LifeNet Health

Patent Trials and Appeals Board

Aug 26, 2020

IPR2019-00569 (P.T.A.B. Aug. 26, 2020)

Trials@uspto.gov Paper 73
571-272-7822 Date: August 26, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

SURGALIGN SPINE TECHNOLOGIES, INC.,
Petitioner,1
v.
LIFENET HEALTH,
Patent Owner.

IPR2019-00569
Patent 6,458,158 B1

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

JUDGMENT
Final Written Decision
Determining No Challenged Claims Unpatentable
Dismissing Petitioner’s Motion to Exclude
Denying Patent Owner’s Motion to Exclude
35 U.S.C. § 318(a)

1 Petitioner recently filed Updated Mandatory Notices indicating that its
name has changed from RTI Surgical, Inc. to Surgalign Spine Technologies,
Inc. See Paper 72.
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Patent 6,458,158 B1
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I. INTRODUCTION
A. Background and Summary
Petitioner filed a Petition (Paper 2, “Pet.”) requesting inter partes
review of claims 1–15 of U.S. Patent No. 6,458,158 B1 (Ex. 1002, “the ’158
patent”). Patent Owner filed a Preliminary Response. Paper 10. We
instituted an inter partes review on all claims and all grounds asserted in the
Petition. See Paper 15 (“Dec. on Inst.”).
After institution of trial, Patent Owner filed a Patent Owner Response.
Paper 31 (“PO Resp.”).2 Petitioner filed a Reply. Paper 42 (“Pet. Reply”).
Patent Owner filed a Sur-Reply. Paper 57 (“Sur-Reply”). We held a hearing
on June 2, 2020, a transcript of which is included in the record. See Paper
70 (“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 not
shown by a preponderance of the evidence that claims 1–15 of the ’158
patent are unpatentable.

2 A public, redacted version of the Patent Owner Response was filed as
Paper 30.
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B. Real Parties in Interest
The parties list only themselves as real parties in interest. See Pet. 3;
Paper 4, 1.
C. Related Matters
Patent Owner asserted the ’158 patent against Petitioner in LifeNet
Health v. RTI Surgical, Inc., No. 1:18-cv-00146-MW-GRJ (N.D. Fla.), filed
June 27, 2018. See Pet. 3; Paper 4, 1. The parties also list another
proceeding at the Board as a related matter: Case IPR2019-00570, which
challenges U.S. Patent No. 8,182,532. See Pet. 3; Paper 4, 1.
D. The ’158 Patent
The ’158 patent relates to a composite bone graft for spinal fusion.
Ex. 1002, 1:10–16. Spinal fusion is a surgical procedure in which a patient’s
intervertebral disc is removed and replaced with an implant to fill the void
between adjacent vertebrae. See Ex. 2001 ¶ 21. After the implantation
procedure, the natural healing process of bones causes the vertebrae to fuse
together over time. Id.; Ex. 1016 ¶¶ 21–23. Implants for spinal fusion can
be made from various materials, including bone obtained from the patient,
which is referred to as autologous bone, or bone obtained from a human
donor, which is allogenic bone. See Ex. 1016 ¶ 25; Ex. 2001 ¶ 26. A bone
graft made from autologous bone is an autograft, and a graft made from
allogenic bone is called an allograft. See Ex. 1016 ¶ 25; Ex. 2001 ¶ 26.
The composite bone graft of the ’158 patent includes a plurality of
bone portions layered to form a graft unit and one or more biocompatible
connectors that hold the graft unit together. Ex. 1002, code (57) (Abstract),
1:10–16, 2:26–28. In the “Background of the Invention,” the ’158 patent
explains that the limited size of cortical bone grafts sometimes prevented
their use for spinal fusions:
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Patent 6,458,158 B1
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Strong cortical bone (the outer layer) is required as a strut in the
interbody position to prevent collapse of the disc space while
healing occurs. For example, cortical bone obtained from a
cadaver source fashioned into struts, is not wide enough for
optimum load bearing. This natural limitation often excludes the
use of a bone graft product.
Id. at 1:48–54. The ’158 patent also states that “[b]one grafts for spinal
application often fail because they are extruded from the implantation site
due to shifting, rotation, and slippage of the graft, are not cellularized, or fail
mechanically.” Id. at 1:62–65.
The ’158 patent purports to solve these problems with a composite
bone graft that can be sized for any application, promotes the growth of
patient bone at the implantation site, provides added stability and mechanical
strength, and does not shift, extrude, or rotate after implantation. Id. at
1:26–33, 2:1–7. Figure 6 of the ’158 patent is reproduced below:

Figure 6 is a perspective view of a composite
bone graft. Id. at 8:63–65.
As depicted in Figure 6, the composite bone graft is made up of a first
cortical bone portion 2, a second cortical bone portion 4, and a cancellous
bone portion 3 disposed between them. Id. at 19:61–63. Cortical bone
pins 7 hold the bone portions together. Id. at 19:63–64. The graft also
includes textured surfaces 14a and 14b. Id.
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Patent 6,458,158 B1
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E. Illustrative Claim
Petitioner challenges claims 1–15, which are all of the claims in the
’158 patent. Claims 1, 2, and 13–15 are independent claims. Claim 1 is
illustrative of the challenged claims and is reproduced below, with additional
line breaks to facilitate review:
1. A composite bone graft, comprising:
a first cortical bone portion;
a second cortical bone portion;
a cancellous bone portion disposed between said first cortical
bone portion and said second cortical bone portion to form a
graft unit; and
one or more bone pins for holding together said graft unit,
wherein said first cortical bone portion and said second cortical
bone portion are not in physical contact, and
wherein said composite bone graft does not comprise an
adhesive and
said bone graft is not demineralized.
Ex. 1002, 45:1–12 (additional line breaks added).
F. Prior Art References and Testimonial Evidence
Petitioner relies on the following references for its challenges:
Name Description Date Exhibit
Wolter
Wolter et al., “Bone Transplantation in the
Area of the Vertebral Column,” Accident
Medicine: Scientific and Clinical Aspects
of Bone Transplantation, vol. 185,
pp. 166–75 (1987).
1987 10103

3 Exhibit 1009 is the original, foreign language version of Wolter. Citations
to Wolter in this decision refer to the English translation in Exhibit 1010.
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Patent 6,458,158 B1
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Name Description Date Exhibit
Grooms U.S. Patent App. Pub. No. 2002/0138143 A1
Sept. 26,
2002 1003
4
Paul U.S. Patent No. 6,258,125 B1 July 10, 2001 1006
5
Coates U.S. Patent No. 5,989,289 Nov. 23, 1999 1008
6
Kozak U.S. Patent No. 5,397,364 Mar. 14, 1995 1012
Boyce U.S. Patent No. 6,123,731 Sept. 26, 2000 1011
7

4 Petitioner asserts that Grooms claims priority, as a continuation-in-part, to
U.S. Patent Application No. 08/920,630 (“the ’630 application”), filed
August 30, 1997. Pet. 20. Petitioner further asserts that Grooms qualifies as
prior art under 35 U.S.C. § 102(e) for its disclosure supported by the written
description of the ’630 application. Id. Patent Owner does not contest that
Grooms qualifies as prior art as to the disclosures cited by the Petitioner
cited in the Petition. PO Resp. 28, 28 n.5.
5 Petitioner contends that Paul claims priority to U.S. Provisional Patent
Application No. 60/095,209 (“the ’209 application”), filed August 3, 1998.
Pet. 23. Petitioner asserts that Paul is prior art under 35 U.S.C. § 102(e) as
to the disclosure supported by the written description of the ’209 application.
Patent Owner does not contest that Paul qualifies as prior art. See generally
PO Resp. 29–30.
6 Petitioner asserts that Coates is prior art under 35 U.S.C. § 102(e) because
the patent issued from an application filed October 9, 1997. Pet. 6. Patent
Owner does not contest that Coates qualifies as prior art. See generally PO
Resp.
7 Petitioner argues that Boyce qualifies as prior art under 35 U.S.C. § 102(e)
because the patent issued from an application filed February 6, 1998. Pet.
6–7. Patent Owner does not contest that Boyce qualifies as prior art. See
generally PO Resp.
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Patent 6,458,158 B1
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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
Michael C.
Sherman
Petitioner’s
technical expert8
Ex. 1015 (declaration of Feb. 18, 2019)
Ex. 2032 (transcript of deposition of Nov.
7, 2019)
Ex. 1026 (declaration of Feb. 25, 2020)
Ex. 2092 (transcript of deposition of Mar.
19, 2020)
Jeffrey S.
Fischgrund,
M.D.
Petitioner’s
technical expert9
Ex. 1016 (declaration of Feb. 18, 2019)
Ex. 2031 (transcript of deposition of Oct.
31, 2019)
Ex. 1028 (declaration of Feb. 23, 2020)
Ex. 2091 (transcript of deposition of Mar.
16, 2020)
John R.
Bianchi
Petitioner’s fact
witness10
Ex. 1025 (declaration of Jan. 24, 2020)
Ex. 2093 (transcript of deposition of Mar.
26, 2020)

8 See Ex. 1015 ¶ 1 (“I have been retained as an expert witness to offer
technical opinions on behalf of RTI Surgical, Inc. . . .”).
9 See Ex. 1016 ¶ 1 (“I have been retained as an expert witness to offer
technical opinions on behalf of RTI Surgical, Inc. . . .”).
10 See, e.g., Ex. 1025 ¶ 1 (“I continued working for RTI until 2006.”); id. ¶ 4
(“I can confirm that the [Confidential Memorandum of Understanding in Ex.
1024] is a record kept by RTI personnel in the ordinary course of
business.”).
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Witness Role Exhibits
Mark E.
Shaffrey,
M.D.
Patent Owner’s
technical
expert11
Ex. 2001 (declaration of June 6, 2019)
Ex. 2028 (declaration of Nov. 26, 2019)
Ex. 1037 (transcript of deposition of Feb.
5, 2020)
David L.
Kaplan,
Ph.D.
Patent Owner’s
technical
expert12
Ex. 2002 (declaration of June 6, 2019)
Ex. 2029 (declaration of Nov. 25, 2019)
Ex. 1038 (transcript of deposition of Jan.
31, 2020)
Barton D.
Gaskins
Patent Owner’s
fact witness13
Ex. 2030 (declaration of Nov. 26, 2019)
Ex. 103914 (transcript of deposition of
Jan. 29, 2020)
G. Asserted Grounds
Petitioner asserts that claims 1–15 are unpatentable on the following
grounds:
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–12 103(a)15 Wolter in view of Grooms
1, 2, 11, 12 103(a) Wolter in view of Paul
3–10 103(a) Wolter in view of Paul and Coates

11 See, e.g., Ex. 2001 ¶ 1 (“I have been retained by Patent Owner LifeNet
Health (“LifeNet”) as an expert. . . .”).
12 See Ex. 2002 ¶ 1 (“I have been retained as an expert witness on behalf of
LifeNet Health. . . .”).
13 See Ex. 2030 ¶ 1 (“I am currently a Senior R&D Manager for LifeNet
Health. . . .”); see also Tr. 61:8–21 (Patent Owner confirming that Mr.
Gaskins is a fact witness); Ex. 1022, 14:19–23 (same).
14 A public, redacted version of the Mr. Gaskins’ deposition was filed as
Ex. 1044.
15 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
Pub. L. No. 112–29, took effect on March 16, 2013. Because the application
that issued as the ’158 patent was filed before March 16, 2013, we apply the
pre-AIA version of § 103.
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Patent 6,458,158 B1
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Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
13 103(a)
Wolter in view of either (1) Grooms
or (2) the combination of Paul and
Kozak
14 103(a)
Wolter in view of either (1) Grooms
in combination with Boyce or
(2) Paul in combination with Boyce
15 103(a) Wolter in view of either (1) Grooms or (2) Paul
1, 2, 11, 12, 14 103(a) Boyce in view of either (1) Grooms or (2) Paul
See Pet. 5–7.
II. LEGAL STANDARDS FOR OBVIOUSNESS
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 non-obviousness such as “commercial
success, long-felt but unsolved needs, failure of others, etc.” Id. at 17–18.
“While the sequence of these questions might be reordered in any particular
case,” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407 (2007), the Federal
Circuit has explained that an obviousness determination can be made only
after consideration of all of the Graham factors. Kinetic Concepts, Inc. v.
Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012).
III. LEVEL OF ORDINARY SKILL IN THE ART
In our Decision on Institution, we adopted Petitioner’s proposal that
an ordinarily skilled artisan at the time of the invention of the ’158 patent
would have had the following education and experience:
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Patent 6,458,158 B1
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at least a bachelor’s degree in mechanical, biomechanical, or
biomedical engineering or a closely-related discipline, as well as
5–10 years of experience designing and developing orthopedic
implants and/or spinal interbody devices and/or bone graft
substitutes. Alternatively, such a person would typically have
had an advanced degree (master’s or doctorate) in one of the
above-identified fields, as well as 3 to 5 years of experience; or
would be a practicing orthopedic surgeon with at least five years
of experience.
Dec. on Inst. 9–10 (quoting Pet. 16–17).
Patent Owner proposes that an ordinarily skilled artisan
would have at least a B.S. in biology, chemistry, biochemistry,
biomedical engineering, or related fields, and two years of
research or work experience related to bone regeneration, bone
grafts, or tissue processing. Such experience may include
harvesting, processing, developing, and clinically using bone
grafts.
PO Resp. 16 (citing Ex. 2028 ¶¶ 19–24). Patent Owner argues that
Petitioner’s proposed level of skill in the art is not sufficiently related to the
relevant field, as the use of “and/or” in Petitioner’s proposal does not require
any experience with bone grafts. Id. at 17. At the oral hearing, however,
Petitioner confirmed that it agrees that an ordinarily skilled artisan must
have experience with bone grafts. Tr. 12:25–14:2. Consistent with the
parties’ agreement on this point, we determine that the level of ordinary skill
in the art requires experience with bone grafts, given the focus on composite
bone grafts in the ’158 patent’s claims and disclosure.
Petitioner’s proposal requires more education or experience than
Patent Owner’s proposal. Based on the full record developed during trial,
we find that Petitioner’s level of education and experience is more consistent
with the level of skill reflected in the prior art references of record and the
disclosure of the ’158 patent. See Daiichi Sankyo Co. v. Apotex, Inc., 501
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Patent 6,458,158 B1
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F.3d 1254, 1256 (Fed. Cir. 2007) (listing the type of problems encountered
in the art, prior art solutions to those problems, and the sophistication of the
technology as factors that may be considered in determining the level of
ordinary skill in the art). In particular, we are unpersuaded that persons with
an undergraduate degree and two years of experience with tissue processing
would have the capabilities that the ’158 patent ascribes to a person of
ordinary skill in the art, including the ability to select and employ methods
for demineralizing bone (Ex. 1002, 13:25–28, 18:41–43), the ability to select
appropriate dimensions for depressions or protrusions to provide an
interlocking fit of bone portions (id. at 14:12–17), the ability to employ
suitable methods for processing bone tissue for use in the graft (id. at 16:40–
43), the ability to select appropriate dimensions for the graft based on the
particular application and site of implantation in a patient (id. at 17:27–31),
and the ability to produce pins from cortical bone and to select the
appropriate number, orientation, and dimensions of pins (id. at 18:1–3,
27:42–56).
Accordingly, we generally adopt Petitioner’s proposed level of
ordinary skill in the art but modified to reflect that experience with bone
grafts is required. Thus, we determine that the person of ordinary skill in the
art would have had at least a bachelor’s degree in mechanical,
biomechanical, or biomedical engineering or a closely-related discipline, as
well as 5–10 years of experience designing and developing orthopedic
implants and/or spinal interbody devices and/or bone graft substitutes, at
least some of which experience includes working with bone grafts.
Alternatively, such a person would typically have had an advanced degree
(master’s or doctorate) in one of the above-identified fields, as well as 3 to 5
years of experience, at least some of which includes working with bone
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Patent 6,458,158 B1
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grafts. As still another alternative, the person of ordinary skill would be a
practicing orthopedic surgeon with at least five years of experience, at least
some of which experience includes working with bone grafts.
We also note that the differences between the parties’ proposed
definition of the level of ordinary skill in the art are not determinative. In
that regard, we agree with Patent Owner that the analysis would be
materially the same under either party’s proposed definition. See PO Resp.
18 (“Nevertheless, the analysis of the issues in this proceeding is the same
regardless of the level of skill ultimately adopted by the Board”).
IV. MOTIONS TO EXCLUDE
A. Petitioner’s Motion to Exclude
Petitioner moves to exclude Exhibits 2085 and 2086, which are two
claim charts Patent Owner relies on to support its assertions of nexus and
copying. See Paper 60. As explained below, we determine that Petitioner’s
obviousness challenges are unpersuasive even without evidence of
secondary considerations. Therefore, we dismiss Petitioner’s motion as
moot.
B. Patent Owner’s Motion to Exclude
Patent Owner moves to exclude Exhibits 1015, 1016, 1026, and 1028.
For the reasons below, we deny Patent Owner’s motion.
1. Exhibits 1015 and 1026
Patent Owner moves to exclude Exhibits 1015 and 1026, which are
declarations of Michael C. Sherman. See Paper 61. Patent Owner urges the
exclusion of Mr. Sherman’s testimony pursuant to Federal Rule of Evidence
702. Id. at 1; Paper 68, 1. Specifically, Patent Owner argues that Mr.
Sherman has insufficient experience regarding composite bone grafts for
spinal fusion and that certain opinions he expresses are based on insufficient
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facts. Paper 61, 4–12; Paper 68, 2–5. Relatedly, Patent Owner argues that
Mr. Sherman’s testimony regarding issues to be considered from the
perspective of an ordinarily skilled artisan is speculative and therefore
inadmissible under Federal Rule of Evidence 402. Paper 61, 4–5, 12.
Petitioner opposes the motion, arguing that Mr. Sherman has
extensive experience under any definition of the field of invention and
provides testimony with a sufficient factual basis. Paper 65, 7–14.
We are not persuaded that Mr. Sherman’s testimony should be
excluded. Mr. Sherman holds both a B.S. and M.S. in Biomedical
Engineering. Ex. 1015, 181. He has “over thirty years of experience in the
medical device industry,” including “over twenty years working in
orthopedic product development with a particular emphasis on spine
implants and instrumentation.” Id. ¶ 5; see also id. ¶¶ 3–8 (describing
education and experience related to spinal implants and bone grafts); Ex.
1026 ¶¶ 14–27 (same). His experience includes developing allogenic bone
spinal implants and cortical bone screws. Ex. 1026 ¶¶ 19–25. Mr. Sherman
testifies that his experience most directly relevant to the design of spinal
bone grafts occurred between 1991 and 2006. Ex. 1026 ¶ 14. Thus,
Mr. Sherman qualifies as a person of ordinary skill in the art under the
definition we have adopted. See supra § III.
Moreover, complete overlap between a witness’s technical
qualifications and the field of the invention is not necessary for the witness’s
testimony to be admissible under Federal Rule of Evidence 702. For
example, the Federal Circuit has upheld a district court’s admission under
Rule 702 of the testimony of a witness who lacked experience in the design
of the patented invention, but had experience with materials selected for use
in the invention. See SEB S.A. v. Montgomery Ward & Co., Inc., 594 F.3d
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1360, 1372–73 (Fed. Cir. 2010); see also Patent Trial and Appeal Board
Consolidated Trial Practice Guide November 201916 at 34 (“There is . . . no
requirement of a perfect match between the expert’s experience and the
relevant field.”). Mr. Sherman has extensive experience and expertise
related to spinal implants, including experience related to spinal bone grafts.
Ex. 1015 ¶¶ 3, 5–7; Ex. 1026 ¶¶ 14–27. Mr. Sherman’s lack of experience
specific to composite spinal bone grafts may detract from the weight to be
given his testimony on certain matters, but it does not render his testimony
inadmissible under Rule 702 or 402.
To support its motion, Patent Owner relies heavily on Sundance, Inc.
v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008). See Paper 61,
4–11. There, the Federal Circuit reviewed the district court’s denial of a
motion to exclude a patent lawyer having no relevant technical expertise
from testifying in a jury trial. Sundance, 550 F.3d at 1361–62. The Federal
Circuit held that because the patent attorney “was never offered as a
technical expert, and in fact was not qualified as a technical expert, it was an
abuse of discretion for the district court to permit him to testify as an expert
on the issues of noninfringement or invalidity.” Id. at 1362. The Federal
Circuit further explained:
The court, in its role as gatekeeper, must exclude expert
testimony that is not reliable and specialized, and which invades
the province of the jury to find facts and that of the court to make
ultimate legal conclusions. Allowing a patent law expert without
any technical expertise to testify on the issues of infringement
and validity amounts to nothing more than advocacy from the
witness stand.

16 Available at www.uspto.gov/sites/default/files/documents/tpgnov.pdf.
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Id. at 1364–65. Here, Mr. Sherman is offered as a technical expert, and he
has substantial technical expertise related to the field of the ’158 patent.
Moreover, in this proceeding, fact-finding and legal determinations are
carried out by the same panel of administrative patent judges, which
eliminates the concern of invading the jury’s province. These distinctions
make Sundance inapposite as a basis for excluding Mr. Sherman’s
testimony.
For the foregoing reasons, we deny Patent Owner’s motion to exclude
Exhibits 1015 and 1026.
2. Exhibits 1016 and 1028
Patent Owner moves to exclude Exhibits 1016 and 1028, which are
declarations of Jeffrey S. Fischgrund, M.D. See Paper 61. Patent Owner
asserts that Dr. Fischgrund’s testimony regarding the state of the art prior to
January 1999 should be excluded pursuant to Federal Rules of Evidence 702
and 402 because they are not based on sufficient facts. Id. at 5, 13–14;
Paper 68, 5. In opposition, Petitioner counters that Dr. Fischgrund’s
testimony is based on his personal knowledge and experience. Paper 65,
13–14 (citing Ex. 1016 ¶ 11, 32–46; Ex. 1028 ¶ 3–4, 8–11; Ex. 2091, 110:9–
13).
We are not persuaded that Dr. Fischgrund’s testimony should be
excluded. Dr. Fischgrund testifies that he has performed spinal fusion
surgery since 1993, and has performed over 5,000 spinal and cervical
fusions in his career. Ex. 1016 ¶ 11. Dr. Fischgrund states that his
knowledge regarding the state of the art is based on the “compendium of my
knowledge of the state-of-the-art, my practice, my partners’ practice, my
knowledge in the field, and expertise in the field.” Ex. 2091, 110:9–13.
Moreover, Dr. Fischgrund cites to contemporaneous publications to support
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his testimony regarding the state of the art throughout the 1980s and 1990s.
Ex. 1028 ¶¶ 9–10. Patent Owner’s arguments go to the weight to be given
Dr. Fischgrund’s testimony, not its admissibility. Accordingly, we deny
Patent Owner’s motion to exclude Exhibits 1016 and 1028.
V. 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).” See Changes to
the Claim Construction Standard for Interpreting Claims in Trial
Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340,
51,358 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective
November 13, 2018) (now codified at 37 C.F.R. § 42.100(b) (2019)).17 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).
The only term that requires express construction is “composite bone
graft.” That phrase appears in each of the challenged claims. In the
Decision on Institution, we preliminarily construed “composite bone graft”
to mean “a bone graft which is made up of two or more distinct bone
portions,” which is the definition in the ’158 patent and the construction
proposed by Petitioner. Dec. on Inst. 11–12 (citing Ex. 1002, 12:49–51; Pet.
17). Following institution, Patent Owner agreed with that construction. PO
Resp. 19. Therefore, we maintain the construction of “composite bone

17 The Petition in this case was filed February 19, 2019. See Paper 3, 1.
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graft” in our Decision on Institution, which construction is agreed on by both
parties and supported by the intrinsic record.
The parties also propose different meanings for the term
“[cortical/cancellous] bone portion.” See PO Resp. 19 (proposing “distinct
piece(s) of bone made solely of [cortical or cancellous] bone”); Pet. Reply 2
(proposing “part or piece of [cortical/cancellous] bone”). We determine that
we need not construe “[cortical/cancellous] bone portion” because even
assuming that this limitation is taught by the references Petitioner relies
upon, we still are not persuaded that Petitioner has demonstrated
obviousness for the reasons discussed below. Thus, construing
“[cortical/cancellous] bone portion” is not necessary to resolve the parties’
dispute. 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).
VI. OBVIOUSNESS GROUNDS LED BY WOLTER
Wolter is the primary reference in each of Petitioner’s first six
grounds. Each of Petitioner’s obviousness challenges led by Wolter relies
on a base combination of Wolter with a reference that teaches a bone pin,
either Grooms or Paul. As discussed in greater detail below, Petitioner’s
proposed combination involves converting Wolter from an autograft to an
allograft and substituting a bone pin (from Grooms or Paul) for Wolter’s
metal screw. Petitioner’s arguments regarding the motivation to modify
Wolter in those ways are common to all of the Wolter-led grounds. See Pet.
27–28, 42–43, 46–47, 53, 57, 62–63; Tr. 35:13–17. Likewise, Patent Owner
presents the same arguments concerning motivation for the Wolter and
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Grooms combination as for the Wolter and Paul combination. See PO Resp.
35–48. Our discussion below focuses on these disputed issues regarding the
motivation to combine Wolter with Grooms or Paul, which issues are
dispositive of all of the Wolter-led grounds.
A. Summary of Wolter
Wolter describes methods of bone transplantation in the vertebral
column. Ex. 1010, 4. The portion of Wolter’s disclosure of greatest
relevance to Petitioner’s challenges is its description of using a “composite
corticospongial block,” also referred to as a “sandwich block.” Figure 1e of
Wolter is reproduced below:

Figure 1e depicts the sandwich block. Id. at 10.
Wolter describes the sandwich block as follows:
This transplant is characterized in that several large
corticospongial bone pieces are united by 1 or 2 small-fragment
spongiosa screws into a fixed block. The removal is carried out
from the iliac wing. The large bone piece is sawed into 2 or 3
parts, which can be placed against one another in a precisely-
fitting manner. This composite corticospongial block has a high
load resistance and is able to bridge over even large defects.
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Id. at 5 (citations omitted).
In preparing the sandwich block transplant, Wolter discloses that
“[o]nly autologous material should be used upon bone transplantation in the
vertebral column area for the filling out of defects and for accumulations, as
well as for intersegmental stiffening.” Id. at 9.
B. Summary of Grooms
Grooms relates to a bone implant for use in spinal fusion procedures.
Ex. 1003 ¶ 3. Specifically, Grooms describes “a cortical bone intervertebral
implant having a substantially ‘D’- or bread-loaf-shaped structure having a
canal into which osteogenic, osteoinductive, or osteoconductive materials
may be packed, which sustains spinal loads, and which is remodeled into the
spine in the course of fusion.” Id. ¶ 9. Figure 8A of Grooms is reproduced
below:

Figure 8A shows implant 800 made of two side-
by-side halves 801A and 801B of cortical bone.
Id. ¶ 49.
Grooms discloses that the implant halves can be held together by drilling
holes through the implants and forcing pins, made of cortical bone, through
the holes. Id. ¶¶ 48–49. Grooms discloses that the implant may be made of
autograft or allograft bone. Id. ¶ 24.
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C. Summary of Paul
Paul discloses an allogenic intervertebral implant for spinal fusion.
Ex. 1006, 1:9–11, 2:12–14. Figure 7 of Paul is reproduced below:

Figure 7 shows a side view of implant 50. Id. at 3:1.
Implant 50 includes top and bottom portions 52, 54, which are retained
together with pins 64 passing through aligned holes 66. Id. at 4:58–60.
“Although pin 64 can be made of any biocompatible material, pin 64 is
preferably made of allogenic bone.” Id. at 4:60–62.
D. Analysis of Petitioner’s Proposed Combinations Based on Wolter
1. Claim 1
a) Petitioner’s Proposed Combination
Petitioner contends in Ground 1 that Wolter teaches each limitation of
claim 1, except for the limitation of one or more bone pins to hold together
portions of the graft. See Pet. 27–31, 42–45. Petitioner asserts that Grooms
teaches the bone pin limitation, and that an ordinarily skilled artisan would
have been motivated to incorporate that feature from Grooms into Wolter.
Id. at 29–30. Petitioner also contends in Ground 2 that Paul teaches the bone
pin limitation, and that an ordinarily skilled artisan would have been
motivated to incorporate that feature from Paul into Wolter. Id. at 42–45.
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In the Decision on Institution, we noted that the specific manner in
which Petitioner proposes to combine Wolter with Grooms in Ground 1 was
unclear. Dec. on Inst. 21. In particular, we explained that “Petitioner does
not specify whether the proposed combination contemplates making and
inserting an autologous bone pin during Wolter’s autograft procedure, or
whether Wolter’s autograft is modified to be an allograft in the proposed
combination.” Id. As to the former possibility, our assessment based on the
preliminary record was that Petitioner had not shown a sufficient motivation
or reasonable expectation of success for that manner of combining Wolter
and Grooms. Id. at 21–23. But we understood Petitioner’s challenge to
encompass combinations in which Wolter’s implant, including a bone pin,
was made from allogenic bone, and as to that second possibility, we
determined that Petitioner had made a sufficient showing regarding
motivation and reasonable expectation of success to justify institution. Id. at
23–25. We also determined that, for Ground 2, “Petitioner’s arguments . . .
make it clear that the proposed combination modifies Wolter to be an
allograft” in light of Paul. Id. at 27.
Following institution, Patent Owner disputed that one of ordinary skill
in the art would have been motivated to combine the bone pins of Grooms or
Paul with Wolter. See PO Resp. 35–48. Patent Owner’s motivation
arguments addressed three potential ways of combining Wolter with Grooms
or Paul: first, an autograft implant from Wolter with an autologous bone pin
from Grooms (id. at 37–38); second, an autograft implant from Wolter with
an allogenic bone pin from Grooms (id. at 38–42); and third, an allograft
implant based on Wolter with an allogenic bone pin from Grooms or Paul
(id. at 42–48).
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In its Reply, Petitioner asserted that its position “has always been that
it would have been obvious to make the Wolter graft from allogenic bone.”
Pet. Reply 9.18 With that clarification, we need not address potential
combinations in which Wolter remains an autograft because Petitioner has
made clear that its challenge is based on modifying Wolter to an allograft.
b) Summary of Parties’ Arguments Regarding Motivation
Petitioner argues that an ordinarily skilled artisan “would have known
that the Wolter graft could be advantageously prepared from allograft bone
. . . because the advantages of allograft bone over autograft bone were well-
understood before the relevant date of the 158 patent.” Pet. 41 (citing Ex.
1003 ¶ 24; Ex. 1015 ¶¶ 392–397); see also id. at 42 (“By the late 1990s, . . .
it was well-accepted that the preparation of spinal implants from allograft
bone . . . was preferred to the use of autograft bone.”) (citing Ex. 1016
¶¶ 36–39). Petitioner argues that at the time of the ’158 patent’s invention in
1999, allografts were a known alternative that avoided morbidity associated
with harvesting autograft bone. Pet. Reply 10 (citing Ex. 1015 ¶¶ 317–318;
Ex. 1037, 20:15–19, 37:12–18; Ex. 1039, 131:11–12). According to
Petitioner, Wolter would not have led ordinarily skilled artisans away from
allograft bone because by 1999, allograft implants were widely used and
Wolter’s reasons for using exclusively autograft bone “were outdated.” Id.
at 11 (citing Ex. 1028 ¶¶ 12–17). Petitioner points to testimony from
Dr. Shaffrey that “in the time of 1999, there was a significant move away
from using autologous bone.” Id. (quoting Ex. 1037, 89:12–91:9); see also

18 Furthermore, Petitioner did not present any argument in its Reply or at
oral argument directed to a combination in which Wolter remains an
autograft. See generally Pet. Reply; Tr. 33:22–35:17.
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id. at 12 (disputing Patent Owner’s assertion that autograft was preferred to
allograft at the time of the invention) (citing Ex. 1039, 128:2–129:5).
As to replacing Wolter’s metal screw with a bone pin, Petitioner
argues that an ordinarily skilled artisan would have been motivated to make
that substitution in order to eliminate a permanent foreign body in the
patient’s spine and to avoid potential complications from loosening of the
screw. Pet. 27–28 (citing Ex. 1015 ¶¶ 300, 348); see also id. at 42 (same
arguments as to combination of Wolter and Paul). Petitioner further argues
that an ordinarily skilled artisan “would have had a reasonable expectation
of successfully making such a substitution because Grooms discloses that
bone pins are suitable to secure distinct portions of a composite bone graft
together.” Id. at 30 (citing 1015 ¶¶ 77–79); see also id. at 42–43 (same
argument as to combination of Wolter with Paul’s bone pin). Petitioner
contends that a bone pin of sufficient strength could be made and inserted
into Wolter’s graft. See Pet. Reply 13–15.
Patent Owner disputes that ordinarily skilled artisans would have been
motivated to make either of the changes to Wolter that Petitioner proposes.
Regarding converting Wolter from an autograft to an allograft, Patent Owner
argues that “Wolter explicitly teaches away from making its graft
configuration from allogenic donor bone.” PO Resp. 44 (citing Ex. 1010, 4,
9). And Patent Owner argues that autografts remained the gold standard
even in 2009, so ordinarily skilled artisans at the time of the invention would
not have “overlook[ed] Wolter’s disavowal of allogenic bone.” PO Resp.
44–45; see Sur-Reply 11–12.
With respect to substituting a bone pin for Wolter’s metal screw,
Patent Owner argues that Wolter’s stacking of three pieces of iliac crest
would prevent a precise fit, which negatively affects stability and detracts
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from Petitioner’s arguments regarding motivation and reasonable
expectation of success. PO Resp. 43; Sur-Reply 13. Patent Owner further
argues that a bone pin impelled through three stacks of iliac crest allografts,
as Petitioner proposes, would break and could not withstand the compressive
forces imposed by Wolter’s configuration. PO Resp. 44; Sur-Reply 14–15.
c) Analysis of Motivation to Combine
We agree with Patent Owner that Petitioner has not shown
persuasively that a skilled artisan would have been motivated to make the
proposed modifications to Wolter, or would have reasonably expected
success in doing so. Our discussion below separately addresses the two
modifications Petitioner proposes to make to Wolter’s graft.
(1) Modifying Wolter to Allograft
Looking first at Petitioner’s modification of Wolter from an autograft
to an allograft, we find that Wolter teaches away from using allogenic bone
because it repeatedly emphasizes that only autologous bone should be used.
See KSR, 550 U.S. at 416 (explaining that when the prior art teaches away
from a combination, that combination is more likely to be nonobvious); see
also PO Resp. 44 (arguing that Wolter teaches away); Sur-Reply 10 (same).
In the first sentence of the article, Wolter discloses that “[a]utologous bone
transplantation represents . . . the most important measure for achieving the
surgical objective.” Ex. 1010, 4. “The use of exclusively autologous bone
material therefore appears to be necessary” for several reasons, including
that “[a]utologous bone material represents, in accordance with the general
view, the best transplant material.” Id. Wolter returns to this point in its
Summary section at the end of the article, explaining again that “[o]nly
autologous material should be used upon bone transplantation in the
vertebral column area for the filling out of defects and for accumulations, as
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well as for intersegmental stiffening.” Id. at 9. And each of the three forms
of transplants that Wolter describes use autologous bone. Id. at 5.
Petitioner’s proposed combination, which requires modifying Wolter’s
autologous bone graft to an allograft, runs counter to Wolter’s explicit
teachings that only autologous bone should be used.
Petitioner argues that ordinarily skilled artisans would have
understood Wolter’s teachings in 1987 to use only autologous bone as
“outdated” by 1999 because by then, allografts had been developed and were
a well-known and widely used alternative to autografts. Pet. Reply 10–11.
Yet the record evidence supports Patent Owner’s responsive point that
allograft implants were already available, known, and used at the time of
Wolter’s publication in 1987. See Sur-Reply 10. Petitioner’s expert, Dr.
Fischgrund, testifies that surgeons were aware of allograft becoming more
available in the 1980s. Ex. 2091, 116:6–22; see also Ex. 1028 ¶ 6 (“[I]n the
1980s, a notable shift in thinking occurred among surgeons, and they began
substituting allografts . . . for traditional autograft surgeries.”) (quoting
Ex. 2035, 1). Dr. Fischgrund took note of a publication showing that in
1985, 5,000–10,000 allograft procedures were performed. Ex. 1028 ¶ 6
(citing Ex. 2035, 1). Dr. Fischgrund agreed that a surgeon who published or
wrote journal articles would have known of the availability of allograft
implants in the late 1980s. Ex. 2091, 121:9–16. Dr. Wolter was the head
physician in the Department for Accident, Restoration and Manual Surgery
at the St. Georg General Hospital and a journal editor. Ex. 1010, 1–2, 4.
Despite Dr. Wolter fitting Dr. Fischgrund’s profile for a person who would
have known of the availability of allograft implants, Wolter taught
exclusively using autologous bone materials in 1987. Ex. 1010, 4. While
Dr. Fischgrund testifies that allografts became more popular between the
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mid-1980s and the mid-1990s (Ex. 1028 ¶ 6), the salient point is that
allografts were already known, available, and used by the time Wolter was
published. Against this backdrop, we are not persuaded by Petitioner’s
argument that the availability of allografts as an alternative to autografts
would have led an ordinarily skilled artisan in 1999 to dismiss Wolter’s
teachings away from allogenic bone as outdated.
The parties dispute whether ordinarily skilled artisans would have
preferred autografts or allografts in 1999. PO Resp. 44–45; Pet. Reply 12;
Sur-Reply 11–13. Patent Owner presents testimony and contemporaneous
articles showing that autografts were the “gold standard” at that time and for
some years afterward. See Ex. 2012, 4; Ex. 2039, 1; Ex. 2011, 1; Ex. 2035,
1; Ex. 2005, 2; Ex. 2014, 1–2; Ex. 2028 ¶¶ 107–109. Petitioner presents
countervailing evidence, including cross-examination testimony from Patent
Owner’s witnesses, suggesting that a shift toward allogenic sources had
taken root by 1999. See Ex. 1037, 89:12–91:9; Ex. 1039, 128:2–129:5; Ex.
1028 ¶ 8. While the record includes evidence supporting both parties’
contentions, Patent Owner’s collection of numerous publications from the
late 1990’s through the next decade describing autografts as the gold
standard represents a strong showing that in 1999, autografts were the more
widely studied and accepted option. See Ex. 2091, 132:24–133:5. However,
we need not decide whether ordinarily skilled artisans in 1999 preferred
autografts or allografts in the abstract. The pertinent question is narrower
and more focused: whether an ordinarily skilled artisan in 1999 would have
been motivated to modify Wolter’s autograft to an allograft.
On that question, we are not persuaded that if ordinarily skilled
artisans in 1999 were interested in creating an allograft, they would have
begun with Wolter, an obscure reference from 12 years earlier, and adapted
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it to an allograft against the reference’s teachings. See PO Resp. 27
(“Wolter’s graft was not accepted or even well-known in the industry in
1999”). Dr. Shaffrey testifies that in the more than 30 years since its
publication, only four German papers have cited Wolter. Ex. 2028 ¶ 74 n.5.
Despite their substantial experience, none of Mr. Sherman, Dr. Fischgrund,
or Dr. Shaffrey were familiar with Wolter before this case began. See
Ex. 2032, 107:8–18 (Mr. Sherman testifying that he had no memory of
having read Wolter before this case); Ex. 2091 (Dr. Fischgrund testifying
that he first saw Wolter in late 2018); Ex. 2001 ¶ 48 (Dr. Shaffrey testifying
that “I am not aware of anyone performing the procedure in Wolter where
multiple blocks are stacked and connected with a metal screw and inserted
into the patient’s spine.”).
Wolter uses autologous bone that is harvested and then implanted in a
single procedure. Ex. 1010, 5 (“Both operating areas are covered
simultaneously, so that the removal of the bone material can be carried out
either in a staggered manner or simultaneously with the vertebral column
operation.”); Ex. 1015 ¶ 43 (“As disclosed by Wolter, autologous bone is
taken from the patient at the time of surgery for use as a transplant.”); PO
Resp. 24 (“Wolter’s procedure follows the traditional Smith-Robinson
methods and principles of harvesting and transplanting autografts.”);
Ex 2028 ¶ 75 (same). In such procedures, surgeons seek to limit the
harvest-to-implant time to the extent possible. Ex. 2028 ¶ 39; Ex. 2031,
47:4–19. Dr. Shaffrey testifies that once a bone block has been removed
from the patient’s iliac crest, “[a]ny time spent on modifying the block
means extended operative times, which translates to potentially higher risks
and complications for the patient.” Ex. 2028 ¶ 39. Dr. Fischgrund testifies
that typically in a Smith-Robinson procedure, “it should take less than five
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minutes to revise a graft after you cut it.” Ex. 2031, 48:5–10. Aside from
time constraints, Dr. Shaffrey explains that “the type of instruments we have
available in the operating room for shaping bone are very, very rudimentary
and difficult.” Ex. 1037, 90:25–91:2.
Wolter’s teaching to stack together pieces of iliac crest in a sandwich
block is a way of filling out a large defect with an autograft that can be
created during surgery. Ex. 1010, 5; Ex. 1015 ¶¶ 44, 49; Ex. 2028 ¶¶ 76–77,
79. Allografts need not be fashioned in an operating room during a time-
limited procedure because “[t]hey are harvested from donated bone of a
cadaver.” Ex. 2028 ¶ 41; see also Ex. 2032, 131:17–132:11 (Mr. Sherman
testifying that in the proposed modification of Wolter to an allograft, it could
be manufactured “in a more refined setting,” and it is “unlikely to be done”
in an operating room because it “wouldn’t be an efficient use of an operating
room”). Thus, as Dr. Fischgrund testifies, “[a]llograft bone can be cut,
machined and assembled to specific configurations and sizes. . . .” Ex. 1016
¶ 38. Considering these differences, we are not persuaded that an ordinarily
skilled artisan seeking to make an allograft in 1999 would have turned to
Wolter, which was tailored to the demands of filling a large defect using an
autograft that can be made during surgery. See Sur-Reply 14 (arguing that
“[t]here is no record evidence that a POSA would have made an allograft
having the structure of Wolter’s allograft”).
While Wolter’s sandwich block may have been expedient and suitable
for the application in which it was intended, we find persuasive
Dr. Shaffrey’s blunt assessment that “it makes no sense to make an allograft
by stacking two or three iliac crest bones.” Ex. 2028 ¶ 104. As Dr. Shaffrey
explains, the irregular surfaces of the iliac crest would impede a precise fit at
the interfaces of the sandwich block. Id. ¶ 105; see also Ex. 1037, 90:20–24
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(Dr. Shaffrey explaining in cross-examination testimony that “iliac crest is
very difficult to work with” and getting pieces of iliac bone “to fit together is
extremely challenging and time-consuming”); Ex. 2032, 112:23–113:14
(Mr. Sherman explaining that Wolter’s graft would not easily rotate, one
section to the other, because of the “slanted . . . and irregular surfaces” of the
bone portions that are in contact with each other in the middle of the graft).
And an imprecise fit, Patent Owner convincingly notes, would negatively
impact the stability of the graft. PO Resp. 43 (citing Ex. 2030 ¶ 27).
Dr. Shaffrey testifies, with citation to several publications, that a more
linear and precise fit would be provided using long bone, which has been the
traditional source of allograft bone. Ex. 2028 ¶ 105. Dr. Shaffrey’s
testimony is supported by Dr. Fischgrund’s cross-examination testimony
that he has never used an allograft version of Wolter’s sandwich block
because he “didn’t have to,” and instead he “found other ways of using
allograft” — namely, stacking pieces of long bone. Ex. 2091, 127:15–
128:10; see also id. at 77:18–21 (testifying that before switching to PEEK
cages in 2008, “when you had a large bony defect and you needed
something bigger, the fibular allograft was the best option”).
For these reasons, we are not persuaded that ordinarily skilled artisans
would have been motivated to modify Wolter’s sandwich block to be an
allograft.
(2) Substituting Bone Pins for a Metal Screw
In addition to converting Wolter to an allograft, Petitioner also
proposes to substitute a bone pin for Wolter’s metal screw. For the
following reasons, we agree with Patent Owner that Petitioner has not shown
that an ordinarily skilled artisan would have been motivated to make that
substitution, or would have reasonably expected success in doing so.
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At the outset, we note that the Petition presents reasons for the
substitution that are rational when considered in isolation. See Pet. 27–28
(citing Ex. 1015 ¶ 300) (arguing that replacement with bone pin would
eliminate permanent foreign body in the patient’s spine and avoid potential
complications from loosening of the bone screw). However, the arguments
and evidence of record lead us to conclude that these potential benefits
would not have motivated the proposed combinations, considering the
disclosure of the references and the technical obstacles that an ordinarily
skilled artisan would have expected to encounter in making the proposed
substitution.
Petitioner’s and Patent Owner’s witnesses are in agreement that bone
pins are weaker than the metal bone screws that Wolter teaches. See
Ex. 1010, 5; see also Ex. 1015 ¶ 45 (Mr. Sherman summarizing that in
Wolter, the graft is assembled “by securing its several sections together with
small-fragment cancellous bone screws”); Ex. 2032, 112:15–17 (Mr.
Sherman agreeing that a small-fragment cancellous bone screw is a metal
screw). Dr. Shaffrey testifies that “a bone pin is significantly weaker than a
metal screw.” Ex. 2028 ¶ 103; see also id. ¶ 102 (explaining that allograft
bone pins are brittle due to extensive processing prior to use). Mr. Gaskins
elaborates on that point, explaining that “[m]etal screws like cancellous bone
screws are much stronger than bone pins and can be created in much larger
sizes because they can be fabricated in virtually any size. Bone pins have to
be very small because they need to be sourced from a unitary piece of donor
bone.” Ex. 2030 ¶ 16. Mr. Sherman agreed in his cross-examination
testimony that a small-fragment cancellous bone screw is stronger than a
cortical bone pin in all axes. See Ex. 2032, 114:2–7. Thus, we agree with
Patent Owner that the proposed substitution of a bone pin for a metal screw
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runs counter to Wolter’s goal to fulfill a recognized need for “a transplant
that is as large and stressable as possible.” Ex. 1010, 5; PO Resp. 47–48;
Sur-Reply 15.
Moreover, Patent Owner persuasively argues that technical difficulties
would have impaired the use of a bone pin in a graft of Wolter’s
configuration, which undermines Petitioner’s motivation arguments as well
as its argument that skilled artisans would have reasonably expected success.
See PO Resp. 39, 43. In particular, the evidence supports Patent Owner’s
argument that Wolter’s stack of three large, irregularly shaped pieces of iliac
bone would be difficult to precisely line up for a bone pin, and it is doubtful
that a bone pin could withstand the force needed to impel a bone pin through
the three sections and their irregular interfaces. See id. As discussed above,
Dr. Shaffrey and Mr. Sherman both describe the surfaces of the iliac bone
sections that are joined together in Wolter’s sandwich block as “irregular.”
Ex. 2028 ¶ 105; Ex. 2032, 112:23–113:14. That description is consistent
with the photographs of the sandwich block in Wolter itself. Ex. 1010, 10
Figs. 1(e)–(f).
As Mr. Gaskins explains, bone pins stabilize allografts through an
“interference fit,” which requires a bone pin to be inserted into a hole that is
slightly smaller than the diameter of the bone pin. Ex. 2030 ¶ 20.19

19 While we recognize that Mr. Gaskins is a fact witness (see supra note 12),
we note that Petitioner did not move to exclude this aspect, or any other
aspect, of Mr. Gaskins’ testimony under Federal Rule of Evidence 701.
Moreover, the testimony appears to be within the scope of Mr. Gaskins’
experiences and observations. See, e.g., Ex. 2030 ¶ 23 (“I have personally
spent hundreds of hours . . . with many failures and many broken pins,
working out the right dimensions of the bone pins and the holes into which
they are inserted.”).
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Successfully creating this interference fit requires machining the bone pin
and the hole in the graft “to a high level of precision.” Id. Mr. Gaskins
further explains that “[e]ach additional bone piece makes it more difficult to
hold the pieces in alignment when drilling a hole through the graft pieces
and when pressing the bone pins through that hole.” Id. ¶ 26. Mr. Gaskins
testifies that irregularities in the cortical surface of bone increase the
probability that a bone pin will break when it is impelled through a large
number of layers that each have irregular interfaces. Id. ¶ 28. Mr. Gaskins’
testimony regarding the precision required for inserting bone pins and bone
pins’ sensitivity to irregular interfaces is supported by Grooms, which
describes extensive machining of the components of the implant before a
bone pin is inserted. See Ex. 1003 ¶¶ 28–33, 48–49; see also Ex. 1006,
4:46–63 (Paul, Petitioner’s other bone pin reference, which also describes
machining before inserting bone pin). We credit Dr. Shaffrey’s testimony
that an ordinarily skilled artisan would not expect success in pushing an
allograft bone pin through Wolter’s graft because passing a bone pin through
“the thick bone tissue and across the irregular interfaces of the iliac crest
would be considered unfeasible by a POSA.” Ex. 2028 ¶ 102.
Petitioner argues that we should discard Dr. Shaffrey’s testimony as
irrelevant because it only relates to “a surgeon’s ability to manually perform
that procedure on autograft bone in an operating room. He did not address
the ability of a POSA to insert a bone pin into a Wolter-style graft prepared
pre-operatively from allograft bone using technologies known at the time.”
Pet. Reply 14. But in the ensuing section of Dr. Shaffrey’s declaration,
which addresses the possibility of turning Wolter’s autograft into an
allograft with an allograft bone pin, Dr. Shaffrey testifies that “using a bone
pin to hold three stacked iliac crest allografts together would not work for
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the same reasons I have discussed with respect to an autograft.” Ex. 2028
¶ 106. And Petitioner does not explain how “technologies known at the
time” of the ’158 patent’s invention would have resolved the difficulties on
which Dr. Shaffrey’s testimony is based. Moreover, Mr. Gaskins’ testimony
regarding the difficulties of inserting a bone pin into a graft does discuss
technologies known at the time the ’158 patent was invented. Ex. 2030
¶ 17–18, 22, 26–28.
As to Mr. Gaskins, Petitioner argues that he merely testifies that the
Wolter graft’s configuration “‘makes it more difficult’ to insert pins and
‘increases the probability’ that a pin will break” but does not testify that
ordinarily skilled artisans “would have been incapable of inserting an
appropriate bone pin into the Wolter graft.” Pet. Reply 15. Yet defending
against obviousness does not require proof that the proposed combination
would have been impossible to make. The relevant question is not
impossibility or incapability, it is whether ordinarily skilled artisans would
have had a “reasonable expectation of success” in pursuing the proposed
combination. Los Angeles Biomedical Research Institute v. Eli Lilly & Co.,
849 F.3d 1049, 1064 (Fed. Cir. 2017). Mr. Gaskins’ testimony regarding the
difficulty of inserting the bone pin and the increased probability of a bone
pin breaking supports Patent Owner’s contentions that one of ordinary skill
in the art would not have been motivated to replace a stronger metal screw
with a weaker bone pin, and would not have had a reasonable expectation of
success in doing so.
Petitioner also argues that the iliac crest bone can provide the “precise
fit” to make an allograft composite bone graft because both the ’158 patent
and Wolter disclose using ilia bone. Pet. Reply 15 n.2. But the composite
graft of the ’158 patent and the sandwich block graft of Wolter are not
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similar in their construction. The ’158 patent describes stacking machined
pieces of bone. Specifically, the ’158 patent forms cortical bone planks 69
and 70 by cutting sections of cortical bone multiple times and smoothing the
bone to achieve a parallel plank of predetermined dimensions. Ex. 1002,
Fig. 11A, 16:55–17:13. Cancellous bone blanks are produced in a similar
manner. Ex. 1002, Fig 11B, 17:21–24.20 The machined and smoothed
planks permitting the use of a bone pin in the ’158 patent are not similar to
Wolter’s graft, in which three pieces of iliac crest bone are stacked and
screwed together. Ex. 1010, 5. Given the differences between the
preparation of the graft in the ’158 patent and Wolter, Petitioner’s reliance
on the ’158 patent does not persuade us that an ordinarily skilled artisan
would have reasonably expected success in using a bone pin rather than a
metal screw to join Wolter’s graft together.
Accordingly, we determine that Petitioner has not shown that an
ordinarily skilled artisan would have been motivated to substitute a bone pin
for Wolter’s metal screw, or would have reasonably expected success in
doing so.
d) Conclusion
Aside from the issues discussed above, the parties also dispute
whether the proposed combination discloses each limitation of claim 1. See
PO Resp. 31–34; Pet. Reply 5–8; Sur-Reply 6–9. We need not decide those
disputed issues because even if we were to agree with Petitioner that the
combinations teach every limitation of claim 1, Petitioner’s obviousness
arguments would still fail because of the deficiencies discussed above

20 Similarly, Grooms and Paul also describe machining of the components of
the implant before a bone pin is inserted. See Ex. 1003 ¶¶ 28–33, 48–49;
Ex. 1006, 4:46–63.
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regarding motivation to combine and reasonable expectation of success.
See, e.g., Adidas AG v. Nike, Inc., 963 F.3d 1355, 1359 (Fed. Cir. 2020)
(affirming Board’s determination that claims were not shown to be obvious
because the petitioner had not demonstrated that an ordinarily skilled artisan
would have been motivated to combine the references).
We also need not consider whether Patent Owner’s evidence of
secondary considerations weighs further against a conclusion of
obviousness. See, e.g., See Otsuka Pharmaceutical Co. v. Sandoz, Inc., 678
F.3d 1280, 1296 (Fed. Cir. 2012) (“Because we agree with the district court
that the Defendants failed to prove that claim 12 of the ’528 patent would
have been prima facie obvious over the asserted prior art compounds, we
need not address the court’s findings regarding objective evidence of
nonobviousness.”); Palo Alto Networks, Inc. v. Finjan, Inc., 748 F. App’x
317, 324 (Fed. Cir. 2018) (“The Board, having found that Finjan had failed
to carry its burden of showing that the instituted prior art disclosed [a
particular] limitation, did not reach the issue of secondary considerations of
nonobviousness. Therefore, it was not necessary for the Board to consider
Dr. Bims’s testimony, which was limited to the issue of secondary
considerations of nonobviousness.”).
We determine that Petitioner has not shown by a preponderance of the
evidence that claim 1 would have been obvious to a person of ordinary skill
in the art based on the combination of Wolter and Grooms or Wolter and
Paul.
2. Claims 2–15
Claim 2 contains many of the same limitations as claim 1 but uses the
linking word “consisting essentially of” rather than “comprising” as in claim
1. Claim 2, therefore, is narrower than claim 1. Claims 3–12 depend
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directly or indirectly from claims 1 and 2. Petitioner does not cite to any
additional evidence or present any additional arguments that address the
deficiencies concerning claim 1. Instead, Petitioner only addresses the
additional limitations in claims 2–12. See Pet. 32–41, 45–52; Pet. Reply 15–
21.
For the same reasons set forth above regarding claim 1, we also
determine that Petitioner has not shown by a preponderance of the evidence
that: (1) claims 2–12 would have been obvious to a person of ordinary skill
in the art based on the combination of Wolter and Grooms, (2) claims 2, 11,
and 12 would have been obvious to a person of ordinary skill in the art based
on the combination of Wolter and Paul, and (3) claims 3–10 would have
been obvious to a person of ordinary skill in the art based on the
combination of Wolter, Paul, and Coates. See supra § VI.D.1.
The Petition also challenges claims 13–15 based on combinations of
either Wolter in view of Grooms or Wolter in view of Paul. Petitioner’s
asserted motivation for an ordinarily skilled artisan to modify Wolter to be
made of allogenic bone and to substitute Wolter’s metal screw with a bone
pin underlies these grounds as well. See Pet. 53, 57, 62–63; Tr. 33:16–
35:17. Petitioner does not cite to any additional evidence or present any
additional arguments that address the deficiencies concerning claim 1. See
Pet. 53–65; Pet. Reply 21–24.
For the same reasons discussed above with respect to claim 1, we
determine that Petitioner has not shown by a preponderance of the evidence
that it would have been obvious to modify Wolter to be made of allogenic
bone and to substitute Wolter’s metal screw with a bone pin. See supra
§ VI.D.1. Accordingly, we determine that Petitioner has not shown by a
preponderance of the evidence that claims 13–15 would have been obvious
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based on combinations of either Wolter in view of Grooms or Wolter in
view of Paul.
VII. OBVIOUSNESS GROUND LED BY BOYCE
Petitioner challenges claims 1, 2, 11, 12, and 14 as obvious over
Boyce in view of either (1) Grooms or (2) Paul. Pet. 65–76; Pet. Reply 24–
26. Patent Owner disputes these challenges. PO Resp. 59–61; Sur-Reply
25.
A. Summary of Boyce
Boyce is directed to an osteoimplant made from an “aggregate of bone
derived elements possessing chemical linkages between their adjacent
surface-exposed collagen.” Ex. 1011, code (57) (Abstract). Figure 6 of
Boyce is reproduced below:

Figure 6 is a perspective view of osteoimplant 60.
Id. at 3:37–39.
Osteoimplant 60 is made up of sheet sections 61 and cube sections 62
arranged in alternating layers. Id. at 8:16–21. Sheet sections 61 are made
from surface demineralized cortical bone, and cube sections 62 are made
from surface demineralized cancellous bone. Id. Once assembled, the
structure is treated to crosslink the surface-exposed collagen molecules to
bond the adjacent bone elements to each other. Id. at 8:21–22, 3:53–56.
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The pattern of channels 63 results in an open structure that permits vascular
penetration of host bone ingrowth. Id. at 8:22–26.
B. Analysis
1. Claims 1, 2, and 14
Independent claims 1, 2, and 14 each recite a bone pin to hold a
composite bone graft together, and further recite that the composite bone
graft is not demineralized. Ex. 1002, 45:1–23, 46:55–48:8. Petitioner
contends that Boyce teaches each limitation of claims 1, 2, and 14, except
for one or more bone pins and a composite bone graft that is not
demineralized. See Pet. 67–76. Petitioner asserts that Boyce teaches adding
mechanical fasteners to increase the graft’s “shape-retaining and/or
mechanical strength characteristics,” so it would have been obvious to
eliminate Boyce’s chemical cross-linking and instead use only the bone pins
of Grooms or Paul to hold the graft together. Pet. 68–69; Pet. Reply 26.
Petitioner further asserts that in the combination of Boyce and Grooms or
Paul, one of ordinary skill in the art would not demineralize the bones of the
graft because demineralization is known to weaken bone. Pet. 70 (citing Ex.
1015 ¶ 28); Pet. Reply 25. Patent Owner counters that substituting a bone
pin in place of Boyce’s chemical crosslinking would destroy Boyce’s
principle of operation and intended purpose. PO Resp. 59–61; Sur-Reply
25.
We find that Petitioner has not shown that one of ordinary skill in the
art would have been motivated to modify Boyce in the proposed manner.
Chemical crosslinking is a central feature of Boyce’s disclosure,
which Boyce describes as the basis for the advantages its graft achieves.
The first sentence of the Summary of the Invention describes “an
osteoimplant which, due to chemical linkages formed between the surface-
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exposed collagen of adjacent partially demineralized bone elements from
which the osteoimplant is manufactured, exhibits good mechanical strength”
and has other beneficial features. Ex. 1011, 1:66–2:3 (emphasis added).
The first sentence of the Description of the Preferred Embodiments similarly
states that the osteoimplant “comprises a solid aggregate of bone-derived
elements having chemical linkages between their surface-exposed collagen
molecules[,] thus bonding adjacent bone elements to each other.” Id. at
3:53–56. The Abstract and the Field of the Invention also highlight that the
implant is made from bone derived elements bonded to each other through
chemical linkages between their surface-exposed collagen. Id. at code (57)
(Abstract), 1:10–14. Throughout its disclosure, Boyce repeatedly
emphasizes that the layers of its graft are bonded to each other through
chemical linkages and provides a detailed description of chemical cross-
linking techniques. Id. at 6:28–7:49, 8:16–40. Boyce describes its figures as
showing crosslinked bone sections, and describes crosslinking in each of its
five examples. Id. at 7:62–65, 8:22–23, 8:39–40, 8:56, 9:12,21 9:26, 9:42–
43, 9:54. Indeed, Petitioner candidly acknowledges that “[t]his chemical
cross-linking process is the asserted invention of Boyce.” Pet. 68; see also
Pet. Reply 24.
Demineralization is also necessary in Boyce’s process. Boyce teaches
that in order to crosslink the bone elements, they “must be at least partially
demineralized” to expose the collagen at their surface. See Ex. 1011, 3:56–
58; see also id. at 3:4–6 (defining “surface-exposed collagen” to mean “the

21 Unlike the other examples, Example 2 does not use the term crosslinking,
but it describes placing the osteoimplant in polyethylene glycol diglycidyl
ether for 12 hours, which Boyce lists as a crosslinking agent. See Ex. 1011,
9:12–13, 6:55.
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result obtained by demineralizing the aforementioned bone-derived
elements”).
Against this backdrop, Petitioner’s proposal eliminates the main
feature that Boyce teaches. We find persuasive Patent Owner’s argument
that Petitioner’s proposed modification to Boyce of removing the chemical
linkage between the surface-exposed collagen of adjacent layers of bone
elements would be inconsistent with Boyce’s central purpose and its
principle of operation. See PO Resp. 60; Plas-Pak Indus., Inc. v. Sulzer
Mixpac AG, 600 F. App’x 755, 759 (Fed. Cir. 2015) (determining that a
combination that removed a system’s stop valves fundamentally altered the
system’s principle of operation when the reference disclosed that the
invention was directed to a system that added stop valves to prevent
backflow); see also In re Ratti, 270 F.2d 810 (Fed. Cir. 1959) (concluding
that a combination requiring a substantial reconstruction and redesign of
elements in a reference changed the reference’s basic principles of
operation).
We also note that Boyce was considered during prosecution of the
’158 patent, as the Petition acknowledges. See Pet. 65–66. The Examiner
rejected the claims as anticipated by Boyce and as obvious over Boyce and
another reference. Ex. 1014, 3–6. Patent Owner amended the claims to
recite that the bone graft is “not demineralized” and argued that this added
limitation distinguished Boyce. Id. at 13–14. In response to that
amendment, the Examiner allowed the claims. Id. at 16. Petitioner argues
that the Examiner did not consider Grooms and Paul, which teach “other
methods (i.e. bone pins) to secure bone portions together without requiring
demineralization.” Pet. 66. We are not persuaded that references teaching
bone pins materially alter the obviousness analysis over Boyce, because
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Boyce itself discloses bone pins. Specifically, Boyce contemplates using
pins or other mechanical fasteners with its graft in order to “supplement or
increase the shape-retaining and/or mechanical characteristics” of the graft.
Ex. 1011, 5:54–57. Petitioner argues that Boyce’s teaching regarding
mechanical fasteners would motivate a skilled artisan toward the proposed
modification because that teaching represents “an acknowledgement of
shortcomings of the cross-linking approach.” Pet. Reply 26 (citing Ex. 1026
¶¶ 90–91). We disagree. In our view, Boyce’s teaching that pins can be
added to supplement the graft’s strength casts further doubt on Petitioner’s
argument that an ordinarily skilled artisan would be motivated to eliminate
crosslinking, the main way Boyce teaches to provide a strong graft, and
instead use only bone pins, which Boyce teaches can be added to a
crosslinked graft to supplement its strength.
We appreciate, as Petitioner points out, that in an obviousness
analysis, prior art references are considered for all they teach. See Pet.
Reply 24. Yet Petitioner has not provided any persuasive reasoning as to
why an ordinarily skilled artisan would adopt the structure of Boyce’s graft
but jettison the crosslinking that is the primary focus of Boyce’s teachings.
Petitioner argues that an ordinarily skilled artisan would be motivated to
eliminate demineralization because it weakens bone. See Pet. 67, 69–70;
Pet. Reply 25; Ex. 1015 ¶ 501; Ex. 1026 ¶ 91. This argument is
unconvincing because it considers demineralization in isolation, whereas
Boyce teaches surface demineralization as one step of the overall process—
specifically, to prepare the surfaces of the bone pieces for crosslinking. The
relevant comparison is not between demineralized bone and bone that has
not been demineralized; it is between a graft formed of bone pieces that
undergo surface demineralization and then chemical crosslinking and a graft
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that is not demineralized and joined with a bone pin. Petitioner does not
provide persuasive evidence or argument to show that an ordinarily skilled
artisan would have expected the former to be weaker than the latter. And as
Patent Owner points out, Boyce touts the mechanical strength of the final
graft it achieves after demineralization and crosslinking. See Ex. 1011,
1:66–2:3, 2:44–47; PO Resp. 60. Thus, we are not persuaded that an
ordinarily skilled artisan would have been motivated to eliminate
demineralization and crosslinking from Boyce’s graft due to a concern that
demineralization would weaken the bone.
The Petition also argues, in a cursory fashion, that “improved
consistency of strength of the connection between graft pieces” and avoiding
the cost and difficulty of demineralization would have motivated the
proposed changes to Boyce. Pet. 70; Ex. 1015 ¶ 505. The “improved
consistency of strength” motivation is unpersuasive for the same reasons as
just discussed. And the purported motivation to avoid cost and difficulty is
undeveloped and overly simplistic. Petitioner only asserts that
demineralization adds cost and difficulty, but Petitioner’s proposal is not to
simply eliminate demineralization and keep the rest of Boyce. Petitioner
does not show that its proposed combination would be less expensive and
difficult overall than Boyce, nor does Petitioner offer any explanation of the
performance tradeoffs that would be expected to accompany the proposed
changes.
We determine that Petitioner has not made a persuasive showing that
one of ordinary skill in the art would have been motivated to substitute
Boyce’s chemical crosslinkage with bone pins from Grooms or Paul.
Accordingly, we determine that Petitioner has not shown by a preponderance
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of the evidence that claims 1, 2, and 14 would have been obvious over
Boyce in view of Grooms or Paul.
2. Claims 11 and 12
Claims 11 and 12 depend from claim 2. Petitioner’s challenge to
these claims builds from its arguments regarding claim 2 and, therefore, also
requires substitution of Boyce’s chemical crosslinkage with bone pins from
Grooms or Paul. See Pet. 73. For the same reasons just discussed, we also
determine that Petitioner has not shown by a preponderance of the evidence
that claims 11 and 12 would have been obvious over Boyce in view of
Grooms or Paul.
3. Conclusion
We determine that Petitioner has not shown, by a preponderance of
the evidence, that claims 1, 2, 11, 12, and 14 would have been obvious over
Boyce in view of Grooms or Paul.
VIII. CONCLUSION
Based on the information presented, we conclude that Petitioner has
not shown, by a preponderance of the evidence, that claims 1–15 of the ’158
patent are unpatentable.
In summary:
Claims

35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1–12 103(a) Wolter in view of Grooms
1–12
1, 2, 11,
12 103(a)
Wolter in view of
Paul
1, 2, 11, 12
3–10 103(a) Wolter in view of Paul and Coates
3–10
13 103(a) Wolter in view of either (1) Grooms
13
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IX. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–15 of the ’158 patent have not been shown
to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude is
dismissed;
FURTHER ORDERED that Patent Owner’s Motion to Exclude is
denied; and
FURTHER ORDERED that parties to the proceeding seeking judicial
review of the decision must comply with the notice and service requirements
of 37 C.F.R. § 90.2.

or (2) the
combination of
Paul and Kozak
14 103(a)
Wolter in view of
either (1) Grooms
in combination
with Boyce or
(2) Paul in
combination with
Boyce

14
15 103(a)
Wolter in view of
either (1) Grooms
or (2) Paul

15
1, 2, 11,
12, 14 103(a)
Boyce in view of
either (1) Grooms
or (2) Paul
1, 2, 11, 12,
14
Overall
Outcome
1–15
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45
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