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-appellants. 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.

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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 Trademark Office, Alexandria, VA.

 MARK S. DAVIES, Orrick, Herrington & Sutcliffe LLP, 

Washington, DC, for amici curiae Acushnet Company, Alliance for Automotive Innovation, Comcast Cable Communications, LLC, Computer and Communication Industry 

Association, Dell, Inc., Garmin International, Inc., Juniper 

Networks, Inc., Micron Technology Inc., SAS Institute, 

Inc., Symmetry, LLC, Taiwan Semiconductor Manufacturing Company, Ltd., Verizon Services Corp., VIZIO, Inc., 

VMware, Inc. Also represented by ALEXANDRA BURSAK, 

New York, NY.

 JAMES OLIVA, American Honda Motor Co., Inc., Torrance, CA, for amicus curiae American Honda Motor Co., 

Inc.

 ROBERT THOMAS SMITH, Katten Muchin Rosenman 

LLP, Washington, DC, for amicus curiae Mylan Pharmaceuticals 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 represented 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 identified claims in an issued patent comply with certain patentability 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 determining 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 authorize an [IPR] to be instituted unless the Director determines that the information presented in the petition . . . 

and any response . . . shows that there is a reasonable likelihood 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 predictably 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 service 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 institute 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 regarding the mandatory threshold conditions for institution, 

at least where, as here, the court challenge is not on a constitutional ground. See Cuozzo, 579 U.S. at 275 (noting 

that it was not addressing challenges that implicate constitutional questions, which present distinct issues regarding 

congressional preclusion of judicial review).1 Thus, Congress 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 constitutional challenge, we hereafter generally refrain from noting 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 statement); Cuozzo, 579 U.S. at 271–75.2

From the outset of the IPR program, the Director delegated 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 authority to delegate to officials within the agency,” that “Congress 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 subordinate officer,” and that, in particular, “Congress assigned 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 review every petition.” Ethicon Endo-Surgery, Inc. v. 

Covidien LP, 812 F.3d 1023, 1031–32 (Fed. Cir. 2016) (footnote omitted). We have also made clear that any institution 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 decision, to decide the patentability of all patent claims challenged 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 determination 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 parallel pending proceedings in the PTO and in the courts. Being 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 efficiency 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 exercising 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 decisions 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 situation of petitioner initiation of both court and agency proceeding); id. § 316(a)(4) (providing that “[t]he Director shall 

prescribe regulations— . . . establishing and governing inter 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 designated 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 Technologies, 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, constitute 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 Judgment 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, enumerating 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 evidence exists that one may be granted if a proceeding 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 final written decision; 

3. investment in the parallel proceeding by 

the court and the parties; 

4. overlap between issues raised in the petition 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 inefficiency and the possibility of conflicting decisions were particularly strong” in NHK, id. at *5. The Board stated

generally that the factors “relate to whether efficiency, fairness, and the merits support the exercise of authority to 

deny institution in view of an earlier trial date in the parallel 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 plaintiffs 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 Request for Comments on Discretion to Institution Trials Before 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 binding agency guidance to govern the PTAB’s implementation 

of various statutory provisions.” Memorandum from PTO 

Director to PTAB, Interim Procedure for Discretionary Denials 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 improve patent quality and limit unnecessary and counterproductive litigation costs,” June 2022 Memo at 1 (quoting 

H.R. Rep. No. 112-98, pt. 1, at 40 (2011)), and its own experience with cost-increasing inefficiency and gamesmanship 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 institution 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 analysis does not apply when the parallel proceeding is not a district-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 petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have 

reasonably been raised before the [Board].” Id. at 3. Finally, the Director announced that, in the application of the 

Fintiv instructions, “when other relevant factors weigh 

against exercising discretion to deny institution or are neutral, the proximity to trial should not alone outweigh all of 

those other factors,” id. at 8, and that, even as to that factor, 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 rulemaking.” Id.

The current challenge seeks prospective relief only, 

and the June 2022 instructions are part of the current operative 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 updated 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 capricious, see 5 U.S.C. § 706(2)(A); and (3) that the Fintiv instructions were issued without compliance with the noticeand-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, arguing that plaintiffs lacked standing and, in the alternative, 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 committed to agency discretion by law,” 5 U.S.C. § 701(a)(1)–

(2). Briefing on that motion followed—on the same schedule as briefing on plaintiffs’ own motion for summary judgment, which the court ruled, at plaintiffs’ urging, was 

sufficiently “intertwined” with the dismissal motion to warrant parallel briefing. Order on Defendants’ Motion for Administrative 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’ Opposition to Defendant’s Motion for Administrative Relief 

Requesting a Stay of Briefing on Plaintiffs’ Motion for Summary 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 reviewable. Id. at *5–6. The court reasoned that 35 U.S.C. 

§ 314(d), together with Cuozzo and Thryv, precluded review because, to rule on the challenges, the court “would 

have to analyze questions that are closely tied to the application and interpretation of statutes” governing institution 

decisions. Id. at *6 (internal quotation marks, for quote 

from Cuozzo and Thryv, omitted). The court therefore dismissed 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 appeal 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 plaintiffs’ claims, at least in part, are based on the patent statute. 

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 alternative, that affirmance is separately required because 

the challenged agency action is “committed to agency discretion 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) exclusion from APA review. See Block v. Community Nutrition 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 address 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 challenge 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 instructions. The statutory challenge is that the instructions allow, and encourage or even require, denial of institution 

contrary to proscriptions plaintiffs draw from the IPR statute. Most concretely, plaintiffs assert that § 315(b)’s setting 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 forbidden, 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-capriciousness challenge is that the Fintiv instructions are not 

“reasonable and reasonably explained.” Federal Communications 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 articulated 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 interpretation of § 318, which prescribes the scope of the final written decision required of the Board in an IPR. The Court

held that § 318 requires the final written decision to “resolve all of the claims in the case.” 138 S. Ct. at 1353. That 

holding was not precluded by the unreviewability of institution 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 review 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 unreviewability governing “application and interpretation of statutes related 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 challenges in this case focus directly and expressly on institution 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 directly 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 institution, 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 questions of interpretation that reach, in terms of scope and impact, 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 institute. 141 S. Ct. at 1977. The Court relied indirectly on 

Cuozzo’s holding that the IPR statute’s text, legislative history, and structure supplied the clear and convincing evidence 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 inherent 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 unreviewability 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 institution, see § 318(b)), not an aspect of the institution determination. 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 mandamus case. See also Mylan, 989 F.3d at 1382 (holding mandamus 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 Commission 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 requested in an individual petition. Rather, it involves a 

challenge to the Director’s instructions to the Board, as delegatee, regarding how to exercise the Director’s institution 

discretion. But we conclude that the IPR statute’s preclusion 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 challenges to the instructions at issue here.

This conclusion rests on what we already confirmed in 

Ethicon, namely, the inevitability and congressional expectation of the Director’s delegation of the institution decision, 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 determinations on her behalf. Such guidance is crucial for ensuring 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 institute is to be respected in the inevitable system of delegation, it must extend to the substance of such instructions. 

If the Director personally made an institution decision 

accompanied by an explanation containing the same reasoning 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 congressionally expected, the same conclusion must follow for 

the instructions given by the Director to the Board as delegatee. 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. Noninstitution determinations are a species of non-enforcement decisions, which are among the few recognized categories 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 suggest that certain agency announcements of non-enforcement 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 required, by 35 U.S.C. § 116 together with 5 U.S.C. § 553, to 

promulgate the institution instructions through noticeand-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 availability of substantive judicial review is distinct from the question 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. Department 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 conclusion 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 congressional 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-andcomment rulemaking to announce instructions for the institution 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 review 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-comment 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 discretion 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 discretion” 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 allocate a lump-sum appropriation, because allocation under 

a lump-sum appropriation was a recognized category of action 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 rulemaking; 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 Lincoln 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 distinction 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 conclude without aggregating the plaintiffs’ asserted threatened harms, an approach taken by plaintiffs without 

arguing for its propriety. See, e.g., Summers v. Earth Island Institute, 555 U.S. 488, 494–97 (2009) (analyzing individual 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 Christian College v. Americans United for Separation of Church 

& State, Inc., 454 U.S. 464, 489 (1982) (“The law of averages 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 motion to dismiss a complaint, like the standing determination 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 satisfaction of the legal requirement, is met. See TransUnion LLC 

v. Ramirez, 141 S. Ct. 2190, 2208 (2021); Lujan v. Defenders 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 notice. 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 omitted). An injury in fact is “a legally protected interest which

is (a) concrete and particularized” and “(b) actual or imminent, not conjectural or hypothetical.” Id. at 560 (internal 

quotation marks omitted). The Court has found an assertion of future injury insufficient where it “involve[d] a significant 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 certainly 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 redressability requirement for standing is relaxed: It is 

enough for that element to be met that “there is some possibility that the requested relief,” namely, notice-and-comment rulemaking, would “prompt the [agency] to 

reconsider the decision that allegedly harmed” the plaintiff. 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. Environmental 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-cv06128, 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 realistically 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 relief,’ ‘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 instructions, which are plausibly alleged to cause more denials of 

institution than might otherwise occur, will continue causing harm in the form of denial of the benefits of IPRs linked 

to the concrete interest possessed by an infringement defendant—even though Apple cannot specify in advance individual 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 infringement 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 noticeand-comment rulemaking. That possibility is confirmed by 

the fact that the Director, in response to comments, announced 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 rulemaking.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 arbitrary and capricious. We reverse the district court’s dismissal 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 merits. 

The parties shall bear their own costs.

AFFIRMED IN PART, REVERSED IN PART, AND 

REMANDED

7 Neither side has suggested mootness of this challenged based on the June 2022 Memo or subsequent clarifications, 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 challenge might not be mooted by a change in challenged conduct if the alteration is itself subject to the same asserted 

deficiency as its predecessor. See, e.g., Davenport v. Washington Education Association, 551 U.S. 177, 182 n.1 (2007); 

Northeastern Florida Chapter of Associated General Contractors 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 clarifications is left to the district court on remand.

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