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2734 Application for Patent Term Adjustment; Due Care Showing [R-2] - 2700 Patent Terms and Extensions


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2734 Application for Patent Term Adjustment; Due Care Showing [R-2]

37 CFR 1.705 Patent term adjustment determination.

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(b) Any request for reconsideration of the patent term adjustment indicated in the notice of allowance, except as provided in paragraph (d) of this section, and any request for reinstatement of all or part of the term reduced pursuant to § 1.704(b) must be by way of an application for patent term adjustment. An application for patent term adjustment under this section must be filed no later than the payment of the issue fee but may not be filed earlier than the date of mailing of the notice of allowance. 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 application for patent term adjustment under this section that requests 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 mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request must also 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 review or reconsideration of the patent term adjustment indicated in the notice of allowance (except as provided in 37 CFR 1.705(d)) and any request for reinstatement of all or part of the term reduced pursuant to 37 CFR 1.704(a) must be filed no later than the payment of the issue fee but may not be filed earlier than the date of mailing of the notice of allowance. 37 CFR 1.705(b) provides that any such request must be by way of an application for patent term adjustment accompanied by the fee set forth in 37 CFR 1.18(e) and a statement of the facts involved. 37 CFR 1.705(b) also provides that such statement of facts must specify: (1) 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 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). Since the Office must complete its determination of patent term adjustment before proceeding to issue the patent (35 U.S.C. 154(b)(3)(D)), the Office must require that such application for patent term adjustment be filed within a non-extendable time period and set forth with particularity why the Office's patent term adjustment determination is not correct. In the absence of these requirements, the issuance of the patent will be further delayed by a protracted patent term adjustment determination proceeding.

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)).

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 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

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

(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 term reinstated would be limited to the period in which the showing establishes that 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 he or she was unable to respond 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 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 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.

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 his or her 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).<

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