2734 Application for Patent Term Adjustment; Due Care Showing [R-11.2013]
37 C.F.R. 1.705 Patent term adjustment determination.
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- (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.
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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 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).
If the Office agrees with applicant’s request for reconsideration of the patent term adjustment determination, the Office will sua sponte issue a certificate of correction to revise the patent term adjustment determination on the patent in accordance with the determination by the Office.
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.
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.
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), Pub. L. No. 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.
I. 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 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.
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 the applicant of the rejection, objection, argument, or other request falls on a 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 § 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 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 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.
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 his or her 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, Express Mail 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.