United States Court of Appeals 

for the Federal Circuit ______________________

AXONICS, INC.,

Appellant

v.

MEDTRONIC, INC.,

Appellee

______________________

2022-1532, 2022-1533

______________________

Appeals from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in Nos. IPR2020-

00680, IPR2020-00712.

______________________

Decided: August 7, 2023

______________________

AARON MATTHEW NATHAN, Tensegrity Law Group LLP, 

McLean, VA, argued for appellant. Also represented by 

AZRA HADZIMEHMEDOVIC, SAMANTHA A. JAMESON, STEPHEN 

SHAHIDA; WILLIAM P. NELSON, MATTHEW D. POWERS, Redwood Shores, CA.

 NAVEEN MODI, Paul Hastings LLP, Washington, DC, 

argued for appellee. Also represented by QUADEER AHMED,

CHETAN BANSAL, STEPHEN BLAKE KINNAIRD, ALEXA LOWMAN.

______________________

Case: 22-1532 Document: 47 Page: 1 Filed: 08/07/2023
2 AXONICS, INC. v. MEDTRONIC, INC.

Before LOURIE, DYK, and TARANTO, Circuit Judges.

DYK, Circuit Judge.

Appellant Axonics, Inc. appeals two inter partes review

(“IPR”) determinations. The Patent Trial and Appeal 

Board held, in relevant part, that Axonics had failed to 

show that claims 1, 5, and 9 of U.S. Patent No. 8,457,758 

(“’758 patent”) and claims 3–6, 9–12, and 15–18 of 

U.S. Patent No. 8,738,148 (“’148 patent”), in patents 

owned by Medtronic, Inc., were unpatentable as anticipated or obvious. In each final written decision, the Board

adopted a claim construction first presented in the patent 

owner’s response after the institution decision and declined

to consider Axonics’ reply arguments and evidence under 

the new claim construction. We hold that the Board’s refusal to consider the new arguments and evidence was erroneous, and we vacate and remand for the Board to 

consider the merits of Axonics’ responsive arguments and 

evidence under the new claim construction.

BACKGROUND

I

The ’758 and ’148 patents, which share a specification,

relate to the transcutaneous (i.e., through the skin) charging of implanted medical devices. This charging occurs by 

inductive coupling, whereby energy is transferred between 

a primary coil in the external charger and a secondary coil 

in the implanted device when the two coils are placed in 

proximity to each other. The patents seek to improve 

charging efficiency by automatically varying the power output of the external charger based on various measured parameters of the current passing through the implanted 

device. For example, in one embodiment, the charger 

would decrease its charging power “if the voltage across rechargeable power source 24” in the implanted device is over 

4.05 volts, J.A. 242 (’758 patent, col. 21, ll. 56–57)

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AXONICS, INC. v. MEDTRONIC, INC. 3

(emphasis omitted); the charger would also decrease its 

charging power if the voltage is less than 4.05 volts but “the 

charging current through rechargeable power source 24 is 

over a current rate” of 50 milliamperes, J.A. 242 (’758 patent, col. 21, ll. 63–64) (emphasis omitted).

The patent claims at issue here require the power of 

the external charger to be automatically varied based on

(in the language of claim 1 of the ’758 patent) a “value associated with [the] current passing through [the] internal 

power source” and a “measured current associated with 

[the] current passing through [the] internal power source.” 

J.A. 242 (’758 patent, col. 22, ll. 41–46). As discussed later, 

the parties have disagreed as to the meaning of these two 

clauses and whether a single disclosure, e.g., a measured 

charging current over 50 milliamperes, could satisfy both 

limitations. The parties agree that claim 1 of the ’758 patent is representative:

1. A system for transcutaneous energy transfer, 

comprising:

an implantable medical device having componentry for providing a therapeutic output, said 

implantable medical device having an internal 

power source and a secondary coil operatively 

coupled to said internal power source, said implantable medical device adapted to be implanted in a patient; and

an external power source having a primary coil, 

said external power source providing energy to 

said implantable medical device when said primary coil of said external power source is 

placed in proximity of said secondary coil of 

said implantable medical device and thereby 

generating a current, having a value, passing 

through said internal power source:

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4 AXONICS, INC. v. MEDTRONIC, INC. 

wherein said external power source automatically 

varies its power output based on a value associated with said current passing through said 

internal power source; 

wherein said external power source automatically 

varies its power output based on a measured 

current associated with said current passing 

through said internal power source. 

J.A. 242 (’758 patent, col. 22, ll. 25–46) (emphasis added). 

We refer to the two “wherein” limitations as the “value” 

limitation and the “measured current” limitation.1 

II

Axonics filed two IPR petitions challenging claims of 

the ’758 and ’148 patents as anticipated by three prior art 

references: Schulman (U.S. Patent No. 3,942,535), 

Fischell,2 and Baumann (U.S. Patent No. 6,227,204). 

Given the parties’ agreement that claim 1 of the 

1 Each challenged claim in this appeal includes (or 

depends from an independent claim that includes) two 

“wherein” clauses similar to those present in claim 1 of the 

’758 patent, requiring the power of the external power 

source to be automatically varied (1) based on a “value” associated with the current passing through the internal 

power source, and (2) based on a specific kind of value, e.g., 

a “measured current,” J.A. 242–44 (’758 patent, claims 1, 

5, & 9), a “signal,” J.A. 272–74 (’148 patent, claims 3, 9, & 

15), or a “measured voltage,” J.A. 272–74 (’148 patent, 

claims 6, 12, & 18), associated with or proportional to the 

current.

2 R.E. Fischell et al., A Long-Lived, Reliable, 

Rechargeable Cardiac Pacemaker, in Advances in Pacemaker Technology 357–82 (M. Schaldach et al. eds. 1975).

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AXONICS, INC. v. MEDTRONIC, INC. 5

’758 patent is representative, we focus on the ’758 IPR and 

the treatment of claim 1 in that proceeding.3

In its petition, Axonics did not propose an express construction of any claim term. But in its claim charts, the 

petition adopted a construction of the two “wherein” 

clauses, stating that “[i]t is . . . clear that the second 

wherein clause simply narrows the ‘value’ of the first 

3 The ’758 petition challenged claims 1, 5, and 9 (the 

only claims of the ’758 patent that Axonics still challenges 

on appeal) as independently anticipated by Schulman, 

Fischell, and Baumann. The petition had originally challenged all of the claims of the ’758 patent (claims 1–12), but 

following the institution decision, Medtronic disclaimed 

claims 3, 7, and 11. The petition had also challenged claims 

2, 4, 6, 8, 10, and 12 as anticipated by Baumann or obvious 

over a combination of Baumann and either Schulman or 

Fischell.

The ’148 petition initially challenged all of the claims 

of the ’148 patent (claims 1–18), but, following the institution decision, Medtronic disclaimed claims 1–2, 7–8, and 

13–14. Axonics continues to challenge on appeal all of the

remaining claims on the grounds asserted in the ’148 petition. The petition, as relevant here, asserted anticipation 

grounds based on Schulman (claims 3–6, 9–12, and 15–18)

and Fischell (claims 3–4, 9–10, and 15–16), but not 

Baumann, and also challenged certain claims (5–6, 11–12, 

and 17–18) as obvious over a combination of Fischell and 

another reference, U.S. Patent No. 3,888,260 (“Fischell 

’260”). Axonics continues to assert obviousness based on 

Fischell and Fischell ’260 for the ’148 patent. As to the obviousness ground, the same question as in the anticipation 

grounds is central—whether the prior art reference (here, 

Fischell) discloses the two “wherein” limitations.

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6 AXONICS, INC. v. MEDTRONIC, INC.

wherein clause to ‘measured current,’ and does not require 

a separate measurement.” J.A. 301 (comparing the claim 

with Schulman); J.A. 317–18 (same with respect to

Fischell); see also J.A. 338 (same with respect to 

Baumann). Axonics thus adopted a “one-input” claim construction under which both “wherein” limitations could be 

satisfied if the external power source automatically varied 

its power output using a single input based on the current 

in the implanted device. Under the implicit one-input 

claim construction, Axonics argued that Schulman, 

Fischell, and Baumann disclosed the two “wherein” limitations because each prior art reference disclosed varying the 

power output of an external charger based on some parameter of the current in the implanted device.

Medtronic filed a preliminary response to the petition 

arguing that Axonics had failed to show that Schulman, 

Fischell, and Baumann disclosed an input anticipating the 

“wherein” limitations under the one-input construction. In 

addressing Axonics invalidity arguments, Medtronic 

agreed that “the Board need not construe any terms because . . . construction is unnecessary to resolve any underlying controversy.” J.A. 509.

Following the parties’ lead, the Board, in its institution 

decision, agreed that “no term requires express construction.” J.A. 609. Indeed, the Board explicitly noted that 

“Patent Owner does not yet dispute Petitioner’s contention 

that the measured current limitation only narrows the 

[value] limitation.” J.A. 621. On the merits of Axonics’ invalidity arguments under the one-input construction, the 

Board found Axonics had shown a reasonable likelihood of 

prevailing and granted institution.

After the Board’s institution decision, Medtronic, in its

patent owner response, for the first time advanced a claim 

construction that each of the two “wherein” clauses in the 

challenged independent claims required a separate input 

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AXONICS, INC. v. MEDTRONIC, INC. 7

(what we will refer to as the “two-input” construction). Under the two-input construction, a “measured current” that 

satisfied the second “wherein” clause could not also qualify 

as a “value” for purposes of the first “wherein” clause. In 

other words, the first “wherein” clause required a second 

“value,” other than the value of the “measured current” of 

the second “wherein” clause. Arguing almost exclusively 

under the two-input construction, Medtronic contended

that the petition had not identified two separate inputs in 

any of the prior art references. In some respects, Medtronic 

went further and argued that Axonics could not have made 

such a showing, because the prior art references in fact did 

not teach two separate inputs.4 Unlike the preliminary response, the final response largely abandoned the argument 

that the petition had failed to show the prior art references 

satisfied the one-input construction.

In Axonics’ reply, it continued to defend the one-input 

construction. But Axonics also argued, under Medtronic’s 

new two-input construction, that each of Schulman, 

Fischell, and Baumann disclosed two separate inputs that 

would satisfy the two “wherein” limitations. In support, 

Axonics submitted a supplemental expert declaration. 

Both the reply and the supplemental expert declaration 

cited additional disclosures in the prior art references pertaining to the same embodiments relied on in the petition.

Medtronic filed a sur-reply continuing to argue the 

prior art references did not disclose two separate inputs

and also arguing it would be prejudicial for the Board to 

4 For example, Medtronic argued that “Schulman 

teaches that the magnetic output signal is used as the sole

input used to regulate the external power source.” 

J.A. 713; see also J.A. 715 (“Indeed, Fischell teaches that it 

is this frequency modulated signal that is used as the sole 

input to regulate the external power source.”).

Case: 22-1532 Document: 47 Page: 7 Filed: 08/07/2023
8 AXONICS, INC. v. MEDTRONIC, INC.

consider Axonics’ new reply arguments without providing 

Medtronic an opportunity to submit its own supplemental 

expert declaration. Medtronic did not seek leave to submit 

a supplemental expert declaration in support of its sur-reply.

III

In the final written decision, the Board adopted the 

two-input construction, concluding that the one-input construction would have rendered the first “wherein” limitation superfluous. The Board then refused to consider 

Axonics’ anticipation arguments and evidence under the

two-input construction.5 The Board found that Axonics 

had not identified anywhere in the petition that the twoinput anticipation arguments had originally been made

and, for that reason, considered them to be improper reply 

arguments. The Board explained that, before filing the petition, “Petitioner had an adequate opportunity to assess 

the ’758 patent and to understand that it disclosed support 

for two separate measurements, but failed to do so.” 

J.A. 36. Although the Board agreed that “Petitioner may 

respond to arguments raised in the Patent Owner Response in its Reply,” the Board concluded that a reply “may 

not offer an entirely new rationale based on a new combination of elements in the asserted references to show unpatentability based on what amounts to a new ground not 

set forth in the Petition.” J.A. 36.

Axonics appeals. We have jurisdiction under 35 U.S.C. 

§ 141(c) and 28 U.S.C. § 1295(a)(4)(A).

5 In the ’148 IPR, the Board declined to consider 

Axonics obviousness arguments on the same grounds.

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AXONICS, INC. v. MEDTRONIC, INC. 9

DISCUSSION

On appeal, Axonics does not argue the Board erred in 

adopting the two-input claim construction, only that the 

Board erred in refusing to consider Axonics’ reply arguments and evidence under the two-input construction.

We review a determination by the Board that, under 

the Board’s own regulations, a party exceeded the scope of 

a proper reply for abuse of discretion. Apple Inc. v. Andrea 

Electronics Corp., 949 F.3d 697, 705 (Fed. Cir. 2020). “An 

abuse of discretion is found if the decision: (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact 

finding; or (4) involves a record that contains no evidence 

on which the Board could rationally base its decision.” 

Ericsson Inc. v. Intellectual Ventures I LLC, 901 F.3d 1374, 

1379 (Fed. Cir. 2018) (citation omitted). We review the 

Board’s compliance with the procedural requirements of 

the Administrative Procedure Act (“APA”) de novo. Sirona 

Dental Sys. GmbH v. Institut Staumann AG, 892 F.3d 

1349, 1352 (Fed. Cir. 2018); 5 U.S.C. § 706(2)(D) (“The reviewing court shall . . . hold unlawful and set aside agency 

action, findings, and conclusions found to be . . . without 

observance of procedure required by law.”).

An IPR is an expedited administrative procedure, 

driven by the invalidity theories presented in a petition. As 

the Supreme Court has explained, “the petitioner’s petition 

. . . is supposed to guide the life of the litigation [in an IPR

proceeding].” SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 

(2018). By creating the IPR procedure, “Congress chose to 

structure a process in which it’s the petitioner . . . who gets 

to define the contours of the proceeding.” Id. at 1355. An 

IPR proceeds “in accordance with or in conformance to the 

petition,” id. at 1356 (internal quotation marks, modification, and citation omitted), and “the petitioner’s 

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10 AXONICS, INC. v. MEDTRONIC, INC.

contentions . . . define the scope of the litigation all the way 

from institution through to conclusion,” id. at 1357.

Under the statute, a petition is required to identify “in 

writing and with particularity . . . the grounds on which the 

challenge to each claim is based, and the evidence that supports the grounds for the challenge to each claim.” 

35 U.S.C. § 312(a)(3); see also Intelligent Bio-Sys., Inc. v. 

Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 

2016). According to patent office guidance, a petitioner 

“may not submit new evidence or argument in reply that it 

could have presented earlier, e.g. to make out a prima facie 

case of unpatentability.” U.S. Patent Trial and Appeal 

Board, Consolidated Trial Practice Guide 73 (Nov. 2019). 

However, under the Board’s rules and consistent with 

the Supreme Court’s decision in SAS, a petitioner is entitled to respond to new arguments made in a patent owner 

response. The rules provide that the petitioner may “respond to arguments raised in the corresponding opposition, 

patent owner preliminary response, or patent owner response.” 37 C.F.R. § 42.23(b). “As we have regularly held, 

the petitioner in an inter partes review proceeding may introduce new evidence after the petition stage if the evidence is a legitimate reply to evidence introduced by the 

patent owner.” Apple, 949 F.3d at 706–07 (internal quotation marks and citation omitted).

The Board’s rules do not address the specific question 

presented here: whether, where a patent owner offers a 

new claim construction for the first time in its response after the institution decision, a petitioner may introduce new 

arguments and evidence in reply under the newly proposed 

claim construction. There is no rule, for example, requiring 

a petition to describe all possible or reasonable claim constructions and to present invalidity theories under those 

constructions.

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AXONICS, INC. v. MEDTRONIC, INC. 11

In a formal adjudication under the APA, such as an IPR 

proceeding, the Board must inform the parties of “the matters of fact and law asserted,” 5 U.S.C. § 554(b)(3), and

“give all interested parties opportunity for . . . the submission and consideration of facts [and] arguments,” id. 

§ 554(c). The Board must also permit parties “to submit 

rebuttal evidence, and to conduct such cross-examination 

as may be required for a full and true disclosure of the 

facts.” Id. § 556(d); see Fanduel, Inc. v. Interactive Games 

LLC, 966 F.3d 1334, 1339 (Fed. Cir. 2020). Thus, in an IPR

proceeding, “the Board must base its decision on arguments that were advanced by a party, and to which the opposing party was given a chance to respond.” Rovalma, 

S.A. v. Bohler-Edelstahl GmbH & Co. KG, 856 F.3d 1019, 

1027 (Fed. Cir. 2017) (citation omitted).

Despite the Supreme Court’s admonition in SAS that 

the petition “is supposed to guide the life of the litigation,” 

138 S. Ct. at 1356, we have specifically held that, under the 

APA, it is permissible for the Board to adopt a new construction, proposed either by the patent owner or by the 

Board itself, in a final written decision.6 But before the

6 See WesternGeco LLC v. ION Geophysical Corp., 

889 F.3d 1308, 1328 (Fed. Cir. 2018) (“[T]he Board was permitted to issue a new construction in the final written decision given that claim construction was a disputed issue 

during the proceedings . . . [and] is not bound to adopt either party’s preferred articulated construction of a disputed claim term.”); Praxair Distribution, Inc. v. 

Mallinckrodt Hospital Prods. IP Ltd., 890 F.3d 1024, 1034 

(Fed. Cir. 2018) (affirming the Board’s decision to adopt a 

claim construction for the first time in the final written decision where “the parties litigated the meaning and relevance of the [disputed] term . . . and the Board resolved the 

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12 AXONICS, INC. v. MEDTRONIC, INC.

Board decides a case under a construction adopted after the 

institution decision, it must give a petitioner an opportunity to respond to the new construction, whether that 

construction was first proposed by the patent owner or the 

Board.7

In this court’s decision in SAS, both parties had agreed 

to the claim construction adopted by the Board in the institution decision, but the Board, without notice, adopted a 

different construction in the final written decision. SAS 

Inst., Inc. v. ComplementSoft, LLC, 825 F.3d 1341, 1351 

(Fed. Cir. 2016), rev’d on other grounds sub nom. SAS Inst., 

Inc. v. Iancu, 138 S. Ct. 1348. We rejected the Board’s reasoning that its approach was permissible “because [the petitioner] could have made construction arguments for the 

term in its IPR petition,” id., a justification similar to the 

one adopted by the Board in this case. See J.A. 36 (“Petitioner had an adequate opportunity [before filing its petition] to assess the ’758 patent and to understand that it 

disclosed support for two separate measurements, but 

failed to do so.”). In SAS, we held that, under the APA, the 

Board “may not change theories midstream” by adopting a 

different claim construction in the final written decision 

than that adopted in the institution decision “without 

issue in [the petitioner’s] favor”). In general, “we have encouraged the Board to change its view of the merits after 

further development of the record [following an institution 

decision] if convinced its initial inclinations were wrong.” 

Fanduel, 966 F.3d at 1340–41 (Fed. Cir. 2020) (internal 

quotation marks, modification, and citation omitted).

7 If the ultimate construction adopted in the final 

written decision is sufficiently similar to a construction disputed by the parties, the Board need not give the parties 

prior notice of the exact construction the Board adopts. See

WesternGeco, 889 F.3d at 1328.

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giving respondents reasonable notice of the change and the 

opportunity to present argument under the new theory.” 

SAS, 825 F.3d at 1351 (internal quotation marks and citation omitted).

Following the Supreme Court’s SAS decision—which 

reversed our SAS decision solely on the ground that the 

Board could not institute on only some of the claims challenged in the petition—we have continued to recognize that

a petitioner is entitled under the APA to respond to new 

claim construction arguments made by a patent owner or 

adopted by the Board sua sponte and that both parties are 

entitled to respond to a new construction adopted by the 

Board sua sponte after an institution decision. In that connection, we have continued to cite as authority our earlier 

SAS decision.

In Ericsson, after the Supreme Court’s SAS decision,

we again addressed a new construction proposed for the 

first time in a patent owner response. 901 F.3d at 1378. In 

its institution decision, following the parties’ lead, the 

Board construed the relevant claim terms under the 

“broadest reasonable interpretation” standard. Id. at 

1378–79. For the first time in the patent owner response, 

because the patent had expired, the patent owner proposed 

a different construction under the standard set forth in 

Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en 

banc).8 In the final written decision, the Board adopted the 

8 Ericsson was decided before the U.S. Patent and 

Trademark Office adopted the Phillips standard for all IPR 

proceedings. See 37 C.F.R. § 42.100(b); Changes to the 

Claim Construction Standard for Interpreting Claims in 

Trial Proceedings Before the Patent Trial and Appeal 

Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018). Even before 

that revision, the Phillips standard applied in IPR 

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14 AXONICS, INC. v. MEDTRONIC, INC.

new claim construction under the Phillips standard but refused to consider portions of petitioner’s reply containing 

arguments and evidence under the newly proposed claim 

construction, explaining “that the reply is not an opportunity for Petitioner to identify, for the first time, new and 

different prior art elements that are alleged to satisfy the 

claim requirements.” Id. at 1379 (internal quotation marks 

and citation omitted).

We vacated, disagreeing that the petitioner’s reply arguments were improper, in part because “the significance 

of [the arguments in the Petition] arose after the Petition 

was filed, in that the Board adopted a different construction of the [relevant] terms after the Petition instituting 

inter partes review was granted.” Id. at 1380. We held 

that, under the APA, the petitioner “should have been 

given an opportunity to respond” to the new claim construction in its reply. Id. We concluded that “[i]n light of [the]

changed circumstances [regarding the correct claim construction], the Board revisited its approach to the claims in 

light of this error, and [the petitioner] likewise deserved an 

opportunity to do the same.” Id.

Similarly, in Hamilton Beach Brands, Inc. v. f’real 

Foods LLC, relying on our earlier decision in SAS, we concluded, again, that a petitioner is entitled to respond to a 

new claim construction. 908 F.3d 1328 (Fed. Cir. 2018). 

There, as here, prior to institution, neither party had proposed an express construction of the relevant terms, and 

the Board instituted under the parties’ implicit understanding of the terms. Id. at 1335. After institution the 

patent owner response proposed a new construction, which 

the Board adopted in its final written decision. Id. Citing 

proceedings concerning expired and soon-to-be-expired patents. See Changes to the Claim Construction Standard, 85 

Fed. Reg. at 51,341.

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our SAS decision, we reiterated the rule that, under the 

APA, the Board cannot adopt a new claim construction 

without giving the petitioner an opportunity to respond. 

Id. at 1338. But we held that those requirements had been 

met because the petitioner was able to respond in its reply 

and at oral argument to the construction proposed in the 

patent owner response. Id. at 1338–39.

In Qualcomm Inc. v. Intel Corp., we again relied on our 

SAS decision and held that, under the APA, parties in an 

IPR must be permitted to respond to a new claim construction adopted by the Board sua sponte after the institution 

decision. 6 F.4th 1256, 1263 (Fed. Cir. 2021). There, 

through the oral argument before the Board, the parties 

had proceeded under a shared understanding of the relevant claim term. Id. at 1261–62. In the final written decision, without providing any notice or opportunity to 

respond, the Board adopted a new claim construction. Id.

at 1262. The patent owner appealed. Relying on our decision in SAS, we held that, because the Board’s construction 

in the final written decision “diverged from the agreedupon” construction of the parties, the Board needed to provide notice and an adequate opportunity to respond. Id. at 

1263.9

We think this case falls squarely within the rule of

SAS, Ericsson, Hamilton Beach, and Qualcomm: that, under the APA, when the Board adopts a new claim construction following institution, an IPR petitioner must have 

9 Compare TQ Delta, LLC v. DISH Network LLC, 

929 F.3d 1350, 1356 (Fed. Cir. 2019) (affirming where the 

Board adopted a claim construction in the final written decision after having not adopted any construction in the institution decision, because the complaining party “had 

notice of the claim construction issue and the opportunity 

to be heard” (citing Hamilton Beach, 908 F.3d at 1339)).

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16 AXONICS, INC. v. MEDTRONIC, INC.

adequate notice and an opportunity to respond under the 

new construction. In particular, the petitioner must be afforded a reasonable opportunity in reply to present argument and evidence under that new construction.10 Here, 

Axonics was not afforded that opportunity. Although the 

Board considered Axonics’ arguments against the new 

claim construction, it refused to consider Axonics’ evidence 

and argument under that construction.

That is not to say a petitioner may rely on new prior 

art in response to a new claim construction presented in 

the patent owner response. We have held that a petitioner 

may not in reply rely on new prior art to teach a claim limitation. See Intelligent Bio-Sys., 821 F.3d at 1369 (holding 

a reply brief and declaration exceeded the proper scope for 

a reply because they cited “a number of non-patent literature references which were not relied upon to support unpatentability in the Petition”). But that is not the situation 

10 Medtronic argues on appeal that Axonics “clearly 

anticipated” the two-input claim construction and should 

have presented argument and evidence under the construction in the petition. Appellee’s Br. 1. The Board made no 

finding that Axonics clearly anticipated the two-input construction in the petition. See SEC v. Chenery Corp., 318 

U.S. 80, 95 (1943) (“[A]n administrative order cannot be 

upheld unless the grounds upon which the agency acted in 

exercising its powers were those upon which its action can 

be sustained.”). There is, moreover, no support for a rule 

that would create challenges including line-drawing and 

unworkability problems and consistency with the regulation that governs the content of a petition, which does not 

direct a petitioner to raise, address, and apply alternative 

possible constructions, but instead requires a petitioner affirmatively to state “[h]ow the challenged claim is to be construed.” 37 C.F.R. § 42.104(b)(3).

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here: Axonics did not rely on new prior art in its reply. We 

leave for another day the question of whether, when presented with a new claim construction, a petitioner can rely 

in its reply on new embodiments from the prior art references that were relied on in the petition. See Apple, 949 

F.3d at 706 (concluding, in a case where there had not been 

a changed claim construction, that petitioner’s reply arguments did not exceed the scope of a proper reply because 

those arguments did not cite new embodiments or new 

prior art). Here, Axonics, in the reply, relied on the same 

embodiments as it relied on in the petition.

Barring argument and evidence in a reply directed to a 

new claim construction proposed by the patent owner 

would create opportunities for sandbagging by the patent 

owner in order to create an estoppel. A patent owner has 

the opportunity in a preliminary response to oppose institution on the ground that the claim construction relied on 

by the petitioner is incorrect, and the Board may adopt the 

patent owner’s proposed claim construction and deny institution if the petition fails to demonstrate a reasonable likelihood that a claim would be unpatentable under the 

correct claim construction. See 35 U.S.C. § 314(a). The result would be that there would be no institution and no estoppel pursuant to 35 U.S.C. § 315(e). But if instead of 

raising the issue in a preliminary response, a patent owner

sits on its strongest claim construction arguments before 

institution and then raises them in response after institution, a patent owner could obtain a favorable final IPR decision and an estoppel without the Board’s reaching the 

merits of any invalidity arguments under the newly

adopted claim construction. Indeed, Medtronic admitted in 

this appeal that the Board’s approach below would allow 

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18 AXONICS, INC. v. MEDTRONIC, INC.

for such sandbagging.11 We are reluctant to adopt a construction of the APA and the Board’s rules that would permit such gamesmanship.

Medtronic argues that it is unfair to permit a new expert declaration to be submitted with a reply, because a patent owner is not permitted to submit a supplemental 

declaration in sur-reply. See 37 C.F.R. § 42.23(b) (“A surreply . . . may not be accompanied by new evidence other 

than deposition transcripts of the cross-examination of any 

reply witnesses.”). But the Board “may waive or suspend” 

such requirements in appropriate cases. See id. § 42.5(b). 

Indeed, while the Board here recognized that declarations 

are not “typically” permitted with sur-replies, it also noted 

Medtronic had not asked for leave to submit an additional 

expert declaration in this case. J.A. 37 n.7. We are confident that in circumstances such as these, the Board will 

allow an appropriate opportunity for a patent owner to submit evidence with a sur-reply.

CONCLUSION

We hold that where a patent owner in an IPR first proposes a claim construction in a patent owner response, a 

petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness

11 The Court: “But isn’t there a risk here of sandbagging, that you realize there’s a good claim construction argument, [and] you leave it out of your preliminary 

response. If you argued it in your preliminary response, 

then maybe institution would be denied and there would 

be no estoppel. But if you hold back on the argument and 

wait to make it until the response, then you get the estoppel. Isn’t there a risk of that?” Medtronic’s counsel: “Certainly, your honor, there is a risk of that . . . .” Oral Arg. at 

14:24–51.

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AXONICS, INC. v. MEDTRONIC, INC. 19

under the new construction, at least where it relies on the 

same embodiments for each invalidity ground as were relied on in the petition. We vacate the Board’s decisions in 

these IPRs and remand for the Board to consider Axonics’

arguments and evidence under the two-input claim construction and, correspondingly, to consider any request by 

Medtronic to present new evidence in support of its surreply.

VACATED AND REMANDED

COSTS

Costs to Axonics.

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