MPEP § 2734 — MPEP § 2734
Current through: 2022-07-01

2734-Application for Patent Term Adjustment; Due Care Showing 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2700 

 Section 2734 
 

 
 
 
 
 
 2734 Application for Patent Term Adjustment; Due Care
 Showing [R-01.2024]
 

 [Editor Note: 37 CFR 1.705(b) and
 (c) below include amendments applicable only to patents granted on
 or after January 14, 2013. See 37 CFR 1.705 (pre-2013-04-01) with
 respect to patents granted prior to January 14, 2013.] 

 
 37 CFR 1.705 Patent term adjustment determination. 

 *****

 
 (b) Any request for reconsideration of the patent term adjustment
 indicated on the patent must be by way of an application for patent term
 adjustment filed no later than two months from the date the patent was granted.
 This two-month period may be extended under the provisions of § 1.136(a) .
 An application for patent term adjustment under this section must be accompanied
 by: 
 
 (1) The fee set forth in § 1.18(e) ; and 
 

 (2) A statement of the facts involved, specifying: 
 
 (i) The correct patent term adjustment and the basis or
 bases under § 1.702 for the
 adjustment; 
 

 (ii) The relevant dates as specified in §§ 1.703(a) through
 (e) for which an adjustment is sought and the
 adjustment as specified in § 1.703(f) to
 which the patent is entitled; 
 

 (iii) Whether the patent is subject to a terminal
 disclaimer and any expiration date specified in the terminal
 disclaimer; and 
 

 (iv)
 
 (A) Any circumstances during the prosecution of
 the application resulting in the patent that constitute a
 failure to engage in reasonable efforts to conclude processing
 or examination of such application as set forth in
 § 1.704 ;
 or
 

 (B) That there were no circumstances constituting a
 failure to engage in reasonable efforts to conclude processing
 or examination of such application as set forth in
 § 1.704 .
 
 

 
 

 
 

 
 

 (c) Any request for reinstatement of all or part of the period of
 adjustment reduced pursuant to § 1.704(b) for failing to
 reply to a rejection, objection, argument, or other request within three months of
 the date of the mailing of the Office communication notifying the applicant of the
 rejection, objection, argument, or other request must be filed prior to the
 issuance of the patent. This time period is not extendable. Any request for
 reinstatement of all or part of the period of adjustment pursuant to
 § 1.704(b) must be accompanied by: 
 
 (1) The fee set forth in § 1.18(f) ; and 
 

 (2) A showing to the satisfaction of the Director that, in
 spite of all due care, the applicant was unable to reply to the rejection,
 objection, argument, or other request within three months of the date of
 mailing of the Office communication notifying the applicant of the
 rejection, objection, argument, or other request. The Office shall not grant
 any request for reinstatement for more than three additional months for each
 reply beyond three months from the date of mailing of the Office
 communication notifying the applicant of the rejection, objection, argument,
 or other request. 
 

 
 

 
 *****

 
 I. OFFICE PROCEDURE FOR THE TREATMENT OF REQUESTS FOR RECONSIDERATION OF PATENT TERM
 ADJUSTMENT 37 CFR
 1.705(b) provides that any request for reconsideration of the
 patent term adjustment indicated on the patent must be by way of an application for
 patent term adjustment which must filed within two months of the date the patent was
 granted and accompanied by the fee set forth in 37 CFR 1.18(e) and a statement of
 the facts involved. 37
 CFR 1.705(b)(2) provides that such statement of facts involved
 must specify: (1) the correct patent term adjustment and the basis or bases under
 37 CFR
 1.702 for the adjustment; (2) the relevant dates as specified in
 37 CFR 1.703(a)
 through (e) for which an adjustment is sought and the adjustment
 as specified in 37 CFR
 1.703(f) to which the patent is entitled; (3) whether the patent
 is subject to a terminal disclaimer and any expiration date specified in the terminal
 disclaimer; and (4) any circumstances, if any, during the prosecution of the application
 resulting in the patent that constitute a failure to engage in reasonable efforts to
 conclude processing or examination of such application as set forth in 37 CFR 1.704 (or a
 statement that there were no such circumstances). The two month period set in
 37 CFR
 1.705(b) is extendable under 37 CFR 1.136(a) for up to five
 additional months (permitting patentee to request reconsideration of the patent term
 adjustment indicated on the patent as late as within seven months after the date the
 patent was granted). 
 

 The Office will conduct a manual redetermination of
 patent term adjustment in response to a request for reconsideration of the patent term
 adjustment. The Office makes the patent term adjustment determination indicated in the
 patent by a computer program that uses the information recorded in the Office's One
 Patent Service Gateway (OPSG) system, except when an applicant 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 (September 18, 2000) (final rule). The patent term adjustment
 provisions of 35
 U.S.C. 154(b) are complex, with numerous types of communications
 exchanged between applicants and the Office during the patent application process. Thus,
 a manual redetermination of patent term adjustment could result in (1) an amount of
 patent term adjustment that is the amount of patent term adjustment requested by the
 applicant; (2) the same amount of patent term adjustment as indicated in the patent
 (i.e., there being no change); or (3) a different amount of patent term adjustment that
 may be higher or lower than the patent term adjustment as indicated in the patent. 
 

 If the patent term adjustment redetermination results in
 the amount of patent term adjustment requested by the applicant, the Office will issue a
 decision granting the request for reconsideration and a certificate of correction that
 indicates the revised patent term adjustment. If the patent term adjustment
 redetermination results in the same amount of patent term adjustment as indicated in the
 patent (i.e., there being no change) and the Office does not require any additional
 information to render a decision on the request for reconsideration, the Office will
 issue a decision denying the request for reconsideration, and this decision is the
 Director's decision on the applicant's request for reconsideration within the meaning of
 35 U.S.C.
 154(b)(4) .
 

 If the patent term adjustment redetermination results in
 a different amount of patent term adjustment (higher or lower than the patent term
 adjustment indicated in the patent), the Office will issue a redetermination of patent
 term adjustment that explains how the Office arrived at the different amount of patent
 term adjustment. This redetermination of patent term adjustment is not the Director's
 decision on the applicant's request for reconsideration within the meaning of
 35 U.S.C.
 154(b)(4) , but is simply a new patent term adjustment
 determination (e.g., a redetermination). If the Office issues such a redetermination of
 patent term adjustment in response to the request for reconsideration, the applicant has
 two months from the date of the redetermination to file a renewed request for
 reconsideration of the patent term adjustment that addresses the issues included in the
 Office's redetermination of patent term adjustment. No additional fee under
 37 CFR
 1.18(e) is required. The two-month period to file a renewed
 request for reconsideration of patent term adjustment is extendable under
 37 CFR
 1.136(a) .
 

 If the patent term adjustment redetermination results in
 the same amount of patent term adjustment as indicated in the patent (i.e., there being
 no change) but the Office requires additional information to render a decision on the
 request for reconsideration of the patent term adjustment, the Office will issue a
 requirement for information to obtain the additional information. This requirement for
 information is not the Director's decision on the applicant's request for
 reconsideration within the meaning of 35 U.S.C. 154(b)(4) . If the Office
 issues a requirement for information in response to the request for reconsideration of
 the patent term adjustment, the applicant has two months from the date of the
 requirement for information to file a renewed request for reconsideration of the patent
 term adjustment. The renewed request should supply the required information and no
 additional fee is required. This two-month period is extendable under 37 CFR
 1.136(a) .
 

 The Office will again conduct a redetermination of patent
 term adjustment in response to any renewed request for reconsideration, which is filed
 in response to a redetermination of patent term adjustment and/or a requirement for
 information. If this redetermination of patent term adjustment results in the amount of
 patent term adjustment requested by the applicant, the Office will issue a decision
 granting the request for reconsideration and a certificate of correction that indicates
 the revised patent term adjustment. If this redetermination of patent term adjustment
 results in the same amount of patent term adjustment as indicated in the previous
 redetermination of patent term adjustment or in the patent, the Office will generally
 issue a decision denying the request for reconsideration and a certificate of
 correction, if necessary, indicating the revised patent term adjustment as the result of
 a redetermination of patent term adjustment. The decision denying the request for
 reconsideration is the Director's decision on the applicant's request for
 reconsideration within the meaning of 35 U.S.C. 154(b)(4) . In certain,
 limited circumstances, the redetermination may result in another redetermination of
 patent term adjustment or requirement for information. In such a case, applicant will be
 given another opportunity to file a renewed request for reconsideration as described
 above.
 

 Only if the Office issues a decision denying patentee’s
 request for reconsideration, then patentee may appeal such decision to the District
 Court for the Eastern District of Virginia by filing a civil complaint within 180 days
 of the date of the decision on the request for reconsideration of patent term adjustment
 (within the meaning of 35 U.S.C. 154(b)(4) ).
 

 Section 1(h)(3) of the AIA Technical Corrections Act
 amended 35 U.S.C.
 154(b)(4) to provide that “[a]n applicant dissatisfied with the
 Director’s decision on the applicant’s request for reconsideration under paragraph
 (3)(B)(ii) shall have exclusive remedy by a civil action against
 the Director filed in the United States District Court for the Eastern District of
 Virginia within 180 days after the date the Director’s decision on the applicant’s
 request for reconsideration.” The change to 35 U.S.C. 154(b)(4) clarifies that
 (1) a civil action under 35 U.S.C. 154(b)(4) is not an
 alternative to requesting reconsideration of the patent term adjustment under
 35 U.S.C.
 154(b)(3) but is the remedy for an applicant who is dissatisfied
 with the Director’s decision on the applicant’s request for reconsideration under
 35 U.S.C.
 154(b)(3) ; and (2) a civil action provided in 35 U.S.C.
 154(b)(4) is the exclusive remedy for an applicant
 who is dissatisfied with the Director’s decision on the applicant’s request for
 reconsideration. In other words, an applicant that is dissatisfied with the patent term
 adjustment determination on the patent must first request reconsideration under
 35 U.S.C.
 154(b)(3) and 37 CFR 1.705(b) . Only after
 receiving a decision denying the request for reconsideration, may the applicant file a
 civil action, proscribed in 35 U.S.C. 154(b)(4) , if the
 applicant is dissatisfied with the decision on the request for reconsideration. This
 statutory change is applicable for all patents that issue on or after January 14, 2013. 
 

 For patents that issued prior to January 14, 2013,
 35 U.S.C.
 154(b)(4) previously required that patentee commence a civil
 action within 180 days of the grant of the patent. Patentee is not entitled to equitable
 tolling of the 180-day period to commence the civil action in the district court where
 patentee did not lack sufficient facts on which it could sue but instead waited until
 another, unrelated party secured a favorable ruling on a legal theory in another court
 proceeding. See Novartis AG v. Lee, 740 F.3d 593, 109 USPQ2d 1385
 (Fed. Cir. 2014). It is noted, however, that the U.S. District Court for the District of
 Columbia affirmed a prior decision of the court holding that the 180-day deadline under
 35 U.S.C.
 154(b)(4)(A) for filing a lawsuit challenging a PTA determination
 was tolled in the circumstances of that case by the patent holders' timely requests for
 reconsideration of the PTA determinations set forth in the patents at issue. See
 Bristol-Myers Squibb Co. v. Kappos, 891 F. Supp. 2d 135 (D.D.C.
 2012) (denying reconsideration of the decision published at 841 F. Supp. 2d 238 (D.D.C.
 2012)). Section 1(n) of the AIA Technical Corrections Act provides that amendments made
 in section 1(h) shall take effect on January 14, 2013 (the date of enactment) and shall
 apply to the proceedings commenced on or after January 14, 2013. Section 1(n) of the
 Technical Corrections Act does not limit the applicability of the changes in section
 1(h) to applications filed on or after January 14, 2013. Cf. Section 4405(a) of the
 American Inventors Protection Act of 1999 (AIPA), Public Law 106-113, 113 Stat. 1501,
 1501A-552 through 1501A-591 (limiting the applicability of the patent term adjustment
 provisions of the AIPA to applications filed on or after May 29, 2000 (the date that is
 six months after the enactment of AIPA)). Patent term adjustment proceedings are not
 “commenced” until the Office notifies the applicant of the Office’s patent term
 adjustment determination under 35 U.S.C. 154(b)(3) , which now
 occurs when the patent is granted. Accordingly, the changes to 35 U.S.C. 154 in
 section 1(h) of the AIA Technical Corrections Act apply to any patent granted on or
 after January 14, 2013. 
 

 II. DUE CARE SHOWING 37 CFR
 1.705(c) implements the provisions of 35 U.S.C.
 154(b)(3)(C) and specifically provides that a request for
 reinstatement of all or part of the period of adjustment reduced pursuant to
 37 CFR
 1.704(b) for failing to reply to a rejection, objection, argument,
 or other request within three months of the date of mailing of the Office communication
 notifying the applicant of the rejection, objection, argument, or other request must
 include: (1) the fee set forth in 37 CFR 1.18(f) ; and (2) a showing to
 the satisfaction of the Director that, in spite of all due care, the applicant was
 unable to reply to the rejection, objection, argument, or other request within three
 months of the date of mailing of the Office communication notifying the applicant of the
 rejection, objection, argument, or other request. 37 CFR 1.705(c) also provides that
 the Office shall not grant any request for reinstatement for more than three additional
 months for each reply beyond three months of the date of mailing of the Office
 communication notifying the applicant of the rejection, objection, argument, or other
 request ( 35 U.S.C.
 154(b)(3)(C) ). 35 U.S.C. 154(b)(3)(C) and
 37 CFR
 1.705(c) also requires that the request for reinstatement be filed
 prior to the issuance of the patent. Because 35 U.S.C. 154(b)(3)(C) requires that
 the request be filed prior to the issuance of the patent, the Office will not consider
 or act on a request for reinstatement in a paper filed after the patent is issued. For
 example, a request for reinstatement cannot be made as part of a request for
 reconsideration under 37 CFR 1.705(b) . Applicants are
 aware during the pendency of the application of situations where the reply was filed
 more than three months after the Office communication notifying the applicant of the
 rejection, objection, argument, or other request. If applicants believe that they can
 make the required showing that, in spite of all due care, the applicant was unable to
 rely to the rejection, objection, argument or other Office request within three months,
 then applicants should file the request for reinstatement promptly and no later than at
 least one day prior to the issuance of the patent. Applicants need not review of the
 patent term adjustment calculation to establish a request for reinstatement under
 37 CFR
 1.705(c) . The Office will not delay issuance of the patent but
 will make a decision on the request for reinstatement after the grant of the patent and
 if appropriate, issue a certificate of correction to revise the patent term adjustment
 determination on the patent. 
 

 As noted supra, 37 CFR
 1.705(c) continues to require that any request for reinstatement
 of all or part of the cumulative period of time of an adjustment reduced under
 35 U.S.C.
 154(b)(2)(C) , on the basis of a showing that, in spite of all due
 care, the applicant was unable to respond within the three-month period, must be filed
 prior to the issuance of the patent. Thus, where an applicant is seeking reinstatement
 under 35 U.S.C.
 154(b)(3)(C) of patent term adjustment reduced under
 35 U.S.C.
 154(b)(2)(C) , the showing required by 35 U.S.C.
 154(b)(3)(C) must be filed prior to the issuance of the patent.
 However, where the patentee is not seeking reinstatement under 35 U.S.C.
 154(b)(3)(C) of patent term adjustment reduced under
 35 U.S.C.
 154(b)(2)(C) , but is simply contending that the Office's patent
 term adjustment determination is in error with respect to the three-month timeframe in
 35 U.S.C.
 154(b)(2)(C)(ii) (e.g., a reply is filed within the three-month
 timeframe in 35 U.S.C.
 154(b)(2)(C)(ii) , but the Office's patent term adjustment
 determination treats the reply as having been filed outside the three-month period in
 35 U.S.C.
 154(b)(2)(C)(ii) ), any request for reconsideration or review of a
 patent term adjustment determination is by way of an application for patent term
 adjustment under 37 CFR 1.705(b) filed no later than
 two months from the date the patent was granted (this two-month period being extendable
 under the provisions of 37 CFR 1.136(a) ). 
 

 Filing a reply outside of three months after an Office action is
 per se a failure to engage in reasonable efforts to conclude
 prosecution under 35
 U.S.C. 154(b)(2)(C)(ii) unless applicant can establish that the
 delay was “in spite of all due care.” The provisions of 35 U.S.C. 21(b) 
 are applicable to the determination of three-month period for reply. If the last day of
 the three-month period from the Office communication notifying the applicant of the
 rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal
 holiday within the District of Columbia, then action, may be taken, or the fee paid, on
 the next succeeding secular or business day without loss of any patent term adjustment
 under 37
 CFR 1.704(b) . See ArQule v. Kappos, 793 F.
 Supp. 2d 214 (D.D.C. 2011). For example, an applicant’s three-month reply time period
 expires on a Saturday and the applicant files a reply that is received by the Office on
 the following Monday, which is not a federal holiday within the District of Columbia. In
 this case, any patent term would not be reduced under 37 CFR
 1.704(b) because the reply was received on Monday, the next
 succeeding secular or business day after the expiration of the three-month reply time.
 Accordingly, a request for reinstatement of all or part of the period of adjustment
 under 37
 CFR 1.705(c) would not be applicable since applicant would not
 have been deemed to reply more than three months from the date of the Office action.
 

 The Office “shall reinstate all or part of the cumulative
 period of time of an adjustment reduced under [ 35 U.S.C. 154(b)(2)(C) ] if the
 applicant… makes a showing that, in spite of all due care, the applicant was unable to
 respond within the 3-month period….” See 35 U.S.C. 154(b)(3)(C) . The “due
 care” of a reasonably prudent person standard has been applied in deciding petitions
 under the “unavoidable delay” standard of 35 U.S.C. 133 . See In re
 Mattullath, 38 App. D.C. 497, 514-15 (1912) (“the word ‘unavoidable’ … is
 applicable to ordinary human affairs, and requires no more or greater care or diligence
 than is generally used and observed by prudent and careful men in relation to their most
 important business”) (quoting and adopting Ex parte Pratt, 1887 Dec.
 Comm’r Pat. 31, 32-33); see also Ray v. Lehman, 55 F.3d 606, 609, 34
 USPQ2d 1786, 1787 (Fed. Cir. 1995) (“in determining whether a delay…was unavoidable, one
 looks to whether the party…exercised the due care of a reasonably prudent person”).
 While the legislative history of the American Inventors Protection Act of 1999 is silent
 as to the meaning of the phrase “in spite of all due care,” the phrases “all due care”
 and “unable to respond” invoke a higher degree of care than the ordinary due care
 standard of 35
 U.S.C. 133 , as well as the “reasonable efforts to conclude
 processing or examination [or prosecution] of an application” standard of
 35 U.S.C.
 154(b)(2)(C)(i) and (iii) . Therefore, applicants should not rely
 upon decisions relating to the “unavoidable delay” standard of 35 U.S.C. 133 
 as controlling in a request to reinstate reduced patent term adjustment on the basis of
 a showing that the applicant was unable to respond within the three-month period in
 spite of all due care.
 

Examples
 The following are examples of showings that may establish that the
 applicant was unable to respond within the three-month period in spite of all due
 care:
 

 
 (A) a showing that the original three-month period was
 insufficient to obtain the test data necessary for an affidavit or declaration
 under 37 CFR
 1.132 that was submitted with a reply filed outside the
 original three-month period; 
 

 (B) a showing that the applicant was unable to reply within the
 original three-month period due to a natural disaster; 
 

 (C) a showing that applicant was unable to reply within the
 original three-month period because testing was required to reply to an Office
 action, and the testing necessarily took longer than three months; or 
 

 (D) a showing that the applicant was unable to reply within the
 original three-month period due to illness or death of a sole practitioner of
 record who was responsible for prosecuting the application.
 

 
 The patent term adjustment reinstated would be limited to the period
 in which the showing establishes that the applicant was acting with all due care to
 reply to the Office notice or action, but circumstances (outside applicant’s control)
 made applicant unable to reply in spite of such due care. An applicant will not be
 able to show that the applicant was unable to reply within the three-month period “in
 spite of all due care” if the reply was not filed within the three-month period due
 to reasons within the control of applicant or agencies within the applicant’s
 control. 
 

 Examples of circumstances that would NOT establish that
 the applicant was unable to respond within the three-month period in spite of all due
 care are:
 

 
 (A) an applicant’s or representative’s preoccupation with other
 matters (e.g., an inter partes lawsuit or interference) that
 is given priority over prosecution of the application;
 

 (B) illness or death of the practitioner in charge of the
 application if the practitioner is associated (in a law firm) with other
 practitioners (since the other practitioners could have taken action to reply
 within the three-month period);
 

 (C) time consumed with communications between the applicant and
 the applicant's representative, regardless of whether the applicant resides in
 the United States or chooses to communicate with the United States
 representative via a foreign representative;
 

 (D) vacation or other non-attention to an application that results
 in a failure to reply within the three-month period;
 

 (E) applicant filing a reply on or near the last day of the
 three-month period using first class mail with a certificate of mailing under
 37 CFR
 1.8 , rather than by electronic filing, Priority Mail
 Express ® under 37 CFR
 1.10 or facsimile (if permitted), and the reply is not
 received (filed) in the Office until after the three-month period; or
 

 (F) failure of clerical employees of applicant or applicant’s
 representative to properly docket the Office action or notice for reply or
 perform other tasks necessary for reply within the three-month period.
 

 
 Rarely is the power of attorney given to a single attorney and often
 many attorneys are given power of attorney in an application. An attorney in
 litigation, working on an interference or taking a vacation is generally aware of
 that fact before the event and should make plans for another to take over the work so
 that it is completed and filed in the Office within the three-month period. Thus,
 failure to reply within the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) due to
 preoccupation with other matters (e.g., an inter partes lawsuit or
 interference) given priority over the application, or vacation or other non-attention
 to an application, cannot be relied upon to show that applicant was unable to reply
 “in spite of all due care” under 35 U.S.C. 154(b)(3)(C) .
 

 III. INTERIM PROCEDURE FOR REQUESTING PTA
 RECALCULATION WHEN THE OFFICE FAILS TO RECOGNIZE THE TIMELY FILING OF THE SAFE HARBOR
 STATEMENT For safe harbor statements under 37 CFR 1.704(d) filed
 before July 17, 2023, the Office has created an interim procedure by which a patentee
 can request recalculation of patent term adjustment where the sole reason for contesting
 the patent term adjustment determination is the Office’s failure to recognize a timely
 filed safe harbor statement accompanying an information disclosure statement. The
 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 is not applicable to safe harbor statements filed on or after July 17, 2023,
 because the Office updated the patent term adjustment computer program and provided
 notice to the public that the computer program had been updated in the final rule
 Standardization of the Patent Term Adjustment Statement Regarding
 Information Disclosure Statements, 88 FR 39172 (June 15, 2023). 
 

 Under the interim procedure, recalculation of patent
 term adjustment is requested by submitting form PTO/SB/134 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)”, is available on the USPTO website ( www.uspto.gov ) and is reproduced below.
 The form must be filed within the time period set forth in 37 CFR
 1.705(b) , and the Office 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) . 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. 
 

 If the request for recalculation is not based solely on
 the Office’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 Office’s recalculation of patent term
 adjustment, the Office will treat both papers together as a request for reconsideration
 of the patent term adjustment indicated on the patent under 37 CFR
 1.705(b) and require the fee set forth in 37 CFR
 1.18(e) .
 

 While the Office’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 form PTO/SB/134, it does not waive any extensions of time fees due under
 37 CFR
 1.705(b) and 37 CFR 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 Office may
 only refund fees paid by mistake or in excess of that required ( 35 U.S.C. 42(d) ).
 Thus, the interim procedure 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 Office's error in assessing an applicant delay 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 37 CFR 1.702 through
 1.704 . After the 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 date of the recalculation is mailed or given.
 No extensions of time will be granted. If patentee responds to the recalculation by
 requesting changes to the recalculation based on issues 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 Office’s determination of the amount of recalculated patent term adjustment is
 different from that printed on the front of the patent, the Office will sua
 sponte issue a certificate of correction that reflects the recalculated
 patent term adjustment. If patentee files a response after the Office’s recalculation
 and the Office maintains its recalculation, the Office 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 Office's
 initial recalculation of patent term adjustment under the interim procedure described
 above is not the Director’s decision under 35 U.S.C.
 154(b)(4) . 
 

 A copy of form PTO/SB/134 is reproduced below.

 

 

 

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 2701-Patent Term 

 2702-2709-[Reserved] 

 2710-Term Extensions or Adjustments for Delays Within the USPTO Under 35 U.S.C. 154 

 2711-2719-[Reserved] 

 2720-Applications Filed Between June 8, 1995, and May 28, 2000 

 2721-2729-[Reserved] 

 2730-Applications Filed on or After May 29, 2000; Grounds for Adjustment 

 2731-Period of Adjustment 

 2732-Reduction of Period of Adjustment of Patent Term 

 2733-Patent Term Adjustment Determination 

 2734-Application for Patent Term Adjustment; Due Care Showing 

 2735-[Reserved] 

 2736-Third-Party Papers 

 2737-2749-[Reserved] 

 2750-Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156 

 2751-Eligibility Requirements 

 2752-Patent Term Extension Applicant 

 2753-Application Contents 

 2754-Filing Date 
 2754.01-Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) 

 2754.02-Filing Window for an Application Under 35 U.S.C. 156(d)(5) 

 2754.03-[Removed and Reserved] 

 
 

 2755-Eligibility Determination 
 2755.01-Interim Extension of Patent Term During the Processing of the Application 

 2755.02-Interim Extension of Patent Term Before Product Approval 

 
 

 2756-Correspondence Between the USPTO and the Regulatory Agency 

 2757-Regulatory Agency Determination of the Length of the Regulatory Review Period 
 2757.01-Due Diligence Determination 

 
 

 2758-Notice of Final Determination - Calculation of Patent Term Extension 

 2759-Certificate of Extension of Patent Term 

 2760-Trade Secret, Confidential, and Protective Order Material 

 2761-Multiple Applications for Extension of Term of the Same Patent or of Different Patents for the Same Regulatory Review Period
 for a Product 

 2762-Duty of Disclosure in Patent Term Extension Proceedings 
 2762.01-Duty of Disclosure When a Terminal Disclaimer is Filed During Patent Term Extension Proceedings 

 
 

 2763-Limitation of Third-Party Participation 

 2764-Express Withdrawal of Application for Extension of Patent Term 

 2765-Petition for Stay in Processing of Patent Term Extension Application 

 2766-Processing of Patent Term Extension Applications When Reissue Has Been Filed 

 

 

 
 

 
 
 

 
 

 

 
 
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 Last Modified: 
 
 03/09/2026 20:50:49