83_FR_55315 83 FR 55102 - Interim Procedure for Requesting Recalculation of the Patent Term Adjustment With Respect to Information Disclosure Statements Accompanied by a Safe Harbor Statement

83 FR 55102 - Interim Procedure for Requesting Recalculation of the Patent Term Adjustment With Respect to Information Disclosure Statements Accompanied by a Safe Harbor Statement

DEPARTMENT OF COMMERCE
Patent and Trademark Office

Federal Register Volume 83, Issue 213 (November 2, 2018)

Page Range55102-55104
FR Document2018-24004

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 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.

Federal Register, Volume 83 Issue 213 (Friday, November 2, 2018)
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Rules and Regulations]
[Pages 55102-55104]
From the Federal Register Online  [www.thefederalregister.org]
[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



     55102             Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Rules and Regulations

     compliance, please contact the person                   $100,000,000 (adjusted for inflation) or              surface to bottom, between river mile
     listed in the FOR FURTHER INFORMATION                   more in any one year. Though this rule                142 and 143.
     CONTACT section.                                        will not result in such an expenditure,                 (b) Regulations. In accordance with
        Small businesses may send comments                   we do discuss the effects of this rule                the general regulations in 33 CFR part
     on the actions of Federal employees                     elsewhere in this preamble.                           165, subpart C, no person may enter or
     who enforce, or otherwise determine                                                                           remain in the safety zone created in this
     compliance with, Federal regulations to                 F. Environment
                                                                                                                   section or bring, cause to be brought, or
     the Small Business and Agriculture                         We have analyzed this rule under                   allow to remain in the safety zone
     Regulatory Enforcement Ombudsman                        Department of Homeland Security                       created in this section any vehicle,
     and the Regional Small Business                         Directive 023–01 and Commandant                       vessel, or object unless authorized by
     Regulatory Fairness Boards. The                         Instruction M16475.1D, which guide the                the Captain of the Port or his designated
     Ombudsman evaluates these actions                       Coast Guard in complying with the                     representative.
     annually and rates each agency’s                        National Environmental Policy Act of                     (2) To seek permission to enter,
     responsiveness to small business. If you                1969 (42 U.S.C. 4321–4370f), and have                 contact Derrick Barge DB 125 or tug
     wish to comment on actions by                           determined that this action is one of a               RUTH via VHF–FM marine channel 14.
     employees of the Coast Guard, call 1–                   category of actions that do not                       Those in the safety zone must comply
     888–REG–FAIR (1–888–734–3247). The                      individually or cumulatively have a                   with all lawful orders or directions
     Coast Guard will not retaliate against                  significant effect on the human                       given to them by the COTP or the
     small entities that question or complain                environment. This rule involves a safety              COTP’s designated representative.
     about this rule or any policy or action                 zone lasting less than 30 days that will                 (c) Enforcement period. This safety
     of the Coast Guard.                                     prohibit vessel traffic to transit between            zone is in effect from 7 a.m. until 5 p.m.
                                                             Columbia River Mile 142 and 143                       on October 27, 2018 through November
     C. Collection of Information
                                                             during diving and vessel recovery                     16, 2018. It will be subject to
       This rule will not call for a new                     operations. It is categorically excluded              enforcement this entire period unless
     collection of information under the                     from further review under paragraph                   the Captain of the Port, Columbia River
     Paperwork Reduction Act of 1995 (44                     L60(a) of Appendix A, Table 1 of DHS                  (COTP) determines it is no longer
     U.S.C. 3501–3520).                                      Instruction Manual 023–01–001–01,                     needed. The Coast Guard will inform
     D. Federalism and Indian Tribal                         Rev. 01. A Record of Environmental                    mariners of any change to this period of
     Governments                                             Consideration supporting this                         enforcement via Broadcast Notice to
                                                             determination is available in the docket              Mariners.
        A rule has implications for federalism               where indicated under ADDRESSES.
     under Executive Order 13132,                                                                                     Dated: October 26, 2018.
     Federalism, if it has a substantial direct              G. Protest Activities                                 D.F. Berliner,
     effect on the States, on the relationship                 The Coast Guard respects the First                  Captain, U.S. Coast Guard, Acting Captain
     between the national government and                     Amendment rights of protesters.                       of the Port Sector Columbia River.
     the States, or on the distribution of                   Protesters are asked to contact the                   [FR Doc. 2018–23955 Filed 11–1–18; 8:45 am]
     power and responsibilities among the                    person listed in the FOR FURTHER                      BILLING CODE 9110–04–P
     various levels of government. We have                   INFORMATION CONTACT section to
     analyzed this rule under that Order and                 coordinate protest activities so that your
     have determined that it is consistent                   message can be received without                       DEPARTMENT OF COMMERCE
     with the fundamental federalism                         jeopardizing the safety or security of
     principles and preemption requirements                  people, places or vessels.                            Patent and Trademark Office
     described in Executive Order 13132.
        Also, this rule does not have tribal                 List of Subjects in 33 CFR Part 165                   37 CFR Part 1
     implications under Executive Order                        Harbors, Marine safety, Navigation                  [Docket No. PTO–P–2018–0030]
     13175, Consultation and Coordination                    (water), Reporting and recordkeeping
     with Indian Tribal Governments,                         requirements, Security measures,                      Interim Procedure for Requesting
     because it does not have a substantial                  Waterways.                                            Recalculation of the Patent Term
     direct effect on one or more Indian                       For the reasons discussed in the                    Adjustment With Respect to
     tribes, on the relationship between the                 preamble, the Coast Guard amends 33                   Information Disclosure Statements
     Federal Government and Indian tribes,                   CFR part 165 as follows:                              Accompanied by a Safe Harbor
     or on the distribution of power and                                                                           Statement
     responsibilities between the Federal                    PART 165—REGULATED NAVIGATION
     Government and Indian tribes. If you                    AREAS AND LIMITED ACCESS AREAS                        AGENCY: United States Patent and
     believe this rule has implications for                                                                        Trademark Office, Commerce.
     federalism or Indian tribes, please                     ■ 1. The authority citation for part 165              ACTION: Notification of interim
     contact the person listed in the FOR                    continues to read as follows:                         procedure.
     FURTHER INFORMATION CONTACT section                       Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
     above.                                                  33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
                                                                                                                   SUMMARY:   The patent laws provide for
                                                             Department of Homeland Security Delegation            patent term adjustment in the event that
     E. Unfunded Mandates Reform Act                                                                               the issuance of the patent is delayed due
                                                             No. 0170.1.
       The Unfunded Mandates Reform Act                      ■ 2. Add § 165.T13–0998 to read as                    to certain enumerated administrative
     of 1995 (2 U.S.C. 1531–1538) requires                   follows:                                              delays. The USPTO makes the patent
     Federal agencies to assess the effects of                                                                     term adjustment determination included
     their discretionary regulatory actions. In              § 165.T13–0998 Safety Zone; Columbia                  on the patent by a computer program
     particular, the Act addresses actions                   River, Cascade Locks, OR.                             that uses the information recorded in
     that may result in the expenditure by a                   (a) Location. The following area is                 the USPTO’s Patent Application
     State, local, or tribal government, in the              designated safety zone: All navigable                 Locating and Monitoring (PALM)
     aggregate, or by the private sector of                  waters of the Columbia River, from                    system. The USPTO will be modifying


VerDate Sep<11>2014   16:11 Nov 01, 2018   Jkt 247001   PO 00000   Frm 00010   Fmt 4700   Sfmt 4700   E:\FR\FM\02NOR1.SGM   02NOR1


                       Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Rules and Regulations                                       55103

     its computer program that calculates                    efforts to conclude processing or                     Board or Federal court that requires the
     patent term adjustment to recognize                     examination of an application.’’ 35                   USPTO to issue a supplemental Office
     when an applicant files an information                  U.S.C. 154(b)(2)(C)(i) and (iii). The                 action. See 37 CFR 1.704(c)(6),
     disclosure statement concurrently with                  USPTO implemented the patent term                     1.704(c)(8), 1.704(c)(9), and (c)(10).
     a safe harbor statement. In order to                    adjustment provisions of the AIPA in a                Similarly, unless the submission for a
     assist both applicants and the USPTO,                   final rule published in September of                  request for continued examination after
     the USPTO is providing a new form for                   2000. See Changes to Implement Patent                 a notice of allowance has been mailed
     applicants to use when making a safe                    Term Adjustment Under Twenty-Year                     is solely an information disclosure
     harbor statement. The USPTO is also                     Patent Term, 65 FR 56365 (Sept. 18,                   statement and it is accompanied by a
     establishing an interim procedure and                   2000) (final rule).                                   safe harbor statement in compliance
     providing a form for patentees to request                  The ‘‘regulations establishing the                 with 37 CFR 1.704(d), 37 CFR 1.704
     a recalculation of their patent term                    circumstances that constitute a failure of            provides for a reduction of any patent
     adjustment determination for alleged                    an applicant to engage in reasonable                  term adjustment if a request for
     errors due to the USPTO’s failure to                    efforts to conclude processing or                     continued examination is filed after the
     recognize that an information disclosure                examination of an application’’ (35                   mailing of a notice of allowance. See 37
     statement was accompanied by a safe                     U.S.C. 154(b)(2)(C)(iii)) are set forth in            CFR 1.704(c)(12).
     harbor statement.                                       37 CFR 1.704. 37 CFR 1.704 provides for                  A proper safe harbor statement under
     DATES: Effective Date: This procedure is                a reduction of any patent term                        37 CFR 1.704(d) must state that each
     effective November 2, 2018.                             adjustment if an information disclosure               item of information contained in the
     FOR FURTHER INFORMATION CONTACT: Kery                   statement (1) is filed after a notice of              information disclosure statement: (1)
     A. Fries, Senior Legal Advisor, Office of               allowance or after an initial reply by the            Was first cited in any communication
     Patent Legal Administration, Office of                  applicant; or (2) is filed as a preliminary           from a patent office in a counterpart
     Deputy Commissioner for Patent                          paper or paper after a decision by the                foreign or international application or
     Examination Policy, by telephone at                     Board or Federal court that requires the              from the USPTO, and this
     (571) 272–7757, or by mail addressed to:                USPTO to issue a supplemental Office                  communication was not received by any
     Mail Stop Comments-Patents,                             action. See 37 CFR 1.704(c)(6),                       individual designated in 37 CFR 1.56(c)
     Commissioner for Patents, P.O. Box                      1.704(c)(8), 1.704(c)(9), and 1.704(c)(10).           more than thirty days prior to the filing
     1450, Alexandria, VA 22313–1450.                        37 CFR 1.704 also provides for a                      of the information disclosure statement
                                                             reduction of any patent term adjustment               (37 CFR 1.704(d)(1)(i)); or (2) is a
     SUPPLEMENTARY INFORMATION: The
                                                             if a request for continued examination is
     American Inventors Protection Act of                                                                          communication that was issued by a
                                                             filed after the mailing of a notice of
     1999 or AIPA (Pub. L. 106–113, 113                                                                            patent office in a counterpart foreign or
                                                             allowance. See 37 CFR 1.704(c)(12).
     Stat. 1501, 1501A–552 through 1501A–                       37 CFR 1.704(d), however, provides                 international application or by the
     591 (1999)) amended 35 U.S.C. 154(b) to                 that a paper containing only an                       USPTO, and this communication was
     provide for patent term adjustment in                   information disclosure statement in                   not received by any individual
     the event that the issuance of the patent               compliance with 37 CFR 1.97 and 1.98                  designated in 37 CFR 1.56(c) more than
     is delayed due to one or more of the                    will not be considered a failure to                   thirty days prior to the filing of the
     enumerated administrative delays listed                 engage in reasonable efforts to conclude              information disclosure statement (37
     in 35 U.S.C. 154(b)(1). Under the patent                prosecution (processing or examination)               CFR 1.704(d)(1)(ii)).
     term adjustment provisions of the AIPA,                 of the application under 37 CFR                          The USPTO performs an automated
     a patentee generally is entitled to patent              1.704(c)(6), (c)(8), (c)(9), or (c)(10) if the        calculation of how much patent term
     term adjustment for the following                       information disclosure statement is                   adjustment, if any, is due to a patentee
     reasons: (1) If the USPTO fails to take                 accompanied by one of the statements                  using the information recorded in the
     certain actions during the examination                  set forth in 37 CFR 1.704(d)(1)(i) or                 USPTO’s PALM system, except when a
     and issue process within specified time                 (d)(1)(ii) (a ‘‘safe harbor statement’’).             patentee requests reconsideration
     frames (35 U.S.C. 154(b)(1)(A)); (2) if the             Similarly, 37 CFR 1.704(d) also provides              pursuant to 37 CFR 1.705. See Changes
     USPTO fails to issue a patent within                    that a request for continued examination              to Implement Patent Term Adjustment
     three years of the actual filing date of                in compliance with 37 CFR 1.114                       under Twenty-Year Patent Term, 65 FR
     the application (35 U.S.C. 154(b)(1)(B));               containing only an information                        56365, 56370, 56380–81 (Sept. 18, 2000)
     and (3) for delays due to interference or               disclosure statement in compliance with               (final rule). Currently, the computer
     derivation proceedings, secrecy orders,                 37 CFR 1.97 and 1.98 will not be                      program used for this automated
     or successful appellate review (35                      considered a failure to engage in                     calculation cannot determine whether a
     U.S.C. 154(b)(1)(C)). See 35 U.S.C.                     reasonable efforts to conclude                        compliant safe harbor statement under
     154(b)(1). The AIPA, however, sets forth                prosecution (processing or examination)               37 CFR 1.704(d) accompanied an
     a number of conditions and limitations                  of the application under 37 CFR                       information disclosure statement. Thus,
     on any patent term adjustment accrued                   1.704(c)(12) if the information                       this computer program calculates the
     under 35 U.S.C. 154(b)(1). Specifically,                disclosure statement included in request              patent term adjustment total as if no
     35 U.S.C. 154(b)(2)(C) provides, in part,               for continued examination is                          compliant safe harbor statement under
     that ‘‘[t]he period of adjustment of the                accompanied by a safe harbor statement.               37 CFR 1.704(d) was made. As the
     term of a patent under [35 U.S.C.                       Thus, unless the information disclosure               USPTO develops its next generation
     154(b)(1)] shall be reduced by a period                 statement is accompanied by a safe                    information technology (IT) systems that
     equal to the period of time during which                harbor statement in compliance with 37                will address this problem, the USPTO is
     the applicant failed to engage in                       CFR 1.704(d), 37 CFR 1.704 provides for               introducing an interim procedure for
     reasonable efforts to conclude                          a reduction of any patent term                        patentees to request a patent term
     prosecution of the application’’ and that               adjustment if an information disclosure               adjustment recalculation when a safe
     ‘‘[t]he Director shall prescribe                        statement (1) is filed after a notice of              harbor statement pursuant to 37 CFR
     regulations establishing the                            allowance or after an initial reply by the            1.704(d) was filed, and a new form for
     circumstances that constitute a failure of              applicant; or (2) is filed as a preliminary           applicants to use when making a safe
     an applicant to engage in reasonable                    paper or paper after a decision by the                harbor statement.


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     55104             Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Rules and Regulations

        Interim Procedure for Requesting                     is noted that the fee specified in 37 CFR             form titled, ‘‘Patent Term Adjustment
     Recalculation: The USPTO has created                    1.18(e) is required for a request for                 Statement under 37 CFR 1.704(d)’’
     the following interim procedure by                      reconsideration under 37 CFR 1.705,                   (PTO/SB/133) for applicant’s use when
     which a patentee may request                            and the USPTO may only refund fees                    submitting the information disclosure
     recalculation of patent term adjustment                 paid by mistake or in excess of that                  statement. The USPTO is planning to
     where the sole reason for contesting the                required (35 U.S.C. 42(d)). Thus, the                 update the patent term adjustment
     patent term adjustment determination is                 interim procedure set forth in this                   computer program to recognize when
     the USPTO’s failure to recognize a                      document is not a basis for requesting                form PTO/SB/133 has been filed. Once
     timely filed safe harbor statement                      a refund of the fee specified in 37 CFR               updated, the patent term adjustment
     accompanying an information                             1.18(e) for any request for                           computer program will perform the
     disclosure statement. The USPTO’s                       reconsideration under 37 CFR 1.705,                   patent term calculation by taking into
     interim procedure waives the fee under                  including any previously filed request                account that applicant filed a compliant
     37 CFR 1.705(b)(1) as set forth in 37 CFR               that was solely based on the USPTO’s                  safe harbor statement under 37 CFR
     1.18(e) to file the request for                         error in assessing a reduction to the                 1.704(d) when it performs the patent
     reconsideration. The interim procedure                  amount of patent term adjustment under                term adjustment calculation. When
     will remain in effect until the USPTO                   37 CFR 1.704(c)(6), (c)(8), (c)(9), (c)(10),          applicant provides the safe harbor
     can update the patent term adjustment                   or (c)(12) for the submission of an                   statement with the information
     computer program and provide notice to                  information disclosure statement that                 disclosure statement, use of form
     the public that the computer program                    was accompanied by the statement                      PTO/SB/133 is not required, but it is
     has been updated.                                       under 37 CFR 1.704(d).                                very strongly recommended as the
        Under the interim procedure,                            The Office of Petitions will manually              failure to use this form may result in the
     recalculation of patent term adjustment                 review the request for recalculation of               patent term adjustment calculation not
     is requested by submitting a form in lieu               patent term adjustment filed under the                taking into account that such a
     of the request and fee set forth in 37 CFR              interim procedure. Specifically, the                  statement was filed. The form will be
     1.705(b). This form, ‘‘Request for                      Office of Petitions will review the                   available on the USPTO’s website at
     Reconsideration of Patent Term                          accuracy of the patent term adjustment                https://www.uspto.gov/patent/patents-
     Adjustment in View of Safe Harbor                       calculation in view of regulations                    forms. The Office of Management and
     Statement Under 37 CFR 1.704(d)’’                       37 CFR 1.702 through 1.704 as part of                 Budget (OMB) has determined that,
     (PTO/SB/134) will be available on the                   the recalculation. Upon review by the                 under
     USPTO website at https://                               Office of Petitions, the patentee will be             5 CFR 1320.3(h), form PTO/SB/133 does
     www.uspto.gov/patent/patents-forms.                     given one opportunity to respond to the               not collect ‘‘information’’ within the
        The Office of Management and Budget                  recalculation. The response must be                   meaning of the Paperwork Reduction
     (OMB) has determined that, under 5                      filed by patentee within two months of                Act of 1995.
     CFR 1320.3(h), Form PTO/SB/134 does                     the mail date of the recalculation. No
     not collect ‘‘information’’ within the                  extensions of time will be granted. If                   Applicants who submit form PTO/SB/
     meaning of the Paperwork Reduction                      patentee responds to the recalculation                133 with an information disclosure
     Act of 1995. The form must be filed                     by requesting changes to the                          statement will be considered to be
     within the time period set forth in 37                  recalculation not related to the safe                 making a proper safe harbor statement,
     CFR 1.705(b), and the USPTO will not                    harbor statement, patentee must comply                and the filing will be reflected in the file
     grant any request for recalculation of the              with the requirements of 37 CFR                       record. Applicants may not alter the
     patent term adjustment that is not                      1.705(b)(1) and (2).                                  pre-printed text of form PTO/SB/133.
     timely filed. The time period set forth                    If patentee fails to respond to the                The presentation to the USPTO
     set forth in 37 CFR 1.705(b) may be                     recalculation and the USPTO’s                         (whether by signing, filing, submitting,
     extended under the provisions of 37                     determination of the amount of                        or later advocating) of any USPTO form
     CFR 1.136(a).                                           recalculated patent term adjustment is                with text identifying the form as a
        If the request for recalculation is not              different from that printed on the front              USPTO-generated form by a party,
     based solely on the USPTO’s failure to                  of the patent, the USPTO will sua                     whether a practitioner or non-
     recognize a timely filed, compliant safe                sponte issue a certificate of correction              practitioner, constitutes a certification
     harbor statement under 37 CFR 1.704(d),                 that reflects the recalculated patent term            under 37 CFR 11.18(b) that the existing
     the patentee must file a request for                    adjustment. If patentee files a timely                text and any certifications or statements
     reconsideration of the patent term                      response after the USPTO’s                            on the form have not been altered other
     adjustment indicated on the patent                      recalculation and the USPTO maintains                 than permitted by EFS-Web
     under 37 CFR 1.705(b) with the fee set                  its recalculation, the USPTO will issue               customization. See 37 CFR 1.4(d)(3). As
     forth in 37 CFR 1.18(e). If a patentee                  its decision confirming its recalculation             a result of using the form, the USPTO’s
     files both form PTO/SB/134 and a                        pursuant to 35 U.S.C. 154(b)(3)(B)(ii),               computer program, once updated, will
     request under 37 CFR 1.705(b) prior to                  and this decision is the Director’s                   take the safe harbor statement into
     the USPTO’s recalculation of patent                     decision under 35 U.S.C. 154(b)(4). The               account when patent term adjustment is
     term adjustment, the USPTO will treat                   USPTO’s initial recalculation of patent               calculated, thereby eliminating the need
     the papers as a request for                             term adjustment under the procedure                   to file a request for reconsideration of
     reconsideration of the patent term                      outlined in this document is not the                  patent term adjustment under 37 CFR
     adjustment indicated on the patent                      Director’s decision under 35 U.S.C.                   1.705(b) for this matter.
     under 37 CFR 1.705(b) and charge the                    154(b)(4).
                                                                                                                     Dated: October 30, 2018.
     fee set forth in 37 CFR 1.18(e).                           New Form for Applicants to Use when
        While the USPTO’s interim procedure                  Making a Statement Pursuant to 37 CFR                 Andrei Iancu,
     waives the fee under 37 CFR 1.705(b)(1)                 1.704(d): In order to aid in recognizing              Under Secretary of Commerce for Intellectual
     as set forth in 37 CFR 1.18(e) to file the              when a compliant safe harbor statement                Property and Director of the United States
     PTO/SB/134, it does not waive any                       under 37 CFR 1.704(d) has been filed                  Patent and Trademark Office.
     extensions of time fees due under 37                    with an information disclosure                        [FR Doc. 2018–24004 Filed 11–1–18; 8:45 am]
     CFR 1.705(b) and 1.136. In addition, it                 statement, the USPTO has created a                    BILLING CODE 3510–16–P




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Document Created: 2018-11-02 01:09:55
Document Modified: 2018-11-02 01:09:55
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of interim procedure.
DatesEffective Date: This procedure is effective November 2, 2018.
ContactKery 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
FR Citation83 FR 55102 

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