United States Court of Appeals 

for the Federal Circuit ______________________ 

ETHICON ENDO-SURGERY, INC.,

Appellant

v.

COVIDIEN LP,

Appellee

______________________ 

2014-1771

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in No. IPR2013-

00209.

______________________ 

Decided: January 13, 2016

______________________ 

 PHILIP STATON JOHNSON, Johnson & Johnson, New

Brunswick, NJ, argued for appellant. Also represented by 

STEVEN D. MASLOWSKI, RUBEN H. MUNOZ, JASON WEIL, 

Akin, Gump, Strauss, Hauer & Feld, LLP, Philadelphia, 

PA; PRATIK A. SHAH, HYLAND HUNT, Washington, DC. 

 KATHLEEN DALEY, Finnegan, Henderson, Farabow, 

Garrett & Dunner, LLP, Washington, DC, argued for 

appellee. Also represented by J. MICHAEL JAKES; J. DEREK 

MCCORQUINDALE, Reston, VA.
2 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

 KATHERINE TWOMEY ALLEN, Appellate Staff, Civil 

Division, United States Department of Justice, Washington, DC, argued for intervenor Michelle K. Lee. Also 

represented by BENJAMIN C. MIZER, MARK R. FREEMAN;

NATHAN K. KELLEY, SCOTT WEIDENFELLER, STACY BETH 

MARGOLIES, Office of the Solicitor, United States Patent 

and Trademark Office, Alexandria, VA. 

______________________ 

Before NEWMAN, DYK, and TARANTO, Circuit Judges.

Opinion for the court filed by Circuit Judge DYK. 

Dissenting opinion filed by Circuit Judge NEWMAN. 

DYK, Circuit Judge. 

Ethicon Endo-Surgery, Inc. (“Ethicon”) owns U.S. Patent No. 8,317,070 (“the ’070 patent”). Covidien LP 

(“Covidien”) petitioned the United States Patent and 

Trademark Office (“PTO”) for inter partes review of 

claims 1–14 of the ’070 patent. The PTO, through a panel 

of the Patent Trial and Appeals Board (“PTAB” or 

“Board”), granted the petition. On the merits, the same 

Board panel found all challenged claims invalid as obvious over the prior art. Ethicon appeals, asserting that the 

Board’s final decision is invalid because the same Board 

panel made both the decision to institute and the final 

decision. Ethicon also asserts that the Board erred in 

finding the claims obvious. 

We first hold that 35 U.S.C. § 314(d) does not preclude 

us from hearing Ethicon’s challenge to the authority of 

the Board to render a final decision. On the merits we

hold that neither the statute nor the Constitution precludes the same panel of the Board that made the decision 

to institute inter partes review from making the final 

determination. We also find no error in the Board’s 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 3

determination that the ’070 patent claims would have 

been obvious over the prior art. Accordingly, we affirm. 

BACKGROUND

The claims of the ’070 patent are directed to a surgical 

device used to staple, secure, and seal tissue that has

been incised. As the specification describes, a typical 

embodiment can both make the incision and simultaneously apply lines of staples on opposing sides of the incision. ’070 Patent col. 7 ll. 5–31. As is commonly done 

during endoscopic procedures, a surgeon will insert the 

device into the patient and will pull a trigger to latch onto 

a desired tissue. Once attached, the surgeon will then 

pull another trigger, which causes a blade to move, cutting the desired tissue. Simultaneously, rows of staples 

on either side of the cutting blade are actuated against a 

staple forming surface, both securing and sealing the 

newly-cut tissue. 

Claim 1 is representative of the claimed invention:

A surgical stapling device comprising an end effector that comprises: 

a circular anvil having a staple forming 

surface;

a plurality of staples facing the staple 

forming surface of the anvil, each staple 

comprising a main portion and two 

prongs, wherein the two prongs each comprise a first and a second end, wherein the 

first ends are connected to opposite ends of 

the main portion, and wherein the two 

prongs extend non-parallelly from the 

main portion; and

a staple driver assembly comprising a plurality of staple drivers, wherein each sta-
4 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

ple driver supports one of the plurality of 

staples and is configured such that, when 

the staple driver assembly is actuated, 

each staple driver drives the staple into 

the staple forming surface of the anvil, 

wherein a first quantity of the staples have 

a first pre-deformation height, measured 

from a lower surface of the main portion to 

the second end of the first prong, and a 

second quantity of the staples having a 

second pre-deformation height, measured 

from a lower surface of the main portion to 

the second end of the first prong, wherein 

the first height is less than the second 

height, such that when the staple driver 

assembly is actuated, the first quantity of 

staples have a different formed staple 

length than the second quantity of staples. 

(emphases added). 

Surgical staplers were not new at the time of the ’070

patent. As the patent specification itself describes, these 

types of devices were well known and had been commonly 

used. ’070 Patent col. 1 ll. 45-47. The ’070 patent claims

two primary aspects of stapler design: the use of staples of 

different pre-formed and formed heights (i.e., heights 

before and after stapling) and the use of staples with nonparallel legs. It is undisputed that both of these improvements, separately, were also well-known in the prior 

art. Thus, the purported inventive aspect of the ’070

patent is the combination of these two features in a 

surgical stapler. The patent discloses no particular 

synergy resulting from the combination.

According to the prior art disclosures and the specification, the use of staples of different pre-formed and 

formed heights is beneficial in a number of ways. For 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 5

example, “rows of inside staples [can] serve to provide a 

hemostatic barrier, while the outside rows of staples with 

larger formed heights [can] provide a cinching effect 

where the tissue transitions from the tightly compressed 

hemostatic section to the non-compressed adjacent section.” ’070 Patent col. 2 ll. 8–12. This is beneficial because these staples of different sizes “decrease[] leakage 

rates . . . and provide[] short and long-term tissue 

strength” after incision. J.A. 290. The use of these different sized staples thus allows this type of device to be used 

on a broader range of tissue thicknesses. As is uncontested, these staples of varying pre-formed and formed 

heights were first disclosed 25 years ago by prior art 

references Tyco Healthcare International Publication No. 

WO 2003/094747 and U.S. Patent No. 4,941,623. 

The primary benefit of using non-parallel legs on staples is that the staple legs press against the side of the 

staple cartridge and stay in the cartridge without falling 

out. J.A. 454. As is also uncontested, the use and benefit 

of these staples was previously disclosed in a 1970 U.S. 

Patent, No. 3,494,533, and were well known by those in 

the field, even according to Ethicon’s own expert, who 

testified that he used nonparallel staples “maybe 50 or 75 

percent of the time” in his practice. 

In 2010, Covidien began selling surgical staplers that, 

Ethicon contends, embody the claimed invention of the 

’070 patent. The brochures for these staplers, featuring 

what Covidien called “Tri-Staple technology,” tout “progressive staple heights” that allow “consistent performance over a broader range of tissue thickness.” J.A. 

1101, J.A. 1126. Notably absent from these brochures, 

though, was any mention of non-parallel legs on the 

staples. The staplers using this technology were very 

successful, achieving over $1 billion in product sales 

within the first three years of their introduction to the 
6 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

market. According to Covidien, the Tri-Staple devices are 

likely to be one of their most successful product lines ever. 

Covidien filed a petition with the PTO on March 25, 

2013, requesting inter partes review of claims 1–14 of the 

’070 patent on the ground that the claims would have 

been obvious over the prior art. The Board granted the 

petition on August 26, 2013. 

In its June 9, 2014, final decision, the same panel of 

the Board that instituted the inter partes review rejected 

all of Ethicon’s arguments and found all challenged 

claims of the ’070 patent obvious under 35 U.S.C. § 103. 

It noted that Ethicon admitted that all of the recited 

elements of the patent claims were found in the prior art. 

Relying on Covidien’s expert testimony, the Board concluded that one of skill in the art would have been motivated to combine the prior art staplers disclosing staples 

of varying heights with staples of non-parallel legs to 

securely hold the staples in the cartridge because the 

benefits of both were well known at the time of the invention. Further, the Board found no suggestion in the prior 

art teaching away from combining these elements. The 

Board alternatively found that it would have been obvious 

to try to combine non-parallel staples with the prior art 

devices disclosing staples of varying heights because of 

the “limited choice” of staple designs. J.A. 15. Finally, it 

found that Ethicon’s evidence of secondary considerations 

did “not overcome the strong case of obviousness.” J.A. 

19.

Ethicon appeals. We have jurisdiction under 28 

U.S.C. § 1295(a)(4)(A). We review the Board’s factual 

findings for substantial evidence and its legal conclusions 

de novo. In re Baxter Int'l, Inc., 678 F.3d 1357, 1361 (Fed.

Cir. 2012). 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 7

DISCUSSION

I 

Ethicon challenges the final decision of the Board, arguing that the final decision should be set aside because it 

was made by the same panel that made the decision to 

institute inter partes review. 

The America Invents Act1 (“AIA”) gives the Director 

the authority to determine whether an inter partes review 

should be initiated, and the Director has delegated this 

authority to the Board.2 The statute specifically gives the 

Board the power to decide the ultimate question of patent 

validity. See 35 U.S.C. § 318 (requiring that “the Patent 

Trial and Appeal Board shall issue a final written decision with respect to the patentability of any patent claim 

challenged by the petitioner”). The PTO has determined 

that, in the interest of efficiency, the decision to institute 

and the final decision should be made by the same Board 

panel, in line with the purposes of the AIA, which requires the Director consider the “efficient administration 

of the [PTO], and the ability of the [PTO] to timely complete proceedings” in promulgating regulations. 35 U.S.C. 

§ 316(b). Ethicon contends that this combination of 

1 The relevant portions of the Leahy-Smith America 

Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) have

been codified in Title 35 of the U.S. Code. 

2 See 35 U.S.C. § 314(a) (“The Director may not authorize an inter partes review 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.”); 37 C.F.R. § 42.4(a) (stating that the “Board 

institutes the trial on behalf of the Director”). 

 
8 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

functions is improper because the statutory text and 

structure, guided by constitutional principles, require that 

the decision to institute not be made by the same panel of 

the Board that makes the ultimate decision and, in fact,

that the statute does not authorize the Director to delegate the institution decision to the Board at all. 

A 

Before we can turn to the substantive questions 

raised by Ethicon’s challenge, we must first decide whether we have jurisdiction to address the combination of 

functions issue. The PTO, as intervenor, argues that 35 

U.S.C. § 314(d) bars us from considering this issue on 

appeal because it is an issue concerning the institution of 

an inter partes review proceeding. 

Section 314(d) provides that “[t]he determination by 

the Director whether to institute an inter partes review

shall be final and nonappealable.” 35 U.S.C. § 314(d)

(emphasis added). Section 314(d) here plainly “prohibits 

review of the decision to institute [inter partes review] 

even after a final decision.” In re Cuozzo Speed Techs., 

LLC, 793 F.3d 1268, 1273 (Fed. Cir. 2015). It does not, 

however, preclude review of the final decision. Indeed, 

§ 319 specifically provides for appeal of a final decision: 

“[a] party dissatisfied with the final written decision of 

the Patent Trial and Appeal board . . . may appeal the 

decision.” 35 U.S.C. § 319; see also Versata Dev. Grp., Inc. 

v. SAP Am., Inc., 793 F.3d 1306, 1322 (Fed. Cir. 2015). 

Here, Ethicon does not challenge the institution decision, but rather alleges a defect in the final decision. It

argues that the final decision is invalid because it was 

made by the same panel that instituted inter partes

review. Section 314(d) does not prevent us from hearing a 

challenge to the authority of the Board to issue a final 

decision. 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 9

B 

On the merits, Ethicon argues that having the same 

panel make the decision to institute and then later decide 

the merits of the inter partes review raises “serious due 

process concerns.” Appellant’s Br. 35. According to 

Ethicon, because the panel of the Board is first exposed to 

a limited record consisting of the petition and patent 

holder’s preliminary response, there is a risk that the 

panel may prejudge the case before seeing a full record, 

thereby depriving a patent holder of a due process right to 

an impartial decision maker. Ethicon argues that to 

avoid these constitutional concerns, we must construe the 

statute to preclude the Director from delegating the 

decision to institute to the same panel of the Board that 

makes the final decision. We disagree with Ethicon and 

conclude that, where, as here, there are no other separate 

procedural-fairness infirmities alleged, the PTO’s assignment of the institution and final decisions to one panel of 

the Board does not violate due process under governing 

Supreme Court precedent. 

The leading case involving due process and the combination of functions is the Supreme Court’s decision in

Withrow v. Larkin, 421 U.S. 35 (1975). In Withrow, the 

question was whether a physician’s due process rights 

had been violated by a state medical board’s suspension of 

his license when the same board both investigated, and 

then later adjudicated, the issue. Id. at 46. The Court 

held that there was no due process violation, finding that 

combining the investigative and adjudicatory functions in 

a single body does not raise constitutional concerns. Id.

at 58. Similarly, the Court found no due process violation 

where Administrative Law Judges determine Social 

Security disability benefits and, at the preliminary stage, 

“investigate facts and develop the arguments both for and 

against granting benefits,” Sims v. Apfel, 530 U.S. 103, 

111 (2000), and “act[] as an examiner charged with devel-
10 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

oping the facts.” Richardson v. Perales, 402 U.S. 389, 410

(1971). In fact, “[t]he Supreme Court has never held a 

system of combined functions to be a violation of due 

process, and it has upheld several such systems.” 2 

Richard J. Pierce, Jr., Administrative Law Treatise § 9.9, 

p. 892 (5th ed. 2010). 

Lower courts have also rejected due process challenges to systems of adjudication combining functions in an 

agency. See, e.g., Riggins v. Goodman, 572 F.3d 1101, 

1112 (10th Cir. 2009) (no due process concerns in a system for deciding whether to terminate tenured public 

employees which combined investigative and adjudicatory 

functions); In re Seidman, 37 F.3d 911, 924–26 (3d Cir. 

1994) (no due process violation in combining “functions of 

investigation, prosecution and adjudication” in the Director of the Office of Thrift Supervision when banker was 

sanctioned); NLRB v. Aaron Bros. Corp., 563 F.2d 409, 

413 (9th Cir. 1977) (no due process violation when Regional Director of the NLRB “exercised both investigative 

and adjudicative responsibilities in connection with the 

issuance and resolution of [an] unfair labor practice 

complaint”); Jonal Corp. v. Dist. Of Columbia, 533 F.2d 

1192, 1197 (D.C. Cir. 1976) (no due process violation 

simply because of combined functions when contract 

dispute was decided by officials appointed by officer 

representing the government). And we have held that 

there is no due process issue when, in the anti-dumping 

context, a Department of Commerce official makes both 

the decision to institute and then the final determination. 

NEC Corp. v. U.S., 151 F.3d 1361, 1374 (Fed. Cir. 1998). 

Ethicon cites no case to the contrary.

Here, combining the decision to institute with the final decision in a single panel is less problematic than the 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 11

situation in Withrow.3 The Board first decides whether a 

petition demonstrates a likelihood of success on the 

merits, and, if it does, makes a decision to institute inter 

partes review. During the merits, the Board decides 

whether the petition actually succeeds. Both the decision 

to institute and the final decision are adjudicatory decisions and do not involve combining investigative and/or 

prosecutorial functions with an adjudicatory function. 

The inter partes review procedure is directly analogous to 

a district court determining whether there is “a likelihood 

of success on the merits” and then later deciding the 

merits of a case. See, e.g., Fed. R. Civ. P. 65; Winter v. 

Natural Res. Def. Council, Inc., 555 U.S. 7, 20 (2008). As 

Withrow also made clear, “pretrial involvements,” such as 

“issuing or denying a temporary restraining order or a 

preliminary injunction” do not “raise any constitutional 

barrier against the judge’s presiding” over the later trial. 

See Withrow, 421 U.S. at 56.

Lastly, Ethicon argues that the Board panel’s exposure to a limited record in the decision to institute improperly biases it so as to disqualify it from making the 

final decision on the merits. But, as Withrow held, adjudicators are afforded a “presumption of honesty and 

integrity” and even “exposure to evidence presented in 

nonadversary investigative procedures is insufficient in 

itself to impugn the fairness of [adjudicators] at a later 

adversary hearing.” Withrow, 421 U.S. at 47, 55. As the 

3 Note that the Administrative Procedure Act prohibits “[a]n employee or agent engaged in the performance 

of investigative or prosecuting functions for an agency” 

from participating “in the decision . . . except as witness 

or counsel.” 5 U.S.C. § 554(d). However, the APA imposes no separation obligation as to those involved in preliminary and final decisions.

 
12 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

Court has also made clear, “opinions held by judges as a 

result of what they learned in earlier proceedings” are 

“not subject to deprecatory characterization as ‘bias’ or 

‘prejudice.’” Liteky v. U.S., 510 U.S. 540, 551 (1994).4 

To rise to the level of presenting actual bias, the challenger must show that an adjudicator is exposed to unofficial, “extrajudicial” sources of information. See Liteky, 

510 U.S. at 554. For example, the Supreme Court in 

Withrow pointed to a case in which a judge in a criminal 

context improperly served as a “one-man grand jury,” 

charged two witnesses who appeared before him in the 

grand jury proceeding with criminal contempt, and then 

tried and convicted them. 421 U.S. at 53. In line with 

traditional ethical rules that generally prohibit judges 

from being witnesses in cases in which they preside, see, 

e.g., Fed. R. Evid. 605, the problem in that case was that 

the judge “called on his own personal knowledge and 

impression of what had occurred in the grand jury room 

and his judgment was based in part on this impression, 

4 See also Hortonville Joint Sch. Dist. No. 1 v. Hortonville Educ. Ass’n, 426 U.S. 482, 493 (1976) (“Mere 

familiarity with the facts of a case gained by an agency in 

the performance of its statutory role does 

not . . . disqualify a decisionmaker.”); Goldberg v. Kelly, 

397 U.S. 254, 271 (1970) (“[P]rior involvement in some 

aspects of a case will not necessarily bar a welfare official 

from acting as a decision maker.”); Mangels v. Pena, 789 

F.2d 836, 838 (10th Cir. 1986) (finding that adjudicator’s 

pre-hearing exposure to an investigative report did not 

violate due process); Vanelli v. Reynolds Sch. Dist. No. 7, 

667 F.2d 773, 776 (9th Cir. 1982) (finding that a school 

board’s participation in an initial termination decision did 

not render the board impermissibly biased when it conducted a subsequent termination hearing). 

 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 13

the accuracy of which could not be tested by adequate 

cross-examination.” In re Murchison, 349 U.S. 133, 138

(1955). There is no allegation of exposure to extra-judicial 

information here. We see no due process concerns in 

combining the functions of initial decision and final 

disposition in the same Board panel. 

C 

We now turn to Ethicon’s statutory arguments. Ethicon argues that the history, structure, and content of the 

AIA reflect a congressional intent to withhold the power 

of the Director to delegate to the Board the power to 

institute inter partes review. This was allegedly designed

to insulate the Board as final decision maker from the 

supposed taint of the decision to institute the proceeding. 

Ethicon argues that because Congress (1) specifically gave 

the Director the power to institute, see, e.g., 35 U.S.C. 

§ 314(a), (2) did not explicitly give the Director authority 

to delegate the institution decision to the Board, and (3)

gave the Board the power to make the final determination, Congress intended to keep the functions of institution and final decision separate. 

There is nothing in the statute or legislative history of 

the statute indicating a concern with separating the 

functions of initiation and final decision. Ethicon ignores 

the longstanding rule that agency heads have implied 

authority to delegate to officials within the agency, even 

without explicit statutory authority and even when agency officials have other statutory duties. 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. For example, more than 100 years ago, the Supreme Court in Parish v. United States found that the 

Surgeon General had properly delegated authority to an 

assistant Surgeon General to place orders with vendors
14 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

because “it is impossible for a single individual to perform 

in person all the duties imposed on him by office.” 100 

U.S. 500, 504 (1879). 

The implicit power to delegate to subordinates by the 

head of an agency was firmly entrenched in Fleming v. 

Mohawk Wrecking & Lumber Co., where the Supreme 

Court held the administrator of an agency could delegate

the power to sign and issue subpoenas to regional administrators despite absence of an explicit authorization in 

the statute. 331 U.S. 111, 122 (1947). “When a statute 

delegates authority to a federal officer or agency, subdelegation to a subordinate federal officer or agency is presumptively permissible absent affirmative evidence of a 

contrary congressional intent.” U.S. Telecom Ass’n v. 

FCC, 359 F.3d 554, 565 (D.C. Cir. 2004); see also Kobach 

v. U.S. Election Assistance Comm’n, 772 F.3d 1183, 1190 

(10th Cir. 2014) (finding that the courts of appeals that 

have spoken on the issue are “unanimous in permitting 

subdelegations to subordinates . . . so long as the enabling 

statute and its legislative history do not indicate a prohibition on subdelegation”). The general principle is so well 

accepted that the Supreme Court has called it “unexceptional.” See United States v. Giordano, 416 U.S. 505, 514

(1974). 

Ethicon argues that Cudahy Packing Co. of Louisiana 

v. Holland, 315 U.S. 357 (1942), holds that affirmative 

authority to delegate is required. The Supreme Court 

has not cited Cudahy since 1958 “and the lower courts no 

longer follow it.” 1 Richard J. Pierce, Jr., supra § 2.7, p. 

125. Despite some language in Cudahy suggesting that 

express authority to delegate is required, the Supreme 

Court later clarified in Fleming that the Cudahy decision 

was based on explicit legislative history that “showed that 

a provision granting authority to delegate . . . had been 

eliminated when the bill was in Conference.” Fleming, 

331 U.S. at 120. Thus, Cudahy simply stands for the
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 15

unremarkable proposition that congressional intent to 

preclude delegation can sometimes be found in the legislative history.5 Ethicon can point to no legislative history

or any other aspects of the AIA here suggesting that 

delegation by the Director to the Board is impermissible. 

Quite the contrary, Congress obviously assumed that 

the Director would delegate. Before the AIA, the Director, 

as head of the PTO, regularly assigned tasks to subordinate officers. See, e.g., 35 U.S.C. § 131 (“the Director shall 

issue a patent”); § 132(a) (“the Director shall notify the 

applicant” of a rejection of a patent application); § 251(a) 

(“the Director shall” reissue amended patents). This 

carried over to the AIA, where 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

5 Ethicon’s reliance on our previous decision in 

Splane v. West, 216 F.3d 1058 (Fed. Cir. 2000) is also 

misplaced. Splane cannot be read to require express 

authorization in light of the Supreme Court’s Fleming 

case (not cited in Splane), which makes clear that express 

authorization is not required. Ethicon, in addition, relies 

on two inapposite D.C. Circuit cases finding no delegation 

to outside agencies—Shook v. D.C. Fin. Responsibility & 

Mgmt. Assistance Auth., 132 F.3d 775, 782 (D.C. Cir. 

1998) and Halverson v. Slater, 129 F.3d 180, 185–86 (D.C.

Cir. 1997). These cases are not applicable to the current 

situation because “[t]he presumption that subdelegations 

are valid absent a showing of contrary congressional 

intent applies only to” subdelegations, not delegations to 

outside agencies. U.S. Telecom Ass’n, 359 F.3d at 565. 

“There is no such presumption covering subdelegations to 

outside parties.” Id.

 
16 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

review would mean that the Director could not herself

review every petition.6 

Ethicon finally argues that the existence of 35 U.S.C. 

§ 3(b)(3)(B), which allows the Director to delegate duties 

to officers and employees she appoints, evidences a congressional purpose to cabin the Director’s authority with 

respect to delegation. See 35 U.S.C. § 3(b)(3) (providing 

that “[t]he Director shall . . . appoint such officers . . . as 

the Director considers necessary, . . . and delegate to them 

such of the powers vested in the Office as the Director 

may determine”). Ethicon argues that this means that 

the Director cannot delegate to other officers of the PTO, 

like members of the Board, whom she does not appoint. 

Ethicon primarily relies on one sentence from the Supreme Court’s decision in Fleming stating that a provision 

“specifically authoriz[ing] delegation as to a particular 

function” may “lend[] support to the view that when 

Congress desired to give authority to delegate, it said so 

explicitly.” 331 U.S. at 121 (emphasis added). 

Section 3(b)(3) is not such a provision. Not only does 

it not delegate a “particular function,” but it is not primarily a delegation provision at all. It is, instead, a

source of authority for the Director to appoint subordi6 See 35 U.S.C. § 314 (authorizing the Director to 

institute inter partes review, but requiring that the 

decision to institute be made within 3 months of either 

when a response was filed or could have been filed); H.R. 

Rep. No. 110-314, Patent Reform Act of 2007, at 3 (2007) 

(“With fewer limitations on future challenges and a larger 

universe of patents open to challenge, CBO expects that 

the number of inter partes proceedings would increase 

under the bill. Based on information from PTO, CBO 

expects at least 100 additional employees would be necessary to handle that increase in patent challenges.”). 

 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 17

nates and assign them tasks. This is a situation where 

Congress has “mention[ed] a specific official only to make 

it clear that this official has a particular power rather 

than to exclude delegation to other officials.” United 

States v. Mango, 199 F.3d 85, 90 (2d Cir. 1999). It is not a 

provision delegating a specific named function to a specific named official. See Giordano, 416 U.S. at 513; Mango, 

199 F.3d at 90. It would indeed be strange to read 

§ 3(b)(3) as limiting delegation to the Deputy Director, 

who is appointed by the Secretary of Commerce and not 

the Director, see 35 U.S.C. § 3(b)(1), who would then be 

left with no other tasks other than to step in the shoes of 

the Director “in the event of [her] absence or incapacity.” 

See 35 U.S.C. § 3(b)(1). Thus, § 3(b)(3) cannot be read to 

limit the ability of the Director to delegate tasks to agency 

officials not mentioned in § 3(b)(3). We conclude that the 

Director here has the inherent authority to delegate 

institution decisions to the Board. 

Moreover, Congress’s vesting of broad rulemaking 

powers in the head of the agency is an alternate source of 

authority to delegate. As the Supreme Court noted in

Fleming, “rule-making power may itself be an adequate 

source of authority to delegate a particular function, 

unless by express provision of the Act or by implication it 

has been withheld.” 331 U.S. at 121. Here, Congress 

gave the Director broad rulemaking power to “govern the 

conduct of the proceedings in the Office,” 35 U.S.C. 

§ 2(b)(2), and to “establish[] and govern[] inter partes 

review under this chapter,” 35 U.S.C. § 316(a)(4). Congress undoubtedly intended the Director to have power by 

rulemaking to define the structure of inter partes review, 

including the power to subdelegate tasks assigned to her

in the interest of efficiency. The Director promulgated a 

regulation allowing the Board to institute inter partes

review “on behalf of the Director.” 37 C.F.R. § 42.4(a). 

This rule itself is entitled to Chevron deference. Chevron, 
18 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 

842–43 (1984). The reference to “the Director” in the 

statute is ambiguous as to whether it requires her personal participation and the regulation is a permissible 

interpretation of the statute. See Chevron, 467 U.S. at 

842–43; Cuozzo, 793 F.3d at 1279; Cooper Techs. Co. v. 

Dudas, 536 F.3d 1330, 1335 (Fed. Cir. 2008). 

In short, both as a matter of inherent authority and 

general rulemaking authority, the Director had authority 

to delegate the institution decision to the Board. There is 

nothing in the Constitution or the statute that precludes 

the same Board panel from making the decision to institute and then rendering the final decision.

II

We now turn to the merits of the Board’s decision 

finding the claims of the ’070 patent obvious in view of the 

prior art. Obviousness is a question of law based on 

underlying factual findings, including: (1) the level of 

ordinary skill in the art; (2) the scope and content of the 

prior art; (3) the differences between the claims and the 

prior art; and (4) secondary considerations of nonobviousness, such as commercial success, long-felt but unmet 

needs, failure of others, and unexpected results. See KSR 

Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 406 (2007); Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17–18 

(1966). 

Ethicon does not challenge the Board’s finding that all 

of the claim elements are found in the prior art, nor does 

it challenge the Board’s determination that a person of 

ordinary skill would have been motivated to combine 

those prior art elements to come up with the invention in 

the ’070 patent. Ethicon instead argues that the Board 

did not properly take into account the secondary considerations of non-obviousness. 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 19

First, Ethicon argues that the Board failed to consider 

the commercial success of an allegedly infringing Covidien

device. Our case law establishes that for evidence of 

commercial success to be relevant, “the patentee must 

establish a nexus between the evidence of commercial 

success and the patented invention.” Wyers v. Master 

Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010). 

Ethicon argues that the Board failed to afford Ethicon 

a presumption of nexus between the commercial success 

of an allegedly infringing product made by Covidien and 

the patented features. It contends that because it showed 

that the Covidien devices were infringing, the commercial 

success of those devices is a strong secondary indication of 

non-obviousness which the Board ignored. However, 

regardless of any presumption of nexus, Ethicon’s own 

evidence demonstrates that other non-patented features 

and features known in the prior art underlay the commercial success of Covidien’s allegedly infringing product. 

“[I]f the commercial success is due to an unclaimed feature of the device” or “if the feature that creates the 

commercial success was known in the prior art, the success is not pertinent.” Ormco Corp. v. Align Tech., Inc., 

463 F.3d 1299, 1312 (Fed. Cir. 2006). 

As the Board recognized, the Covidien products contained numerous unclaimed features, “such as ergonomic 

design, precise articulation, and reloads that provide 

simpler selection and reduced inventory,” which may 

instead have been responsible for the commercial success 

of the products. J.A 19. Other unclaimed features, such 

as “[u]ncompromised staple line strength” and “[s]uperior 

[l]eak [r]esistance,” are touted in brochures advertising 

the Covidien products. J.A. 1101. The Board concluded 

that, in light of these unclaimed features, Ethicon had 

“not shown sufficient credible evidence that the sales of 

the [Covidien devices] are the result of the claimed invention.” J.A. 19. We agree. 
20 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

In addition, the Board had substantial evidence before 

it that the commercial success of the Covidien products 

was primarily attributable to a single feature present in 

the prior art, varying staple heights, rather than the 

combination of prior art features that is the alleged 

invention of the ’070 patent. The evidence demonstrates 

that the Covidien products were successful because of 

their “graduated compression design and progressive 

staple heights, which provide less stress on tissue during 

compression and clamping.” J.A. 1126. In addition, the 

varied staple heights allowed for “[b]roader indicated 

tissue thickness ranges” and “[c]onsistent performance 

over a broader range of tissue thicknesses.” J.A. 1101. As 

the Board found and Ethicon concedes, the use of staples 

of different heights was well known in the prior art at the 

time of the ’070 patent. J.A. 9. Nowhere does Ethicon 

demonstrate, or even argue, that the commercial success 

of the Covidien products is attributable to the combination of the two prior art features—varied staple heights 

and non-parallel staple legs—that is the purportedly

inventive aspect of the ’070 patent.

Lastly, Ethicon argues that the Board failed to weigh

its evidence demonstrating a long-felt but unresolved 

need. Here, Ethicon only pointed to a single passage in a 

marketing brochure (and expert testimony based on that 

marketing brochure) touting the advantages of the 

Covidien products to demonstrate long-felt need. But at 

most, these demonstrate a long-felt need for staples of 

different heights (a feature in the prior art), not the 

combination of features that is the invention here. As the 

Board found, this single brochure “does not support the 

assertion that there was a long-felt but unresolved need 

in the industry” for the claimed invention. J.A. 21. The 

Board did not err in concluding the asserted claims would 

have been obvious.

AFFIRMED
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 21

COSTS

Costs to appellee.
United States Court of Appeals 

for the Federal Circuit ______________________ 

ETHICON ENDO-SURGERY, INC.,

Appellant

v.

COVIDIEN LP,

Appellee

______________________ 

2014-1771

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in No. IPR2013-

00209.

______________________ 

NEWMAN, Circuit Judge, dissenting. 

I respectfully dissent, for the majority’s holdings are 

contrary to the Leahy-Smith America Invents Act, Pub. L. 

No. 112-29, 25 Stat. 284 (2011) (codified at Title 35 of the 

United States Code). The post-grant proceedings established by the Act were intended as “quick and cost effective alternatives to litigation.” H.R. Rep. No. 112–98, pt. 

1, at 48 (2011). That legislative plan has been repeatedly 

thwarted by the implementing bodies, administrative and 

judicial.

These post-grant proceedings were designed to provide rigorous inquiry and confident adjudication as a 

surrogate for district court litigation, with the added 
2 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

benefits of administrative expertise and efficiency. As 

part of this new agency procedure, the Act established a 

threshold step called “institution” by the Director of the 

PTO followed by trial and adjudication, by a new adjudicatory body established in the PTO. The “institution” step 

is a carefully designed threshold, whereby only meritorious challenges will be considered. And as a safeguard of 

administrative objectivity, the legislation divided the 

functions of institution and trial into separate bodies 

within the PTO.

The panel majority states that “there is nothing in the 

Constitution or the statute that precludes the same Board 

panel from making the decision to institute and then 

rendering the final opinion.” Maj. Op. at 18. That is 

incorrect. The statute requires that these proceedings be 

separated, the first decision required to be made by the 

Director, and the second decision made by the Board. 

This court has now endorsed proceedings in which the 

Board makes both decisions. This procedure cannot be 

reconciled with the statute.

At the first stage, the Director determines whether 

the review is to be instituted. 35 U.S.C. § 314(a) (“The 

Director may not authorize an inter partes review 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 one of the 

claims challenged in the petition.”). (Of course, the Director may designate an examiner or solicitor to conduct this 

initial review.)

If instituted by the Director, the Board then conducts 

a trial on the merits. 35 U.S.C. § 316(c) (“The Patent 

Trial and Appeal Board shall, in accordance with section 

6, conduct each inter partes review instituted under this 

chapter.”). “The statute thus separates the Director’s 

decision to ‘institute’ the review, § 314, on one hand from 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 3

the Board’s ‘conduct’ of the review ‘instituted’ by the 

Director, § 316(c), and the Board’s subsequent ‘written 

decision,’ § 318, on the other.” St. Jude Med., Cardiology 

Div., Inc. v. Volcano Corp., 749 F.3d 1373, 1375 (Fed. Cir. 

2014).

The threshold determination to institute post-grant 

review requires the Director to find that there is morelikely-than-not an error in the grant of at least one claim 

of the patent. When such finding is made by the Director, 

the newly created independent tribunal in the PTO conducts a full trial, with discovery, testimony, experts, and 

other trappings of district court litigation. This trial, and 

the ensuing Board decision, are independent of and give 

no deference to the Director’s decision “to institute” the 

proceeding. In turn, the Board’s decision is not subject to 

review by the Director or in the district courts, and can be 

appealed only to this court. Our decision, in turn, cannot 

be challenged in infringement litigation between these 

parties.

The bifurcated design of post-grant review is clear not 

only from the language of §§ 314(a) and 316(c), but pervades the structure of these post-grant proceedings. 

Congress unambiguously placed these separate determinations in different decision-makers, applying different 

criteria. The majority’s endorsement of the PTO’s statutory violation departs not only from the statute, but also 

from the due process guarantee of a “fair and impartial 

decision-maker.”

I 

Post-Grant Proceedings are a Surrogate for 

District Court Litigation

The America Invents Act is the result of more than six 

years of discussion, debate, negotiation, and collaboration 

among innovative industries, independent inventors, 

legislators, academics, research institutions, entrepre-
4 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

neurs, the concerned public, the intellectual property bar, 

and the PTO—all seeking to resolve problems that had 

arisen in the patent system. The key advance of the 

America Invents Act is its creation of a new procedure for 

reviewing previously granted patents, to shift determination of patent validity from the courts to the expert agency, to provide “quick and cost effective alternatives to 

litigation” and thereby to restore the innovation incentive 

of an effective system of patents. H.R. Rep. No. 112-98, 

pt. 1, at 48 (2011).

The design and intent of the America Invents Act is 

that these new PTO proceedings will provide early, reliable, and less costly adjudication of the major issues of 

patent validity. See 157 Cong. Rec. S5327 (Sept. 6, 2011) 

(statement of Sen. Leahy) (“This bill will establish a more 

efficient and streamlined patent system that will improve 

patent quality and limit unnecessary and counterproductive litigation costs, while making sure no party’s access 

to court is denied.”).

These new proceedings were developed in the context 

of the shortcomings of the then-existing inter partes

reexamination system. That system authorized third 

parties or the patentee to request reexamination on 

showing a “substantial new question of patentability.” 35 

U.S.C. § 312(a). Reexamination then proceeded similarly 

to initial examination, including the right of amendment; 

appeal could be taken to the Patent Office Board of Appeals and Interferences and then to the courts. Criticism 

focused on the prevalence of cumulative and harassing 

attacks, whereby the vitality of the patent could be consumed by multiple and time-consuming proceedings. The 

America Invents Act sought to address these concerns, as 

well as the expense and duration of litigation of validity 

in the district courts.

The America Invents Act requires an initial decision 

by the Director as to whether post-grant review is war-
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 5

ranted at all; this is required to be made within three 

months of the filing of a petition for review. 35 U.S.C. § 

314(b); see 157 Cong. Rec. S1376 (Mar. 28, 2011) (statement of Sen. Kyl) (“Among the reforms that are expected 

to expedite these proceedings are . . . the elevated threshold for instituting proceedings. The elevated threshold 

will require challengers to front load their case.”). The 

statute requires petitioners to demonstrate a “reasonable 

likelihood” of invalidity as to at least one claim, in order 

for institution to be granted. 35 U.S.C. § 314(a).

Interlocutory appeal of a decision on the question of 

institution is barred by statute. The legislative record 

explains that the America Invents Act “eliminates intermediate administrative appeals of inter partes proceedings to the BPAI . . . . By reducing two levels of appeals to

just one, this change will substantially accelerate the 

resolution of inter partes cases.” 157 Cong. Rec. S1376 

(Mar. 28, 2011) (statement of Sen. Kyl). However, this 

salutary purpose did not discard the protections of due 

process. 

The threshold institution proceeding is designed to 

avoid the disadvantages of the prior inter partes practice, 

for: “The Patent Office has indicated that it currently is 

forced to accept many requests for ex parte and inter 

partes reexamination that raise challenges that are 

cumulative to or substantially overlap with issues previously considered by the Office with respect to the patent.” 

Id. The institution step also protects the patent owner 

from “attacks on patents that raise issues that are substantially the same as issues that were already before the 

Office with respect to the patent.” Id.

This institution procedure, which “requir[es] the petitioner to present a prima facie case justifying a rejection 

of the claims in the patent,” id. at S1375, tracks the 

obligation of a complainant to provide a legally sufficient 

pleading. Thereafter the adjudicatory body conducts a 
6 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

trial and completes its proceedings within one year (with 

extension for good cause shown). 35 U.S.C. § 316(a)(11); 

see 157 Cong. Rec. S1366 (Mar. 8, 2011) (Republican Pol. 

Comm. Leg. Notice S.23 (Feb. 28, 2011) entered by Sen. 

Kyl) (“These reforms add additional procedural protections to the process by converting the reexamination into 

an adjudicative proceeding to be known as ‘inter partes 

review.’ Inter partes review must be completed with one 

year of being instituted.”).

The America Invents Act requires that the trial be 

conducted, and the matter finally decided, by a different 

part of the PTO than makes the decision to institute. 

These post-grant proceedings have become the new frontier of patent litigation.1 Threatening the viability of this 

new system, however, is the disregard of the procedures 

established by the America Invents Act.

II

The Statutory Separation of the Decision to 

Institute and the Decision on Validity

The panel majority holds that the decision to institute 

may be made by the PTAB, not by the Director, and that 

it may be made by the same PTAB panel that would then 

conduct the trial and make the validity decision. This 

violation of the statute has been criticized by practitioners, citing the “actual or perceived bias against the patent 

owner” because the administrative patent judges are “put 

1 As of October 31, 2015, the PTO had received 

more than 4000 petitions under this statute, see Patent 

Trial and Appeal Board Statistics, at 2 (Oct. 31, 2015) 

available at http://www.uspto.gov/sites/default/files/

documents/2015-10-31%20PTAB.pdf. Of the 2,450 completed proceedings, the Office instituted more than 1200 

trials. Id. at 9.

 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 7

in the position of defending their prior decisions to institute the trial.” AIPLA, Comments on PTAB Trial Proceedings, at 20 (Oct. 16, 2014), available at 

http://www.uspto.gov/ip/boards/bpai/aipla_20141016.pdf.

It cannot be ignored that this transfer to the Board of 

the Director’s statutory assignment violates the text, 

structure, and purpose of the America Invents Act. The 

statutory separation of roles cannot be abrogated by 

either the PTO or this court.

In defense of abrogation, the panel majority cites a

treatise that reports that administrative agencies have 

been authorized to perform both investigative and adjudicatory functions. Maj. Op. at 10 (citing 2 Richard J. 

Pierce, Jr., Administrative Law Treatise § 9.9, p. 892 (5th 

ed. 2010).). However, such authorization cannot violate 

the implementing legislation. 

Due process guarantees “a fair trial in a fair tribunal.” 

In re Murchison, 349 U.S. 133, 136 (1955). Permitting the 

same decision-maker to review its own prior decision may 

not always provide the constitutionally required impartial 

decision maker. “The right to an impartial decision 

marker is unquestionably an aspect of procedural due 

process. . . . This applies to administrative proceedings as 

well as judicial trials.” NEC Corp. v. United States, 151 

F.3d 1361, 1371 (Fed. Cir. 1998) (internal citations omitted).

As stated in Matthews v. Eldridge, “identification of 

the specific dictates of due process generally requires 

consideration of three distinct factors,” 424 U.S. 319, 335 

(1976). The three factors are “the private interest that 

will be affected by the official action,” the “risk of an 

erroneous deprivation,” and the “fiscal and administrative 

burdens that the additional or substitute procedural 

requirement would entail.” Id. Here, the first two factors 

weigh heavily in favor of the divided decision-making of 

the America Invents Act, with scant additional burden.
8 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

In evaluating administrative processes for prejudgment this court has considered the “bifurcation” of other 

decision-making processes and the “statutory and regulatory protections” for the party subject to a deprivation. 

NEC Corporation, 151 F.3d at 1371. In NEC Corporation

this court upheld the bifurcated administrative process 

involved in antidumping duty proceedings:

First of all, an antidumping investigation is bifurcated: Commerce makes less-than-fair value determinations for a class or kind of foreign 

merchandise, and the ITC makes injury determinations. Only if Commerce determines that the 

merchandise is being sold at less-than-fair value, 

see 19 U.S.C. § 1673(1) (1994), and the ITC determines that a domestic industry is materially 

injured or is threatened with material injury, see

19 U.S.C. § 1673(2), does Commerce issue an antidumping order. See 19 U.S.C. § 1673. This bifurcation reduces the risk that an improper bias 

will deprive importers of their due process rights.

151 F.3d at 1373. In contrast, the unitary procedure now

implemented by the PTO and ratified by this court enlarges, rather than reduces, the “risk [of] improper bias.” 

Id. 

If bifurcated decision-making is required to reduce the 

risk of erroneous deprivation in antidumping proceedings, 

similar protection is at least as appropriate for post-grant 

proceedings. And contrary to the panel majority’s holding, Congress explicitly provided for exactly that kind of 

decisional separation in the America Invents Act.

My colleagues also suggest analogy to a district 

court’s preliminary determination of whether there is “a 

likelihood of success on the merits” for purposes of responding to a request for preliminary injunction. Maj. 

Op. at 11 (citing Fed. R. Civ. P. 65). However, such

decisions are immediately subject to appeal.
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 9

In Withrow v. Larkin, 421 U.S. 35, 58 n.25 (1975), the 

Court expressly reserved the question of “[a]llowing a 

decisionmaker to review and evaluate his own prior 

decision.” We need not decide this question here, for the 

possible potential conflict was foreseen by the legislators, 

and by statute was forestalled. All that is needed is to 

apply the statute as it was written. The statute divides 

post-grant authority between the Director, who is responsible for deciding whether to institute review, and the 

Board of administrative patent judges, charged with 

conducting the trial and rendering a decision on patent 

validity. The statute bars the Board from rendering both 

the institution and final decisions. As this court has

recognized, “institution and invalidation are two distinct 

actions.” Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 

F.3d 1306, 1319 (Fed. Cir. 2015) (“In addition to being 

deeply embedded in federal administrative law, the 

distinction is built into the structure of this particular 

AIA statute.”).

The statute repeats several times the requirement 

that the Director make the institution decision. See, e.g., 

35 U.S.C. § 314(c) (notification must be made of “the 

Director’s determination under subsection (a)”); § 314(d) 

(the Director may join parties “[i]f the Director institutes 

an inter partes review”). The Director’s institution decision carries a different burden of persuasion, is decided on 

limited submissions before trial, and is barred from 

appeal. In its implementing regulations, the Office excludes all substantive evidence from the patent owner’s 

preliminary response, including expert declarations or 

other rebuttal evidence. 37 C.F.R. § 42.107(c). Thus the 

statutory structure favors institution, for the overarching

purpose is to provide a forum for early, expeditious review 

of granted patents. By placing the institution decision in 

different hands than the trial, Congress acted to preserve 

the process from human frailty.
10 ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP

The statute is equally clear that it is the Board that 

conducts the trial and issues a final decision. See 35 

U.S.C. §§ 316(c), 318(a). This legislative assignment of 

functions cannot be ignored. See Corley v. United States, 

556 U.S. 303, 314 (2009) (“[O]ne of the most basic interpretative canons [is] that [a] statute should be construed 

so that effect is given to all its provisions, so that no part 

will be inoperative or superfluous, void or insignificant.” 

(internal citations omitted, alterations in original)); cf.

United States v. Giordano, 416 U.S. 505, 514 (1974) 

(holding that where a statute authorized wiretaps only by 

the Attorney General or any Assistant Attorney General 

specially designated, the statute “fairly read, was intended to limit the power to authorize wiretap applications” to 

the expressly named positions).

Statutes must be interpreted to conform to “the design 

of the statute as a whole and to its object and policy.” 

Crandon v. United States, 494 U.S. 152, 158 (1990). The 

legislative division of these decisional roles is not subject 

to agency or judicial modification, whether by adjudication or by rulemaking. The PTO’s rulemaking authority 

does not extend to changing statutorily defined procedures. In promulgating 37 C.F.R. § 42.4 to transfer the 

Director’s institution responsibility to the Board, the PTO 

departed from the statute. See Ernst & Ernst v. Hochfelder, 425 U.S. 185, 213–14 (1976) (“The rulemaking 

power granted to an administrative agency charged with 

the administration of a federal statute is not the power to 

make law. Rather, it is the power to adopt regulations to 

carry into effect the will of Congress as expressed by the 

statute.”).

“Although an agency’s interpretation of the statute 

under which it operates is entitled to some deference, ‘this 

deference is constrained by our obligation to honor the 

clear meaning of a statute, as revealed by its language, 

purpose, and history.’” Se. Cmty. Coll. v. Davis, 442 U.S. 

397, 411 (1979) (quoting Teamsters v. Daniel, 439 U.S. 
ETHICON ENDO-SURGERY, INC. v. COVIDIEN LP 11

551, 566 n. 20 (1979)); see Muwwakkil v. Office of Pers. 

Mgmt., 18 F.3d 921, 925 (Fed. Cir. 1994) (“When an 

agency’s interpretation of a statute it is entrusted to 

administer is contrary to the intent of Congress, as divined from the statute and its legislative history, we owe 

it no deference.”).

SUMMARY

The post-grant proceedings of the America Invents 

Act are a pioneering measure to shift several aspects of 

patent validity from the district courts to the PTO. The 

legislative purpose is to provide optimum decisional 

objectivity, in order to restore public confidence in the 

reliability of patents as investment incentives; this requires that the PTO proceedings conform to the statute. I 

respectfully dissent.