I.       BACKGROUND

A. Twenty-Year Patent Term: Section 532(a) of the Uruguay Round Agreements Act (URAA)[1] amended 35 U.S.C. § 154 to provide that the term of a U.S. patent applied for on or after June 8, 1995 begins on its date of issue and ends on the date that is twenty years from the filing date of the application, or from the earliest filing date for which a benefit is claimed under 35 U.S.C. § 120, 121, or 365(c). The URAA also contained provisions, codified at 35 U.S.C. § 154(b), for patent term extension[2] due to certain examination delays. The URAA specifically provided for patent term extension for delays due to interference (which has since been replaced by derivation), secrecy order, or successful appellate review.[3]

B. Patent Term Adjustment: The American Inventors Protection Act of 1999 (AIPA)[4] revised 35 U.S.C. § 154(b) to provide for “patent term adjustment,” which included the bases for patent term extension under the URAA as well as additional bases for extension or adjustment.[5] Generally, the AIPA provides patent term adjustment for the following: (1) failure of the USPTO to take certain actions during the examination and issue process within specified time frames (known as “A” delays[6]); (2) failure of the USPTO to issue a patent within three years of the filing date of the application (known as “B” delays[7]); and (3) delays due to interference (now derivation[8]), secrecy order, or successful appellate review (known as “C” delays[9]).[10] The AIPA also sets forth a number of conditions and limitations on any patent term adjustment accorded to a patent.[11]

The Leahy-Smith America Invents Act (AIA) Technical Corrections Act AIA—an Act to correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code (AIA Technical Corrections Act)[12]—amended the AIPA patent term adjustment provisions. Specifically, section 1(h) of the AIA Technical Corrections Act revised the date from which the first “A” delay and the “B” delay is measured in a Patent Cooperation Treaty (PCT) international application (PCT application), as well as the provisions for notifying applicants of any patent term adjustment, and for seeking judicial review of patent term adjustment determinations.[13]

II.       AIPA PATENT TERM ADJUSTMENT—IN GENERAL

The patent term adjustment statute—35 U.S.C. § 154(b)—provides: (1) the bases for patent term adjustment in subsection (b)(1); (2) conditions and limitations (including possible reductions) of patent term adjustment in subsection (b)(2); (3) for patent term adjustment determinations by the USPTO in subsection (b)(3); and (4) for judicial review and third party challenges in subsection (b)(4).

The USPTO’s implementing regulations are in 37 C.F.R. §§ 1.702 through 1.705. 37 C.F.R. § 1.702 sets out the bases for patent term adjustment, and 37 C.F.R. § 1.703 sets out how any patent term adjustment is calculated. 37 C.F.R. § 1.704 sets out what circumstances will result in a reduction of patent term adjustment, as well as how any period of reduction is calculated. 37 C.F.R. § 1.705 provides for patent term adjustment determinations by the USPTO and requests for reconsideration of patent term adjustment determinations.[14]

III.       USPTO DELAYS RESULTING IN PATENT TERM ADJUSTMENT

A. The “A” Delays (35 U.S.C. § 154(b)(1)(A)): The “A” delay patent term adjustment provision applies when the USPTO fails to take certain actions during the examination and issue process within specified time frames and are set out in 35 U.S.C. § 154(b)(1)(A). The patent term adjustment statute provides that if the USPTO fails to meet any of the time frames set out in the “A” provision, “the term of the patent shall be extended 1 day for each day after the end of the period specified in [each of the “A” provision time frames], until the action . . . is taken.”[15]

1. First “A” Delay—First Action on an Application: The first “A” delay is failure of the USPTO to provide a notification under 35 U.S.C. § 132 (an Office action) or a notice of allowance under 35 U.S.C. § 151 (a Notice of Allowance) within fourteen months of (1) the filing date of an application under 35 U.S.C. § 111(a), or (2) the date of commencement of the national stage under 35 U.S.C. § 371[16] in a PCT application.[17] The USPTO regulations define the period of adjustment resulting from this delay as the number of days in the period beginning on the day after the date that is fourteen months after the date on which the application was filed under 35 U.S.C. § 111(a) or the date the national stage commenced under 35 U.S.C. § 371(b) or (f) in a PCT application and ending on the date of mailing of the first of either an Office action (35 U.S.C. § 132) or a Notice of Allowance (35 U.S.C. § 151).[18] A PCT applicant seeking to take advantage of early commencement of the national stage for patent term adjustment purposes must provide an express request under 35 U.S.C. § 371(f) and not rely upon general language requesting early examination and allowance.[19]

The USPTO has indicated that it considers the Office actions or notifications under 35 U.S.C. § 132 meeting the first “A” delay provision[20] to include Office actions issued during the course of examination under 35 U.S.C. § 131, which—in addition to an Office action on the merits of an application—includes a written restriction or election of species requirement, a requirement for information,[21] or an ex parte Quayle[22] Office action.[23] The USPTO, however, does not consider notices issued during the preexamination process to be Office actions or notifications under 35 U.S.C. § 132.[24] In addition, a flawed Office action is still considered an Office action or notification under 35 U.S.C. § 132 for patent term adjustment purposes, provided it is sufficiently informative to place the applicant on notice of the basis for rejection, objection, or requirement.[25]

2. Second “A” Delay—Responding to Replies and Appeals: The second “A” delay is failure of the USPTO to respond to a reply under 35 U.S.C. § 132 or an appeal taken under 35 U.S.C. § 134 within four months.[26] In defining the applicable period of delay under this “A” delay provision, the USPTO regulations set out three situations: (1) responding to a reply to a non-final Office action;[27] (2) responding to a reply to a final Office action;[28] and (3) responding to an appeal brief (“an appeal taken under [35 U.S.C. §] 134”[29]).[30]

For replies to a non-final Office action, the USPTO regulations define the period of adjustment resulting from this delay in responding to a reply to a non-final Office action as the number of days in the period beginning on the day after the date that is four months after the date a reply under 37 C.F.R. § 1.111 was filed and ending on the date of mailing of the first of either an Office action or a Notice of Allowance.[31]

For replies to a final Office action, the USPTO regulations define the period of adjustment resulting from this delay in responding to a reply to a final Office action as the number of days in the period beginning on the day after the date that is four months after the date a reply in compliance with 37 C.F.R. § 1.113(c) was filed and ending on the date of mailing of the first of either an Office action or a Notice of Allowance.[32] An applicant may file a request for reconsideration or proposed amendments after a final rejection or Office action.[33] A reply under 37 C.F.R. § 1.113(c), however, is limited to cancellation of, or appeal from the rejection of, each rejected claim. An applicant may also file a request for continued examination (RCE)[34] in reply to a final Office action. Thus, an applicant’s patent term adjustment “clock” does not stop, and the USPTO’s patent term adjustment “clock” does not start, until the applicant files an amendment that places the application in condition for allowance (which may be limited to canceling all rejected claims), an RCE, or an appeal from the rejection of each rejected claim.[35]

For an appeal brief, the USPTO regulations define the period of adjustment resulting from this delay in responding to an appeal as the number of days in the period beginning on the day after the date that is four months after the date a compliant appeal brief[36] was filed and ending on the date of mailing of the first of any of an examiner’s answer, an Office action, or a Notice of Allowance.[37]

3. Third “A” Delay—Acting on an Application After Appeal: The third “A” delay is failure of the USPTO to act on an application within four months after the date of a decision by the Patent Trial and Appeal Board (Board)[38] under 35 U.S.C. § 134 or 135 or a decision by a Federal court under 35 U.S.C. § 141, 145, or 146 in a case in which allowable claims remain in the application.[39] The USPTO interprets “allowable claims remain in the application” as requiring that after the Board or court decision there is at least one pending claim that is not withdrawn from consideration and is not subject to a rejection, objection, or other requirement.[40] The USPTO states that the “allowable claims remain in the application” provision applies in the following situations: (1) at least one claim is allowable (not merely objected to) at the time the examiner’s answer is mailed and is not canceled before, or made subject to a rejection as a result of, the appellate review; or (2) when all of the rejections applied to at least one claim are reversed, and such claim is not made subject to a rejection, as a result of the appellate review.[41] The USPTO regulations define the period of adjustment resulting from this delay as the number of days in the period beginning on the day after the date that is four months after the date of a final decision by the Board or by a Federal court where at least one allowable claim remains in the application and ending on the date of mailing of the first of either an Office action or a Notice of Allowance.[42]
4. Fourth “A” Delay—Issuing an Allowed Application: The fourth “A” delay is failure of the USPTO to issue a patent within four months after the date on which the issue fee was paid and all outstanding requirements were satisfied.[43] The USPTO regulations define the period of adjustment resulting from this delay as the number of days in the period beginning on the day after the date that is four months after the date the issue fee was paid and all outstanding requirements were satisfied and ending on the date a patent was issued.[44]

B. The “B” Delays (35 U.S.C. § 154(b)(1)(B)): The “B” delay patent term adjustment is failure of the USPTO to issue a patent within three years of: (1) the filing date of an application under 35 U.S.C. § 111(a); or (2) the date of commencement of the national stage under 35 U.S.C. § 371 in a PCT application.[45] The patent term adjustment statute provides that if the USPTO fails to meet this three-year time frame, “the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued.”[46] The USPTO regulations define the period of adjustment resulting from this delay as the number of days in the period beginning on the day after the date that is three years after the date on which the application was filed under 35 U.S.C. § 111(a), or the national stage commenced under 35 U.S.C. § 371(b) or (f) in a PCT application,[47]and ending on the date a patent was issued.[48]

The “B” provision excludes certain periods from its three-year period. These “B” provision exclusions apply both in determining whether the three-year period has been exceeded, as well as in determining the period of adjustment if the three-year period has been exceeded, regardless of whether the “B” provision exclusion event occurs before or after the three-year period has been exceeded.[49]

Several of the “B” delay exclusions[50] are related to “C” delay provisions. The “B” delay exclusions periods pertaining to interference/derivation and secrecy orders are covered in two corresponding “C” delay provisions.[51] The “B” delay exclusion period pertaining to appellate review is covered in a corresponding “C” delay provision, “if the patent was issued under a decision in the review reversing an adverse determination of patentability.”[52]

1. First “B” Exclusion—Continued Examination Requests: The first “B” provision exclusion is for any time consumed by continued examination of the application requested by the applicant under 35 U.S.C. § 132(b) (e.g., RCEs).[53] The USPTO regulations define this “B” provision exclusion period as the number of days in the period beginning on the date on which any request for continued examination of the application under 35 U.S.C. § 132(b) (RCE) was filed and ending on the date of mailing of the Notice of Allowance.[54]

This provision as originally implemented in 2000 defined the “B” provision exclusion “time consumed by continued examination” period as continuing until the date the patent was granted. The Federal Circuit, however, determined that the time consumed by continued examination under 35 U.S.C. § 132(b) does not include the time after a Notice of Allowance unless the USPTO actually resumes examination of the application after allowance.[55] The time consumed by continued examination under 35 U.S.C. § 132(b) (this “B” provision exclusion period), however, does not end until the actual allowance of an application, even if prior proceedings, such as a declaration of interference, “suggest” that the claims are allowable.[56]

If, however, the USPTO fails to recognize the filing of a continued examination request (e.g., an application is held abandoned because an RCE is not recognized), the time consumed by continued examination does not begin until the USPTO is actually conducting continued examination: i.e., until the application has been forwarded to the examiner for continued examination.[57]

2. Second “B” Exclusion—Interference/Derivation Proceedings: The second “B” provision exclusion is any time consumed by a proceeding under 35 U.S.C. § 135(a) (deviation or interference proceedings).[58] The USPTO regulations define this “B” provision exclusion period as the sum of: (1) the number of days in the period beginning on the date an interference or derivation proceeding was instituted to involve the application in the interference or derivation proceeding and ending on the date that the interference or derivation proceeding was terminated with respect to the application; and (2) the number of days in the period beginning on the date prosecution in the application was suspended by the Office due to interference or derivation proceedings not involving the application and ending on the date of the termination of the suspension.[59]
3. Third “B” Exclusion—Secrecy Orders: The third “B” provision exclusion is any time consumed by the imposition of an order under 35 U.S.C. § 181 (a secrecy order).[60] The USPTO regulations define this “B” provision exclusion period as the sum of: (1) the number of days the application was maintained in a sealed condition; (2) the number of days in the period beginning on the date of mailing of an examiner’s answer in the application under secrecy order and ending on the date the secrecy order was removed; (3) the number of days in the period beginning on the date applicant was notified that an interference or derivation proceeding would be instituted but for the secrecy order and ending on the date the secrecy order was removed; and (4) the number of days in the period beginning on the date of a notification that the application is in condition for allowance but for the secrecy order[61] and ending on the date of mailing of the Notice of Allowance.[62]
4. Fourth “B” Exclusion—Appellate Review: The fourth “B” provision exclusion is any time consumed by appellate review by the Board or by a Federal court.[63] The USPTO regulations define this “B” provision exclusion period as the number of days in the period beginning on the date on which jurisdiction over the application passes to the Board[64] and ending on the first of the date that jurisdiction by the Board ends[65] or the date of the last decision by a Federal court in an appeal under 35 U.S.C. § 141 or a civil action under 35 U.S.C. § 145.[66]
5. Fifth “B” Exclusion—Applicant Requested Delays: The fifth “B” provision exclusion is “any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by [35 U.S.C. § 154(b)](3)(C).”[67] This “B” provision exclusion is treated as circumstances constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.[68]

C. The “C” Delays (35 U.S.C. § 154(b)(1)(C)): The “C” delay patent term adjustment is for delays due to derivation proceedings, secrecy orders, and “successful” appellate review. The patent term adjustment statute provides that the patent is delayed by one or more of these proceedings, the term of the patent “shall be extended 1 day for each day of the pendency of the proceeding, order, or review, as the case may be.”[69]

1. First “C” Delay—Interference/Derivation Proceedings: The first “C” delay is for interference or derivation proceedings under 35 U.S.C. § 135(a).[70] The USPTO regulations define the period of adjustment resulting from this delay as the sum of: (1) the number of days in the period beginning on the date an interference or derivation proceeding was instituted to involve the application in the interference or derivation proceeding and ending on the date that the interference or derivation proceeding was terminated with respect to the application; and (2) the number of days in the period beginning on the date prosecution in the application was suspended by the Office due to interference or derivation proceedings not involving the application and ending on the date of the termination of the suspension.[71] This provision tracks the “B” delay exclusion period for deviation or interference proceedings, in that the applicant is entitled to “C” delay adjustment for any interference/derivation proceeding time (whether or not pendency of the application exceeds three years), but that time is excluded in determining whether the applicant is entitled to three-year “B” delay adjustment.[72]
2. Second “C” Delay—Secrecy Orders: The second “C” delay is for imposition of a secrecy order under 35 U.S.C. § 181.[73] The USPTO regulations define the period of adjustment resulting from this delay as the sum of: (1) the number of days the application was maintained in a sealed condition; (2) the number of days in the period beginning on the date of mailing of an examiner’s answer in the application under secrecy order and ending on the date the secrecy order was removed; (3) the number of days in the period beginning on the date applicant was notified that an interference or derivation proceeding would be instituted but for the secrecy order and ending on the date the secrecy order was removed; and (4) the number of days in the period beginning on the date of a notification that the application is in condition for allowance but for the secrecy order (D-10 Notice) and ending on the date of mailing of the Notice of Allowance.[74] This provision similarly tracks the “B” provision exclusion period for secrecy orders, in that the applicant is entitled to “C” delay adjustment for any secrecy order time (again whether or not pendency of the application exceeds three years), but that time is excluded in determining whether the applicant is entitled to three-year “B” delay adjustment.[75]
3. Third “C” Delay—“Successful” Appellate Review: The third “C” delay is for appellate review by the Board or by a Federal court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability (“successful appellate review”).[76] The USPTO regulations define the period of adjustment resulting from this delay as the number of days in the period beginning on the date on which jurisdiction over the application passes to the Board and ending on the date of a final decision in favor of the applicant by the Board or by a Federal court.[77] This provision differs from the “B” provision exclusion period for appellate review, in that the applicant is entitled to “C” delay adjustment for appellate review time (again whether or not pendency of the application exceeds three years) only if “the patent was issued under a decision in the review reversing an adverse determination of patentability,”[78] but all appellate review time is excluded in determining whether the applicant is entitled to three-year “B” delay adjustment.[79] This provision also differs from the “B” provision exclusion period for appellate review in that the period of adjustment for “C” delay appellate review time ends on the date of a final decision in favor of the applicant by the Board or by a Federal court,[80] where the corresponding “B” provision exclusion period ends on the later of the date that jurisdiction by the Board ends or the date of the last decision by a Federal court.[81]

a. Successful Appellate Review – Patent Issued under a Decision in the Review Reversing an Adverse Determination of Patentability: The successful appellate review provision requires that there be a Board decision reversing the examiner’s unpatentability ruling or a Federal court decision reversing the Board’s unpatentability ruling.[82] An examiner’s decision to allow the application after the appeal, including after a series of appeals and reopenings of prosecution, does not quality as successful appellate review, absent a decision by the Board or a Federal court.[83] This may be important when the appeal and reopening of prosecution take place after the filing of an RCE, as an applicant is not entitled to “C” delay adjustment absent a decision by the Board or a Federal court, and time consumed by RCEs is excluded from any “B” delay adjustment.[84]

The USPTO interpreted the successful appellate review provision in 2000 as requiring a decision by the Board or a Federal court that results in the reversal of all rejections of at least one claim, with that claim not being subject to a new ground of rejection.[85] This reading of the successful appellate review provision[86] enables the USPTO to determine whether a Board or court decision is such that “the patent was issued under a decision in the review reversing an adverse determination of patentability” from information concerning the decision that is recorded in the PALM system.[87] The Federal Circuit, in upholding a decision by the USPTO that the appellate review at issue did not qualify as successful appellate review, interpreted “the patent was issued under a decision in the review reversing an adverse determination of patentability” even more narrowly.[88] The Federal Circuit explained that the successful appellate review provision[89] requires more than just a Board (or Federal court) decision “reversing an adverse determination of patentability,” but that the phrase “issued under a decision in the review” requires that at least one claim must “issue[ ] under” the mandate of the appellate decision, and “[a]t a minimum, this means that at least one claim that ‘issued’ must have been analyzed by the Board or District Court that issued the ‘decision in the review.’”[90] The Federal Circuit further stated that this “statutory requirement is not met if the claim that ultimately issues differs substantively from the claim under review.”[91] The Federal Circuit rejected the patentee’s argument a “‘patent was issued under a decision in the review’” if “the claim would not have issued but-for the successful appeal,” stating that such an “interpretation effectively reads out the phrase ‘in which the patent was issued under a decision in the review.’”[92] Thus, even if there is a Board or Federal court decision that results in the reversal of all rejections of at least one claim (and with that claim not being subject to a new ground of rejection), to obtain patent term adjustment under the successful appellate review provision, an applicant must ensure that at least one claim in the patent issued under the mandate of the Board or Federal court decision: i.e., that at least one claim in the patent does not differ substantively from a claim reviewed in the Board or Federal court decision and for which the Board or Federal court decision reversed the adverse patentability determination (and not simply a particular rejection).

The USPTO’s rules implementing the successful appellate review provision also provide that if an application is remanded by the Board and the remand is the last action by the Board prior to the mailing of a Notice of Allowance in the application, the remand shall be considered “a decision in the review reversing an adverse determination of patentability” under the successful appellate review provision.[93] This provision was added in 2004 when there were a number of remands by the Board that resulted in the examiner not returning the application to the Board for decision but simply allowing the application.[94] Such remands followed by an allowance are less frequent now than they were in the early 2000s. It remains to be seen whether the Federal Circuit would consider a patent issued following such a remand to be a “patent was issued under a decision in the review reversing an adverse determination of patentability” under the successful appellate review provision.

b. Appellate Review Time: The USPTO initially treated appellate review time for purposes of both the exclusion from the “B” delay period and the “C” delay period as beginning on the date of a notice of appeal. The USPTO, however, determined that the better reading of the AIPA patent term adjustment statute would be treat appellate review time as beginning on the date on which jurisdiction over the application passes to the Board, both for purposes of the successful appellate review provision[95] and the exclusion of all appellate review time from the three-year “B” delay provision.[96] [97] With this change, the time taken after the filing of a notice of appeal (including appeal conferences, reopening of prosecution, and allowances without a Board decision) could be considered under the three-year “B” delay provision.[98]

IV.    LIMITATIONS ON PATENT TERM ADJUSTMENT

A. Overlapping Delays: The first limitation on patent term adjustment is that to the extent that periods of delay attributable to grounds specified in the “A” provision, “B” provision, and “C” provision overlap, the period of any patent term adjustment “shall not exceed the actual number of days the issuance of the patent was delayed.”[99] The USPTO’s initial interpretation of this provision was: if an application is entitled to an adjustment under the three-year “B” provision,[100] the entire period during which the application was pending before the USPTO (except for periods excluded under the “B” provision[101]), and not just the period beginning three years after the actual filing date of the application, is the relevant period in determining whether periods of delay “overlap” under 35 U.S.C. § 154(b)(2)(A).[102] The Federal Circuit disagreed with this interpretation, taking the position that “A” delay and “B” delay overlap only when there is an overlap in the periods used to measure the amount of adjustment under the “A” delay and “B” delay provisions.[103] The USPTO adjusted its patent term adjustment computer program for consistency with this decision and created a streamlined process for patentees to request a patent term adjustment recalculation, but the USPTO restricted this recalculation possibility to those applicants who were within the time period for seeking reconsideration of a USPTO patent term adjustment determination or decision on reconsideration of a patent term adjustment determination, or judicial review of a USPTO patent term adjustment determination.[104] This resulted in a few lawsuits challenging, without success, the USPTO’s interim procedure and the USPTO’s restriction of this interim procedure to those who were within the time period for seeking reconsideration of a USPTO patent term adjustment determination or decision on reconsideration of a patent term adjustment determination, or judicial review of a USPTO patent term adjustment determination.[105]

B. Disclaimers: The second limitation on patent term adjustment is that “[n]o patent the term of which has been disclaimed beyond a specified date may be adjusted under [35 U.S.C. § 154] beyond the expiration date specified in the disclaimer.”[106] A terminal disclaimer—a disclaimer of term beyond a particular date—may and often is filed to address obviousness-type (or “nonstatutory”) double patenting, and thus terminal disclaimers and double patenting are treated as “inextricably intertwined.”[107] If a patent is subject to a terminal disclaimer, 35 U.S.C. § 154(b)(2)(B) places a limit on any amount of patent term adjustment under 35 U.S.C. § 154 the patent may receive.[108] Where a patent is not subject to a terminal disclaimer, whether there is double patenting is based on the patent’s expiration date after any patent term adjustment is applied.[109]

C. Reduction of Patent Term Adjustment: In addition to the previously discussed limitations on patent term adjustment, the period of patent term adjustment “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.”[110] The patent statute specifically sets out one failure to engage in reasonable efforts (a three-month response time frame),[111] and then provides that the USPTO Director “shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.”[112] Thus, the circumstances resulting in a reduction of patent term adjustment are a combination of statute and regulation.

1. Time Frame for Applicant Replies: The failure to engage in reasonable efforts specifically set forth in the patent statute is “[w]ith respect to adjustments to patent term made under the [“B” provision], an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of 3 months that are taken to respond to a notice from the Office making any rejection, objection, argument, or other request, measuring such 3-month period from the date the notice was given or mailed to the applicant.[113] The USPTO implemented this provision in 37 C.F.R. § 1.704(b), applying this failure to engage in reasonable efforts to the “A” and “C” provisions in addition to the “B” provision. This three-month timeframe for replies to Office actions applies regardless of the time period set for reply in the Office action or notice.[114]
2. Failures to Engage Defined by Regulation: The remaining circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application (“failure to engage in reasonable efforts”) are set forth in 37 C.F.R. § 1.704(c), which sets out various actions or delays in taking action (inaction) that amount to a failure to engage in reasonable efforts along with the resulting period of reduction.[115] If an applicant’s conduct falls within one of the enumerated failures to engage in reasonable efforts specified in 37 C.F.R. §§ 1.704(c)(1) through (c)(14), the patent term adjustment “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.”[116] There is no requirement that the applicant’s conduct actually have delayed prosecution of the application or caused the USPTO to exceed a patent term adjustment time frame.[117] However, the period of reduction for failure to engage in reasonable efforts may not exceed “the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.”[118]

a. Suspension of Action: The first failure to engage in reasonable efforts set out in the USPTO’s regulations is suspension of action[119] at the applicant’s request.[120] This will result in the period of patent term adjustment being reduced by the number of days beginning on the date a request for suspension of action was filed and ending on the date of the termination of the suspension.

b. Deferral of Issuance: The second failure to engage in reasonable efforts set out in the USPTO’s regulations is deferral of issuance of a patent[121] at the applicant’s request.[122] This will result in the period of patent term adjustment being reduced by the number of days beginning on the date a request for deferral of issuance of a patent 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.

c. Abandonment of the Application: The third failure to engage in reasonable efforts set out in the USPTO’s regulations is abandonment of the application or late payment of the issue fee.[123] This will result in the period of patent term adjustment being reduced by the number of days beginning on the date of abandonment or the day after the date the issue fee was due and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed.

d. Delayed Petition to Withdraw Abandonment: The fourth failure to engage in reasonable efforts set out in the USPTO’s regulations is failure to file a petition to withdraw the holding of abandonment or to revive an application within two months from the date of mailing of a notice of abandonment.[124] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date that is two months from the date of mailing of a notice of abandonment and ending on the date a petition to withdraw the holding of abandonment or to revive the application was filed.

e. Conversion of Provisional Application: The fifth failure to engage in reasonable efforts set out in the USPTO’s regulations is conversion of a provisional application[125] into a nonprovisional application.[126]This will result in the period of patent term adjustment being reduced by the number of days beginning on the date the provisional application was filed and ending on the date a compliant[127] request to convert the provisional application into a nonprovisional application was filed.[128] Filing a nonprovisional application that claims benefit of a prior-filed provisional application is often referred to colloquially as “conversion” of the provisional application. This failure to engage provision is not directed to this customary practice of a filing a nonprovisional application claiming benefit of a prior-filed provisional application, but is directed to the literal conversion of a provisional application itself into a nonprovisional application, a practice that is uncommon and inadvisable except in extremely limited situations.[129]

f. Preliminary Amendment/Paper: The sixth failure to engage in reasonable efforts set out in the USPTO’s regulations is submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action or Notice of Allowance that requires the mailing of a supplemental Office action or Notice of Allowance.[130] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date that is eight months from either the date on which the application was filed or the date of commencement of the national stage under 35 U.S.C. § 371(b) or (f) in a PCT application and ending on the date the preliminary amendment or other preliminary paper was filed.

g. Incomplete Replies: The seventh failure to engage in reasonable efforts set out in the USPTO’s regulations is submission of a reply having an omission (See 37 C.F.R. § 1.135(c)).[131] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed.

h. Supplemental Reply/Paper: The eighth failure to engage in reasonable efforts set out in the USPTO’s regulations is submission of a supplemental reply or other paper, other than a supplemental reply or other paper expressly requested by the examiner, after a reply has been filed.[132] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date the initial reply was filed and ending on the date that the supplemental reply or other such paper was filed.

i. Submissions After Board Decision: The ninth failure to engage in reasonable efforts set out in the USPTO’s regulations is submission of an amendment or other paper after a decision by the Board, other than a decision designated as containing a new ground of rejection[133] or “statement under [37 C.F.R.] § 41.50(c),”[134] or a decision by a Federal court, less than one month before the mailing of an Office action or a Notice of Allowance that requires the mailing of a supplemental Office action or supplemental Notice of Allowance.[135] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date of the decision by the Board or by a Federal court and ending on date the amendment or other paper was filed.

j. Submissions After Allowance: The tenth failure to engage in reasonable efforts set out in the USPTO’s regulations is submission of an amendment after allowance[136] or other paper after a Notice of Allowance has been given or mailed, excluding an amendment or other paper expressly requested by the Office, or an RCE in compliance with 37 C.F.R. § 1.114.[137] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date of mailing of the Notice of Allowance and ending on the date the amendment after allowance or other paper was filed.

Certain after allowance submissions, such a paper expressly requested by the Office, an RCE in compliance with 37 C.F.R. § 1.114, or a request for reinstatement of reduced patent term adjustment, are excluded by the express terms of the rules.[138] The USPTO has also indicated that the submission of the following papers after a Notice of Allowance will not result in a reduction of patent term adjustment under 37 C.F.R. § 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 (IDS) with a statement in compliance with 37 C.F.R. § 1.704(d); (11) the resubmission by the applicant of unlocatable paper(s) previously filed in the application (37 C.F.R. § 1.251); (12) a request for acknowledgment of a compliant[139] IDS, provided that the applicant had requested that the examiner acknowledge the IDS prior to the Notice of Allowance, or the request for acknowledgement was the applicant’s first opportunity to request that the examiner acknowledge the IDS; (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.[140]

k. Delayed Compliant Appeal Brief: The eleventh failure to engage in reasonable efforts set out in the USPTO’s regulations is failure to file a compliant appeal brief within three months from the date on which a notice of appeal to the Board was filed.[141] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date three months from the date on which a notice of appeal to the Board was filed and ending on the date a compliant appeal brief in (or RCE in compliance with 37 C.F.R. § 1.114) was filed.

l. After Allowance Request for Continued Examination: The twelfth failure to engage in reasonable efforts set out in the USPTO’s regulations is submission of a request for continued examination under 35 U.S.C. § 132(b) after any Notice of Allowance has been mailed.[142] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the date of mailing of the Notice of Allowance and ending on the date the request for continued examination under 35 U.S.C. § 132(b) was filed.

m. Delay in Putting an Application in Condition for Examination: The thirteenth failure to engage in reasonable efforts set out in the USPTO’s regulations is failure to provide an application in condition for examination within 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 national stage under 35 U.S.C. § 371(b) or (f) in a PCT application.[143] This will result in the period of patent term adjustment being reduced by the number of days beginning on the day after the 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 national stage under 35 U.S.C. § 371(b) or (f) in a PCT application and ending on the date the application is in condition for examination.

There is no requirement that the applicant have been notified by the USPTO of the need for corrective action to place the application in condition for examination within this eight-month period.[144] Where the USPTO does notify an applicant of the need for corrective action to place the application in condition for examination, the applicant must reply to that USPTO notice and place the application in condition for examination within three months of the date of the USPTO notice and also within eight months of the filing of the application under 35 U.S.C. § 111(a) (or of the date of commencement of the national stage under 35 U.S.C. § 371(b) or (f) in a PCT application) to avoid a reduction of patent term adjustment.[145]

The phrase “in condition for examination” is defined in an application filed under 35 U.S.C. § 111(a) as meaning that the application includes: (1) a specification, including at least one claim and an abstract, with compliant application papers and drawings (if any),[146] and any required English-language translation;[147] (2) a compliant “Sequence Listing” (if applicable);[148] (3) an inventor’s oath or declaration, or application data sheet containing the information specified in 37 C.F.R. § 1.63(b); (4) the basic filing fee,[149] search fee,[150] examination fee,[151] and any required application size fee;[152] and (5) any required certified copy of a previously filed application.[153] The phrase “in condition for examination” is defined in a PCT application as meaning that the application has entered the national stage[154] and includes: (1) a specification, including at least one claim and an abstract, with compliant application papers and drawings (if any); (2) a compliant “Sequence Listing” (if applicable);[155] (3) an inventor’s oath or declaration or an application data sheet containing the information specified in 37 C.F.R. § 1.63(b); (4) the search fee,[156] examination fee,[157] and (5) and any required application size fee.[158]

An application, however, will be considered as having compliant papers, drawings (if any), and “Sequence Listing” (if applicable) for purposes of 37 C.F.R. § 1.704(f) on the filing date of the latest reply (if any) correcting the papers, drawings, or “Sequence Listing,” that is prior to the date of mailing of the either an Office action or a Notice of Allowance.[159] Thus, the issuance of a requirement for corrected application papers or drawings, or for a compliant “Sequence Listing,” with or after the issuance of either an Office action or a Notice of Allowance does not trigger a patent term adjustment reduction under 37 C.F.R. § 1.704(c)(13).

n. Continuing Applications: The fourteenth failure to engage in reasonable efforts set out in the USPTO’s regulations is further prosecution via a continuing application.[160] This will result in the period of patent term adjustment being reduced by any period that is prior to the actual filing date of the application that resulted in the patent. This provision is designed to ensure that patent term adjustment accumulated in a prior or parent application does not carry over to a continuing application.[161] This provision may now be superfluous as the Federal Circuit has held that “the plain language of 35 U.S.C. § 154(b)(1)(A) does not provide patent term adjustment in continuing applications based on delays in the prosecution of parent applications.”[162]

3. Period of Reduction: The USPTO’s regulations specify the resulting period of reduction of any patent term adjustment when setting out the circumstances constituting a failure to engage in reasonable efforts to conclude processing or examination of an application.[163] The period of reduction, however, may not exceed “the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application,” and thus may not include “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.”[164] The USPTO has indicated that a patentee who believes that the period of reduction exceeds the period of time during which the patentee failed to engage in reasonable efforts to conclude prosecution of the application because there is no identifiable effort the patentee could have undertaken to conclude prosecution of the application may raise the issue in a request for reconsideration of the patent term adjustment.[165] The USPTO, however, has rejected the argument that the applicant must be notified by the USPTO of the need for corrective action before there is an identifiable effort the patentee (applicant) could have undertaken to place an application in condition for examination.[166]

4. Information Disclosure Statements: Safe Harbor: Filing an IDS at an inopportune time during the prosecution of an application may result in a reduction of patent term adjustment. Specifically, filing an IDS after the filing of a reply to an Office action (a supplemental paper) or after a Notice of Allowance will result in a reduction of any patent term adjustment.[167] Filing an IDS prior to a first Office action or first action Notice of Allowance (a preliminary paper), or after a Board decision but before the next Office action or a Notice of Allowance, will also result in a reduction of any patent term adjustment if the IDS was filed within one month of the Office action or Notice of Allowance and requires a supplemental Office action or Notice of Allowance.[168] Filing an IDS with a reply to an Office action, however, will not result in a reduction of patent term adjustment under these patent term adjustment reduction provisions.

The patent term adjustment regulations also contain a “safe harbor” with respect to IDSs: a paper containing only an IDS that complies with the IDS rules[169] will not result in a reduction of patent term adjustment under these patent term adjustment reduction provisions,[170] if accompanied by a statement that the IDS was filed within a thirty-day, non-extendable period.[171] This “safe harbor” time period is different from the time period for the timeliness statement under the IDS rules: thirty days for the patent term adjustment “safe harbor” versus three months for timeliness under the IDS rules.[172] The required language for the patent term adjustment “safe harbor” statement is also different from the language for the timeliness statement under the IDS rules, [173] in that the patent term adjustment “safe harbor” statement covers only information contained in a communication from a patent office in a counterpart foreign or international application or from the USPTO.[174]

The USPTO revised its regulations in June of 2023 to provide that this safe harbor statement must be submitted on the USPTO safe harbor statement form (PTO/SB/133) using the appropriate document code (PTA.IDS).[175] If not submitted on the USPTO safe harbor statement form (PTO/SB/133), the applicant will need to file a request for reconsideration of the patent term adjustment to obtain the benefit of having submitted an IDS with a safe harbor statement.[176] The USPTO cautions that no changes may be made to the statements on the USPTO safe harbor statement form, and that the presentation to the Office (whether by signing, filing, submitting, or later advocating) of this form, whether by a practitioner or non-practitioner, constitutes a certification under 37 C.F.R. § 11.18(b) that the existing text and any certification statements on this form have not been altered.[177]

V. USPTO PATENT TERM ADJUSTMENT DETERMINATIONS

The patent statute provides that the USPTO Director “shall prescribe regulations establishing procedures for the application for and determination of patent term adjustments under this subsection.”[178] The patent statute also provides that under these procedures, the Director shall (1) “make a determination of the period of any patent term adjustment under [35 U.S.C. § 154(b)], and shall transmit a notice of that determination no later than the date of issuance of the patent”;[179] and “provide the applicant one opportunity to request reconsideration of any patent term adjustment determination made by the Director.”[180]

A. Initial Patent Term Adjustment Determination: The patent term adjustment regulations provide that the patent will include notification of any patent term adjustment.[181] The USPTO cannot calculate the patent term adjustment until the issue date is known, which occurs at most only a few weeks prior to issuance.[182] The USPTO makes the patent term adjustment determinations indicated in patents by a computer program (the “patent term adjustment calculator”) that uses information recorded in its Patent Application Locating and Monitoring (PALM) system[183] relating to the communications exchanged between applicants and the USPTO during the patent application process.[184] The patent examiner is not involved in patent term adjustment determinations (or requests for reconsideration of patent term adjustment).

The patent term adjustment calculations in brief: the overall patent term adjustment is calculated by summing the periods of “A” delay, “B” delay, and “C” delay (the plus adjustments), eliminating any overlapping periods, and then subtracting any reduction periods.[185] The periods of delay in the “C” provision are measured from the beginning date to ending date of the proceeding, order, or review. The periods of delay in the “A” and “B” provisions, however, are measured from “after the end” of the specified time frame. Thus, the periods of delay in the “A” and “B” provisions are measured from the day “after the date” (and not the date itself).

The USPTO uses the actual filing dates of applicant replies and other submissions, and not the date indicated on a certificate of mailing or transmission under 37 C.F.R. § 1.8, in its patent term adjustment calculation.[186] The carry-over provisions of 35 U.S.C. § 21(b), however, are applicable to the patent term adjustment time periods. This cuts both ways. When the date that is three months from the issue date of an Office action falls on a weekend or Federal holiday, a reply filed on the first business day after the expiration of that three-month is not considered an applicant delay under 35 U.S.C. § 154(b)(2)(C)(ii) and 37 C.F.R. § 1.704(b).[187] However, when the thirty-month period for national stage commencement falls on a weekend or Federal holiday, national stage commencement does not begin until the first business day after the expiration of that thirty-month period.[188]

B. Request for Reconsideration of Patent Term Adjustment Determinations: The patent term adjustment regulations also provide 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 filed no later than two months from the date the patent was granted, but that this two-month time period may be extended under the provisions of 37 C.F.R. § 1.136(a). 37 C.F.R. § 1.136(a) allows for extension of a time period by up to an additional five months (subject to any statutory limitation).

An application for patent term adjustment under 37 C.F.R. § 1.705 must be accompanied by a fee[189] and a statement of the facts involved. The statement of facts must specify: (1) the correct patent term adjustment and the basis or bases for the adjustment;[190] (2) the relevant dates as specified in 37 C.F.R. §§ 1.703(a) through (e) for which an adjustment is sought and the patent term 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 (4a) 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;[191] or (4b) that there were no circumstances constituting a failure to engage in reasonable efforts to conclude processing or examination of the application.[192]

If there is a request for reconsideration of the patent term adjustment, the USPTO will conduct a manual redetermination of the patent term adjustment.[193] This manual redetermination of patent term adjustment could result in the patentee receiving more patent term adjustment, the same amount of patent term adjustment (no change), or a lower amount of patent term adjustment as the initial patent term adjustment indicated in the patent.[194] Put simply, the USPTO’s manual redetermination of the patent term adjustment in response to a request for reconsideration may result in a lower amount of patent term adjustment, and that new amount becomes the USPTO’s patent term adjustment determination.[195]

The USPTO has indicated that it considers the provisions of 37 C.F.R. § 1.705 to be the sole avenue for seeking reconsideration of a patent term adjustment determination, whether the USPTO’s patent term adjustment determination is greater than or less than the adjustment that the applicant or patentee believes to be appropriate.[196] The USPTO has indicated that it will treat letters submitted by applicants and patentees stating that the USPTO’s patent term adjustment determination indicated on a notice of allowance, issue notification, or patent is greater than what the applicant or patentee believes is appropriate by placing these letters in the file of the application or patent without comment, but that a patentee may also file a terminal disclaimer at any time disclaiming any period considered in excess of the appropriate patent term adjustment.[197]

C. Reinstatement of Reduced Patent Term Adjustment: The patent term adjustment statute also provides that the USPTO Director “shall reinstate all or part of the cumulative period of time of an adjustment under [35 U.S.C. § 154(2)(C)] if the applicant, prior to the issuance of the patent, makes a showing that, in spite of all due care, the applicant was unable to respond within the 3-month period, but in no case shall more than three additional months for each such response beyond the original 3-month period be reinstated.”[198] The key aspects of this provision are that: (1) the showing must be made “prior to issuance of the patent” and (2) the showing required is that “the applicant was unable to respond” “in spite of all due care.”[199] The USPTO has indicated that the “in spite of all due care” standard is higher than the (now former) “unavoidable delay” standard, and also provides a few examples of what might qualify under the “in spite of all due care” standard.[200]

VI. JUDICIAL REVIEW OF USPTO PAYENT TERM ADJUSTMENT DETERMINATIONS

35 U.S.C. § 154(b)(4) provides that “an applicant dissatisfied with the Director’s decision on the applicant’s request for reconsideration under [35 U.S.C. § 154(b)](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 of the Director’s decision on the applicant’s request for reconsideration”[201] and that “[c]hapter 7 of title 5 shall apply to such action” (i.e., the civil action is governed by the Administrative Procedure Act). 35 U.S.C. § 154(b)(4) then provides that [a]ny final judgment resulting in a change to the period of adjustment of the patent term shall be served on the Director, and the Director shall thereafter alter the term of the patent to reflect such change.”[202]

Finally, the statute provides that the determination of a patent term adjustment under this subsection shall not be subject to appeal or challenge by a third party prior to the grant of the patent. While this provision has a “prior to the grant of the patent” limitation, the USPTO is likely to advise third parties that their remedy, if one exists, is the provision of 35 U.S.C. § 282(c)[203] concerning the defense during the extended (adjusted) term of a patent as to 35 U.S.C. § 154(b).[204]

VII      MISCELLANY

A. Impact of the Demise of Chevron: Patent term adjustment is one of the few areas in which the Federal Circuit has applied the Chevron doctrine[205] in reviewing the patent-related decisions of the USPTO.[206] Some decisions discuss Chevron deference in upholding the USPTO’s decision,[207] even to say it is unnecessary,[208] where others state that the USPTO’s interpretation is at odds with the statutory language so Chevron is to no avail.[209] The demise of Chevron, however, may not result in a wholesale revisiting of the Federal Circuit’s patent term adjustment decisions.

In dispatching Chevron, the Supreme Court noted that Congress may, subject to constitutional limits, and often does, confer discretionary authority on agencies.[210] The patent statute gives the USPTO general authority to establish regulations that “govern the conduct of proceedings” in the USPTO.[211] The patent term adjustment statute also gives the USPTO express authority in two specific areas: (1) one provides that “[t]he Director shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application”;[212] and (2) another provides that “[t]he Director shall prescribe regulations establishing procedures for the application for and determination of patent term adjustments under [35 U.S.C. § 154(b)].”[213]

As to regulations pertaining to the circumstances defined as failures of an applicant to engage in reasonable efforts to conclude processing or examination of an application,[214] the procedures for patent term adjustment determinations,[215] or the minutia of patent prosecution practice before the USPTO,[216] the USPTO’s regulations in these areas are likely to be given considerable respect, if not “deference.”[217] The Federal Circuit, however, is now less likely to defer to the USPTO’s interpretation of patent term adjustment provisions that do not confer authority on the USPTO to regulate.[218]

B. Patent Term Adjustment Impact on Recent PIER Initiative: The USPTO implemented a PCT Informed Examination Request (PIER) pilot program.[219] Under the PIER program, the USPTO will issue a requirement for information under 37 C.F.R. § 1.105 in selected PCT applications, which will require the applicant to indicate, on a prescribed USPTO form, whether to: (1) proceed with examination, (2) delay examination for twelve months, or (3) expressly abandon the application.[220]

The USPTO indicates that this requirement for information meets the requirement of 35 U.S.C. § 154(b)(1)(A)(i):[221] i.e., that such a requirement for information meets the requirement to provide an Office action (a notification) under 35 U.S.C. § 132 (Office action) within fourteen months of the date of commencement of the national stage under 35 U.S.C. § 371 in the PCT application. It remains to be seen whether the Federal Circuit would consider a PIER requirement for information as qualifying as a notification under 35 U.S.C. § 132 for patent term adjustment purposes. If a PIER requirement for information qualifies as a notification under 35 U.S.C. § 132 for patent term adjustment purposes, the PIER requirement for information stops the USPTO’s fourteen-month clock, and the applicant’s response to the PIER requirement for information is a reply under 35 U.S.C. § 132 both for purposes of stopping the applicant’s three-month patent term adjustment clock,[222] and also for purposes of starting the USPTO’s four-month patent term adjustment clock.[223]

A PIER requirement for information may not be considered a notification under 35 U.S.C. § 132 for patent term adjustment purposes, or may require a case-by-case determination as to whether any particular PIER requirement for information is a notification under 35 U.S.C. § 132 for patent term adjustment purposes.[224] A PIER requirement for information is not issued as a result of an examination conducted pursuant to 35 U.S.C. § 131 and does not request information of the type set forth in 37 C.F.R. § 1.105(a)(1). In the USPTO’s initial implementation of the patent term adjustment provisions in 2000, the USPTO indicated that a requirement for information under 37 C.F.R. § 1.105 is issued as a result of the examination conducted pursuant to 35 U.S.C. § 131, and thus an Office action containing a requirement for information under 37 C.F.R. § 1.105 is a notification under 35 U.S.C. § 132.[225] The USPTO distinguished Office actions issued as a result of the examination conducted pursuant to 35 U.S.C. § 131, such as restriction requirements and requirements for information under 37 C.F.R. § 1.105, from preexamination notices that preceded the examination, and which were not considered a notification under 35 U.S.C. § 132 for patent term adjustment purposes.[226] A PIER requirement for information, however, precedes examination under 35 U.S.C. § 131 and is more comparable to the preexamination notices that the USPTO does not otherwise consider to be notifications under 35 U.S.C. § 132.

* Robert W. Bahr, partner Maier & Maier PLLC, former Deputy Commissioner of Patent Examination Policy.

[1] Pub. L. 103-465, 108 Stat. 4809 (1994).

[2] URAA patent term extension (URAA PTE), or AIPA patent term adjustment, should not be confused with patent term extension under 35 U.S.C. § 156 (Hatch-Waxman PTE). Hatch-Waxman PTE compensates for patent term effectively lost due to a requirement for pre-marketing regulatory review and approval (35 U.S.C. § 156), and was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act).

[3] 35 U.S.C. § 154(b) (1994).

[4] Pub. L. 106-113, 113 Stat. 1501, 1501A-552 through 1501A-591 (1999). The USPTO implemented the AIPA patent term adjustment provisions in the final rule Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. 56366 (Sept. 18, 2000).

[5] The URAA and AIPA together resulted in the patent term extension provisions of the URAA being applicable to patents resulting from applications filed on or after June 8, 1995, but before May 29, 2000, and the patent term adjustment provisions of the AIPA being applicable to patents resulting from applications filed on or after May 29, 2000.

The URAA patent term extension provisions contained a five-year cap. 35 U.S.C. § 154(b) (1994). Since it is now more than twenty-five years after May 29, 2000, the effective date of the patent term adjustment provisions of the AIPA, it is unlikely that any unexpired patent is covered by the URAA patent term extension provisions.

[6] 35 U.S.C. § 154(b)(1)(A).

[7] 35 U.S.C. § 154(b)(1)(B).

[8] Section 3 of the Leahy-Smith America Invents Act (AIA) changed the U.S. patent system from a first to invent (FTI) to a first inventor to file (FITF) system, which included replacing interference proceedings with derivation proceedings. See Pub. L. No. 112-29, 125 Stat. 284, 288-91 (2011).

[9] 35 U.S.C. § 154(b)(1)(C).

[10] 35 U.S.C. § 154(b)(1).

[11] 35 U.S.C. § 154(b)(2).

[12] Pub. L. 112–274, 126 Stat. 2456 (2013).

[13] The USPTO implemented the patent term adjustment provisions of the AIA Technical Corrections Act in the final rule Revisions To Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act, 79 Fed. Reg. 27755 (May 15, 2014).

[14] Chapter 2700 of the Manual of Patent Examining Procedure (MPEP) pertains to patent term adjustment and patent term extension. MPEP §§ 2730 through 2736 specifically address the AIPA patent term adjustment provisions.

[15] 35 U.S.C. § 154(b)(1)(A).

[16] The national stage commences in a PCT application on the date that is thirty months from the priority date of the PCT application (PCT Art. 22), except that at the express request of the applicant, the national stage may commence at any time at which the application is in order for such purpose and complies with the applicable requirements of 35 U.S.C. § 371(c). 35 U.S.C. § 371(b) and (f). Prior to the AIA Technical Corrections Act, the fourteen-month period in 35 U.S.C. § 154(b)(1)(A)(i) was measured from the date on which the application “fulfilled the requirements of section 371” in a PCT application. See Revisions To Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act, 79 Fed. Reg. at 27756.

[17] 35 U.S.C. § 154(b)(1)(A)(i) and 37 C.F.R. § 1.702(a)(1).

[18] 37 C.F.R. § 1.703(a)(1).

[19] Actelion Pharm., Ltd. v. Matal, 881 F.3d 1339, 1345-46 (Fed. Cir. 2018).

[20] 35 U.S.C. § 154(b)(1)(A)(i)

[21] 37 C.F.R. § 1.105 provides for requirements for information.

[22] Under Ex parte Quayle, 1935 Comm’r Dec. 11 (1935), if the claims of an application are allowed, the prosecution of the application may be closed except as to amendments that address outstanding formal objections. MPEP § 714.14.

[23] See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56368.

[24] See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56368.

[25] Pfizer, Inc. v. Lee, 811 F.3d 466, 475-76 (Fed. Cir. 2016) (“the applicants’ and examiner’s exchanges concerning the challenged restriction requirement were part of the typical ‘back and forth’ process of patent prosecution. The underlying ‘purpose of [patent term adjustment] is to “compensate patent applicants for certain reductions in patent term that are not the fault of the applicant,” not to guarantee the correctness of the agency’s every decision’”)(quoting Univ. of Mass. v. Kappos, 903 F. Supp. 2d 77, 86 (D.D.C. 2012), which quotes H.R. Rep. No. 106-464, at 125 (1999)); see also Idorsia Pharm., Ltd. v. Iancu, 2019-2346, 7 (Fed. Cir. May 11, 2020) (“[a] restriction requirement need not be correct to satisfy the statutory notice requirement”).

[26] 35 U.S.C. § 154(b)(1)(A)(ii) and 37 C.F.R. § 1.702(a)(2).

[27] 37 C.F.R. § 1.703(a)(2).

[28] 37 C.F.R. § 1.703(a)(3).

[29] The USPTO interprets “the phrase ‘the date on which’ an ‘appeal was taken’ in 35 U.S.C. [§] 154(b)(1)(A)(ii) to mean the date an appeal brief under [37 C.F.R.] § 1.192 was filed.” Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56385-87.

[30] 37 C.F.R. § 1.703(a)(4).

[31] 37 C.F.R. § 1.703(a)(2).

[32] 37 C.F.R. § 1.703(a)(3).

[33] 37 C.F.R. § 1.116 provides for amendments and evidence submitted after a final Office action.

[34] 37 C.F.R. § 1.114 provides for RCEs. 37 C.F.R. § 1.114 requires a reply to a final Office action as if it were a non-final Office action (37 C.F.R. § 1.114(c)), and filing an RCE results in the withdrawal of the finality of any Office action and the entry and consideration of that reply (37 C.F.R. § 1.114(d)).

[35] Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384 (Fed. Cir. 2019).

[36] A compliant appeal brief is an appeal brief that complies with the requirements of 37 C.F.R. § 41.37.

[37] 37 C.F.R. § 1.703(a)(4).

[38] The Patent Trial and Appeal Board (PTAB) was the Board of Patent Appeals and Interferences (BPAI) when patent term adjustment was first implemented in 2000.

[39] 35 U.S.C. § 154(b)(1)(A)(iii) and 37 C.F.R. § 1.702(a)(3).

[40] See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56369.

[41] See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56369.

[42] 37 C.F.R. § 1.703(a)(5).

[43] 35 U.S.C. § 154(b)(1)(A)(iv) and 37 C.F.R. § 1.702(a)(4).

[44] 37 C.F.R. § 1.703(a)(6).

[45] 35 U.S.C. § 154(b)(1)(B) and 37 C.F.R. § 1.702(b).

[46] 35 U.S.C. § 154(b)(1)(B).

[47] Prior to the AIA Technical Corrections Act, the three-year period in 35 U.S.C. § 154(b)(1)(B) was measured from “the actual filing date of the application in the United States” in both applications under 35 U.S.C. § 111(a) and PCT applications. See Revisions To Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act, 79 Fed. Reg. at 27756. The change to 35 U.S.C. § 154(b)(1)(B) in the AIA Technical Corrections Act did not require a change in USPTO practice because the USPTO interpreted the phrase “actual filing date of the application in the United States” in former 35 U.S.C. § 154(b)(1)(B) as the date of commencement of the national stage under 35 U.S.C. § 371 in a PCT application when the patent term adjustment provisions of 35 U.S.C. § 154(b) were initially implemented in 2000. See Revisions To Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act, 79 Fed. Reg. at 27756 (citing Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56382–84, for its explanation of why the phrase “actual filing date of the application in the United States” in 35 U.S.C. § 154(b)(1)(B) must mean the date the national stage commenced under 35 U.S.C. § 371(b) or (f) in the case of a PCT application).

[48] 37 C.F.R. § 1.703(b).

[49] Novartis AG v. Lee, 740 F.3d 593, 601 (Fed. Cir. 2014) (“[t]he better reading of the language is that the patent term adjustment time should be calculated by determining the length of the time between application and patent issuance, then subtracting any continued examination time (and other time identified in (i), (ii), and (iii) of [35 U.S.C. § 154](b)(1)(B)), and determining the extent to which the result exceeds three years”).

While ultimately resolved by the Federal Circuit in Novartis, this provision was subject to conflicting interpretations in the district courts. The District Court for the Eastern District of Virginia and District Court for the District of Columbia issued decisions holding that the exclusions applied in determining whether the three-year period had been exceeded, but that these exclusion provisions did not have any effect on patent term adjustment if the exclusion event(s) did not occur (e.g., a RCE was filed) within three years from the filing date of the application. Exelixis, Inc. v. Kappos, 906 F. Supp. 2d. 474 (E.D. Va. 2012) (Exelixis I), and Novartis AG v. Kappos, 904 F. Supp. 2d. 58 (D.D.C. 2012). The District Court for the Eastern District of Virginia, however, subsequently issued a decision adopting the approach that the exclusions applied in determining the amount of patent term adjustment regardless of whether the exclusion occurred before or after the three-year period. Exelixis, Inc. v. Kappos, 919 F. Supp. 2d. 689 (E.D. Va. 2013) (Exelixis II).

[50] 35 U.S.C. § 154(b)(1)(B)(ii).

[51] 35 U.S.C. § 154(b)(1)(C)(i) and (ii).

[52] 35 U.S.C. § 154(b)(1)(C)(iii)

[53] 35 U.S.C. § 154(b)(1)(B)(i) and 37 C.F.R. § 1.702(b)(1).

[54] 37 C.F.R. § 1.703(b)(1).

[55] Novartis AG v. Lee, 740 F.3d 593, 602 (Fed. Cir. 2014). The USPTO revised 37 C.F.R. § 1.703(b)(1) for consistency with this aspect of Novartis in early 2015. See Changes to Patent Term Adjustment in View of the Federal Circuit Decision in Novartis v. Lee, 80 Fed. Reg. 1346 (Jan. 9, 2015).

[56] Mayo Found. for Med. Educ. & Research v. Iancu, 938 F.3d 1343, 1350-51 (Fed. Cir. 2019) (“a declaration of an interference is [not] tantamount to a Notice of Allowance,” the applicant “requested continued examination, and that is what it received, both before and after the interference proceeding,” and “the time between termination of an interference and the date of mailing of the Notice of Allowance is ‘time consumed by continued examination of the application requested by the applicant under section 132(b)’ pursuant to 35 U.S.C. § 154(b)(1)(B)(i))”).

[57] Ariad Pharm., Inc. v. Matal, 283 F. Supp. 3d 503, 512 (E.D. Va. 2018) (“in computing ‘time consumed by continued examination,’ the USPTO should not include time when the USPTO was plainly not conducting continued examination, but instead negligently concluded that the patent application had been abandoned”).

[58] 35 U.S.C. § 154(b)(1)(B)(ii) and 37 C.F.R. § 1.702(b)(2).

[59] 37 C.F.R. § 1.703(b)(2).

[60] 35 U.S.C. § 154(b)(1)(B)(ii) and 37 C.F.R. § 1.702(b)(3).

[61] A notification under 37 C.F.R. § 5.3(c), otherwise known as a D-10 Notice. MPEP § 130.

[62] 37 C.F.R. § 1.703(b)(3).

[63] 35 U.S.C. § 154(b)(1)(B)(ii) and 37 C.F.R. § 1.702(b)(4).

[64] 37 C.F.R. § 41.35(a) sets out when jurisdiction over an application passes to the Board. 37 C.F.R. § 41.35(a) provides that jurisdiction over the proceeding passes to the Board upon the filing of a reply brief or the expiration of the time in which to file such a reply brief, whichever is earlier.

[65] 37 C.F.R. § 41.35(b) sets out when jurisdiction over an application by the Board ends. 37 C.F.R. § 41.35(b) provides that when the Board has entered a final decision, jurisdiction over an application by the Board ends when judicial review is sought or the time for seeking judicial review has expired. 37 C.F.R. § 41.35(b) provides that in other situations jurisdiction over an application by the Board ends when (1) the Director or the Board enters a remand order; (2) a proper express abandonment is recognized; (3) a proper RCE is filed; (4) the Board enters an order of dismissal after the appellant fails to take a required action; or (5) the appellant reopens prosecution in the application in response to a new ground of rejection.

[66] 37 C.F.R. § 1.703(b)(4).

[67] 35 U.S.C. § 154(b)(1)(B)(iii).

[68] Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56369 (“[t]he provisions of 35 U.S.C. [§] 154(b)(1)(B)(iii) concerning the period of pendency consumed by delays in the processing of the application requested by the applicant are treated in [37 C.F.R.] § 1.704 as such delays are circumstances constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application”).

[69] 35 U.S.C. § 154(b)(1)(C).

[70] 35 U.S.C. § 154(b)(1)(C)(i) and 37 C.F.R. § 1.702(c).

[71] 37 C.F.R. § 1.703(c).

[72] 37 C.F.R. § 1.703(b)(2).

[73] 35 U.S.C. § 154(b)(1)(C)(ii) and 37 C.F.R. § 1.702(d).

[74] 37 C.F.R. § 1.703(d).

[75] 37 C.F.R. § 1.703(b)(3).

[76] 35 U.S.C. § 154(b)(1)(C)(iii) and 37 C.F.R. § 1.702(e).

[77] 37 C.F.R. § 1.703(e).

[78] 35 U.S.C. § 154(b)(1)(C)(iii).

[79] 35 U.S.C. § 154(b)(1)(B)(ii).

[80] 37 C.F.R. § 1.703(e).

[81] 37 C.F.R. § 1.703(b)(4).

[82] Chudik v. Hirshfeld, 987 F.3d 1033, 1039-40 (Fed. Cir. 2021) (the words of 35 U.S.C. § 154(b)(1)(C)(iii), “in their most natural meaning when applied to an examiner’s unpatentability ruling, require that the patent issue under a Board decision that reversed the examiner’s unpatentability ruling or under a court decision that reversed a Board unpatentability ruling in the matter”).

[83] Chudik v. Hirshfeld, 987 F.3d 1033, 1040 (Fed. Cir. 2021) ([t]he statutory language speaks of ‘appellate review by’ the Board or a court,” and “[i]n light of that language, the subsequent reference to a ‘decision in the review’ is most naturally understood to refer to a decision by the appellate tribunal, i.e., the Board or a court, not, e.g., an examiner’s ‘decision’ to reopen prosecution made during the review (whether the review is deemed to start when the notice of appeal is filed or later)”).

[84] Chudik v. Hirshfeld, 987 F.3d 1033, 1041 (Fed. Cir. 2021) (“[t]he unavailability of B-delay for nearly two years (655 days) of delay in the PTO illustrates what applicants should understand when deciding whether to request a continued examination rather than take an immediate appeal” and “[t]he potential benefit of immediate re-engagement with the examiner through such continued examination comes with a potential cost”).

[85] See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56370 (“[t]he phrase “in which the patent was issued under a decision in the review reversing an adverse determination of patentability” (a final decision in favor of the applicant) in 35 U.S.C. § 154(b)(1)(C)(iii) requires a Board of Patent Appeals and Interferences [now PTAB] or Federal court decision in the review that reverses all of the rejections of at least one claim and that such claim is not subject to a rejection under [37 C.F.R.] § 1.196(b) [now 37 C.F.R. § 41.50(b)]”).

[86] 35 U.S.C. § 154(b)(1)(C)(iii).

[87] See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56370 (“the Office must make its patent term adjustment determinations by a computer program that uses the information recorded in the Office’s automated patent application information system (the Patent Application Location and Monitoring system or PALM system). Thus, the Office must determine whether the . . . decision was of a nature such that ‘the patent was issued under a decision in the review reversing an adverse determination of patentability’ under 35 U.S.C. [§] 154(b)(1)(C)(iii) from information concerning the decision susceptible of being recorded in the PALM system (rather than by a case-by-case review of each decision)”).

[88] SawStop Holding LLC v. Vidal, 48 F.4th 1355 (Fed. Cir. 2022).

[89] 35 U.S.C. § 154(b)(1)(C)(iii).

[90] SawStop Holding LLC v. Vidal, 48 F.4th 1355, 1362 (Fed. Cir. 2022) (“[t]he plain language of “issued under a decision in the review” means that at least one claim must “issue[ ] under” the mandate of the appellate decision,” which “[a]t a minimum, this means that at least one claim that ‘issued’ must have been analyzed by the Board or District Court that issued the “decision in the review”).

[91] SawStop Holding LLC v. Vidal, 48 F.4th 1355, 1362 (Fed. Cir. 2022) (“[t]he statutory requirement [of 35 U.S.C. § 154(b)(1)(C)(iii)] is not met if the claim that ultimately issues differs substantively from the claim under review”).

[92] SawStop Holding LLC v. Vidal, 48 F.4th 1355, 1362 (Fed. Cir. 2022) (“Sawstop [argues] that the claim would not have issued but-for the successful appeal, and thus the ‘patent was issued under a decision in the review,’ [but] we disagree. Under Sawstop’s reading, the (C) delay provision could apply when an adverse determination of patentability is overcome on appeal, regardless of substantive amendments made after the appeal to secure allowance. This interpretation effectively reads out the phrase ‘in which the patent was issued under a decision in the review,’ and thus cannot be sustained.”).

[93] 37 C.F.R. § 1.702 specifically provides that: “[i]f an application is remanded by a panel of the Patent Trial and Appeal Board and the remand is the last action by a panel of the Patent Trial and Appeal Board prior to the mailing of a notice of allowance under 35 U.S.C. [§] 151 in the application, the remand shall be considered a decision by the Patent Trial and Appeal Board as that phrase is used in 35 U.S.C. [§] 154(b)(1)(A)(iii), a decision in the review reversing an adverse determination of patentability as that phrase is used in 35 U.S.C. [§] 154(b)(1)(C)(iii), and a final decision in favor of the applicant under [37 C.F.R.] § 1.703(e).”

37 C.F.R. § 1.702, however, also provides that “[a] remand by a panel of the Patent Trial and Appeal Board shall not be considered a decision in the review reversing an adverse determination of patentability as provided in this paragraph if there is filed a request for continued examination under 35 U.S.C. [§] 132(b) that was not first preceded by the mailing, after such remand, of at least one of an action under 35 U.S.C. [§] 132 or a notice of allowance under 35 U.S.C. [§] 151.”

[94] Revision of Patent Term Extension and Patent Term Adjustment Provisions, 69 Fed. Reg. 21704 (Apr. 22, 2004) (“[t]he Office has . . . determined that there are a number of BPAI panel remands that convey the weakness in the examiner’s adverse patentability determination in a manner tantamount to a decision reversing the adverse patentability determination,” and “[t]he changes in this final rule address the situation in which an examiner responds to [such] a remand by a BPAI panel by allowing the application (either with or without further action by applicant), rather than returning the application with a response to the issues raised in the remand to the BPAI for a decision on the appeal”).

[95] 35 U.S.C. § 154(b)(1)(C)(iii).

[96] 35 U.S.C. § 154(b)(1)(B)(ii).

[97] See Revision of Patent Term Adjustment Provisions Relating to Appellate Review, 77 Fed. Reg. 49354 (Aug. 16, 2012).

[98] See Revision of Patent Term Adjustment Provisions Relating to Appellate Review, 77 Fed. Reg. at 49355.

[99] 35 U.S.C. § 154(b)(2)(A); see also 37 C.F.R. § 1.703(f).

[100] 35 U.S.C. § 154(b)(1)(B).

[101] 35 U.S.C. § 154(b)(1)(B)(i) through (iii).

[102] See Explanation of 37 CFR 1.703(f) and of the United States Patent and Trademark Office Interpretation of 35 U.S.C. 154(b)(2)(A), 69 Fed. Reg. 34283 (Jun. 21, 2004).

[103] Wyeth v. Kappos, 591 F.3d 1364, 1369-70 (Fed. Cir. 2010).

[104] See Interim Procedure for Patentees To Request a Recalculation of the Patent Term Adjustment To Comply With the Federal Circuit Decision in Wyeth v. Kappos Regarding the Overlapping Delay Provision of 35 U.S.C. 154(b)(2)(A), 75 Fed. Reg. 5043 (Feb. 1, 2010).

[105] Daiichi Sankyo Co. v. Lee, 791 F.3d 1373 (Fed. Cir. 2015), and Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014).

[106] 35 U.S.C. § 154(b)(2)(B) see also 37 C.F.R. § 1.703(g).

[107] In re Cellect, LLC, 81 F.4th 1216, 1228 (Fed. Cir. 2023), and Boehringer Ingelheim Int’l GmbH v. Barr Lab’ys, Inc., 592 F.3d 1340, 1346 (Fed. Cir. 2010).

[108] This is different from the interplay between Hatch-Waxman patent term extension or PTE (35 U.S.C. § 156), which is applied after any terminal disclaimer is given effect in the patent. Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018).

[109] In re Cellect, LLC, 81 F.4th 1216, 1229 (Fed. Cir. 2023).

[110] 35 U.S.C. § 154(b)(2)(C)(i); see also 37 C.F.R. § 1.704(a).

[111] 35 U.S.C. § 154(b)(2)(C)(ii).

[112] 35 U.S.C. § 154(b)(2)(C)(iii).

[113] 35 U.S.C. § 154(b)(2)(C)(ii).

[114] Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56371.

[115] 37 C.F.R. §§ 1.704(c)(1) through (c)(14).

[116] 35 U.S.C. § 154(b)(2)(C)(i).

[117] Gilead Scis., Inc. v. Lee, 778 F.3d 1341, 1349 (Fed. Cir. 2015).

[118] Supernus Pharms., Inc. v. Iancu, 913 F.3d 1351, 1361 (Fed. Cir. 2019). The Supernus decision resulted in the USPTO revising certain patent term adjustment reduction provisions to specify a period of reduction equal to the “period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application” consistent with Supernus. See Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 85 Fed. Reg. 36335 (Jun. 16, 2020). Ironically, the provision at issue in Supernus (37 C.F.R. § 1.704(c)(8)) was not revised in that rulemaking.

[119] 37 C.F.R. § 1.103 provides for suspension of action by the USPTO.

[120] 37 C.F.R. § 1.704(c)(1).

[121] 37 C.F.R. § 1.314 provides for deferral of issuance of a patent.

[122] 37 C.F.R. § 1.704(c)(2).

[123] 37 C.F.R. § 1.704(c)(3).

[124] 37 C.F.R. § 1.704(c)(4).

[125] An application under 35 U.S.C. § 111(b).

[126] An application under 35 U.S.C. § 111(a).

[127] A request in compliance with 37 C.F.R. § 1.53(c)(3).

[128] 37 C.F.R. § 1.704(c)(5).

[129] 35 U.S.C. § 111(b)(5) and 37 C.F.R. § 1.53(c)(3) provide for the conversation of a provisional application into a nonprovisional application.

[130] 37 C.F.R. § 1.704(c)(6).

[131] 37 C.F.R. § 1.704(c)(7).

[132] 37 C.F.R. § 1.704(c)(8).

[133] 37 C.F.R. § 41.50(b) provides for new grounds of rejection by the Board.

[134] This appears to be a relic of former provisions of 37 C.F.R. § 41.50. Prior to 2012, 37 C.F.R. § 41.50(c) provided for statements by the Board as to how a claim may be amended to overcome a rejection. This provision was eliminated in early 2012. Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals, 76 Fed. Reg. 72270, 72279 (Nov. 22, 2011).

[135] 37 C.F.R. § 1.704(c)(9).

[136] 37 C.F.R. § 1.312 provides for amendments after allowance.

[137] 37 C.F.R. § 1.704(c)(10).

[138] See 37 C.F.R. §§ 1.704(c)(10) and (e).

[139] An IDS in compliance with 37 C.F.R. §§ 1.97 and 1.98.

[140] Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 85 Fed. Reg. at 36339.

[141] 37 C.F.R. § 1.704(c)(11).

[142] 37 C.F.R. § 1.704(c)(12).

[143] 37 C.F.R. § 1.704(c)(13).

[144] H. Lundbeck, A/S v. United States Patent and Trademark Office, Case No. 1:23-cv-1105 (E.D. Va. July 2024).

[145] In addition to the “eight-month” requirement of 37 C.F.R. § 1.704(c)(13), 35 U.S.C. § 154(b)(2)(C)(ii) and 37 C.F.R. § 1.704(b) provide that not responding to an Office notice or action within three months is an applicant delay.

[146] 37 C.F.R. § 1.52 sets out the requirements for application papers, and 37 C.F.R. § 1.84 sets out the requirements for drawings.

[147] 37 C.F.R. § 1.52(d) or § 1.57(a).

[148] 37 C.F.R. §§ 1.831 through 1.835 sets out the requirements for sequence listings.

[149] 37 C.F.R. § 1.16(a) or (c).

[150] 37 C.F.R. § 1.16(k) or (m).

[151] 37 C.F.R. § 1.16(o) or (q).

[152] 37 C.F.R. § 1.16(s).

[153] 37 C.F.R. § 1.57(a).

[154] 37 C.F.R. § 1.491(b).

[155] 37 C.F.R. §§ 1.831 through 1.835 sets out the requirements for sequence listings.

[156] 37 C.F.R. § 1.492(b).

[157] 37 C.F.R. § 1.492(c).

[158] 37 C.F.R. § 1.492(j).

[159] 37 C.F.R. § 1.703(f).

[160] 37 C.F.R. § 1.704(c)(14).

[161] Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56373 (“if the application that resulted in the patent is a continuing application (including a CPA), the period of adjustment set forth in § 1.703 (if any) will not include any period that is prior to the actual filing date of the application”).

[162] Mohsenzadeh v. Lee, 790 F.3d 1377, 1382 (Fed. Cir. 2015).

[163] 37 C.F.R. § 1.704(c).

[164] Supernus Pharms., Inc. v. Iancu, 913 F.3d 1351, 1359 (Fed. Cir. 2019).

[165] Patent Term Adjustment Procedures in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 84 Fed. Reg. at 20345.

[166] H. Lundbeck, A/S v. United States Patent and Trademark Office, Case No. 1:23-cv-1105 (E.D. Va. July 2024).

[167] 37 C.F.R. §§ 1.704(c)(8) (supplemental replies/papers), (c)(10) (after allowance submissions), and (c)(12) (after allowance RCEs).

[168] 37 C.F.R. §§ 1.704(c)(6) (preliminary amendments/papers) and (c)(9) (submissions after Board decision).

[169] 37 C.F.R. §§ 1.97 and 1.98.

[170] 37 C.F.R. § 1.704(d)(1). The “safe harbor” specifically applies to the provisions of 37 C.F.R. §§ 1.704(c)(6), (c)(8), (c)(9), (c)(10), and (c)(12).

[171] The “safe harbor” statement is that each item of information contained in the IDS: (1) was first cited in any communication from a patent office in a counterpart foreign or international application or from the USPTO (Office), and this communication was not received by any individual designated in 37 C.F.R. § 1.56(c) more than thirty days prior to the filing of the IDS; or (2) is a communication that was issued by a patent office in a counterpart foreign or international application or by the USPTO (Office), and this communication was not received by any individual designated in 37 C.F.R. § 1.56(c) more than thirty days prior to the filing of the IDS. 37 C.F.R. § 1.704(d)(1)(i) and (ii). This thirty day period is non-extendable. 37 C.F.R. § 1.704(d)(2).

[172] 37 C.F.R. § 1.97(e).

[173] The IDS timeliness statement is either: (1) that each item of information contained in the IDS was first cited in any communication from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the IDS; or (2) that no item of information contained in the IDS was cited in a communication from a foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification after making reasonable inquiry, no item of information contained in the IDS was known to any individual designated in 37 C.F.R. § 1.56(c) more than three months prior to the filing of the IDS. 37 C.F.R. § 1.97(e).

[174] Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56373 (the “safe harbor” provision “will permit applicants to submit information cited in a communication from a foreign patent office in a counterpart application to the Office without a reduction in patent term adjustment if an information disclosure statement is promptly (within thirty days of receipt of the communication) submitted to the Office”). This “safe harbor” provision was revised in 2011 to also cover information contained in a communication from the USPTO. Revision of Patent Term Adjustment Provisions Relating to Information Disclosure Statements, 76 Fed. Reg. 74700 (Dec. 1, 2011).

[175] Standardization of the Patent Term Adjustment Statement Regarding Information Disclosure Statements, 88 Fed. Reg. 39172 (Jun. 15, 2023), codified at 37 C.F.R. § 1.704(d)(3).

[176] 37 C.F.R. § 1.704(d)(3).

[177] 37 C.F.R. § 1.704(d)(3). This requirement (no alterations to the existing text and any certification statements) exists for all USPTO forms. 37 C.F.R. § 1.4(d)(6).

[178] 35 U.S.C. § 154(b)(3)(A).

[179] Prior to the AIA Technical Corrections Act, the USPTO was required to provide a patent term adjustment determination with the notice of allowance. The issue date, which is unknown when a notice of allowance is issued, is necessary to calculate the applicable patent term adjustment, and thus the USPTO adopted a two-part patent term adjustment determination process to comply with this requirement. See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56374; see also Novartis AG v. Lee, 740 F.3d 593, 600 n.1 (Fed. Cir. 2014) (noting the correction of this flaw in the patent term adjustment statute).

[180] 35 U.S.C. § 154(b)(3)(B).

[181] 37 C.F.R. § 1.705(a).

[182] The patent term adjustment determination to be indicated in a patent is calculated at the time the Issue Notification is prepared and is provided with the Issue Notification and printed on the front page of the patent.

[183] The information recorded in the PALM system is available to applicants through the USPTO’s Patent Center.

[184] See Patent Term Adjustment Procedures in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 84 Fed. Reg. at 20344.

[185] 37 C.F.R. § 1.703(f).

[186] 37 C.F.R. § 1.703(f).

[187] ArQule v. Kappos, 793 F. Supp. 2d 214 (D.D.C. 2011).

[188] Actelion Pharm., Ltd. v. Matal, 881 F.3d 1339, 1346 (Fed. Cir. 2018).

[189] 37 C.F.R. § 1.18(e).

[190] 37 C.F.R. § 1.702.

[191] 37 C.F.R. § 1.704.

[192] 37 C.F.R. § 1.705(b).

[193] See Revisions To Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act, 79 Fed. Reg. at 27757.

[194] See Revisions To Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act, 79 Fed. Reg. at 27757.

[195] Actelion Pharm., Ltd. v. Matal, 881 F.3d 1339 (Fed. Cir. 2018) (situation in which a request for reconsideration resulted in a reduction of patent term adjustment).

[196] Treatment of Letters Stating That the USPTO’s Patent Term Adjustment Determination Is Greater Than What the Applicant or Patentee Believes Is Appropriate, 75 Fed. Reg 42079, 42080 (Jul. 20, 2010) (petitions under 37 C.F.R. § 1.182 or 1.183, or requests for a certificate of correction under either 35 U.S.C. 254 and 37 C.F.R. § 1.323 or 35 U.S.C. 255 and 37 C.F.R. § 1.324, are not substitute fora to obtain reconsideration of a patent term adjustment determination indicated in a notice of allowance).

[197] Treatment of Letters Stating That the USPTO’s Patent Term Adjustment Determination Is Greater Than What the Applicant or Patentee Believes Is Appropriate, 75 Fed. Reg 42080.

[198] 35 U.S.C. § 154(b)(3)(C). The USPTO implemented this provision in 37 C.F.R. § 1.705(c).

[199] 35 U.S.C. § 154(b)(3)(C).

[200] See Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56389 (three-month period insufficient to obtain the test data necessary for an affidavit or declaration under 37 C.F.R. § 1.132, unable to reply within the three-month period due to a natural disaster, unable to reply within the three-month period due to illness or death of a sole practitioner responsible for prosecuting the application).

[201] Prior to the AIA Technical Corrections Act, the time period for commencing a civil action was 180 days from patent grant, which often resulted in the USPTO not issuing a final decision on a request for reconsideration until after the time period for commencing a civil action had expired. The AIA Technical Corrections Act measures the time period for commencing a civil action from the date of the USPTO Director’s decision on the request for reconsideration, avoiding the equitable tolling issues of the former provision of 35 U.S.C. § 154(b)(4). See Janssen Pharmaceutica, N.V. v. Rea, 928 F. Supp. 2d 102 (D.D.C. 2013), Bristol-Myers Squibb Co. v. Kappos, 841 F. Supp. 2d 238 (D.D.C. 2012).

[202] In reality, the patentee and USPTO in these civil actions are disputing the interpretation of a provision of the patent term adjustment statute (35 U.S.C. § 154(b)) or the validity or application of the USPTO patent term adjustment regulations, and are not having a disagreement about how to do math: calculating the duration between two dates or adding or subtracting numbers. The court decisions generally answer the legal question and leave the actual patent term adjustment calculation to the parties.

[203] 35 U.S.C. § 282(c) provides in part that: “[i]nvalidity of the extension of a patent term or any portion thereof under [35 U.S.C. §] 154(b) or [35 U.S.C. §] 156 because of the material failure—(1) by the applicant for the extension, or (2) by the Director, to comply with the requirements of such section shall be a defense in any action involving the infringement of a patent during the period of the extension of its term and shall be pleaded.”

[204] 37 C.F.R. 1.705(d) (“[n]o submission or petition on behalf of a third party concerning patent term adjustment under 35 U.S.C. [§] 154(b) will be considered by the Office,” and “[a]ny such submission or petition will be returned to the third party, or otherwise disposed of, at the convenience of the Office”).

[205] Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984).

[206] There are, however, also a number of decisions (e.g., Actelion, Mohsenzadeh, Daiichi Sankyo, Pfizer, Novartis) that do not mention Chevron.

[207] E.g., Gilead, Intra-Cellular Therapies.

[208] E.g., Chudik, SawStop.

[209] E.g., Wyeth, Supernus.

[210] Loper Bright Enters. v. Raimondo, Sec’y of Commerce, 603 U.S. 369, 404 (2024).

[211] 35 U.S.C. § 2(b)(2).

[212] 35 U.S.C. § 154(b)(2)(C)(iii).

[213] 35 U.S.C. § 154(b)(3)(A).

[214] E.g., Gilead.

[215] E.g., Daiichi Sankyo.

[216] E.g., Intra-Cellular Therapies.

[217] See Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 286-87 (2016) (J. Thomas concurring) (dismissing Chevron as a “fiction” but joining the Court’s decision because the patent statute at issue (35 U. S. C. § 316(a)(4)) “contains an express and clear conferral of authority to the Patent Office to promulgate rules governing its own proceedings,” and asking whether the USPTO’s rule is reasonable, is effectively asking whether the rulemaking was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” in conformity with the Administrative Procedure Act).

[218] For example, the “A,” “B,” and “C” delay provisions of 35 U.S.C. § 154(b)(1) (e.g., Pfizer, Novartis, Chudik, SawStop) and the overlapping delay provision of 35 U.S.C. § 154(b)(A) (Wyeth).

[219] PCT Informed Examination Request Pilot Program, 91 Fed. Reg. 17949 (Apr. 9, 2026).

[220] PCT Informed Examination Request Pilot Program, 91 Fed. Reg. at 17950.

[221] PCT Informed Examination Request Pilot Program, 91 Fed. Reg. at 17951.

[222] 35 U.S.C. § 154(b)(2)(C)(ii) (provides that not responding to an Office notice or action within three months is an applicant delay).

[223] in 35 U.S.C. § 154(b)(1)(A)(ii) (provides that not responding to a reply under 35 U.S.C. § 132 within four months is a USPTO delay).

[224] In Pfizer, Inc. v. Lee, 811 F.3d 466 (Fed. Cir. 2016), and Idorsia Pharm., Ltd. v. Iancu, 2019-2346, 7 (Fed. Cir. May 11, 2020), the Federal Circuit held that the restriction requirements at issue satisfied the requirements of 35 U.S.C. § 132 for patent term adjustment purposes. These decisions, however, did not state that every restriction requirement, much less every requirement for information under 37 C.F.R. § 1.105, will satisfy the requirements of 35 U.S.C. § 132 for patent term adjustment purposes requirement, but rather involved an individualized review of the restriction requirement at issue in each of these cases.

[225] Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56368.

[226] Changes To Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 Fed. Reg. at 56368.

The USPTO announced a new PCT Informed Examination Request (PIER) pilot program for 371 national stage applications.

Under this pilot PIER program, the USPTO will issue a requirement for information (PIER RFI) in selected 371 applications. The USPTO will not accept requests to opt out of the PIER pilot program.

The PIER RFI will require the applicant to respond by requesting one of: (1) proceeding with examination; (2) a 12-month delay in examination; or (3) the express abandonment of the application. The response to the PIER RFI must be filed using a new USPTO form: the PTO/SB/478.

The USPTO considers the PIER RFI to be an Office action under 35 U.S.C. § 132, meaning that it satisfies the 14-month patent term adjustment (PTA) time frame. While not stated, this also means that the applicant’s response to a PIER RFI is a reply for purposes of the first 4-month PTA time frame.

Proceeding with Examination: The request to proceed with examination may be accompanied by a preliminary amendment. A preliminary amendment may be desirable in view of the PCT International Search Report (ISR), Written Opinion, and any Supplemental International Search (SIS) or International Preliminary Examination Report (IPER).

A 12-month Delay: The request for a 12-month delay will result in a “non-terminable” delay in examination. The 12-month period will be measured from the USPTO’s receipt of the applicant’s response requesting the delay. This response will be considered an applicant delay for PTA purposes.

Express Abandonment: There is also an option to request express abandonment. The benefit of filing this response appears to be questionable since (1) any 371 application is likely to have been published during the PCT international stage, (2) the USPTO indicates that it will not refund any search or examination fees for an application expressly abandoned in response to the PIER RFI, and (3) the USPTO indicates that simply not responding to a PIER RFI will result in abandonment of the application.

The notice was published in today’s Federal Register at 91 Fed. Reg. 17949-52.