecessary, ineffective,
costly, or unduly burdensome to both government and private sector
operations.
To support its regulatory reform efforts on the Task Force, the
USPTO assembled a Working Group on Regulatory Reform (Working Group),
consisting of subject matter experts from each of the business units
that implement the USPTO's regulations, to consider, review, and
recommend ways that the regulations could be improved, revised, and
streamlined. In considering the revisions, the USPTO, through its
Working Group, incorporated into its analyses all presidential
directives relating to regulatory reform. The Working Group reviewed
existing regulations, both discretionary and required by statute or
judicial order. The USPTO also solicited comments from stakeholders
through a web page established to provide information on the USPTO's
regulatory reform efforts, and through the Department's Federal
Register Notice titled ``Impact of Federal Regulations on Domestic
Manufacturing'' (82 FR 12786, Mar. 7, 2017), which addressed the impact
of regulatory burdens on domestic manufacturing. These efforts led to
the development of candidate regulations for removal based on the
USPTO's assessment that these regulations were not needed and/or that
elimination
[[Page 2760]]
could improve the USPTO's body of regulations. To facilitate review and
public comment, the USPTO consolidates and proposes in this rule
revisions to patent regulations in Part 1 and Patent Trial and Appeal
Board regulations in Part 42. Other proposals to remove regulations on
other subject areas may be published separately.
II. Regulations Proposed for Removal
This proposed rulemaking would remove regulations concerning
reservation clauses, petitions from the refusal of a primary examiner
to admit an amendment, and publication of amendments to the regulations
in 37 CFR part 1. This proposed rulemaking would also remove
regulations concerning limits that the Director can impose on the
number of inter partes reviews and post-grant reviews in 37 CFR part
42.
In particular, this proposed rulemaking would remove 37 CFR 1.79.
Section 1.79 prohibits reservation clauses, i.e., it prohibits a
pending patent application from containing a reservation for a future
patent application of subject matter disclosed but not claimed in the
pending application. An applicant's ability to claim benefit of a prior
application is affirmatively provided elsewhere in statute and
regulation (as described below), and the explicit prohibition of Sec.
1.79 on reservation clauses (which do not confer this benefit) dates
from a time when the mechanism for properly claiming benefit of a prior
application was less clear and less fully developed in USPTO's
regulations and guidance. The proposed removal of Sec. 1.79 is not an
endorsement of reservation clauses nor an invitation for applicants to
include reservation clauses in applications. The Office does not expect
the use of reservation clauses to significantly increase once the
proposed rulemaking is made final, because such reservation clauses
provide no legal benefit, regardless of Sec. 1.79. For example, the
inclusion of a reservation clause in a pending application would not
change any of the requirements for a future application to benefit from
the earlier filing date of the pending application. The authority for
the future application to benefit from the earlier filing date of the
pending application would stem, as it does now, from the fulfillment of
requirements set forth in statutory and regulatory provisions in which
a reservation clause plays no role, e.g., 35 U.S.C. 120 and 37 CFR
1.78. Nor would the inclusion of a reservation clause protect against
rejections for statutory or nonstatutory double patenting. In view of
the fact that the inclusion of a reservation clause provides no legal
benefit, and given that the affirmative ability to claim benefit of a
prior application is more fully and completely described elsewhere in
USPTO's regulations and guidance (unlike when Sec. 1.79 was first
adopted), the prohibition of reservation clauses in Sec. 1.79 is
unnecessary.
Section 1.79 also permits a patent application disclosing unclaimed
subject matter to contain a reference to a later filed application of
the same applicant or owned by a common assignee disclosing and
claiming that subject matter. This provision of Sec. 1.79 is
duplicative and therefore unnecessary. 37 CFR 1.78 provides for cross-
references to other applications, including cross-references to
applications for which a benefit is not claimed, which encompasses the
later filed applications identified in Sec. 1.79. Thus, once the
proposed rulemaking is made final, applicants will continue to be able
to include in a pending application a reference to a later filed
application as currently provided for in Sec. 1.79.
This proposed rulemaking would remove Sec. 1.127, which also is
duplicative. Section 1.127 indicates that a petition to the Director
under 37 CFR 1.181 may be filed upon a refusal by a primary examiner to
admit an amendment, in whole or in part. Section 1.127 is unnecessary.
The language of Sec. 1.181 makes clear that a refusal by a primary
examiner to admit an amendment is petitionable under Sec. 1.181. The
Manual of Patent Examining Procedure (9th ed. 2014) (Rev. Nov. 2015)
also makes this fact clear in its discussion at section 1002.02(c).
Thus, once the proposed rulemaking is made final, applicants will
continue to be able to petition under Sec. 1.181 the refusal by a
primary examiner to admit an amendment, in whole or in part.
This proposed rulemaking additionally would remove 37 CFR 1.351.
Section 1.351 states that all amendments to the regulations in 37 CFR
part 1 will be published in the Official Gazette and in the Federal
Register. Section 1.351 is unnecessary. In accordance with the
requirements of the Administrative Procedure Act (APA) and guidance
from the Office of Management and Budget (OMB), the Office publishes
any amendments to 37 CFR part 1 in the Federal Register. The APA
generally requires the Office to give public notice of any regulatory
change, and OMB's guidance with respect to rulemaking makes clear that
publication in the Federal Register is the required means for giving
public notice. Furthermore, the Office intends to continue publishing
all amendments to the regulations in 37 CFR part 1 in the Official
Gazette. Thus, once the proposed rulemaking is made final, the Office
will continue the practice of publishing all amendments to the
regulations in 37 CFR part 1 in the Federal Register, as required by
OMB, and in the Official Gazette.
Finally, this proposed rulemaking would remove 37 CFR 42.102(b) and
42.202(b), both of which are now out of date. Section 42.102(b)
provides that the Director may impose a limit on the number of inter
partes reviews that may be instituted during each of the first four
one-year periods that the Leahy-Smith America Invents Act (AIA) is in
effect. Section 42.202(b) has a similar provision for post-grant
reviews. Neither rule remains necessary because the fourth anniversary
of the effective date of the AIA has passed.
The regulations proposed in this rule for removal achieve the
objective of making the USPTO's regulations more streamlined and less
burdensome, while enabling the USPTO to fulfill its mission goals. The
USPTO's analysis shows that removal of these regulations is not
expected to substantially reduce the burden on the impacted community;
however, the regulations are nonetheless being eliminated because they
are ``outdated, unnecessary, or ineffective'' regulations encompassed
by the directives in Executive Order 13777.
III. Discussion of Proposed Rules Changes
Part 1
Section 1.79: Section 1.79 is removed and reserved.
Section 1.127: Section 1.127 is removed and reserved.
Section 1.351: Section 1.351 is removed and reserved.
Part 42
Section 42.102(b): Section 42.102(b) is removed and reserved.
Section 42.202(b): Section 42.202(b) is removed and reserved.
Rulemaking Considerations
A. Administrative Procedure Act: The changes in this proposed
rulemaking involve rules of agency practice and procedure, and/or
interpretive rules. See Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199,
1204 (2015) (Interpretive rules ``advise the public of the agency's
construction of the statutes and rules which it administers.''
(citation and internal quotation marks omitted)); Nat'l Org. of
Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375
[[Page 2761]]
(Fed. Cir. 2001) (Rule that clarifies interpretation of a statute is
interpretive.); Bachow Commc'ns Inc. v. FCC, 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.).
Accordingly, prior notice and opportunity for public comment for
the changes in this proposed rulemaking are not required pursuant to 5
U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206
(Notice-and-comment procedures are required neither when an agency
``issue[s] an initial interpretive rule'' nor ``when it amends or
repeals that interpretive rule.''); 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)(A))). The Office, however, is publishing these proposed
changes for comment as it seeks the benefit of the public's views on
the Office's proposed implementation of the proposed rule changes.
B. Regulatory Flexibility Act: For the reasons set forth herein,
Senior Counsel for Regulatory and Legislative Affairs, Office of
General Law, of the USPTO, 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 proposed rule would remove the provisions at 37 CFR 1.79,
concerning the prohibition of reservation clauses, Sec. 1.127,
concerning petitions from refusal to admit amendment, and Sec. 1.351,
concerning the publication of amendments to rules. These regulations
are removed because they are not necessary. This rule would also remove
37 CFR 42.102(b) and 42.202(b), which provide that the Director may
impose a limit on the number of inter partes reviews and post-grant
reviews that may be instituted during each of the first four one-year
periods that the AIA is in effect. These regulations are no longer
necessary because the fourth anniversary of the effective date of the
AIA has passed.
Removing these regulations achieves the objective of making the
USPTO's regulations more effective and more streamlined, while enabling
the USPTO to fulfill its mission goals. The removal of these
regulations is not expected to substantively impact parties as parties
would either continue to be able to take the same action under a
different regulatory provision, or the rights or obligations of the
parties would not be changed in any way. For these reasons, 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.
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 and applicable:
(1) Made a reasoned determination that the benefits justify the costs
of the rule; (2) tailored the rule to impose the least burden on
society consistent with obtaining the regulatory objectives; (3)
selected a regulatory approach that maximizes net benefits; (4)
specified performance objectives; (5) identified and assessed available
alternatives; (6) 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; (7) attempted to
promote coordination, simplification, and harmonization across
government agencies and identified goals designed to promote
innovation; (8) considered approaches that reduce burdens and maintain
flexibility and freedom of choice for the public; and (9) ensured the
objectivity of scientific and technological information and processes.
E. Executive Order 13771 (Reducing Regulation and Controlling
Regulatory Costs): This proposed rule is expected to be an Executive
Order 13771 deregulatory action.
F. 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).
G. 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).
H. 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).
I. 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).
J. 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).
K. Executive Order 12630 (Taking of Private Property): This
rulemaking will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630 (Mar. 15, 1988).
L. 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 USPTO
will submit a report containing the final rule and other required
information to the United States Senate, the United States House of
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).
M. Unfunded Mandates Reform Act of 1995: The changes set forth 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
[[Page 2762]]
necessary under the provisions of the Unfunded Mandates Reform Act of
1995. See 2 U.S.C. 1501 et seq.
N. National Environmental Policy Act: This rulemaking will not have
any effect on the quality of the environment and is thus categorically
excluded from review under the National Environmental Policy Act of
1969. See 42 U.S.C. 4321 et seq.
O. 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 that involve the use of
technical standards.
P. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.) requires that the Office consider the impact of
paperwork and other information collection burdens imposed on the
public. This rulemaking does not involve an information collection that
is subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549).
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
37 CFR Part 1
Administrative practice and procedure, Courts, Freedom of
Information, Inventions and patents, Reporting and recordkeeping
requirements, Small businesses.
37 CFR Part 42
Administrative practice and procedure, Inventions and patents.
For the reasons stated in the preamble, the Office proposes to
amend parts 1 and 42 of title 37 as follows:
PART 1--RULES OF PRACTICE IN PATENT CASES
0
1. The authority citation for part 1 continues to read as follows:
Authority: 35 U.S.C. 2(b)(2).
Sec. 1.79 [Removed and reserved]
0
2. Section 1.79 is removed and reserved.
Sec. 1.127 [Removed and reserved]
0
3. Section 1.127 is removed and reserved.
Sec. 1.351 [Removed and reserved]
0
4. Section 1.351 is removed and reserved.
PART 42--TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD
0
5. The authority citation for part 42 continues to read as follows:
Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, 135, 311, 312, 316,
321-326 and Public Law 112-29, 125 Stat. 284; and Pub. L. 112-274,
126 Stat. 2456.
Sec. 42.102 [Amended]
0
6. Amend Sec. 42.102 by removing and reserving paragraph (b).
Sec. 42.202 [Amended]
0
7. Amend Sec. 42.202 by removing and reserving paragraph (b).
Dated: January 11, 2018.
Joseph Matal,
Associate Solicitor, performing the functions and duties of the Under
Secretary of Commerce for Intellectual Property and Director of the
United States Patent and Trademark Office.
[FR Doc. 2018-00769 Filed 1-18-18; 8:45 am]
BILLING CODE 3510-16-P