[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.

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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]
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