Sage Products, LLC v. Coke Morgan Stewart, Acting Under Secretary of Commerce for Intellectual Property

United States Court of Appeals
for the Federal Circuit
______________________
SAGE PRODUCTS, LLC,
Appellant
v.
COKE MORGAN STEWART, ACTING UNDER
SECRETARY OF COMMERCE FOR
INTELLECTUAL PROPERTY AND ACTING
DIRECTOR OF THE UNITED STATES PATENT
AND TRADEMARK OFFICE,
Intervenor
______________________
2023-1603, 2023-1604
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2021-
01201, IPR2021-01202.
______________________
Decided: April 15, 2025
______________________
SANDRA A. F RANTZEN, McAndrews, Held & Malloy,
Ltd., Chicago, IL, argued for appellant. Also represented
by D EBORAH L AUGHTON, BEN M AHON, ROBERT ANTHONY
SURRETTE .
SHEHLA WYNNE, Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, argued for
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SAGE PRODUCTS, LLC v. STEWART 2
intervenor. Also represented by P ETER J. AYERS , SARAH E.
CRAVEN, AMY J. N ELSON.
______________________
Before REYNA, CUNNINGHAM , and STARK, Circuit Judges.
STARK, Circuit Judge.
Sage Products, LLC (“Sage”) challenges the final writ-
ten decisions (“FWD”) of the Patent Trial and Appeal Board
(“Board”) finding all challenged claims of two of its patents
unpatentable. Becton, Dickinson and Co. (“BD”), the orig-
inal appellee in this appeal, withdrew after filing its brief.
The Director of the U.S. Patent and Trademark Office
(“PTO”) then exercised her right to intervene, under 35
U.S.C. § 143, and continued the appeal by relying on the
briefing already filed by BD.1 We affirm the judgment of
the Board.
I
A
Sage’s U.S. Patent Nos. 10,398,642 (“’642 patent”) and
10,688,067 (“’067 patent”), are both entitled “Sterilized
Chlorhexidine Article and Method of Sterilizing a Chlor-
hexidine Article.” The ’067 patent is a continuation of the
’642 patent. They share a common specification and a com-
mon effective filing date of November 25, 2015.2
The patented invention relates to a sterilized chlorhex-
idine product in a package, such as an applicator filled with
an antiseptic composition for disinfecting skin. At issue in
1 Because the PTO relies on BD’s briefing, we refer
to arguments advanced in BD’s briefing as those of the
PTO.
2 Like the parties, we cite the specification of the ’642
patent.
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SAGE PRODUCTS, LLC v. STEWART 3
this appeal are claims 1-3, 5-8, 10-18, and 20 of the ’642
patent and claims 1-3, 5-8, and 10-19 of the ’067 patent.
Challenged claims 1, 7, and 10 of the ’642 patent, repro-
duced below, illustrate the limitations at issue in this ap-
peal:
1. A sterilized chlorhexidine product for topical dis-
infection, said sterilized chlorhexidine product
comprising:
a sterilized chlorhexidine gluconate compo-
sition;
an applicator for facilitating application of
the sterilized chlorhexidine composition;
and
a receptacle containing the sterilized chlor-
hexidine gluconate composition to provide
the sterilized chlorhexidine gluconate com-
position to impregnate the applicator when
the receptacle is compromised;
wherein the sterilized chlorhexidine glu-
conate composition comprises chlorhexi-
dine gluconate and alcohol.
7. The sterilized chlorhexidine product of claim 1,
wherein the sterilized chlorhexidine gluconate
composition further comprises one or more addi-
tives selected from the group consisting of a steri-
lized surfactant, a sterilized pH adjuster, a
sterilized odorant, a sterilized colorant, a sterilized
stabilizer, a sterilized skin protectant, a sterilized
preservative, or combinations thereof.
10. The sterilized chlorhexidine product of claim 1,
wherein said sterilized chlorhexidine article has a
sterility assurance level [SAL] of from 10-3 to 10-9.
J.A. 228 (emphasis added).
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SAGE PRODUCTS, LLC v. STEWART 4
The specification recites that a product may be referred
to as “sterilized” “where such sterility can be validated.”
J.A. 216 at col. 3 ll. 56-61. Sterilization methods mentioned
in the patents include heat and radiation treatments.
B
The Board relied on four key pieces of prior art in find-
ing Sage’s claims unpatentable. The first is the ChloraPrep
Public Assessment Report (“PAR”), a publication of the
United Kingdom’s (“UK’s”) Medicine and Healthcare Prod-
ucts Regulatory Agency (“MHRA”). The PAR sets out the
MHRA’s grant of a marketing license for a specific medical
product, ChloraPrep, and includes approved packaging in-
formation for that product. In particular, the PAR de-
scribes the ChloraPrep composition as comprising 20
mg/ml of chlorhexidine gluconate “for disinfection of the
skin prior to invasive medical procedures,” and depicts an
applicator that a user squeezes to break an interior am-
poule of the solution for application. J.A. 1524. Notably,
the PAR includes required labeling stating that
“ChloraPrep with Tint is a sterile alcoholic antiseptic solu-
tion containing chlorhexidine gluconate and isopropyl alco-
hol in an applicator” and that the “applicator is sterile until
the packaging is opened.” J.A. 1529 (emphasis added).
The Board additionally looked to the British Standard
EN 556-1 (“BS EN-556-1”), which establishes the UK’s re-
quirements for labeling a medical device as being sterile.
J.A. 1951 (“Sterilization of medical devices – Requirements
for medical devices to be designated ‘STERILE’ – Part 1:
Requirements for terminally sterilized medical devices”).
BS EN-556-1 specifies that, in order to designate a termi-
nally sterilized device as “sterile,” the “probability of there
being a viable micro-organism on/in the device shall be
equal to or less than 1 × 10 -6.” J.A. 1958. BS EN-556-1
goes on to explain that the term “terminally sterilized” re-
fers to the “condition of a medical device which has been
exposed to a sterilization process in a packaged or
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SAGE PRODUCTS, LLC v. STEWART 5
assembled form that maintains the sterility of the medical
device or a defined portion thereof.” J.A. 1957.
Another prior art reference the Board relied on is U.S.
Patent Application Publication 2015/0190535, “Systems,
Methods, and Devices for Sterilizing Antiseptic Solutions”
(“Degala”). J.A. 1568. Degala discloses sterilizing antisep-
tic solutions by exposing them to a sterilizing temperature
from “about 85° C[] to about 135° C” for “from about 1 mi-
nute to about 19 hours.” J.A. 1568. Degala explains that
the European Union (“EU”), unlike the United States, re-
quires topical antiseptics to have some degree of steriliza-
tion, adding that one “known antiseptic solution containing
2% w/v chlorhexidine gluconate in 70% v/v isopropanol in
water, manufactured by CareFusion Corp., is sterilized for
EU countries using a known sterilization method” involv-
ing heat treatment. J.A. 1570 ¶ 2.
The final prior art reference pertinent to the issues be-
fore us is U.S. Patent Publication No. 2014/0371695, “Skin
Antiseptic Applicator and Methods of Making and Using
the Same” (“Chiang”). J.A. 3318. Chiang is “directed to
skin antiseptic composition applicators, particularly to
skin antiseptic composition applicators that include one or
more antimicrobial (e.g., antiseptic) materials in a single
use applicator.” J.A. 3330 ¶ 3. Chiang states:
[T]he ChloraPrep® applicator, provided by Care-
Fusion, has the active skin antiseptic composition,
containing chlorhexidine gluconate (CHG), stored
in a breakable glass ampule inside the applicator
device. In the ChloraPrep® applicator, the sealed
glass ampule protects the CHG composition during
the sterilization process from ethylene oxide pene-
tration which could otherwise compromise the effi-
cacy of the antiseptic composition.
J.A. 3330 ¶ 10. Sage’s expert, Dr. William Rutala, cited
Chiang as demonstrating the state of the art at the time of
the ’067 invention, including that, in his opinion, “the
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SAGE PRODUCTS, LLC v. STEWART 6
prevailing knowledge [was] that the [chlorhexidine glu-
conate] composition within ChloraPrep was not sterilized.”
J.A. 3802-03 ¶ 331 (emphasis added).
C
During the inter partes review (“IPR”) proceedings, BD
advanced three grounds for finding the challenged claims
of the ’642 patent and ’067 patent unpatentable: (1) the
claims are anticipated by the PAR; (2) the claims are obvi-
ous over the PAR, given the knowledge of a person of ordi-
nary skill in the art (“skilled artisan”); and (3) the claims
are obvious over the PAR in view of Degala. In instituting
the IPR and evaluating the petition, the Board construed
the term “sterilized” to mean “the component or composi-
tion has been subjected to a suitable sterilization process
such that sterility can be validated.” J.A. 6193. Then, in
its FWD, the Board found that a skilled artisan at the time
of the invention would have known, through education and
experience, that the term “sterile,” as used in the PAR in
the UK, is equivalent to the term “sterilized,” as used in
the United States and, particularly, in the Sage patents.
Reviewing the totality of the evidence before it, including
both parties’ experts’ reports and testimony, the Board de-
termined each of the challenged claims was unpatentable
on all three of the petition’s grounds.
Sage timely appealed. We have jurisdiction pursuant
to 28 U.S.C. § 1295(a)(4)(A).
II
“A claim is anticipated if each and every element as set
forth in the claim is found, either expressly or inherently,
in a single prior art reference.” Arbutus Biopharma Corp.
v. ModernaTX, Inc., 65 F.4th 656, 662 (Fed. Cir. 2023).
“Anticipation is a question of fact subject to substantial ev-
idence review.” IOENGINE, LLC v. Ingenico Inc., 100
F.4th 1395, 1402 (Fed. Cir. 2024) (cleaned up). “Substan-
tial evidence is such relevant evidence as a reasonable
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SAGE PRODUCTS, LLC v. STEWART 7
mind might accept as adequate to support a conclusion.”
Id. (internal quotation marks and citation omitted). “[T]he
possibility of drawing two inconsistent conclusions from
the evidence does not prevent an administrative agency’s
finding from being supported by substantial evidence.”
Consolo v. Fed. Mar. Comm’n, 383 U.S. 607, 620 (1966).
Moreover, we “defer to the Board’s findings concerning the
credibility of expert witnesses.” Incept LLC v. Palette Life
Scis., 77 F.4th 1366, 1377 (Fed. Cir. 2023).
“What the prior art discloses . . . [is a] fact question[]
that we review for substantial evidence.” Intel Corp.
v. PACT XPP Schweiz AG, 61 F.4th 1373, 1378 (Fed. Cir.
2023); see also PAR Pharm., Inc. v. TWI Pharms., Inc., 773
F.3d 1186, 1196-97 (Fed. Cir. 2014) (“What a reference
teaches and whether it teaches toward or away from the
claimed invention are questions of fact.”).
The Board’s finding regarding the level of skill in the
art a person of ordinary skill would possess is a question of
fact that we review for substantial evidence. See Best Med.
Int’l, Inc. v. Elekta Inc., 46 F.4th 1346, 1353 (Fed. Cir.
2022); see also Innovention Toys, LLC v. MGA Entertain-
ment, Inc., 637 F.3d 1314, 1324 (Fed. Cir. 2013).
We review the Board’s interpretation of “what has been
put before it” in a petition, and what arguments it presents
and does not present, for an abuse of discretion. See Core-
photonics, Ltd. v. Apple Inc., 84 F.4th 990, 1002-03 (Fed.
Cir. 2023); Henny Penny Corp. v. Frymaster LLC, 938 F.3d
1324, 1330 (Fed. Cir. 2019).
III
Resolution of this appeal requires us to decide three
principal issues: (1) whether substantial evidence supports
the Board’s finding that a skilled artisan would have un-
derstood the PAR to describe a “sterilized” composition and
“sterilized” product; (2) whether substantial evidence sup-
ports the Board’s additional findings that all elements of
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SAGE PRODUCTS, LLC v. STEWART 8
each of the challenged claims were also disclosed in the
PAR; and (3) whether the Board committed procedural er-
rors. As we explain below, Sage has not persuaded us there
is any reversible error on any of these points.
A
The PAR states that “ChloraPrep with Tint is a sterile
alcoholic antiseptic solution,” “[t]he sterile applicators are
individually packaged in an ethyl vinyl acetate film,” and
“the applicator is sterile unless seal is broken.” J.A. 1526,
1529 (emphasis added). Each of the challenged claims in
Sage’s patents requires a “sterilized chlorhexidine product”
or a “sterilized chlorhexidine article” comprising a “steri-
lized chlorhexidine gluconate composition” (emphasis
added). Sage argued to the Board, and reiterates to us,
that the PAR’s use of the term “sterile” stemmed from a
mistaken belief – widely shared in the pertinent commu-
nity of skilled artisans – that the antiseptic composition in
ChloraPrep was sterile when, in fact, it was not. The Board
took account of this contention and found that a skilled ar-
tisan would have understood the PAR’s references to “ster-
ile” meets the Board’s construction of “sterilized,” which is
“the article/component/composition recited as ‘sterilized’
has been subjected to a suitable sterilization process such
that sterility can be validated.” J.A. 12.3 Substantial evi-
dence supports the Board’s finding.
The Board identified the skilled artisan as “pos-
sess[ing] at least an undergraduate bachelor’s degree in
the pharmaceutical sciences, pharmacy, biochemistry, mi-
crobiology, or a related field, with at least four years of ex-
perience with sterilization processes for medical products
and their components, as well as familiarity with antisep-
tics such as chlorhexidine.” J.A. 17. Sage did not object to
3 Sage does not challenge the Board’s construction of
“sterilized.”
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SAGE PRODUCTS, LLC v. STEWART 9
the Board’s definition and did not offer its own description
of the qualifications of the skilled artisan. Sage’s expert,
Dr. Rutala, “agree[d] with this definition;” indeed, the
Board’s requirement of “at least four years of experience
with sterilization processes” was adopted by the Board on
the recommendation of Dr. Rutala. J.A. 6348; see also J.A.
16-17, 3468.
On appeal, Sage now insists that this definition was er-
roneous because it did not require the skilled artisan to be
familiar with the challenges involved in the sterilization of
chlorhexidine gluconate, and also because the Board read
into its definition a familiarity with UK regulations that
Sage asserts the skilled artisan would lack. These are chal-
lenges to the Board’s factual findings and they lack merit
– because the Board’s findings are supported by substan-
tial evidence.
Given the party’s positions, the Board confronted a fac-
tual dispute as to whether the skilled artisan would read
the PAR as disclosing “sterilized” products and composi-
tions, as that term is used in the Sage patents. To resolve
this dispute, the Board found it necessary not only to make
a finding as to the definition of the skilled artisan but also
to make additional findings as to the knowledge of such a
person. Specifically, the Board found that the skilled arti-
san – who had, as Sage’s expert opined, “at least four years
of experience” – would know about the differing regulatory
requirements in the United States and the UK. That
knowledge would include recognizing that the PAR, an
MHRA publication about a UK medical product, would
have to satisfy UK regulatory standards, including the BS
EN-556-1 standard, to be labeled “sterile.” J.A. 28-29 (find-
ing skilled artisan “would have understood the term ‘ster-
ile’ in a regulatory document to unequivocally disclose[] a
SAL [sterility assurance level] from 10 -3 to 10 -9”) (internal
quotation marks omitted); see also J.A. 1958 (BS EN-556-
1: “For a terminally-sterilized medical device to be desig-
nated ‘STERILE’, the theoretical probability of there being
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SAGE PRODUCTS, LLC v. STEWART 10
a viable micro-organism present on/in the device shall be
equal to or less than 1 × 10 -6.”).
The Board found “it implausible that someone with
four years of experience with sterilization processes for
medical products and their components would lack famili-
arity with the regulatory regimes that set the conditions
under which the products or processes they work with may
be used.” J.A. 42. Substantial evidence, including the tes-
timony of BD’s expert, Dr. Dabbah, supports this finding.
J.A. 1381-83, 1387. Dr. Dabbah explained that a skilled
artisan having the education and experience required by
the Board’s definition would know the differences between
the United States and UK regulatory standards for “ster-
ile” and would know, therefore, that the PAR’s references
to “sterile” items would satisfy the challenged claims’ re-
quirement for “sterilized” items. J.A. 1355.
Relatedly, the Board found that (i) even though BS EN-
556-1 does not expressly apply to “medical products” such
as ChloraPrep, but instead to medical devices, and it is a
voluntary “standard,” a skilled artisan would nonetheless
understand that a medical product like ChloraPrep would
comply with those standards in order to be labeled “sterile”
in the UK; and (ii) the same skilled artisan would not have
viewed sterilization of chlorhexidine gluconate at the per-
tinent time as being impossible or any more difficult than
“routine.”4 Substantial evidence, including the testimony
of BD’s expert, Dr. Dabbah, whom the Board repeatedly
credited over Dr. Rutala, see, e.g., J.A. 37-38, supports each
4 The Board acknowledged the “evidence identified
by Patent Owner regarding the challenges of developing
sterilized” chlorhexidine gluconate and observed that “[i]n
the absence of a disclosed method for sterilizing [chlorhex-
idine gluconate], these concerns might be persuasive. But
here, methods for sterilizing [chlorhexidine gluconate]
were known and disclosed in the Degala patent.” J.A. 65.
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SAGE PRODUCTS, LLC v. STEWART 11
of these findings. J.A. 1348, 1355, 1372-73, 1381-83.
Therefore, Sage’s contention that the Board allegedly erred
by requiring a skilled artisan to know UK regulatory re-
quirements while not needing to know the supposed chal-
lenges in sterilizing chlorhexidine products is meritless, as
it relies on rejection of the Board’s actual, supported find-
ings.
Contrary to Sage’s contentions, the Board did not “ig-
nore” or “disregard” evidence. Instead, the Board surveyed
all of the competing evidence – including, for example, the
history of mislabeling of the United States-version of
ChloraPrep as “sterile,” and found, as it is permitted to do,
that BD’s evidence outweighed Sage’s. See J.A. 38-43.
Additionally, since a skilled artisan would understand
“sterile,” as used in the PAR, to satisfy the “sterilized”
claim limitation of the challenged claims, the Board’s con-
clusion that the PAR teaches a sterilized chlorhexidine
product or article – that is, a sterilized chlorhexidine com-
position and an applicator – is also supported by substan-
tial evidence. As the Board noted, the PAR explicitly
discloses that the whole product “’is sterile until the pack-
aging is opened,’” indicating that the composition and ap-
plicator are both sterile. J.A. 25 (quoting J.A. 1529). The
Board cited as support for this finding the evidence we have
already identified above, including testimony from both
parties’ experts, as well as Chiang, which the Board found
“reflects the knowledge of” the skilled artisan that the
ChloraPrep product – the subject of the PAR – was known
to use a sealed glass container to protect the solution.
J.A. 25-27. This disclosure in Chiang , the Board found,
“reinforces” its finding that the ChloraPrep PAR discloses
sterilization of the entire ChloraPrep product. J.A. 26-27.
The Board cited substantial evidence for each of these de-
terminations.
Applying its definition of the skilled artisan, the Board
also evaluated, and rejected, Sage’s criticisms of BD’s
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SAGE PRODUCTS, LLC v. STEWART 12
expert, Dr. Dabbah. The Board found that Dr. Dabbah met
the education and experience requirements of its defini-
tion, qualifying him to opine from the perspective of such a
person. The Board also correctly observed that Sage did
not move to exclude Dr. Dabbah’s testimony. In the course
of its analysis, then, the Board was free to, and did, credit
Dr. Dabbah’s opinions and decide how much weight to give
them. See, e.g., J.A. 25, 29, 37. Sage has identified no re-
versible error.
B
While the bulk of the parties’ briefing relates to the is-
sues of “sterilization” and the knowledge of the skilled ar-
tisan, which we have addressed above, Sage also
challenges the Board’s findings regarding certain limita-
tions in the dependent claims. In particular, Sage contends
that the PAR does not disclose the “sterilized colorant” lim-
itation of the colorant claims and does not disclose the
“sterilized chlorhexidine article has a [SAL] of from 10 -3 to
10 -9” of the SAL claims. We conclude that the record con-
tains substantial evidence for the Board’s findings with re-
spect to these limitations.
With respect to the colorant claims, Sage observes that
the colorant described in the PAR is in a container distinct
from the glass ampoule of chlorhexidine gluconate, and ar-
gues that the PAR lacks any explicit disclosure that the
colorant container is itself sterilized. The Board disagreed,
relying instead on the testimony of Dr. Rutala and Dr. Dab-
bah to find that any inactive ingredients – including a col-
orant – would have to be sterilized in order for the PAR to
accurately describe the composition as sterile. The Board
also pointed to the PAR’s statement that “ChloraPrep with
Tint is a sterile alcoholic antiseptic solution.” J.A. 61-62
(citing J.A. 1526). Thus, substantial evidence supports the
Board’s conclusion that the dependent colorant claims are
anticipated by the PAR.
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SAGE PRODUCTS, LLC v. STEWART 13
Substantial evidence also supports the Board’s finding
that the PAR teaches that the sterilized chlorhexidine glu-
conate of ChloraPrep has a SAL falling within the range of
10 -3 to 10 -9, thereby meeting the SAL limitation. After the
Board determined that “sterile” as used in the PAR means
“sterilized” as construed in the challenged claims, the
Board evaluated Dr. Dabbah’s testimony that the applica-
ble regulatory standard (BS EN-556-1) requires a SAL of
10 -6 or less. Crediting Dr. Dabbah, the Board concluded
that the person of ordinary skill would have “understood
the product disclosed in the ChloraPrep PAR to have a ste-
rility assurance level” within the scope of the claims. J.A.
63. Thus, substantial evidence supports the Board’s con-
clusion that the dependent SAL claims are anticipated by
the PAR.5
5 Contrary to Sage’s suggestion, the Board’s refer-
ence to BS EN-556-1 is not improper in the context of ana-
lyzing whether the PAR anticipates Sage’s claims. Open.
Br. at 39 (“The Board’s anticipation analysis, based on ma-
terials outside of PAR, was flawed as a matter of law.”). An
anticipation analysis is undertaken from the perspective of
the person of ordinary skill in the art and, therefore, must
take account of the knowledge of such a person. See Ar-
throcare Corp. v. Smith & Nephew, Inc., 406 F.3d 1365,
1373-74 (Fed. Cir. 2005) (“[E]ven if a piece of prior art does
not expressly disclose a limitation, it anticipates if a person
of ordinary skill in the art would understand the prior art
to disclose the limitation and could combine the prior art
description with his own knowledge to make the claimed
invention.”). As we have already held, the Board had sub-
stantial evidence for its finding that a skilled artisan would
have known of UK regulatory standards for sterility, as
embodied in BS EN-556-1. Such a person would have car-
ried that knowledge with her when examining each of the
challenged claims.
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C
Sage additionally faults the Board for committing what
it contends are numerous procedural errors in its anticipa-
tion analysis. We do not agree.
Sage argues that the Board exceeded its proper role in
an IPR, which is limited to evaluating whether the grounds
asserted in a petition have been proven, and improperly
created its own grounds and supporting arguments that
BD never raised. “It is for the Board to determine what
grounds are being articulated in a petition and what argu-
ments and evidence are being referred to in the responses
and any replies.” Corephotonics, 84 F.4th at 1002. We find
no abuse of discretion in the Board’s reading of the petition
as contending that “sterile,” as used in the PAR, would be
understood by the skilled artisan to mean “sterilized” as
recited in the claims.
Much of what Sage complains about simply repeats, in
procedural garb, the same factual challenge we have al-
ready discussed relating the knowledge of the person of or-
dinary skill in the art. See supra III.A. As we have held,
the Board had substantial evidence for its finding that such
a person (as defined by the Board, without objection from
Sage) would understand “sterile” as used in the PAR to
teach the same thing as is meant by the “sterilization” lim-
itations of the challenged claims. This contention was al-
ways a component of BD’s theory that the PAR anticipates
Sage’s claims, as an anticipatory reference must disclose
all limitations of those claims. J.A. 6029-30, 6043-44.
Then, after Sage disputed this factual assertion in its pa-
tent owner response, see, e.g., J.A. 6354-55 (“Petitioner con-
flates the terms ‘sterile’ and ‘sterilized’ when assessing the
PAR’s disclosure.”); id. (“[A skilled artisan] would not have
understood the bare use of the word ‘sterile’ in a 2010 doc-
ument describing an antiseptic product – especially
ChloraPrep – to mean that it had been sterilized.”), BD, in
reply, responded with further argument and evidence
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SAGE PRODUCTS, LLC v. STEWART 15
directly responsive to Sage’s disagreements, see, e.g., J.A.
6434, 6436-37 (arguing that Sage “blurs two distinct prod-
ucts . . . the ChloraPrep UK product and the ChloraPrep
US product” and that “a [skilled artisan] would have
properly understood that the ChloraPrep UK product was
subject to different regulations than the US product”).
There was no abuse of discretion in the Board permitting
BD to do so. See Corephotonics, 84 F.4th at 1002.
All of this, as we have said, put before the Board the
question of how a skilled artisan would have understood
“sterile” as used in the PAR. To do so, the Board decided it
had to delve into not just the undisputed identification of
who is the pertinent skilled artisan, but also had to assess
what that skilled artisan would know. In the FWD, the
Board considered all the evidence and argument before it
and, necessarily and properly, resolved the factual dispute.
In doing so, the Board did not exceed its role, but rather
fulfilled it.
There was likewise nothing improper in the Board re-
lying on evidence outside of the PAR to make findings as to
what the skilled artisan would understand the PAR to be
disclosing. It is true, as Sage emphasizes, that the Board
considered the opinion of BD’s expert, Dr. Dabbah, in its
anticipation analysis. See, e.g., J.A. 37, 42. Our precedents
establish that expert opinion “may be used to interpret [an]
allegedly anticipating reference and to shed light on what
it would have meant to” a person having ordinary skill in
the art. Monsanto Tech. LLC v. E.I. DuPont de Nemours &
Co., 878 F.3d 1336, 1345 (Fed. Cir. 2018); see also Telemac
Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1328
(Fed. Cir. 2001) (“[R]ecourse to extrinsic evidence is proper
to determine whether a feature, while not explicitly dis-
cussed, is necessarily present in a reference.”).
Sage also argues that the Board erred by relying on
declarations from BD employees and confidential quality
assurance protocol documents about BD’s UK-marketed
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SAGE PRODUCTS, LLC v. STEWART 16
version of ChloraPrep. In the FWD, after laying out Dr.
Dabbah’s expert testimony as well as the teachings of
Degala, the Board added that “two of Petitioner’s employ-
ees confirm that the version of C[h]loraPrep product sold
in the U.K. had sterilized chlorhexidine gluconate.” J.A.
40. The employee-witnesses merely confirmed what Dr.
Dabbah had already made clear to the Board’s satisfaction:
that the regulatory standard, BS EN-556-1, applied to the
UK ChloraPrep product, and that this fact would have been
known to a skilled artisan. J.A. 29 (“We credit Dr. Dab-
bah’s testimony . . . and find that a [skilled artisan] would
have understood that the product described in the
ChloraPrep PAR was required to comply with applicable
standards, including BS EN-556-1.”). Hence, even if the
Board’s confirmatory reference to the non-prior-art confi-
dential employee declarations, including their incorpora-
tion of confidential quality assurance protocol information,
see, e.g., J.A. 2279, was error, it was harmless because it
did not prejudice Sage. See In re Chapman, 595 F.3d 1330,
1338 (Fed. Cir. 2010) (“The judicial review provision of the
APA includes a harmless error rule.”).
In sum, none of the supposed procedural errors Sage
accused the Board of committing provides a meritorious ba-
sis to reverse or vacate the Board decision.
IV
Sage raises numerous other arguments, only one of
which requires additional, brief comment. This is Sage’s
contention that the Board erred in its determination that
the PAR is enabled. We have held that enablement of an
anticipatory reference may be demonstrated by another
reference when that additional reference shows that the
claimed subject matter was in the public’s possession. See
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d
1368, 1379 (Fed. Cir. 2001). Here, the Board found that
the PAR was enabled by relying on: (i) Dr. Dabbah’s testi-
mony that a skilled artisan would be familiar with terminal
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SAGE PRODUCTS, LLC v. STEWART 17
sterilization procedures, (ii) Chiang’s teachings that
ChloraPrep was sterilized using ethylene oxide, (iii) Dr.
Rutala’s testimony discussing sterilization using ethylene
oxide gas, and (iv) Degala’s disclosure regarding known
methods to sterilize a chlorhexidine gluconate solution.
Contrary to Sage’s accusation, the Board did not consider
Degala to fill in gaps in the PAR but, instead, to assess the
state of the prior art at the time the patent application was
filed, which the Board is permitted to do. See, e.g., In re
Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Hence, once
again, we find no merit to Sage’s criticism.
V
We have considered the parties’ remaining arguments
relating to anticipation and find them unpersuasive. Our
disposition of this case solely on anticipation grounds ren-
ders it unnecessary to consider the Board’s obviousness de-
terminations. Hence, for the foregoing reasons, we affirm
the decision of the Board.
AFFIRMED
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