NuVasive, Inc.

Patent Trials and Appeals Board

Jul 8, 2020

IPR2019-00546 (P.T.A.B. Jul. 8, 2020)

Trials@uspto.gov Paper 58
571-272-7822 Date: July 8, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

ALPHATEC HOLDINGS, INC., and ALPHATEC SPINE, INC.,
Petitioner,
v.
NUVASIVE, INC.,
Patent Owner.

IPR2019-00546
Patent 8,187,334 B2

Before DENISE M. POTHIER, HYUN J. JUNG, and
SHEILA F. McSHANE, Administrative Patent Judges.
JUNG, Administrative Patent Judge.

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

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I. INTRODUCTION
We have jurisdiction under 35 U.S.C. § 6. This Final Written
Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
A. Background and Summary
Alphatec Holdings, Inc., and Alphatec Spine, Inc., (collectively,
“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting institution of an
inter partes review of claim 16 of U.S. Patent No. 8,187,334 B2 (Ex. 1001,
“the ’334 patent”). NuVasive Inc. (“Patent Owner”) filed a Preliminary
Response. Paper 10. Pursuant to 35 U.S.C. § 314, we instituted an inter
partes review of the ’334 patent. Paper 17 (“Dec. to Inst.”). In particular,
we instituted review of claim 16 on all presented challenges. Dec. to Inst. 2,
26, 33, 35.
After institution, Patent Owner filed a Response (Paper 27, “PO
Resp.”), to which Petitioner filed a Reply (Paper 35, “Pet. Reply”). Patent
Owner thereafter filed a Sur-Reply (Paper 41, “PO Sur-reply”).
Patent Owner also filed a motion to exclude (Paper 39, “Mot.”), and
Petitioner filed an Opposition to Patent Owner’s Motion to Exclude (Paper
45, “Opp.”), to which Patent Owner filed a Reply (Paper 49, “Mot. Reply”).
In an Order (Paper 38), we authorized Patent Owner to file a Supplemental
Sur-Reply, which was filed (Paper 42) and Petitioner to file a Supplemental
Sur-Sur-Reply, which was also filed (Paper 43). An oral hearing in this
proceeding was held on April 3, 2020; a transcript of the hearing is included
in the record (Paper 55, “Tr.”). See also Exs. 1066, 2062 (parties’ errata
sheets for the transcript).
For the reasons that follow, we determine that Petitioner has not
shown by a preponderance of the evidence that claim 16 of the ’334 patent is
unpatentable. We also deny Patent Owner’s Motion to Exclude.
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B. Real Parties in Interest
Petitioner states that “Alphatec Holdings, Inc. and Alphatec Spine,
Inc. are the real-parties-in-interest for purposes of this proceeding.” Pet. 70.
“In accordance with 37 C.F.R. § 42.8(b)(1), Patent Owner identifies
NuVasive, Inc. as the real party-in-interest.” Paper 4, 2.
C. Related Matters
The parties indicate that the ’334 patent has been asserted in
NuVasive, Inc. v. Alphatec Holdings, Inc., Case No. 3:18-cv-00347-CAB-
MDD (S.D. Cal.) and Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No.
3:12-cv-002738-CAB-MDD (S.D. Cal.). Pet. 70; Paper 4, 2. The parties
also indicate that the ’334 patent is the subject of IPR2019-00361. Pet. 70;
Paper 4, 2.
Patent Owner additionally notes that the ’334 patent was previously
challenged in Cases IPR2013-00507 and IPR2013-00508. Paper 4, 2 (citing
In re NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016)); see also Pet. 1 (stating
that “the Federal Circuit affirmed the Board’s finding in IPR2013-00507
(Ex. 1004) that sole independent claim 1 of the ’334 patent and eighteen
dependent claims (2–5, 10, 11, 14, 15, and 19–28) are invalid”). A related
patent, U.S. Patent No. 8,361,156 B2, is challenged in IPR2019-00362.
Pet. 70; Paper 4, 2.
D. The ’334 Patent (Ex. 1001)
The ’334 patent issued May 29, 2012, from an application filed April
4, 2011, which is a continuation of an application filed on March 29, 2005,
and claims priority to a provisional application filed on March 29, 2004.
Ex. 1001, codes (22), (45), (60), (63), 1:7–13.
The ’334 patent particularly relates to “a system and method for spinal
fusion comprising a spinal fusion implant of non-bone construction . . . to
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introduce the spinal fusion implant into any of a variety of spinal target
sites.” Id. at 1:18–21. Figure 2 of the ’334 patent is reproduced below.

Figure 2 shows a perspective view of a lumbar fusion implant. Id. at 3:36.
The spinal fusion implant is introduced into the disc space via a lateral
approach to the spine or via a posterior, anterior, antero-lateral, or postero-
lateral approach, and is made from a radiolucent material, such as PEEK
(poly-ether-ether-ketone). Id. at 5:10–15, 5:29–33.
Common attributes of the various embodiments of spinal fusion
implant 10 includes top surface 31, bottom surface 33, lateral sides 14,
proximal side 22, and distal side 16. Id. at 6:6–9, Figs. 2–3. Spinal fusion
implant 10 may have “a width ranging between 9 and 18 mm, a height
ranging between 8 and 16 mm, and a length ranging between 25 and 45
mm.” Id. at 5:15–19.
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Spinal fusion implant 10 also preferably includes anti-migration
features, such as ridges 6 and pairs of spike elements 7–9, designed to
increase friction between spinal fusion implant 10 and adjacent contacting
surfaces of vertebral bodies. Id. at 6:21–32, Figs. 2–3. Spike elements 7–9
are preferably made from materials having radiopaque characteristics. Id. at
6:35–38.
Spinal fusion implant 10 has fusion apertures 2, separated by medial
support 50, extending through top surface 31 and bottom surface 33. Id. at
6:57–59, Figs. 2–3. “[F]usion apertures 2 function primarily as an avenue
for bony fusion between adjacent vertebrae.” Id. at 6:59–61.
E. Sole Challenged Claim
The ’334 patent has 28 claims, and claims 1–5, 10, 11, 14, 15, and 19–
28 were cancelled in IPR2013-00507. Ex. 1001, 34. Petitioner challenges
claim 16, which depends from cancelled claim 1. Claims 1 and 16 are
reproduced below.
1. A spinal fusion implant of non-bone construction
positionable within an interbody space between a first vertebra
and a second vertebra, said implant comprising:
an upper surface including anti-migration elements to
contact said first vertebra when said implant is positioned within
the interbody space, a lower surface including anti-migration
elements to contact said second vertebra when said implant is
positioned within the interbody space, a distal wall, a proximal
wall, a first sidewall and a second sidewall, said distal wall,
proximal wall, first sidewall, and second sidewall comprising a
radiolucent material;
wherein said implant has a longitudinal length greater than
40 mm extending from a proximal end of said proximal wall to a
distal end of said distal wall;
wherein a central region of said implant includes portions
of the first and second sidewalls positioned generally centrally
between the proximal wall and the distal wall, at least a portion
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of the central region defining a maximum lateral width of said
implant extending from said first sidewall to said second
sidewall, wherein said longitudinal length is at least two and half
times greater than said maximum lateral width;
at least a first fusion aperture extending through said upper
surface and lower surface and configured to permit bone growth
between the first vertebra and the second vertebra when said
implant is positioned within the interbody space, said first fusion
aperture having: a longitudinal aperture length extending
generally parallel to the longitudinal length of said implant, and
a lateral aperture width extending between said first sidewall to
said second sidewall, wherein the longitudinal aperture length is
greater than the lateral aperture width; and
at least three radiopaque markers; wherein a first of the at
least three radiopaque markers is at least partially positioned in
said distal wall, a second of said at least three radiopaque markers
is at least partially positioned in said proximal wall, and a third
of said at least three radiopaque markers is at least partially
positioned in said central region.

16. The spinal fusion implant of claim 1, further
comprising a fourth radiopaque marker situated within said
implant, said fourth radiopaque marker positioned in said central
region at a position spaced apart from said third radiopaque
marker.

Ex. 1001, 12:32–13:4, 13:51–14:3.
F. Asserted Prior Art and Proffered Testimonial Evidence
Petitioner identifies the following references as prior art in the
asserted grounds of unpatentability:
(1) U.S. Patent No. 5,192,327, issued March 9, 1993 (Ex. 1007,
“Brantigan”);
(2) U.S. Patent No. 5,860,973, issued January 19, 1999 (Ex. 1032,
“Michelson”);
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(3) U.S. Patent Application Publication No. US 2002/0165550 A1,
published November 7, 2002 (Ex. 1040, “Frey”);
(4) U.S. Patent Application Publication No. US 2003/0028249 A1,
published February 6, 2003 (Ex. 1008, “Baccelli”); and
(5) James L. Berry et al., A Morphometric Study of Human Lumbar
and Selected Thoracic Vertebrae, 12 Spine 362–367 (1987) (Ex. 1022,
“Berry”).
In support of its challenges, Petitioner provides a Declaration of
Charles L. Branch, Jr., M.D. (Ex. 1002). See Pet. 22, 26–70. Patent Owner
proffers a Declaration of Jim A. Youssef, M.D. (Ex. 2055), Declaration of
Carl R. McMillan, Ph.D. (Ex. 2057), and Declaration of Matthew Link
(Ex. 2059). Deposition transcripts for Dr. Branch (Ex. 2022), Dr. Youssef
(Ex. 1050), Dr. McMillan (Ex. 1051), and Mr. Link (Ex. 1052) were filed.
G. Asserted Grounds
Petitioner asserts that claim 16 would have been unpatentable on the
following grounds:
Claim Challenged 35 U.S.C. §1 References/Basis
16 103 Frey, Michelson, Baccelli
16 103 Brantigan, Baccelli, Berry, Michelson
Pet. 22, 26–70.

1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
Pub. L. No. 112–29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16,
2013. Because the application from which the ’334 patent issued was a
continuation of an application filed before that date and claims the benefit of
a filing date of provisional application also filed before that date, our
citations to Title 35 are to its pre-AIA version. See Ex. 1001, codes (60),
(63), 1:7–12.
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II. ANALYSIS
A. Patent Owner’s Motion to Exclude
Patent Owner moves to exclude Exhibits 1041, 1042, 1053–1056,
1059–1062, 1064, and 1065. Mot. 1, 5–8 (discussing Ex. 1064 along with
other exhibits). Patent Owner indicates that objections to these exhibits
were previously filed. Id. at 1 (citing Papers 23, 36). Patent Owner, as the
“moving party,” “has the burden of proof to establish that it is entitled to the
requested relief.” 37 C.F.R. § 42.20(c).
1. Exhibits 1041 and 1042
Exhibits 1041 and 1042 are declarations by Richard Hynes, M.D. filed
in IPR2013-00507 and IPR2013-00508, respectively. Patent Owner argues
that these exhibits should be excluded as irrelevant under Rules 401 and 402
of Federal Rules of Evidence (“FRE”). Mot. 2.
Patent Owner contends that “Petitioner relies on these exhibits solely
to support the assertion that it is presenting a materially different theory
compared to what was presented in these earlier proceedings.” Id. at 1
(citing Pet. 25–26). Patent Owner agrees that a different theory has been
presented and argues that the agreement “should be considered a stipulated
fact,” so that Exhibits 1041 and 1042 should be excluded. Id. at 2.
Petitioner responds that Exhibits 1041 and 1042 demonstrate that
claim 18 is unpatentable based on a combination of references not
previously presented in IPR2013-00507 and IPR2013-00508 and are
relevant to § 325(d) issues. Opp. 1. Patent Owner replies that Petitioner’s
assertions undermines its collateral estoppel arguments and states that “[t]o
the extent the materially different nature of Petitioner’s current Petition and
the prior IPRs is deemed an admission of fact, these exhibits should be
excluded.” Mot. Reply 1.
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Patent Owner’s basis for moving to exclude Exhibits 1041 and 1042 is
that they support Petitioner’s contention, and Patent Owner agrees with that
contention. The mere fact that an exhibit supports the parties’ agreement
does not demonstrate a reason to exclude it from the record.
Accordingly, we deny Patent Owner’s Motion to Exclude with respect
to Exhibits 1041 and 1042.
2. Exhibits 1053 and 1054
Exhibit 1053 is U.S. Patent No. 6,241,770 B1 to Michelson, issued
June 5, 2001, and Exhibit 1054 is an article titled “Minimally Invasive
Anterior Retroperitoneal Approach to the Lumbar Spine” by Paul C.
McAfee et al., from pages 1476–1484 of volume 23, number 13 of Spine,
published in 1998. Patent Owner argues that these exhibits should be
excluded under Rules 401–403 as irrelevant to a ground of review, likely to
cause confusion, and prejudicial. Mot. 2–5.
In particular, Patent Owner contends that “Petitioner cites these
exhibits in support of a prima facie case of obviousness raised for the first
time in Petitioner’s Reply” and to fill a gap identified in the Patent Owner
Response. Id. at 2–4 (citing Pet. 4–5, 30, 45, 47–48; PO Resp. 20–23; Pet.
Reply 10). Petitioner responds that Exhibits 1053 and 1054 are proper
rebuttal evidence. Opp. 2. Petitioner also identifies which of Patent
Owner’s arguments that the exhibits rebut and how they respond to those
arguments. Id. at 2–4 (citing PO Resp. 9, 30; Pet. Reply 2–4, 10, 15–16).
Patent Owner replies that “Petitioner does not contest that it could have
presented them with the Petition” and “concedes that it is improper in reply
to rely on a new rationale to combine the prior art references.” Mot.
Reply 2. Patent Owner reiterates its arguments that Exhibits 1053 and 1054
support a new rationale for combining the references. Id. at 2–4 (citing
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Pet. 4–5, 31–32, 41–42; Opp. 3–4). Patent Owner also argues that these
exhibits fail to support the theory presented in the Petition. Id. at 4 (citing
Pet. 30; Opp. 3–4).
The parties dispute whether Exhibits 1053 and 1054 support rebuttal
arguments or are new arguments. Patent Owner’s arguments are not
properly the subject of a motion to exclude based on inadmissibility, but
rather should have been filed as a motion to strike because they seek to
exclude belatedly presented evidence that Patent Owner contends exceeds
the proper scope of reply. In any event, because the dispute has been
presented (see Papers 38, 42, 43), and the exhibits at issue support a proper
rebuttal argument, we deny Patent Owner’s Motion to Exclude with respect
to Exhibits 1053 and 1054.
3. Exhibits 1055 and 1056
Exhibit 1055 is an article titled “A Carbon Fiber Implant to Aid
Interbody Lumbar Fusion” by John W. Brantigan, M.D. and Arthur D.
Steffee, M.D., from pages 2106–2117 of volume 18, number 14 of Spine,
published in 1993. Patent Owner argues that Exhibit 1055 should be
excluded under Rules 401–403 because it is cited in Petitioner’s Reply with
no substantive discussion and no explanation of its significance. Mot. 5.
Exhibit 1056 is an excerpt from a transcript in related litigation. The
excerpt contains Dr. Brantigan’s direct testimony regarding implants. See
Ex. 1056, 2–9. Patent Owner argues that Exhibit 1056 should be excluded
under Rules 106 and 401–403 because it is “more likely to cause confusion
and unreasonable prejudice than add probative value.” Mot. 5. Specifically,
Patent Owner argues that Exhibit 1056 is an incomplete document from
another proceeding, omits other information that should be considered, and
is irrelevant to this proceeding. Id. at 5–6. Patent Owner also argues that,
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because Exhibit 1056 is an excerpt, it is confusing and fails to provide
context. Id. at 6.
Petitioner responds that Exhibits 1055 and 1056 were offered to rebut
Dr. Youssef’s testimony. Opp. 6. Petitioner argues that the exhibits are,
thus, relevant and their relevance outweighs any risk of confusion. Id.
Petitioner also contends that Patent Owner relied on Exhibit 1055 in
previous litigation and relies on exhibits from the same litigation to support
arguments in this proceeding. Id. (citing Ex. 2029; Ex. 2030; Ex. 2060, 27–
29, 51).
Patent Owner replies that Petitioner “improperly attempt[s] to back-
fill arguments regarding Exhibit 1055” and the arguments are “belated and
non-responsive.” Mot. Reply 5 (citing Opp. 6). Patent Owner also replies
that “Petitioner approved of NuVasive’s filing of EX2060 as a complete
version of the transcript Petitioner filed as EX1056” and “fails to establish
the admissibility of its exhibits.” Id. (citing Mot. 5–8; Opp. 6).
Petitioner cites Exhibits 1055 and 1056 in its Reply in support of its
argument that Dr. Youssef was unaware of Patent Owner’s reliance on
Brantigan. Pet. Reply 4–5. Some of Patent Owner’s arguments are again
not properly the subject of a motion to exclude based on inadmissibility
because they seek to exclude belatedly presented evidence that Patent Owner
contends exceeds the proper scope of reply. In any event, we do not agree
with Patent Owner that the explanation of its significance is insufficient or
that these exhibits are irrelevant. The exhibits at issue are properly
presented as rebuttal evidence to aid in determining what weight we should
afford to Dr. Youssef’s testimony in this proceeding. These exhibits inform
us about Dr. Youssef’s knowledge about a reference asserted in this
proceeding which, in turn with all other record evidence, may or may not
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affect the credence we give to Dr. Youssef’s opinion of the asserted
reference.
Accordingly, Patent Owner has not satisfied its burden to show that
Exhibits 1055 and 1056 should be excluded, and thus, we deny Patent
Owner’s Motion to Exclude with respect to Exhibits 1055 and 1056.
4. Exhibits 1059 and 1064
Exhibit 1059 is an excerpt from a transcript of the deposition of Dr.
Youssef in related litigation, and Exhibit 1064 is open payments data for Dr.
Youssef. Patent Owner argues that these exhibits should be excluded under
Rules 106 and 401–403 because they are “more likely to cause confusion
and unreasonable prejudice than add probative value.” Mot. 5.
In particular, Patent Owner argues that Exhibit 1059 is an incomplete
document from another proceedings, omits other information that should be
considered, and is irrelevant to this proceeding. Id. at 5–6. According to
Patent Owner, Exhibits 1059 and 1064 support that Dr. Youssef has been
compensated for consulting services provided to Patent Owner beyond this
proceeding and the partial record is confusing, provides minimal context,
and likely to cause undue prejudice. Id. at 6, 8; see also id. at 6–7 (arguing
that Dr. Branch has also provided consulting services). Petitioner responds
that they were offered “to demonstrate the bias associated with Dr.
Youssef’s opinions.” Opp. 7–8. Petitioner also describes Dr. Branch’s
consulting arrangement with Medtronic and other companies. Id. at 8.
Patent Owner replies that “Petitioner’s use of [Exhibit 1064] is
misleading and incomplete because Dr. Branch testified during his
deposition in the district court case that he was paid several million dollars
as a consultant for Medtronic and that this range of compensation reflected
fair market value” and that “Petitioner does not contest the authenticity or
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veracity of Dr. Branch’s testimony.” Mot. Reply 5 (citing Mot. 6–7;
Opp. 8). Patent Owner does not provide a reply specific to Exhibit 1059.
See id.
Dr. Youssef’s testimony (Ex. 1059) and open payments data
(Ex. 1064) would aid in determining bias, if any, that may have affected his
opinion in this proceeding. Because these exhibits aid in determining what
weight we should give to his testimony, we deny Patent Owner’s Motion to
Exclude with respect to Exhibits 1059 and 1064.
5. Exhibits 1060, 1061, and 1065
Exhibits 1060, 1061, and 1065 are, respectively, an excerpt of
Petitioner’s Reply to Patent Owner’s Response in IPR2013-00206, an
excerpt of an expert report regarding damages in related litigation, and a
declaration by Mr. Link in support of a motion for preliminary injunction in
related litigation. Patent Owner argues that these exhibits should be
excluded under Rules 106 and 401–403 of the FRE because they are “more
likely to cause confusion and unreasonable prejudice than add probative
value.” Mot. 5. As discussed below, Patent Owner also argues that Exhibit
1060 should be excluded under Rules 401 and 402 for other reasons. See id.
at 8.
In particular, Patent Owner argues that Exhibits 1060, 1061, and 1065
are incomplete documents from other proceedings, omits other information
that should be considered, and are irrelevant to this proceeding. Id. at 5–6.
Patent Owner also argues that, because these exhibits are excerpts, they are
confusing and fail to provide context. Id. at 6. For Exhibits 1061 and 1065,
Petitioner responds that they “were offered to rebut Patent Owner’s evidence
of secondary indicia of non-obviousness.” Opp. 7. For Exhibit 1060,
Petitioner does not provide a response. See id. at 7–8 (arguments under the
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heading “Exhibits 1059–1061, 1064–1065”). Patent Owner does not provide
a reply specific to these exhibits. See Mot. Reply 5.
Because we do not rely on Exhibit 1060, we deny as moot Patent
Owner’s Motion to Exclude with respect to Exhibit 1060. For the reasons
discussed below, we do not reach Patent Owner’s asserted objective indicia
for nonobviousness and do not consider evidence thereof. Therefore, we
deny as moot Patent Owner’s Motion to Exclude with respect to Exhibits
1061 and 1065.
6. Exhibits 1060 and 1062
Exhibits 1060 is an excerpt of Petitioner’s Reply to Patent Owner’s
Response in IPR2013-00206, and Exhibit 1062 is an order regarding a
motion to dismiss counts in related litigation. Patent Owner argues that
these exhibits should be excluded under Rules 401 and 402. Mot. 8. Patent
Owner contends that the exhibits were filed with Petitioner’s Reply but were
not cited and are, thus, not relevant to the proceeding. Id. Petitioner does
not respond to these arguments. See generally Opp.
Because we do not rely on Exhibits 1060 and 1062 in our analysis, we
deny as moot Patent Owner’s Motion to Exclude with respect to Exhibits
1060 and 1062.
B. Legal Standards
In an inter partes review, 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 in its challenges,
Petitioner must prove unpatentability by a preponderance of the evidence.
35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
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A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made 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 prior art; (3)
the level of ordinary skill in the art; and (4) objective evidence of
nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
As discussed below, the parties’ disputes are related to each of the
above-listed underlying factual determinations. After reviewing the
complete record, we conclude that Petitioner has not shown by a
preponderance of the evidence that one of ordinary skill in the art would
have combined the asserted references in the manner asserted by Petitioner.
C. Level of Ordinary Skill in the Art
Petitioner asserts that one of ordinary skill in the art “would have a
medical degree with two or three years’ experience performing procedures
using interbody spinal fusion implants” or “would have a mechanical or
biomechanical engineering degree with at least two years’ experience
working in developing implant devices and associated instruments with
significant access to orthopedic surgeons or neurosurgeons.” Pet. 28
(quoting Ex. 1002 ¶ 18). In our Decision to Institute, we preliminarily
adopted Petitioner’s unopposed proposal. Dec. to Inst. 13.
Patent Owner responds that Petitioner “fails to view the art through
the knowledge of a [person of ordinary skill in the art] at the time” because,
as an example, the person of ordinary skill in the art “would not be familiar
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with developments in the art that came after the relevant time, such as
XLIF.” 2 PO Resp. 9 (citing Ex. 2055 ¶¶ 28–29). However, Patent Owner
does not dispute Petitioner’s asserted qualifications for one of ordinary skill
in the art and applies those qualifications. See Tr. 27:19–28:9.
In determining the level of ordinary skill in the art, various factors
may be considered, 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.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
(citation and internal quotation marks omitted).
Based on the full record before us, we see no reason to disturb our
preliminary finding regarding the level of ordinary skill in the art. Patent
Owner does not expressly provide its own definition of a level of ordinary
skill in the art. See PO Resp. 9. Patent Owner also applies Petitioner’s
asserted qualifications for one of ordinary skill in the art. See Tr. 27:19–
28:9. Accordingly, we maintain and reaffirm that one of ordinary skill in the
art “‘would have a medical degree with two or three years’ experience
performing procedures using interbody spinal fusion implants’” or “‘would
have a mechanical or biomechanical engineering degree with at least two
years’ experience working in developing implant devices and associated
instruments with significant access to orthopedic surgeons or
neurosurgeons.’” Dec. to Inst. 13 (citing Pet. 28; Ex. 1002 ¶ 18). This level

2 Mr. Link indicates that XLIF is an abbreviation for “eXtreme Lateral
Interbody Fusion.” Ex. 2059 ¶ 3. Patent Owner also describes XLIF is an
“XLIF product line, including CoRoent® XL implants” and “a minimally
invasive surgical approach to spinal fusion surgery that . . . accesses the disc
space from the lateral aspect of the patient.” PO Resp. 66 (citing Ex. 2059
¶¶ 4–8).
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of skill in the art is consistent with the disclosure of the ’334 patent and the
prior art of record. Also, our analysis below does not hinge on whether one
of ordinary skill in the art would have been familiar with XLIF technology
or developments in the art that come after the relevant time.
Dr. Branch, Petitioner’s expert, has completed residencies and a
fellowship in neurosurgery departments between 1985–1987, has taught
spinal surgery since 1987, focusing his practice and research on spinal
diseases and injuries (e.g., minimally invasive lumbar interbody fusion
techniques), and has obtained various patents related to spinal surgery,
spinal implants, and spinal surgical instrumentation. Ex. 1002 ¶¶ 5–13;
Ex. 1003. Dr. Branch’s qualifications are sufficient as a person of skill in
the art for purposes of this proceeding.
Dr. Youssef, Patent Owner’s expert, is an orthopedic surgeon, has
been a practicing spine surgeon for over two decades, including treating
spinal injuries and performing spine surgery, is a member or fellow of
various organizations related to surgery, orthopedics, and the spine, has
written articles related to the spine, treatments, and surgery, and is a named
inventor on patents related to spine implants and fixations systems.
Ex. 2055 ¶¶ 1–12. Dr. McMillin, another of Patent Owner’s experts, has a
B.S. in mechanical engineering and Ph.D. in Macromolecular Science, has
experience in the field of biomedical engineering beginning in 1974,
including designing orthopedic products for the spine, and has served on
various committees or advisory boards in the biomedical industry. Ex. 2057
¶¶ 1–7; Ex. 2058. Both, Dr. Branch’s and Dr. McMillin’s qualifications are
sufficient as persons of skill in the art for purposes of this proceeding.
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D. Claim Construction
On October 11, 2018, the Office revised its rules to harmonize the
Board’s claim construction standard with that used in federal district court.
Changes to the Claim Construction Standard for Interpreting Claims in Trial
Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51340
(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)). This rule change
applies to petitions filed on or after November 13, 2018, so the revised claim
construction standard applies to this proceeding. Id.; see Pet. 26 (stating that
the “Board applies ‘the standard used in federal courts . . . ’” (quoting 83
Fed. Reg. at 51343)); Paper 3, 1 (according filing date of January 10, 2019
to the Petition).
Petitioner states that “no express construction is needed to resolve the
issues in this Petition.” Pet. 26. In our Decision to Institute, we stated that
“[w]e interpret ‘longitudinal length’ and ‘longitudinal aperture length’
consistent with the claim language, and further express interpretation is not
required for purposes of this Decision.” Dec. to Inst. 12. We also
determined that no express interpretation of any claim term was required at
that stage of the proceeding. Id. at 12–13.
Patent Owner proposes interpretations for “longitudinal length,”
“longitudinal aperture length,” and “central region.” PO Resp. 4–8. For the
reasons discussed below, a preponderance of the evidence does not persuade
us that one of ordinary skill in the art would have made Petitioner’s
proposed combination of Frey, Michelson, and Baccelli or Brantigan,
Baccelli, Berry, and Michelson. Our determination does not depend on a
particular interpretation for “longitudinal length,” “longitudinal aperture
length,” and “central region.”
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Accordingly, we do not need to provide express claim interpretations
for any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean
Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we
need only construe terms ‘that are in controversy, and only to the extent
necessary to resolve the controversy’”) (citing Vivid Techs., Inc. v. Am. Sci.
& Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
E. Ground Based on Frey, Michelson, and Baccelli
Petitioner argues that Frey and Michelson were previously determined
to teach or suggest all the limitations of claim 1 and that Baccelli teaches or
suggests the further limitations recited by dependent claim 16. Pet. 31, 32–
38. Petitioner also argues that one of ordinary skill in the art would have
been motivated to combine Frey as modified by Michelson with the further
teachings of Baccelli. Id. at 29, 38.
Patent Owner responds the asserted references do not teach all the
limitations of claims 1 and 16, Petitioner fails to provide a motivation to
combine the references, and Petitioner fails to show collateral estoppel
should be applied to the limitations of claim 1 incorporated in claim 16 by
dependency. PO Resp. 19–25, 27–31, 34–55. Patent Owner also presents
objective indicia of non-obviousness. Id. at 55–59.
For the reasons below, Petitioner does not persuade us by a
preponderance of the evidence that one of ordinary skill in the art would
have been motivated to combine Frey as modified by Michelson with the
teachings of Baccelli.
1. Scope and Content of the Asserted Prior Art
a) Frey (Ex. 1040)
Frey relates to “implants insertable in the spinal disc space,” and
specifically relates to “implants, methods and instruments for use in a
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posterior lateral approach to the disc space, including a transforaminal
approach.” Ex. 1040 ¶ 2. Figure 55 of Frey is reproduced below.

Figure 55 is a plan view of an implant. Id. ¶¶ 66, 67. “Implant 1000
is an interbody fusion device or cage that can be packed with bone growth
material or other known substance and inserted into disc space D1 to
promote bony fusion between vertebrae V1 and V2.” Id. ¶ 140. It has a
“boomerang or banana shape.” Id.
Implant 1000 also “includes a concave posterior wall 1002 and an
opposite convex anterior wall 1004,” “an arcuate leading end wall 1006 and
an arcuate trailing end wall 1008” that “connect posterior wall 1002 and
anterior wall 1004,” and grooves 1014, 1016 that “engage the vertebral
endplates to resist posterior and anterior migration of implant 1000 in the
disc space.” Id. ¶¶ 141, 143. Implant 1000 has “upper openings 1018a and
1018b separated by an upper strut 1019.” Id. ¶ 144. “Implant 1000 can be
made from titanium, surgical grade stainless steel, or other bio-compatible
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material using fabricating techniques known in the art,” such as PEEK. Id.
¶¶ 149, 181.
A dual lobe implant such as implant 1000, “is placed in the disc space
D1 and has a length sufficient to span the disc space from the distal portion
37 to the proximal portion 41.” Id. ¶ 130. Figure 63 of Frey is reproduced
below.

Figure 63 is a plan view of another embodiment of an implant. Id.
¶¶ 71, 75. “Implant 1400 is an interbody fusion device or cage that can be
packed with bone growth material or other known substance and inserted
into disc space D1 to promote bony fusion between adjacent vertebrae V1
and V2.” Id. ¶ 150. “Implant 1400 includes a body having a leading end
portion 1450, a trailing end portion 1452, and a middle portion 1454
therebetween.” Id. ¶ 151.
“In order to provide avenues for bone growth through implant 1400,
. . . leading end portion 1450 includes first chamber 1418 and trailing end
portion 1452 includes second chamber 1420.” Id. ¶ 154. “Middle portion
1454 includes a middle chamber 1422.” Id.
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“A first strut 1424 is located between first chamber 1418 and third
chamber 1422 and extends between posterior wall 1402 and anterior wall
1404,” and a “second strut 1426 is located between second chamber 1420
and third chamber 1422 and extends between posterior wall 1402 and
anterior wall 1404.” Id.
Also, “[a] number of radiographic markers 1438 can also be provided
in implant 1400 to facilitate X-ray assessment of the locating and positioning
of implant 1400 in the patient's body,” and “[s]uch markers are particularly
useful for an implant 1400 made from radiolucent material.” Id. ¶ 156. Frey
describes that “markers 1438 are provided at the midline of anterior wall
1404 at the anterior most point defined by offset portion 1434” and “at the
posterior-most points of trailing end wall 1408 and leading end wall 1406.”
Id. “Positioning markers 1438 at these locations provides an indication of
the anterior and posterior placement of implant 1400 in the disc space, and
also an indication of the lateral placement of implant 1400 in the disc
space.” Frey also states that “[a]lignment of the end wall markers 1438 in a
lateral X-ray indicates proper orientation of implant 1400 in the disc space in
the A-P direction.” Id.
b) Michelson (Ex. 1032)
Michelson relates “particularly to spinal fusion implants for insertion
from the side of a patient (translateral) across the transverse width of the
spine and between two adjacent vertebrae.” Ex. 1032, 1:16–19; see also id.
at 3:3–5 (describing translateral approach).
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Figures 18 and 19 of Michelson are reproduced below.

Figure 18 is a perspective side view of a spinal fusion implant, and Figure 19
is a perspective lateral anterior view of a segment of the spinal column with
the implants shown in Figure 18 “inserted from the lateral aspect in a
modular fashion in the disc space between two adjacent vertebrae along the
transverse width of the vertebrae.” Id. at 5:31–39. Michelson states that the
“transverse width of a vertebra is measured from one lateral aspect of the
spine to the opposite lateral aspect” and that the “depth of a vertebra is
measured from the anterior aspect to the posterior aspect of the spine.” Id. at
3:7–10.
Michelson’s implant “is dimensioned to fit within the disc space
created by the removal of disc material between two adjacent vertebrae,”
“has a length that is substantially greater than the depth of the vertebrae and
a width that approximates the depth of the vertebrae,” “has more surface
area of contact and thus permits greater stability,” and “may be inserted into
the disc space through a hollow tube.” Id. at 3:34–40, 3:51–52. 3:61–63.
The dimensions of the implant “permit[] a single implant to be inserted by a
single procedure into the spine.” Id. at 3:46–50.
Spinal implant 1000 “has a narrower width such that more than one
spinal fusion implant 1000 may be combined in a modular fashion for
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insertion within the disc space D between the adjacent vertebrae.” Id. at
10:50–55. Spinal implant 1000 is an alternative embodiment of a preferred
embodiment that has “a width in the range of 24 mm to 32 mm, with the
preferred width being 26 mm; and a length in the range of 32 mm to 50 mm,
with 42 mm being the preferred length.” Id. at 10:42–47, Fig. 17.
Michelson also claims an implant “having a length that is greater than one
half the transverse width of the vertebrae, said length being substantially
greater than the depth of the vertebrae.” Id. at 11:21–26.
c) Baccelli (Ex. 1008)
Baccelli “relates to intervertebral implant.” Ex. 1008 ¶ 1. Figures 1
and 2 of Baccelli are reproduced below.

Figures 1 and 2 show perspective and plan views of an implant. Id.
¶ 29. Implant 2 is made up of a cage having wall 4 with first portion 4a that
is horseshoe shaped and joined to second portion 4b that is cylindrical,
superior main face 8, and inferior main face 10 opposite face 8. Id. ¶¶ 33–
35. Wall 4 defines hole 7 that extends between faces 8, 10. Id. ¶¶ 34–35.
Faces 8 and 10 have a toothed profile forming teeth 12. Id. ¶¶ 36–37. The
cage has spikes 24 on faces 8, 10. Id. ¶ 41, Figs. 3–5. Fitting tool 40 puts
the cage into place. Id. ¶¶ 44–45, Fig. 9.
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“The cage can be made of a material that is transparent to X-rays” and
“can have one or more markers 47 included therein and serving, because
they are opaque to X-rays, to identify the position and/or presence of the
implant when X-rays are taken during or after the operation.” Id. ¶ 50. “The
spikes 24 can be inserted and fixed rigidly in the ducts formed in the cage.”
Id. ¶ 51. “They too can be made of a material that is opaque to X-rays.” Id.
2. Claim 16
Claim 16 depends from claim 1 and recites “a fourth radiopaque
marker situated within said implant, said fourth radiopaque marker
positioned in said central region at a position spaced apart from said third
radiopaque marker.” Ex. 1001, 13:51–14:3.
Petitioner relies on Baccelli for teaching the limitations of claim 16.
Pet. 32–36 (citing Ex. 1002 ¶¶ 162–165; Ex. 1008 ¶¶ 36, 41, 44, 50, 51,
Figs. 1–5, 8, 9). In particular, Petitioner argues that Baccelli’s implant has
four radiopaque markers, “one at least partially positioned in the distal wall,
a second at least partially positioned in the proximal wall, a third at least
partially positioned in the central region, and a fourth positioned in the
central region at a position spaced apart from the third radiopaque marker.”
Id. at 32–33 (citing Ex. 1002 ¶¶ 162–164; Ex. 1008 ¶¶ 41, 50–51).
Petitioner also argues that one of ordinary skill in the art would have
been motivated to combine Frey and Michelson, as the Board and the
Federal Circuit concluded previously. Pet. 29 (citing Ex. 1002 ¶¶ 142–143,
147–149; Ex. 1005, 14–17). According to Petitioner, the combination of
Frey and Michelson further modified by Baccelli would have rendered
obvious claim 16. Id. at 38 (citing Ex. 1002 ¶ 168).
In particular, Petitioner contends that “Frey describes a number of
radiopaque markers in an implant.” Id. at 36 (citing Ex. 1040 ¶ 156).
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Petitioner also argues that Frey teaches the use of radiographic markers in
implants, does not limit the number of markers included in an implant, and
teaches that alignment of markers indicates proper orientation of an implant.
Id. at 29 (citing Ex. 1002 ¶ 161; Ex. 1040 ¶ 156). Petitioner, thus, argues
that “it would have been obvious . . . to add a fourth radiopaque marker, like
Baccelli teaches, to the Frey implant to give surgeons additional
information,” such as “proper orientation of the implant in the disc space in
the saggital plane that bisects the patient into left and right through the
spinous process.” Id. at 36–37 (citing Ex. 1002 ¶ 161). Petitioner also
argues that a fourth radiopaque marker would allow surgeons to determine
the position of the implant from anterior-to-posterior and lateral X-rays. Id.
at 37 (citing Ex. 1002 ¶ 166).
Petitioner further relies on Baccelli for teaching the placement of
markers in the distal wall, proximal wall, and central region of a radiolucent
spinal fusion implant. Id. at 30 (citing Ex. 1008, Figs. 1–5, 8, 9). Petitioner,
thus, contends that one of ordinary skill in the art “would have been
motivated to include radiopaque markers in all four walls of the radiolucent
Frey lateral implant to enable surgeons to visualize orientation and location
of the implant during and after surgery.” Id. (citing Ex. 1002 ¶¶ 161, 166;
Ex. 1040, Figs. 55, 59).
Petitioner also argues that it would have been obvious “to position
markers in the middle (e.g., the midline of the anterior wall and the midline
of the posterior wall) of Frey’s sidewalls, as well as in the leading and
trailing ends of the implant” because such positioning “allow[s] surgeons to
align the markers with the spinous process and the lateral ends of the
vertebrae” and the alignment of markers in the sidewalls “indicates proper
orientation of the implant in the disc space in the saggital plane . . . .” Id. at
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30–31 (citing Ex. 1002 ¶ 161). Petitioner further argues that combining
Frey, Michelson, and Baccelli “amounts to nothing more than rearranging
known mechanical elements to achieve a predictable result.” Id. at 31
(citing Ex. 1002 ¶¶ 143–144, 148–150).
a) Patent Owner’s Response
Patent Owner responds that the “Federal Circuit expressly
acknowledged that motivation to combine length and width dimensions from
different references was not considered and was not necessary to the
judgment in IPR2013-00507.” PO Resp. 27 (citing Pet. 29; Ex. 1005, 14–
17). Patent Owner also argues that any previous motivation to combine
“would not [be] applicable to the different obviousness theories advanced
here.” Id. at 27–28 (citing Pet. 26).
Patent Owner also responds that (1) Petitioner misapprehends the
teachings of Baccelli (id. at 28 (citing Ex. 1008 ¶ 41)); (2) Petitioner does
not provide a reason to import the proposed marker configuration into Frey
(id.); and (3) the asserted motivation is conclusory, nonsensical, and was
rejected by the Federal Circuit as impermissible hindsight (id. at 28–31
(citing Pet. 29, 31; Ex. 1002 ¶ 161; Ex. 2017, 7:9–8:13; Ex. 2022, 124:14–
125:13; Ex. 2028 ¶ 60; Ex. 2055 ¶¶ 104–123)). In particular, Patent Owner
argues that Petitioner “fails to explain how adding an additional marker
would enable locating the implant when Frey teaches that the existing
positioning of the markers already provides an indication of A-P and lateral
placement as well as implant orientation,” “the proposed modification would
not assist the surgeon in locating the implant,” and the proposed
modification “would undermine the stated motivation.” Id. at 29 (citing Ex.
2055 ¶¶ 114–123).
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According to Patent Owner, “the proposed modification would only
decrease the surgeon’s ability to confirm the implant was properly oriented”
because a fourth radiopaque marker would result in ambiguous X-ray
images. Id. at 29 (citing Ex. 2022, 124:14–125:13; Ex. 2055 ¶¶ 121–123).
Patent Owner contends that, on a lateral X-ray, the proposed fourth marker
in addition to two markers 1438 positioned at the posterior-most points of
walls 1406, 1408 would result in two images of markers near the posterior
edge of the implant. Id. at 30 (citing Ex. 2055 ¶¶ 121–123). The two
images of markers can mean either proper placement because the X-ray
would show the fourth marker separated from markers 1438 or improper
alignment because the X-ray would show the fourth marker and one of
markers 1438 separated from the other marker 1438. Id. at 30 (citing
Ex. 2055 ¶¶ 121–123).
b) Parties’ Reply Arguments
Petitioner replies that it “does not rely on Baccelli for the ‘central
region’ limitation” and “relies on the orientation disclosed in Baccelli of four
radiopaque markers.” Pet. Reply 9 (citing PO Resp. 19–22). Petitioner also
argues that Patent Owner “read[s] the prior art in i[]solation disconnected
from the relevant state-of-art.” Id. (citing PO Resp. 29–30).
Patent Owner replies that “Petitioner admits that the theory of
unpatentability is different here that in IPR2013-00507.” PO Sur-reply 11
(citing Pet. 26, 29; PO Resp. 27–28; Pet. Reply 7). Patent Owner also
argues that Petitioner abandons the marker positioning of Baccelli, “offers
no meaningful response,” and relies on a “mischaracterization of Baccelli as
teaching placing two radiopaque markers in the claimed central region.” Id.
at 15–17 (citing Pet. 30–31, 34–35, 40; PO Resp. 18–23, 28–31; Pet.
Reply 10; Ex. 1002 ¶¶ 29–30; Ex. 1008 ¶ 41, Figs. 1, 5; Ex. 2017, 7:9–8:13;
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Ex. 2028 ¶ 60). According to Patent Owner, Petitioner pivots to a new
reference. Id. at 17–18 (citing Pet. Reply 2–3; Ex. 1054, 3)
c) Insufficient Reason to Combine the References
Petitioner relies on Frey for describing “a number of radiopaque
markers in an implant.” Pet. 36 (citing Ex. 1040 ¶ 156). Specifically,
Petitioner contends that Frey teaches markers 1438, their positions in an
implant, and how markers 1438 provide an indication of anterior and
posterior placement, lateral placement, and proper orientation in the disc
space. Id. (citing Ex. 1040 ¶ 156).
We find that paragraph 156 of Frey teaches that a “number of
radiographic markers 1438 can be provided in implant 1400 to facilitate X-
ray assessment of the locating and positioning of implant 1400 in a patient’s
body,” and that “markers 1438 are provided at the midline of anterior
wall 1404 at the anterior most point defined by offset portion 1434” and “at
the posterior-most points of trailing end wall 1408 and leading end wall
1406.” Ex. 1040 ¶ 156. We also find that “[p]ositioning markers 1438 at
these locations provides an indication of the anterior and posterior placement
of implant 1400 in the disc space, and also an indication of the lateral
placement of implant 1400 in the disc space.” Id. According to Frey,
“[a]lignment of the end wall markers 1438 in a lateral X-ray indicates proper
orientation of implant 1400 in the disc space in the A-P direction.” Id.
The parties’ declarants agree as to what Frey teaches in paragraph
156, and we credit their testimony because the record supports it. Ex. 1002
¶ 161; Ex. 1040 ¶ 156; Ex. 2055 ¶¶ 119, 120. We, thus, find that Frey
teaches that its placement of markers 1438 in implant 1400 provides, in a
lateral X-ray, indications of “the anterior and posterior placement of implant
1400 in the disc space,” “the lateral placement of implant 1400 in the disc
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space,” and “proper orientation of implant 1400 in the disc space in the A-P
direction.” Ex. 1002 ¶ 161; Ex. 1040 ¶ 156; Ex. 2055 ¶¶ 119, 120.
According to Petitioner, one of ordinary skill in the art would have
been motivated to add a fourth radiopaque marker to Frey’s implant “to
enable surgeons to visualize the orientation and location of the implant
during and after surgery,” “to allow surgeons to align the markers with the
spinous process and the lateral ends of the vertebrae,” and “to give surgeons
additional information.” Pet. 30–31 (citing Ex. 1002 ¶¶ 161, 166; Ex. 1040,
Figs. 55, 59), 31 (citing Ex. 1002 ¶ 161), 36 (citing Ex. 1002 ¶ 161).
Petitioner argues that the fourth radiopaque marker would provide, for
example, “proper orientation of the implant in the disc space in the sagittal
plane that bisects the patient into left and right through the spinous process”
(id. at 31 (citing Ex. 1002 ¶ 161)) and “alignment of markers at the midline
of both the anterior and posterior walls in an anterior X-ray indicates proper
orientation of the implant in the disc space in the sagittal plane that bisects
the patient into left and right through the spinous process” (id. at 36–37
(citing Ex. 1002 ¶ 161)).
Petitioner cites paragraphs 161 and 166 of Dr. Branch’s declaration
for support. See Pet. 30, 31, 36–37. Dr. Branch opines that the
addition of a fourth radiopaque marker—as described by
Baccelli—would provide additional, valuable information to
surgeons because, for example, alignment of markers at the
midline of both the anterior and posterior walls in an anterior X-
ray indicates proper orientation of the implant in the disc space
in the sagittal plane that bisects the patient into left and right
through the spinous process.
Ex. 1002 ¶ 161. Dr. Branch also opines that markers in the proximal, distal,
and central region of Frey’s implant would “assist a surgeon in locating the
spinal fusion implant during and after surgery.” Id. ¶ 166. Dr. Branch
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testifies that “a total of four radiopaque markers in an implant would have
allowed surgeons to see in an anterior-to-posterior (front) X-ray whether the
implant is askew relative to the spinous process and the lateral edges of the
vertebrae during and after lateral insertion” and that a
lateral (side) X-ray of the same implant would allow the surgeon
identify the position of the posterior sidewall of Frey relative to
the posterior edge of the vertebral body (bordering the spinal
canal) and the anterior sidewall of Frey relative to the anterior
edge of the vertebral body (bordering the aorta and vena cava).
Id. Paragraphs 161 and 166 do not cite to any supporting evidence. Also,
Dr. Branch confirms that the fourth radiopaque marker would be added at
the “most concave portion of” implants 1000 and 1400. Ex. 2022, 124:14–
125:13.
Patent Owner provides testimony from its declarant to argue that
Petitioner presents an insufficient reason for modifying Frey in view of
Baccelli. PO Resp. 29 (citing Ex. 2055 ¶¶ 114–123). Dr. Youssef testifies
that “Frey explains that the placement of markers 1438 on the anterior- and
posterior-most positions on the implant serve to identify anterior/posterior
positioning and proper alignment in the disc space.” Ex. 2055 ¶ 120 (citing
Ex. 1040 ¶ 156). As discussed above, we find that Frey teaches placing
markers 1438 provides in a lateral X-ray indications of anterior-to-posterior
placement, lateral placement, and proper orientation of the implant in the
disc space in the anterior-to-posterior direction. Ex. 1002 ¶ 161; Ex. 1040
¶ 156; Ex. 2055 ¶¶ 119, 120.
Frey also supports Dr. Youssef’s statement that “when positioned in
the disc space, a lateral X-ray will show an image of the anterior marker and,
if properly aligned, a single image for the two posterior markers.” Ex. 2055
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¶¶ 119, 120; Ex 1002 ¶ 161; Ex. 1040 ¶ 156. Reproduced below is an
annotated Figure 63 of Frey from Dr. Youssef’s declaration.

Figure 63 is a plan view of an embodiment of Frey’s implant and has
been annotated with blue stars representing the positions of markers 1438
and a red star representing Petitioner’s proposed fourth marker. Ex. 1040
¶¶ 71, 75; Ex. 2022, 124:14–125:13; Ex. 2055 ¶ 122. Dr. Youssef explains
that “[o]n a lateral X-ray, as disclosed by Frey, the additional marker
confuses interpretation of the implant position” because “[f]or example, two
radiopaque signals on the posterior edge could mean either proper placement
of the implant (alignment of both blue markers) or that the implant is not
properly aligned (alignment of a red and blue marker).” Ex. 2055 ¶ 123.
Dr. Youssef concludes that “[n]o other marker [other than those already
disclosed in Frey] is necessary to determine proper placement of Frey.” Id.
¶ 122.
Frey supports Dr. Youssef’s testimony, and the parties do not dispute,
that a lateral X-ray would show alignment of markers 1438 when Frey’s
implant is properly aligned in the disc space. Ex 1002 ¶ 161; Ex. 1040
¶ 156; Ex. 2055 ¶¶ 119, 120. Frey also implicitly supports that a lateral X-
ray would show markers 1438 not aligned with each other when Frey’s
implant is not properly aligned in the disc space. Ex. 1040 ¶ 156. There is
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no dispute that the proposed fourth radiopaque marker would show in a
lateral X-ray, and Petitioner does not address Patent Owner’s argument that
a fourth radiopaque marker would make a lateral X-ray ambiguous. See Pet.
Reply 8–9 (arguing under “Motivation to combine” that other references
teach a “central region” and Patent Owner reads the references in isolation).
In view of the full record before us, we credit Dr. Youssef’s testimony
(Ex. 2055 ¶¶ 114–123) over Dr. Branch’s testimony (Ex 1002 ¶¶ 161, 166)
because Dr. Youssef’s opinion is more consistent with the teachings of Frey.
Ex. 1040 ¶ 156.
Petitioner also argues that combining Frey, Michelson, and Baccelli
“amounts to nothing more than rearranging known mechanical elements to
achieve a predictable result.” Pet. 31 (citing Ex. 1002 ¶¶ 143–144, 148–
150). Even if we were to agree that Petitioner’s proposed combination is a
rearrangement of known mechanical elements, as discussed above, placing
Petitioner’s a fourth marker at the location that Petitioner proposes would
result in an ambiguous lateral X-ray, and the record provides no other
support that one of skill in the art would have made this rearrangement.
Accordingly, for the reasons above and based on the full record before
us, we determine that Petitioner does not present a sufficient reason why one
of ordinary skill in the art would have modified Frey in view of Michelson
and Baccelli.
F. Ground Based on Brantigan, Baccelli, Berry, and Michelson
Petitioner argues that Brantigan, Baccelli, Berry, and Michelson teach
or suggest the limitations of claims 1 and 16. Pet. 42–69. Petitioner also
argues that one of ordinary skill in the art would have been motivated to
combine these references. Id. at 38–42.
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Patent Owner responds that the asserted references do not teach all the
limitations of claims 1 and 16, and that Petitioner fails to provide a
motivation to combine the references. PO Resp. 25–27, 31–34. Patent
Owner also presents objective indicia of non-obviousness. Id. at 55–59.
For the reasons below, Petitioner does not persuade us by a
preponderance of the evidence that the asserted reason for combining
Brantigan, Baccelli, Berry, and Michelson has rational underpinnings, and,
for separate reasons, that there is a motivation to combine the references.
1. Scope and Content of the Asserted Prior Art
Michelson (Ex. 1032) and Baccelli (Ex. 1008) are discussed above.
a) Brantigan (Ex. 1007)
Brantigan “relates to inert rigid vertebral prosthetic devices and
methods for implanting the devices between adjacent vertebrae.” Ex. 1007,
1:7–9. Brantigan specifically “deals with ring-like prosthetic plugs or discs
used singly or stacked together between vertebrae to form support [struts] in
the spinal column and having rigid surfaces facilitating anchoring and
providing valleys for bone ingrowth from adjoining vertebrae.” Id. at 1:14–
15.
Brantigan provides “biologically acceptable, but inert rigid annular
prosthesis units . . . to support and fuse with adjacent vertebrae in both the
cervical, thoracic spine and lumbar portions of a human vertebral column.”
Id. at 1:64–68. “The rings are bottomed on the opposing end faces of
adjoining vertebrae” and “are preferably oval shaped with medial-lateral and
anterior-posterior dimensions in the same ratio as normal vertebral bodies
. . . .” Id. at 1:18–21. They “are generally oval shaped to conform with the
general outline perimeter of the vertebrae.” Id. at 2:2–4. “Each of the oval
implants is sized to match the height of an average disc and thus, can vary
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from 10 to 15 mm for the lumbar area and from 7-11 mm for the cervical
area.” Id. at 2:20–23. Figure 1 of Brantigan is reproduced below.

Figure 1 shows a perspective view of a full oval prosthetic device. Id.
at 3:21–22. Oval ring plug 11 has opposed sides 11a, ends 11b, top and
bottom surfaces 11c, and central upstanding aperture 11d.3 Id. at 4:5–10.
Top and bottom surfaces 11c have ridges 12 for engaging adjacent vertebrae.
Id. at 4:15–16, 5:22–26; see also id. at 6:5–16 (describing stack of plugs 11
between vertebrae). One of side walls 11a has an internally threaded
hole 13 for receiving a mounting tool, and interiors of side walls 11a have
grooves 14 for mounting rectangular connecting bar 15. Id. at 4:20–27.
Bar 15 separates central aperture 11d into two chambers that can be “packed
with bone graft material to expedite the fusion of the prosthesis device in the
spinal column.” Id. at 4:50–53; see also id. at 2:15–19 (describing
placement of bone graft material).
“The individual plugs or the stack of plugs can be introduced
anteriorly, laterally or posteriorly depending upon conditions . . . .” Id. at

3 Brantigan also describes “11d” as a central aperture (Ex. 1007, 4:13–14,
4:50) and a hollow interior (id. at 6:37). See also id., Figs. 1, 11 (showing
reference number 11).
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5:30–32; see also id. at 2:34–38 (describing implants of varying height
achieved by stacks of rings of varying height), 2:55–66 (describing
placement and insertion), 6:61–7:6 (describing insertion of plugs 11).
Brantigan further discusses that the devices “are also provided in partial
(preferably hemi-oval) annular shape to accommodate those surgical
procedures where only a portion of the vertebrae or disc is damaged,” and
“[t]wo such hemi-oval rings can be used in the posterior lumbar area in side-
by-side relation.” Id. at 2:2–8, 3:24–25, Fig. 2.
“The implants are preferably made of radiolucent material such as
carbon fiber reinforced polymers known commercially as ‘Peek’,
(polyetherether ketone) . . . .” Id. at 3:9–11. Figure 6 of Brantigan is
reproduced below.

Figure 6 shows a perspective view of a modified device with an
integral cross bar. Id. at 3:21–22, 3:36–37, Fig. 6. Modified device 30 is
plug 31 with the same shape as plug 11 but has reinforcing bar 32 integral
with side walls 31a. Integral internal partition 324 bisects hollow

4 Brantigan describes element “32” as a cross bar, a reinforcing bar, and
internal partition. Id. at 3:36–37, 5:37–43, Fig. 6.
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interior 235 (not shown) forming “side-by-side apertures through the plug
adapted to receive bone graft material.” Id. at 5:37–43, Fig. 6.
b) Berry (Ex. 1022)
Berry presents “results of a morphometric study of selected human
vertebrae undertaken to provide data for implant design.” Ex. 1022, 362.
Berry states that “[a]ccurate anatomic descriptions of vertebral shape are
necessary for the development of implantable devices and spinal
instrumentation” and that the “current study was undertaken due to a lack of
information needed for design projects involving instrumentation for the
lumbar and thoracic vertebrae.” Id.
“With present and future applications in mind, virtually the entire
geometry of the vertebrae was quantified by recording a total of 27
measurements per vertebra.” Id. “The means and standard deviations of the
dimensional data for all 240 vertebrae are presented in Table 1.” Id. at 363;
see also id. at 364 (presenting Table 1).
2. Claim 1
Petitioner does not assert that Patent Owner is estopped from arguing
the patentability of claim 1 over the asserted combination of Brantigan,
Baccelli, Berry, and Michelson. See generally Pet.; see also id. at 32
(arguing that “Patent Owner is therefore estopped from arguing that claim 1
renders any dependent claim patentable over Frey and Michaelson [sic.] as
those references have been definitively established as rendering claim 1,
among others, unpatentable”) (emphasis added).

5 Brantigan also describes element “23” as a tool receiving recess (id. at 5:1–
2, 5:32–33).
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For our analysis below, we need only address the limitation “wherein
said longitudinal length is at least two and half times greater than said
maximum lateral width” of claim 1, which is an element of claim 16 due to
its dependency.
a) wherein said longitudinal length is at least two and half times
greater than said maximum lateral width;
Petitioner contends that Brantigan teaches substantially all the
limitations of claim 1 with citations to Brantigan and Dr. Branch’s
declaration. Pet. 42–54, 57–60. Specifically, for “said longitudinal length is
at least two and half times greater than said maximum lateral width,”
Petitioner argues that Brantigan teaches “an implant with a longitudinal
length that is greater than 40 mm.” Id. at 54 (citing Ex. 1002 ¶ 204;
Ex. 1019, 6–9).
Petitioner turns to Michelson for “express[ly] teaching to make the
implant ‘narrower’ so that they ‘may be combined in a modular fashion for
insertion within the disc space D between adjacent vertebrae.’” Id. at 54
(citing Ex. 1032, 10:50–55). Petitioner contends that a “narrower implant
for lateral insertion would be easier to fit within the hollow tube Michelson
describes to facilitate insertion into the disc space.” Id. at 54–55 (citing
Ex. 1032, 3:61–65; Ex. 1002 ¶ 221).
According to Petitioner, Michelson teaches that spinal fusion implant
900 “has ‘a length in the range of 32 mm to 50 mm’ and ‘a width that
approximates the depth of the vertebrae’” and that spinal fusion implant
1000 “is similar to the spinal fusion implant 900, but has a narrower width
such that more than one spinal fusion implant 1000 may be combined in a
modular fashion for insertion within the disc Space D between the adjacent
vertebrae.” Id. at 55–56 (citing Ex. 1032, 10:32–59, Figs. 18, 19). In
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Petitioner’s view, both Brantigan and Michelson teach modularity, both are
directed to “laterally-inserted implants that are sized to span the full
transverse width of the lumbar vertebra,” and “Brantigan teaches modifying
the width in the direction of insertion of a spinal fusion implant in the same
way Michelson teaches.” Id. at 55 (citing Ex. 1007, 1:18–21, 1:65–68, 2:2–
11, 2:55–66, 4:5–8, 5:30–35; Ex. 1032, 3:1–10, 3:35–53, 10:50–55, claim
1).
Petitioner contends that Michelson expressly teaches preferred
dimensions for spinal fusion implant 900 “but does not specify what region
of the lumbar spine those dimensions pertain to.” Id. at 56 (citing Ex. 1002
¶ 225). Petitioner argues that “in modifying Brantigan in view of
Michelson’s long-and-narrow modular teaching for a fusion between L4 and
L5, for example,” one of ordinary skill in the art “would have referred to
Berry” because Berry provides mean widths of human vertebrae that can be
between 31.9 mm at L1 and 35.1 mm at L5. Id. at 56 (citing Ex. 1002
¶¶ 176, 225, 226; Ex. 1022, 362–364, Table 1). Petitioner argues that,
“[a]pplying the standard deviations reported in Berry,” one of ordinary skill
in the art “would have been motivated to modify Michelson’s long-and-
narrow implants to have widths ranging from 14.1 mm L1 to 18.95 mm for
L5” and, thus when modifying Brantigan in view of Michelson, “to have
widths ranging from 16.15 mm to 18.95 mm.” Id. at 56–57 (citing Ex. 1002
¶¶ 226, 227; Ex. 1022, 364, Table 1).
Petitioner, thus, asserts that one of ordinary skill in the art “would
have been motivated to design an L5 spinal fusion implant that was
‘approximately 18 mm wide’” and that, “[a]pplying the standard deviations
of Berry, an implant for spinal fusion between L4 and L5 . . . would be at
least 46.3 mm in longitudinal length, which is more than two and a half
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times greater than approximately 18 mm in maximum lateral width.” Id. at
57 (citing Ex. 1002 ¶ 227). Therefore, according to Petitioner, “Brantigan in
view of Berry and Michelson further disclose[s] that the length is at least
two and a half times greater than the maximum lateral width.” Id. at 54
(citing Ex. 1002 ¶¶ 216–227).
Under “Motivation to Combine Brantigan with Baccelli, Berry, and
Michelson” (id. at 38–42), Petitioner contends that Brantigan teaches
implants that are introduced laterally with dimensions appropriate for the
space between vertebrae. Id. at 38–39 (citing Ex. 1007, 1:20–21, 2:2–4,
4:3–4, 4:6–7, 5:30–35, Figs. 8, 10). Petitioner argues that one of ordinary
skill in the art “would have known the average dimensions of the human
vertebrae” from, for example, Berry. Id. at 39.
Petitioner also argues that “Michelson explains the benefits associated
with lateral insertion of the Brantigan implant: increased safety, decreased
patient discomfort, and increased structural support that an ‘oversized’
implant provides” and that Michelson teaches “these benefits can be
accomplished by inserting the long-and-narrow implant of Figures 18–19
modularly, allowing a narrower implant to be inserted through a hollow
tube, thereby decreasing patient surgical discomfort by reducing incision
size.” Id. at 40–41 (citing Ex. 1032, Abstract, 2:19–67, 3:56–4:24, 10:20–
59, Figs. 18–19; Ex. 1002 ¶ 175). Petitioner further argues that a “narrower
implant for lateral insertion would be easier to fit within the hollow tube
Michelson describes to facilitate insertion into the disc space.” Id. at 54–55
(citing Ex. 1002 ¶ 221; Ex. 1032, 3:61–65).
According to Petitioner, Michelson explains the benefits of lateral
insertion achieved through inserting long-and-narrow implants. Id. at 40–41
(citing Ex. 1002 ¶ 175; Ex. 1032, Abstract, 2:19–67, 3:56–4:24, 10:20–59,
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Figs. 18, 19). Petitioner thus contends that one of ordinary skill in the art
would have been motivated to make Brantigan’s implant narrower in view of
Michelson’s teachings and the dimensions taught by Berry. Id. at 41 (citing
Ex. 1002 ¶ 176; Ex. 1022, 364; Ex. 1032, 3:61–65, 10:20–59, Figs. 18, 19).
Petitioner argues that one of ordinary skill in the art “would have been
motivated to make Brantigan’s laterally-inserted lumbar spinal fusion
implants ‘narrower’ for insertion in a modular fashion through a hollow tube
to increase patient safety and minimize invasiveness.” Id. at 41 (citing
Ex. 1032, 3:61–65); see also id. at 54 (arguing that one of ordinary skill in
the art “would have been motivated to modify the width of the Brantigan
implant, which has ‘medial-lateral and anterior-posterior dimensions in the
same ratios as normal vertebral bodies’ (Ex. 1007, 1:20–21) according to
Michelson’s express teaching to make the implant ‘narrower’ so that they
‘may be combined in a modular fashion for insertion within the disc space D
between adjacent vertebrae’”) (citing also Ex. 1032, 10:50–55). Petitioner
additionally contends that one of ordinary skill in the art would have had a
reasonable expectation of success in modifying the references in the manner
asserted. Id. at 41–42 (citing Ex. 1002 ¶ 177).
(1) Patent Owner’s Response
Patent Owner responds that one of ordinary skill in the art would not
have been motivated to combine Brantigan, Baccelli, Berry, and Michelson.
PO Resp. 31–34. Specifically, Patent Owner argues that Petitioner’s
proposed modification “to make Brantigan bigger according to Berry” is
“nonsensical” because “Brantigan did modify his implants according to
Berry.” Id. at 32 (citing Ex. 2029, 7; Ex. 2057 ¶¶ 15, 21–27).
Patent Owner also responds that Petitioner fails to explain how
“mak[ing] Brantigan . . . modular according to Michelson” “would increase
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patient safety or minimize invasiveness.” Id. (citing Ex. 2055 ¶¶ 89–95).
According to Patent Owner, “neither Michelson nor Brantigan disclose
sequential insertion of modular members into the disc space but they instead
teach assembly prior to insertion.” Id. (citing Ex. 1007, Abstract, 1:18–21,
1:59–61, 2:2–11, 2:34–43, 3:25–31, 4:23–49, 5:18–21, Figs. 1, 3, 4;
Ex. 1011, 8; Ex. 1032, 3:46–49, 10:50–53; Ex. 2055 ¶¶ 41–47, 55–64;
Ex. 2057 ¶¶ 16, 37–48).
Patent Owner further responds that, because of the anti-migration
elements of Brantigan, sequential insertion of the proposed modular
Brantigan implants would have decreased safety and increased invasiveness.
Id. at 32–34 (citing Ex. 1007, 5:22–26, 6:14–16, Fig. 1; Ex. 1032, 8:20–22;
Ex. 1040 ¶¶ 116, 139, 140, Figs. 29, 53; Ex. 2022, 69:22–70:7, 70:15–24,
85:21–24, 97:10–98:24; Ex. 2055 ¶¶ 46–49, 124–132; Ex. 2057 ¶¶ 46–49).
Patent Owner argues that the proposed modification to use two modular
implants would be riskier, more invasive, and result in less stability. Id. at
34 (citing Ex. 2055 ¶ 129; Ex. 2057 ¶¶ 44–46). Patent Owner also argues
that two implants would “make it more difficult to interpret radiopaque
markers placed on the implants.” Id. (citing Ex. 2055 ¶ 133).
(2) Petitioner’s Reply
Petitioner replies that it did not argue that modular implants would be
assembled within the disc space. Pet. Reply 1 (citing PO Resp. 12).
Petitioner argues that it is undisputed that Brantigan and Michelson teach
modular implants and “[n]one requires assembly.” Id.; see also id. at 1–2
(citing Ex. 1054, 2, 5, 6, 9, Figs. 4–5) (asserting the use of “two parallel
transverse interbody cages” was known), 4 (citing Ex. 1053, 2:20–37)
(arguing that side-by-side implants were known).
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Petitioner also replies that Michelson teaches a narrow implant
consistent with the modularity of Brantigan and Michelson. Id. at 9 (citing
Pet. 54–55; Ex. 1002 ¶¶ 204, 216–227; Ex. 1007, 1:20–21, 2:4–11;
Ex. 1019, 6–9; Ex. 1032, 3:61–65, 10:50–55). Petitioner further replies that
“Brantigan and Michelson are directed to implants that span the width of the
lumbar vertebra” and one of ordinary skill in the art “would look to Berry to
size Brantigan in view of Michelson.” Id. at 9–10 (citing Pet. 55–57; Ex.
1022, 1–3).
(3) Patent Owner’s Sur-Reply
Patent Owner replies that Petitioner fails to justify why one of
ordinary skill in the art would make a modular implant or why modularity
would increase safety and minimize invasiveness. PO Sur-reply 12 (citing
Pet. 54–57). Patent Owner contends that neither Brantigan nor Michelson
teach “sequential insertion of modular members” and argues that Patent
Owner’s evidence shows that one of ordinary skill in the art would have
expected modular implants to decrease safety and increase invasiveness. Id.
(citing PO Resp. 32–34; Ex. 2022, 69:22–70:24, 97:10–99:24; Ex. 2055, 41–
49, 124–133; Ex. 2057, 15–16, 21–27, 37–49).
Patent Owner also replies that Petitioner does not address its argument
that a “modular approach would make it more difficult to interpret
radiopaque markers placed on the implants.” Id. at 13. According to Patent
Owner, Petitioner’s declarant understood that Michelson teaches sequential
insertion. Id. (citing Ex. 2022, 121:15–122:7). Patent Owner argues that
“Petitioner provides no meaningful rebuttal and fails to substantiate that the
proposed modification would increase safety and minimize invasiveness.”
Id. (citing PO Resp. 32–34).
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Patent Owner further replies that Petitioner incorrectly and without
support contends that Brantigan and Michelson teach modular implants. Id.
at 13–14 (citing Pet. 11; PO Resp. 17–18). According to Patent Owner, the
Petition argued that a person of ordinary skill in the art “would have been
motivated to modify the full-oval Brantigan device (i.e., plug 11 or 30) . . .
not the hemi-oval device.” Id. at 14 (citing Pet. 38–41). Patent Owner
argues that “there is no dispute that Petitioner points to Michelson Figs. 18–
19 and associated text as teaching a modular implant.” Id. (citing Pet. 2–4,
14, 41, 54; PO Resp. 14–15). Patent Owner also argues that “[b]oth
Michelson and Brantigan teach assembly of modular implants as NuVasive
explained in detail in its response.” Id. (citing PO Resp. 14–15, 17–18, 53;
Ex. 1032, 10:53–54; Ex. 1051, 49:18–50:5; Ex. 2055 ¶¶ 59–62; Ex. 2057
¶¶ 35–40).
Patent Owner further argues that it presented corroborating evidence
that the Brantigan implants were sized to fit within the annulus fibrosis in
the present and past proceedings. Id. at 14–15 (citing Pet. Reply 4; Ex.
1007; Ex. 1056; Ex. 2029, 8; Ex. 2060, 19:20–20:8, 23:12–18, 24:4–25:4,
26:21–27:3, 34:23–37:21, 40:8–23, 41:13–23, 47:15–22, 47:23–48:9, 49:10–
15, 69:12–25; Ex. 2061). Patent Owner also contends that arguments
relying improperly on Exhibits 1053 and 1054 “have nothing to do with the
modularity of Michelson.” Id. at 15 (citing Pet. Reply 1–4).
(4) Insufficient Reason for Modifying Brantigan in view of
Michelson
(a) Michelson Teaches Inserting a Single Implant by a
Single Procedure
According to Petitioner, “Michelson teaches ‘spinal fusion implant
1000’” that “has a narrower width such that more than one spinal fusion
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implant 1000 may be combined in a modular fashion for insertion within the
disc space D between the adjacent vertebrae.’” Pet. 55–56 (quoting from
Ex. 1032, 10:48–59). In response, Patent Owner points to column 10, lines
50–53 of Michelson, paragraphs 41–47 and 55–64 of Dr. Youssef’s
declaration, and paragraphs 16 and 37–48 of Dr. McMillan’s declaration.
PO Resp. 32. Dr. Youssef and Dr. McMillin point us to column 3, lines 46–
49 and column 10, lines 50–53 of Michelson. Ex. 2055 ¶¶ 46, 47; Ex. 2057
¶¶ 33, 34.
The first of these cited portions states that “[t]he dimensions of the
translateral spinal fusion implant of the present invention permits a single
implant to be inserted by a single procedure into the spine and to engage
more of the adjacent vertebrae.” Ex. 1032, 3:46–49 (emphasis added); see
also Ex. 1002 ¶ 113 (citing Ex. 1032, 3:47–53) (Petitioner’s declarant Dr.
Branch stating that “Michelson explains how ‘[t]he dimensions of the
translateral spinal fusion implant of the present invention permits a single
implant to be inserted by a single procedure into the spine and to engage
more of the adjacent vertebrae’”), ¶ 217 (quoting Ex. 1032, 3:35–53);
Ex. 2022, 105:11–17 (Dr. Branch agreeing that Michelson describes a single
implant inserted in a single procedure). We find that column 3, lines 46–49
of Michelson teaches inserting a single implant by a single procedure, and
not inserting modular components of an implant to be assembled in the
spine. Ex. 2055 ¶ 47; Ex. 2057 ¶ 33.
Our finding is supported by the immediately following sentence in
Michelson that states “[a]s a result, the translateral spinal fusion implant of
the present invention has more surface area of contact and thus permits
greater stability so as to withstand torque.” Ex. 1032, 3:49–52; see also Ex.
2022, 105:18–106:2 (Dr. Branch agreeing that Michelson’s single implant
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has more surface area of contact and permits greater stability). Together
with the “single implant . . . to engage more of the adjacent vertebrae”
described in the previous sentence, we determine that a “single implant,”
even if it is made up of modular components, must already be assembled to
be the “single implant” that “engage[s] more of the adjacent vertebrae,” “has
more surface area of contact,” and “permits greater stability.” See Ex. 1032,
3:46–52. Stated differently, although Michelson describes that implant 1000
“has a narrower width such that more than one spinal fusion implant 1000
may be combined in a modular fashion for insertion within the disc space D
between the adjacent vertebrae,” based on the teachings of Michelson, the
modular components of implant 1000, collectively, in an assembled fashion,
constitute the “single implant” that “engage[s] more of the adjacent
vertebrae” “has more surface area of contact,” and “permits greater
stability.” Ex. 1032, 3:46–52, 10:51–54.
We credit Dr. Youssef’s testimony that “a benefit of [Michelson’s]
implant is that only a single implant is needed for stability” because the
above-discussed portions of Michelson support it. Ex. 2055 ¶ 45 (citing
Ex. 1032, 3:46–49). The full record also supports Dr. Youssef’s testimony
that Michelson teaches “combining modular components for insertion in the
disc space—it does not describe combining components in the disc space
after serial insertion.” Ex. 2055 ¶ 47.
We also credit Dr. McMillin’s testimony that “Michelson does not
disclose inserting implants into the disc space piece-by-piece.” Ex. 1032,
3:46–52; Ex. 2057 ¶ 33. The full record supports Dr. McMillin’s testimony
that “such an insertion method would be contrary to what Michelson
describes as a benefit of the inventive implants—that is, the invention
permits using a single implant inserted in a single procedure.” Ex. 2057 ¶ 33
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(citing Ex. 1032, 3:46–49); see also Ex. 2022, 69:22–70:7 (Dr. Branch
indicating that revising the position of an implant with antimigration
elements “is not the optimal technique” because “pulling it back against
antimigration elements . . . injures the endplate and might actually obligate
you to put in a different size implant”).
Although Dr. Branch quotes column 3, lines 46–52 of Michelson in
several paragraphs related to the challenge based on Brantigan, Baccelli,
Berry, and Michelson, he does not explain how this portion or any other part
of Michelson teaches or suggests a sequential insertion of modular
components. See, e.g., Ex. 1002 ¶¶ 113, 208, 217. For the reasons above,
we credit Drs. Youssef’s and McMillan’s testimony over Dr. Branch’s
testimony regarding the single implant of Michelson and that Michelson
does not teach sequential insertion of implants.
For the reasons above, based on the full record before us, we
determine that Michelson teaches inserting a single implant by a single
procedure. Ex. 1032, 3:46–52, 10:48–54; Ex. 2055 ¶¶ 45–47; Ex. 2057
¶¶ 33, 34; Ex. 2022, 105:11–106:2. The full record does not persuade us
that Michelson teaches inserting implants in a sequential manner, as argued
by Petitioner.
(b) Michelson Teaches Combining Modular Components
before Insertion
Petitioner argues that one of ordinary skill in the art “would have been
motivated to make Brantigan’s laterally-inserted lumbar spinal fusion
implants ‘narrower’ for insertion in a modular fashion through a hollow tube
to increase patient safety and minimize invasiveness.” Pet. 41 (emphasis
added) (citing Ex. 1002 ¶ 176; Ex. 1022, 364; Ex. 1032, 3:61–65, 10:20–59,
Figs. 18, 19); see also id. at 54 (citing Ex. 1007, 1:20–21; Ex. 1032, 10:50–
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55). Dr. Branch also uses the phrase “for insertion in a modular fashion” in
his declaration. See Ex. 1002 ¶ 176 (Dr. Branch stating that a person of
ordinary skill in the art “would have been motivated to achieve the benefits
of Michelson by making Brantigan’s laterally-inserted lumbar spinal fusion
implants ‘narrower’ for insertion in a modular fashion through a hollow tube
to increase patient safety and minimize invasiveness”) (emphasis added).
Petitioner does not specifically contend if the modified narrower Brantigan
implants would be combined before insertion or after insertion. See Pet. 41,
54; Ex. 1002 ¶ 176. Petitioner, however, replies that it did not argue that
modular implants would be assembled within the disc space. Pet. Reply 1
(citing PO Resp. 12).
Patent Owner contends that Michelson teaches combining before, not
after, insertion, and thus, cannot teach sequential insertion of modular
members. PO Resp. 32 (citing Ex. 1007, Abstract, 1:18–21, 1:59–61, 2:2–
11, 2:34–43, 3:25–31, 4:23–49, 5:18–21, Figs. 1, 3, 4; Ex. 1011, 8; Ex.
1032, 3:46–49, 10:50–53; Ex. 2055 ¶¶ 41–47, 55–64; Ex. 2057 ¶¶ 16, 37–
48). As discussed above, we find that Michelson teaches inserting a single
implant by a single procedure, not inserting modular members of an implant
to be assembled in the spine, because a single implant provides stability and
insertion in a single procedure. Ex. 1032, 3:46–52; Ex. 2055 ¶¶ 45–47;
Ex. 2057 ¶¶ 33, 34; see also Ex. 2022, 105:18–106:2 (Dr. Branch agreeing
that Michelson’s single implant has more surface area of contact and permits
greater stability).
Also, as discussed above, Michelson describes that implant 1000 “has
a narrower width such that more than one spinal fusion implant 1000 may be
combined in a modular fashion for insertion within the disc space D
between the adjacent vertebrae.” Ex. 1032, 10:51–54 (emphasis added).
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Dr. Branch does not explain how this portion of Michelson teaches or
suggests a sequential insertion of modular components. See Ex. 1002
¶¶ 110–117 (opining as to what Michelson teaches), 118 (quoting from
Ex. 1032, 10:50–55 without further explanation), 169–245 (opining that
Brantigan, Baccelli, Berry, and Michelson would have rendered obvious
claims 1 and 16). Dr. McMillin states that a person of ordinary skill in the
art “would have understood Michelson to disclose what is stated expressly—
the implant is assembled prior to insertion thereby retaining the benefits of
using a single implant inserted through a single procedure.” Ex. 2057 ¶ 34
(quoting Ex. 1032, 10:50–53).
We credit Dr. McMillin’s testimony because column 10, lines 50–53
of Michelson supports it. We also find Dr. McMillan’s testimony more
credible than Dr. Branch’s testimony regarding this particular portion of
Michelson. Ex. 1002 ¶ 118 (quoting from Ex. 1032, 10:50–55 without
further explanation); Ex. 2057 ¶ 34 (quoting from Ex. 1032, 10:50–53 and
explaining that assembly prior to insertion retains Michelson’s disclosed
benefit).
Dr. Branch also opines that a person of ordinary skill would have
modified Brantigan’s laterally-inserted spinal fusion implants to be narrower
or long-and-narrow in view of Michelson “for insertion in a modular
fashion.” Ex. 1002 ¶¶ 176, 224. Dr. Branch further opines that Brantigan
describes a similar modularity concept. Id. ¶ 96 (citing Ex. 1007, 1:13–16,
2:4–5), ¶ 222 (citing Ex. 1007, 2:4–11).
Based on the full record, even if Brantigan teaches inserting implants
in a modular fashion, Michelson teaches inserting a single implant in a
single procedure to engage more of the adjacent vertebrae and permit greater
stability to withstand torque. Ex. 1032, 3:46–54, 3:61–65, 10:50–54;
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Ex. 2055 ¶¶ 45–47; Ex. 2057 ¶¶ 33, 34. Petitioner does not address why one
of ordinary skill in the art would insert Brantigan’s implant in a modular
fashion in view of Michelson’s teaching to insert a single implant in a single
procedure. See Pet. 38–69; Pet. Reply 9–12; Ex. 1032, 3:46–52; see also
Ex 2022, 69:22–70:7 (Dr. Branch indicating that revising the position of an
implant with antimigration elements “is not the optimal technique” because
“pulling it back against antimigration elements . . . injures the endplate and
might actually obligate you to put in a different size implant”), 105:18–
106:2 (Dr. Branch agreeing that Michelson’s single implant has more
surface area of contact and permits greater stability).
Patent Owner also contends that inserting modular implants would be
less safe and would increase invasiveness, contrary to Petitioner’s reason for
the modification, because of the anti-migration elements of Brantigan
prevent moving a first implant to add another implant. PO Resp. 32–34
(citing Ex. 1007, 5:22–26, 6:14–16, Fig. 1; Ex. 1032, 8:20–22; Ex. 1040
¶¶ 116, 139, 140, Figs. 29, 53; Ex. 2022, 69:22–70:7, 70:15–24, 85:21–24,
97:10–98:24; Ex. 2055 ¶¶ 46–49, 124–132; Ex. 2057 ¶¶ 46–49).
Based on Petitioner’s Reply and our determinations above,
Petitioner’s proposed modification “for insertion in a modular fashion”
would include two Brantigan implants modified to be long and narrow as
taught by Michelson and assembled before insertion. See Pet. 40–41, 54–57;
see also Pet. Reply 4 (arguing that one of ordinary skill in the art would have
known of implants “inserted across the disc space in side-by-side pairs”).
Thus, the two modified Brantigan implants, in view of Michelson’s teaching
of a single implant assembled before insertion, would have to be larger than
any one of the non-modified Brantigan implants, and require a larger
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insertion pathway, which is contrary to Petitioner’s contention that the
proposed modification would “minimize invasiveness” (Pet. 41).
We note that, if modified implants were to be assembled after
insertion, then we would agree with Petitioner that its proposed modification
would minimize invasiveness because the proposed modification would be
able to take advantage of the narrower implants. The full record shows,
however, that inserting narrower implants would not necessarily increase
safety because Michelson does not teach sequential insertion of modular
components let alone that sequential insertion of modular components would
make the procedure safe and simple. Ex. 1032, 3:46–49, 3:61–65, 10:50–54;
Ex. 2055 ¶¶ 90–96 (Dr. Youssef testifying that implementing Michelson’s
modularity concept would be more invasive and less safe); Ex. 2057 ¶ 16
(Dr. McMillan testifying that serial insertion of modular members would be
unsafe and more invasive).
Thus, based on the full record, we find that Michelson teaches that
implant 1000 “has a narrower width such that more than one spinal fusion
implant 1000 may be combined in a modular fashion for insertion within the
disc space D between the adjacent vertebrae,” that one of ordinary skill in
the art would have understood Michelson to be teaching combining implants
1000 before insertion when Michelson states “combin[ing] in a modular
fashion for insertion,” and that one of ordinary skill in the art would not have
understood that Michelson to be teaching the sequential insertion of modular
components to be combined after insertion. Ex. 1032, 3:46–54, 3:61–65,
10:50–54; Ex. 2055 ¶¶ 45–47, 90–96; Ex. 2057 ¶¶ 16, 33, 34.
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(c) Michelson Teaches Inserting Through a Tube Making a
Procedure Safe and Simple
The parties do not dispute that the modified implant would be inserted
through a tube. See Pet. 41; PO Resp. 31–34; Pet. Reply 9–11; PO Sur-reply
12–15. The parties also do not dispute that Michelson teaches engaging a
hollow tube to the lateral aspect of the spine through a lateral, anterior, or
anterolateral incision. See PO Resp. 31–34; Pet. Reply 9–11; PO Sur-reply
12–15; see also Ex. 1002 ¶ 112 (testifying that Michelson’s implant is
inserted in a translateral approach to the spine).
Michelson teaches that “[t]he translateral spinal fusion implant of the
present invention may be inserted into the disc space through a hollow tube
which is engaged to the lateral aspect of the spine through a lateral, anterior,
or anterolateral incision making the procedure safe and simple.” Ex. 1032,
3:61–65.
Based on the full record, we find that Michelson teaches inserting a
single translateral spinal fusion implant into the disc space through a hollow
tube, which is engaged to the lateral aspect of the spine through, at least, a
lateral incision makes the procedure safe and simple. See Ex. 1032, 3:46–
49, 3:61–65; Ex. 1002 ¶ 114 (quoting from Ex. 1032, 3:56–60) (testifying
that Michelson’s translateral implants are safer than implants inserted from
the front or back), ¶ 115 (quoting from Ex. 1032, 3:61–65) (testifying that
Michelson’s lateral approach maximizes safety).
Thus, based on the full record, we find that Michelson does not teach
that “insertion in a modular fashion” makes a procedure safe and simple or
that safety arises necessarily from making an implant long and narrow.
Pet. 41; Ex. 1002 ¶¶ 112, 114, 115; Ex. 1032, 3:46–49, 3:61–65; Ex. 2055
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¶¶ 90–96; Ex. 2057 ¶¶ 16, 35–43; see also Ex. 2022, 97:10–98:24 (Dr.
Branch discussing the considerations for inserting a second implant).
(d) Petitioner does not rely on Baccelli or Berry for a
Reason to Make an Implant Narrower for Insertion in a
Modular Fashion
As discussed above, Petitioner modifies Brantigan’s implant in view
of Baccelli, Berry, and Michelson. Pet. 38–42. Petitioner relies on Baccelli
for teaching “one or more—and in particular, four—markers in a radiolucent
spinal fusion implant.” Id. at 39 (citing Ex. 1002 ¶ 172; Ex. 1008 ¶ 50).
Petitioner relies on Berry only for “the average dimensions of the human
vertebrae” known to ordinary skilled artisans at the time of invention, which
is not related to modularity. Id.
We determine that neither Baccelli nor Berry provide support for
making a narrower implant “for insertion in a modular fashion through a
hollow tube to increase patient safety and minimize invasiveness.” Id. at 41.
(e) Determining Petitioner’s Reason Lacks Rational
Underpinnings
In view of our findings discussed above, Petitioner fails to persuade us
by a preponderance of the evidence that one of ordinary skill in the art
“would have been motivated to make Brantigan’s laterally-inserted lumbar
spinal fusion implants ‘narrower’ for insertion in a modular fashion through
a hollow tube to increase patient safety and minimize invasiveness.” Pet. 41
(emphasis added).
Because Michelson teaches that inserting a single implant through a
tube makes the procedure safe and simple, Michelson does not support
Petitioner’s proposed modification to make Brantigan’s implant narrower
“for insertion in a modular fashion through a hollow tube to increase patient
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safety and minimize invasiveness.” Pet. 41; Ex. 1032, 3:46–52, 10:48–54;
Ex. 2055 ¶¶ 45–47; Ex. 2057 ¶¶ 33, 34; Ex. 2022, 105:11–106:2.
Also, because Michelson teaches that inserting its implant through a
hollow tube engaged to the lateral aspect of the spine through one of several
listed incisions makes the procedure safe and simple, Michelson does not
support Petitioner’s proposed modification to Brantigan’s implant “for
insertion in a modular fashion . . . to increase patient safety.” Pet. 41;
Ex. 1002 ¶¶ 112, 114, 115; Ex. 1032, 3:46–49, 3:61–65; Ex. 2055 ¶¶ 90–96;
Ex. 2057 ¶¶ 16, 44–47. Additionally, neither Baccelli nor Berry provide, or
are relied upon to provide, a rational underpinning for Petitioner’s proposed
modification. Pet. 38–42.
For the reasons above, based on the full record, we find that
Michelson does not support that Petitioner’s proposed modification to
Brantigan would increase patient safety and minimize invasiveness. We,
therefore, determine that Petitioner’s rationale lacks a rational underpinning.
3. Claim 16
Claim 16 depends from claim 1 and recites “a fourth radiopaque
marker situated within said implant, said fourth radiopaque marker
positioned in said central region at a position spaced apart from said third
radiopaque marker.” Ex. 1001, 13:51–14:3. Petitioner contends that
Baccelli teaches the subject matter of claim 16. Pet. 63–69 (citing Ex. 1002
¶¶ 240–243; Ex. 1008 ¶¶ 36, 41, 44, 50, 51, Figs. 1–5, 8, 9).
Petitioner argues that, “[b]ecause Brantigan does not describe [or]
mention radiopaque markers in the proximal and distal walls or the central
region of the implant,” it would have been obvious to include four markers
in the proximal, distal, and side walls of Brantigan “to enable surgeons to
visualize the orientation and location of the implant during and after
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surgery” and “to allow surgeons to align the markers with the spinous
process and the lateral ends of the vertebrae.” Id. at 67 (Ex. 1002 ¶¶ 172–
174). Petitioner also argues that adding radiopaque markers “would have
allowed surgeons to see in an anterior-to-posterior (front) X-ray whether and
to what degree the implant is askew relative to the spinous process and the
lateral edges of the vertebrae during and after lateral insertion,” as well as
allow surgeons to identify the position of posterior sidewall relative to the
posterior edge of the vertebrae or the position of the anterior sidewall
relative to the anterior edge of the vertebrae. Id. at 68–69 (citing Ex. 1002
¶ 174)). Petitioner, thus, contends that Brantigan, Baccelli, Berry, and
Michelson would have rendered obvious claim 16. Id. at 69 (citing Ex. 1002
¶ 245).
Also, in connection with limitations regarding “at least three
radiopaque markers” recited by claim 1, Petitioner argues that Baccelli
teaches at least three radiopaque markers with one each in the distal,
proximal, and side walls. Pet. 60–63 (citing Ex. 1002 ¶¶ 236–238; Ex. 1008
¶¶ 36, 41, 44, 50, 51, Figs. 1–5, 8, 9). Petitioner contends that, because
“Brantigan’s spinal fusion implant is radiolucent and transparent to X-rays”
and because “Baccelli instructs a [person of ordinary skill in the art] to
include four radiopaque markers in the implant,” one of ordinary skill in the
art “would have been motivated to include radiopaque markers in all four
walls of the radiolucent Brantigan lateral implant to enable surgeons to
visualize the orientation and location of the implant during and after surgery,
including, for example, alignment with the spinous process and the lateral
ends of the vertebrae.” Id. at 39–40 (citing Ex. 1002 ¶¶ 172, 173; Ex. 1007,
Figs. 8, 10; Ex. 1008 ¶¶ 50, 51, Figs. 1–5, 8, 9).
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a) Patent Owner’s Response
Patent Owner responds that Brantigan, Baccelli, Berry, and Michelson
fail to teach third and fourth radiopaque markers in the “central region” as
recited by claims 1 and 16. PO Resp. 19–23. Patent Owner also responds
that Petitioner’s reason why one of ordinary skill in the art would have
modified Brantigan to have a radiopaque marker on each of the four walls of
the implant should be rejected as improperly based on hindsight, “fails for
the same reason as discussed above,” and “is based on a misapprehension of
the contents of Baccelli.” Id. at 31–32 (citing Pet. 38–41, 54–57). As
discussed above for claim 1, Patent Owner also responds that Petitioner’s
proposed modification does not increase patient safety or minimize
invasiveness. Id. at 32–34.
b) Parties’ Reply Arguments
Petitioner replies that Patent Owner’s interpretation of “central
region” is unsupported and that Petitioner does not rely on Baccelli for the
required “central region” and instead relies on Baccelli for teaching the
orientation of four radiopaque markers. Pet. Reply 5 (citing PO Resp. 19–
23), 8–9 (citing PO Resp. 19–22). Petitioner also replies that one of
ordinary skill in the art would have been motivated to include Baccelli’s four
radiopaque markers. Id. at 9 (citing Pet. 67–69). Petitioner further replies
that its proposed combination teaches the limitations of claim 16 and one of
ordinary skill in the art would have been motivated to combine the
references to arrive at claim 16. Id. at 10–11 (citing Pet. 63–69; PO Resp.
19–22, 31–32; Ex. 1008 ¶¶ 36, 41, 44, 50, 51, Figs. 1–5, 8, 9).
Patent Owner replies that “Petitioner’s marker configuration argument
is based on impermissible hindsight.” PO Sur-reply 1. Patent Owner also
replies that Petitioner does not meaningfully respond to Patent Owner’s
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arguments, applies an incorrect interpretation of “central region,” and
misapprehends Baccelli’s teachings. Id. at 1 (citing PO Resp. 2, 4–8, 18–23,
28), 9–10 (citing Pet. 2; Pet. Reply 5; PO Resp. 4–8, 18–23, 28), 10–11
(citing Pet. 30, 40; PO Resp. 18–23, 28–29), 15–17 (citing Pet. 30–31, 34–
35, 40; PO Resp. 18–23, 28–31; Pet. Reply 10,11; Ex. 1002 ¶¶ 29–30; Ex.
1007 ¶ 41; Ex. 2017, 7:9–8:13; Ex. 2028 ¶ 60).
c) Insufficient Reason for Including a Fourth Radiopaque Marker
As discussed above in connection with claim 1, Petitioner contends
that one of ordinary skill in the art would have been motivated to narrow the
width of Brantigan’s implant “so that they ‘may be combined in a modular
fashion for insertion within the disc space D between adjacent vertebrae.’”
Pet. 54 (citing Ex. 1007, 1:20–21; Ex. 1032, 10:50–55); see also id. at 41
(arguing that one of ordinary skill in the art “would have been motivated to
make Brantigan’s laterally-inserted lumbar spinal fusion implants ‘narrower’
for insertion in a modular fashion through a hollow tube to increase patient
safety and minimize invasiveness”) (citing Ex. 1032, 3:61–65). For the
reasons discussed for claim 1, Petitioner does not persuade us that one of
ordinary skill in the art would have made the proposed combination to
render obvious claim 1, from which claim 16 depends. Petitioner’s
arguments for claim 16 do not remedy the deficiencies of claim 1.
Additionally, for claim 16, Petitioner contends that it would have been
obvious “to include the four markers Baccelli teaches into the proximal,
distal, and sidewalls of the radiolucent lateral Brantigan implant to enable
surgeons to visualize the orientation and location of the implant during and
after surgery.” Id. at 67 (citing Ex. 1002 ¶ 173; Ex. 1007, Figs. 8, 10).
Based on the full record, Petitioner does not persuade us that one of
ordinary skill in the art would have modified Brantigan’s implant so that
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they may be combined in a modular fashion for insertion and so that each
one would have four radiopaque markers in each of their four walls. See id.
at 41, 54, 67. The proposed modifications would result in the combination
having at least eight total radiopaque markers. Petitioner’s reason for
“position[ing] markers in the middle (e.g., central region or widest portion)
of Brantigan’s sidewalls, as well as in the leading and trailing ends of the
implant, to allow surgeons to align the markers with the spinous process and
the lateral ends of the vertebrae” does not persuasively address why eight
total radiopaque markers would be needed. See id. at 41, 54, 67; Ex. 1002
¶ 173. As discussed above, when addressing the other proposed challenge,
Frey provides evidence that its three markers 1438 provide indications of
anterior-to-posterior placement, lateral placement, and proper orientation of
the implant in the disc space in the anterior-to-posterior direction. Ex. 1002
¶ 161; Ex. 1040 ¶ 156; Ex. 2055 ¶¶ 119, 120.
Petitioner does not present a sufficient reason, if three radiopaque
markers were known to be sufficient for proper orientation of an implant in
the disc space, why one of ordinary skill in the art would have included an
additional fourth marker or make modular implants that would result in eight
markers when the modular implants are combined for insertion. See Pet. 41,
54, 67.
Thus, when considering Petitioner’s two proposed modifications
together, we are not persuaded that Petitioner presents a sufficient reason
that one of ordinary skill in the art would have modified Brantigan to have
four radiopaque markers in modular implants that would be combined for
insertion within the disc space.
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G. Weighing the Graham Factors
“Once all relevant facts are found, the ultimate legal determination [of
obviousness] involves the weighing of the fact findings to conclude whether
the claimed combination would have been obvious to an ordinary artisan.”
Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350, 1361
(Fed. Cir. 2017). Above, based on full record before us, we provide our
factual findings regarding (1) the level of ordinary skill in the art, (2) the
scope and content of the prior art, and (3) any differences between the
claimed subject matter and the prior art.
In particular, we find that Petitioner’s proposed level of ordinary skill
in the art is consistent with the prior art of record, but Petitioner does not
persuade us by a preponderance of the evidence that one of ordinary skill in
the art would have been motivated to combine Frey, Michelson, and
Baccelli. Petitioner also does not persuade us by a preponderance of the
evidence that one of ordinary skill in the art would have been motivated to
combine Brantigan, Baccelli, Berry, and Michelson
Petitioner, thus, does not persuade us by a preponderance of the
evidence that claim 16 of the ’334 patent is unpatentable over (1) Frey,
Michelson, and Baccelli or (2) Brantigan, Baccelli, Berry, and Michelson.
H. Other Arguments
Patent Owner also argues that the asserted references fail to teach or
suggest certain limitations of claim 16 (see PO Resp. 19–27), asserts that
estoppel should not be applied (see id. at 34–55), and presents objective
indicia of nonobviousness (see id. at 55–59). The parties provide reply
arguments regarding these issues. Pet. Reply 6–8, 9, 11–14; PO Sur-reply
2–11, 15–23.
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Because we determine that Petitioner does not present a sufficient
reason for combining Frey, Michelson, and Baccelli or combining
Brantigan, Baccelli, Berry, and Michelson, we do not reach these other
arguments.

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III. CONCLUSION
In summary:

IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claim 16 of U.S. Patent No. 8,187,334 B2 has not
been shown, by a preponderance of the evidence, to be unpatentable;
FURTHER ORDERED that Patent Owner’s Motion to Exclude is
denied; and
FURTHER ORDERED that, because this is a Final Written Decision,
the 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.
Claim

35
U.S.C. §
References/Basis Claim
Shown
Unpatentable
Claim
Not Shown
Unpatentable
16 103 Frey, Michelson, Baccelli
16
16
103
Brantigan,
Baccelli, Berry,
Michelson
16
Overall
Outcome
16
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FOR PETITIONER:
Jovial Wong
David P. Dalke
Nimalka R. Wickramasekera
WINSTON & STRAWN LLP
jwong@winston.com
ddalke@winston.com
nwickramasekera@winston.com

FOR PATENT OWNER:
Michael T. Rosato
Paul D. Tripodi II
Sonja R. Gerrard
Jad A. Mills
WILSON SONSINI GOODRICH & ROSATI
mrosato@wsgr.com
ptripodi@wsgr.com
sgerrard@wsgr.com
jmills@wsgr.com