Court Opinion

ID: 9378751
Source: CourtListenerOpinion
Date Created: 2023-03-13 15:01:00.297533+00
Date Added: 2024-06-11T17:15:56.056538
License: Public Domain

Case: 22-1249    Document: 71      Page: 1    Filed: 03/13/2023

   United States Court of Appeals
       for the Federal Circuit
                   ______________________

 APPLE INC., CISCO SYSTEMS, INC., GOOGLE LLC,
        INTEL CORPORATION, EDWARDS
   LIFESCIENCES CORPORATION, EDWARDS
              LIFESCIENCES LLC,
                Plaintiffs-Appellants

                              v.

  KATHERINE K. VIDAL, UNDER SECRETARY OF
  COMMERCE FOR INTELLECTUAL PROPERTY
    AND DIRECTOR OF THE UNITED STATES
      PATENT AND TRADEMARK OFFICE,
              Defendant-Appellee
            ______________________

                         2022-1249
                   ______________________

    Appeal from the United States District Court for the
 Northern District of California in No. 5:20-cv-06128-EJD,
 Judge Edward J. Davila.
                 ______________________

                  Decided: March 13, 2023
                  ______________________

    CATHERINE CARROLL, Wilmer Cutler Pickering Hale and
 Dorr LLP, Washington, DC, argued for all plaintiffs-appel-
 lants. Plaintiffs-appellants Apple Inc., Cisco Systems, Inc.,
 Intel Corporation also represented by DAVID LEHN;
 REBECCA M. LEE, San Francisco, CA; MARK D. SELWYN,
 Palo Alto, CA; ALYSON ZUREICK, New York, NY.
Case: 22-1249    Document: 71     Page: 2     Filed: 03/13/2023

 2                                          APPLE INC.   v. VIDAL

     NATHAN K. KELLEY, Perkins Coie LLP, Washington,
 DC, for plaintiff-appellant Google LLC. Also represented
 by ANDREW DUFRESNE, Madison, WI.

     CHRISTY G. LEA, Knobbe, Martens, Olson & Bear, LLP,
 Irvine, CA, for plaintiffs-appellants Edwards Lifesciences
 Corporation, Edwards Lifesciences LLC. Also represented
 by JOHN B. SGANGA, JR.

     WEILI J. SHAW, Appellate Staff, Civil Division, United
 States Department of Justice, Washington, DC, argued for
 defendant-appellee.      Also represented by MICHAEL
 GRANSTON, DANIEL TENNY; MICHAEL S. FORMAN, THOMAS
 W. KRAUSE, AMY J. NELSON, FARHEENA YASMEEN RASHEED,
 Office of the Solicitor, United States Patent and Trade-
 mark Office, Alexandria, VA.

     MARK S. DAVIES, Orrick, Herrington & Sutcliffe LLP,
 Washington, DC, for amici curiae Acushnet Company, Al-
 liance for Automotive Innovation, Comcast Cable Commu-
 nications, LLC, Computer and Communication Industry
 Association, Dell, Inc., Garmin International, Inc., Juniper
 Networks, Inc., Micron Technology Inc., SAS Institute,
 Inc., Symmetry, LLC, Taiwan Semiconductor Manufactur-
 ing Company, Ltd., Verizon Services Corp., VIZIO, Inc.,
 VMware, Inc. Also represented by ALEXANDRA BURSAK,
 New York, NY.

      JAMES OLIVA, American Honda Motor Co., Inc., Tor-
 rance, CA, for amicus curiae American Honda Motor Co.,
 Inc.

     ROBERT THOMAS SMITH, Katten Muchin Rosenman
 LLP, Washington, DC, for amicus curiae Mylan Pharma-
 ceuticals Inc.  Also represented by ERIC THOMAS
 WERLINGER; DEEPRO MUKERJEE, LANCE SODERSTROM, New
 York, NY.
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 APPLE INC.   v. VIDAL                                      3

     MICHAEL BERTA, Arnold & Porter Kaye Scholer LLP,
 San Francisco, CA, for amicus curiae Tesla, Inc. Also rep-
 resented by JAMES SHERWOOD, Tesla, Inc., Washington,
 DC.
                 ______________________

    Before LOURIE, TARANTO, and STOLL, Circuit Judges.
 TARANTO, Circuit Judge.
     Plaintiffs are Apple Inc. and four other companies that
 have repeatedly been sued for patent infringement and
 thereafter petitioned the Director of the Patent and
 Trademark Office (PTO) to institute inter partes reviews
 (IPRs), under 35 U.S.C. §§ 311–319, so that the PTO’s
 Patent Trial and Appeal Board could adjudicate the
 petitions’ unpatentability challenges to patent claims that
 had been asserted against them in court. In the present
 action, brought against the Director in district court under
 the Administrative Procedure Act (APA), 5 U.S.C. §§ 701–
 706, plaintiffs challenge instructions the Director issued to
 the Board to inform it how to exercise, under delegation by
 the Director, the Director’s discretion whether to institute
 a requested IPR. Plaintiffs assert that the instructions are
 likely to produce too many denials of institution requests.
 The district court dismissed the APA action on the ground
 that the Director’s instructions were made unreviewable by
 the IPR provisions of the patent statute.
     We affirm in part and reverse in part. We affirm the
 unreviewability dismissal of plaintiffs’ challenges to the
 instructions as being contrary to statute and arbitrary and
 capricious. No constitutional challenges are presented.
 But we reverse the unreviewability dismissal of plaintiffs’
 challenge to the instructions as having been improperly
 issued because they had to be, but were not, promulgated
 through notice-and-comment rulemaking under 5 U.S.C.
 § 553. That challenge, we also hold, at least Apple had
 standing to present. We remand for further proceedings on
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 4                                           APPLE INC.   v. VIDAL

 the lone surviving challenge. Like the district court, we do
 not reach the merits of that challenge.
                               I
                               A
      In the America Invents Act (AIA), Pub. L. No. 112-29,
 125 Stat. 284 (2011), Congress authorized the filing of a
 petition asking the PTO to conduct an IPR of whether iden-
 tified claims in an issued patent comply with certain pa-
 tentability requirements of novelty or obviousness over
 prior art. 35 U.S.C. § 311(a)–(b). The Board is the PTO
 component assigned to perform the IPR adjudication if a
 review is instituted, id. §§ 6(b)(4), 316–318, with the
 Board’s “final written decision” in the IPR subject to appeal
 to this court, id. § 319; see id. § 141. But it is the PTO’s
 Director to whom Congress assigned the task of determin-
 ing whether to institute a review in the first place. Id.
 § 314(b); see Thryv, Inc. v. Click-To-Call Technologies, LP,
 140 S. Ct. 1367, 1370–71 (2020).
     For the Director to institute, certain preconditions
 must be met. One prerequisite, for all petitions, is the
 crossing of a merits “threshold”: “The Director may not au-
 thorize an [IPR] to be instituted unless the Director deter-
 mines that the information presented in the petition . . .
 and any response . . . shows that there is a reasonable like-
 lihood that the petitioner would prevail with respect to at
 least 1 of the claims challenged in the petition.” 35 U.S.C.
 § 314(a). Another prerequisite, applicable in the predicta-
 bly common situation where the patent owner has already
 sued the petitioner (or a real party in interest or privy) for
 infringement of the patent, is compliance with a timing
 limit: The petition must be filed within one year after ser-
 vice of the infringement complaint. Id. § 315(b).
     Even when such requirements are met, however, the
 statute uses no language commanding institution. “The
 Director is permitted, but never compelled, to institute an
 IPR[, a]nd no petitioner has a right to such institution.”
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 APPLE INC.   v. VIDAL                                       5

 Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V.,
 989 F.3d 1375, 1382 (Fed. Cir. 2021). The Supreme Court
 explained in SAS Institute, Inc. v. Iancu: “§ 314(a) invests
 the Director with discretion on the question whether to in-
 stitute review.” 138 S. Ct. 1348, 1356 (2018); see also
 Cuozzo Speed Technologies, LLC v. Lee, 579 U.S. 261, 273
 (2016) (citing § 314(a) and stating: “no mandate to institute
 review”).
      Congress not only left the discretion to the Director but
 also protected its exercise from judicial review, even re-
 garding the mandatory threshold conditions for institution,
 at least where, as here, the court challenge is not on a con-
 stitutional ground. See Cuozzo, 579 U.S. at 275 (noting
 that it was not addressing challenges that implicate consti-
 tutional questions, which present distinct issues regarding
 congressional preclusion of judicial review). 1 Thus, Con-
 gress declared: “The determination by the Director
 whether to institute an inter partes review under [§ 314]
 shall be final and nonappealable.” 35 U.S.C. § 314(d).
 Based on that provision, whose terms apply whether the
 determination is negative or positive, the Supreme Court
 has held that the institution decision is unreviewable, even
 in a proper appeal of a final written decision reached by the
 Board after a positive institution determination: “Congress
 has committed the decision to institute inter partes review
 to the Director’s unreviewable discretion.” United States v.
 Arthrex, Inc., 141 S. Ct. 1970, 1977 (2021); see Thryv, 140

     1 Because the present case does not involve a constitu-
 tional challenge, we hereafter generally refrain from not-
 ing that the unreviewability principle at issue has not been
 extended to constitutional challenges.
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 6                                           APPLE INC.   v. VIDAL

 S. Ct. at 1372–73 (relied on by Arthrex for above state-
 ment); Cuozzo, 579 U.S. at 271–75. 2
     From the outset of the IPR program, the Director dele-
 gated the institution authority to the Board. 37 C.F.R.
 § 42.4(a); see Arthrex, 141 S. Ct. at 1977; Thryv, 140 S. Ct.
 at 1371. We have upheld that delegation, recognizing “the
 longstanding rule that agency heads have implied author-
 ity to delegate to officials within the agency,” that “Con-
 gress regularly gives heads of agencies more tasks than a
 single person could ever accomplish, necessarily assuming
 that the head of the agency will delegate the task to a sub-
 ordinate officer,” and that, in particular, “Congress as-
 signed the Director the decision to institute, necessarily
 assuming that the popularity of inter partes review and the
 short time frame to decide whether to institute inter partes
 review would mean that the Director could not herself re-
 view every petition.”       Ethicon Endo-Surgery, Inc. v.
 Covidien LP, 812 F.3d 1023, 1031–32 (Fed. Cir. 2016) (foot-
 note omitted). We have also made clear that any institu-
 tion decision made by the Board as delegatee of the
 Director is subject to reversal by the Director. In re Palo
 Alto Networks, Inc., 44 F.4th 1369, 1375 & n.3 (Fed. Cir.
 2022) (stating that “the Director plainly has the authority
 to revoke the delegation or to exercise her review authority
 in individual cases despite the delegation”); see Arthrex,

     2  In SAS, the Supreme Court held that § 318, whose
 subject is not institution but the scope of a required final
 written decision, requires the Board, in its final written de-
 cision, to decide the patentability of all patent claims chal-
 lenged in the petition. 138 S. Ct. at 1354–57. It follows, as
 a corollary, that the institution determination must be an
 all-or-nothing one, a “binary” one, id. at 1355, regarding
 the claims to be reviewed. It is that institution determina-
 tion which is the subject of the unreviewability principle of
 Arthrex, Thryv, and Cuozzo.
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 APPLE INC.   v. VIDAL                                        7

 141 S. Ct. at 1980 (“The Director . . . controls the decision
 whether to institute inter partes review . . . .”).
                               B
      The one-year time limit of § 315(b), already mentioned,
 makes clear that Congress recognized the likelihood of par-
 allel pending proceedings in the PTO and in the courts. Be-
 ing sued for infringement provides a defendant a distinct
 motivation to seek cancellation, through an IPR, of patent
 claims asserted against it in court. 3 The existence of such
 overlapping proceedings raises self-evident issues of effi-
 ciency and interbranch relations. But Congress generally
 left the two branches to exercise their available discretion
 to address such issues. Congress enacted no provision for
 this scenario that directs the court to stay its case in light
 of a pending request for IPR or an instituted IPR. Nor did
 Congress enact a provision prescribing how the Director is
 to address such an overlapping pending court case in exer-
 cising the discretion whether to institute an IPR.
                               1
     The Director addressed this topic in 2019 and 2020 by
 exercising the authority to “designate[] past PTAB deci-
 sions as ‘precedential’ for future panels.” Arthrex, 141 S.
 Ct. at 1980 (citing § 316(a)(4), quoted supra n.2, and
 § 3(a)(2)(A), which states that “[t]he Director shall be

     3  Other provisions also reflect Congress’s expectation
 that the same patent claims might well be at issue in both
 an IPR proceeding and a court case. See, e.g., 35 U.S.C.
 § 315(e)(2) (estoppel bar); id. § 315(a)(2) (addressing situa-
 tion of petitioner initiation of both court and agency pro-
 ceeding); id. § 316(a)(4) (providing that “[t]he Director shall
 prescribe regulations— . . . establishing and governing in-
 ter partes review under this chapter and the relationship
 of such review to other proceedings under this title,” the
 latter including actions in court, see id. § 281).
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 8                                          APPLE INC.   v. VIDAL

 responsible for providing policy direction and management
 supervision for the Office”); see Trial and Appeal Board,
 Standard Operating Procedure 2 (Revision 10) at 1–2
 (Standard Procedure 2). Specifically, the Director desig-
 nated as precedential, and hence binding on Board panels
 (Standard Procedure 2 at 11), two Board decisions that had
 denied IPR petitions: NHK Spring Co. v. Intri-Plex Tech-
 nologies, Inc., IPR2018-00752, 2018 WL 4373643 (P.T.A.B.
 Sept. 12, 2018) (designated precedential on May 7, 2019),
 and Apple Inc. v. Fintiv, Inc., IPR2020-00019, 2020 WL
 2126495 (P.T.A.B. Mar. 20, 2020) (designated precedential
 on May 5, 2020). Both decisions address the role, in the
 decision whether to institute an IPR, of the pendency of
 district-court infringement litigation involving the same
 patents. The decisions, designated as precedential, consti-
 tute instructions from the Director regarding how the
 Board is to exercise the Director’s institution discretion.
     The decisions articulate “a discretionary standard for
 denying IPR petitions based on pending parallel litigation.”
 Plaintiffs’ Notice of Motion and Motion for Summary Judg-
 ment at 5, Apple Inc. v. Iancu, No. 20-cv-06128, 2021 WL
 5232241, (N.D. Cal. Nov. 10, 2021), ECF No. 65, 2020 WL
 8339428 (heading, capitalization removed except for
 “IPR”). In NHK, the Board relied on “the advanced state of
 the district court proceeding” involving the same patent to
 deny institution, reasoning that, given the projected trial
 date in the parallel court case, conducting an IPR would be
 an inefficient use of agency resources. 2018 WL 4373643,
 at *7. In Fintiv, the Board elaborated on NHK, enumerat-
 ing six factors—the last one open-ended—to be assessed in
 deciding whether to institute an IPR in parallel with an
 overlapping court case:
       1. whether the court granted a stay or evi-
       dence exists that one may be granted if a pro-
       ceeding is instituted;
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 APPLE INC.   v. VIDAL                                         9

        2. proximity of the court’s trial date to the
        Board’s projected statutory deadline for a fi-
        nal written decision;
        3. investment in the parallel proceeding by
        the court and the parties;
        4. overlap between issues raised in the peti-
        tion and in the parallel proceeding;
        5. whether the petitioner and the defendant
        in the parallel proceeding are the same party;
        and
        6. other circumstances that impact the
        Board’s exercise of discretion, including the
        merits.
 2020 WL 2126495, at *2. The Board explained how certain
 facts on the enumerated topics tend to weigh for or against
 institution, id. at *3–7, and how the “concerns of ineffi-
 ciency and the possibility of conflicting decisions were par-
 ticularly strong” in NHK, id. at *5. The Board stated
 generally that the factors “relate to whether efficiency, fair-
 ness, and the merits support the exercise of authority to
 deny institution in view of an earlier trial date in the par-
 allel proceeding,” id. at *3. The Board summarized: “[I]n
 evaluating the factors, the Board takes a holistic view of
 whether efficiency and integrity of the system are best
 served by denying or instituting review.” Id.
                                2
      The above instructions (the Fintiv instructions) were
 the subject of this case when it was filed in district court,
 when it was decided by the district court, and when plain-
 tiffs filed their brief as appellants in this court. Thereafter,
 on June 21, 2022, the Director updated the instructions.
 On that day, having issued a request for comments, see Re-
 quest for Comments on Discretion to Institution Trials Be-
 fore the Patent Trial and Appeal Board, 85 Fed. Reg.
 66,502 (Oct. 20, 2020), and having received hundreds of
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 10                                         APPLE INC.   v. VIDAL

 comments, the Director announced (without publication in
 the Federal Register) “several clarifications” to the Fintiv
 instructions “under the Director’s authority to issue bind-
 ing agency guidance to govern the PTAB’s implementation
 of various statutory provisions.” Memorandum from PTO
 Director to PTAB, Interim Procedure for Discretionary De-
 nials in AIA Post-Grant Proceedings with Parallel District
 Court Litigation at 2–3 (June 21, 2022) (June 2022 Memo).
      The Director described Congress’s aim “to establish a
 more efficient and streamlined patent system that will im-
 prove patent quality and limit unnecessary and counter-
 productive litigation costs,” June 2022 Memo at 1 (quoting
 H.R. Rep. No. 112-98, pt. 1, at 40 (2011)), and its own ex-
 perience with cost-increasing inefficiency and gamesman-
 ship when parallel PTO proceedings and court cases exist,
 id. The Director now instructed the Board that it should
 not “rely on the Fintiv factors to discretionarily deny insti-
 tution in view of parallel district court litigation where a
 petition presents compelling evidence of unpatentability.”
 Id. at 2. The Director further stated that the Fintiv analy-
 sis does not apply when the parallel proceeding is not a dis-
 trict-court case but a proceeding within the International
 Trade Commission. Id. at 2–3. The Director added that no
 Fintiv-based institution denial would occur “where a peti-
 tioner presents a stipulation not to pursue in a parallel pro-
 ceeding the same grounds or any grounds that could have
 reasonably been raised before the [Board].” Id. at 3. Fi-
 nally, the Director announced that, in the application of the
 Fintiv instructions, “when other relevant factors weigh
 against exercising discretion to deny institution or are neu-
 tral, the proximity to trial should not alone outweigh all of
 those other factors,” id. at 8, and that, even as to that fac-
 tor, a particular “scheduled trial date” was not a reliable
 indicator of proximity, which instead should be assessed
 based “the most recent statistics on median time-to-trial
 for civil actions in the district court” hearing the parallel
 case, id.
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 APPLE INC.   v. VIDAL                                     11

     The Director stated that the new instructions would
 apply to all pending proceedings in the PTO and “remain
 in place until further notice.” Id. at 9. But the Director
 added that “[t]he Office expects to replace this interim
 guidance with rules after it has completed formal rulemak-
 ing.” Id.
     The current challenge seeks prospective relief only,
 and the June 2022 instructions are part of the current op-
 erative instruction set regarding institution decisions by
 the Board as delegatee of the Director. 4 It would seem
 proper, therefore, were it important, to consider the up-
 dated instructions rather than the Fintiv instructions
 alone. See National Treasury Employees Union v. Von
 Raab, 489 U.S. 656, 661 n.1 (1989) (deciding case based on
 agency program as altered after court of appeals decision).
 But none of our conclusions in this appeal depend on
 whether we consider the Fintiv instructions or the updated
 instructions.
                              C
      On August 31, 2020, Apple and three other companies
 filed suit in the Northern District of California, seeking to
 challenge the Fintiv instructions on three grounds under
 the APA: (1) that the Director acted contrary to the IPR
 provisions of the patent statute, see 5 U.S.C. § 706(2)(C);
 (2) that the Fintiv instructions are arbitrary and capri-
 cious, see 5 U.S.C. § 706(2)(A); and (3) that the Fintiv in-
 structions were issued without compliance with the notice-
 and-comment rulemaking requirements of 5 U.S.C. § 553,

     4   For subsequent clarifications from the Director, see
 OpenSky Industries, LLC v. VLSI Tech. LLC, IPR2021-
 01064, 2022 WL 4963049, at *20 (P.T.A.B. Oct. 4, 2022)
 (precedential) (Director’s Decision on Determining Abuse
 of Process), and CommScope Technologies LLC v. Dali
 Wireless, Inc., IPR2022-01242, 2023 WL 2237986, at *2
 (P.T.A.B. Feb. 27, 2023) (Director’s Decision on Rehearing).
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 12                                        APPLE INC.   v. VIDAL

 as assertedly required by that APA provision and by 35
 U.S.C. § 316. Apple, 2021 WL 5232241, at *3. An amended
 complaint added a fifth plaintiff but asserted the same
 challenges. The government moved to dismiss the case, ar-
 guing that plaintiffs lacked standing and, in the alterna-
 tive, that APA review was unavailable both because (1)
 “statutes preclude judicial review” of the matters presented
 and (2) the challenges are to “agency action [that] is com-
 mitted to agency discretion by law,” 5 U.S.C. § 701(a)(1)–
 (2). Briefing on that motion followed—on the same sched-
 ule as briefing on plaintiffs’ own motion for summary judg-
 ment, which the court ruled, at plaintiffs’ urging, was
 sufficiently “intertwined” with the dismissal motion to war-
 rant parallel briefing. Order on Defendants’ Motion for Ad-
 ministrative Relief Requesting a Stay of Briefing on
 Plaintiffs’ Motion for Summary Judgment at 1, Apple, No.
 20-cv-06128, 2021 WL 5232241, ECF No. 70; Plaintiffs’ Op-
 position to Defendant’s Motion for Administrative Relief
 Requesting a Stay of Briefing on Plaintiffs’ Motion for Sum-
 mary Judgment at 2, Apple, No. 20-cv-06128, 2021 WL
 5232241, ECF No. 69.
     On November 10, 2021, the district court granted the
 government’s motion to dismiss. Apple, 2021 WL 5232241,
 at *1–6. The district court first concluded that plaintiffs
 had standing. Id. at *4–5. The court then concluded that
 their challenges were to Director actions that were not re-
 viewable. Id. at *5–6. The court reasoned that 35 U.S.C.
 § 314(d), together with Cuozzo and Thryv, precluded re-
 view because, to rule on the challenges, the court “would
 have to analyze questions that are closely tied to the appli-
 cation and interpretation of statutes” governing institution
 decisions. Id. at *6 (internal quotation marks, for quote
 from Cuozzo and Thryv, omitted). The court therefore dis-
 missed the case and “terminate[d] [p]laintiffs’ motion for
 summary judgment.” Id. Like the parties before us, we
 treat this dismissal as invoking the exclusion from the APA
 applicable where “statutes preclude judicial review.” 5
 U.S.C. § 701(a)(1).
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 APPLE INC.   v. VIDAL                                      13

      Plaintiffs appealed on December 8, 2021, and that ap-
 peal ripened when the district court entered final judgment
 on December 13, 2021. We have jurisdiction over the
 timely appeal under 28 U.S.C. § 1295(a)(1) because plain-
 tiffs’ claims, at least in part, are based on the patent stat-
 ute.
                               II
     Plaintiffs argue on appeal that the district court erred
 when it held that the IPR provisions of the patent statute
 “preclude judicial review” of the challenged agency actions,
 bringing the case within the APA exclusion stated in 5
 U.S.C. § 701(a)(1). The government, in response, defends
 the district court’s § 701(a)(1) ruling and argues, in the al-
 ternative, that affirmance is separately required because
 the challenged agency action is “committed to agency dis-
 cretion by law,” § 701(a)(2), and because plaintiffs lack
 standing. We may consider the § 701(a)(1) unreviewability
 issue first and need not consider § 701(a)(2) and standing
 unless we find a challenge to lie outside the § 701(a)(1) ex-
 clusion from APA review. See Block v. Community Nutri-
 tion Institute, 467 U.S. 340, 353 n.4 (1984). We decide the
 issues presented, which are entirely legal, de novo. See
 Alarm.com Inc. v. Hirshfeld, 26 F.4th 1348, 1354 (Fed. Cir.
 2022); Digitalis Education Solutions, Inc. v. United States,
 664 F.3d 1380, 1384 (Fed. Cir. 2012).
     We begin with plaintiffs’ first two challenges (urging
 that the Director’s instructions violate the IPR statute and
 are arbitrary and capricious), which we consider together.
 We affirm the § 701(a)(1) dismissal of those challenges and
 so need not consider § 701(a)(2) or standing. We then ad-
 dress the remaining challenge (concerning the absence of
 notice-and-comment rulemaking). We hold that neither
 § 701(a)(1) nor § 701(a)(2) bars review of the third chal-
 lenge and that at least Apple has standing to press it. We
 therefore reverse the dismissal as to the third challenge
 and remand.
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 14                                         APPLE INC.   v. VIDAL

                               A
     Plaintiffs’ first two counts in their amended complaint
 challenge the content of the Director’s institution instruc-
 tions. The statutory challenge is that the instructions al-
 low, and encourage or even require, denial of institution
 contrary to proscriptions plaintiffs draw from the IPR stat-
 ute. Most concretely, plaintiffs assert that § 315(b)’s set-
 ting of an outer time limit on filing a petition, where the
 petitioner or its privy or the real party in interest has been
 sued on the patent in court, implies that the Director is for-
 bidden, when determining whether to institute, to consider
 the timing of the petition within that limit and the stage of
 development of the court case. The arbitrary-and-capri-
 ciousness challenge is that the Fintiv instructions are not
 “reasonable and reasonably explained.” Federal Commu-
 nications Commission v. Prometheus Radio Project, 141 S.
 Ct. 1150, 1158 (2021) (“The APA’s arbitrary-and-capricious
 standard requires that agency action be reasonable and
 reasonably explained.”); Snyder v. McDonough, 1 F. 4th
 996, 1005 (Fed. Cir. 2021). Plaintiffs assert that the Fintiv
 instructions’ directive to consider the time to trial in the
 parallel court case disregards the unreliability of court-set
 trial dates, which are frequently moved forward. For both
 challenges, plaintiffs invoke some of the policies articu-
 lated in the legislative process leading to the creation of the
 IPR program in the 2011 AIA.
     These two challenges have institution as their direct,
 immediate, express subject. In this respect, the challenges
 are critically different from the challenge the Supreme
 Court agreed with in SAS, a decision on which plaintiffs
 rely. There, the subject of the challenge was the interpre-
 tation of § 318, which prescribes the scope of the final writ-
 ten decision required of the Board in an IPR. The Court
 held that § 318 requires the final written decision to “re-
 solve all of the claims in the case.” 138 S. Ct. at 1353. That
 holding was not precluded by the unreviewability of insti-
 tution decisions already articulated in Cuozzo, even though
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 APPLE INC.   v. VIDAL                                       15

 the § 318 holding had, as a corollary, the effect of requiring
 the Director’s decision whether to institute a requested re-
 view to be essentially an all-or-nothing one. Id. at 1358–
 60. As the Court explained in Thryv, the merely collateral
 effect of a provision concerning “the manner in which the
 agency’s review ‘proceeds’ once instituted” did not bring
 SAS within the principle of unreviewability of “whether the
 agency should have instituted review at all.” 140 S. Ct. at
 1376.
      SAS thus does not alter the principle of unreviewabil-
 ity governing “application and interpretation of statutes re-
 lated to the [PTO’s] decision to initiate inter partes
 review.’” Id. at 1373 (internal quotation marks omitted)
 (quoting Cuozzo, 579 U.S. at 275); see id. at 1376 n.8.
 Plaintiffs’ statutory and arbitrary-and-capriciousness chal-
 lenges in this case focus directly and expressly on institu-
 tion standards, nothing else. The Supreme Court in
 Cuozzo and Thryv did not exclude any challenge from the
 reviewability bar where the invoked provisions of law di-
 rectly govern institution—as the Court understood was the
 case for the pleading provision that was at issue in Cuozzo
 (§ 312(a)(3) (a petition “may be considered only if . . .”) and
 the timing provision that was at issue in Thryv (§ 315(b)
 (an IPR “may not be instituted if . . .”). See Thryv, 140 S.
 Ct. at 1373, 1376 n.8. 5

     5  The Court in Cuozzo recognized, as SAS was soon to
 illustrate, that some statutory provisions addressed to
 other matters might have an indirect bearing on institu-
 tion, and for that reason the Cuozzo Court said that it was
 not deciding “the precise effect of § 314(d) on appeals that
 implicate constitutional questions, that depend on other
 less closely related statutes, or that present other ques-
 tions of interpretation that reach, in terms of scope and im-
 pact, well beyond” § 314. 579 U.S. at 275. The Court in
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 16                                         APPLE INC.   v. VIDAL

      In Arthrex, the Supreme Court confirmed the principle
 of unreviewability of the Director’s decision whether to in-
 stitute. 141 S. Ct. at 1977. The Court relied indirectly on
 Cuozzo’s holding that the IPR statute’s text, legislative his-
 tory, and structure supplied the clear and convincing evi-
 dence required to overcome the strong presumption in
 favor of reviewability generally, 579 U.S. at 273, and on
 Cuozzo’s application of the unreviewability principle even
 in a case in which a review was instituted and completed
 and a proper appeal was taken to this court of the Board’s
 final written decision, id. at 271–75. The Court in Arthrex
 directly relied on Thryv, in which the Court, as in Cuozzo,
 applied the unreviewability principle in a proper appeal
 and made clear that the principle bars judicial resolution
 of even run-of-the-mill statutory interpretation issues in-
 herent in an institution determination by the Director as
 long as the statutory provision is one sufficiently focused
 on institution itself, as the Court held was true of § 315(b),
 Thryv, 140 S. Ct. at 1372–73. Nothing in the unreviewa-
 bility principle repeatedly affirmed by the Supreme Court
 in this setting, moreover, turns on whether the Director
 has provided an explanation (as the Board, as delegatee,
 typically does). That is hardly surprising, as the Supreme

 Cuozzo further stated that its holding did not “enable the
 agency to act outside its statutory limits by, for example,
 canceling a patent claim for ‘indefiniteness under § 112’ in
 an inter partes review.” Id. The example given is the
 PTO’s “canceling a patent claim” in an IPR (after institu-
 tion, see § 318(b)), not an aspect of the institution determi-
 nation. Id. The Court in Thryv subsequently noted,
 without elaboration, that it was not “decid[ing] whether
 mandamus might be available in an extraordinary case.”
 140 S. Ct. at 1374 n.6. The case before us is not a manda-
 mus case. See also Mylan, 989 F.3d at 1382 (holding man-
 damus standard not met for challenge to denial based on
 Fintiv instructions).
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 APPLE INC.   v. VIDAL                                      17

 Court has rejected the notion that “if the agency gives a
 ‘reviewable’ reason for otherwise unreviewable action, the
 action becomes reviewable.” Interstate Commerce Commis-
 sion v. Brotherhood of Locomotive Engineers, 482 U.S. 270,
 283 (1987).
     The present case, unlike Thryv and Cuozzo, does not
 involve a petition-specific challenge, i.e., a challenge to a
 Director determination whether to institute a review re-
 quested in an individual petition. Rather, it involves a
 challenge to the Director’s instructions to the Board, as del-
 egatee, regarding how to exercise the Director’s institution
 discretion. But we conclude that the IPR statute’s preclu-
 sion of review, as now settled by the Supreme Court based
 on statutory text, legislative history, and structure, must
 encompass preclusion of review of the content-focused chal-
 lenges to the instructions at issue here.
     This conclusion rests on what we already confirmed in
 Ethicon, namely, the inevitability and congressional expec-
 tation of the Director’s delegation of the institution deci-
 sion, given the large number of institution decisions the
 Director would otherwise have to make personally, in
 highly technical matters involving significant records,
 while fulfilling many other responsibilities. See Ethicon,
 812 F.3d at 1031–32. Given the need for delegation, and
 the Director’s “political responsibility of determining which
 cases should proceed,” Saint Regis Mohawk Tribe v. Mylan
 Pharmaceuticals Inc., 896 F.3d 1322, 1327–28 (Fed. Cir.
 2018), the Director must be able to give guidance in the
 form of instructions to her delegatee(s)—the Board (or
 Board panels)—about how to make the institution determi-
 nations on her behalf. Such guidance is crucial for ensur-
 ing that such determinations will overwhelmingly be made
 in accordance with the policy choices about institution she
 would follow if she were making the determinations herself
 and, relatedly, for minimizing the number of occasions on
 which she has to reverse such determinations, as she may
 do, see Palo Alto Networks, 44 F.4th at 1375. If the
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 18                                         APPLE INC.   v. VIDAL

 congressional preclusion of review of the decision to insti-
 tute is to be respected in the inevitable system of delega-
 tion, it must extend to the substance of such instructions.
     If the Director personally made an institution decision
 accompanied by an explanation containing the same rea-
 soning as appears in the instructions here at issue, then
 the decision would be unreviewable for being contrary to
 statute or arbitrary and capricious. For the IPR system to
 function with the delegations that are inevitable and con-
 gressionally expected, the same conclusion must follow for
 the instructions given by the Director to the Board as dele-
 gatee. We therefore affirm the district court’s dismissal of
 plaintiffs’ first two challenges under 5 U.S.C. § 701(a)(1). 6

      6 In the first two challenges, plaintiffs assert that the
 instructions, because of their content, will likely lead to
 non-institution determinations that will harm them. Non-
 institution determinations are a species of non-enforce-
 ment decisions, which are among the few recognized cate-
 gories of agency action that are generally “committed to
 agency discretion by law,” 5 U.S.C. § 701(a)(2). See Cuozzo,
 579 U.S. at 273 (“[T]he agency’s decision to deny a petition
 is a matter committed to the Patent Office’s discretion.”
 (citing § 701(a)(2))); Department of Homeland Security v.
 Regents of University of California, 140 S. Ct. 1891, 1905–
 06 (2020); Department of Commerce v. New York, 139 S. Ct.
 2551, 2565 (2019); Lincoln v. Vigil, 508 U.S. 182, 191
 (1993); Heckler v. Chaney, 470 U.S. 821, 831–32 (1985).
 Some court decisions from outside the Supreme Court sug-
 gest that certain agency announcements of non-enforce-
 ment policy may fall outside the § 701(a)(2) exclusion from
 APA review. See, e.g., Crowley Caribbean Transport, Inc.
 v. Pena, 37 F.3d 671, 676 (D.C. Cir. 1994). The Supreme
 Court in Regents, when presented with an argument along
 those lines, did not reach the argument, because it held
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 APPLE INC.   v. VIDAL                                     19

                              B
     Plaintiffs’ third challenge is that the Director was re-
 quired, by 35 U.S.C. § 116 together with 5 U.S.C. § 553, to
 promulgate the institution instructions through notice-
 and-comment rulemaking procedures. This challenge, we
 conclude, may be pressed under the APA. We also hold
 that at least Apple has standing to press it.
                              1
      Whether notice-and-comment rulemaking procedures
 had to be employed for an agency action presents a matter
 “quite apart from the matter of substantive reviewability”
 of the action for being contrary to statute or arbitrary and
 capricious. Lincoln v. Vigil, 508 U.S. 182, 195 (1993); see
 American Medical Association v. Reno, 57 F.3d 1129, 1134
 (D.C. Cir. 1995) (“[U]nder the APA the ultimate availabil-
 ity of substantive judicial review is distinct from the ques-
 tion of whether the basic rulemaking strictures of notice
 and comment and reasoned explanation apply. . . . The
 APA’s procedural requirements are enforceable apart from
 the reviewability of the underlying action, and, indeed,
 support several important functions wholly distinct from
 judicial review.”) (omission of internal Lincoln citation and
 quote); Story v. Marsh, 732 F.2d 1375, 1381, 1384 (8th Cir.
 1984); Natural Resources Defense Council v. U.S. Depart-
 ment of Energy, 362 F. Supp. 3d 126, 147 (S.D.N.Y. 2019);
 Batalla Vidal v. Duke, 295 F. Supp. 3d 127, 148 (E.D.N.Y.
 2017). Given this recognized distinction, we reject a con-
 clusion of unreviewability, under § 701(a)(1) or (2), for
 plaintiffs’ third challenge.

 that the policy at issue was not a mere non-enforcement
 policy. 140 S. Ct. at 1906–07. We do not reach it either, as
 we affirm dismissal of plaintiffs’ first two challenges based
 on § 701(a)(1) and so need not decide whether § 701(a)(2)
 would independently support dismissal.
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 20                                         APPLE INC.   v. VIDAL

     Here, as discussed above, the Supreme Court has held
 that clear and convincing evidence establishes a congres-
 sional protection from judicial review of the substance of
 the Director’s institution discretion. That holding does not
 cover, and we see no basis for extending it to protect as
 well, the Director’s choice of whether to use notice-and-
 comment rulemaking to announce instructions for the in-
 stitution decision. The government here has not shown
 that anything in § 314(d) or elsewhere in the IPR statute
 supplies clear and convincing evidence that there was to be
 no judicial review of the choice of announcement procedure,
 a matter for which generally applicable standards exist.
 See, e.g., Lincoln, 508 U.S. at 196; Xi’an Metals & Minerals
 Import & Export Co. v. United States, 50 F.4th 98, 105–06
 (Fed. Cir. 2022). In these circumstances, we have been
 shown no sufficient justification for a conclusion that the
 high standard of § 701(a)(1) for inferring a preclusion of re-
 view is met for this distinct issue.
     Nor have we been presented a persuasive justification
 for concluding that the use or non-use of notice-and-com-
 ment rulemaking procedures is a matter “committed to
 agency discretion by law,” 5 U.S.C. § 701(a)(2). The general
 rule that non-enforcement choices are committed to agency
 discretion by law, see supra n.5, does not mean that the
 choice of announcement procedure for issuing instructions
 for the making of choices is also committed to agency dis-
 cretion by law. And at least because of the developed
 standards under 5 U.S.C. § 553, this is not a case where
 there is “no meaningful standard” by which to judge the
 process choice. Department of Commerce v. New York, 139
 S. Ct. 2551, 2568 (2019) (considering whether matter was
 “one of those areas traditionally committed to agency dis-
 cretion” and, then, whether there was “no meaningful
 standard” to use the judge the agency action).
     The Supreme Court’s decision in Lincoln supports our
 conclusion about reviewability regarding plaintiffs’ third
 challenge. The Court there held that § 701(a)(2) barred
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 APPLE INC.   v. VIDAL                                     21

 review of the substance of an agency’s choice of how to al-
 locate a lump-sum appropriation, because allocation under
 a lump-sum appropriation was a recognized category of ac-
 tion committed to the agency’s discretion. Lincoln, 508
 U.S. at 191–95. But the Court was not asked to and did
 not hold unreviewable, for compliance with 5 U.S.C. § 553,
 the agency’s choice not to use notice-and-comment rule-
 making; instead, it decided, on the merits, that § 553 did
 not require notice-and-comment rulemaking for the agency
 decision at issue. Id. at 195–99. The government in Lin-
 coln explained this distinction, stating: “The rulemaking
 provision of the APA, 5 U.S.C. 553, may itself provide ‘law
 to apply’ for reviewing agency procedures, even if there is
 otherwise no jurisdiction to review the substance of an
 agency decision.” Brief for Petitioners, Lincoln, 508 U.S.
 182 (No. 91-1833), 1992 WL 547219, at *10 n.8 (citing
 Story, 732 F.2d at 1381, 1384). We conclude that the dis-
 tinction applies here.
                              2
     We also conclude that at least Apple has standing to
 press the challenge to the Director’s instructions as invalid
 for want of notice-and-comment rulemaking. We so con-
 clude without aggregating the plaintiffs’ asserted threat-
 ened harms, an approach taken by plaintiffs without
 arguing for its propriety. See, e.g., Summers v. Earth Is-
 land Institute, 555 U.S. 488, 494–97 (2009) (analyzing in-
 dividual plaintiffs separately); ASARCO Inc. v. Kadish,
 490 U.S. 605, 615 (1989) (“[T]he doctrine of standing to sue
 is not a kind of gaming device that can be surmounted
 merely by aggregating the allegations of different kinds of
 plaintiffs, each of whom may have claims that are remote
 or speculative taken by themselves.”); Valley Forge Chris-
 tian College v. Americans United for Separation of Church
 & State, Inc., 454 U.S. 464, 489 (1982) (“The law of aver-
 ages is not a substitute for standing.”). We will focus on
 Apple alone, and our conclusion that it has standing to
 press the remaining challenge permits us to reverse the
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 22                                         APPLE INC.   v. VIDAL

 dismissal and remand for the merits of that challenge to be
 addressed (along with any question about standing of other
 plaintiffs available for decision on remand if necessary).
 See, e.g., Little Sisters of the Poor Saints Peter & Paul Home
 v. Pennsylvania, 140 S. Ct. 2367, 2379 n.6 (2020); Rumsfeld
 v. Forum for Academic & Institutional Rights, Inc., 547
 U.S. 47, 52 n.2 (2006).
      In reviewing a standing determination made on a mo-
 tion to dismiss a complaint, like the standing determina-
 tion before us in this appeal, we assess standing de novo.
 Ford Motor Co. v. United States, 688 F.3d 1319, 1323 (Fed.
 Cir. 2012). We ask if the standard at the complaint stage,
 requiring allegations of fact plausibly indicating satisfac-
 tion of the legal requirement, is met. See TransUnion LLC
 v. Ramirez, 141 S. Ct. 2190, 2208 (2021); Lujan v. Defend-
 ers of Wildlife, 504 U.S. 555, 560–61 (1992); James v. J2
 Cloud Services, LLC, 887 F.3d 1368, 1372 (Fed. Cir. 2018).
 We focus on the allegations of the complaint, but, under the
 regional circuit’s law we apply, we may also consider, at
 least, matters of which we may properly take judicial no-
 tice. See Lee v. City of Los Angeles, 250 F.3d 668, 689–90
 (9th Cir. 2001).
      For a plaintiff to have standing, the plaintiff must show
 (1) an “injury in fact,” (2) “a causal connection between the
 injury and the conduct complained of,” and (3) a likelihood
 that “the injury will be redressed by a favorable decision.”
 Lujan, 504 U.S. at 560–61 (internal quotation marks omit-
 ted). An injury in fact is “a legally protected interest which
 is (a) concrete and particularized” and “(b) actual or immi-
 nent, not conjectural or hypothetical.” Id. at 560 (internal
 quotation marks omitted). The Court has found an asser-
 tion of future injury insufficient where it “involve[d] a sig-
 nificant degree of guesswork.” Trump v. New York, 141 S.
 Ct. 530, 536 (2020). On the other hand, “[a]n allegation of
 future injury may suffice if the threatened injury is cer-
 tainly impending, or there is a substantial risk that the
 harm will occur.” Susan B. Anthony List v. Driehaus, 573
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 APPLE INC.   v. VIDAL                                      23

 U.S. 149, 159 (2014) (internal quotation marks omitted)
 (quoting Clapper v. Amnesty International USA, 568 U.S.
 398, 414 n.5 (2013)); Department of Commerce, 139 S. Ct.
 at 2566. Of particular significance for this case, when a
 plaintiff asserts an entitlement to a rulemaking, the re-
 dressability requirement for standing is relaxed: It is
 enough for that element to be met that “there is some pos-
 sibility that the requested relief,” namely, notice-and-com-
 ment rulemaking, would “prompt the [agency] to
 reconsider the decision that allegedly harmed” the plain-
 tiff. Massachusetts v. Environmental Protection Agency,
 549 U.S. 497, 518 (2007); see Summers, 555 U.S. at 496–97;
 Lujan, 504 U.S. at 572 n.7; Iowa League of Cities v. Envi-
 ronmental Protection Agency, 711 F.3d 844, 871 (8th Cir.
 2013); Sierra Club v. Environmental Protection Agency, 699
 F.3d 530, 533 (D.C. Cir. 2012).
      Apple is non-speculatively threatened with harm to a
 legally protected interest from the challenged instructions.
 The complaint asserts harm with only brief elaboration.
 See Amended Complaint, ¶¶ 23, 28, Apple, No. 20-cv-
 06128, 2021 WL 5232241, ECF No. 54; J.A. 1134; J.A. 1136.
 But that is enough in this case. We may take judicial notice
 that Apple is a repeat player, in the relevant respect, on a
 very large scale. On a regular basis, for many years, it has
 been sued for infringement (giving it a concrete stake) and
 then petitioned for an IPR of patent claims at issue in that
 suit. Some of the petitions have been denied—for Apple, at
 least in Fintiv itself—based on the institution instructions
 at issue.
      Given that history, it is far from speculative that this
 sequence will be repeated in the future, considering Apple’s
 size and use of a wide variety of technologies and the real-
 istically perceived advantages of the IPR process, including
 the applicability of a lighter burden of persuasion to prevail
 in challenging a patent claim than the burden applicable
 in district court. See Jibril v. Mayorkas, 20 F.4th 804, 815
 (D.C. Cir. 2021) (concluding that “extensive” history
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 24                                         APPLE INC.   v. VIDAL

 supporting “future plans” can establish injury in fact); N.B.
 ex rel. Peacock v. District of Columbia, 682 F.3d 77, 84 (D.C.
 Cir. 2012) (“[A]lthough ‘past . . . conduct does not in itself
 show a present case or controversy regarding injunctive re-
 lief,’ ‘past wrongs’ may serve as ‘evidence bearing on
 whether there is a real and immediate threat of repeated
 injury.’” (cleaned up) (quoting City of Los Angeles v. Lyons,
 461 U.S. 95, 102 (1983))). It is not unduly conjectural, but
 “the predictable effect” of the instructions, Department of
 Commerce, 139 S. Ct. at 2566, that the challenged instruc-
 tions, which are plausibly alleged to cause more denials of
 institution than might otherwise occur, will continue caus-
 ing harm in the form of denial of the benefits of IPRs linked
 to the concrete interest possessed by an infringement de-
 fendant—even though Apple cannot specify in advance in-
 dividual IPR requests (filed with an infringement suit
 pending) that will be denied. These facts, we conclude,
 mean that “there is a substantial risk that the harm will
 occur” in the future because of the instructions. Susan B.
 Anthony List, 573 U.S. at 159 (internal quotation marks
 omitted) (quoting Clapper, 568 U.S. at 414 n.5). The injury
 is concrete and legally protected, because of the infringe-
 ment suit, so the injury and causation requirements for
 standing are met.
     The applicable standard for redressability here is also
 met. There is a genuine possibility that the instructions
 would be changed in a way favorable to Apple in a notice-
 and-comment rulemaking. That possibility is confirmed by
 the fact that the Director, in response to comments, an-
 nounced favorable clarifications in the June 2020 Memo.
     For those reasons, we conclude that Apple has standing
 to press the claim that the challenged instructions were
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 APPLE INC.   v. VIDAL                                      25

 improperly put in place without notice-and-comment rule-
 making. 7
                              III
      For the foregoing reasons, we affirm the district court’s
 judgment dismissing plaintiffs’ challenges to the Director’s
 instructions as substantively contrary to statute and as ar-
 bitrary and capricious. We reverse the district court’s dis-
 missal for unreviewability of plaintiffs’ challenge to the
 Director’s instructions as having improperly been issued
 without notice-and-comment rulemaking, a challenge that
 we also conclude at least Apple has standing to press. We
 remand for consideration of this one challenge on the mer-
 its.
     The parties shall bear their own costs.
   AFFIRMED IN PART, REVERSED IN PART, AND
                 REMANDED

     7   Neither side has suggested mootness of this chal-
 lenged based on the June 2022 Memo or subsequent clari-
 fications, see supra n.4, which, like their predecessors, were
 not put in place through notice-and-comment rulemaking
 (including publication in the Federal Register). A chal-
 lenge might not be mooted by a change in challenged con-
 duct if the alteration is itself subject to the same asserted
 deficiency as its predecessor. See, e.g., Davenport v. Wash-
 ington Education Association, 551 U.S. 177, 182 n.1 (2007);
 Northeastern Florida Chapter of Associated General Con-
 tractors of America v. City of Jacksonville, 508 U.S. 656,
 661–63 (1993); 13C Charles A. Wright & Arthur R. Miller,
 Federal Practice and Procedure § 3533.6 at n.63 (3d ed.
 2022). The post-Fintiv clarifications do not appear to moot
 plaintiffs’ third challenge, the only one remaining after our
 unreviewability holding regarding the first two challenges.
 Any further exploration of the effect of the post-Fintiv clar-
 ifications is left to the district court on remand.