LifeNet Health

Patent Trials and Appeals Board

Aug 4, 2020

IPR2019-00573 (P.T.A.B. Aug. 4, 2020)

Trials@uspto.gov Paper 74
571-272-7822 Date: August 4, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

RTI SURGICAL, INC.,
Petitioner,
v.
LIFENET HEALTH,
Patent Owner.

IPR2019-00573
Patent 9,585,986 B2

Before GEORGE R. HOSKINS, TIMOTHY J. GOODSON, and
CHRISTOPHER C. KENNEDY, Administrative Patent Judges.
GOODSON, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining Some Challenged Claims Unpatentable
Denying Petitioner’s Motion to Exclude
Dismissing Patent Owner’s Motion to Exclude
35 U.S.C. § 318(a)

I. INTRODUCTION
A. Background and Summary
Petitioner RTI Surgical, Inc., filed a Petition (Paper 2, “Pet.”)
requesting inter partes review of claims 1–27 of U.S. Patent No.
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9,585,986 B2 (Ex. 1003, “the ’986 patent”). Patent Owner LifeNet Health
filed a Preliminary Response. Paper 9. The record of the preliminary
proceeding also included a Reply from Petitioner and a Sur-Reply from
Patent Owner. See Papers 16, 19. We instituted an inter partes review on
all claims and all grounds asserted in the Petition. See Paper 20 (“Dec. on
Inst.”).
After institution of trial, Patent Owner filed a Patent Owner Response.
Paper 33 (“PO Resp.”).1 Petitioner filed a Reply. Paper 43 (“Pet. Reply”).
Patent Owner filed a Sur-Reply. Paper 55 (“Sur-Reply”).2 We held a
hearing on May 11, 2020, a transcript of which is included in the record.
See Paper 73 (“Tr.”).
We have authority under 35 U.S.C. § 6. Petitioner bears the burden of
proving unpatentability of the challenged claims, and the burden of
persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l
Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner
must prove unpatentability by a preponderance of the evidence. See
35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is
issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
For the reasons discussed below, we determine that Petitioner has
shown by a preponderance of the evidence that claims 1–6, 9–20, 23, and 24
of the ’986 patent are unpatentable, but Petitioner has not shown by a
preponderance of the evidence that claims 7, 8, 21, 22, and 25–27 are
unpatentable.

1 A public, redacted version of the Patent Owner Response was filed as
Paper 32.
2 A public, redacted version of the Sur-Reply was filed as Paper 56.
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B. Real Parties in Interest
The parties list only themselves as real parties in interest. See Pet. 3;
Paper 3, 2.
C. Related Matters
Patent Owner asserted the ’986 patent against Petitioner in LifeNet
Health v. RTI Surgical, Inc., No. 3:18-cv-817 (M.D. Fla.), filed June 25,
2018. See Pet. 3–4. That case was transferred to another judicial district and
is now captioned as LifeNet Health v. RTI Surgical, Inc., No. 1:18-cv-00146-
MW-GRJ (N.D. Fla.). See Paper 3, 1.
We also note that a related patent, U.S. Patent No. 6,569,200 (“the
’200 patent”), was asserted in LifeNet Health v. LifeCell Corp., No. 2:13-cv-
486 (E.D. Va.) (“LifeCell Litigation”). In that case, after a two-week trial, a
jury found that the accused products infringed and that the defendant failed
to establish the invalidity of the asserted claims, and awarded approximately
$35 million in damages. The district court denied the defendant’s post-trial
motions, and the Federal Circuit affirmed. See LifeNet Health v. LifeCell
Corp., 837 F.3d 1316, 1321 (Fed. Cir. 2016) (Ex. 2002, 6).
Patent Owner lists two Board proceedings as related: IPR2019-00571,
which challenges the ’200 patent, and IPR2019-00572, which challenges
U.S. Patent No. 9,579,420 B2 (Ex. 1002, “the ’420 patent”). See Paper 3, 1.
D. The ’986 Patent
The ’986 patent relates to plasticized tissue grafts. E.g., Ex. 1003,
code (54). The ’986 patent discloses that “[s]oft tissue products are typically
provided as fresh-frozen or freeze-dried,” but that “freeze-drying causes
grafts to be brittle and typically causes shrinkage where the shrinkage is
often not uniform, thereby causing graft failure.” Id. at 3:46–51, 3:57–61.
The ’986 patent further discloses that “solvent preservation . . . can cause
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irreversible denaturation of proteins, and solubilization of solvent soluble
components, including for example, lipids.” Id. at 3:60–63. According to
the ’986 patent, typical methods of preparing tissue grafts necessitate a
rehydration step for implantation. Id. at 3:63–66.
The ’986 patent discloses the use of a plasticizer, such as glycerol, in
the preparation of tissue grafts. See id. at code (57), 5:33–35. The
plasticizer “replaces water in the molecular structure of the bone or soft
tissue matrix.” Id. at code (57). The patent purports to solve problems in
the prior art “by providing a plasticized dehydrated bone and/or soft tissue
product that exhibits materials properties that approximate those properties
present in normal hydrated tissue, is not brittle and does not necessitate
rehydration prior to implantation.” Id. at 5:45–49. Consequently, “the
dehydrated bone or soft tissue plasticized product can be placed directly into
an implant site without significant preparation in the operating room.” Id. at
code (57).
E. Illustrative Claim
Claim 1, reproduced below, is illustrative of the challenged claims:
1. A plasticized soft tissue graft suitable for transplantation into a
human, comprising:
a cleaned soft tissue graft having an internal matrix; and
one or more plasticizers contained in said internal matrix, said
one or more plasticizers not being removed from said internal
matrix prior to packaging,
wherein said plasticized soft tissue graft does not require
refrigeration or freezing for storage,
wherein the plasticized soft tissue graft has mechanical
properties approximating mechanical properties of natural soft
tissue.
Ex. 1003, 24:38–48.
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F. Prior Art References and Testimonial Evidence
Petitioner relies on three references for its challenges:
Reference Patent or Publication No. Date Exhibit
Livesey US 5,336,616 Aug. 9, 1994 1004
Walker WO 98/07452 Feb. 26, 1998 1005
Werner US 4,357,274 Nov. 2, 1982 1006
The parties have also provided witness testimony. The table below
lists the witnesses, their roles in this proceeding, and the exhibits in which
their testimony is presented:
Witness Role Exhibits
David
McQuillan,
Ph.D.
Petitioner’s
technical expert3
Ex. 1034 (declaration of Jan. 28, 2019);
Ex. 2015 (transcript of deposition of
Oct. 8, 2019);
Ex. 1045 (declaration of Feb. 11, 2020);
Ex. 1059 (declaration of Mar. 10, 2020).
David L.
Kaplan,
Ph.D.
Patent Owner’s
technical expert4
Ex. 1018 (declaration of June 24, 2014);
Ex. 2016 (declaration of Nov. 11, 2019);5
Ex. 1057 (declaration of Dec. 4, 2019);
Ex. 1046 (transcript of deposition of Jan.
10, 2020).

3 See Ex. 1034 ¶ 1 (“I have been retained as an expert witness to offer
technical opinions on behalf of RTI Surgical, Inc. . . . .”).
4 See Ex. 2016 ¶ 1 (“I have been retained as an expert witness on behalf of
Patent Owner . . . .”); id. ¶ 11 (“Based upon my education, experience, and
qualifications, I consider myself to be an expert in the fields of biomaterials,
biopolymers, tissue engineering, and regenerative medicine, including the
processing and use of bone and soft-tissue for transplantation into
humans.”).
5 A redacted public version of this declaration is in Exhibit 2136.
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Witness Role Exhibits
Arun
Sharma
Patent Owner’s
commercial
success expert6
Ex. 2125 (declaration of Nov. 12, 2019);7
Ex. 1044 (declaration of Dec. 6, 2019);
Ex. 1056 (transcript of deposition of Jan.
24, 2020).
G. Asserted Grounds
Petitioner asserts that claims 1–27 are unpatentable on the following
grounds:
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
11, 12 102(b) Walker
1–3, 5, 9, 11–15, 23–258 103(a) Walker
1–6, 9–20, 23, 24 102(b) Livesey
1–6, 9–20, 23, 24 103(a) Livesey
1–10, 13–25, 27 103(a) Walker and Livesey
26 103(a) Walker, Livesey and Werner
See Pet. 5.
II. MOTIONS TO EXCLUDE
A. Petitioner’s Motion to Exclude
Petitioner moves to exclude several documents from the LifeCell
Litigation, as well as the testimony of Patent Owner’s experts based on those
documents. See Paper 63. Specifically, Petitioner moves to exclude Exhibit

6 See Ex. 2125 ¶ 5 (“I have been retained by counsel for LifeNet to evaluate
whether soft tissue grafts with RTU features made possible by the
challenged claims have been commercially successful.”).
7 A redacted public version of this declaration is in Exhibit 2137.
8 As we pointed out in the Decision on Institution, claim 5 is not listed in the
“Identification of Challenge” or the relevant section heading of the Petition,
but it is addressed in the Petition’s argument for this ground. See Dec. on
Inst. 5 n.2; Pet. 5, 30, 34–35. Thus, we understand this ground to include
claim 5.
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2049, which is a lengthy excerpt of the trial transcript from the LifeCell
Litigation, and Exhibits 2053, 2056–2062, 2065, and 2069, which are
documents from the LifeCell Litigation relating to product sales information
or market analysis. Id. at 3–6. Petitioner argues that both the transcript and
documents are inadmissible hearsay under Federal Rule of Evidence 802,
and that the documents are inadmissible under Federal Rule of Evidence 901
for lack of authentication. Id. at 3–8. Petitioner further argues that
Exhibits 2016 and 2125, setting forth Patent Owner’s experts’ testimony
relying on the transcript and documents from the LifeCell Litigation,
“simply add[] another level of inadmissible hearsay” and that Patent Owner
has not shown that experts would reasonably rely on documents like these in
forming opinions. Id. at 9–11; Paper 69, 4–5.
Patent Owner opposes the motion, arguing that experts in Dr.
Kaplan’s and Mr. Sharma’s fields would reasonably rely on sworn testimony
and admitted trial exhibits relating to product information, sales and revenue
data, and internal business planning documents in forming opinions
regarding the secondary considerations topics on which they testify. See
Paper 65, 4–6. Patent Owner further argues that Federal Rule of Evidence
703 allows admission of facts or data underlying an expert’s opinion even if
they would otherwise be inadmissible, and that the transcript and documents
from the LifeCell Litigation should be admitted so that the Board can fully
consider the opinions of Dr. Kaplan and Mr. Sharma. Id. at 7–8.
Federal Rule of Evidence 703 provides that an expert may base an
opinion on facts or data that is not admissible “[i]f experts in the particular
field would reasonably rely on those kinds of facts or data in forming an
opinion on the subject.” Fed. R. Evid. 703. We are persuaded by Patent
Owner’s argument that experts in Dr. Kaplan’s and Mr. Sharma’s fields
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would reasonably rely on the kinds of facts and data in the LifeCell
Litigation transcript and documents in forming opinions on the subjects on
which they testify. See Paper 65, 6. Further, Rule 703 provides that “if the
facts or data would otherwise be inadmissible, the proponent of the opinion
may disclose them to the jury only if their probative value in helping the jury
evaluate the opinion substantially outweighs their prejudicial effect.” Fed.
R. Evid. 703. The Board has repeatedly applied Rule 703 to deny motions to
exclude materials underlying expert opinions, reasoning that the benefit to
the Board of assessing the underlying support for the expert testimony
outweighs any prejudicial effect. See, e.g., Argentum Pharms. LLC v.
Research Corp. Techs., Inc., IPR2016-00204, Paper 85, 48 (PTAB Mar. 22,
2017) (“[T]he probative value of reviewing the documents substantially
assisted our evaluation of Patent Owner’s contentions regarding
skepticism.”); LG Chem, Ltd. v. Celgard, LLC, IPR2014-00692, Paper 76,
44–45 (PTAB Oct. 5, 2015) (“[W]e find that these exhibits have substantial
probative value in helping us to evaluate Dr. White’s opinion.”).9 We
follow that same course here, based on our determination that the value of
reviewing the transcript and documents from the LifeCell Litigation in

9 One panel determined that Rule 703’s restriction on disclosure of otherwise
inadmissible facts or data to the factfinder is inapplicable in Board
proceedings. See Nestle Healthcare Nutrition, Inc. v. Steuben Foods, Inc.,
IPR2015-00249, Paper 76, 13–14 (PTAB June 2, 2016) (“Our determination
is not made by a jury, so this caveat does not apply. See 37 C.F.R.
§ 42.62(b) (portions of the Federal Rules of Evidence relating to juries do
not apply).”). Because we find that the test is met here — i.e., the probative
value of the underlying exhibits outweighs their prejudicial effect — it is
unnecessary for us to determine whether Rule 703’s restriction on disclosure
applies in Board proceedings.
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assessing the weight to be given to Patent Owner’s experts’ testimony
substantially outweighs any prejudicial effect.
For the foregoing reasons, we deny Petitioner’s motion to exclude.
B. Patent Owner’s Motion to Exclude
Patent Owner moves to exclude Exhibit 1048 as lacking
authentication and because a certified translation of the entire document has
not been provided. See Paper 62, 1. Because we do not rely on Exhibit
1048 in this Decision, we dismiss as moot Patent Owner’s motion to
exclude.
III. LEVEL OF ORDINARY SKILL IN THE ART
In our Decision on Institution, based on the parties’ proposals and the
record at that stage, we found that the following background and experience
reflected the level of ordinary skill in the art:
(1) a master’s degree in biology, chemistry, physiology,
biochemistry, biomaterials engineering, biomedical engineering,
or a related field, and approximately three years of research or
work experience related to preparing and/or processing tissue for
transplantation into humans, or (2) a bachelor’s degree in
biology, chemistry, physiology, biochemistry, biomaterials
engineering, biomedical engineering, or a related field, and
approximately five years of research or work experience related
to preparing and/or processing tissue for transplantation into
humans.
Dec. on Inst. 5–6. The parties do not address the level of ordinary skill in
the art in the post-institution briefing, and the full trial record does not alter
our preliminary determination of the level of ordinary skill in the art. Thus,
we maintain our finding quoted above regarding the level of ordinary skill in
the art.
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IV. CLAIM CONSTRUCTION
“In an inter partes review proceeding, a claim of a patent . . . shall be
construed using 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.
§ 42.100(b) (2019).10 That standard “includ[es] construing the claim in
accordance with the ordinary and customary meaning of such claim as
understood by one of ordinary skill in the art and the prosecution history
pertaining to the patent.” Id.; see also Phillips v. AWH Corp., 415 F.3d 1303
(Fed. Cir. 2005) (en banc).
We discuss three terms below, which are the only terms that require
express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
F.3d 795, 803 (Fed. Cir. 1999) (claim terms need only be construed “to the
extent necessary to resolve the controversy”); see also Nidec Motor Corp. v.
Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
(applying Vivid Techs. in the context of an inter partes review).
A. “plasticized”
In the LifeCell Litigation, the district court construed a “plasticized”
graft as a graft that is:
composed of an internal matrix where free and loosely bound
waters of hydration in the tissue have been replaced with one or
more plasticizers without altering the orientation of the collagen
fibers, such that the mechanical properties, including the
material, physical and use properties, of the tissue product are
similar to those of normal hydrated tissue.

10 The Petition in this case was filed January 29, 2019. See Paper 3, 1.
Moreover, the Phillips standard applies in this proceeding for the additional
reason that the ’986 patent is expired. See Prelim. Resp. 16 n.5.

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Ex. 1019, 7–8. The Federal Circuit reviewed that construction on appeal and
did not disturb it. Ex. 2002, 10–11.
For purposes of our Decision on Institution, we adopted this same
construction, noting that the construction was agreed-upon by the parties and
was supported by the Specification of the ’986 patent. Dec. on Inst. 7 (citing
Pet. 12–13; Prelim. Resp. 19; Ex. 1003, 7:37–41, 8:16–25, 9:28–32).
Following institution, Patent Owner continues to advocate for this
construction. See PO Resp. 13 (stating that “[t]he Board correctly adopted
the parties’ proposed construction” of this term in the Decision on
Institution). Petitioner’s post-institution briefing presents no claim
construction argument on this term, or any other modification of its initial
position that this construction should govern. See Pet. 12–13; see also Pet.
Reply 2–5 (presenting claim construction arguments on other terms but not
“plasticized”).
Thus, we adopt the parties’ agreed construction of this term, as set
forth above.
B. “impregnated”
The ’986 patent defines “impregnating” to mean “any processing
conditions which result in filling the internal matrix of a bone graft with a
plasticizer composition.” Ex. 1003, 7:1–4. Patent’s Owner’s proposed
construction of “impregnated” is “filled,” which is the construction the
district court adopted in the LifeCell Litigation. See PO Resp. 18; Ex. 1019,
14. Petitioner’s only claim construction argument regarding this term is that
it does not require completely filling, but Patent Owner subsequently
confirmed its agreement that impregnating does not require completely
filling. See Pet. Reply 4; Sur-Reply 4. Based on the express definition in
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the patent and the parties’ apparent agreement, we construe “impregnated”
to mean “filled.”
C. “cleaned”
1. Background
Like the two terms discussed above, “cleaned” was also construed by
the district court in the LifeCell Litigation. Specifically, the district court
adopted Patent Owner’s proposed construction of “a process during which
cellular elements and small molecular weight solutes are removed.” Ex.
1019, 9–10. The Federal Circuit did not review the district court’s
construction of that term in the appeal of the LifeCell Litigation. See Ex.
2002; see also Tr. 69:12–17 (Patent Owner’s counsel stating that the Federal
Circuit did not address the construction of “cleaned”). The district court’s
construction sets the stage for the claim construction dispute in this
proceeding, as the parties’ arguments seek to clarify or build upon that
construction.
At the institution stage in this proceeding, the parties disputed whether
the proper construction of “cleaned” encompasses partial removal of cellular
elements and small molecular weight solutes. See Dec. on Inst. 7–8 (citing
Pet. 12; Prelim. Resp. 18–19). Based on the preliminary record at that stage,
we agreed with Petitioner that “‘cleaned’ . . . encompasses soft tissue grafts
in which some but not necessarily all cellular elements and small molecular
weight solutes have been removed.” Id. at 8. In reaching that preliminary
determination, we noted that the “the ’986 patent discloses that, even when
tissue has been ‘cleaned,’ it can nevertheless be ‘further cleaned,’ indicating
that ‘cleaned’ tissue retains at least some elements that could be ‘further
cleaned’ if desired.” Id. (citing Ex. 1003, 10:7–15).
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2. Summary of the Parties’ Contentions During Trial
Following institution, Patent Owner agreed that “‘cleaned’ does not
require all of the cellular elements and small molecular weight solutes to
have been removed, but with a caveat.” PO Resp. 15. According to Patent
Owner, an ordinarily skilled artisan “would understand that a ‘cleaned’ soft
tissue graft must have enough cellular elements and small molecular weight
solutes removed to avoid transmission of disease and rejection of the tissue
by the patient’s body.” Id. (citing Ex. 2016 ¶¶ 61–72). Patent Owner asserts
that “[t]he processes to create a ‘cleaned’ graft in the ’986 patent are
conventional, known in the art, and described in several cited patents and
applications.” Id. at 16 (citing Ex. 2016 ¶¶ 61–72; Ex. 1003, 6:44–47, 9:38–
54, 10:26–27, 11:20–34). Those processes, Patent Owner contends, remove
enough cellular elements to reduce the potential for transmission of infective
agents. Id.
Petitioner responds that Patent Owner’s construction limits “cleaned”
to fully cleaned, in contradiction of the Specification’s teaching that cleaned
tissue can still be further cleaned. Pet. Reply 3 (citing Ex. 1003, 10:7–15,
11:4–7; Ex. 1045 ¶¶ 21, 26). Petitioner further argues that Patent Owner’s
construction conflates cleaning, which is intended to reduce the likelihood of
rejection by the patient, with sterilization, which prevents disease
transmission. Id. at 3–4 (citing Ex. 1045 ¶¶ 27, 62). And Petitioner argues
that Patent Owner’s construction conflicts with the construction adopted by
the district court in the LifeCell Litigation. Id. at 2. Petitioner’s proposed
construction is the one adopted in the LifeCell Litigation. Tr. 7:8–11.
In its Sur-Reply, Patent Owner argues that Petitioner’s expert,
Dr. McQuillan, agrees that an ordinarily skilled artisan would understand a
cleaned graft to be one that has been subjected to a process to prevent
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adverse immunogenic responses. Sur-Reply 3 (citing Ex. 1034 ¶¶ 22–23).
Patent Owner also disputes the distinction Petitioner draws between cleaning
and sterilization, arguing that this position “contradicts the ’986 patent
specification and the disclosures incorporated [therein] that disclose the use
of conventional methods to remove cellular elements from tissue in order to
prevent disease transmission.” Id. at 4 (citing Ex. 2016 ¶¶ 65–70; Ex. 1003,
9:38–54, 10:49–54; Ex. 2044, 3:21–37).
3. Analysis
In considering the parties’ dispute over this term’s meaning, we look
first to the language of the claims. See Phillips, 415 F.3d at 1314 (“Quite
apart from the written description and the prosecution history, the claims
themselves provide substantial guidance as to the meaning of particular
claim terms.”).
The language of independent claims 1, 10, 13, and 27 of the ’986
patent, in which the disputed term appears, is broad and generic in that it
simply recites that the soft tissue graft is cleaned. In contrast, claim 11
recites that “cellular elements are substantially removed from said soft
tissue,” and claim 12 similarly recites “substantially removing cellular
elements from soft tissue.” Ex. 1003, 25:27–28, 25:35–36.11 We also
consider the language of claims in related patents. See Trustees of Columbia

11 We note that dependent claim 3 recites that “cellular elements have been
removed from the soft tissue graft” and dependent claim 15 recites a similar
limitation. Ex. 1003, 24:52–54, 26:1–2. These dependent claims, which the
parties do not focus on in their claim construction arguments, do not aid the
analysis because the parties both agree that cellular elements are removed by
cleaning; the disputed question is how much. Because dependent claims 3
and 15 would not narrow the claims from which they depend under either
party’s proposed construction, they shed little light on the disputed claim
construction issue.
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University v. Symantec Corp., 811 F.3d 1359, 1369 (Fed. Cir. 2016) (“We
have previously held that where multiple patents ‘derive from the same
parent application and share many common terms, we must interpret the
claims consistently across all asserted patents.’”); see also Phillips, 415 F.3d
at 1314 (“Differences among claims can also be a useful guide in
understanding the meaning of particular claim terms.”). In the related ’420
patent, the independent claims include the same broad “cleaned” term and
dependent claim 13 adds the limitation that “said plasticized soft tissue graft
is essentially free from cellular elements.” Ex. 1002, 25:15–17. The
language of claims 11 and 12 in the ’986 patent and claim 13 in the related
’420 patent shows that when the patentee wished to be specific about the
amount of cellular material that must be removed, it knew how to do so.
Here, for the claims of the ’986 patent in which the disputed term appears,
the patentee chose instead to use the broad term “cleaned.”
The genericness of the term “cleaned,” in comparison to the
specificity of the language used in other claims, tends to support an
interpretation that the term does not require any particular amount of cellular
material to be removed. See Intellectual Ventures I LLC v. T-Mobile USA,
Inc., 902 F.3d 1372, 1378 (Fed. Cir. 2018) (“Since ‘[i]t is the claims that
define the metes and bounds of the patentee’s invention,’ ‘[t]he patentee is
free to choose a broad term and expect to obtain the full scope of its plain
and ordinary meaning unless the patentee explicitly . . . disavows its full
scope.’”) (quoting Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d
1362, 1367 (Fed. Cir. 2012)).
Turning to the Specification, the ’986 patent is generic and open-
ended regarding cleaning, relying on background knowledge and citation to
other prior art references for its disclosure of cleaning processes. For
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example, the patent defines “cleaned bone graft” as “a bone graft that has
been processed using means know[n] in the art, to remove bone marrow
elements.” Ex. 1003, 6:44–47; see also id. at 9:38–40 (“Bone processing
and cleaning procedures suitable for use with the present invention include
known processes . . . .”). Likewise, the patent explains that “[b]one and soft
tissue grafts can be cleaned and processed using conventional methods.” Id.
at 10:26–27; see also id. at 11:21–23 (“For example, tissue can be processed
and cleaned according to any method including known methods . . . .”). In
the patent’s two examples relating to soft tissue grafts, cleaning is achieved
by placing a prepared graft “in a basin containing a 1:100 dilution of
Allowash Solution or other surfactant(s) for at least 15 minutes.” Id. at
23:2–5, 23:56–58. Thus, we agree with Patent Owner’s frank
acknowledgement that the cleaning methods described in the ’986 patent are
“conventional.” PO Resp. 16; Sur-Reply 4.
The parties and their experts disagree on the degree of cellular
element removal that is achieved by the cleaning techniques described in the
Specification. See, e.g., PO Resp. 15 n.2 (citing Ex. 1034 ¶ 35) (disputing
Dr. McQuillan’s statement that the cleaning methods described in the ’986
patent would provide only some cleaning of the tissue); Ex. 2016 ¶ 71 n.5
(“I disagree with Dr. McQuillan’s characterization that the cleaning
methods, including the Allowash treatment, described in the subject patents
would provide only ‘some cleaning of the tissue.’ Allowash is known to be
effective in removing cellular elements and small molecular weight solvents
to render the tissue safe for implantation.”) (citations omitted); Ex. 1045
¶ 25 (“Dr. Kaplan ignores that the Allowash technique that is marketed as
readying a soft tissue graft for implantation is much more involved than the
bath/rinse disclosed at Examples 9 and 10 of the LifeNet patents.”). We
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need not resolve that dispute because the Specification only describes these
techniques as potential methods of cleaning and does not specify any cellular
removal result that must be obtained before a tissue is adequately cleaned.
In other words, regardless of the level of cellular material that the cleaning
processes referenced in the Specification were capable of removing under
certain protocols, the Specification never indicates that those results are
critical to achieve a “cleaned” graft. Instead, the Specification simply lists
multiple known ways that a graft can be cleaned.
For similar reasons, we need not resolve the parties’ dispute over the
purported distinction between cleaning and sterilization. Even accepting
Patent Owner’s argument that an important purpose of cleaning a tissue graft
is to prevent disease transmission, the Specification does not purport to set
any particular standard of efficacy for a “cleaned” graft toward that goal.
Patent Owner’s proposed construction requires that a soft tissue graft does
not qualify as “cleaned” unless disease transmission and rejection of the
tissue by the patient’s body have been prevented. PO Resp. 15. But Patent
Owner does not point us to, and we do not find, any portion of the
Specification supporting that these criteria must be met for a “cleaned” graft.
We recognize that the Specification includes a description that “[a]fter
the sterile water wash[,] the tissue (for example bone tissue) is cleaned of
virtually all cellular elements (for example, bone marrow) present in the
tissue and the cleaned tissue can be further processed.” Ex. 1003, 11:24–27.
However, that description does not purport to define “cleaned” but simply
describes one “example.” Id. at 11:21. Indeed, Patent Owner has expressly
stated that “‘cleaned’ does not require all of the cellular elements and small
molecular weight solutes to have been removed.” PO Resp. 15.
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We have also considered the extrinsic evidence that the parties have
presented. See Phillips, 415 F.3d at 1317 (“[W]hile extrinsic evidence can
shed useful light on the relevant art, we have explained that it is less
significant than the intrinsic record in determining the legally operative
meaning of claim language.”) (internal citations and quotations omitted).
The testimony of Dr. Kaplan, Patent Owner’s expert, indicates that an
advantage or goal of the known cleaning techniques is to “reduc[e] the
potential for transmission of disease” or remove elements “that can
potentially transmit disease or cause an immune reaction in the recipient.”
Ex. 2016 ¶¶ 68, 70. Patent Owner also points to Dr. McQuillan’s testimony
that prior art cleaning techniques “reduced the risk for adverse immunogenic
responses” and “reduce[d] the risk of an adverse reaction in the transplant
recipient.” Ex. 1034 ¶¶ 23–24. Patent Owner’s reliance on these aspects of
Dr. Kaplan’s and Dr. McQuillan’s testimony substitutes the goal of reducing
the potential for adverse outcomes with a guarantee of avoiding them.
Indeed, it is unclear what quantity or percentage of cellular elements
and small molecular weight solutes would need to be removed to avoid
transmission of disease and rejection of the tissue by the patient’s body, and
neither Patent Owner nor Dr. Kaplan attempts to draw that line. See PO
Resp. 15 (“No matter the precise number of cellular elements and small
molecular weight solutes removed, a POSA would understand that a
‘cleaned’ soft tissue graft must have enough . . . removed to avoid
transmission of disease and rejection of the tissue by the patient’s body.”).
Consequently, the extrinsic evidence of record does not persuade us that
ordinarily skilled artisans would consider a tissue to be “cleaned” only if the
potential for adverse results has been eliminated.
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Based on the foregoing, we adopt the district court’s construction of
“cleaned” to mean “a process during which cellular elements and small
molecular weight solutes are removed.” We further determine that this term
does not specify any particular amount of cellular elements and small
molecular weight solutes that must be removed.
V. ANTICIPATION BY WALKER
A. Legal Standards
“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., 814 F.2d 628, 631
(Fed. Cir. 1987). Moreover, “[b]ecause the hallmark of anticipation is prior
invention, the prior art reference — in order to anticipate under 35 U.S.C.
§ 102 — must not only disclose all elements of the claim within the four
corners of the document, but must also disclose those elements ‘arranged as
in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369
(Fed. Cir. 2008). Whether a reference anticipates is assessed from the
perspective of an ordinarily skilled artisan. See Dayco Prods., Inc. v. Total
Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive
question regarding anticipation [i]s whether one skilled in the art would
reasonably understand or infer from the [prior art reference’s] teaching that
every claim element was disclosed in that single reference.”) (citation
omitted).
B. Summary of Walker
Walker discloses “[a] method of sterili[z]ing material . . . for
implantation into a human or animal body” in which the material is treated
with “a substance . . . selected so as to maintain certain physical
characteristics of the material such as flexibility and/or structure of cells or
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extra cellular material.” Ex. 1005, 1 at code (57).12 “Suitable substances
include . . . glycerol.” Id. Walker teaches that its method “can be used on
gra[ft]s for implantation or on biological material such as vascular tissue etc.
and has the advantage that the substance does not react with water and so the
material can be treated in solution without drying out or becoming brittle.”
Id. Walker’s method includes storing the material in an ethanol solution,
treating with glycerol, and treating with ethylene oxide to sterilize. See id. at
4:2–3, 5:17–20. Walker discloses that the “pre-sterili[z]ing treatment,”
which may include treatment with glycerol, “enables the material
substantially to retain certain physical characteristics, such as flexibility, and
can suitably replace at least some of the water contained in the material.” Id.
at 6:20–24.
C. Analysis
Independent claims 11 and 12 both require that cellular elements are
“substantially” removed from the soft tissue. The Petition argues that
Walker discloses that limitation because “the biological material is stored in
ethanol before treatment with glycerol. A POSITA would have recognized
that storing the biological tissue in ethanol would at least partially, if not
substantially, remove cellular components from the soft tissue.” Pet. 21
(citing Ex. 1005, 9:19–20, 17:3–5; Ex. 1034 ¶¶ 84, 303); see also id. at 25
(same argument as to claim 12 and citing Ex. 1034 ¶¶ 84, 308).
In our Decision on Institution, based on the record at that stage, we
assessed that the Petition did not establish a reasonable likelihood of
prevailing on this ground. See Dec. on Inst. 12. In reaching that

12 In our pin cites to Walker, page numbers refer to the stamp added by
Petitioner to the lower right corner of each page of Walker.
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determination, we noted that the Petition and the portions of Dr.
McQuillan’s testimony on which the Petition relied to address this limitation
purported to show only partial removal of cellular elements through
Walker’s pre-treatment storage in ethanol; the argument and evidence did
not demonstrate substantial removal as the claims require. Id. at 10–12.
In its Reply, Petitioner argues as follows:
Walker teaches that the grafts are plasticized in a composition
including ethanol for 16+ hours. A POSITA would have
understood that given the 16+ hour ethanol bath[,] substantially
all native cells present in the soft tissue graft will have had their
cell membranes solubilized and substantially all of that loose
cellular content would be rinsed away.
Pet. Reply 11–12 (citing Ex. 1045 ¶ 22).
We agree with Patent Owner that Petitioner’s Reply argument
improperly shifts to a new theory different than that presented in the
Petition. See Sur-Reply 10. “[T]he expedited nature of IPRs bring with it an
obligation for petitioners to make their case in their petition to institute.”
Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359,
1369 (Fed. Cir. 2016); see also Ericsson Inc. v. Intellectual Ventures I LLC,
901 F.3d 1374, 1380 (Fed. Cir. 2018) (“[T]he Board has discretion to
determine whether a petition for inter partes review identified the specific
evidence relied on in a reply and when a reply contention crosses the line
from the responsive to the new.”).
The Petition relied on Walker’s storage in ethanol before the glycerol
treatment to disclose that cellular elements are “substantially” removed. See
Pet. 20–21 (addressing this limitation in claim 11 by arguing that “[i]n the
Walker method, the biological material is stored in ethanol before treatment
with glycerol”); id. at 25 (same argument with respect to the corresponding
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limitation in claim 12); see also Tr. 18:11–14 (Petitioner agreeing that the
Petition relied on storage in ethanol before plasticization). But in the Reply,
rather than defending the argument in the Petition, Petitioner moved on to a
new argument that the substantial removal limitation is met by exposure to
ethanol during the glycerol treatment. Pet. Reply 11–12. Petitioner’s Reply
argument points to a different step in Walker’s process and, therefore, relies
on different evidence than that identified in the Petition. We determine that
Petitioner’s Reply argument is an impermissible new argument.
The argument presented in the Petition is unpersuasive for the same
reasons discussed in the Decision on Institution, which Petitioner did not
address in its Reply. In particular, neither the relevant portions of the
Petition nor the cited paragraphs of Dr. McQuillan’s testimony include an
affirmative assertion that treatment of soft tissue with ethanol as disclosed
by Walker will substantially remove cellular elements as required by claims
11 and 12. The Petition argues only that an ordinarily skilled artisan would
have recognized that storage in ethanol prior to incubation in glycerol would
“at least partially, if not substantially, remove cellular components from the
soft tissue.” Pet. 21, 25. And Dr. McQuillan testifies that the pre-glycerol
“storage of the tissue in ethanol . . . would at least partially remove
potentially adverse immunogenic cellular components from the tissue by
solubilizing the lipid cell membrane.” Ex. 1034 ¶ 84 (emphasis added); id.
¶ 303 (similar); id. ¶ 308 (similar).
Neither the Petition nor Dr. McQuillan explain why the “partial”
removal of cellular elements that Walker satisfies the claim language
requiring “substantial[]” removal of cellular elements. Indeed, the Petition’s
argument that cellular elements are “at least partially, if not substantially,
remov[ed]” indicates that Petitioner’s view is that Walker might disclose
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what is claimed. But a mere possibility is insufficient to support
anticipation. See Cont’l Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264,
1269 (Fed. Cir. 1991) (“Inherency . . . may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.”).
For these reasons, we conclude that Petitioner has not demonstrated
by a preponderance of the evidence that Walker anticipates claims 11 and
12.
VI. OBVIOUSNESS BASED ON WALKER
A. Legal Standards
In Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966), the
Supreme Court set out a framework for assessing obviousness under § 103
that requires consideration of four factors: (1) the “level of ordinary skill in
the pertinent art,” (2) the “scope and content of the prior art,” (3) the
“differences between the prior art and the claims at issue,” and
(4) “secondary considerations” of nonobviousness such as “commercial
success, long-felt but unsolved needs, failure of others, etc.” Id. at 17–18.
B. Claims 11 and 12
Petitioner’s arguments that claims 11 and 12 are obvious based on
Walker are offered “[t]o the extent it is determined that Walker does not
explicitly disclose that ‘no refrigeration or freezing is required,’ or that the
tissue ‘can be stored at room temperature.’” Pet. 32. Petitioner does not
present any treatment of the substantial removal limitation for the
obviousness argument separate from the arguments it presented for
anticipation. See id. at 32–36; see also Pet. Reply 21 (merely referring back
to anticipation arguments to address substantial removal limitation).
Because Petitioner’s obviousness arguments do not address or remedy the
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deficiencies regarding the substantial removal limitation (see supra § V.C),
we determine that Petitioner has not demonstrated by a preponderance of the
evidence that claims 11 and 12 would have been obvious based on Walker.
C. Claims 1–3, 5, 9, 13–15, and 23–25
Claim 1 recites a plasticized soft tissue graft that “does not require
refrigeration or freezing for storage.” Ex. 1003, 24:44–45.
Petitioner argues that “[t]o the extent it is determined that Walker
does not explicitly disclose”13 this limitation, it “would have been obvious to
a POSITA at the time of the alleged invention.” Pet. 32 (citing Ex. 1034
¶ 314). According to Petitioner, with citation to the testimony of Dr.
McQuillan, “[n]othing in Walker would have led a POSITA to understand
that the plasticized soft tissue graft of Walker requires any special conditions
for storage and a POSITA would have understood Walker to disclose a soft
tissue graft that could be stored at room temperature.” Id. at 32–33 (citing
Ex. 1034 ¶ 315); see also Pet. Reply 23–24 (“Refrigeration and freezing are
special storage conditions. If Walker’s grafts required such special storage
conditions, Walker would have expressly so stated.”).
Patent Owner responds that “without some teaching in Walker, a
POSA would have no reason to assume specific storage conditions of
Walker, and there is no suggestion in Walker to adopt the required storage
conditions of the challenged claims of the ’986 patent.” PO Resp. 32 (citing
Ex. 2016 ¶ 256).

13 Petitioner’s phrasing suggests that this argument is presented in the
alternative, as a backup in the event that it is unsuccessful in showing that
Walker expressly discloses this limitation. But Petitioner never argues that
Walker expressly discloses this limitation, so the obviousness theory is the
sole argument on this limitation, not an alternative or backup.
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We agree with Patent Owner that Petitioner’s arguments and evidence
regarding this limitation are unpersuasive. We do not follow Petitioner’s
inference that Walker’s silence regarding storage conditions means that the
grafts do not require refrigeration or freezing. See Pet. 32–33; Pet. Reply
23–24. That argument is undermined by the evidence that storage stability
without refrigeration or freezing was noteworthy in this field, which
suggests the contrary understanding of Walker’s silence on storage
conditions: if Walker’s grafts were stable for storage without refrigeration or
freezing, Walker would have noted that advantageous feature.
Most notable in this regard is Livesey, Petitioner’s other primary
reference, which touts that its “packaged dried tissue may be stored for
extended time periods under ambient conditions. Transportation may be
accomplished via standard carriers and under standard conditions relative to
normal temperature exposure and delivery times.” Ex. 1004, 6:6–11. A
graft that “can be easily stored and transported at ambient temperatures” is
one of the “criteria” that Livesey states for its grafts. Id. at 4:43–46, 4:54–
55. Petitioner’s argument that it goes without saying that Walker’s grafts are
stable without special storage conditions is inconsistent with Livesey.
In addition, Patent Owner has presented evidence showing that
storage stability without refrigeration is a feature that manufacturers have
highlighted in marketing their grafts. See PO Resp. 64; Ex. 2016 ¶¶ 310,
312; Ex. 2050, 1 (listing benefits of LifeCell’s Strattice product, including
that it “[o]ffers enhanced ease of use – Strattice Tissue Matrix requires no
rehydration or orientation and can be stored at room temperature”);
Ex. 2066, 4 (listing benefits of LifeCell’s AlloDerm Ready to Use product,
including “[n]o refrigeration required”); Ex. 2080, 1 (advertising LifeNet’s
DermACELL product by stating that is “ready to use out of the package and
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stored at room temperature, eliminating the need for refrigeration and
rehydrating processes”); Ex. 2081, 1 (advertising LifeNet’s OrACELL
product by stating that it “can be stored at room temperature”); Ex. 2084, 7
(noting that a benefit of LifeNet’s ArthroFlex product is that it is “stored at
room temperature”). The significance of this feature to the marketplace cuts
against Petitioner’s argument that Walker’s silence on the issue of storage
would have been understood to mean no refrigeration was needed.
We have considered Dr. McQuillan’s testimony that skilled artisans
would have understood in 1998 that soft tissue grafts preserved with glycerol
do not require refrigeration, but we note that no underlying support is
provided for that testimony. Ex. 1034 ¶ 316. We also do not find in that
testimony any persuasive explanation of why an ordinarily skilled artisan
would have had that understanding. We therefore give this testimony little
weight. See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed.
Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude
that the lack of factual corroboration warrants discounting the opinions
expressed in the declarations.”); Skky, Inc. v. MindGeek, s.a.r.l., 859 F.3d
1014, 1019 (Fed. Cir. 2017) (“[T]he Board was not required to credit
[appellant]’s expert evidence simply because [appellant] offered it.”). The
’986 patent places substantial emphasis on the benefit that its grafts do not
require special storage conditions, calling out that feature in the first
sentence of both the Abstract and the Field of the Invention. See Ex. 1003,
at code (57), 1:18–20. Considering that emphasis, we also agree with Patent
Owner that Petitioner’s argument and Dr. McQuillan’s testimony bears the
imprint of improper hindsight. See Otsuka Pharm. Co. v. Sandoz, Inc., 678
F.3d 1280, 1296 (Fed. Cir. 2012) (“The inventor’s own path itself never
leads to a conclusion of obviousness; that is hindsight.”).
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In short, we are not persuaded that, absent any discussion of storage
conditions in Walker, an ordinarily skilled artisan would understand from
Walker’s disclosure that the grafts could be stored without refrigeration or
freezing, as Petitioner contends. Based on that deficiency, we conclude that
Petitioner has not demonstrated by a preponderance of the evidence that
claim 1 would have been obvious based on Walker.
Petitioner’s challenges to claims 2, 3, 5, 9, 13–15, and 23–25 are
deficient for the same reason. Claims 2, 3, 5, and 9 depend from claim 1.
Independent claim 13 recites “packaging the plasticized soft tissue graft
without refrigeration or freezing.” Ex. 1003, 25:52–53. Petitioner’s
arguments regarding that limitation in claim 13 are the same as its arguments
concerning the similar limitation in claim 1. See Pet. 32–34; Pet. Reply 23–
24. Claims 14, 15, and 23–25 depend from claim 13. Thus, for the reasons
discussed above, we determine that Petitioner has not demonstrated by a
preponderance of the evidence that claims 2, 3, 5, 9, 13–15, and 23–25
would have been obvious based on Walker.
VII. ANTICIPATION BY LIVESEY
A. Summary of Livesey
Livesey discloses a method for processing and preserving
collagen-based biological tissues for transplantation. Ex. 1004, Abstract.
The method includes several successive treatment steps, including:
(1) applying a processing solution to remove cells; (2) applying a
cryoprotectant solution; (3) freezing; (4) drying; (5) storing; and
(6) rehydrating. Id. at Abstract, 4:19–43.
In step (1), the biological tissue is incubated in a processing solution
to remove viable antigenic cells, without damaging the basement membrane
complex or the structural integrity of the collagen matrix. Id. at 5:1–14. In
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this way, the biological tissue “is devoid of certain viable cells which
normally express major histocompatibility complex antigenic determinants
and other antigens which would be recognized as foreign by the recipient.”
Id. at 1:21–26.
In step (2), the biological tissue is incubated in a cryopreservation
solution to minimize ice crystal damage during the freezing step (3), and
minimize structural damage during the drying step (4). Id. at 3:35–38,
5:15–24, 11:9–24. Glyercol is disclosed as a suitable cryoprotectant. Id. at
3:35–38, 11:49–60.
In step (5), the biological tissue is stored for extended periods of time
under ambient conditions. Id. at 6:1–11. In step (6), the biological tissue is
rehydrated prior to the tissue being transplanted into a human patient. Id. at
6:12–29.
B. Claim 1
1. Undisputed Limitations
The only disputed aspects of Petitioner’s anticipation challenge to
claim 1 based on Livesey are portions of the “plasticized” limitation —
specifically, the aspects of our construction of that limitation requiring that
the free and loosely bound waters are replaced with plasticizer, and that the
mechanical properties of the plasticized tissue are similar to those of normal
hydrated tissue. See PO Resp. 34–41. As to the undisputed limitations,
“[t]he Board is ‘not required to address undisputed matters’ or arguments
about limitations with which it was never presented.” LG Elecs., Inc. v.
Conversant Wireless Licensing S.A.R.L., 759 F. App’x 917, 925 (Fed. Cir.
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2019) (quoting In re Nuvasive, Inc., 841 F.3d 966, 974 (Fed. Cir. 2016)).14
Nevertheless, to provide a complete record, we briefly summarize our
findings regarding the uncontested limitations.
The preamble recites “[a] plasticized soft tissue graft suitable for
transplantation into a human.” The “plasticized” term, which is also recited
in the body of claim 1, is disputed and is separately discussed below. See
infra § VII.B.2. Patent Owner presents no argument to show that the
remaining aspects of the preamble are limiting, or (if limiting) are not
disclosed by Livesey. See PO Resp. 14, 34–41.15 Although Petitioner
argues that the preamble is presumptively non-limiting and that Patent
Owner has failed to show otherwise, Pet. Reply 23, Petitioner’s arguments
account for the possibility that the preamble is limiting. See Pet. 36–37. We
are persuaded by Petitioner’s argument that, to the extent the entire preamble
is limiting, Livesey discloses a soft tissue graft suitable for transplantation
into a human. See id.; Ex. 1034 ¶ 328. Livesey describes “a method for
processing and preserving collagen-based biological tissues for
transplantation” into a “host” without eliciting an immune response.
Ex. 1004, 4:39–52; see also id. at 1:15–21 (“This invention relates to

14 See also Papst Licensing GmbH & Co. v. Samsung Elecs. Am., 924 F.3d
1243, 1250 (Fed. Cir. 2019) (holding that patentee forfeited argument for
patentability because it did not present it to the Board); Bradium Techs. LLC
v. Iancu, 923 F.3d 1032, 1048 (Fed. Cir. 2019) (explaining that arguments
not presented to the Board are waived).
15 Patent Owner asserts in its Patent Owner Response that “[t]he Board
correctly noted that the preamble is limiting” (PO Resp. 13 (citing Dec. on
Inst. 13)), but our Decision on Institution simply “assume[d] that the
preamble is limiting” for the purposes of that decision given the dearth of
argument on that point. See Dec. on Inst. 13 n.4.
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methods for procuring . . . tissues derived from humans and animals for
transplantation into humans or other animals.”).
Claim 1 further recites “a cleaned soft tissue graft having an internal
matrix.” We find Petitioner has shown Livesey’s grafts are cleaned, and
have an internal matrix. See Pet. 14, 37; Ex. 1034 ¶¶ 61, 329. Livesey
describes that “the tissue is . . . incubated in a processing solution to remove
viable antigenic cells . . . from the structural matrix without damaging the
basement membrane complex or the structural integrity of the collagen
matrix,” such that “the structural integrity of the matrix is maintained
including collagen fibers and elastin.” Ex. 1004, 5:1–14; see also id.
at 23:62–67 (disclosing a specific decellularizing solution used to clean
human skin tissue). We credit Dr. McQuillan’s unopposed testimony that an
ordinarily skilled artisan would understand this disclosure to reflect cleaning
of a graft having an internal matrix, under the claim construction of
“cleaned” we have adopted above. See Ex. 1034 ¶¶ 61, 329.
Next, claim 1 recites “one or more plasticizers contained in said
internal matrix, said one or more plasticizers not being removed from said
internal matrix prior to packaging.” We find Petitioner has shown the
internal matrix of Livesey’s tissue would contain the plasticizer glycerol in
view of Livesey’s disclosure of incubating tissue with a cryopreservation
solution containing glycerol as a cryoprotectant, “until complete penetration
of the components of the cryosolution is achieved.” Ex. 1004, 11:49–51,
12:34–37, 14:47–50, 15:11–13; see Pet. 15, 38–39; Ex. 1034 ¶¶ 28, 62–64,
331.
Claim 1 further recites “wherein said plasticized soft tissue graft does
not require refrigeration or freezing for storage.” We are persuaded by
Petitioner’s argument that Livesey’s grafts do not require refrigeration or
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freezing for storage. See Pet. 39; Ex. 1034 ¶ 332. Livesey describes that
“the packaged dried tissue may be stored for extended time periods under
ambient conditions. Transportation may be accomplished via standard
carriers and under standard conditions relative to normal temperature
exposure and delivery times.” Ex. 1004, 6:6–11.
Finally, claim 1 recites “wherein the plasticized soft tissue graft has
mechanical properties approximating mechanical properties of natural soft
tissue.” This limitation essentially restates one facet of the construction we
have adopted for the “plasticized” term. The parties’ arguments concerning
this limitation are discussed below. See infra § VII.B.2.b. For the reasons
discussed below, we are persuaded by Petitioner’s arguments that Livesey
discloses this limitation.
2. “Plasticized”
As discussed above in Section IV.A, we construe “plasticized” to
mean that the graft is “composed of an internal matrix where free and
loosely bound waters of hydration in the tissue have been replaced with one
or more plasticizers without altering the orientation of the collagen fibers,
such that the mechanical properties, including the material, physical and use
properties, of the tissue product are similar to those of normal hydrated
tissue.” Patent Owner’s arguments address both (1) the replacement of
waters of hydration in the matrix, and (2) this is done without altering the
orientation of collagen fibers such that the mechanical properties of the graft
are similar to those of normal hydrated tissue. See PO Resp. 34. Patent
Owner treats its arguments on that second aspect as equally applicable to the
final limitation of claim 1, which recites that “the plasticized soft tissue graft
has mechanical properties approximating mechanical properties of natural
soft tissue.” See Ex. 1003, 24:46–48 (emphasis added); PO Resp. 38.
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a) Free and Loosely Bound Waters
We find that Livesey discloses its cryoprotectants include plasticizers
(such as glycerol) which replace free and loosely bound water in the tissue
matrix of Livesey’s grafts, as Petitioner contends.
Livesey describes incubating its grafts in a cryopreservation solution
containing one or more cryoprotectants. Ex. 1004, 5:15–24, 11:49–51,
12:31–37; see Pet. 15, 36–37. Many of Livesey’s “cryoprotectants” are
identified as “plasticizers” by the ’986 patent. Ex. 1034 ¶¶ 62–64; id. ¶ 330
(testifying “Livesey’s ‘cryoprotectant’ serves the same function as the
‘plasticizer’ in the 986 patent”); see Pet. 38. These common substances
include glycerol, sucrose,16 sorbitol, propylene glycol, proline, and
combinations thereof. Compare Ex. 1004, 11:49–55, with Ex. 1003, 7:54–
63. As described in Livesey, the incubation achieves “complete penetration”
of the cryoprotectants within the graft tissue, such that the cryoprotectants
“penetrate[] and exert[] colligative action within the cells.” Ex. 1004,
12:34–37, 14:47–50, 15:11–17.
Dr. McQuillan testifies that an ordinarily skilled artisan would
understand the described penetration and colligative action of
cryoprotectants “mean[s] that glycerol or other small cryoprotectants replace
free or loosely bound water in the internal matrix and preserve the structural
integrity of the tissue.” Ex. 1034 ¶ 62; see Pet. 15. In support,

16 Curiously, Dr. McQuillan testifies that sucrose is not a “plasticizer as [he]
understand[s] that term to be used in the [’986 patent].” Ex. 1045 ¶ 35. It is
difficult to reconcile this testimony with the fact that the ’986 patent
identifies sucrose as a plasticizer. Ex. 1003, 7:58. Regardless, it remains
true that many other identified substances are the same.
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Dr. McQuillan cites van Baare17 as establishing that, as of the ’986 patent’s
February 1998 priority date, “a person of ordinary skill would know that
glycerol was a preferred preservative” in part because it “was ideal as a
water replacement agent.” Ex. 1034 ¶ 25 (citing Ex. 1031, S77–S80).
Dr. McQuillan further testifies that the cryopreservation process of Livesey
is “the same” as the plasticization process of the ’986 patent, because both
incubate a cleaned soft tissue graft in glycerol under conditions that obtain
complete penetration of the glycerol in the tissue matrix, and so will achieve
the same results. Ex. 1034 ¶¶ 64, 330, 377; Pet. Reply 14–15 (citing
Ex. 1004, 11:17–23, 11:49–51, 12:33–37).
Dr. Kaplan testifies that Livesey does not disclose replacing free or
loosely bound waters of hydration with a cryoprotectant. Ex. 2016
¶¶ 207–211; see PO Resp. 35–38; Sur-Reply 14–16. According to
Dr. Kaplan, Livesey instead discloses that the “cryoprotectant simply reacts
with the free water in the graft to keep the water from crystalizing during
freezing,” and “does nothing to” the loosely bound water. Ex. 2016 ¶ 207
(citing Ex. 1004, 11:32–35, 11:55–60). According to Dr. Kaplan, the
penetration of Livesey’s cryoprotectant into the tissue “thus maintains the
water in the tissue in an amorphous state” (i.e., prevents the water from
crystallizing into ice) during the subsequent freezing of the graft, so the
cryoprotectant “does not replace the water in the matrix.” Id. ¶¶ 207–209
(citing Ex. 1004, 12:36–37, 15:15–18, 15:22–24, 17:15–19, 17:49–51).
Based on this understanding of how Livesey’s cryoprotectants function,
Dr. Kaplan testifies “the fact that Livesey even uses a cryoprotectant proves

17 Ex. 1031, J. van Baare et. al., Virucidal effect of glycerol as used in donor
skin preservation, 20 Burns Suppl. 1, S77–S80 (1994).
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that water remains in the graft.” Id. ¶ 208. Further, according to
Dr. Kaplan, the fact that Livesey dries its grafts after cryopreservation and
freezing establishes that the cryopreservation does not plasticize the grafts,
because otherwise the drying step would not be needed. Id. ¶¶ 85–87,
139–143, 211.
Upon review of the foregoing, we note first that claim 1 does not
specify a particular amount or percentage of free and loosely bound water in
the tissue matrix that must be replaced by the plasticizer. Dr. McQuillan and
Dr. Kaplan agree that Livesey’s cryoprotectant incubation achieves complete
penetration of the cryoprotectants within the tissue, so the cryoprotectants
exert colligative action within the cells. See, e.g., Ex. 1004, 12:34–37,
14:47–50, 15:11–17; Ex. 1034 ¶ 62; Ex. 2016 ¶¶ 207–208. The witnesses
disagree, however, as to whether such penetration and colligative action
corresponds to the cryoprotectants replacing free and loosely bound in the
tissue matrix. On that particular point, we find Dr. McQuillan’s testimony to
be more persuasive than Dr. Kaplan’s testimony, because it is more
consistent with Livesey’s disclosure.
For example, Livesey discloses that “[t]he physicochemical effects of
cryoprotectants” such as glycerol include “dehydrative effects on cells by
osmotic action.” Ex. 1004, 17:3–9 (emphasis added), 11:49–51. This is
consistent with van Barre, which refers to “the dehydrating action of
glycerol” and indicates “[g]lycerol will dehydrate the skin, the extracted
water being replaced by glycerol, preserving the original structure” such that
“[t]he remaining water is optimally distributed throughout the tissue.”
Ex. 1031, S77 (emphasis added); Ex. 1034 ¶ 25. Thus, Livesey and
van Barre indicate at least a portion of the cryoprotectant that penetrates into
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the tissue matrix will dehydrate the tissue by replacing some, but perhaps not
all, of the free and loosely bound water in the matrix.
This finding is not contradicted by the Livesey disclosures cited by
Dr. Kaplan. These disclosures most pertinently reflect that “[s]uitable
cryoprotectants structure water molecules such that the freezing point is
reduced and/or the rate of cooling necessary to achieve the vitreous phase is
reduced.” Ex. 1004, 11:55–68 (emphasis added). Similarly: “The action of
glycerol and other small polar compounds has been interpreted as
penetrating and exerting colligative action within the cells,” such that “the
colligative action of the penetrating compounds maintains water in the
liquid state at temperatures below 0°C.,” the freezing point of water. Id. at
15:11–22 (emphases added). These disclosures indicate at least a portion of
the cryoprotectant that penetrates into the tissue matrix will maintain water
in the liquid state during Livesey’s freezing step following the
cryopreservation step, to help prevent the formation of ice which can
damage the tissue. See id. at 11:32–35, 15:20–30, 17:10–25, 17:47–53.
Reading Livesey as a whole, we find that the cryoprotectant
dehydrates the tissue by replacing some of the free and loosely bound water
in the matrix. At the same time, the cryoprotectant also preserves other
water in the matrix in a liquid state during the freezing step. These actions
combine to help protect the tissue from damage during the freezing step, by
reducing and controlling ice crystal formation during the freezing step. The
disclosed actions of the cryoprotectant (replacing some water in the matrix,
and controlling ice formation by water that remains) are not mutually
exclusive. Claim 1 does not require anything more, or different.
Our findings are not inconsistent with Livesey’s additional disclosure
of drying the graft after freezing the graft. See, e.g., Ex. 1004, Abstract
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(stating Livesey’s “method includes the steps of . . . treatment with a
cryoprotectant solution followed by freezing, drying . . . ”); Ex. 2016 ¶¶ 85–
87, 139–142, 269 (discussing various disclosures of Livesey relating to the
post-freeze drying step). Livesey’s cryoprotectant preserves some (but not
all) of the water in a liquid state during the freezing step, which may then be
removed by Livesey’s post-freeze drying step. Moreover, as Petitioner
points out, the ’986 patent itself discloses processes that involve freeze-
drying after plasticization, and claim 1 does not preclude freeze-drying after
plasticization. See Ex. 1003, 10:26–42, 23:41–42, 24:28–29; Pet. Reply 17–
18; Dec. on Inst. 20. Thus, we are not persuaded by Patent Owner’s
contention that the drying step of a free-drying process is necessarily
inconsistent with plasticization of the graft before the freeze-drying.
Patent Owner finally contends Dr. McQuillan’s testimony is deficient
because he opines only that Livesey’s cryoprotectant replaces “free or
loosely bound water,” not that the cryoprotectant would replace both kinds
of water, as required by claim 1. PO Resp. 36–37 (citing Ex. 1034 ¶ 62).
However, we agree with Petitioner’s rebuttal that Dr. McQuillan’s original
declaration testimony, when read as a whole, properly addresses this claim
requirement. See Pet. Reply 15; Ex. 1045 ¶ 37 n.5; Ex. 1034 ¶¶ 62, 377,
290.
Thus, we find that Livesey discloses its cryoprotectants include
plasticizers (such as glycerol) which replace free and loosely bound water in
the tissue matrix of Livesey’s grafts.
b) Mechanical Properties
For the following reasons, we find that Livesey discloses that the
orientation of the collagen fibers is not altered, such that the mechanical
properties, including material, physical, and use properties, of its
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cryopreserved tissue grafts are similar to (and approximate) normal hydrated
tissue, as Petitioner contends.
Livesey describes that “[a]nalysis of the end product by light and
electron microscopy has demonstrated it to be structurally intact with normal
collagen banding and the presence of collagen bundles in the matrix of the
dermis and with structural preservation of the lamina densa and anchoring
fibrils of basement membrane complex.” Ex. 1004, 25:12–17; see Pet. 16,
39–40, 43. Further, “degradation of the basement membrane complex is
avoided and the structural integrity of the matrix is maintained including
collagen fibers and elastin” by Livesey’s pre-cryopreservation cleaning
process. Ex. 1004, 5:1–14; see Pet. 37, 41. Thus, Livesey’s method
“attempts to cool and store biological samples without causing structural and
functional damage.” Ex. 1004, 14:59–63; Ex. 1034 ¶¶ 72, 79.
We credit Dr. McQuillan’s testimony that an ordinarily skilled artisan
would understand these disclosures to reflect that “the native orientation of
the collagen fibers and the mechanical properties of the soft tissue are
maintained.” Ex. 1034 ¶ 65; id. ¶¶ 71–73, 78–81. For example,
Dr. McQuillan states “anchoring fibrils are more difficult to preserve than
collagen fibrils,” so an ordinarily skilled artisan “would recognize that
retaining these structural elements as described in Livesey is a sensitive
surrogate for maintaining the overall structural integrity of the internal
matrix,” including the native orientation of collagen fibers. Id. ¶ 73.
Further, “the functioning of [a] soft tissue graft is highly dependent on the
structure of the soft tissue graft and, therefore, where the structure of a soft
tissue graft is maintained, the function would be maintained as well.” Id.
¶ 81.
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We have considered Patent Owner’s counter-arguments, but we do not
find them persuasive. See PO Resp. 34, 38–42; Ex. 2016 ¶¶ 212–216. First,
Dr. Kaplan acknowledges Livesey’s statement that the cryopreserved tissue
is “structurally intact with normal collagen banding” (Ex. 1004, 25:12–17),
but concludes this is not sufficient to satisfy claim 1. Ex. 2016 ¶ 213;
PO Resp. 39. In support, Dr. Kaplan states: “Collagen banding is a pattern
characteristic of an assembled [individual] collagen fiber,” whereas claim 1
is directed to “the structure of a collection of several collagen fibers” which
is what determines whether the tissue matrix structure and the resulting
mechanical properties have been preserved. Ex. 2016 ¶¶ 147, 213 (citing
Ex. 2018, 4); id. ¶¶ 34–36 (discussing structure of “collagen bundles” and
“collagen fibers” in tissue matrix); PO Resp. 4–5, 39–40.
The foregoing testimony does not distinguish persuasively between
the “normal collagen banding” seen in Livesey’s cryopreserved tissue
(Ex. 1004, 25:12–17) and unaltered collagen fiber orientation as required by
claim 1. Livesey focuses specifically on preserving the collagen structure in
the tissue graft. See, e.g., Ex. 1004, Abstract (“A method for processing and
preserving an acellular collagen-based tissue matrix for transplantation is
disclosed.”), 1:15–30 (indicating the field of Livesey’s invention is to
preserve collagen-based tissues for transplantation, including “a selectively
preserved extracellular protein matrix . . . made up of collagen and other
proteins” to provide a structural template for population with new viable
cells within the host), 14:36–63.
We find Dr. Kaplan’s testimony attempting to differentiate between
collagen banding or bundles on the one hand, and the orientation of collagen
fibers on the other hand, to be confusing, undeveloped, and unsupported by
citation to evidence. See Ex. 2016 ¶¶ 147, 271. Dr. Kaplan does cite
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Exhibit 2018, page 4, as part of his testimony, but he does not explain how
Exhibit 2018 supports his testimony, and we are unable to draw the
connection ourselves. See id. We further credit Dr. McQuillan’s rebuttal
testimony that “if the collagen is damaged such that it is no longer similar to
normal hydrated tissue, the damage would be apparent in Livesey’s light
microscopy analysis,” and “[i]f the orientation of collagen fibers is altered,
this will be observed by changes in collagen bundles.” Ex. 1045 ¶ 46; Pet.
Reply 16.
Dr. Kaplan secondly takes issue with Dr. McQuillan’s testimony that
Livesey’s “structural preservation of the . . . anchoring fibrils of basement
membrane complex” (Ex. 1004, 25:12–17) is a sensitive surrogate for
maintaining the native orientation of collagen fibers. Ex. 2016 ¶¶ 148, 272;
PO Resp. 40. Dr. Kaplan states that the basement membrane is a “discrete
portion of the dermis layer of the skin,” so “information regarding the
basement membrane alone cannot inform a POSA about the state of the
entire dermal matrix.” Ex. 2016 ¶ 272 (citing Ex. 2041, 46, 47);
PO Resp. 40.
We find that Dr. McQuillan’s testimony in this regard is somewhat
overstated, in that he does not provide evidence that anchoring fibrils are
more difficult to preserve than collagen fibrils. Ex. 1034 ¶ 73; Ex. 1045
¶ 47. Nonetheless, Livesey’s disclosure that its cryopreservation process
structurally preserves the lamina densa and anchoring fibrils is consistent
with, and does support if not as strongly as Dr. McQuillan indicates, our
finding that Livesey’s cryopreservation process also leaves unaltered the
orientation of collagen fibers in the tissue matrix.
Dr. Kaplan thirdly takes issue with Livesey’s imaging methods, which
he describes as “zoom[ing] in with an electron microscope [to] view[] a
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single point of the tissue,” whereas the claimed invention requires “the
internal matrix must remain unaltered across the entire tissue to maintain
mechanical properties that are similar to normal hydrated tissue.” Ex. 2016
¶ 273 (citing Ex. 2042, 477); see PO Resp. 41; Sur-Reply 16–17. According
to Dr. Kaplan, determining Livesey’s cryopreserved tissue is “plasticized” as
required by claim 1 requires more than viewing the tissue under a
microscope, “such as through mechanical testing.” Ex. 2016 ¶ 273; see
PO Resp. 41. Dr. Kaplan testifies that the stress testing of Livesey’s
Example 4 is the only such testing reported in Livesey, and this testing
indicates the tissue’s physical properties are “changed as a result of the
freeze-drying and rehydration.” Ex. 2016 ¶ 274; Ex. 1004, 28:8–36, 28:52–
53 (stating Livesey’s cryopreserved, freeze-dried, and rehydrated grafts
“w[ere] found to be able to withstand greater stress load than control
samples”); see PO Resp. 41.
We find the foregoing testimony unpersuasive because it is
inconsistent with Livesey’s disclosure. Livesey concludes that microscopy
“[a]nalysis . . . has demonstrated” the cryopreserved tissue to be structurally
intact with normal collagen banding and other structural preservations.
Ex. 1004, 25:12–17. We credit Dr. McQuillan’s reply testimony that this
disclosure reflects more than zooming in on a single point of the tissue
matrix, as Dr. Kaplan would have it, and instead reflects “assessment across
multiple fields of tissue samples” in order to reach the disclosed conclusion.
Ex. 1045 ¶ 48; Pet. Reply 18–19.
For all of the foregoing reasons, we find Livesey’s cryopreservation
process does not alter the orientation of collagen fibers in the graft’s tissue.
Next, Dr. McQuillan and Dr. Kaplan agree that preserving the orientation of
collagen fibers is a crucial factor when ensuring that the mechanical
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properties of the graft, including material, physical, and use properties, are
similar to normal hydrated tissue. Dr. McQuillan testifies that “the
functioning of [a] soft tissue graft is highly dependent on the structure of the
soft tissue graft and, therefore, where the structure of a soft tissue graft is
maintained, the function would be maintained as well.” Ex. 1034 ¶ 81.
Dr. McQuillan further testifies Livesey’s disclosure reflects that “the native
orientation of the collagen fibers and the mechanical properties of the soft
tissue are maintained.” Id. ¶ 65; id. ¶¶ 71–73, 78–81. Dr. Kaplan similarly
testifies that “[t]he structural hierarchy and the precise orientation and
organization of the collagen chains is important in providing the properties
of the tissue” such that an “intact, hierarchical structure defines the material,
physical, and use features of that tissue.” Ex. 2016 ¶¶ 35–36.
Livesey’s disclosure is consistent with this testimony from the
technical experts. Livesey discloses “incubat[ing]” soft tissue samples in
glycerol, which is the same material disclosed by the ’986 patent as resulting
in tissue plasticization when tissue is soaked in the composition. See
Ex. 1004, 5:27–28, 11:17–18, 11:49–51, 12:31–33; Ex. 1003, 7:54–55. It is
unclear how or why subjecting the same materials (soft tissue) to the same
composition (glycerol) as part of the same process (incubation/soaking)
would not result in the same product, i.e., a tissue graft with mechanical
properties being similar to those of natural tissue. See Ex. 1034 ¶¶ 64, 72,
79; Ex. 1045 ¶¶ 34–35, 37.
Patent Owner’s rebuttal to the foregoing consideration directs us to
Dr. Kaplan’s testimony that Livesey provides stress test results of the tissue
disclosed in Example 4, which reflect that the tissue’s physical properties are
“changed as a result of the freeze-drying and rehydration.” Ex. 2016 ¶ 274.
In particular, Livesey indicates the cryopreserved, freeze-dried, and
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rehydrated grafts “w[ere] found to be able to withstand greater stress load
than control samples.” Ex. 1004, 28:8–36, 28:52–53. But, the issue here is
whether Livesey’s cryopreservation process — which Petitioner equates to
the plasticization required by claim 1 — leads to the mechanical properties
of the graft being similar to normal hydrated tissue. The testing of
Example 4 instead evaluates samples that have been cryopreserved, and
additionally freeze-dried and rehydrated. This testing therefore is not a fair
analysis of whether Livesey’s cryopreservation satisfies the plasticization
requirements of claim 1.18 Also, Livesey suggests that other examples
function in the same way as natural tissue, such as by supporting cell growth
within the tissue graft. See Ex. 1004, 25:18–42 (Example 1), 26:51–54
(Example 2). Thus, Dr. Kaplan does not explain persuasively how or why
Livesey’s incubating of the same material within the same composition
would not result in the same product, as in Walker and the ’986 patent.
Patent Owner further attacks Petitioner’s reliance on Livesey’s
examples, on the basis that Dr. McQuillan admits the cryoprotectants used in
the examples are not plasticizers. See Sur-Reply 13 (citing Ex. 1045 ¶ 35).
Patent Owner, however, mischaracterizes Dr. McQuillan’s testimony.
Dr. McQuillan pertinently states only that: “Although not all of the
cryoprotectants disclosed in Livesey are plasticizers as I understand that
term to be used in the [’986 patent] (e.g., sucrose, dextran), glycerol

18 The microscopy analysis that we cite above also was applied to
cryopreserved, freeze-dried, and rehydrated grafts. See Ex. 1004, 24:6–29
(cryopreservation), 24:30–64 (freeze-drying), 25:4–11 (storage and
rehydration), 25:12–17 (microscopy analysis of “the end product”).
However, we cite to the microscopy analysis as support for finding that the
orientation of the collagen fibers is maintained, which holds true for each of
the steps in the process if it holds true for the end product.
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certainly is.” Ex. 1045 ¶ 35. Moreover, we disagree with Dr. McQuillan’s
testimony that sucrose is not a plasticizer, because the ’986 patent expressly
identifies sucrose as a plasticizer, along with propylene glycol. Ex. 1003,
7:54–58. The cryopreservation solutions used in each of Livesey’s examples
all include sucrose, propylene glycol, or both. Ex. 1004, 24:7–18
(Example 1), 26:17–27 (Example 2), 27:28–34 (Example 3), 28:8–13
(Example 4), 29:40–47 (Example 5). Thus, we do not agree with Patent
Owner’s argument that Livesey’s examples are irrelevant here.
For the foregoing reasons, we find that Livesey discloses that the
mechanical properties, including material, physical, and use properties, of its
cryopreserved tissue grafts are similar to normal hydrated tissue, and that the
orientation of the collagen fibers is not altered by the cryopreservation.
3. Conclusion
For the reasons discussed above, we determine Petitioner has
demonstrated by a preponderance of the evidence that Livesey anticipates
claim 1.
C. Claims 2–6, 9–20, 23, and 24
Petitioner identifies disclosure in Livesey that teaches each limitation
in claims 2–6, 9–20, 23, and 24. See Pet. 44–56. Patent Owner does not
present any argument for these claims other than what we have already
considered with respect to claim 1. See LG Elecs., 759 F. App’x at 925
(“The Board is ‘not required to address undisputed matters’ or arguments
about limitations with which it was never presented.”); Papst, 924 F.3d
at 1250; Bradium, 923 F.3d at 1048. After considering the evidence and
arguments of record, we determine Petitioner has demonstrated by a
preponderance of the evidence that Livesey anticipates these claims.
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VIII. OBVIOUSNESS BASED ON LIVESEY
Petitioner argues that claims 1–6, 9–20, 23, and 24 would have been
obvious to an ordinarily skilled artisan in view of Livesey “[t]o the extent
any limitation of those claims is not explicitly disclosed in Livesey.”
Pet. 56. The claims challenged in this obviousness ground based on Livesey
are the same claims that are challenged in the anticipation ground based on
Livesey. The Petition’s argument for this ground spans less than two pages,
and the only limitation that is specifically addressed is the requirement of
“one or more plasticizers contained in said internal matrix.” See id. at 56–
57. As discussed above, Patent Owner does not challenge Petitioner’s
assertion that Livesey discloses the limitation in question, and we find that
Livesey discloses it. See supra § VII.B.1. Thus, the contingency for which
Petitioner offered this ground has not occurred.
Because Petitioner’s predicate for offering this back-up obviousness
ground is not met, we do not reach this ground. Having determined that
Petitioner has demonstrated by a preponderance of the evidence that 1–6, 9–
20, 23, and 24 are anticipated by Livesey, we need not reach the question of
whether these same claims also would have been obvious based on Livesey.
See Boston Scientific Scimed, Inc. v. Cook Group Inc., 809 Fed. Appx. 984,
990 (Fed. Cir. 2020) (rejecting argument that it is improper for the Board to
decline to address a petitioner’s alternative grounds with respect to claims it
found unpatentable on other grounds, and determining that “the Board need
not address issues that are not necessary to the resolution of the
proceeding”); see also Beloit Corp. v. Valmet Oy, 742 F.2d 1421, 1423 (Fed.
Cir. 1984) (explaining that an administrative agency “is at perfect liberty” to
reach a decision based on a single dispositive issue because doing so “can
not only save the parties, the [agency], and [the reviewing] court
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unnecessary cost and effort, it can greatly ease the burden on [the agency]
faced with a . . . proceeding involving numerous complex issues and
required by statute to reach its conclusion within rigid time limits”).
IX. OBVIOUSNESS OVER WALKER AND LIVESEY
Petitioner contends that claims 1–10, 13–25, and 27 would have been
obvious over Walker in view of Livesey. See Pet. 57–62. Petitioner offers
this ground to account for the possibility that Walker does not disclose four
claim elements, one of which is a plasticized soft tissue graft that does not
require refrigeration or freezing for storage. Id. at 58. Petitioner asserts that
Livesey teaches that feature. See id. at 59 (citing Ex. 1004, 6:6–11).
Petitioner contends that an ordinarily skilled artisan “would have been
motivated to combine the teaching in Livesey, that the tissue can be stored
for extended periods of time under ambient conditions, with the method of
Walker to provide a plasticized soft tissue graft that would not require
special conditions for storage.” Id. (citing Ex. 1034 ¶¶ 380–382).
According to Petitioner, an ordinarily skilled artisan “would have had a
reasonable expectation of success in combining the process of Walker with
these teachings of Livesey because Livesey teaches the same processing
steps as Walker and even lists glycerol, the pre-sterilizing substance used in
Walker, as an alternative substance that can be used with its own process.”
Id. (citing Ex. 1034 ¶ 382).
Patent Owner responds that Petitioner “fails to explain how a POSA
would actually combine the disclosures of Walker with Livesey or how [the]
combination would lead to the claimed method.” PO Resp. 43. Patent
Owner disputes Petitioner’s contention that Livesey teaches the same
processing steps as Walker by noting that “Livesey uses freeze-drying to
preserve its tissue, and Walker does not.” Id. at 45. Patent Owner argues
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that given the differences in Walker’s and Livesey’s processing steps, an
ordinarily skilled artisan would not have a reasonable expectation of success
in combining them. Id. (citing Ex. 2016 ¶ 288).
In its Reply, Petitioner has no response to these points from Patent
Owner other than to state, without support or explanation, that “there is no
merit to arguments that Walker cannot be combined with Livesey.” Pet.
Reply 25.
We agree with Patent Owner that Petitioner has not provided an
adequate explanation of how it proposes to combine Walker’s and Livesey’s
processes. Relatedly, we are not persuaded by Petitioner’s argument that an
ordinarily skilled artisan would have had a reasonable expectation of success
in combining the references in the claimed manner. To the extent
Petitioner’s proposed combination is to simply carry out Walker’s process
but apply Livesey’s teaching regarding storage conditions to Walker’s
product, Petitioner has not presented persuasive evidence that skilled
artisans would have reasonably expected success in doing so. We credit
Dr. Kaplan’s testimony that “the reason that the grafts of Livesey do not
require refrigeration or freezing and can be stored at room temperature is the
fact that the tissue is freeze-dried and intended for storage in its desiccated
state.” Ex. 2016 ¶ 289. Consequently, an ordinarily skilled artisan would
not expect success in combining Livesey’s teachings regarding storage
conditions “with the process of Walker without also combining the freeze-
drying process with Walker as well.” Id. And, as Patent Owner correctly
notes, the Petition does not specify incorporating any such freeze-drying
steps from Livesey into Walker’s process. PO Resp. 46.
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For the foregoing reasons, we determine that Petitioner has not
demonstrated by a preponderance of the evidence that claims 1–10, 13–25,
and 27 would have been obvious over Walker in view of Livesey.
X. OBVIOUSNESS OVER WALKER, LIVESEY, AND WERNER
A. Summary of Werner
Werner discloses methods of manufacturing “sclero protein
transplants.” Ex. 1006 at [57] (abstract). In particular, Werner discloses a
method in which tissue such as “raw dura matter from humans” is treated
with H2O2, degreased, rinsed, treated with a glycerin solution, and then
dried. Id. at 2:21–29. Werner discloses that the “glycerin impregnates the
transplant by a diffusion process.” Id. at 2:5–6. Werner discloses that its
“product is soft and no rehydration is necessary prior to its use.” Id. at 2:39–
40.
B. Analysis
In this ground, Petitioner challenges dependent claim 26 by adding
Werner to the base combination of Walker and Livesey. See Pet. 63 (“It
would . . . have been evident to a POSITA that Werner’s teaching could be
advantageously incorporated into the method of Walker and Livesey.”). The
addition of Werner does not remedy the deficiency discussed above
regarding the base combination of Walker and Livesey. See supra § IX.
Accordingly, we determine that Petitioner has not demonstrated by a
preponderance of the evidence that claim 26 would have been obvious over
Walker in view of Livesey and Werner.
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XI. CONCLUSION
The outcome for the challenged claims in this proceeding is set forth
below.19 In summary:

19 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 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).
20 As discussed in Section VIII, we do not reach this ground.
Claims

35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not shown
Unpatentable
11, 12 102(b) Walker 11, 12
1–3, 5, 9,
11–15,
23–25
103(a) Walker
1–3, 5, 9, 11–
15, 23–25
1–6, 9–
20, 23,
24
102(b) Livesey
1–6, 9–20, 23,
24

1–6, 9–
20, 23,
24
103(a) Livesey20

1–10,
13–25,
27
103(a) Walker and Livesey
1–10, 13–25,
27
26 103(a) Walker, Livesey, and Werner
26
Overall
Outcome
1–6, 9–20, 23,
24
7, 8, 21, 22,
25–27
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XII. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–6, 9–20, 23, and 24 have been proven by a
preponderance of the evidence to be unpatentable;
FURTHER ORDERED that claims 7, 8, 21, 22, and 25–27 have not
been proven by a preponderance of the evidence to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied;
FURTHER ORDERED that Patent Owner’s Motion to Exclude is
dismissed as moot;
FURTHER ORDERED that, no later than ten days after the issuance
of this decision, the parties may file a joint motion to seal, explaining why
the present decision should remain under seal, and including a redacted
version of this decision that can be made publicly available;
FURTHER ORDERED that the present decision shall remain under
seal until any joint motion to seal the present decision is resolved;
FURTHER ORDERED that the present decision shall be made public
if, after the expiration of the time for the parties to file a joint motion to seal,
no such motion has been filed; and
FURTHER ORDERED that, because this is a final written decision,
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:
Herbert D. Hart III
David D. Headrick
Alejandro Menchaca
Gregory C. Schodde
Scott P. McBride
McANDREWS, HELD & MALLOY, LTD.
hhart@mcandrews-ip.com
dheadrick@mcandrews-ip.com
amenchaca@mcandrews-ip.com
gschodde@mcandrews-ip.com
smcbride@mcandrews-ip.com

FOR PATENT OWNER:
Michael H. Jacobs
Deborah H. Yellin
Vincent J. Galluzzo
Shannon Lentz
Ali H.K. Tehrani (pro hac vice)
CROWELL & MORING LLP
mjacobs@crowell.com
dyellin@crowell.com
vgalluzo@crowell.com
slentz@crowell.com
atehrani@crowell.com