Interim Procedure for Requesting Recalculation of the Patent Term Adjustment With Respect to Information Disclosure Statements Accompanied by a Safe Harbor Statement, 55102-55104 [2018-24004]
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Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Rules and Regulations
compliance, please contact the person
listed in the FOR FURTHER INFORMATION
CONTACT section.
Small businesses may send comments
on the actions of Federal employees
who enforce, or otherwise determine
compliance with, Federal regulations to
the Small Business and Agriculture
Regulatory Enforcement Ombudsman
and the Regional Small Business
Regulatory Fairness Boards. The
Ombudsman evaluates these actions
annually and rates each agency’s
responsiveness to small business. If you
wish to comment on actions by
employees of the Coast Guard, call 1–
888–REG–FAIR (1–888–734–3247). The
Coast Guard will not retaliate against
small entities that question or complain
about this rule or any policy or action
of the Coast Guard.
C. Collection of Information
This rule will not call for a new
collection of information under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520).
D. Federalism and Indian Tribal
Governments
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government. We have
analyzed this rule under that Order and
have determined that it is consistent
with the fundamental federalism
principles and preemption requirements
described in Executive Order 13132.
Also, this rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have a substantial
direct effect on one or more Indian
tribes, on the relationship between the
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or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes. If you
believe this rule has implications for
federalism or Indian tribes, please
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section
above.
E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
Federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
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$100,000,000 (adjusted for inflation) or
more in any one year. Though this rule
will not result in such an expenditure,
we do discuss the effects of this rule
elsewhere in this preamble.
F. Environment
We have analyzed this rule under
Department of Homeland Security
Directive 023–01 and Commandant
Instruction M16475.1D, which guide the
Coast Guard in complying with the
National Environmental Policy Act of
1969 (42 U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves a safety
zone lasting less than 30 days that will
prohibit vessel traffic to transit between
Columbia River Mile 142 and 143
during diving and vessel recovery
operations. It is categorically excluded
from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023–01–001–01,
Rev. 01. A Record of Environmental
Consideration supporting this
determination is available in the docket
where indicated under ADDRESSES.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to contact the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
2. Add § 165.T13–0998 to read as
follows:
■
§ 165.T13–0998 Safety Zone; Columbia
River, Cascade Locks, OR.
(a) Location. The following area is
designated safety zone: All navigable
waters of the Columbia River, from
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surface to bottom, between river mile
142 and 143.
(b) Regulations. In accordance with
the general regulations in 33 CFR part
165, subpart C, no person may enter or
remain in the safety zone created in this
section or bring, cause to be brought, or
allow to remain in the safety zone
created in this section any vehicle,
vessel, or object unless authorized by
the Captain of the Port or his designated
representative.
(2) To seek permission to enter,
contact Derrick Barge DB 125 or tug
RUTH via VHF–FM marine channel 14.
Those in the safety zone must comply
with all lawful orders or directions
given to them by the COTP or the
COTP’s designated representative.
(c) Enforcement period. This safety
zone is in effect from 7 a.m. until 5 p.m.
on October 27, 2018 through November
16, 2018. It will be subject to
enforcement this entire period unless
the Captain of the Port, Columbia River
(COTP) determines it is no longer
needed. The Coast Guard will inform
mariners of any change to this period of
enforcement via Broadcast Notice to
Mariners.
Dated: October 26, 2018.
D.F. Berliner,
Captain, U.S. Coast Guard, Acting Captain
of the Port Sector Columbia River.
[FR Doc. 2018–23955 Filed 11–1–18; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No. PTO–P–2018–0030]
Interim Procedure for Requesting
Recalculation of the Patent Term
Adjustment With Respect to
Information Disclosure Statements
Accompanied by a Safe Harbor
Statement
United States Patent and
Trademark Office, Commerce.
ACTION: Notification of interim
procedure.
AGENCY:
The patent laws provide for
patent term adjustment in the event that
the issuance of the patent is delayed due
to certain enumerated administrative
delays. The USPTO makes the patent
term adjustment determination included
on the patent by a computer program
that uses the information recorded in
the USPTO’s Patent Application
Locating and Monitoring (PALM)
system. The USPTO will be modifying
SUMMARY:
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Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Rules and Regulations
its computer program that calculates
patent term adjustment to recognize
when an applicant files an information
disclosure statement concurrently with
a safe harbor statement. In order to
assist both applicants and the USPTO,
the USPTO is providing a new form for
applicants to use when making a safe
harbor statement. The USPTO is also
establishing an interim procedure and
providing a form for patentees to request
a recalculation of their patent term
adjustment determination for alleged
errors due to the USPTO’s failure to
recognize that an information disclosure
statement was accompanied by a safe
harbor statement.
DATES: Effective Date: This procedure is
effective November 2, 2018.
FOR FURTHER INFORMATION CONTACT: Kery
A. Fries, Senior Legal Advisor, Office of
Patent Legal Administration, Office of
Deputy Commissioner for Patent
Examination Policy, by telephone at
(571) 272–7757, or by mail addressed to:
Mail Stop Comments-Patents,
Commissioner for Patents, P.O. Box
1450, Alexandria, VA 22313–1450.
SUPPLEMENTARY INFORMATION: The
American Inventors Protection Act of
1999 or AIPA (Pub. L. 106–113, 113
Stat. 1501, 1501A–552 through 1501A–
591 (1999)) amended 35 U.S.C. 154(b) to
provide for patent term adjustment in
the event that the issuance of the patent
is delayed due to one or more of the
enumerated administrative delays listed
in 35 U.S.C. 154(b)(1). Under the patent
term adjustment provisions of the AIPA,
a patentee generally is entitled to patent
term adjustment for the following
reasons: (1) If the USPTO fails to take
certain actions during the examination
and issue process within specified time
frames (35 U.S.C. 154(b)(1)(A)); (2) if the
USPTO fails to issue a patent within
three years of the actual filing date of
the application (35 U.S.C. 154(b)(1)(B));
and (3) for delays due to interference or
derivation proceedings, secrecy orders,
or successful appellate review (35
U.S.C. 154(b)(1)(C)). See 35 U.S.C.
154(b)(1). The AIPA, however, sets forth
a number of conditions and limitations
on any patent term adjustment accrued
under 35 U.S.C. 154(b)(1). Specifically,
35 U.S.C. 154(b)(2)(C) provides, in part,
that ‘‘[t]he period of adjustment of the
term of a patent under [35 U.S.C.
154(b)(1)] shall be reduced by a period
equal to the period of time during which
the applicant failed to engage in
reasonable efforts to conclude
prosecution of the application’’ and that
‘‘[t]he Director shall prescribe
regulations establishing the
circumstances that constitute a failure of
an applicant to engage in reasonable
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efforts to conclude processing or
examination of an application.’’ 35
U.S.C. 154(b)(2)(C)(i) and (iii). The
USPTO implemented the patent term
adjustment provisions of the AIPA in a
final rule published in September of
2000. See Changes to Implement Patent
Term Adjustment Under Twenty-Year
Patent Term, 65 FR 56365 (Sept. 18,
2000) (final rule).
The ‘‘regulations establishing the
circumstances that constitute a failure of
an applicant to engage in reasonable
efforts to conclude processing or
examination of an application’’ (35
U.S.C. 154(b)(2)(C)(iii)) are set forth in
37 CFR 1.704. 37 CFR 1.704 provides for
a reduction of any patent term
adjustment if an information disclosure
statement (1) is filed after a notice of
allowance or after an initial reply by the
applicant; or (2) is filed as a preliminary
paper or paper after a decision by the
Board or Federal court that requires the
USPTO to issue a supplemental Office
action. See 37 CFR 1.704(c)(6),
1.704(c)(8), 1.704(c)(9), and 1.704(c)(10).
37 CFR 1.704 also provides for a
reduction of any patent term adjustment
if a request for continued examination is
filed after the mailing of a notice of
allowance. See 37 CFR 1.704(c)(12).
37 CFR 1.704(d), however, provides
that a paper containing only an
information disclosure statement in
compliance with 37 CFR 1.97 and 1.98
will not be considered a failure to
engage in reasonable efforts to conclude
prosecution (processing or examination)
of the application under 37 CFR
1.704(c)(6), (c)(8), (c)(9), or (c)(10) if the
information disclosure statement is
accompanied by one of the statements
set forth in 37 CFR 1.704(d)(1)(i) or
(d)(1)(ii) (a ‘‘safe harbor statement’’).
Similarly, 37 CFR 1.704(d) also provides
that a request for continued examination
in compliance with 37 CFR 1.114
containing only an information
disclosure statement in compliance with
37 CFR 1.97 and 1.98 will not be
considered a failure to engage in
reasonable efforts to conclude
prosecution (processing or examination)
of the application under 37 CFR
1.704(c)(12) if the information
disclosure statement included in request
for continued examination is
accompanied by a safe harbor statement.
Thus, unless the information disclosure
statement is accompanied by a safe
harbor statement in compliance with 37
CFR 1.704(d), 37 CFR 1.704 provides for
a reduction of any patent term
adjustment if an information disclosure
statement (1) is filed after a notice of
allowance or after an initial reply by the
applicant; or (2) is filed as a preliminary
paper or paper after a decision by the
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55103
Board or Federal court that requires the
USPTO to issue a supplemental Office
action. See 37 CFR 1.704(c)(6),
1.704(c)(8), 1.704(c)(9), and (c)(10).
Similarly, unless the submission for a
request for continued examination after
a notice of allowance has been mailed
is solely an information disclosure
statement and it is accompanied by a
safe harbor statement in compliance
with 37 CFR 1.704(d), 37 CFR 1.704
provides for a reduction of any patent
term adjustment if a request for
continued examination is filed after the
mailing of a notice of allowance. See 37
CFR 1.704(c)(12).
A proper safe harbor statement under
37 CFR 1.704(d) must state that each
item of information contained in the
information disclosure statement: (1)
Was first cited in any communication
from a patent office in a counterpart
foreign or international application or
from the USPTO, and this
communication was not received by any
individual designated in 37 CFR 1.56(c)
more than thirty days prior to the filing
of the information disclosure statement
(37 CFR 1.704(d)(1)(i)); or (2) is a
communication that was issued by a
patent office in a counterpart foreign or
international application or by the
USPTO, and this communication was
not received by any individual
designated in 37 CFR 1.56(c) more than
thirty days prior to the filing of the
information disclosure statement (37
CFR 1.704(d)(1)(ii)).
The USPTO performs an automated
calculation of how much patent term
adjustment, if any, is due to a patentee
using the information recorded in the
USPTO’s PALM system, except when a
patentee requests reconsideration
pursuant to 37 CFR 1.705. See Changes
to Implement Patent Term Adjustment
under Twenty-Year Patent Term, 65 FR
56365, 56370, 56380–81 (Sept. 18, 2000)
(final rule). Currently, the computer
program used for this automated
calculation cannot determine whether a
compliant safe harbor statement under
37 CFR 1.704(d) accompanied an
information disclosure statement. Thus,
this computer program calculates the
patent term adjustment total as if no
compliant safe harbor statement under
37 CFR 1.704(d) was made. As the
USPTO develops its next generation
information technology (IT) systems that
will address this problem, the USPTO is
introducing an interim procedure for
patentees to request a patent term
adjustment recalculation when a safe
harbor statement pursuant to 37 CFR
1.704(d) was filed, and a new form for
applicants to use when making a safe
harbor statement.
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Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Rules and Regulations
Interim Procedure for Requesting
Recalculation: The USPTO has created
the following interim procedure by
which a patentee may request
recalculation of patent term adjustment
where the sole reason for contesting the
patent term adjustment determination is
the USPTO’s failure to recognize a
timely filed safe harbor statement
accompanying an information
disclosure statement. The USPTO’s
interim procedure waives the fee under
37 CFR 1.705(b)(1) as set forth in 37 CFR
1.18(e) to file the request for
reconsideration. The interim procedure
will remain in effect until the USPTO
can update the patent term adjustment
computer program and provide notice to
the public that the computer program
has been updated.
Under the interim procedure,
recalculation of patent term adjustment
is requested by submitting a form in lieu
of the request and fee set forth in 37 CFR
1.705(b). This form, ‘‘Request for
Reconsideration of Patent Term
Adjustment in View of Safe Harbor
Statement Under 37 CFR 1.704(d)’’
(PTO/SB/134) will be available on the
USPTO website at https://
www.uspto.gov/patent/patents-forms.
The Office of Management and Budget
(OMB) has determined that, under 5
CFR 1320.3(h), Form PTO/SB/134 does
not collect ‘‘information’’ within the
meaning of the Paperwork Reduction
Act of 1995. The form must be filed
within the time period set forth in 37
CFR 1.705(b), and the USPTO will not
grant any request for recalculation of the
patent term adjustment that is not
timely filed. The time period set forth
set forth in 37 CFR 1.705(b) may be
extended under the provisions of 37
CFR 1.136(a).
If the request for recalculation is not
based solely on the USPTO’s failure to
recognize a timely filed, compliant safe
harbor statement under 37 CFR 1.704(d),
the patentee must file a request for
reconsideration of the patent term
adjustment indicated on the patent
under 37 CFR 1.705(b) with the fee set
forth in 37 CFR 1.18(e). If a patentee
files both form PTO/SB/134 and a
request under 37 CFR 1.705(b) prior to
the USPTO’s recalculation of patent
term adjustment, the USPTO will treat
the papers as a request for
reconsideration of the patent term
adjustment indicated on the patent
under 37 CFR 1.705(b) and charge the
fee set forth in 37 CFR 1.18(e).
While the USPTO’s interim procedure
waives the fee under 37 CFR 1.705(b)(1)
as set forth in 37 CFR 1.18(e) to file the
PTO/SB/134, it does not waive any
extensions of time fees due under 37
CFR 1.705(b) and 1.136. In addition, it
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is noted that the fee specified in 37 CFR
1.18(e) is required for a request for
reconsideration under 37 CFR 1.705,
and the USPTO may only refund fees
paid by mistake or in excess of that
required (35 U.S.C. 42(d)). Thus, the
interim procedure set forth in this
document is not a basis for requesting
a refund of the fee specified in 37 CFR
1.18(e) for any request for
reconsideration under 37 CFR 1.705,
including any previously filed request
that was solely based on the USPTO’s
error in assessing a reduction to the
amount of patent term adjustment under
37 CFR 1.704(c)(6), (c)(8), (c)(9), (c)(10),
or (c)(12) for the submission of an
information disclosure statement that
was accompanied by the statement
under 37 CFR 1.704(d).
The Office of Petitions will manually
review the request for recalculation of
patent term adjustment filed under the
interim procedure. Specifically, the
Office of Petitions will review the
accuracy of the patent term adjustment
calculation in view of regulations
37 CFR 1.702 through 1.704 as part of
the recalculation. Upon review by the
Office of Petitions, the patentee will be
given one opportunity to respond to the
recalculation. The response must be
filed by patentee within two months of
the mail date of the recalculation. No
extensions of time will be granted. If
patentee responds to the recalculation
by requesting changes to the
recalculation not related to the safe
harbor statement, patentee must comply
with the requirements of 37 CFR
1.705(b)(1) and (2).
If patentee fails to respond to the
recalculation and the USPTO’s
determination of the amount of
recalculated patent term adjustment is
different from that printed on the front
of the patent, the USPTO will sua
sponte issue a certificate of correction
that reflects the recalculated patent term
adjustment. If patentee files a timely
response after the USPTO’s
recalculation and the USPTO maintains
its recalculation, the USPTO will issue
its decision confirming its recalculation
pursuant to 35 U.S.C. 154(b)(3)(B)(ii),
and this decision is the Director’s
decision under 35 U.S.C. 154(b)(4). The
USPTO’s initial recalculation of patent
term adjustment under the procedure
outlined in this document is not the
Director’s decision under 35 U.S.C.
154(b)(4).
New Form for Applicants to Use when
Making a Statement Pursuant to 37 CFR
1.704(d): In order to aid in recognizing
when a compliant safe harbor statement
under 37 CFR 1.704(d) has been filed
with an information disclosure
statement, the USPTO has created a
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form titled, ‘‘Patent Term Adjustment
Statement under 37 CFR 1.704(d)’’
(PTO/SB/133) for applicant’s use when
submitting the information disclosure
statement. The USPTO is planning to
update the patent term adjustment
computer program to recognize when
form PTO/SB/133 has been filed. Once
updated, the patent term adjustment
computer program will perform the
patent term calculation by taking into
account that applicant filed a compliant
safe harbor statement under 37 CFR
1.704(d) when it performs the patent
term adjustment calculation. When
applicant provides the safe harbor
statement with the information
disclosure statement, use of form
PTO/SB/133 is not required, but it is
very strongly recommended as the
failure to use this form may result in the
patent term adjustment calculation not
taking into account that such a
statement was filed. The form will be
available on the USPTO’s website at
https://www.uspto.gov/patent/patentsforms. The Office of Management and
Budget (OMB) has determined that,
under
5 CFR 1320.3(h), form PTO/SB/133 does
not collect ‘‘information’’ within the
meaning of the Paperwork Reduction
Act of 1995.
Applicants who submit form PTO/SB/
133 with an information disclosure
statement will be considered to be
making a proper safe harbor statement,
and the filing will be reflected in the file
record. Applicants may not alter the
pre-printed text of form PTO/SB/133.
The presentation to the USPTO
(whether by signing, filing, submitting,
or later advocating) of any USPTO form
with text identifying the form as a
USPTO-generated form by a party,
whether a practitioner or nonpractitioner, constitutes a certification
under 37 CFR 11.18(b) that the existing
text and any certifications or statements
on the form have not been altered other
than permitted by EFS-Web
customization. See 37 CFR 1.4(d)(3). As
a result of using the form, the USPTO’s
computer program, once updated, will
take the safe harbor statement into
account when patent term adjustment is
calculated, thereby eliminating the need
to file a request for reconsideration of
patent term adjustment under 37 CFR
1.705(b) for this matter.
Dated: October 30, 2018.
Andrei Iancu,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2018–24004 Filed 11–1–18; 8:45 am]
BILLING CODE 3510–16–P
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]]>Agencies
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Rules and Regulations]
[Pages 55102-55104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24004]
=======================================================================
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No. PTO-P-2018-0030]
Interim Procedure for Requesting Recalculation of the Patent Term
Adjustment With Respect to Information Disclosure Statements
Accompanied by a Safe Harbor Statement
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notification of interim procedure.
-----------------------------------------------------------------------
SUMMARY: The patent laws provide for patent term adjustment in the
event that the issuance of the patent is delayed due to certain
enumerated administrative delays. The USPTO makes the patent term
adjustment determination included on the patent by a computer program
that uses the information recorded in the USPTO's Patent Application
Locating and Monitoring (PALM) system. The USPTO will be modifying
[[Page 55103]]
its computer program that calculates patent term adjustment to
recognize when an applicant files an information disclosure statement
concurrently with a safe harbor statement. In order to assist both
applicants and the USPTO, the USPTO is providing a new form for
applicants to use when making a safe harbor statement. The USPTO is
also establishing an interim procedure and providing a form for
patentees to request a recalculation of their patent term adjustment
determination for alleged errors due to the USPTO's failure to
recognize that an information disclosure statement was accompanied by a
safe harbor statement.
DATES: Effective Date: This procedure is effective November 2, 2018.
FOR FURTHER INFORMATION CONTACT: Kery A. Fries, Senior Legal Advisor,
Office of Patent Legal Administration, Office of Deputy Commissioner
for Patent Examination Policy, by telephone at (571) 272-7757, or by
mail addressed to: Mail Stop Comments-Patents, Commissioner for
Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
SUPPLEMENTARY INFORMATION: The American Inventors Protection Act of
1999 or AIPA (Pub. L. 106-113, 113 Stat. 1501, 1501A-552 through 1501A-
591 (1999)) amended 35 U.S.C. 154(b) to provide for patent term
adjustment in the event that the issuance of the patent is delayed due
to one or more of the enumerated administrative delays listed in 35
U.S.C. 154(b)(1). Under the patent term adjustment provisions of the
AIPA, a patentee generally is entitled to patent term adjustment for
the following reasons: (1) If the USPTO fails to take certain actions
during the examination and issue process within specified time frames
(35 U.S.C. 154(b)(1)(A)); (2) if the USPTO fails to issue a patent
within three years of the actual filing date of the application (35
U.S.C. 154(b)(1)(B)); and (3) for delays due to interference or
derivation proceedings, secrecy orders, or successful appellate review
(35 U.S.C. 154(b)(1)(C)). See 35 U.S.C. 154(b)(1). The AIPA, however,
sets forth a number of conditions and limitations on any patent term
adjustment accrued under 35 U.S.C. 154(b)(1). Specifically, 35 U.S.C.
154(b)(2)(C) provides, in part, that ``[t]he period of adjustment of
the term of a patent under [35 U.S.C. 154(b)(1)] shall be reduced by a
period equal to the period of time during which the applicant failed to
engage in reasonable efforts to conclude prosecution of the
application'' and that ``[t]he Director shall prescribe regulations
establishing the circumstances that constitute a failure of an
applicant to engage in reasonable efforts to conclude processing or
examination of an application.'' 35 U.S.C. 154(b)(2)(C)(i) and (iii).
The USPTO implemented the patent term adjustment provisions of the AIPA
in a final rule published in September of 2000. See Changes to
Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR
56365 (Sept. 18, 2000) (final rule).
The ``regulations establishing the circumstances that constitute a
failure of an applicant to engage in reasonable efforts to conclude
processing or examination of an application'' (35 U.S.C.
154(b)(2)(C)(iii)) are set forth in 37 CFR 1.704. 37 CFR 1.704 provides
for a reduction of any patent term adjustment if an information
disclosure statement (1) is filed after a notice of allowance or after
an initial reply by the applicant; or (2) is filed as a preliminary
paper or paper after a decision by the Board or Federal court that
requires the USPTO to issue a supplemental Office action. See 37 CFR
1.704(c)(6), 1.704(c)(8), 1.704(c)(9), and 1.704(c)(10). 37 CFR 1.704
also provides for a reduction of any patent term adjustment if a
request for continued examination is filed after the mailing of a
notice of allowance. See 37 CFR 1.704(c)(12).
37 CFR 1.704(d), however, provides that a paper containing only an
information disclosure statement in compliance with 37 CFR 1.97 and
1.98 will not be considered a failure to engage in reasonable efforts
to conclude prosecution (processing or examination) of the application
under 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10) if the information
disclosure statement is accompanied by one of the statements set forth
in 37 CFR 1.704(d)(1)(i) or (d)(1)(ii) (a ``safe harbor statement'').
Similarly, 37 CFR 1.704(d) also provides that a request for continued
examination in compliance with 37 CFR 1.114 containing only an
information disclosure statement in compliance with 37 CFR 1.97 and
1.98 will not be considered a failure to engage in reasonable efforts
to conclude prosecution (processing or examination) of the application
under 37 CFR 1.704(c)(12) if the information disclosure statement
included in request for continued examination is accompanied by a safe
harbor statement. Thus, unless the information disclosure statement is
accompanied by a safe harbor statement in compliance with 37 CFR
1.704(d), 37 CFR 1.704 provides for a reduction of any patent term
adjustment if an information disclosure statement (1) is filed after a
notice of allowance or after an initial reply by the applicant; or (2)
is filed as a preliminary paper or paper after a decision by the Board
or Federal court that requires the USPTO to issue a supplemental Office
action. See 37 CFR 1.704(c)(6), 1.704(c)(8), 1.704(c)(9), and (c)(10).
Similarly, unless the submission for a request for continued
examination after a notice of allowance has been mailed is solely an
information disclosure statement and it is accompanied by a safe harbor
statement in compliance with 37 CFR 1.704(d), 37 CFR 1.704 provides for
a reduction of any patent term adjustment if a request for continued
examination is filed after the mailing of a notice of allowance. See 37
CFR 1.704(c)(12).
A proper safe harbor statement under 37 CFR 1.704(d) must state
that each item of information contained in the information disclosure
statement: (1) Was first cited in any communication from a patent
office in a counterpart foreign or international application or from
the USPTO, and this communication was not received by any individual
designated in 37 CFR 1.56(c) more than thirty days prior to the filing
of the information disclosure statement (37 CFR 1.704(d)(1)(i)); or (2)
is a communication that was issued by a patent office in a counterpart
foreign or international application or by the USPTO, and this
communication was not received by any individual designated in 37 CFR
1.56(c) more than thirty days prior to the filing of the information
disclosure statement (37 CFR 1.704(d)(1)(ii)).
The USPTO performs an automated calculation of how much patent term
adjustment, if any, is due to a patentee using the information recorded
in the USPTO's PALM system, except when a patentee requests
reconsideration pursuant to 37 CFR 1.705. See Changes to Implement
Patent Term Adjustment under Twenty-Year Patent Term, 65 FR 56365,
56370, 56380-81 (Sept. 18, 2000) (final rule). Currently, the computer
program used for this automated calculation cannot determine whether a
compliant safe harbor statement under 37 CFR 1.704(d) accompanied an
information disclosure statement. Thus, this computer program
calculates the patent term adjustment total as if no compliant safe
harbor statement under 37 CFR 1.704(d) was made. As the USPTO develops
its next generation information technology (IT) systems that will
address this problem, the USPTO is introducing an interim procedure for
patentees to request a patent term adjustment recalculation when a safe
harbor statement pursuant to 37 CFR 1.704(d) was filed, and a new form
for applicants to use when making a safe harbor statement.
[[Page 55104]]
Interim Procedure for Requesting Recalculation: The USPTO has
created the following interim procedure by which a patentee may request
recalculation of patent term adjustment where the sole reason for
contesting the patent term adjustment determination is the USPTO's
failure to recognize a timely filed safe harbor statement accompanying
an information disclosure statement. The USPTO's interim procedure
waives the fee under 37 CFR 1.705(b)(1) as set forth in 37 CFR 1.18(e)
to file the request for reconsideration. The interim procedure will
remain in effect until the USPTO can update the patent term adjustment
computer program and provide notice to the public that the computer
program has been updated.
Under the interim procedure, recalculation of patent term
adjustment is requested by submitting a form in lieu of the request and
fee set forth in 37 CFR 1.705(b). This form, ``Request for
Reconsideration of Patent Term Adjustment in View of Safe Harbor
Statement Under 37 CFR 1.704(d)'' (PTO/SB/134) will be available on the
USPTO website at https://www.uspto.gov/patent/patents-forms.
The Office of Management and Budget (OMB) has determined that,
under 5 CFR 1320.3(h), Form PTO/SB/134 does not collect ``information''
within the meaning of the Paperwork Reduction Act of 1995. The form
must be filed within the time period set forth in 37 CFR 1.705(b), and
the USPTO will not grant any request for recalculation of the patent
term adjustment that is not timely filed. The time period set forth set
forth in 37 CFR 1.705(b) may be extended under the provisions of 37 CFR
1.136(a).
If the request for recalculation is not based solely on the USPTO's
failure to recognize a timely filed, compliant safe harbor statement
under 37 CFR 1.704(d), the patentee must file a request for
reconsideration of the patent term adjustment indicated on the patent
under 37 CFR 1.705(b) with the fee set forth in 37 CFR 1.18(e). If a
patentee files both form PTO/SB/134 and a request under 37 CFR 1.705(b)
prior to the USPTO's recalculation of patent term adjustment, the USPTO
will treat the papers as a request for reconsideration of the patent
term adjustment indicated on the patent under 37 CFR 1.705(b) and
charge the fee set forth in 37 CFR 1.18(e).
While the USPTO's interim procedure waives the fee under 37 CFR
1.705(b)(1) as set forth in 37 CFR 1.18(e) to file the PTO/SB/134, it
does not waive any extensions of time fees due under 37 CFR 1.705(b)
and 1.136. In addition, it is noted that the fee specified in 37 CFR
1.18(e) is required for a request for reconsideration under 37 CFR
1.705, and the USPTO may only refund fees paid by mistake or in excess
of that required (35 U.S.C. 42(d)). Thus, the interim procedure set
forth in this document is not a basis for requesting a refund of the
fee specified in 37 CFR 1.18(e) for any request for reconsideration
under 37 CFR 1.705, including any previously filed request that was
solely based on the USPTO's error in assessing a reduction to the
amount of patent term adjustment under 37 CFR 1.704(c)(6), (c)(8),
(c)(9), (c)(10), or (c)(12) for the submission of an information
disclosure statement that was accompanied by the statement under 37 CFR
1.704(d).
The Office of Petitions will manually review the request for
recalculation of patent term adjustment filed under the interim
procedure. Specifically, the Office of Petitions will review the
accuracy of the patent term adjustment calculation in view of
regulations 37 CFR 1.702 through 1.704 as part of the recalculation.
Upon review by the Office of Petitions, the patentee will be given one
opportunity to respond to the recalculation. The response must be filed
by patentee within two months of the mail date of the recalculation. No
extensions of time will be granted. If patentee responds to the
recalculation by requesting changes to the recalculation not related to
the safe harbor statement, patentee must comply with the requirements
of 37 CFR 1.705(b)(1) and (2).
If patentee fails to respond to the recalculation and the USPTO's
determination of the amount of recalculated patent term adjustment is
different from that printed on the front of the patent, the USPTO will
sua sponte issue a certificate of correction that reflects the
recalculated patent term adjustment. If patentee files a timely
response after the USPTO's recalculation and the USPTO maintains its
recalculation, the USPTO will issue its decision confirming its
recalculation pursuant to 35 U.S.C. 154(b)(3)(B)(ii), and this decision
is the Director's decision under 35 U.S.C. 154(b)(4). The USPTO's
initial recalculation of patent term adjustment under the procedure
outlined in this document is not the Director's decision under 35
U.S.C. 154(b)(4).
New Form for Applicants to Use when Making a Statement Pursuant to
37 CFR 1.704(d): In order to aid in recognizing when a compliant safe
harbor statement under 37 CFR 1.704(d) has been filed with an
information disclosure statement, the USPTO has created a form titled,
``Patent Term Adjustment Statement under 37 CFR 1.704(d)'' (PTO/SB/133)
for applicant's use when submitting the information disclosure
statement. The USPTO is planning to update the patent term adjustment
computer program to recognize when form PTO/SB/133 has been filed. Once
updated, the patent term adjustment computer program will perform the
patent term calculation by taking into account that applicant filed a
compliant safe harbor statement under 37 CFR 1.704(d) when it performs
the patent term adjustment calculation. When applicant provides the
safe harbor statement with the information disclosure statement, use of
form PTO/SB/133 is not required, but it is very strongly recommended as
the failure to use this form may result in the patent term adjustment
calculation not taking into account that such a statement was filed.
The form will be available on the USPTO's website at https://www.uspto.gov/patent/patents-forms. The Office of Management and Budget
(OMB) has determined that, under 5 CFR 1320.3(h), form PTO/SB/133 does
not collect ``information'' within the meaning of the Paperwork
Reduction Act of 1995.
Applicants who submit form PTO/SB/133 with an information
disclosure statement will be considered to be making a proper safe
harbor statement, and the filing will be reflected in the file record.
Applicants may not alter the pre-printed text of form PTO/SB/133. The
presentation to the USPTO (whether by signing, filing, submitting, or
later advocating) of any USPTO form with text identifying the form as a
USPTO-generated form by a party, whether a practitioner or non-
practitioner, constitutes a certification under 37 CFR 11.18(b) that
the existing text and any certifications or statements on the form have
not been altered other than permitted by EFS-Web customization. See 37
CFR 1.4(d)(3). As a result of using the form, the USPTO's computer
program, once updated, will take the safe harbor statement into account
when patent term adjustment is calculated, thereby eliminating the need
to file a request for reconsideration of patent term adjustment under
37 CFR 1.705(b) for this matter.
Dated: October 30, 2018.
Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2018-24004 Filed 11-1-18; 8:45 am]
BILLING CODE 3510-16-P
