Last month, the U.S. Patent and Trademark Office published a final rule in the Federal Register (85 Fed. Reg. 36335), in which the Office set forth revisions to the rules of practice concerning Patent Term Adjustment (PTA) in view of the Federal Circuit's decision in Supernus Pharm., Inc. v. Iancu. The final rule implements revisions that were previously discussed in a notice of proposed rulemaking published by the Office in May 2019 (see "USPTO Proposes Revisions to PTA Rules in View of Supernus v. Iancu"). With respect to the PTA rules being changed, the Office is revising the period of reduction of PTA in the following subsections of 37 C.F.R. § 1.704:

• Deferral of issuance of a patent (37 C.F.R. § 1.704(c)(2));
• Abandonment of an application (37 C.F.R. § 1.704(c)(3));
• Submission of a preliminary amendment (37 C.F.R. § 1.704(c)(6));
• Submission of papers after a decision by the Patent Trial and Appeal Board or by a Federal court (37 C.F.R. § 1.704(c)(9)); and
• Submission of papers after a notice of allowance under 35 U.S.C. § 151 (37 C.F.R. § 1.704(c)(10)).

According to the Office's notice, the revisions to the rules will specify a period of reduction corresponding to "the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution" as opposed to the consequences to the Office of applicant's failure to engage in reasonable efforts to conclude prosecution.

In Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit reversed the entry of summary judgment by the District Court for the Eastern District of Virginia, which concluded that the U.S. Patent and Trademark Office had not erred in calculating the PTA for U.S. Patent No. 8,747,897. During prosecution of U.S. Application No. 11/412,100, which issued as the '897 patent, the Examiner issued a final Office Action, and Supernus responded by filing a Request for Continued Examination (RCE). After filing the RCE, Supernus was notified that an opposition had been filed in related European Patent No. EP 2 010 189 (which had issued from a European application corresponding to an International application that claimed priority from the '100 application). One hundred days after the European Patent Office's notification of the opposition, Supernus filed a supplemental Information Disclosure Statement (IDS) citing the Notice of Opposition and other documents concerning the opposition. The USPTO ultimately issued the '100 application as the '897 patent, determining that the '897 patent was entitled to 1,260 days of PTA. The Office's PTA determination included an assessment of 886 days of applicant delay, of which 646 days were assessed for the time between the filing of the RCE and the submission of the supplemental IDS. Supernus filed a request for Reconsideration of Patent Term Adjustment, but the Office rejected Supernus' request, concluding that the 646-day reduction in PTA was proper.

Supernus challenged the Office's PTA determination in the Eastern District of Virginia, contending that it was entitled to at least 546 of the 646 days of PTA reduction (i.e., the period of time between the filing of the RCE and the EPO notification of opposition). The District Court granted summary judgment in favor of the USPTO, finding that the USPTO did not err in the PTA calculation for the '897 patent.

In January of 2019, the Federal Circuit reversed the District Court's grant of summary judgment in favor of the USPTO, finding that because there were "no identifiable efforts" that Supernus could have undertaken in the time period between the filing of an RCE during prosecution of the application that issued as the '897 patent and the mailing of an EPO notification of opposition for a European counterpart patent (which resulted in Supernus filing a supplemental Information Disclosure Statement during prosecution of the '897 patent), Supernus had not failed to engage in reasonable efforts to conclude prosecution during that time period. The Federal Circuit noted in Supernus that "Congress expressly granted the USPTO authority to determine what constitutes reasonable efforts [under 35 U.S.C. § 154(b)(2)(C)(i)], but the USPTO lacks any authority to exceed the statutory 'equal to' limitation by including the 546-day time period during which it does not contend that Supernus failed to undertake reasonable efforts to conclude prosecution." The Court therefore found the USPTO's PTA reduction for the '897 patent to be inconsistent with the PTA statute, accorded no deference to the USPTO's application of the regulations at issue in the circumstances of this case, and reversed and remanded the District Court's summary judgment order.

In the final rule, the Office points out that "[t]he Federal Circuit in Supernus held that a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application." As a result, the final rule revises certain provisions of 37 C.F.R § 1.704 for consistency with the Federal Circuit's decision in Supernus. The final rule explains that "[w]hile the Federal Circuit decision in Supernus involved 37 CFR 1.704(c)(8), there are several provisions in 37 CFR 1.704(c)(1) through (c)(14) whose period of reduction corresponds to or includes the consequences to the USPTO of the applicant's failure to engage in reasonable efforts to conclude prosecution, rather than 'the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution.'" Therefore, the final rule addresses that issue with respect to 37 C.F.R. § 1.704(c)(2), (3), (6), (9), and (10).

One addition to the rules revisions discussed in the Office's notice of proposed rulemaking involves after-allowance amendments or other after-allowance papers that are "expressly requested by the Office." In the final changes to 37 C.F.R. § 1.704(c)(10), the Office has excluded after-allowance amendments or other after-allowance papers that are "expressly requested by the Office" from the after-allowance amendments or other after-allowance papers that will result in a reduction of PTA under § 1.704(c)(10). Thus, the final rule states that "an amendment under § 1.312 or other paper not expressly requested by the USPTO (i.e., a 'voluntary' amendment under § 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under § 1.704(c)(10)." The notice also indicates that "[a]n amendment under § 1.312 or other paper going beyond what was requested by the USPTO (i.e., including material not expressly requested by the USPTO in addition to what was requested by the USPTO) would not be considered 'an amendment under § 1.312 or other paper expressly requested by the Office' under § 1.704(c)(10)" (emphasis added).

The notice points out that the phrase "expressly requested by the Office" in § 1.704(c)(10) "requires a specific request in an Office action or notice, or in an Examiner's Interview Summary (PTOL–413), for the amendment under § 1.312 or other paper" (emphasis added), and explains that:

[G]eneric language in an Office action or notice, such as a statement in a notice of allowability containing an examiner's amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by § 1.312 (section 1302.04 of the Manual of Patent Examining Procedure (MPEP)), is not a basis for considering an amendment under § 1.312 to be "expressly requested by the Office" within the meaning of § 1.704(c)(10) as adopted in this final rule. Similarly, the provisions of §§ 1.56, 1.97, and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper "expressly requested by the Office" within the meaning of § 1.704(c)(10). An information disclosure statement in compliance with §§ 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under § 1.704(c)(10) (or § 1.704(c)(6), (8), or (9) if the information disclosure statement is accompanied by a statement under § 1.704(d)).

Significantly, the notice indicates that even if an amendment under § 1.312 or other paper is expressly requested by the USPTO, if the amendment or other paper is not filed within three months from the date of mailing or transmission of the USPTO communication notifying the applicant of such request, the submission will result in a reduction of PTA under § 1.704(b).

According to the Office's notice, the final rule took effect on July 16, 2020, and the final rule applies to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. The notice also indicates that the Office is currently modifying its PTA computer program, which uses information recorded in the USPTO's Patent Application Locating and Monitoring (PALM) system to make an initial PTA determination, to implement the changes in the final rule. The Office notes that it will decide any timely request for reconsideration of such PTA determinations provided that the request complies with 37 C.F.R. § 1.705(b) (i.e., is made within seven months of patent issuance), regardless of whether the notice of allowance was mailed on or after July 16, 2020.

In addressing the seven comments the Office received in response to its notice of proposed rulemaking, the final rule also indicates that nothing in the revisions to 37 C.F.R. § 1.704(c)(10) has changed the list of papers that can be submitted after a notice of allowance is mailed without adversely impacting PTA. In particular, the Office has explained that the following papers may be submitted after a notice of allowance is mailed without resulting in a reduction of PTA under § 1.704(c)(10):

(1) Fee(s) Transmittal (PTOL–85B); (2) power of attorney; (3) power to inspect; (4) change of address; (5) change of entity status (micro/small/not small entity status); (6) a response to the examiner's reasons for allowance or a request to correct an error or omission in the "Notice of Allowance" or "Notice of Allowability"; (7) status letters; (8) requests for a refund; (9) an inventor's oath or declaration; (10) an information disclosure statement with a statement in compliance with § 1.704(d); (11) the resubmission by the applicant of unlocatable paper(s) previously filed in the application (§ 1.251); (12) a request for acknowledgment of an information disclosure statement in compliance with §§ 1.97 and 1.98, provided that the applicant had requested that the examiner acknowledge the information disclosure statement prior to the notice of allowance, or the request for acknowledgement was the applicant's first opportunity to request that the examiner acknowledge the information disclosure statement; (13) comments on the substance of an interview where the applicant-initiated interview resulted in a notice of allowance; and (14) letters related to government interests (e.g., those between NASA and the USPTO).

In addition, as discussed above, the Office has now added "an amendment under § 1.312 or other paper expressly requested by the Office" to the list of documents above.

Marked-up versions of the rules that the Office has revised are set forth below (note: subsections of 37 C.F.R. § 1.704(c) in which the term "mailing date" was changed to "date of mailing," but where no changes were made to the period of reduction of PTA, are not included below; a complete version of the revised rule can be found in the Federal Register notice for the final rule; bold, underlined text indicates changes to the rules since the Office's notice of proposed rulemaking).

1.704 Reduction of period of adjustment of patent term.

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(c) * * *

(2) Deferral of issuance of a patent under § 1.314, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under § 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued;

(3) Abandonment of the application or late payment of the issue fee, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the date the issue fee was due and ending on the earlier of:
(i) The date of mailing of the decision reviving the application or accepting late payment of the issue fee; or
(ii) The date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed;

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(6) Submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of:
(i) The number of days, if any, beginning on the day after the mailing date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the original Office action or notice of allowance national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date of mailing of the supplemental Office action or notice of allowance; the preliminary amendment or
(ii) Four months other preliminary paper was filed;

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(9) Submission of an amendment or other paper after a decision by the Board of Patent Appeals Trial and Interferences Appeal Board, other than a decision designated as containing a new ground of rejection under § 1.19641.50(b) of this title or statement under § 1.19641.50(c) of this title, or a decision by a Federal court, less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or supplemental notice of allowance, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of:
(i) The number of days, if any, beginning on the day after the mailing date of the original Office action decision by the Patent Trial and Appeal Board or notice of allowance by a Federal court and ending on the mailing date of the supplemental Office action or notice of allowance; amendment or
(ii) Four months other paper was filed;

(10) Submission of an amendment under § 1.312 or other paper, other than an amendment under § 1.312 or other paper expressly requested by the Office or a request for continued examination in compliance with § 1.114, after a notice of allowance has been given or mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of:
(i) The number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under § 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other paper; or
(ii) Four months;