Court Opinion

ID: 3169257
Source: CourtListenerOpinion
Date Created: 2016-01-13 17:01:13.477206+00
Date Added: 2024-06-11T11:59:48.028106
License: Public Domain

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.