Incept LLC

Patent Trials and Appeals Board

Apr 13, 2021

IPR2020-00002 (P.T.A.B. Apr. 13, 2021)

Trials@uspto.gov Paper 62
571-272-7822 Entered: April 13, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

PALETTE LIFE SCIENCES, INC.,
Petitioner,
v.
INCEPT LLC,
Patent Owner.

IPR2020-00002
Patent 8,257,723 B2

Before ERICA A. FRANKLIN, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
FRANKLIN, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 318(a)

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I. INTRODUCTION
This is a Final Written Decision in an inter partes review of claims
1–24 (“the challenged claims”) of U.S. Patent No. 8,257,723 B2 (Ex. 1001,
“the ’723 patent”). We have jurisdiction under 35 U.S.C. § 6, and enter this
Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the
reasons set forth below, we determine that Palette Life Sciences, Inc.
(“Petitioner”) has shown, by a preponderance of the evidence, that the
challenged claims are unpatentable. See 35 U.S.C. § 316(e). Additionally,
we deny Petitioner’s Motion to Exclude Evidence.
A. Procedural History
Petitioner filed a Petition for an inter partes review of the challenged
claims under 35 U.S.C. § 311. Paper 2 (“Pet.”). Petitioner supported the
Petition with the Declaration of Adam Dicker, M.D., Ph.D. (Ex. 1003).
Incept LLC (“Patent Owner”) filed a Preliminary Response to the Petition.
Paper 7 (“Prelim. Resp.”).
On April 17, 2020, pursuant to 35 U.S.C. § 314(a), we instituted trial
to determine whether any challenged claim of the ’723 patent is unpatentable
based on the grounds raised in the Petition:
Claim(s) Challenged 35 U.S.C. §1 Reference(s)
1, 6, 8–12, 14, 15, 17–22 102(e) Wallace2
1–6, 8–12, 14–24 103(a) Wallace

1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125
Stat. 284 (Sept. 16, 2011), amended 35 U.S.C. §§ 102 and 103, effective
March 16, 2013. Because the application from which the ’723 patent issued
was filed before that date, the pre-AIA version of §§ 102 and 103 applies.
2 Wallace et al., US 6,624,245 B2, issued Sep. 23, 2003 (“Wallace,”
Ex. 1010).
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Claim(s) Challenged 35 U.S.C. §1 Reference(s)
7, 13 103(a) Wallace, Griffith-Cima3
1–12, 14–24 103(a) Ball,4 Carroll5
13 103(a) Ball, Carroll, Griffith-
Cima
Paper 8 (“Institution Decision” or “Inst. Dec.”).
Patent Owner filed a Corrected Patent Owner Response to the
Petition. Paper 24 (“PO Resp.”). Patent Owner supported the Response
with the Declarations of Timothy N. Showalter, M.D., M.P.H. (Ex. 2001),
Gary E. Wnek, Ph.D. (Ex. 2002), and Jessica Ray (Ex. 2026), as well as the
Supplemental Declaration of Dr. Showalter (Ex. 2027). Petitioner filed a
Reply to the Patent Owner Response. Paper 37 (“Pet. Reply”). Petitioner
supported the Reply with a Supplemental Declaration from Dr. Dicker (Ex.
1109), along with the Declarations of Zhiban Guan, Ph.D. (Ex. 1110) and
DeForest McDuff, Ph.D. (Ex. 1108). Patent Owner filed a Sur-Reply to
Petitioner’s Reply. Paper 47 (“PO Sur-Reply”). Petitioner filed a Motion to
Exclude Evidence. Paper 48 (“Mot.”). Patent Owner filed an Opposition to
the motion. Paper 50 (“Opp.”). Petitioner filed a Reply to Patent Owner’s
Opposition. Paper 51 (“Mot. Reply”).

3 Griffith-Cima et al., PCT Publication No. WO 94/25080, published Nov.
10, 1994 (“Griffith-Cima,” Ex. 1011).
4 Ball, A. B. S. et al., Silicone Implant to Prevent Visceral Damage During
Adjuvant Radiotherapy for Retroperitoneal Sarcoma, 63 BRITISH J.
RADIOLOGY 346–48 (1990) (“Ball,” Ex. 1012).
5 Carroll, US 6,375,634 B1, issued Apr. 23, 2002 (“Carroll,” Ex. 1013).
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On January 12, 2021, the parties presented arguments at an oral
hearing. Paper 49. The hearing transcript has been entered in the record.
Paper 56 (“Tr.”).6
B. Real Parties-in-Interest
Petitioner identifies itself and Pharmanest AB as real parties-in-
interest. Pet. 1. Petitioner also identifies Galderma S.A., Galderma
Laboratories, Inc., Galderma Laboratories LP, Galderma Research &
Development SNC, Nestlé Skin Health, Inc., Nestlé Skin Health S.A., Nestlé
S.A., EQT Partners AB, Public Sector Pension Investment Board (PSP
Investments), Luxinva, and Abu Dhabi Investment Authority as possible real
parties-in-interest. Id.
Patent Owner identifies Incept LLC and Boston Scientific Corporation
as real parties-in-interest. Paper 5, 1.
C. Related Proceedings
Petitioner filed a second petition for inter partes review of the ’723
patent (IPR2020-00003), for which we denied institution. Pet. 2. Petitioner
also filed petitions for inter partes review of related U.S. Patent No.
7,744,913 B2 in IPR2020-00004 (institution granted) and IPR2020-00005
(institution denied). Id.
Patent Owner states that it “is not presently aware of any proceedings
other than those cited in the Petition.” Paper 5, 1.

6 With Board authorization, Patent Owner filed a Notice of Corrections to
the hearing transcript. Paper 59.
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D. The ’723 Patent
The ’723 patent relates to a method of placing a degradable filler
between the radiation target tissue (e.g., the prostate) and other tissues (e.g.,
the rectum) to increase the distance between the target tissue and the other
tissues, so that the other tissues receive less radiation than the target tissue.
Ex. 1001, 2:28–32. The degradable filler is installed once before radiation
treatment and does not require subsequent manipulation, repositioning, or
removal. Id. at 2:31–35. Fillers are biodegradable by either hydrolysis,
proteolysis, the action of cells in the body, or by a combination of those
mechanisms. Id. at 4:66–5:1. The Specification explains, “[b]iodegradation
may be measured by palpitation or other observations to detect the change in
volume of a filler after its introduction into a patient.” Id. at 5:1–3.
Biodegradation may occur over the course of weeks or months after
introduction depending on the requirements for administering radiation
therapy. Id. at 5:4–16.
The ’723 patent describes a filler as “a substance that occupies a
volume after its introduction into a body.” Id. at 4:34–35. Filler materials
include alginate, collagen, gelatin, fibrin, fibrinogen, albumin, polyethylene
glycol, thixotropic polymers, and thermoreversible polymers. Id. at 4:35–
46. Biocompatible materials are preferred, especially collagen or hyaluronic
acid. Id. at 5:3–4. Fillers may also include osmotic agents and contain
drugs. Id. at 5:17–29. The filler may be injected through a needle into the
patient’s body. Id. at 10:51–53. After introduction into the body, the filler
may increase in volume and form a gel in situ through a variety of processes,
depending on the material. See id. at 5:30–56, 7:42–53. A filler solution
may have low viscosity when stored and higher viscosity after in situ self-
assembly in the patient. Id. at 5:48–50.
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The ’723 patent also describes a study that shows a method of
injecting collagen into Denonvillier’s space, i.e., the region located between
the rectum and the prostate, to displace the rectum away from the prostate
during radiation therapy. Id. at 3:15–26; 15:1–16:32 (Example 2). The
Specification explains that the combination of body temperature and pH
causes the collagen fibrils to cooperate to form a fibrin gel. Id. at 5:43–48.
In reporting the results of the study described in Example 2, the
Specification notes that “[t]he collagen degraded in less than about sixty
days and required no procedures after its initial introduction into the
patients.” Id. at 3:20–22. Patients receiving the collagen injections
“appeared to have minimal rectal side effects associated from their
radiotherapy.” Id. at 3:30–32.
E. Illustrative Claim
Of the challenged claims, claim 1, reproduced below, is the only
independent claim and is illustrative of the claimed subject matter.
1. A method of delivering a therapeutic dose of radiation
to a patient comprising
introducing a biocompatible, biodegradable filler between
an organ and a nearby tissue to increase a distance between the
organ and the tissue, and
treating the tissue with a therapeutic dose of radiation so
that the presence of the filler causes the organ to receive less of
the dose of radiation compared to the amount of the dose of
radiation the organ would receive in the absence of the filler,
wherein the filler is introduced as an injectable material
and is a gel in the patient, and wherein the filler is removable by
biodegradation in the patient.
Ex. 1001, 16:49–59 (spacing added).
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II. PATENTABILITY ANALYSIS
A. Principles of Law
To prevail in its challenges to the patentability of all claims of the
’723 patent, Petitioner must demonstrate by a preponderance of the evidence
that the claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R.
§ 42.1(d) (2019). “In an [inter partes review], the petitioner has the burden
from the onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid. Tech., Inc., 815 F.3d 1356, 1363
(Fed. Cir. 2016); see also 35 U.S.C. § 312(a)(3) (2012) (requiring inter
partes review petitions to identify “with particularity . . . the evidence that
supports the grounds for the challenge to each claim”). That burden of
persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l
Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015); see also In re
Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375–78 (Fed. Cir. 2016)
(discussing the burden of proof in inter partes review).
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628,
631 (Fed. Cir. 1987).
A claim is unpatentable for obviousness if, to one of ordinary skill in
the pertinent art, “the differences between the subject matter sought to be
patented and the prior art are such that the subject matter as a whole would
have been obvious at the time the invention was made.” 35 U.S.C. § 103(a)
(2006); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
The question of obviousness is resolved on the basis of underlying factual
determinations including the scope and content of the prior art, any
differences between the claimed subject matter and the prior art, the level of
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ordinary skill in the art, and objective evidence of nonobviousness. Graham
v. John Deere Co., 383 U.S. 1, 17–18 (1966). “An obviousness
determination requires finding both ‘that a skilled artisan would have been
motivated to combine the teachings of the prior art references to achieve the
claimed invention, and that the skilled artisan would have had a reasonable
expectation of success in doing so.’” CRFD Research, Inc. v. Matal, 876
F.3d 1330, 1340 (Fed. Cir. 2017) (quoting Intelligent Bio-Sys., Inc. v.
Illumina Cambridge Ltd., 821 F.3d 1359, 1367–1368 (Fed. Cir. 2016)).
We analyze Petitioner’s asserted grounds of unpatentability in
accordance with the above-stated principles.
B. Level of Ordinary Skill in the Art
We consider the asserted grounds of unpatentability in view of the
understanding of a person of ordinary skill in the art (“POSA”), and thus we
begin by addressing the level of ordinary skill in the art. The level of skill in
the art is a factual determination that provides a primary guarantee of
objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174
F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham, 383 U.S. at 17–18; Ryko
Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)).
Petitioner asserts that a POSA at the time of the invention would
include someone having a medical degree with practical, academic, or
industrial experience in radiation oncology, including knowledge of the side
effects of radiation treatment. Pet. 11–12 (citing Ex. 1003 ¶¶ 30–31).
Petitioner also asserts that a POSA at the time of the invention would have
experience in performing radiation treatments known at the time of the
invention, and methods of shielding or protecting normal tissue or organs
from harmful effects of such radiation treatments. Id. at 12. Petitioner’s
expert, Dr. Dicker explains that such experience “may come from the
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POSA’s own experience, or may come through research or work
collaborations with other individual(s) with experience in the medical or
biotechnology industry, e.g., as members of a research team or group.”
Ex. 1003 ¶ 30.
At the institution stage, we preliminarily adopted Petitioner’s
definition, with the clarification that the experience of the hypothetical
POSA also includes an understanding of polymer science via their own
research or collaborative work with a research team or group in the medical
or biotechnology industry. Inst. Dec. 6 (citing Ex. 1003 ¶ 30). We
explained that definition is consistent with the level of skill in the art at the
time of the invention as reflected by the prior art. Id. Patent Owner does not
challenge that definition. PO Resp. 1. Accordingly, for this Decision we
adopt the same definition, while also recognizing that this level of ordinary
skill in the art is reflected in the prior art of record. See Okajima v.
Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can
reflect appropriate level of ordinary skill in art).
We have reviewed the credentials of Petitioner’s declarant, Dr.
Dicker, and Patent Owner’s declarant Dr. Showalter, and consider each of
them to be qualified to provide their opinion on the level of skill and the
knowledge of a POSA at the time of the invention.7 As discussed in the our
Trial Practice Guide,
An expert witness must be qualified as an expert by knowledge,
skill, experience, training, or education to testify in the form of

7 Petitioner also submits the testimony of Dr. Guan and Patent Owner also
submits the testimony of Dr. Wnek, relating to their qualifications and
experience in polymer chemistry. See Exs. 1110, 2002. We consider both
of those declarants to be sufficiently qualified to render their testimony for
that matter.
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an opinion. Fed. R. Evid. 702. There is, however, no requirement
of a perfect match between the expert’s experience and the
relevant field. SEB S.A. v. Montgomery Ward & Co., 594 F.3d
1360, 1373 (Fed. Cir. 2010). A person may not need to be a
person of ordinary skill in the art in order to testify as an expert
under Rule 702, but rather must be “qualified in the pertinent
art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356,
1363–64 (Fed. Cir. 2008).

Patent Trial and Appeal Board Consolidated Trial Practice Guide November
2019 (“CTPG”) (available at https://www.uspto.gov/sites/default/files/
documents/tpgnov.pdf), 34.
Patent Owner challenges Petitioner’s expert, Dr. Dicker, by asserting
that he is not one of ordinary skill in the art. PO Resp. 3. Specifically,
Patent Owner asserts that “Petitioner’s expert makes no mention of research
or collaborative work in polymer science, neither in his testimony (Ex. 1003
¶¶ 2–12) nor in his CV (Ex. 1004).” Id. Thus, according to Patent Owner,
“Dr. Dicker’s conclusions regarding Wallace’s disclosure therefore lack
credibility and relevance to this proceeding, because they are not informed
by the perspective of the POSA, as defined by the Board.” Id.
Petitioner rebuts Patent Owner’s challenge of Dr. Dicker’s
qualifications in the Reply by asserting that “Dr. Dicker has a bachelor’s
degree in Chemistry and a Ph.D. in Molecular Pharmacology and
Therapeutics, where his research for both involved using polymer tools.”
Pet. Reply 7 (citing Ex. 1109 ¶ 17) (Dr. Dicker declaring that he completed
classes that included polymer chemistry topics and concepts for his
Bachelor’s degree in Chemistry). Petitioner and Dr. Dicker explain also that
his research has included cross-disciplinary projects working directly with
material and polymer scientists that involved the use of polymers . . . .” Id.
at 7; Ex. 1109 ¶¶ 18–19.
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Patent Owner did not address or challenge Dr. Dicker’s testimony
regarding his education and experience in polymer science in Patent
Owner’s Sur-Reply.8 Based on our consideration of Dr. Dicker’s education
and experience, we find that Petitioner has demonstrated, through properly
submitted rebuttal evidence, that Dr. Dicker has a sufficient understanding
of polymer science through his education and collaborative work with a
research team that qualify him to provide his opinions in this proceeding.
To the extent that Petitioner challenges Patent Owner’s expert,
Dr. Showalter, as lacking the foundation necessary to opine as a person of
ordinary skill in the art, we address that as part of the weight to be given his
testimony in our obviousness analysis. Pet. Reply 8–9. Insofar as
Petitioner’s challenge of Dr. Showalter may be viewed as an assertion that
he is not qualified to provide an opinion on the level of skill and the
knowledge of a person of ordinary skill in the art at the time of the
invention, we disagree. According to Petitioner, it is undisputed that Dr.
Showalter “lacked the requisite training to have gained an in-depth
knowledge of the field of radiation oncology until well after the ’723
patent’s critical date,” as he was only a second-year medical student at that

8 Petitioner properly submitted Dr. Dicker’s declaration in support of
Petitioner’s Reply as it provided testimony to rebut Patent Owner’s
challenge of Dr. Dicker’s qualifications as one of ordinary skill in the art.
As explained in our Trial Practice Guide, a party may submit rebuttal
evidence in support of its reply. See CTPG at 73 (citing Belden Inc. v. Berk-
Tek LLC, 805 F.3d 1064, 1077–78 (Fed. Cir. 2015)). Patent Owner had an
opportunity to cross-examine Dr. Dicker regarding that testimony and
comment on the declaration and cross-examination in its Sur-Reply, see id.,
but did neither, see Tr. 53:22–54:23 (Patent Owner’s counsel confirming
that it had an opportunity in its Sur-Reply to address Petitioner’s Reply
rebuttal arguments relating to Patent Owner’s challenge of Dr. Dicker’s
qualifications but did not do so).
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time. Id. at 8. However, as Petitioner acknowledges, Dr. Showalter relied
on his knowledge and training gained after 2002 to establish his knowledge
from the perspective of one having ordinary skill in the art. Id.
Petitioner does not challenge Dr. Showalter’s current level of
education and training as not satisfying the definition of a person of ordinary
skill in the art. Nor do we find any basis for doing so. Moreover, we find no
basis to conclude that a testifying expert must have himself or herself
possessed the requisite qualifications for a POSA as of the patent’s critical
date as opposed to obtaining such qualifications at some later point in time.
To hold otherwise would arbitrarily impose an age requirement for expert
witnesses testifying in patent cases. Thus, based on our consideration of
Dr. Showalter’s current education and training, we find that he is qualified to
provide his opinion regarding the level of skill and the knowledge of a
POSA at the time of the invention.
C. Claim Construction
Having defined the ordinarily skilled artisan, we now turn to claim
construction. Where, as here, a Petition is filed on or after November 13,
2018, the Board applies the same claim construction standard that would be
used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37
C.F.R. § 41.100(b) (2019).
Under that standard, claim terms “are generally given their ordinary
and customary meaning” as understood by a person of ordinary skill in the
art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303,
1312–13 (Fed. Cir. 2005) (en banc). “In determining the meaning of the
disputed claim limitation, we look principally to the intrinsic evidence of
record, examining the claim language itself, the written description, and the
prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic
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Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips,
415 F.3d at 1312–17). Extrinsic evidence is “less significant than the
intrinsic record in determining ‘the legally operative meaning of claim
language.’” Phillips, 415 F.3d at 1317.
Petitioner offers a proposed claim construction for the term “consists
essentially of collagen.” Pet. 14. The term appears in dependent claim 17,
which recites, in part, that the “biocompatible, biodegradable material
consists essentially of collagen.” Ex. 1001, 18:1–2. Petitioner asserts that
“[t]he transition phrase ‘consists essentially of’ ‘limits the scope of a claim
to the specified ingredients and those that do not materially affect the basic
and novel characteristic(s) of a composition.’” Pet. 14 (quoting In re Herz,
537 F.2d 549, 551–52 (CCPA 1976)). Therefore, according to Petitioner,
claim 17 “allows components other than collagen to be present so long as
they do not prevent collagen from being used as a biocompatible,
bioabsorbable filler.” Id.
In our Institution Decision, we found Petitioner’s construction to be
consistent with the Specification and case law. Inst. Dec. 8. We also noted
that the claim term “collagen” is used broadly by the Specification,
encompassing more than just naturally occurring collagen. Id. According to
the Specification, “collagen” may be “natural or synthetic,” “human origin
or non-human origin,” and “material[] intelligently designed to mimic
collagen or some of the structural or functional features of collagen.” Id.
(quoting Ex. 1001, 7:65–8:10) (alteration in original). Patent Owner has not
challenged our preliminary construction for the term “consists essentially of
collagen,” see generally PO Resp., nor do we see any reason to modify it
here. Accordingly, we maintain our construction for that term in this
Decision.
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Petitioner also offers a proposed claim construction for the term
“filler.” Pet. 13–14. Patent Owner does not challenge that proposed
construction or offer any of its own proposed constructions for any other
claim term. See generally PO Resp. Based upon our analysis of the
patentability challenges, we determine that it is unnecessary to expressly
construe the term “filler” or any other claim terms for purposes of rendering
this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355,
1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent
necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am.
Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
D. Anticipation by Wallace
Petitioner asserts that claims 1, 6, 8–12, 14, 15, and 17–22 are
anticipated by Wallace. Pet. 24–30; Pet. Reply 9–18. Patent Owner
disagrees. PO Resp. 6–34.
1. Wallace
Wallace relates to a method of forming a biocompatible gel at a
selected site within a patient’s body. Ex. 1010, Abstract. In particular,
Wallace relates to a “composition prepared by admixture of individually
reactive polymer components, wherein the admixture initiates rapid
crosslinking and gel formation.” Id. at 1:16–19. The gel may be formed
from an injectable reaction mixture, injected at a specific site within a
patient’s body, that crosslinks at the site of the injection. Id. at 10:8–12.
Wallace states that the gel can “be used as a large space-filling device for
organ displacement in a body cavity during surgical or radiation procedures,
for example, to protect the intestines during a planned course of radiation to
the pelvis.” Id. at 33:64–67.
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Wallace explains that the gel may be formed from a polymer
including biodegradable segments or blocks that are hydrolyzed in the
presence of water or enzymatically cleaved in situ. Id. at 19:3–19. Preferred
naturally occurring hydrophilic polymers include collagen, albumin, fibrin,
fibrinogen, carboxylated polysaccharides, and aminated polysaccharides,
such as hyaluronic acid. Id. at 19:59–65, 20:1–3. The gels may include
tensile strength enhancers, such as polyglycolide and polylactide fibers. Id.
at 24:21–23.
2. Analysis
a) Independent claim 1
Petitioner asserts that Wallace discloses each and every element of
claim 1. Pet. 24. In particular, Petitioner asserts that Wallace discloses a
method of using polymer gel compositions as a space-filling device to
displace organs, such as the intestines and pelvis, relative to one another in a
patient to increase the distance between such organs during radiation therapy
to, thereby, protect the intestines during radiation to the pelvis. Id. at 25–26.
Petitioner asserts also that Wallace discloses that the polymer gels are
biocompatible and biodegradable. Id. at 25 (citing Ex. 1010, Abstract, 1:14–
15, 3:43–49, 19:3–9, 19:9–19, 28:7–19; Ex. 1003 ¶ 121). According to
Petitioner, Wallace’s compositions are introduced as an injectable material
because Wallace discloses injecting its composition into a patient’s body.
Id. at 27 (citing Ex. 1010, 1:39–45, 2:5–9, 10:9–12; Ex. 1003 ¶ 125).
Additionally, Petitioner asserts that Wallace’s composition is a gel in the
patient because Wallace teaches that its compositions form into gels when
mixed. Id. (citing Ex. 1010, 1:14–15, 1:39–45, 2:5–9, 2:12–16, 2:26–32,
3:43–49, 19:3–19; Ex. 1003 ¶¶ 125–126).
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Petitioner reasons, because Wallace uses a biodegradable material, a
person having ordinary skill in the art “would have appreciated that the
compositions, when left in the patient’s body, would be removed by
biodegradation.” Id. at 27 (citing Ex. 1003 ¶ 126). Petitioner asserts that
Wallace “expressly discloses such an effect” by explaining that the
compositions have “biodegradable segments” that are “hydrolyzed in the
presence of water and/or enzymatically cleaved in situ.” Id. (quoting Ex.
1010, 19:3–9). Having considered the record as a whole, including the
teachings of the cited references, the testimony of the parties’ experts, and
the arguments by the parties, we determine that Petitioner has shown by a
preponderance of the evidence that Wallace discloses each limitation of
independent claim 1. We address each of those disclosures below, in
connection with Patent Owner’s arguments.
Wallace discloses a method for the rapid formation of a biocompatible
gel that may be carried out at a selected site within a patient’s body. Ex.
1010, Abstract. Wallace explains that its method involves admixing two
“biocompatible crosslinking component[s]” to form a gel in less than one
minute. Id. Wallace also refers to the biocompatible components as
“reactive components,” because they “rapidly react with each other to form a
crosslinked gel.” Id. at 2:15–17. Wallace describes the admixtures,
interchangeably, as a “biocompatible polymer compositions” and “reactive
polymer composition[s].” Id. at 1:15–16; 2:13–14. Wallace states that
“[t]he reactive compositions of the present invention can be used in a variety
of different applications.” Id. at 28:30–31. Wallace provides a “detailed
description of several specific applications” of its compositions. In
particular, as both parties have recognized, Wallace states that “[t]he
compositions can also be used as a large space-filling device for organ
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displacement in a body cavity during surgical or radiation procedures, for
example, to protect the intestines during a planned course of radiation to the
pelvis.” Id. at 33:64–67.
According to Patent Owner, a POSA would not have interpreted
Wallace’s disclosure that “[t]he compositions can also be used as a large
space-filling device for organ displacement in a body cavity” to refer to all
of its disclosed compositions. PO Resp. 6–8 (quoting Ex. 1010, 33:64–67).
Patent Owner asserts that a POSA would have instead understood Wallace’s
reference to “the compositions” that can be used as a space-filling device to
encompass fewer than all of Wallace’s disclosed compositions. Based on
those assertions, Patent Owner contends that a POSA would not have known
which subset of Wallace’s compositions could be used for such purpose. Id.
at 8–13. To support its contentions, Patent Owner attempts to demonstrate
that Wallace uses the term “the compositions” to describe “a wide range of
applications of its technology that demand entirely incompatible materials
properties,” such that the term must refer to some subset of the
compositions. Id. at 8–9.
As its first example, Patent Owner asserts that Wallace discloses that
“the compositions” may be used to promote adhesion of tissues to one
another and also to prevent adhesion of tissues to one another. Id. at 9
(citing Ex. 1010, 31:41–44; 32:59–33:7). According to Patent Owner and
Dr. Wnek, it would be “nonsensical to a POSA to have interpreted Wallace
as disclosing that all of Wallace’s compositions are able to both promote and
prevent adhesion, entirely opposite functions.” Id. (citing Ex. 2002 ¶ 16).
As its next example, Patent Owner asserts that Wallace teaches that
“the compositions” may be used to repair or replace certain body tissues,
ranging from synovial fluid and vitreous to bone. Id. at 9–10. According to
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Patent Owner and Dr. Wnek, a POSA “would not have understood Wallace
as teaching that the same polymeric compositions suitable for replacing
[synovial fluid and] the vitreous also would have been suitable for replacing
bone,” because their physical and mechanical properties are widely different.
Id. at 11.
In the Reply, Petitioner addresses Patent Owner’s argument by
asserting, among other things, that “Wallace gives clear guidance on how the
same composition can be used to both promote and prevent tissue adhesion
through different application methods.” Pet. Reply 12 (emphasis omitted).
To support that assertion, Petitioner refers to Wallace’s teaching to bring
tissues together before crosslinking has occurred to promote adhesion,
whereas preventing adhesion involves bringing tissues together after
crosslinking has reached equilibrium. Id. (citing Ex. 1010, 31:11–21;
32:58–33:8; Ex. 1110 ¶ 24) (emphasis added).
Similarly, Petitioner asserts that “Wallace provides straightforward
guidance as to how a given composition can be adapted according to the
type of tissue being repaired.” Id. To support that assertion, Petitioner
refers to Wallace’s teaching optimizing concentration of each crosslinkable
component and acknowledging ordinary skill in the art, along with Dr.
Guan’s comparison of Wallace’s disclosures of sealant compositions to that
of the ’723 patent. Id. (citing Ex. 1010, 27:30–33; 28:39–41; Ex. 1110 ¶¶
25, 28–29). Petitioner and Dr. Dicker note also that Wallace discloses the
same steps for introducing the gel compositions for tissue augmentation and
for use as a space-filling device. Id. (citing Ex. 1109 ¶¶ 34–35 (citing Ex.
1010, Abstract, 2:26–33, 19:3–19, 32:45–49, 33:64–67; Ex. 1110 ¶¶ 26–
27)).
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Based upon our review of the arguments and evidence, we determine
that the preponderance of the evidence supports Petitioner’s position that a
POSA would have understood Wallace’s disclosure that its compositions
may be used as a space-filling device applies generally to all its
compositions. When teaching that its compositions can be used as a large
space-filling device for organ displacement in a body cavity during radiation
procedures, Wallace does not limit that teaching to any “subset” of its
disclosed compositions. Ex. 1010, 33:64–67. We are not persuaded
otherwise by Patent Owner’s assertion that Wallace teaches that the
compositions may be used to promote or prevent adhesion to tissue, and to
repair or replace a range of body tissues. As noted above, Wallace expressly
states that it’s the “compositions of the present invention can be used in a
variety of different applications.” Id. at 28:30–31. Wallace provides a
“detailed description of several specific applications” of its compositions.
Wallace does not, however, separate or categorize the components used for
those compositions based on those applications. Rather, as Petitioner has
persuasively demonstrated, Wallace provides sufficient guidance on how the
same general compositions can be used or adapted for those seemingly
disparate applications. Pet. Reply 10–13. Indeed, we note that Patent
Owner has not addressed nor challenged Petitioner’s showing in that regard
in the Patent Owner’s Sur-Reply.
Next, Patent Owner asserts that, even if a POSA understood that
Wallace’s compositions are disclosed for use as a space-filling device,
Petitioner has not shown that any particular composition has all of the
claimed properties, i.e., one that is (a) biocompatible, (b) biodegradable, (c)
introduced as an injectable material, (d) a gel in the patient, and (e)
removable by biodegradation. PO Resp. 14–34.
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As for biocompatibility of the composition, Patent Owner
acknowledges that “Wallace repeatedly describes its compositions as
‘biocompatible.’” Id. at 14. Despite Wallace’s disclosure of the
compositions being biocompatible, Patent Owner asserts that “a POSA
would not have known whether any of them actually was biocompatible
without testing them.” Id. According to Patent Owner, Wallace’s reported
evidence regarding one of its compositions raises doubt about the
biocompatibility of that composition. Id. In particular, Patent Owner asserts
that Wallace’s crosslinking chemistry involves either thiol-based
nucleophilic substitution, which would require a pH significantly above
physiologic pH, or free radial addition, which would require the presence of
potentially toxic initiators, “either of which would expose the surrounding
tissue to substantial risk of damage.” Id. at 14–17 (citing Ex. 2002 ¶ 27).
Regarding elevated pH concerns with nucleophilic substitution, Patent
Owner draws support from two of its declarants, Drs. Wnek and Showalter.
Id. at 21–23. Patent Owner asserts that Drs. Wnek and Showalter “agree
that a POSA would have had substantial concern that a gel made according
to Wallace’s thiol crosslinking by nucleophilic substitution would not be
compatible due to tissue inflammation” caused by elevated pH. Id. at 22–23
(citing Ex. 2001 ¶¶ 24–25; Ex. 2002 ¶ 35). In particular, Dr. Wnek testifies
that “[t]he time that the elevated pH would persist is difficult to predict
because it depends on several factors, but there nonetheless is a substantial
risk that a 1-2 mL gel, as described in Wallace’s examples, could persist as a
pH reservoir for a week or more.” Ex. 2002 ¶ 34. According to Dr. Wnek,
materials for use in vivo “are invariably designed to have a pH of 7.4 (or
very close to 7.4) to avoid tissue reactions, unless there is a specific
therapeutic purpose to have some other pH that is sufficiently compelling to
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outweigh the risk of tissue damage a pH mismatch would be expected to
cause.” Id. ¶ 35.
Dr. Showalter testifies that a “POSA would have appreciated that
exposing the organs and tissues within the body to a composition having pH
lower or higher than pH 7.4 presents a substantial risk of injury from
chemical damage to the cells of the organs and tissues,” resulting in an
inflammatory response from the body’s immune system to repair the
damage. Ex. 2001 ¶ 24. According to Dr. Showalter, “[b]ecause of this risk
of tissue damage, products intended for placement inside the body are
designed to have a pH as close to 7.4 as possible, unless some medical
necessity dictates otherwise . . . .” Id. In Dr. Showalter’s opinion, “the use
of a device to reduce radiation dose to nearby organs during radiation
treatment does not present such medical necessity for a nonphysiologic pH.”
Id.
In the Reply, Petitioner relies on Dr. Dicker’s testimony to assert that
“treatment protocols often involve a risk-benefit analysis and the insertion of
a foreign body for treatment purposes will almost always induce some type
of inflammatory response.” Pet. Reply 14 (citing Ex. 1109 ¶¶ 39–40, 46).
According to Petitioner and Dr. Dicker, a radiation oncologist would have
known that risk and would have been “willing to tolerate such risk when
pursuing a protocol that would benefit patients in terms of their cancer
treatment.” Id. (citing Ex. 1109 ¶¶ 43–46). Dr. Dicker explains, “as with all
therapeutic compositions reviewed by the U.S. Food & Drug Administration
[(“FDA”)], the risks and benefits are taken into account when evaluating
therapeutic drugs for approval.” Ex. 1109 ¶ 40.
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For example, Dr. Dicker provides a list of FDA approved therapeutic
compositions that are administered either above or below a physiologic pH
of 7.4, including: furosemide injection (pH between 8.0–9.3); phenytoin
injection (adjusted to pH 12 with sodium hydroxide); DuraSeal (a two-
component mixture with one component dissolved in a pH 10 buffer and a
second component dissolved in a pH 4 buffer); and insulin glargine (pH 4).
Id. ¶ 41; see Pet. Reply 14.
Dr. Dicker further challenges Dr. Showalter’s opinion by noting that
Dr. Showalter admitted in his deposition that the SpaceOAR rectal tissue
spacer, a commercial product that Patent Owner purports to be covered by
the ’723 patent, is injected in a basic pH composition upon administration.
Ex. 1109 ¶ 41 (citing Ex. 1106, 94:16–95:1). Dr. Dicker also observes that
“[n]either Dr. Showalter nor Dr. Wnek point to any experiments or
disclosure in their declaration that support a long-term harm if the pH is
higher or lower than pH 7.4.” Id. ¶ 42 (citing Ex. 1110 ¶ 30) (Dr. Guan’s
testimony that he disagrees that an elevated pH would discourage a polymer
chemist from employing Wallace’s polymers and noting that “Dr. Wnek
points to no experiments or disclosure in his declaration that support a long-
term harm if a basic formulation is used in the body.”)).
In Dr. Dicker’s opinion, Dr. Showalter’s testimony that a POSA
would have been discouraged from using Wallace’s polymer compositions
based on pH alone is not credible based on FDA approved products having a
pH above or below 7.4, as set forth above, and Dr. Wnek’s deposition
testimony that a polymer chemist would not be able to conclude that a
composition introduced as an injectable material is not biocompatible based
solely on the fact that is has a pH of 8.5. Id. (citing Ex. 1111, 35:15–36:2).
Further, Petitioner and Dr. Dicker explain that “[i]t was understood
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homeostasis within the body was achieved fairly quickly, even with
compositions requiring basic pH conditions.” Pet. Reply 16 (citing Ex. 1109
¶ 44).
Based upon our review of the arguments and evidence, we find that
the preponderance of the evidence supports Petitioner’s position that a
POSA would not have doubted the biocompatibility of Wallace’s polymer
compositions based on an elevated pH required for nucleophilic substitution.
To begin, as Patent Owner acknowledges, PO Resp. 14, Wallace expressly
discloses that its compositions are biocompatible. See, e.g., Ex. 1010, Title
(“Rapid-Gelling Biocompatible Polymer Composition and Associated
Methods of Preparation and Use.”), 1:15–16 (“This invention relates
generally to biocompatible polymer compositions that rapidly crosslink to
form a gel.”). Moreover, Wallace discloses use of the same polymeric
materials, including hyaluronic acid and collagen, that the ’723 patent
identifies as “biocompatible.” Compare Ex. 1001, 5:3–4 (“Biocompatible
materials are preferred, especially collagen or hyaluronic acid”) with Ex.
1010, 19:59–65, 20:1–3 (identifying hyaluronic acid and collagen among
preferred polymers).
Patent Owner has not persuasively demonstrated otherwise based
upon the testimony of Drs. Wnek and Showalter that a skilled artisan would
have had “substantial concern that a gel made according to Wallace’s thiol
crosslinking by nucleophilic substitution would not be compatible due to
tissue inflammation” caused by elevated pH. PO Resp. 21–23 (citing Ex.
2001 ¶¶ 24–25; Ex. 2002 ¶ 35). We do not assign persuasive weight to their
testimony because, as Drs. Dicker and Guan have observed, “[n]either Dr.
Showalter nor Dr. Wnek point to any experiments or disclosure in their
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declaration that support a long-term harm if the pH is higher or lower than
pH 7.4.” Ex. 1109 ¶ 42 (citing Ex. 1110 ¶ 30).
At most, we find that Patent Owner, through the testimony of Drs.
Wnek and Showalter, has established that introducing Wallace’s polymer
composition in vivo may result in an inflammatory response to a temporarily
elevated pH,9 and that such risk of tissue inflammation is analyzed in the
context of the potential benefit to a patient for whom treatment with the
composition is being considered. That showing does not contradict
Wallace’s disclosure or demonstrate that Wallace’s compositions are not
biocompatible. As Petitioner persuasively argues, “treatment protocols often
involve a risk-benefit analysis and the insertion of a foreign body for
treatment purposes will almost always induce some type of inflammatory
response.” Pet. Reply 14 (citing Ex. 1109 ¶¶ 39–40, 46).
The risk potential of a treatment alone does not dictate its
biocompatibility. Indeed, as Dr. Dicker credibly demonstrates, a number of
FDA-approved treatments involve similar risks related to variations in pH.
On the other hand, we have a somewhat bare assertion from Dr. Showalter
that, in his opinion, “the use of a device to reduce radiation dose to nearby
organs during radiation treatment does not present such medical necessity
for a nonphysiologic pH.” Ex. 2001 ¶ 24. Dr. Showalter reaches that
conclusion after discussing “a substantial concern of tissue damage” based
on exposing tissue to an elevated pH, “especially if the composition were to
remain in contact with the tissue for any length of time.” Id. However, to
the extent that Dr. Showalter conducted any risk-benefit analysis to reach his

9 See Ex. 2002 ¶ 34 (Dr. Wnek testifying that the duration of pH reservoir is
difficult to predict, but Wallace’s exemplary gels would likely persist for a
week or more.).
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conclusion that the risk posed by an elevated pH outweighed the benefit
provided by the composition in radiation patients, we do not assign
persuasive weight to his conclusion. As Dr. Dicker noted, Dr. Showalter’s
testimony that a POSA would not have viewed Wallace’s compositions as
biocompatible based on an elevated pH is undermined by the deposition
testimony of Dr. Wnek that even a polymer chemist would not be able to
conclude that a composition introduced as an injectable material is not
biocompatible based solely on the fact that is has a pH of 8.5, i.e., an
elevated pH. Ex. 1109 ¶ 42 (citing Ex. 1111, 35:15–36:2).
Accordingly, based on the preponderance of the evidence, we find that
a person of ordinary skill in the art would have not have doubted the
biocompatibility or otherwise been discouraged from employing Wallace’s
polymer compositions based on an elevated pH required for nucleophilic
substitution for the reasons discussed by Petitioner and Drs. Dicker and
Guan.10
Patent Owner also relies on the testimony of Drs. Showalter and
Wnek to assert that the radical initiators required for crosslinking by free
radical addition and identified by Wallace, i.e., organic peroxides and azo
compounds, cleave or decompose into toxic chemicals that “should not be
introduced into a patient without a very clear medical necessity for their
specific presence, which is not the case for the fillers of the challenged
claims.” PO Resp. 23–24 (citing Ex. 2001 ¶¶ 26–29; Ex. 2002 ¶ 37).
In the Reply, Petitioner notes that “the ’723 patent encompasses fillers
that ‘are crosslinked by a radical reaction upon contact with a radical

10 We note that Patent Owner has not responded to Petitioner’s arguments or
evidence relating to the biocompatibility of Wallace’s compositions in
Patent Owner’s Sur-Reply. See PO Sur-Reply.
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initiator,’” and refers to prior art disclosures of in situ formation of free-
radical polymerizable and UV-light irradiated hydrogels. Pet. Reply 17
(citing Ex. 1001, 9:37–54; Ex. 1110 ¶¶ 41–42). Petitioner and Dr. Guan
note that those reactions described in the prior art cited in the ’723 patent
“are similar to those described in Wallace and were well-recognized
chemical reactions that were capable of producing a biocompatible product.”
Id. (citing Ex. 1110 ¶ 43; Ex. 1109 ¶¶ 52–53).
Based on our consideration of the evidence and arguments, we find
Dr. Guan’s testimony that Wallace’s use of free-radical initiated and UV-
irradiation for hydrogel polymerization is a “well-recognized and accepted
chemical reaction, and depending upon the monomers chosen is able to
produce a biocompatible product,” Ex. 1110 ¶ 43, to be credible and
persuasive. As Petitioner and Dr. Guan demonstrate, at the time of the
invention, preparing free-radical cross-linked polymers was known to be a
suitable technique that was even employed in the ’723 patent. Id. ¶¶ 41–42;
Pet. Reply 17.
Patent Owner asserts also that “Petitioner does not explain how
Wallace provides any meaningful guidance to the reader about how to pick
and choose particular pairs of component cores, molecular weights, reactive
groups, linkers, and other ingredients to achieve compositions having the
claimed properties of gelation, injectability, and removability by
degradation.” PO Resp. 33.
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In the Reply, Petitioner asserts that “the type of compositions taught
by Wallace are expressly contemplated as “suitable fillers” by the ’723
patent through its incorporation of Rhee.”11 Pet. Reply 15 (citing Ex. 1001,
4:49–53; Ex. 1109 ¶¶ 49–50; Ex. 1110 ¶ 35). Petitioner asserts that “[t]he
compositions disclosed by Rhee greatly overlap with those discussed in
Wallace.” Id. at 10–11 (citing Ex. 1110 ¶¶ 35–40). According to Petitioner,
“Rhee provides just as many, if not more, options,” as Wallace, so that as
Patent Owner considered Rhee’s disclosure is enabling, it must recognize
that Wallace is also. Id. at 17–18 (citing In re Paulsen, 30 F.3d 1475, 1481
n.9 (Fed. Cir. 1994) (noting specification would not be enabling if held to
the same standard urged for the reference); Ex. 1110 ¶ 19. Patent Owner has
not responded to these assertions by Petitioner in its Patent Owner’s Sur-
Reply. See PO Sur-Reply.
Having considered the record, as a whole, we disagree with Patent
Owner’s assertion that “the range of compositions within the ambit of
Wallace’s disclosure is so vast that a POSA could neither have at once
envisaged all of them nor have known what properties any particular one of
them would have.” PO Resp. 31 (quotation marks omitted). That assertion
by Patent Owner is based on its argument that Wallace does not exemplify
biocompatible compositions. See id. at 27. However, as explained in the
preceding discussion, we do not find persuasive support for that position in
view of Wallace’s express teaching to the contrary and upon weighing the
testimony of the parties’ experts.

11 Rhee et al., US Patent No. 5,874,500, issued Feb. 23, 1999 (“Rhee,” Ex.
1136).
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We have also found Wallace’s biocompatible filler compositions to be
biodegradable, and removable by biodegradation as Wallace teaches that the
compositions include “biodegradable segments” that are “hydrolyzed in the
presence of water and/or enzymatically cleaved in situ.” Ex. 1010, 19:3–9.
We have additionally found that Wallace teaches that its compositions may
be introduced as an injectable material, id. at 1:39–45, 2:5–9, 10:9–12, and
form a gel in the patient, id. at, 1:14–15, 1:39–45, 2:5–9, 2:12–16, 2:26–32,
3:43–49, 19:3–19. Wallace’s disclosure of various options for each
component of its composition does not change those characteristics of its
filler composition that are recited by claim 1.
Accordingly, having considered the record as a whole, we find that
Petitioner has shown by a preponderance of the evidence that independent
claim 1 of the ’723 patent is anticipated by Wallace.
b) Dependent claims 6, 8–12, 14–15, 17–22
Petitioner has also identified the disclosures in Wallace that teach
each of the specific components of the filler composition set forth in
dependent claims 6, 8–12, 14, 15, and 17–22. See Pet. 27–30. Patent Owner
does not raise any additional arguments challenging Petitioner’s showing for
those claims.12 Thus, for the same reasons stated above in relation to
independent claim 1, from which claims 6, 8–12, 14, 15, and 17–22 depend,
along with Petitioner’s arguments and evidence set forth those dependent
claims, we find that Petitioner has shown by a preponderance of the

12 Patent Owner refers to dependent claim 16 in its Patent Owner Response
argument relating to Petitioner’s anticipation challenge, however, claim 16 is
not challenged in the anticipation ground. See PO Resp. 32. Thus, we do
not address that claim here.
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evidence that dependent claims 6, 8–12, 14, 15, and 17–22 of the ’723 patent
are anticipated by Wallace.
E. Obviousness over Wallace
Petitioner asserts that claims 1–6, 8–12, and 14–24 are unpatentable
over Wallace. Pet. 30–37; Pet. Reply 18, 22–28. Patent Owner disagrees.
PO Resp. 34–50; PO Sur-Reply 1–12.
1. Wallace
We incorporate here our discussion of Wallace set forth above in
Section II.D.
2. Analysis
a) Independent claim 1
For its obviousness ground over Wallace alone, Petitioner refers to its
anticipation ground based upon Wallace and asserts that, “to the extent
Wallace does not explicitly disclose the use of a gel that is both
biocompatible and biodegradable, Wallace renders use of such a gel
obvious.” Pet. 30. Petitioner and Dr. Dicker rely upon Wallace’s teachings
that (a) the polymers used in its compositions are “essentially nondegradable
over a period of at least several months,” and (b) the linking groups used to
form the composition may promote or discourage hydrolysis, or provide a
site for enzymatic degradation. Id. at 30–31 (citing Ex. 1003 ¶¶ 143–157).
According to Petitioner and Dr. Dicker, those teachings would have given a
person having ordinary skill in the art at the time of the invention “[a] reason
to use, and a reasonable expectation of success in using, a gel, like those
taught by Wallace, which was both biocompatible and biodegradable to
displace an organ for radiation therapy.” Id. at 31 (citing Ex. 1003 ¶ 152).
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In particular, Petitioner asserts that a person of ordinary skill in the art
would have been aware that biocompatible filler devices were commonly
used to displace organs during radiation therapy. Id. (citing Ex. 1003
¶¶ 144–147, 153–154). Petitioner asserts also that a person of ordinary skill
would have understood that non-biodegradable fillers “would need to be
removed from the patient subsequent to therapy so that the displaced organ
could return to its original position.” Id. at 31–32 (citing Ex. 1003 ¶ 151).
Petitioner asserts that the skilled artisan would have known that if a
biodegradable filler was used instead, it could be left in the patient’s body
and absorbed over a set period of time, thus obviating the need to surgically
remove the filler after radiation therapy concludes. Id. (citing Ex. 1003 ¶
151). Further, Petitioner asserts that a person of ordinary skill in the art at
the time would have had a reasonable expectation of success in using a
biocompatible, biodegradable gel to displace an organ during radiation
therapy “because Wallace expressly taught gel compositions that may be
successfully configured to be both biocompatible and biodegradable and that
may be successfully used as a tissue-displacement device.” Id. at 32 (citing
Ex. 1003 ¶¶ 150–157).
Patent Owner refers to its arguments raised regarding the anticipation
ground and asserts that they “apply equally to the single-reference
obviousness challenge.” PO Resp. 34. According to Patent Owner,
“Petitioner does not show that the POSA would have had the ability to
design such a filler based on Wallace and the knowledge in the art,” and
“Dr. Wnek explains why the POSA would not have been able to do so.” Id.
We have considered Patent Owner’s arguments and evidence. We do
not find that Dr. Wnek’s testimony is entitled to persuasive weight, as
discussed in the anticipation ground. Rather, because we have credited the
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testimony of Drs. Dicker and Guan over the testimony of Drs. Showalter and
Wnek, and found that Petitioner has shown persuasively that a person of
ordinary skill in the art would have understood that Wallace teaches the
biocompatibility and biodegradability of its compositions, as discussed in
the anticipation ground, and because we have found that Wallace also
teaches the use of its compositions to displace an organ for radiation therapy,
we determine that a preponderance of the evidence supports Petitioner’s
position that Wallace teaches each limitation of claim 1 and would have
motivated a person of ordinary skill in the art to use Wallace’s compositions
for the disclosed purpose of displacing an organ for radiation therapy, as
recited in claim 1, with a reasonable expectation of success.
Even if Wallace were to be viewed as not teaching each claim
limitation, we agree with Petitioner that, based on the current record and
persuasive testimony of Drs. Dicker and Guan, Wallace would have
suggested to a person of ordinary skill in the art to select and prepare a
biocompatible, biodegradable polymer gel, according to its disclosure, for
use as a filler between an organ and nearby tissue during radiation therapy to
minimize the dose of radiation received by the nearby tissue, with a
reasonable expectation of success. Wallace refers to its compositions as
being “biocompatible” throughout the disclosure. See generally Ex. 1010.
Additionally, Wallace describes using its compositions as a space-filling
device for organ displacement in radiation procedures to protect nearby
tissue from exposure to such radiation. Id. at 33:64–67. Wallace dedicates
much of the Specification to the topic of forming polymer compositions to
achieve certain biological characteristics, including degradation and
biodegradability. See, e.g., id. at 3:30–40, 7:25–29, 16:22–23, 44–64, 19:3–
19, 20:46–47. Indeed, as we mentioned above, Wallace’s teaching that all
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suitable polymers disclosed are “essentially nondegradable in vivo over a
period of at least several months,” id. at 7:25–29, teaches, or at least
suggests, that those polymers are essentially degradable in the body over a
period of more than at least several months.
Accordingly, having considered the record as a whole, we find that
Petitioner has shown by a preponderance of the evidence that independent
claim 1 of the ’723 patent is obvious over Wallace.
b) Dependent claims 2–6, 8–12, 14–24
Petitioner has also demonstrated how Wallace teaches or suggests
each additional limitation of dependent claims 2–6, 8–12, and 14–24. See
Pet. 32–36. Patent Owner does not raise any additional arguments
challenging Petitioner’s showing for those claims in this ground. Thus, for
the same reasons stated above in relation to independent claim 1, from which
claims 2–6, 8–12, and 14–24 depend, along with Petitioner’s arguments and
evidence set forth for those dependent claims, we find that Petitioner has
shown by a preponderance of the evidence that the limitations of dependent
claims 2–6, 8–12, and 14–24 of the ’723 patent are taught or suggested by
Wallace, and that a person of ordinary skill in the art would have motivated
with a reasonable expectation of success to prepare the combinations in the
manner recited by each of the challenged dependent claims.
We continue our analysis below with a discussion of Patent Owner’s
asserted secondary considerations of nonobviousness for claim 1.
c) Secondary Considerations
Regarding independent claim 1 of the ’723 patent, Patent Owner
asserts that the commercial success of the claimed invention demonstrates its
nonobviousness. PO Resp. 37. Patent Owner explains that real party-in-
interest Boston Scientific Corporation markets an implantable synthetic
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hydrogel, SpaceOAR®. Id. According to Patent Owner, “[t]he FDA-cleared
SpaceOAR procedure practices claim 1 of the ’723 patent and has enjoyed
major success since its introduction, approximately doubling its case volume
year after year until, by 2019, it was used in over half of the prostate
radiation therapies in the U.S.” Id. Patent Owner sets forth in a claim chart
a comparison of challenged claim 1 to the SpaceOAR procedure. Id. at 38.
Patent Owner asserts that the FDA cleared SpaceOAR hydrogel for
marketing in April 2015. Id. at 44.
Patent Owner and its declarant, Jessica Ray, set forth the following
table as evidence of the SpaceOAR’s commercial success:

Id. at 44; Ex. 2026 ¶ 22. The table above has two columns: the left column
is labeled “Year” and includes 5 rows indicating years 2015–2019; the right
column in the table is labeled “SpaceOAR hydrogel units, U.S.” and
includes figures for each corresponding year listed in the left column. PO
Resp. 44; Ex. 2026 ¶ 22. Patent Owner asserts that “[t]he sales data was
obtained from its custodian, Boston Scientific Corporation Senior
Accountant, Jessica Ray, who describes how the data is stored and was
retrieved from the company’s business records.” PO Resp. 45 (citing Ex.
2026 ¶¶ 1–21; Ex. 2027 ¶ 42). Ms. Ray introduces the table in her
declaration by stating, “[i]n summary, my review of Boston Scientific
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Corporation’s business records of the number of SpaceOAR hydrogel units
indicates the following annual unit shipments to external customers (i.e.,
physicians and hospitals) in the United States.” Ex. 2026 ¶ 22. Patent
Owner asserts that “Dr. Showalter has been a provider of SpaceOAR
hydrogel placement since June 2016 and therefore has personal knowledge
and experience that corroborates the numbers reported in [Ms. Ray’s
declaration].” PO Resp. 45 (citing Ex. 2001 ¶ 44).
Relying on the testimony of Dr. Showalter, and data from the table for
year 2019, Patent Owner asserts that “about 55% of all prostate cancer
radiation therapy treatments that year are estimated to have included Space
OAR placement.” Id. (citing Ex. 2027 ¶ 43). Dr. Showalter reaches that
placement percentage estimate by first referring to an estimated 174,650 new
cases of prostate cancer in the United States in 2019. Ex. 2027 ¶ 43. From
there, Dr. Showalter refers to reporting that 545 of 1,653 men underwent
radiotherapy during a trial in the United Kingdom. Id. (citing Ex. 2020,
147)13. According to Dr. Showalter, the rate of radiation therapy is about the
same in the United States. Id. Based on that opinion, Dr. Showalter testifies
that roughly one third of prostate cancer cases are treated with radiation in
the United States. Id. He explains that because one third of the estimated
174,650 new cases of prostate cancer in the United States is 58,217, that is
the number of patients in the United States who received radiation therapy in
2019. Id. Therefore, according to Dr. Showalter, based on the 32,099
SpaceOAR cases in 2019, about 55% of all prostate cancer radiation therapy
treatments that year are estimated to have included SpaceOAR placement.

13 Gay et al., Radiation Therapy for Prostate Cancer, 115 (2) J. MISSOURI
MED. 146–150 (2018) (Ex. 2020).
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Id. Patent Owner asserts that Dr. Showalter “attributes this enormous
growth and success of SpaceOAR hydrogel to the substantial improvements
to speed, safety, and efficacy that SpaceOAR hydrogel provides in prostate
cancer radiation therapy.” PO Resp. 46–47 (citing Ex. 2001 ¶ 47).
Petitioner asserts, among other things, that Patent Owner’s evidence
does not demonstrate SpaceOAR’s commercial success. Pet. Reply 22. In
particular, Petitioner asserts that Patent Owner’s evidence is insufficient
because it does not include information such as a detailed analysis of the
SpaceOAR sales. Id. at 22–23.14 Additionally, Petitioner asserts also that
Dr. Showalter’s estimate that the SpaceOAR enjoys 55% market-penetration
is unreliable because he “relies on flawed inputs and incorrect assumptions”
because: (a) his “conclusions regarding the percent of prostate cancer cases
receiving radiation treatment . . . are based on a relatively small, randomized
sample size of men in the U.K. treated over ten years ago,” (b) his
“assumptions regarding market penetration are based on newly diagnosed
cases in 2019 . . . rather than the entire pool of patients who could receive
radiotherapy in a given year, resulting in Dr. Showalter overstating
SpaceOAR’s market penetration,” and (c) he failed to compare SpaceOAR
to the several competing radiotherapy spacer options available on the
market. Id. at 24–25.
Having considered the arguments and evidence presented by the
parties, we agree with Petitioner that Patent Owner has not met its burden of
production for its assertion of commercial success. Pet. Reply 22 (citing

14 Petitioner asserts also that Patent Owner’s nexus analysis is insufficient.
Pet. Reply 25. Although that argument appears to have merit, we do not
reach the issue of nexus, as we determine that Patent Owner has not
provided sufficient evidence that the SpaceOAR was a commercial success.
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ZUP, LLC v. Nash Manufacturing, Inc., 896 F.3d 1365, 1373 (Fed. Cir.
2018). In particular, we find Patent Owner’s evidence is insufficient.
Commercial success is “usually shown by significant sales in a relevant
market.” J.T. Eaton & Co. v. Atlantic Paste & Glue Co., 106 F.3d 1563,
1571 (Fed. Cir. 1997).
Patent Owner bases its alleged commercial success on units shipped
and not sales data. In the Patent Owner Response, Patent Owner asserts that
SpaceOAR has achieved commercial success because “its case volume in the
U.S. has roughly doubled year-on-year through 2019.” PO Resp. 44
(emphasis added). In support of that assertion, Patent Owner sets forth the
table prepared by its declarant, Ms. Ray, and states that “[t]he sales data was
obtained from its custodian . . . Jessica Ray.” Id. at 45 (citing Ex. 2026 ¶ 22)
(emphasis added). Ms. Ray, however, does not describe the data in the table
as “sales” data. Nor does she use the term “case volume.” Rather, Ms. Ray
specifically states that her summary table entries for the number of
SpaceOAR hydrogel units indicate “annual unit shipments.” Ex. 2026 ¶ 22.
Ms. Ray’s explains that units shipped include “regular sales, replacement
units, and free sample units.” Id. ¶ 7.
For years 2015, 2016, and 2017, Ms. Ray discusses in her declaration
what portion of the total units for each year represent regular sales,
replacement units and free samples, but then combines them to provide the
total units shipment data for each of those years in her summary table. Id.
¶¶ 10–15.15 For years 2018 and 2019, she explains that the software used to
access the units shipped did not distinguish regular sales, replacement units

15 Among other issues with Ms. Ray’s reported data, we note that the report
generated for shipment and sales data for years 2015–2017 was based on a
yearly search without identifying when shipments or sales began in 2015.
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and sample units. Id. ¶¶ 16, 19. Thus, the record does not specify the
regular sales portion of the total units reported for each of those years. In
any event, for the three years that sales data was available for SpaceOAR,
Patent Owner does not relay or rely on such data in its Patent Owner
Response or in its Sur-Reply. See PO Resp. 37–50; PO Sur-Reply 1–12.
Rather, Patent Owner refers only to the data reflecting the total units shipped
annually during 2015–2019, when it asserts that SpaceOAR’s “case volume
in the U.S. has roughly doubled year-on-year through 2019” as evidence of
commercial success. PO Resp. 44.
Patent Owner has not shown how the units of product shipped, alone,
demonstrates commercial success based on sales. Based upon our review,
we find the shipment data, without more, is insufficient to draw that
conclusion. As noted above, the number of units shipped relied upon by Ms.
Ray include products that were given away as samples or replacements, and
the record does not demonstrate whether the year-over-year increase in units
shipped is attributable to increased sales as opposed to an increase in
samples and replacements that were shipped. Moreover, even if Patent
Owner’s evidence demonstrated “consistent doubling of U.S. sales year after
year, from about 1,000 units in 2015 to over 32,000 units in 2019,” PO Sur-
Reply 2, neither Ms. Ray nor Dr. Showalter have explained how those sales
exhibit a commercial success in the context of the market as a whole.
Accordingly, we do not find that the evidence of product shipment submitted

See, e.g., Ex. 2026 ¶¶10–11. Thus, even in terms of shipments increasing
between 2015 and 2016, we are unaware whether that comparison involves
twelve months of shipments in 2015. When questioned about the 2015 data
at the hearing, Patent Owner’s counsel responded by stating, “I’m pretty
certain it’s not a full year of sales. But I believe it’s about a half year of
sales.” Tr. 35:7–11.
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demonstrates commercial success of claim 1 so as to support a finding of
nonobviousness.
Insofar as Patent Owner seeks to establish commercial success by
asserting that “about 55% of all prostate cancer radiation therapy treatments
that year are estimated to have included SpaceOAR placement,” PO Resp.
46 (citing Ex. 2027 ¶ 43), we find that the evidence relied upon for that
assertion is not sufficiently supported. To begin, that assertion relies, in
part, on Dr. Showalter’s estimate of “new cases” of prostate cancer in the
United States in 2019. Ex. 2027 ¶ 43. He has not explained why he limits
his analysis to only new cases in that year, as opposed to all existing cases at
that time. Id. Next, Dr. Showalter inexplicably relies on data from a United
Kingdom radiotherapy trial to provide a rate of radiation therapy cases in the
United States. Id. (citing Ex. 2020, 147).
Further, the referenced United Kingdom trial did not purport to
include all new or existing radiotherapy patients in the United Kingdom for
a given year, but rather, it merely involved a number of “recruited” men
from a specific age category for its study. See Ex. 2020, 147 (“The trial
recruited 1643 men 50 to 69 years old.”). Yet, Dr. Showalter relied on that
number of recruited men and the subset of those men who were randomly
administered radiotherapy in that trial to support his opinion that “[r]oughly
one third of prostate cancer cases are treated with radiation.” Ex. 2027 ¶ 43
(citing Ex. 2020, 147).
As additional support, Dr. Showalter relies on his own experience
“based on percentage of cases referred to [him] by urologist[s],” that roughly
one third of prostate cancer patients in the United States undergo radiation
therapy. Id. Finally, Dr. Showalter relies on Ms. Ray’s data for the number
of SpaceOAR units shipped as his evidence of the number of SpaceOAR
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placement or treatments in patients for that year. Neither Patent Owner nor
Dr. Showalter point to any evidence in the record that the units shipped is
equivalent to the units actually administered (or sold) in a given year.
Indeed, Ms. Ray’s testimony suggests that those figures are not equivalent at
least based on the fact that the units shipped includes replacement units. See
Ex. 2026 ¶ 7.
Based on at least the foregoing deficiencies, we do not find Dr.
Showalter’s testimony that about 55% of all prostate cancer radiation
therapy treatments in 2019 included SpaceOAR placement to be credible, as
his calculations are insufficiently supported by the evidence. Accordingly,
we do not find that Dr. Showalter’s testimony in that regard demonstrates
commercial success of the SpaceOAR product that would be sufficient to
support a finding of nonobviousness.
d) Conclusion as to Obviousness
We base our final determination regarding obviousness upon an
analysis of the foregoing arguments and evidence. We have considered each
of the Graham factors and determine that Petitioner has met its overall
burden of proving obviousness based on this challenge. As part of that
analysis, we have considered the asserted secondary considerations of
nonobviousness and, as explained above, Patent Owner has not met its
burden of production regarding commercial success. Accordingly, based
upon the preponderance of the evidence, we conclude that claims 1–6, 8–12,
and 14–24 of the ’723 patent are unpatentable as obvious over Wallace.
F. Obviousness over Wallace and Griffith-Cima
Petitioner asserts that claims 7 and 13 are unpatentable as obvious
over Wallace and Griffith-Cima. Pet. 37–38; Pet. Reply 18, 22–28. Patent
Owner disagrees. PO Resp. 34–50; PO Sur-Reply 1–12.
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We incorporate here our discussion of Wallace set forth above in
Section II.C.
1. Griffith-Cima
Griffith-Cima relates to slowly polymerizing, biocompatible,
biodegradable hydrogels that promote engraftment and provide three
dimensional templates for new cell growth. Ex. 1011, 9:32–37. Griffith-
Cima teaches a method of suspending cells in a hydrogel solution and
injecting the solution directly into a site in a patient, where the hydrogel
hardens into a matrix with cells dispersed in it. Id. at 10:3–7. Ultimately,
the hydrogel degrades, leaving only the resulting tissue. Id. at 10:12–13.
Griffith-Cima teaches that hydrogel materials include polysaccharides such
as alginate. Id. at 15:27–34.
2. Analysis
Claims 7 and 13 depend from claim 1. Claim 7 recites that the filler
comprises alginate. Ex. 1001, 17:4–5. Claim 13 recites that the filler
comprises a thermoreversible polymer. Id. at 17:16–17. Regarding claim 7,
Petitioner asserts that Wallace discloses that the compositions may include a
carboxylated polysaccharide and that an ordinary artisan would have
understood alginate to be a carboxylated polysaccharide that was known to
form a hydrogel in situ, as taught by Griffith-Cima. Pet. 37 (citing Ex. 1010,
19:59–67; Ex. 1011, 11:28–12:8; Ex. 1003 ¶ 184). Moreover, Petitioner
asserts that “[A]pplicant cited to Griffith-Cima to overcome an enablement
rejection as evidence that alginate was known to form a hydrogel prior to the
time of invention,” during prosecution of the parent application to the ’723
patent. Id. (citing Ex. 1006, 199, 254). According to Petitioner, a person of
ordinary skill in the art would have, thus, “appreciated the similarities
between alginate and the materials disclosed in Wallace,” and therefore
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“found the use of alginate in the gel compositions of Wallace to be well-
known, well-understood, and predictable.” Id. at 38 (citing Ex. 1003 ¶¶
183–184).
Regarding claim 13, Petitioner asserts that Wallace teaches that the
gel compositions may include synthetic hydrophilic polymers, including
poly(ethylene oxide)-poly(propylene oxide) copolymers and block polymers.
Pet. 38 (citing Ex. 1010, 8:26–30; Ex. 1003 ¶¶ 185–188). Petitioner notes
that during prosecution, Applicant cited Pluronics as an example of a block
copolymer based on ethylene oxide and propylene oxide that is a well-
known thermoreversible polymer that can form a gel. Id. (citing Ex. 1006,
256, 273). Petitioner asserts that Griffith-Cima teaches the use of Pluronics
to form a biocompatible hydrogel that may be crosslinked by temperature.
Id. (citing Ex. 1011, 15:20–34). Thus, Petitioner asserts that a person of
ordinary skill in the art would have found the use of thermoreversible
polymers in the gel compositions to be well known, well understood, and
predictable. Id. (citing Ex. 1003 ¶¶181–182).
Regarding this ground, Patent Owner asserts only that “claims 7 and
13 should be confirmed as patentable over Wallace and Griffith-Cima,”
apparently for the same reasons Patent Owner raised for Petitioner’s
challenge based on Wallace alone. PO Resp. 36.
Thus, for the same reasons set forth in our analysis for the ground
based on Wallace alone, along with Petitioner’s arguments and evidence set
forth for dependent claims 7 and 13, we find that Petitioner has shown by a
preponderance of the evidence that the limitations of those dependent claims
are taught or suggested by Wallace and Griffith-Cima, and that a person of
ordinary skill in the art would have motivated with a reasonable expectation
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of success to combine alginate in the filler, as required by claim 7, or to
combine a thermoreversible polymer in the filler, as required by claim 13.
Patent Owner does not raise any secondary considerations regarding
the methods recited by claims 7 and 13. Accordingly, based on the
foregoing, we determine that Petitioner has shown by a preponderance of the
evidence that claims 7 and 13 are rendered obvious by the combined
teachings of Wallace and Griffith-Cima.
G. Remaining Grounds of Obviousness
In the remaining grounds of obviousness, Petitioner asserts: (1) claims
1–12 and 14–24 are unpatentable as obvious over Ball and Carroll, Pet. 38–
51; Pet. Reply 18–28; and (2) claim 13 is unpatentable as obvious over Ball,
Carroll, and Griffith-Cima, Pet. 51–52. Patent Owner disagrees. PO Resp.
37–54; PO Sur-Reply 1–13. Because Petitioner challenges the same claims
in these grounds that we conclude are unpatentable based upon anticipation
and obviousness grounds involving Wallace, we decline to reach these
remaining grounds. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359
(2018) (holding a petitioner “is entitled to a final written decision addressing
all of the claims it has challenged” (emphasis added)); Boston Sci. Scimed,
Inc. v. Cook Grp. Inc., Nos. 2019-1594, -1604, -1605, 2020 WL 2071962, at
*4 (Fed. Cir. Apr. 30, 2020) (non-precedential) (recognizing that the “Board
need not address issues that are not necessary to the resolution of the
proceeding” and, thus, agreeing that the Board has “discretion to decline to
decide additional instituted grounds once the petitioner has prevailed on all
its challenged claims”).
III. PETITIONER’S MOTION TO EXCLUDE
Petitioner moves to exclude Exhibits 2001, 2002, 2026, and 2027.
Mot. 1; Mot. Reply 1. Patent Owner opposes the motion. Opp. 1. As the
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moving party, Petitioner has the burden of proof to establish that it is entitled
to the requested relief. 37 C.F.R. § 42.20(c).
Petitioner asserts that Exhibits 2001, 2002, 2026, and 2027 should be
excluded in their entirety under Federal Rules of Evidence (“FRE”) 401 and
402 as irrelevant evidence, FRE 403 as prejudicial, confusing, a waste of
time, duplicative or other reasons, and for failing to comply with FRE 702,
703, and 705 relating to testimony and opinions of an expert witness. Mot.
1. The challenged exhibits are the declarations of Patent Owner’s experts.
Exhibit 2001 is the declaration of Dr. Showalter, Exhibit 2002 is the
declaration of Dr. Wnek, Exhibit 2026 is the declaration of Ms. Ray, and
Exhibit 2027 is the supplemental declaration of Dr. Showalter.
Generally, Petitioner’s objections implicate the weight and sufficiency
of the testimony of these declarants, rather than their admissibility. We are
in a position to discern whether such testimony should be entitled to weight,
either as a whole or with regard to specific issues. And, as set forth in our
analysis of patentability, we have done just that. Accordingly, we deny the
Motion to Exclude Exhibits 2001, 2002, 2026, and 2027.
IV. CONCLUSIONS
For the foregoing reasons, we conclude that Petitioner has shown by a
preponderance of the evidence that claims 1, 6, 8–12, 14, 15, and 17–22 of
the ’723 patent are unpatentable as anticipated by Wallace; claims 1–6, 8–
12, and 14–24 are unpatentable as obvious over Wallace; and claims 7 and
13 are unpatentable as obvious over Wallace in combination with Griffith-
Cima.16 Additionally, we deny Petitioner’s Motion to Exclude.

16 Should Patent Owner wish to pursue amendment of the challenged
claims in a reissue or reexamination proceeding subsequent to the
issuance of this decision, we draw Patent Owner’s attention to the April
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In summary:

2019 Notice Regarding Options for Amendments by Patent Owner
Through Reissue or Reexamination During a Pending AIA Trial
Proceeding. See 84 Fed. Reg. 16,654 (Apr. 22, 2019). If Patent Owner
chooses to file a reissue application or a request for reexamination of
the challenged patent, we remind Patent Owner of its continuing
obligation to notify the Board of any such related matters in updated
mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
17 As discussed in Section II.G. above, we do not reach the grounds based
upon Ball and Carroll, as we have determined that those claims are
unpatentable based on the Wallace grounds set forth in this table.
Claims 35 U.S.C. § References
Claims
Shown
Unpatentable17
Claims
Not shown
Unpatentable
1, 6, 8–12,
14, 15, 17–22
102(e) Wallace 1, 6, 8–12,
14, 15, 17–22

1–6, 8–12,
14–24
103(a) Wallace 1–6, 8–12,
14–24

7, 13 103(a) Wallace,
Griffith-
Cima
7, 13
1–12, 14–24 103(a) Ball, Carroll
13 103(a) Ball, Carroll,
Griffith-
Cima

Overall
Outcome
1–24
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V. ORDER
Accordingly, it is hereby:
ORDERED that based on a preponderance of the evidence, claims 1–
24 of the ’723 patent are unpatentable;
FURTHER ORDERED Petitioner’s Motion to Exclude is denied; and
FURTHER ORDERED because this is a final written decision, the
parties to this proceeding seeking judicial review of our Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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For PETITIONER:
Jeffrey Guise
Lora Green
Richard Torczon
Lorelei Westin
Kristin Havranek
Tasha Thomas
Tung-On Kong
WILSON SONSINI GOODRICH & ROSATI
jguise@wsgr.com
lgreen@wsgr.com
rtorczon@wsgr.com
lwestin@wsgr.com
khavranek@wsgr.com
tthomas@wsgr.com
tkong@wsgr.com

For PATENT OWNER:
Peter Chen
Jennifer L. Robbins
COVINGTON & BURLING LLP
pchen@cov.com
jrobbins@cov.com