2734 Application for Patent Term Adjustment; Due Care Showing
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[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.]
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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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I. OFFICE PROCEDURE FOR THE TREATMENT OF REQUESTS FOR RECONSIDERATION OF PATENT TERM ADJUSTMENT
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 and a statement of the facts involved.
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 for which an adjustment is sought and the adjustment 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 (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).
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.
II. DUE CARE SHOWING
A request for reinstatement of all or part of the period of adjustment reduced 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; 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.
Filing a reply outside of three months after an Office action is per se a failure to engage in reasonable efforts to conclude prosecution unless applicant can establish that the delay was “in spite of all due care.”
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 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, rather than by electronic filing, Priority Mail Express® 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.
III. OPTIONAL PROCEDURE FOR SEEKING A PATENT TERM ADJUSTMENT CALCULATION FOR INTERNATIONAL APPLICATIONS THAT ISSUE BETWEEN JANUARY 14, 2013 AND MAY 13, 2014
IV. INTERIM PROCEDURE FOR REQUESTING PTA RECALCULATION WHEN THE OFFICE FAILS TO RECOGNIZE THE TIMELY FILING OF THE SAFE HARBOR STATEMENT
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.
