| Allowance, Patent Term Adjustment or Extension |
Referenced Items (296, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312) |
(297) 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 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
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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.
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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
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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.
October 30, 2018 ANDREI IANCU
Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office
[1456 OG 246]