RSB Spine, LLC

Patent Trials and Appeals Board

Apr 15, 2021

IPR2020-00264 (P.T.A.B. Apr. 15, 2021)

Trials@uspto.gov Paper 46
571.272.7822 Date: April 15, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

MEDACTA USA, INC., PRECISION SPINE, INC.,
and LIFE SPINE, INC.,
Petitioner,

v.

RSB SPINE, LLC,
Patent Owner.
_______________

IPR2020-00264
Patent 9,713,537 B2
_______________

Before PATRICK R. SCANLON, MICHAEL L. WOODS, and
ERIC C. JESCHKE, Administrative Patent Judges.

WOODS, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining No Challenged Claims Unpatentable
35 U.S.C. § 318(a)
Dismissing Petitioner’s Motion to Exclude
37 C.F.R. § 42.64

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I. INTRODUCTION
Medacta USA, Inc., Precision Spine, Inc., and Life Spine, Inc.
(collectively, “Petitioner”) filed a Petition to institute an inter partes review
of claims 1, 3–6, 10, 13–15, 18, 19, 21, 22, 24, 29, and 30 (the “challenged
claims”) of U.S. Patent No. 9,713,537 B2 (Ex. 1002, “the ’537 patent”).
Paper 2 (“Pet.”). We instituted an inter partes review of these claims. Paper
24 (“Institution Decision” or “Inst. Dec.”).
After institution, RSB Spine, LLC (“Patent Owner”) filed a Patent
Owner’s Response (Paper 27 (“PO Resp.” or “Response”)), to which
Petitioner replied (Paper 31 (“Pet. Reply” or “Reply”)). Patent Owner also
filed a Sur-reply to Petitioner’s Reply. Paper 34 (“PO Sur-reply” or “Sur-
reply”).
Oral argument, or hearing, was held on February 23, 2021, and the
transcript of the hearing has been entered as Paper 45 (“Transcript” or
“Tr.”).
We have jurisdiction 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) (2018); 37 C.F.R. § 42.1(d) (2019). This Final Written
Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
For the reasons that follow, Petitioner has not shown that any of the
challenged claims are unpatentable.

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A. Related Proceedings
The parties identify five pending proceedings in the U.S. District
Court for the District of Delaware involving the ’537 patent: (1) RSB Spine,
LLC. v. Life Spine, Inc., No. 18-cv-1972 (D. Del.); (2) RSB Spine, LLC. v.
Medacta USA, Inc., No. 18-cv-1973 (D. Del.); (3) RSB Spine, LLC. v.
Precision Spine, Inc., No. 18-cv-1974 (D. Del.); (4) RSB Spine, LLC v. Xtant
Medical Holdings, Inc., No. 18-cv-1976 (D. Del.); and (5) RSB Spine, LLC.
v. DePuy Synthes, Inc., No. 19-cv-1515 (D. Del.) (collectively, the
“Delaware Litigations”). Pet. 1–2; Paper 5, 2. The Delaware Litigations
also involve a related patent, U.S. Patent No. 6,713,234 B2 (“the ’234
patent”). Pet. 1.
On the same day as the filing of the Petition in this Proceeding
(December 13, 2019), Petitioner filed an additional petition for inter partes
review of the same challenged claims (1, 3–6, 10, 13–15, 18, 19, 21, 22, 24,
29, and 30) in IPR2020-00275. IPR2020-00275, Paper 4. We denied
institution in that proceeding. IPR2020-00275, Paper 22.
Also that same day, Petitioner filed petitions for inter partes review of
(1) claims 1–10, 13, 14, 16, 18–20, 22, 24, 25, 28, 29, 31 and 32 of the ’234
patent in IPR2020-00274, and (2) claims 35, 37, and 39 of the ’234 patent in
IPR2020-00265. IPR2020-00265, Paper 2; IPR2020-00274, Paper 4. We
granted institution in those proceedings. IPR2020-00265, Paper 24;
IPR2020-00274, Paper 22.
Finally, the parties identify “related” U.S. Patent Application No.
15/723,522 as currently pending before the U.S. Patent and Trademark
Office. Pet. 2; Paper 5, 2.
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B. The ’537 Patent (Ex. 1002)
The ’537 patent is titled “Bone Plate Stabilization System and Method
for its Use.” Ex. 1002, code (54).1 The patent describes a system with a
base plate configured to fit primarily between anterior portions of two
adjacent vertebral bodies’ (or bones’) lip osteophytes for treating disorders
of the spine. See id. at code (57), 4:6–12. The patent further describes
surgical treatment of the spine accomplished by removing the intervertebral
disc material from the space between two adjacent vertebral bodies, and
replacing it with a surgical implant and bone graft to promote fusion of the
two vertebral bodies.2 See id. at 4:7–15. To illustrate an embodiment of the
described system, we reproduce Figures 1 and 2, below:

1 Throughout this Final Written Decision, we omit any bolding of reference
numerals or claim numbers in quotations from the ’537 patent and from
prior art references.
2 The terms “disc” and “disk” are used interchangeably in the record. See,
e.g., Ex. 1002, 3:54 (using the term “disc”), 12:49 (using the term “disk”).
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The ’537 patent explains that Figures 1 and 2 are perspective views of
a bone stabilization plate system according to the invention, with Figure 1
(left) depicting the system assembled between adjacent vertebrae. Id. at
5:63–67. In particular, these figures depict bone stabilization plate system
10 comprising base plate 20 having a first end and a second end, with
primary member 21 and secondary member 22 at the second end of the base
plate. Id. at 8:33–36. In this embodiment, secondary member 22 is angled
relative to primary member 21. Id. at 8:37–38. As shown in Figure 1, base
plate 20 may be mounted to adjacent vertebral bodies (14, 16) with bone
graft 12 interposed between the bodies. See id. at 8:46–49. Bone graft, or
bone tissue, promotes fusion between the vertebral bodies. See id. at 13:16–
18.
We also reproduce Figure 3 of the ’537 patent, below:

Figure 3 is a cross-sectional view of the bone plate stabilization
system assembled between adjacent vertebrae. Id. at 6:1–3. As shown
collectively in this figure and Figures 1 and 2, bottom surface 26 of base
plate 20 contacts bone graft 12, and primary member 21 has a top surface,
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denoted as 28. See id. at 8:48–56, Figs. 1, 2. Primary member 21 also has
side wall 32 at the first end of base plate 20 that contacts first vertebral body
14. Id. at 8:56–58. The top surface of base plate 20 may also have apertures
for receiving one or more bone screws. See id. at 8:58–60. In this
embodiment, primary member 21 includes two first bone screw holes 42 for
receiving first bone screws 24. See id. at 9:8–11, Fig. 2. Bone screw holes
42 are angled relative to the bottom surface of the base plate so that a first
bone screw extending through the hole extends through the base plate at an
angle. Id. at 9:11–18, Fig. 4. Secondary member 22 also includes a bone
screw hole or slot 48 for receiving second bone screw 25. Id. at 9:26–28.
Second bone screw 25 is received through bone screw slot 48 and into
second vertebral body 16. Id. at 9:28–30.

C. Illustrative Claims
Petitioner challenges claims 1, 3–6, 10, 13–15, 18, 19, 21, 22, 24, 29,
and 30. Pet. 1. Of these claims, claims 1, 15, and 21 are independent. Ex.
1002, 37:65–40:57. We reproduce claim 1, below, reformatted from the
version provided in the ’537 patent to include bracketed alphanumeric
nomenclature that corresponds with Petitioner’s nomenclature. See, e.g.,
Pet. 23–41.
1. [1(Preamble)] A bone stabilization plate system
comprising:
[1(a)] a base plate having a top surface, first and second
ends, a bottom surface, and a plurality of bone screw holes,
[1(b)] wherein the base plate is configured to fit
primarily between anterior portions of adjacent vertebral
bones’ lip osteophytes to bear weight to hold the vertebral
bones while sharing weight with bone graft material for
fusion; and
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[1(c)] a plurality of bone screws configured to fit in the
plurality of bone screw holes, respectively;
[1(d)] wherein the vertebral bones have top surfaces and
have side surfaces generally facing each other;
[1(e)] wherein a first of the bone screw holes, being
configured to receive a first of the bone screws, extends at least
partially from the top surface of the base plate and opens at least
partially toward the side surface of a first of the vertebral bones;
[1(f)] wherein a second of the bone screw holes, being
configured to receive a second of the bone screws, extends at
least partially from the top surface of the base plate and opens at
least partially toward the lip osteophyte of a second of the
vertebral bones; and
[1(g)] wherein each and every one of the plurality of bone
screw holes is configured to receive one of the bone screws
angled relative to the base plate and oriented generally in an
anterior-posterior direction through at least partially the top
surface of the base plate.
Ex. 1002, 37:65–38:24; Pet. 23–41.
We also reproduce dependent claims 10 and 24, below:
10. The system as set forth in claim 1, wherein the base
plate includes two lateral tabs configured to fit between the lip
osteophytes of the vertebral bones and extending from opposite
ends of the bottom surface of the base plate in a direction
generally transverse to the vertebral bones.
Id. at 38:51–55 (emphasis added).
24. The system as set forth in claim 21, wherein the base
plate has more than two bone screw holes, a first one of the bone
screw holes extends partially through both the bottom surface
and the first end, and a second one of the bone screw holes
extends partially through both the bottom surface and the second
end.
Id. at 40:27–32 (emphasis added).
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D. Asserted Grounds of Unpatentability
Petitioner contends that the challenged claims are unpatentable based
on the following asserted grounds (Pet. 5):
Ground3 Claim(s)
Challenged
35 U.S.C. §4 Reference(s)/Basis
1 1, 10, 13, 14,
21, 22, 29
103 Fraser5 (fused
embodiment)
2 3, 15, 19 103 Fraser (fused embodiment),
Byrd6
3 1, 3, 13–15, 19,
21, 22, 29
103 Fraser (two-piece
embodiment)
4 4–6, 24, 30 103 Fraser (both embodiments),
Michelson7
5 18 103 Fraser (both embodiments),
Michelson, Byrd
Petitioner supports its challenge with declarations from Mr. Michael
C. Sherman (Exs. 1005, 1023). Patent Owner submits testimony from Mr.
Troy D. Drewry (Ex. 2006).

3 For clarity and consistency of record, we adopt the parties’ reference to the
numbered “grounds” in our Final Written Decision. See Pet. 5 (referring to
the five challenges as Grounds 1–5); see also PO Resp. i–ii (referencing
Grounds 1–5).
4 The Leahy-Smith America Invents Act (“AIA”) included revisions to 35
U.S.C. § 103 that became effective on March 16, 2013. Pub. L. No. 112-29,
§§ 3(c), 3(n)(1), 125 Stat. 284, 287, 293 (2011). Because there is no dispute
that the challenged claims of the ’537 patent have an effective filing date
before March 16, 2013, we apply the pre-AIA version of § 103. See also
Pet. 3–4 (confirming same).
5 US 6,432,106 B1, issued Aug. 13, 2002 (Ex. 1007).
6 US 7,077,864 B2, issued July 18, 2006 (Ex. 1008).
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II. ANALYSIS
A. Level of Ordinary Skill in the Art
The level of ordinary skill in the art is “a prism or lens” through which
we view the prior art and the claimed invention. Okajima v. Bourdeau, 261
F.3d 1350, 1355 (Fed. Cir. 2001). The person of ordinary skill in the art
(“POSITA”) is a hypothetical person who is presumed to have known the
relevant art at the time of the invention. In re GPAC, Inc., 57 F.3d 1573,
1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art,
we may consider certain factors, including the “type of problems
encountered in the art; prior art solutions to those problems; rapidity with
which innovations are made; sophistication of the technology; and
educational level of active workers in the field.” Id. (internal quotation
marks omitted).
Petitioner contends that a person having ordinary skill in the art “at
the time of the alleged invention would have had at least a Bachelor of
Science degree in the field of Mechanical, Biomechanical or Biomedical
engineering with at least 5 years of experience designing and developing
orthopedic implants and/or spinal interbody devices.” Pet. 17.
Patent Owner, on the other hand, contends that
A person of ordinary skill in the relevant art as of April
2003 would be a biomedical engineer with a bachelor’s degree
in mechanical engineering or biomedical engineering and two or
more years of experience in biomechanical engineering,
biomedical engineering, and/or spinal implant devices. A person
could also have qualified as a person of ordinary skill in the art
with some combination of (1) more formal education (such as an
M.D. in addition to a bachelor’s degree in mechanical
engineering) and less technical experience or (2) less formal

7 WO 00/66045, published Nov. 9, 2000 (Ex. 1006).
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education and more technical or professional experience in the
fields listed above.
PO Resp. 6 (citing Ex. 2006 ¶¶ 9–10).
In the Institution Decision, we adopted Petitioner’s proposed level of
ordinary skill in the art. Inst. Dec. 20. Although the level of ordinary skill
in the art proposed by Patent Owner (and applied by Mr. Drewry (see, e.g.,
Ex. 2006 ¶¶ 8–11)) differs slightly from the level proposed by Petitioner and
adopted in our Institution Decision, Patent Owner stated, at the oral
argument, that the differences are not “material” and that Patent Owner’s
and Mr. Drewry’s positions would be the same under either level. See Tr.
56:17–57:4.
Because we agree that the differences in the two levels are immaterial,
we continue to apply Petitioner’s proposed level of ordinary skill in the art in
the analysis below. Regardless, the analysis would be the same under Patent
Owner’s proposed level.

B. Claim Construction
In inter partes reviews, the Board interprets claim language using the
same claim construction standard that would be used in a civil action under
35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303
(Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard,
we generally give claim terms their ordinary and customary meaning, as
would be understood by a person of ordinary skill in the art at the time of the
invention, in light of the language of the claims, the specification, and the
prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic
evidence, when available, may also be useful when construing claim terms
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under this standard, extrinsic evidence should be considered in the context of
the intrinsic evidence. See id. at 1317–19.
Petitioner proposes constructions for the following claim terms:
(1) “base plate”; (2) “lip osteophyte”; and (3) “screw retainer.” Pet. 17–23.
In the claim construction section of its Response, Patent Owner addresses
only the term “base plate.” PO Resp. 6–10; see also id. at 7 (stating that
Patent Owner “addresses the constructions of other terms, as proposed by
[Petitioner] or preliminarily adopted by the Board, as necessary, in the
sections that follow”).
Based on the full record developed at trial, we construe only the terms
“configured to fit primarily between anterior portions of adjacent vertebral
bones’ lip osteophytes” and “base plate configured to . . . bear weight”
(emphases added). We do not discern a need to construe explicitly any of
the other claim language discussed in this section or any other claim terms
because doing so would have no effect on the analysis below. See Nidec
Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
(Fed. Cir. 2017) (stating that “we need only construe terms ‘that are in
controversy, and only to the extent necessary to resolve the controversy’”
(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
(Fed. Cir. 1999))).

1. “base plate is configured to fit primarily between anterior
portions of adjacent vertebral bones’ lip osteophytes”
In the Delaware Litigations, the parties agree that the term “primarily”
means “mainly” and “does not connote a temporal aspect.” See Ex. 1021, 6.
In our Institution Decision, we adopted the parties’ district court
interpretation and preliminarily construed “primarily” to mean “mainly.”
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Inst. Dec. 32. We encouraged the parties to address this interpretation in
future briefing if they disagreed with our preliminary construction. Id.
In its Response, Patent Owner did not dispute our interpretation and
instead appeared to agree with it. See PO Resp. 6–10 (construing only “base
plate”); see also id. at 35–36 (arguing that the majority of the implant must
fit between the anterior portions of adjacent lip osteophytes).
Petitioner, on the other hand, contends that Patent Owner’s
“interpretation of the limitation is incorrect.” Pet. Reply 18. Petitioner
proposes that the “limitation requires the base plate to be implanted between
the lip osteophytes (i.e., viewed laterally from a side-view).” Id. In support
of this interpretation, Petitioner cites the prosecution history of the ’537
patent, submitting that, during prosecution, “PO argued prior art cage
devices are not configured to fit primarily between anterior portions of the
bone bodies’ lip osteophytes because the top plates cover portions of the top
surfaces of the bones bodies.” Id. (citing in relevant part Ex. 1004, 218–19).
We disagree that Patent Owner’s—or our—claim construction is
incorrect.
Petitioner’s citation to the prosecution history does not support its
position that Patent Owner’s or our construction is wrong. Petitioner fails to
explain how the prosecution history limits the meaning of the term
“primarily,” or otherwise explain why the claimed limitation does not
require a majority of the base plate be configured to fit between anterior
portions of adjacent lip osteophytes. The cited portion of the prosecution
history does not demonstrate that the patent applicant’s statements amount to
a “disavowal . . . ‘clear and unmistakable’ to one of ordinary skill in the art”
as to the meaning of “primarily.” See Elbex Video. Ltd. v. Sensormatic
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Elecs. Corp., 508 F.3d 1366, 1371 (Fed. Cir. 2007) (quoting Omega Eng’g,
Inc. v. Raytek Corp., 334 F.3d 1314, 1326 (Fed. Cir. 2003)). Rather, the
cited portion of the prosecution history includes statements from the patent
applicant that distinguishes prior art base plates that fit on the anterior side
surfaces (or faces) of adjacent vertebral bodies. See Ex. 1004, 218–19. We
do not see these statements as conflicting with our construction of the term
“primarily,” which we interpret to mean “mainly” (Inst. Dec. 32), or
otherwise conflict with Patent Owner’s understanding that a majority of the
claimed “base plate” must be “configured to fit primarily between anterior
portions of adjacent vertebral bones’ lip osteophytes” (PO Resp. 35–36; Ex.
1002, 38:1–3) in order to satisfy the claimed limitation.
Furthermore, the claim does not simply require the base plate to be
configured to fit between lip osteophytes, when viewed laterally, as
Petitioner contends. See Pet. Reply 18. Rather, claim 1 recites, “wherein
the base plate is configured to fit primarily between the anterior portions of
adjacent vertebral bones’ lip osteophytes.” Ex. 1002, 38:1–3 (emphasis
added). We agree with Patent Owner that Petitioner’s proposed definition
ignores the term “primarily.” PO Sur-reply 13. Petitioner’s interpretation of
the limitation renders the term “primarily” superfluous. See Bicon Inc. v.
Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006) (“[C]laims are
interpreted with an eye toward giving effect to all terms in the claim.”); see
also Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir.
2007) (denouncing claim constructions that render phrases in claims
superfluous); Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1372
(Fed. Cir. 2005) (rejecting a proposed claim construction that would render
claim terms superfluous).
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Accordingly, we maintain our initial construction that “primarily”
means “mainly,” as also agreed to by the parties in the Delaware Litigations.
Ex. 1021, 6; Inst. Dec. 32. We further clarify our construction in that
“mainly” requires more than 50% of the base plate be configured to fit
between anterior portions of adjacent vertebral bones’ lip osteophytes, as
understood and argued by the parties. See PO Resp. 35–36 (arguing that a
majority of Fraser’s “base plate” is not configured to fit between the anterior
portions of adjacent vertebral bones’ lip osteophytes); see also Pet. Reply
19–20 (arguing 60% of Fraser’s “base plate” fits between the anterior
portions of the lip osteophytes).

2. “configured . . . to bear weight to hold the vertebral bones
while sharing weight with bone graft material for fusion”
Petitioner submits that the plate of Fraser’s two-piece embodiment
bears weight. See Pet. 71. In particular, Petitioner submits that
A POSITA would understand that after the Fraser . . . implant is
filled with bone graft material and subsequently inserted between
the surfaces of the vertebrae, the vertebrae would be in direct
contact with the bone graft material. A POSITA would further
understand that when the bone screws engage each of the
vertebral bodies, those screws would place a compressive load
on the bone graft material and promote fusion between the
bones. As such, a POSITA would understand that Fraser . . .
discloses that the base plate shares weight with bone graft
material for fusion.
Pet. 71 (citing Ex. 1005 ¶ 279) (emphases added). To paraphrase, Petitioner
submits that a POSITA would have understood that because the bone screws
“would place a compressive load on the bone graft material . . . [,] the base
plate shares weight with bone graft material,” thereby satisfying the
limitation of a “base plate . . . configured . . . to bear weight.” See id.
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In our Institution Decision, we disagreed with Petitioner’s implied
construction that a base plate is configured “to bear weight” if the bone
screws placed a compressive load on the bone graft material. See Inst. Dec.
32–34. We explained that in order for the “base plate” to “bear weight to
hold the vertebral bones while sharing weight with bone graft material,” the
anterior portions of the adjacent lip osteophytes must apply a compressive
force to the base plate. See id. (emphases added).
Petitioner disagrees with our construction in its Reply, arguing that
“the patent applies a broader meaning to the term weight bearing.” Pet.
Reply 28. With the support of Mr. Sherman’s testimony, Petitioner contends
that “the term means ‘holding the vertebral bones, e.g. by imparting
compressive, tensile, torsional, sheer or other load to the base plate.’” Id. at
28–29 (referencing Ex. 1023 ¶ 118) (emphasis added); see Ex. 1023 ¶ 118
(testifying, “in my opinion, the proper construction of this term should be
‘holding the vertebral bones while experiencing compressive, tensile,
torsional, or sheer loads”). Mr. Sherman testifies that this meaning “is
consistent with the plain and ordinary meaning in the medical field.” Ex.
1023 ¶ 120.
In its Sur-reply, Patent Owner argues that Petitioner “seek[s] to
expand the meaning of ‘bear weight’ far beyond its ordinary meaning to
encompass essentially any force exerted on the base plate, regardless of its
source.” PO Sur-reply 21.
We agree with Patent Owner. We further agree that in order to be
configured to “primarily” or “mainly” bear weight, the majority (or more
than 50%) of the base plate must be configured to fit between anterior
portions of adjacent vertebral bones’ lip osteophytes. See PO Resp. 35–36.
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We give words of the claim their “ordinary and customary meaning,”
which is the meaning the term would have to a person of ordinary skill at the
time of the invention, in the context of the entire patent including the
specification. See Phillips, 415 F.3d at 1312–13.
Claim 1 recites, “[a] base plate that is configured to fit primarily
between anterior portions of adjacent vertebral bones lip osteophytes to bear
weight to hold the vertebral bones while sharing weight with bone graft
material for fusion.” Ex. 1002, 38:1–5 (emphasis added). Importantly, the
claim recites, “bear weight,” not “bear load,” as Petitioner’s construction
implies. As discussed below, weight is a gravitational force, whereas not all
loads result from gravity.
Furthermore, Petitioner’s construction is inconsistent with the
Specification’s discussion of weight bearing. The Specification describes
that “[t]he spinal column of vertebrates provides support to bear weight and
protection of the delicate spinal cord and spinal nerves. The spinal column
includes a series of vertebrae stacked on top of each other.” Id. at 3:45–48.
The Specification further describes, “Between each vertebral body is an
intervertebral disk, a cartilaginous cushion to help absorb impact and
dampen compressive forces on the spine” (id. at 3:53–55) and that, after the
disk has been removed, the implanted bone graft and interbody device
“share in the weight bearing during settling of the vertebral bodies” (see,
e.g., id. at 22:15–17). We find the Specification’s discussion of “weight
bearing” refers to the compressive forces from gravity exerted between
adjacent vertebral bodies, which are vertically stacked in relation to one
another.
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Furthermore, the limitation more fully recites, “configured . . . to bear
weight to hold the vertebral bones while sharing weight with bone graft
material.” Ex. 1002, 38:1–5 (emphasis added). Indeed, the plain language
of the claim requires the base plate to be configured to “share weight” with
the bone graft material. Id. Because the bone graft material resides within
the disc space of adjacent vertebral bodies, the bone graft encounters
compressive stress from gravitational forces imparted between the
vertically-stacked vertebrae. See, e.g., id. at 22:15–17. By “sharing weight”
with the bone graft material, the base plate also encounters compressive
stress from gravity when positioned between adjacent lip osteophytes. See
id. at 38:1–5.
We further agree with Patent Owner’s position that Petitioner’s
proposed construction “is so broad that [it] would improperly render the
‘configured to . . . bear weight’ limitation a meaningless nullity, as any
spinal fixation device . . . would experience some types of forces when
affixed to the spine.” PO Sur-reply 21 (emphasis omitted, first alteration in
original). The term “weight” “is the result of the force of gravity acting on
an object, not just any force.” Id. (citing Ex. 2006 ¶ 131). Having weighed
the competing testimony of Mr. Sherman and Mr. Drewry, we credit Mr.
Drewry’s testimony that
a person of ordinary skill would have understood that “weight”
is the result of the force of gravity acting on an object and that
additional compressive “flexion loads” are not the same thing, as
they could be the result of other forces acting on the object, such
as forces generated by an [sic] spinal fusion patient’s neck
muscles.
Ex. 2006 ¶ 131.
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For the foregoing reasons, we maintain the construction of “base plate
is configured . . . to bear weight” from our Institution Decision. Inst. Dec.
34. In particular, giving the language of claim 1 its ordinary and customary
meaning in light the Specification (see Phillips, 415 F.3d at 1313–14), we
determine that, in order for the “base plate” to “bear weight,” the anterior
portions of the adjacent lip osteophytes must apply a compressive force to
the base plate. Because the claim recites “configured to fit primarily
between anterior portions of adjacent vertebral bones’ lip osteophytes to
bear weight” (Ex. 1002, 38:1–5), a POSITA would understand that the
weight bearing occurs between adjacent anterior lip osteophytes.

C. Principles of Law
“In an . . . [inter partes review], the petitioner has the burden from the
onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
Cir. 2016). This burden never shifts to Patent Owner. Dynamic Drinkware,
LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
Petitioner’s challenges are based on obviousness. Pet. 5.
As to obviousness, a claim is unpatentable as obvious under 35 U.S.C.
§ 103(a) if the differences between the claimed subject matter and the prior
art are such that the subject matter, as a whole, would have been obvious at
the time the invention was made to a person having ordinary skill in the art
to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 406 (2007). The question of obviousness is resolved on the basis
of underlying factual determinations, including: (1) the scope and content of
the prior art; (2) any differences between the claimed subject matter and the
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prior art; (3) the level of skill in the art; and (4) where in evidence, so-called
secondary considerations. Graham v. John Deere Co. of Kansas City, 383
U.S. 1, 17–18 (1966).

D. Ground 1: Obviousness over Fraser’s Fused Embodiment
Petitioner contends that claims 1, 10, 13, 14, 21, 22, and 29 are
unpatentable under 35 U.S.C. § 103 in view of Fraser’s “fused implant
embodiment” and the knowledge of a POSITA. Pet. 23. Fraser discloses at
least two embodiments, and Petitioner relies on the fused implant
embodiment under this ground. See id.

1. Fraser (Ex. 1007)
Fraser describes its invention as “an implantable structure for
promoting fusion of adjacent vertebral bodies.” Ex. 1007, 1:14–16. Figures
1 and 2 are reproduced below:

Figure 1 is a “plan view of a fusion cage” and Figure 2 is a “view of
the anterior face of the fusion cage” of Figure 1. Id. at 1:62–65. The
depicted “cage” includes body 10, which, in turn, “includes an anterior face
12, a posterior face 14, a superior face 16, and an inferior face 18.” Id. at
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2:23–27. “The cage further includes a plate 20 that is matable with the body
10.” Id. at 2:34–35. Fraser discloses that “[a]lthough the plate 20 can be
bonded firmly to the body 10 so that the plate and body cannot move with
respect to each other, they can also be mated to allow movement with
respect to each other.” Id. at 2:43–46. Figure 2 shows bone screw holes 36,
38, 40, and 42. Id. at 2:67–3:2. Figures 3 and 8 are reproduced below:

Figure 3, shown on the left, is “a side view of the fusion cage of
[Figure] 1 with bone screws” inserted and Figure 8 “depicts a portion of the
spine following placement of the fusion cage” of Figure 1. Id. at 1:66–67,
2:9–10. Figure 8, reproduced on the right, depicts “portions of the vertebral
bodies are shown cut-away to illustrate the penetration of the bone screws 58
and 60 into the bodies.” Id. at 4:13–15. Fraser discloses:
Prior to inserting a fusion cage between vertebral bodies,
the space bounded by the body 10 and transverse elements 28
and 30 (if included) can be filled with autograft or allograft bone,
or demineralized bone matrix (DBM) to promote fusion. Over a
period of about three months the vertebral bodies fuse.
Id. at 4:38–43.
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Fraser discloses an embodiment in which plate 20 is bonded
with body 10 (referred to as the “fused” embodiment) and an
embodiment in which the plate 20 can slide relative to body 10
(referred to as the “two-piece” embodiment). See id. at 2:43–50.

2. Independent Claim 1
We address the claim limitations using Petitioner’s nomenclature as
identified above. See supra Part I.C.

a) Element 1 (Preamble)
Petitioner submits that the preamble is not limiting, as it does not
breathe life or meaning into the claim. Pet. 23. Nevertheless, Petitioner
submits that Fraser discloses this recitation, quoting the abstract, which
states, “[a] spinal fixation assembly [that] includes a fusion cage to which a
plate is mated.” See id. at 24.

b) Element 1a – Base Plate
Petitioner submits that the “fused implant embodiment” described in
Fraser discloses a “base plate” as claimed. See Pet. 24–25. To support this
assertion, Petitioner submits an annotated version of Figure 8 of Fraser (id.
at 25), which we reproduce, below:
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According to Petitioner, and as shown above in annotated Figure 8,
Fraser discloses fixation plate 66, illustrated in orange, for fusing adjacent
vertebrae. See id. Petitioner submits that the plate “is configured to receive,
retain and orient bone screws, thereby holding the fusion cage and adjacent
vertebral bodies in a stable relationship to promote fusion.” Id. (quoting Ex.
1007, 1:36–42; citing Ex. 1005 ¶ 70).
As to the base plate “having a top surface, first and second ends, [and]
a bottom surface,” Petitioner submits an annotated version of Fraser’s
Figures 1 and 2 (id. at 27), which we reproduce below:
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According to Petitioner, Fraser discloses a base plate with a top
surface (yellow), first end (blue, shown at bottom of Figure 2), second end
(purple, shown at top of Figure 2), and a bottom surface (green, shown
within the cavities of body 10 in Figure 1). See id.
As to the claimed base plate having “a plurality of bone screw holes,”
Petitioner submits an annotated version of Fraser’s Figure 2 (Pet. 29), which
we reproduce, below:

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Figure 2 “is a view of the anterior face of the fusion cage of” Figure 1.
Ex. 1007, 1:64–65. According to Petitioner, four bone screw holes are
depicted in red. Pet. 28.

c) Element 1b – Base Plate Fit
In addressing “wherein the base plate is configured to fit primarily
between anterior portions of adjacent vertebral bones’ lip osteophytes,”
Petitioner submits an annotated version of Fraser’s Figure 8 (Pet. 30), which
we reproduce below:

Petitioner submits that this annotated figure shows that the “cage
includes a body that approximates the shape and size of the annulus portion
of a disk which normally separates two vertebral bodies.” See id. (quoting
Ex. 1007, 2:21–23). Mr. Sherman testifies that Fraser “explicitly teaches it
is important for the implant to sit flush with, or recessed below, the anterior
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surface of the vertebrae.” Ex. 1005 ¶ 84 (citing Ex. 1007, 4:16–19). Fraser
discloses, “It is important to note that screw heads 62 and 64 are flush or
sub-flush with the anterior face surface 66 of the fusion cage, thus
minimizing the likelihood that major blood vessels running along the spine
will be injured.” Ex. 1007, 4:15–19.

d) Element 1c – Bone Screws
Claim 1 recites, “a plurality of bone screws configured to fit in the
plurality of bone screw holes.” Ex. 1002, 38:6–7. Petitioner asserts that
Fraser discloses this limitation, submitting an annotated version of Figure 8
(Pet. 34), which we reproduce, below:

According to Petitioner, and as shown in the above figure, Fraser
discloses bone screws 58 (purple), 60 (green) disposed in bone screw holes
of Fraser’s plate (orange). See id.

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e) Element 1d – Vertebral Bones
Claim 1 recites, “wherein the vertebral bones have top surfaces and
have side surfaces generally facing each other.” Ex. 1002, 38:8–9.
Petitioner submits that Fraser discloses this limitation, submitting an
annotated version of Figure 7 (Pet. 35), which we reproduce, below:

As shown in the annotated version of Figure 7 above, and according
to Petitioner, Fraser discloses adjacent vertebral bodies 54, 50, each having a
top surface (shown in blue) and a side surface (shown in red). Id.

f) Element 1e – First Bone Screw Hole - Side Surface
Claim 1 requires “a first of the bone screw holes . . . extends at least
partially from the top surface of the base plate and opens at least partially
toward the side surface of a first of the vertebral bones.” Ex. 1002, 38:10–
14. Petitioner submits that Fraser discloses this limitation. Pet. 36.
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Petitioner provides an annotated version of Fraser’s Figure 3 (id. at 37) and
Figure 8 (id. at 36), which we reproduce below:

As shown above in annotated Figures 3 (left) and 8 (right), Fraser
discloses first bone screw 46 (green in Figure 8) disposed through a hole
within plate 20 and toward the side surface of first vertebral bone 54. See id.
(citing Ex. 1007, 3:13–17; Ex. 1005 ¶ 95). Petitioner further submits that
Fraser teaches that the angle of insertion (α) may range from 15° to 60°. Id.
at 36–37 (citing Ex. 1007, 3:24–28; Ex. 1005 ¶ 96). Petitioner relies on this
range of screw angles in addressing the next limitation, “lip osteophyte.”
See id. at 38.

g) Element 1f – Second Bone Screw Hole - Lip
Osteophyte
Claim 1 recites “a second of the bone screw holes . . . extends at least
partially from the top surface of the base plate and opens at least partially
toward the lip osteophyte of a second of the vertebral bones.” Ex. 1002,
38:15–19.
Petitioner submits that Fraser’s teaching of screw angles between 15°
to 60° include screw holes that would “open toward the side surface of the
vertebrae or a steep angle to open toward the lip osteophyte.” Pet. 38
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(emphasis added). Petitioner submits that Fraser “discloses this claim
limitation.” Id. at 39. Petitioner also submits an annotated version of Figure
8 (id.), which we reproduce, below:

According to Petitioner, and as shown above, annotated Figure 8
depicts a bone screw (in dark purple) that extends at “a steep angle to open
toward the lip osteophyte.” See id. Petitioner also submits that it would
have been obvious for a POSITA “to perform routine experimentation and
optimization to choose the most suitable angle for each hole based on any
particular patient or set of patients.” Id. (citing Ex. 1005 ¶ 101).

h) Element 1g – Bone Screw Orientation
Petitioner submits that Fraser discloses, “wherein each and every one
of the plurality of bone screw holes is configured to receive one of the bone
screws angled relative to the base plate and oriented generally in an anterior-
posterior direction through at least partially the top surface of the base
plate.” Pet. 40. Petitioner provides an annotated version of Fraser’s Figure
8 (id.), which we reproduce, below:
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According to Petitioner, and as shown above in the annotated version
of Figure 8, Fraser discloses bone screw holes that are angled relative to the
top surface of the base plate and face the posterior direction. Id.

i) Analysis of Independent Claim 1
Patent Owner argues that Fraser’s “base plate” is not “configured to
fit primarily between anterior portions of adjacent vertebral bones’ lip
osteophytes,” as recited in the claim. See PO Resp. 31 (emphasis added). In
support of its position, Patent Owner submits an annotated version of
Fraser’s Figure 1 along with a “[s]implified plan view of anterior and
posterior portions of lip osteophytes” (id. at 36), which we reproduce,
below:
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Above and to the left is an annotated version of Fraser’s Figure 1, which “is
a plan view of a fusion cage.” Ex. 1007, 1:61–62. Above and to the right is
a simplified plan view of anterior and posterior portions of lip osteophytes.
PO Resp. 36. Patent Owner explains that Fraser’s fused implant “would
have essentially equal portions of its outer, ring-shaped walls sitting between
the anterior and posterior portions of the vertebral bones’ lip osteophytes,
respectively.” Id. (citing Ex. 2006 ¶ 94). Patent Owner’s expert testifies
that a POSITA, “even considering just the outer walls alone, would have
recognized that [Fraser’s] fused implant does not primarily or mainly sit
between the anterior portions of the lip osteophytes.” Ex. 2006 ¶ 94
(emphasis omitted).
In response to Patent Owner’s argument, Petitioner contends that
Patent Owner is wrong for two reasons. Pet. Reply 18.
First, Petitioner contends that Patent Owner’s “interpretation of the
limitation is incorrect,” and that the “limitation requires the base plate to be
implanted between the lip osteophytes (i.e., viewed laterally from a side-
view).” Id.
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As explained above, we disagree that Patent Owner’s claim
construction is incorrect. See supra Part II.B.1. The claim does not simply
require that the base plate be configured to be implanted between lip
osteophytes, when viewed laterally, as Petitioner contends. See Pet. Reply
18. Rather, claim 1 recites, “wherein the base plate is configured to fit
primarily between the anterior portions of adjacent vertebral bones’ lip
osteophytes.” Ex. 1002, 38:1–3 (emphasis added). We agree with Patent
Owner that Petitioner’s proposed definition ignores the term “primarily.”
PO Sur-reply 13. Petitioner’s interpretation of the limitation renders the
term primarily superfluous. See Bicon, 441 F.3d at 950 (“[C]laims are
interpreted with an eye toward giving effect to all terms in the claim.”); see
also Stumbo, 508 F.3d at 1362 (denouncing claim constructions that render
phrases in claims superfluous); see also Merck, 395 F.3d at 1372 (rejecting a
proposed claim construction that would render claim terms superfluous). As
we construed it above, the term primarily means mainly, and requires that a
majority of Fraser’s base plate be configured to fit between the anterior
portions of adjacent vertebral bones’ lip osteophytes to satisfy the claim.
See supra Part II.B.1.
Second, Petitioner argues that even if “the claims require the base
plate to be primarily (i.e., more than 50%) within the ‘green’ area of a bone
(as viewed in the superior/inferior direction), Fraser’s base plate meets the
definition.” Pet. Reply 19; see also supra p. 30 (reproducing Patent Owner’s
annotated figures of the anterior and posterior portions of lip osteophytes).
In support of this argument, Petitioner submits the following annotated and
modified versions of Fraser’s Figure 1 (Pet. Reply 20), which we reproduce,
below:
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As shown in the annotated and modified figures above, the orange portions
of the fusion cage represent the portions that allegedly fit between the
anterior portions of adjacent lip osteophytes, whereas the red (or pink)
portions of the fusion cage represent the portions of the cage that allegedly
fit outside of the anterior portions of the lip osteophytes. Petitioner asserts
that “Fraser’s transverse elements 28 and 30 are optional” and “[w]ithout
these elements, sixty percent of the implant is between the anterior portions
of the lip osteophytes,” as shown in the annotated figure to the right. See
Pet. Reply 20 (emphasis added).
Petitioner’s second argument is not persuasive for at least two
reasons.
First, Petitioner’s argument is untimely. “Unlike district court
litigation—where parties have greater freedom to revise and develop their
arguments over time and in response to newly discovered material—the
expedited nature of [inter partes reviews] bring with it an obligation for
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petitioners to make their case in their petition to institute.” Intelligent Bio-
Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016).
As participants in an adjudication under the Administrative Procedure Act,
parties in an inter partes review must be given notice of the “matters of fact
and law asserted,” and the opportunity to meaningfully respond. See Belden
Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1080 (Fed. Cir. 2015). For this
reason, Petitioner may not assert, and we may not base our Final Written
Decision on, late-arising factual assertions or theories. See Dell Inc. v.
Acceleron, LLC, 818 F.3d 1293, 1301 (Fed. Cir. 2016).
In addressing the disputed limitation, the Petition did not rely on
Fraser’s embodiment in which transverse elements 28, 30 are omitted. See
Pet. 29–32; see also PO Sur-reply 12 (“Petitioners cannot cure their failure
to provide in the Petition ‘in writing and with particularity’ an explanation as
to how the fused implant embodiment that they relied upon (i.e., having
transverse elements 28, 30) purportedly satisfies this limitation by arguing
that a different implant (i.e., without transverse elements 28, 30) would
satisfy this limitation in their Reply instead.”). As such, Petitioner’s new
theory in its Reply that relies on Fraser’s embodiment that omits transverse
elements 28, 30 is untimely. See Dell, 818 F.3d at 1301.
Second, even considering Petitioner’s argument, we are not persuaded
by Petitioner’s calculation that 60% of Fraser’s fused implant is configured
to fit between the anterior portions of adjacent lip osteophytes. See Pet.
Reply 20 (“Without [transverse elements 28, 30], sixty percent of the
implant is between the anterior portions of the lip osteophytes.”). Rather, we
agree with Patent Owner that Petitioner’s calculation is based on unreliable
speculation. See PO Sur-reply 14 (“Petitioner[’s] speculation regarding the
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form of such an implant is unsupported and insufficient”). Importantly,
Fraser does not disclose or describe the shape of its implant without
transverse elements 28, 30. Moreover, we are not persuaded that the specific
embodiment relied upon by Mr. Sherman would have the shape presented in
his testimony. See Ex. 1005 ¶ 91; see also supra p. 32 (reproducing the
same figure). Like Patent Owner, we are skeptical of Petitioner’s
“assumptions regarding the size and shape of the bump out on the anterior
face of body 10” as well as Petitioner’s “assumption that all such structure
on the anterior portions of body 10 and on plate 20 would sit between lip
osteophyte portions of the vertebral bones, as opposed to non-lip osteophyte
portions of the bones or outside the bones.” PO Sur-reply 14–15 (emphasis
added). As such, Petitioner has failed to establish, by a preponderance of the
evidence, that Fraser’s fused implant embodiment—even without transverse
elements 28, 30—would be “configured to fit primarily between anterior
portions of adjacent vertebral bones’ lip osteophytes,” as required by claim
1. Ex. 1002, 38:1–3 (emphasis added).
For the foregoing reasons, Petitioner has failed to prove by a
preponderance of the evidence that claim 1 is unpatentable over Fraser’s
fused implant embodiment.

3. Claims 10, 13, 14, 21, 22, and 29
Like independent claim 1, independent claim 21 similarly recites, “a
base plate . . . configured to fit primarily between an anterior portion of the
first bone’s lip osteophyte and an anterior portion of the second bone’s lip
osteophyte while bearing weight.” Ex. 1002, 39:52–40:5. As with claim 1,
Petitioner relies on the same unsupportable assertion that Fraser’s fused
implant embodiment satisfies this limitation. See Pet. 45–46 (relying on the
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analysis of independent claim 1 in setting forth its challenge of independent
claim 21). Accordingly, Petitioner’s challenge of independent claim 21 fails
for the same reasons as Petitioner’s challenge of independent claim 1.
Claims 10, 13, 14, 22, and 29 depend from either claim 1 or 21 (Ex.
1002, 38:51–40:53), and Petitioner’s challenge to these claims inherits the
same infirmity as its challenge under claim 1 (see Pet. 41–51). For the same
reasons that Petitioner has failed to prove by a preponderance of the
evidence that Fraser’s fused implant embodiment, i.e., Petitioner’s alleged
“base plate,” “is configured to fit primarily between anterior portions of
adjacent vertebral bones’ lip osteophytes,” Petitioner has failed to prove that
dependent claims 10, 13, 14, 22, and 29 are unpatentable over Fraser’s fused
implant embodiment.
Further, we discuss below an additional reason that Petitioner has not
demonstrated by a preponderance of the evidence that dependent claim 10
would have been obvious based on Fraser’s fused implant embodiment.
Claim 10 depends from claim 1 and further recites, “wherein the base
plate includes two lateral tabs . . . .” Ex. 1002, 38:51–52. In addressing this
limitation, Petitioner submits the following annotated version of Fraser’s
Figure 1 (Pet. 42):
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Figure 1 is a plan view of Fraser’s fusion cage. Ex. 1007, 1:61–62.
Petitioner submits that this figure depicts “two lateral tabs that extend from
opposite ends of the bottom surface (green) of the base plate.” Pet. 42.
Patent Owner disputes Petitioner’s contention, arguing that Petitioner
“improperly conflates a ‘tab’—i.e., a projection, flap, or short strip attached
to an object—with the side(s) of an object.” PO Resp. 72 (citing Ex. 2006
¶¶ 145–46).
We agree with Patent Owner. Petitioner fails to show that Fraser’s
fused implant embodiment includes the claimed “tabs.” See Pet. 41–43; see
also Pet. Reply 23–24. The portions of Fraser’s fusion cage that Petitioner
identifies as “tabs” are instead contiguous sides of Fraser’s implant. See Ex.
1007, Fig. 1. We disagree with Petitioner’s contention that these structures
are “tabs.”
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Rather, we agree with Mr. Drewry’s testimony that a “tab” is a
“projection, flap, or short strip attached to an object.” See Ex. 2006 ¶ 146.
Mr. Drewry’s definition is consistent with the Specification of the ’537
patent, which describes embodiments having lateral tabs as projections that
extend from opposite sides of the bottom surface of a base plate. See, e.g.,
Ex. 1002, Figs. 1, 2; see also id. at 10:62–65 (“[B]ase plate 20 further
includes a pair of lateral tabs integrally formed with the primary member 21
and extending outwardly from opposite ends of the bottom surface 26 of the
primary member . . . .”). We credit Mr. Drewry’s testimony that Petitioner
fails to “explain why [Fraser’s] contiguous sides of the fused implant
embodiment are ‘tabs’ under a proper understanding of this term.” Ex. 2006
¶ 147.

4. Summary of Ground 1
Based on the foregoing, Petitioner has failed to prove by a
preponderance of the evidence that claims 1, 10, 13, 14, 21, 22, and 29 are
unpatentable over Fraser’s fused implant embodiment.

E. Ground 2: Obviousness over Fraser (Fused Embodiment) and
Byrd
Petitioner contends that claims 3, 15, and 19 are unpatentable under
35 U.S.C. § 103 in view of Fraser’s “fused implant embodiment” in view of
Byrd. Pet. 51.

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1. Byrd (Ex. 1008)
Byrd discloses a “vertebral cage . . . for use in preserving the space
between adjacent vertebral during the process of spinal fusion.” Ex. 1008,
code (57). We reproduce Figures 1 and 2 of Byrd, below:

According to Byrd, Figure 1 depicts a top perspective view of Byrd’s
vertebral cage and Figure 2 depicts a top view of that cage. Id. at 4:62–64.

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2. Analysis
Like independent claim 1, independent claim 15 requires a “base plate
[that] is configured to fit primarily between anterior portions of the bone
bodies’ lip osteophytes.” Ex. 1002, 39:7–14. Petitioner does not rely on
Byrd to address Fraser’s shortcomings, discussed above. See Pet. 57.
Rather, and just as with independent claim 1, Petitioner submits that Fraser’s
fused implant embodiment meets this limitation. See id. (“This element is
analogous in scope to elements recited in claim 1, and is disclosed by
Fraser . . . .”). As such, for the same reasons that Petitioner’s challenge of
independent claim 1 fails, Petitioner’s challenge of independent claim 15
also fails.
Claims 3 and 19 depend from independent claims 1 and 15,
respectively. See Ex. 1002, 38:28–29, 39:38–41. Petitioner’s challenge of
claims 3 and 19 inherits the same infirmity as its challenge of independent
claims 1 and 15. See Pet. 51–54, 63–65.
For the same reasons that Petitioner has failed to prove by a
preponderance of the evidence that Fraser’s fused implant embodiment, i.e.,
Petitioner’s alleged “base plate,” “is configured to fit primarily between
anterior portions of adjacent vertebral bones’ lip osteophytes,” Petitioner has
failed to prove that claims 3, 15, and 19 are unpatentable over Fraser’s fused
implant embodiment in view of Byrd.

F. Ground 3: Obviousness over Fraser’s Two-Piece Embodiment
Petitioner asserts that claims 1–3, 8–16, 19–23, 25–27, and 29 are
unpatentable under 35 U.S.C. § 103 in view of Fraser’s two-piece
embodiment and the knowledge of a POSITA. Pet. 65, 66. As distinguished
from Fraser’s fused embodiment, in which plate 20 is bonded with body 10,
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Fraser’s two-piece embodiment is structured so that plate 20 can slide
relative to body 10. See Ex. 1007, 2:43–50.

1. Petitioner’s Challenge of Independent Claim 1
In addressing the claimed “base plate,” Petitioner submits annotated
versions of Figures 1 and 2 of Fraser (Pet. 68), which we reproduce, below:

According to Petitioner, Fraser depicts that plate 20 and body 10 are
distinct, and not bonded. Id. at 67. In this two-piece embodiment, plate 20
has a top surface (yellow), a first end (blue), a second end (purple), and a
bottom surface (green). Id. at 68.
To address the claimed “base plate is configured to fit primarily
between anterior portions of adjacent vertebral bones’ lip osteophytes to
bear weight and hold the vertebral bones while sharing weight with bone
graft material,” Petitioner submits an annotated version of Figure 8 of Fraser
(id. at 70), which we reproduce, below:
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According to Petitioner, Fraser discloses that “the plate and its screws
are designed to sit flush with anterior surface 66, which is within the cavity
between the bones that was previously occupied by the disk.” Id.
Petitioner also submits that
[a] POSITA would further understand that when the bone
screws engage each of the vertebral bodies, those screws would
place a compressive load on the bone graft material and promote
fusion between the bones. As such, a POSITA would understand
that Fraser discloses that the base plate shares weight with bone
graft material for fusion.
Finally, Fraser teaches a base plate that holds the bones.
Fraser teaches that its “plate is configured to receive, retain and
orient bone screws, thereby holding the fusion cage and
adjacent vertebral bodies in a stable relationship to promote
fusion.”
Therefore, Fraser in view of the knowledge of a POSITA
renders the claim limitation “the base plate is configured to fit
primarily between anterior portions of adjacent vertebral bones’
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lip osteophytes to bear weight to hold the vertebral bones while
sharing weight with bone graft material for fusion” obvious.
Id. at 71–72 (citing Ex. 1007, 4:37–42; Ex. 1005 ¶¶ 279, 280).
Patent Owner argues that Petitioner has “failed to show that [Fraser]
discloses or suggests that plate 20 is configured to bear any weight when
used as part of a spinal implant.” PO Resp. 47.
Patent Owner’s argument is persuasive.
As discussed above, giving the language of claim 1 its ordinary and
customary meaning in light the Specification, we determine that, in order for
the “base plate” to “bear weight,” the anterior portions of the adjacent lip
osteophytes must apply a compressive force, due to gravity, to the base
plate. Supra Part II.B.2.
Petitioner submits that plate 20 (of the two-piece implant of Fraser)
bears weight because the “screws would place a compressive load on the
bone graft material.” Pet. 71 (emphasis added); see also Ex. 1005 ¶¶ 278,
279 (testifying to the same). Petitioner’s assertions, even if true, fail to
satisfy the claimed limitation.
The issue isn’t whether a compressive load is placed on the bone graft
material, as Petitioner contends (see Pet. 71), but whether plate 20 bears a
compressive stress from gravitational forces acting between adjacent lip
osteophytes (see supra Part II.B.2). Furthermore, the express teachings of
Fraser contradict Petitioner’s assertions as to the forces imparted on Fraser’s
plate 20.
Fraser discloses that its body 10 (or fusion cage body) approximates
the shape of the space between adjacent vertebral bodies to “provide an
excellent, stable, load-bearing surface.” Ex. 1007, 4:49–52. Fraser further
discloses that its “transverse elements 28 and 30 enhance the structural
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integrity of the body 10 and provide additional load bearing surface.” Id. at
2:54–56 (emphasis added). Importantly, Fraser teaches that its body 10
bears weight.
Turning to plate 20, rather than bearing weight, Fraser discloses that
“[t]he plate, when included, ensures that the body [10] will not become
dislodged from the spine.” Id. at 4:52–55. We credit Mr. Drewry’s
testimony that Fraser teaches that plate 20 is not necessary, but when it is
included, it is simply provided to prevent load-bearing body 10 from
becoming dislodged. Ex. 2006 ¶ 116. Importantly, Fraser teaches that plate
20 simply keeps body 10 in place, and plate 20 does not bear weight. See
Ex. 1007, 2:54–56, 4:52–55.
We also credit Mr. Drewry’s testimony that Figure 3 of Fraser further
confirms that Fraser’s plate is not configured to bear weight. See Ex. 2006
¶ 117. To illustrate, we reproduce an annotated version of Fraser’s Figure 3
(id.), below:

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Figure 3 depicts a side view of Fraser’s fusion cage with bone screws. Ex.
1007, 1:66–67. Specifically, Figure 3 shows slightly convex inferior face
surface 18 and slightly convex superior face surface 16 with a slightly
tapered wedge profile, in which body 10 (shown in red) is thicker at the
anterior location (on the right) than at the posterior location (on the left). Id.
at 3:31–35. We credit Mr. Drewry’s testimony that
Figure 3 demonstrates that the vertebral bones do not and cannot
rest on plate 20; they rest only on body 10 when the implant is
inserted between such vertebral bones. This arrangement
depicted in Figure 3 further confirms the textual disclosure in
[Fraser]—that the weight is borne exclusively by the fusion cage
body 10 and that (optional) plate 20 is simply configured to keep
the weight-bearing body 10 in place and ensure that it does not
become dislodged from the spine. Plate 20 is not configured to
bear weight itself.
Ex. 2006 ¶ 117 (citing Ex. 1007, 4:49–55).
In its Reply, Petitioner submits an annotated version of Fraser’s
Figure 3 to illustrate how, precisely, Fraser’s plate 20 bears weight. Pet.
Reply 26. We reproduce that annotated figure, below:

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Petitioner submits that annotated Figure 3 depicts bone screws 48 as
imparting a bending moment on Fraser’s plate, as shown by the two green
arrows. Ex. 1023 ¶ 110. Mr. Sherman submits that this “bending moment
puts the anterior portion of the plate into tension and the posterior position of
the plate into compression.” Id. Mr. Sherman further submits a finite
element analysis (“FEA”) to support a finding that Fraser’s plate 20 bears
weight under the Board’s construction. See id. ¶¶ 113–117. We reproduce a
summary of Mr. Sherman’s FEA (id. ¶ 113), below:

As shown above, the FEA includes three different analyses: (1) Result A - in
which the screws are bonded to the plate; (2) Result B – in which the screw
cannot toggle but can slide in and out of the plate; and (3) Result C – in
which the screws can toggle in the plate as well as slide in and out of the
plate. Id. ¶ 114. As also shown above in blue, each of the “Results” depicts
a portion of Fraser’s base plate exposed to compressive stress adjacent the
bone-contacting face of the plate. See id. ¶ 115.
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In response to the FEA, Patent Owner first argues that Petitioner’s
new argument and evidence are untimely. See PO Sur-reply 18–19. Second,
Patent Owner takes issue with Mr. Sherman’s FEA, asserting that he fails
“to identify critical assumptions,” including “whether he accounted for
Fraser’s teaching that the plate has ‘tabs [that] are flexible or readily bent
with respect to the remainder of the plate 20.’” Id. at 22 (citing Pet. Reply
21) (emphasis omitted, alteration in original).
We agree with Patent Owner’s two arguments.
First, Petitioner’s alternative position that Fraser’s bone screws would
impart a bending moment on Fraser’s plate is untimely.
As explained above in connection with Ground 1, unlike in district
court litigation, where parties may freely revise and develop their arguments
over time in response to newly discovered material, the expedited nature of
inter partes reviews obligates petitioners to make their case in the petition.
See Intelligent Bio-Sys., 821 F.3d at 1369. Petitioner may not assert, and we
may not base our Final Written Decision on, late-arising factual assertions or
theories. See Dell, 818 F.3d at 1301.
In the present case, the Petition asserts that the bone “screws would
place a compressive load on the bone graft material” and, because of this, a
POSITA “would understand that [Fraser] discloses that the base plate shares
weight with bone graft material for fusion.” Pet. 71 (emphasis added). The
Petition does not contend that the bone screws impart a bending moment
(with accompanying compressive stresses) or any compressive stress on the
base plate, as Petitioner’s Reply now proposes. Compare id. at 71–72, with
Pet. Reply 26–28. Furthermore, Petitioner does not submit the new bending
moment theory in response to our preliminary claim construction. See Pet.
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Reply 25–28; see also id. at 28 (disputing the Board’s preliminary
construction and arguing that “Bearing Weight Means More Than
Compression”). For at least this reason, we may not base our Final Written
Decision on Petitioner’s late-arising theory that the bone screws would
impart a bending moment resulting in compressive forces on the base plate.
See Dell, 818 F.3d at 1301.
Second, we agree with Patent Owner that Mr. Sherman’s FEA fails to
account for the fact that Fraser’s tabs are flexible, or “readily bent.” See PO
Sur-reply 22 (citing Pet. Reply 21) (emphasis omitted).
Fraser discloses that in some of its embodiments, “the tabs are flexible
or readily bent with respect to the remainder of the plate 20.” Ex. 1007,
3:29–30. Petitioner relies on the embodiment with “flexible or readily bent”
tabs in its challenge, as well. See, e.g., Pet. Reply 1, 21. In particular,
Petitioner submits that “[w]hen the tabs are bent, the orientation, location,
and angle of the screws change relative to the bone surface.” Id. at 1 (citing
Ex. 1007, 3:29–30); see also id. at 21 (“Fraser states that the base plate
includes ‘tabs [that] are flexible or readily bent with respect to the remainder
of the plate.’” (citing Ex. 1007, 3:29–30) (emphasis omitted)). Yet, when
we review Mr. Sherman’s FEA, the flexible tabs are not accounted for. See
Ex. 1023 ¶¶ 109–114. Indeed, if we understand the tabs to be “readily bent,”
we do not see how, exactly, the bending moment that Mr. Sherman testifies
to would be present in plate 20. To Mr. Sherman’s credit, Fraser does not
disclose what, exactly, it means to be “readily bent” or “flexible.” Fraser is
a patent document, not an engineering specification, and it omits critical
details necessary for preparing a meaningful FEA. For example, although
Mr. Sherman assumes that Fraser’s plate is made of a particular titanium
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alloy (Ti-6Al-4V) (Ex. 1023 ¶ 113) and Fraser more generally discloses that
its plate is made of titanium or carbon fiber composites (Ex. 1007, 2:35–36),
Fraser does not precisely disclose the dimensions or composition of the plate
or tabs or otherwise explain how the tabs are “readily bent” or “flexible.”
Absent such detail, we agree with Patent Owner that the FEA “is
unsupported and unreliable.” PO Sur-reply 22.
As such, Petitioner has failed to prove by a preponderance of the
evidence that claim 1 is unpatentable over Fraser’s two-piece embodiment.

2. Independent Claims 15 and 21
Independent claims 15 and 21 are similar to independent claim 1 in
that they each require the base plate to bear weight. See Ex. 1002, 39:12–15
(claim 15 reciting, “base plate is configured . . . to primarily bear weight”);
see also id. at 39:53–40:5 (claim 21 reciting, “base plate . . . configured to fit
primarily between . . . while bearing weight”).
As with its challenge of claim 1, Petitioner relies on the same
unsupported argument that Fraser’s plate 20 is configured to bear weight.
See Pet. 76 (referencing the analysis of claim 1 in its challenge of claim 15);
see also id. at 77 (referencing the analysis of claim 1 in its challenge of
claim 21).
For the same reasons that Petitioner has failed to prove by a
preponderance of the evidence that Petitioner’s alleged “base plate” of
Fraser’s two-piece embodiment bears weight, Petitioner has failed to prove
that independent claims 15 and 21 are unpatentable over Fraser’s two-piece
embodiment.

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3. Dependent Claims 2, 3, 8–14, 16, 19, 20, 22, 23, 25–27, and 29
Claims 2, 3, 8–14, 16, 19, 20, 22, 23, 25–27, and 29 depend from
either claim 1, 15, or 21 (Ex. 1002, 38:25–40:53), and Petitioner’s challenge
to these claims inherits the same infirmity as its challenge under claim 1 (see
Pet. 65–78). For the same reasons that Petitioner has failed to prove by a
preponderance of the evidence that Fraser’s plate is configured to bear
weight, Petitioner has failed to prove that dependent claims 2, 3, 8–14, 16,
19, 20, 22, 23, 25–27, and 29 are unpatentable over Fraser’s two-piece
embodiment.

4. Summary of Ground 3
Petitioner has failed to prove by a preponderance of the evidence that
claims 1–3, 8–16, 19–23, 25–27, and 29 are unpatentable under 35 U.S.C.
§ 103 in view of Fraser’s two-piece embodiment.

G. Ground 4: Obviousness over Fraser in view of Michelson
Petitioner contends that claims 4–6, 24, and 30 are unpatentable as
obvious over Fraser (both the fused and two-piece embodiments) in view of
Michelson. Pet. 5.

1. Michelson (Ex. 1006)
Michelson is an International Patent Publication titled “Spinal Fusion
Implants with Opposed Locking Screws.” Ex. 1006, code (54). Michelson
discloses, in relevant part, a spinal implant with bone screws that “are
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adapted to receive locks to lock the screws to the implants to prevent the
backing out of the bone screws from the implants.” Id. at 9.8

2. Analysis
In challenging dependent claims 4–6, 24, and 30 as unpatentable over
Fraser in view of Michelson, Petitioner does not rely on Michelson to cure
the shortcomings discussed above under Grounds 1–3. See Pet. 79–86.
Rather, Petitioner relies on Michelson’s locking system to “securely hold
bone screws in place.” Id. at 86.
As such, Petitioner’s challenge to dependent claims 4–6, 24, and 30
inherit the same infirmity as its challenge under Grounds 1–3 (see Pet. 65–
78), and Petitioner has failed to prove by a preponderance of the evidence
that these claims are unpatentable over Fraser in view of Michelson.
Further, we discuss below an additional reason that Petitioner has not
demonstrated by a preponderance of the evidence that dependent claim 24
would have been obvious based on Fraser’s fused implant embodiment in
view of Michelson.
Claim 24 depends from claim 21 and further recites, inter alia,
“wherein the base plate has more than two bone screw holes, a first one of
the bone screw holes extends partially through both the bottom surface and
the first end, and a second one of the bone screw holes extends partially
through both the bottom surface and the second end.” Ex. 1002, 40:27–32
(emphases added).

8 Both Petitioner and Patent Owner cite to the internal pagination in
Michelson rather than the page numbers added by Petitioner (e.g.,
“Petitioners 1006-1” on the first page). For consistency, we do the same.
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In addressing this claimed limitation in relation to Fraser’s fused
implant embodiment (Ground 1), Petitioner relies on Michelson’s disclosure
of two bone screw holes. Pet. 81–83. Petitioner submits the following two
annotated versions of Michelson’s Figures 23 and 27 in support of its
position (id. at 83):

In citing these figures, Petitioner submits that Fraser in view of Michelson
teaches “the base plate has more than two bone screw holes [screw holes
430], a first one of the bone screw holes extends partially through both the
bottom surface [green] and the first end [blue], and a second one of the bone
screw holes extends partially through both the bottom surface [green] and
the second end [purple].” Id. (citing Ex. 1005 ¶¶ 393–396) (alterations in
original) (emphasis added).
In combining Fraser with Michelson, Petitioner reasons that a
POSITA would have “recognized that using toggle screws to permit the
bones to settle was advantageous, so long as there was an anti-back out
mechanism,” and explains that the modification would have yielded “a
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spinal implant with an anti-back out plate that can securely hold bone screws
in place.” Pet. 85–86 (citing Ex. 1005 ¶ 406).
Patent Owner argues that Petitioner “fail[s] to explain, for example,
how elements identified from Michelson would have been incorporated into
the [Fraser] implant, or how the implant, as modified, would meet . . . all of
the claim limitations.” PO Resp. 66–67. Patent Owner further argues,
“There is no explanation whatsoever regarding how the Michelson elements
identified for claim 24 would be incorporated into Fraser’s plate 20 and/or
fusion cage body 10.” Id. at 67.
As to dependent claim 24, and to Fraser’s fused implant embodiment,
we agree with Patent Owner.
Petitioner submits annotated versions of Fraser’s Figures 1 and 2 to
identify corresponding structure of Fraser’s fused implant under Ground 1
(Pet. 27):

Petitioner submits that as shown in the annotated version of Fraser’s Figure
1 above, Fraser’s “base plate” has a “bottom surface” in green. See id.
Petitioner alternatively asserts that “a POSITA would recognize that surface
14 could also be the claimed ‘bottom surface.’” Id. n.5 (citing Ex. 1005 ¶
75).
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If surface 14 of Fraser’s fused implant embodiment is the claimed
“bottom surface,” we do not see how the “bone screw holes extend partially
through” the “bottom surface,” as recited in claim 24. Further, we are not
persuaded that the three curved surfaces of Fraser’s inner cavities reasonably
satisfy the claimed “bottom surface” either. We agree with Patent Owner
that Petitioner’s application of the term “bottom surface” “runs contrary to
its ordinary meaning and should be rejected.” See PO Sur-reply 27.
Accordingly, we are not persuaded that claim 24 would have been obvious
over Fraser’s fused implant embodiment in view of Michelson.

3. Summary of Ground 4
Petitioner has failed to prove by a preponderance of the evidence that
claims 4–6, 24, and 30 are unpatentable under 35 U.S.C. § 103 over Fraser
(both the fused and two-piece embodiments) in view of Michelson.

H. Ground 5: Obviousness over Fraser, Michelson, and Byrd
Petitioner contends that claim 18 is unpatentable as obvious over
Fraser (both the fused and two-piece embodiments) in view of Michelson
and Byrd. Pet. 5.
Claim 18 depends from independent claim 15 and further recites, inter
alia, “screw retainer . . . configured to prevent one or more of the bone
screws from backing out.” Ex. 1002, 39:33–37.
In challenging dependent claim 18 as unpatentable over Fraser in view
of Michelson and Byrd, Petitioner does not rely on Michelson or Byrd to
cure the shortcomings discussed above under Grounds 1–4. See Pet. 86–89.
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Rather, Petitioner proposes to modify Fraser by including Michelson’s “anti-
back out screw plate” and Byrd’s “flat bottom surface.” See id. at 88.
As such, Petitioner’s challenge to dependent claim 18 inherits the
same infirmity as its challenge under Grounds 1–4, and Petitioner has failed
to prove by a preponderance of the evidence that claim 18 is unpatentable
over Fraser in view of Michelson and Byrd.

III. MOTION TO EXCLUDE
Petitioner moves to exclude (Paper 37 (“Motion” or “Mot.”)) certain
testimony in the deposition transcript of Patent Owner’s expert, Mr. Drewry,
elicited on redirect examination. See Mot. 1. Specifically, Petitioner seeks
to exclude page 197, line 20 through page 205, line 16 of Exhibit 1024 as
improper redirect testimony based on allegedly leading questions from
Patent Owner’s counsel. See id. at 15. Patent Owner filed an Opposition to
the Motion (Paper 38 (“Opposition” or “Opp.”)), noting that neither party
relied upon the portions of Mr. Drewry’s testimony identified by Petitioner.
See Opp. 1–2.
We dismiss Petitioner’s Motion as moot because we do not rely on
any portion of Mr. Drewry’s deposition testimony in this Final Written
Decision. See Patent Trial and Appeal Board Consolidated Trial Practice
Guide 79–80 (Nov. 2019) (“In the Board’s experience, consideration of the
objected-to evidence is often unnecessary to resolve the patentability of the
challenged claims, and the motion to exclude is moot.”), available at
https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf.

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IV. CONCLUSION
Weighing the evidence of the disclosure of the references, the
competing testimony, and the reasoning to combine the references, we
determine that Petitioner has failed to show, by a preponderance of the
evidence, that any of claims 1, 3–6, 10, 13–15, 18, 19, 21, 22, 24, 29, or 30
of the ’537 patent is unpatentable.
We also dismiss as moot Petitioner’s Motion.
V. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1, 3–6, 10, 13–15, 18, 19, 21, 22, 24, 29, and
30 of the ’537 patent are not determined to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion is dismissed as moot;
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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In summary:

Claims
35
U.S.C.
§
Reference(s)/Basis
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1, 10, 13,
14, 21, 22,
29
103 Fraser (fused
embodiment)
1, 10, 13, 14,
21, 22, 29
3, 15, 19 103 Fraser (fused
embodiment), Byrd
3, 15, 19
1, 3, 13–
15, 19, 21,
22, 29
103 Fraser (two-piece
embodiment)
1, 3, 13–15,
19, 21, 22, 29
4–6, 24, 30 103 Fraser (fused and
two-piece
embodiments),
Michelson
4–6, 24, 30
18 103 Fraser (fused and
two-piece
embodiments),
Michelson, Byrd
18
Overall
Outcome
1, 3–6, 10,
13–15, 18, 19,
21, 22, 24, 29,
30
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PETITIONER:

Dion M. Bregman
Jason C. White
Scott D. Sherwin (pro hac vice)
James J. Kritsas
MORGAN, LEWIS & BOCKIUS LLP
dion.bregman@morganlewis.com
jason.white@morganlewis.com
scott.sherwin@morganlewis.com
james.kritsas@morganlewis.com
Medacta-IPRs@morganlewis.com

Jeffrey N. Costakos
Matthew W. Peters (pro hac vice)
FOLEY & LARDNER LLP
jcostakos@foley.com
mpeters@foley.com

Timothy Devlin
Stephanie Berger (pro hac vice)
DEVLIN LAW FIRM LLC
TD-PTAB@devlinlawfirm.com
sberger@devlinlawfirm.com

PATENT OWNER:

Erik B. Milch
Frank Pietrantonio
Jennifer Volk-Fortier
Joseph Van Tassel
Dustin M. Knight
COOLEY LLP
emilch@cooley.com
fpietrantonio@cooley.com
jvolkfortier@cooley.com
jvantassel@cooley.com
dknight@cooley.com