Opinion

Ethicon Endo-Surgery, Inc. v. Covidien Lp

  • 812 F.3d 1023
  • 117 U.S.P.Q. 2d (BNA) 1639
  • 2016 U.S. App. LEXIS 473
  • 2016 WL 145576
Court
Court of Appeals for the Federal Circuit
Filed
Jan 13, 2016
Status
Published
On the bench
Newman, Dyk, Taranto
Cited by
36 cases
Authority
More cited than 42.9%

for patent claims covering a combination of prior art features, to establish nexus, patentee must show that the evidence of secondary considerations is attributable to “the combination of the two prior art features . . . that is the purportedly inventive aspect of the [challenged] patent” as 20 FOX FACTORY, INC. v. SRAM, LLC opposed to unclaimed features or either prior art feature in isolation

How later courts described this case

  • for patent claims covering a combination of prior art features, to establish nexus, patentee must show that the evidence of secondary considerations is attributable to “the combination of the two prior art features . . . that is the purportedly inventive aspect of the [challenged] patent” as 20 FOX FACTORY, INC. v. SRAM, LLC opposed to unclaimed features or either prior art feature in isolation
  • “[B]oth 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 arresting officers or taking biased actions to increase their caseload.”
  • “There is nothing in the Constitution or the statute that precludes the same Board panel from mak- ing the decision to institute and then rendering the final decision.”
  • "[T]he 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."

Written by the judges who cited it.

The opinion

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, Washing-

ton, 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. Pa-

tent 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 obvi-

ous 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 pre-

cludes 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 simultane-

ously apply lines of staples on opposing sides of the inci-

sion. ’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, cut-

ting 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 ef-

fector 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 com-

prise 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 plu-

rality 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 non-

parallel legs. It is undisputed that both of these im-

provements, 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 specifi-

cation, 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 sec-

tion.” ’070 Patent col. 2 ll. 8–12. This is beneficial be-

cause 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 differ-

ent sized staples thus allows this type of device to be used

on a broader range of tissue thicknesses. As is uncontest-

ed, 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 sta-

ples 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 “pro-

gressive staple heights” that allow “consistent perfor-

mance 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 con-

cluded that one of skill in the art would have been moti-

vated 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 inven-

tion. 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, ar-

guing 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 Act 1 (“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 deci-

sion 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 re-

quires the Director consider the “efficient administration

of the [PTO], and the ability of the [PTO] to timely com-

plete 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 au-

thorize 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 dele-

gate 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 wheth-

er 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 deci-

sion, 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 assign-

ment 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 com-

bination 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 challeng-

es 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 sys-

tem 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 Direc-

tor 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 Re-

gional 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 fi-

nal 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 deci-

sions 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 expo-

sure to a limited record in the decision to institute im-

properly biases it so as to disqualify it from making the

final decision on the merits. But, as Withrow held, adju-

dicators 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 pro-

hibits “[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 impos-

es no separation obligation as to those involved in prelim-

inary 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 chal-

lenger must show that an adjudicator is exposed to unoffi-

cial, “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. Hor-

tonville 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 con-

ducted 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. Ethi-

con 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 determina-

tion, Congress intended to keep the functions of institu-

tion 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 agen-

cy officials have other statutory duties. Congress regular-

ly 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 Su-

preme 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 admin-

istrators 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, subdele-

gation to a subordinate federal officer or agency is pre-

sumptively 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 prohi-

bition on subdelegation”). The general principle is so well

accepted that the Supreme Court has called it “unexcep-

tional.” 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 legis-

lative 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 subordi-

nate 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 con-

gressional 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 Su-

preme 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 pri-

marily a delegation provision at all. It is, instead, a

source of authority for the Director to appoint subordi-

6 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 neces-

sary 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 specif-

ic 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). Con-

gress 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 per-

sonal 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 insti-

tute 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 nonobvious-

ness, 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); Gra-

ham 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 consid-

erations 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 commer-

cial success of Covidien’s allegedly infringing product.

“[I]f the commercial success is due to an unclaimed fea-

ture of the device” or “if the feature that creates the

commercial success was known in the prior art, the suc-

cess is not pertinent.” Ormco Corp. v. Align Tech., Inc.,

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

As the Board recognized, the Covidien products con-

tained 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 inven-

tion.” 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 combina-

tion 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 estab-

lished by the Act were intended as “quick and cost effec-

tive 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 pro-

vide 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 adjudi-

catory body established in the PTO. The “institution” step

is a carefully designed threshold, whereby only meritori-

ous 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 infor-

mation 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 Direc-

tor 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 more-

likely-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 con-

ducts 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 per-

vades the structure of these post-grant proceedings.

Congress unambiguously placed these separate determi-

nations in different decision-makers, applying different

criteria. The majority’s endorsement of the PTO’s statu-

tory 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 determina-

tion of patent validity from the courts to the expert agen-

cy, 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, relia-

ble, 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 counterproduc-

tive 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 Ap-

peals 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 con-

sumed 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) (state-

ment of Sen. Kyl) (“Among the reforms that are expected

to expedite these proceedings are . . . the elevated thresh-

old 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 inter-

mediate administrative appeals of inter partes proceed-

ings 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 previ-

ously 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 sub-

stantially the same as issues that were already before the

Office with respect to the patent.” Id.

This institution procedure, which “requir[es] the peti-

tioner 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 protec-

tions 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 fron-

tier 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 practition-

ers, 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 com-

pleted 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 insti-

tute the trial.” AIPLA, Comments on PTAB Trial Pro-

ceedings, 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 adjudi-

catory 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 omit-

ted).

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 prejudg-

ment this court has considered the “bifurcation” of other

decision-making processes and the “statutory and regula-

tory 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 bifur-

cated: Commerce makes less-than-fair value de-

terminations for a class or kind of foreign

merchandise, and the ITC makes injury determi-

nations. 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 de-

termines that a domestic industry is materially

injured or is threatened with material injury, see

19 U.S.C. § 1673(2), does Commerce issue an an-

tidumping order. See 19 U.S.C. § 1673. This bi-

furcation 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 en-

larges, 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 hold-

ing, 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 re-

sponding 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 respon-

sible 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 deci-

sion carries a different burden of persuasion, is decided on

limited submissions before trial, and is barred from

appeal. In its implementing regulations, the Office ex-

cludes 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 inter-

pretative 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 intend-

ed 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 adjudica-

tion or by rulemaking. The PTO’s rulemaking authority

does not extend to changing statutorily defined proce-

dures. 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. Hoch-

felder, 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 di-

vined 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 re-

quires that the PTO proceedings conform to the statute. I

respectfully dissent.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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