Medtronic, Inc.

Patent Trials and Appeals Board

Sep 13, 2021

IPR2020-00679 (P.T.A.B. Sep. 13, 2021)

Trials@uspto.gov Paper: 64
571.272.7822 Date: September 13, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

AXONICS, INC.,
Petitioner,

v.

MEDTRONIC, INC.,
Patent Owner.
____________

IPR2020-00679
Patent 8,626,314 B2
____________

Before JAMES A. TARTAL, ERIC C. JESCHKE, and
ALYSSA A. FINAMORE, Administrative Patent Judges.

FINAMORE, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining No Challenged Claims Unpatentable
35 U.S.C. § 318(a)
IPR2020-00679
Patent 8,626,314 B2

2
I. INTRODUCTION
Petitioner, Axonics, Inc.,1 filed a Petition (Paper 1, “Pet.”) requesting
an inter partes review of claims 1, 2, 4, 7, 10–12, 14, and 18–24 of U.S.
Patent No. 8,626,314 B2 (“the ’314 patent”) (Ex. 1001). Pet. 1. On
September 15, 2020, we granted institution of an inter partes review.
Paper 8.
During the trial, Patent Owner, Medtronic, Inc., filed a Response
(Paper 28, “PO Resp.”). Petitioner filed a Reply (Paper 47, “Reply”), and
Patent Owner filed a Sur-reply (Paper 55, “Sur-reply”). Oral argument took
place on June 17, 2021, and we have entered the transcript (Paper 63, “Tr.”).
This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a).
For the reasons that follow, we conclude Petitioner has not proven by a
preponderance of the evidence that claims 1, 2, 4, 7, 10–12, 14, and 18–24
are unpatentable.

II. BACKGROUND
A. Real Parties in Interest
Petitioner asserts that it is the real party in interest. Pet. 67; see also
Paper 51 (notifying the Board of the name change from Axonics Modulation
Technologies, Inc. to Axonics, Inc.). Patent Owner maintains that it is the
real party in interest. Paper 4, 1. Patent Owner further maintains that
“Medtronic plc is the ultimate parent of Medtronic, Inc.” (id.), and that

1 During the trial, the name of Petitioner when the Petition was filed,
Axonics Modulation Technologies, Inc., was changed to Axonics, Inc. See
Paper 51.

IPR2020-00679
Patent 8,626,314 B2

3
“Medtronic, Inc. has granted certain rights with respect to the patent-at-issue
to Medtronic Puerto Rico Operations Co., which in-turn has granted certain
rights to Medtronic Logistics, LLC, which in-turn has granted certain rights
to Medtronic USA, Inc.” (id. at 1 n.1).
B. Related Matters
The parties identify Medtronic, Inc. v. Axonics Modulation
Technologies, Inc., No. 8:19-cv-02115 (C.D. Cal. filed Nov. 4, 2011) and
Axonics Modulation Technologies, Inc. v. Medtronic, Inc., IPR2020-00715
(PTAB filed Mar. 16, 2020) (challenging U.S. Patent No. 8,036,756 B2) as
related matters. Pet. 67–68; Paper 4, 2.
C. The ’314 Patent
The invention “relates generally to a method and apparatus that allows
for stimulation of body tissue, particularly sacral nerves.” Ex. 1001,
1:34–36. More specifically, the invention “relates to an implantable medical
electrical lead having at least one stimulation electrode adapted to be
implanted near the sacral nerves for stimulation of a bundle of sacral nerve
fibers and a fixation mechanism for providing chronic stability of the
stimulation electrode and lead.” Id. at 1:36–41.
Leads typically have a number of ring-shaped stimulation electrodes
spaced along a distal segment of the lead body, which is adapted to be
passed into the foramen along a selected sacral nerve. Id. at 2:47–51. Each
distal stimulation electrode is coupled to a lead conductor extending
proximally through the lead body. Id. at 2:52–54. The proximal end of each
lead conductor is coupled to a connector that is adapted to be coupled with
an implantable pulse generator (IPG). Id. at 2:54–59.
IPR2020-00679
Patent 8,626,314 B2

4
The ’314 patent describes that “[a] problem associated with
implantation of permanent and temporary neurostimulation leads involves
maintaining the discrete ring-shaped electrode(s) in casual contact . . . or in
close proximity to the sacral nerve to provide adequate stimulation of the
sacral nerve, while allowing for some axial movement of the lead body.” Id.
at 3:22–28. According to the ’314 patent, “physicians spend a great deal of
time with the patient under general anesthetic placing the leads due to the
necessity of making an incision exposing the foramen and due to the
difficulty in optimally positioning the small size stimulation electrodes
relative to the sacral nerve.” Id. at 3:29–33.
The invention of the ’314 patent “provides a solution to the problems
associated with implanting and maintaining electrical leads in body tissue,
particularly muscle tissue to maintain one or more lead electrode in relation
to a particular body site, through use of minimally invasive implantation
techniques.” Id. at 5:48–53. A sacral nerve stimulation lead of the invention
is shown in Figure 1, reproduced below.
IPR2020-00679
Patent 8,626,314 B2

5

Figure 1 is a plan view showing implantable medical lead 10 for sacral nerve
stimulation. Id. at 8:51–52, 9:25–26. Implantable medical lead 10 includes
lead body 15 with electrode array 20 that extends proximally from lead
distal end 45 and comprises P stimulation electrodes. Id. at 6:26–30,
9:25–30. As shown in Figure 1, electrode array 20 includes stimulation
electrodes 25, 30, 35, 40 such that P=4. Id. at 9:25–30. Each stimulation
electrode 25, 30, 35, 40 is electrically coupled to the distal end of a coiled
wire lead conductor extending proximally through distal portion 50 and
proximal portion 55 of lead body 15. Id. at 9:41–45. The proximal end of
each lead conductor is coupled to one of P connector elements 65, 70, 75, 80
in proximal connector element array 60 along proximal portion 55 adjacent
proximal end 85. Id. at 6:33–37, 9:45–49. Connector elements 65, 70, 75,
80 are adapted to be coupled with a neurostimulator IPG. Id. at 9:62–65.
IPR2020-00679
Patent 8,626,314 B2

6
To inhibit axial movement of lead body 15 and dislodgement of
stimulation electrodes 25, 30, 35, 40, a fixation mechanism adapted to
engage subcutaneous tissue is formed on lead body 15 proximal to electrode
array 20 in distal portion 50. Id. at 5:65–6:5, 10:12–16. The fixation
mechanism comprises M tine elements in tine element array 120. Id.
at 6:5–8, 10:16–19. As shown in Figure 1, tine element array 120 includes
tine elements 125, 130, 135, 140 such that M=4. Id. at 10:16–19.
A tine element is shown in Figure 3, reproduced below.

Figure 3 is an expanded perspective view showing one of tine elements 125,
130, 135, 140. Id. at 8:59–60. Each tine element comprises N flexible,
pliant tines. Id. at 6:8–9, 10:26–27. As shown in Figure 3, the tine element
includes tines 145, 150, 155, 160 such that N=4. Id. at 10:26–29. Each tine
extends through a tine length from attached tine end 165 to free tine end 170.
Id. at 10:29–32. Attached tine end 165 is attached to lead body 15 at a tine
attachment site so that the tine extends outwardly of lead body 15 and
proximally toward lead proximal end 85. Id. at 10:32–35. The tines are
adapted to be folded inward against lead body 15 when fitted into and
constrained by the lumen of an introducer, and the folded tines do not
overlap one another. Id. at 6:15–19, 10:35–41.
IPR2020-00679
Patent 8,626,314 B2

7
The steps of implanting lead 10 are illustrated in Figures 6 and 7,
reproduced below.

Figures 6 and 7 are cross-section views of the sacrum schematically
illustrating the steps of implanting lead 10. Id. at 9:1–9. Introducer 200 can
IPR2020-00679
Patent 8,626,314 B2

8
be advanced into position over a guide wire previously percutaneously
advanced into the foramen from a skin incision. Id. at 11:46–48. Lead 10 is
advanced through the introducer lumen proximal end opening into the
introducer lumen. Id. at 11:58–61. Electrode array 20 and tine element
array 120 are disposed within the pre-positioned introducer lumen for
implantation in relation to the sacral nerve accessed through the foramen and
in the subcutaneous tissue, respectively. Id. at 11:61–65. As shown in
Figure 6, lead 10 is advanced distally out of the introducer lumen distal end
opening to advance electrode array 20 into or through the foramen from the
posterior entrance into casual contact with the more anterior sacral nerve.
Id. at 11:66–12:6. After electrical testing to establish optimal positioning,
introducer 200 is retracted proximally, and distal-to-proximal tine
elements 125, 130, 135, 140 are successively released from the introducer
lumen, as shown in Figure 7. Id. at 12:6–11. Once introducer 200 is
completely removed, proximal portion 55 of lead body 15 is bent laterally
and implanted through a subcutaneously tunneled path to the
neurostimulator IPG. Id. at 12:20–25.
D. Challenged Claims
Petitioner challenges claims 1, 2, 4, 7, 10–12, 14, and 18–24 of the
’314 patent. Pet. 1, 16. Claims 1, 11, and 18 are independent. Ex. 1001,
13:51–14:11, 14:54–15:20, 15:55–16:31. Independent claim 1 is illustrative
and reproduced below, adding Petitioner’s labels for the limitations.
1. [1.0] A system comprising:
[1.a] an implantable medical lead comprising:
[1.b] a lead body extending between a proximal end and a
distal end;
[1.c] a plurality of conductors within the lead body;
IPR2020-00679
Patent 8,626,314 B2

9
[1.d] a plurality of electrodes, wherein each electrode is
electrically connected to a conductor of the plurality of
conductors; and
[1.e] a plurality of tine elements extending from the lead
body, wherein all tine elements of the plurality of tine
elements are positioned between a most proximal
electrode of the plurality of electrodes and the proximal
end of the lead body, [1.f] each tine element comprising
a plurality of flexible, pliant tines, each tine having a
tine width and thickness and extending a tine length
from an attached tine end to a free tine end, the attached
tine end attached to the lead body from a tine
attachment site and supporting the tine extending
outwardly of the lead body and proximally toward the
lead proximal end, [1.g] wherein the plurality of tines
of the plurality of tine elements are adapted to be folded
inward against the lead body when fitted into and
constrained by a lumen of an introducer without
overlapping one another and deploy outward to engage
body tissue when the introducer is withdrawn to release
the plurality of tines, [1.h] wherein the plurality of tine
elements is separate from and axially displaced from
the plurality of electrodes.
Id. at 13:51–14:11.
Like independent claim 1, independent claim 11 recites a system
comprising an implantable medical lead having a lead body, a plurality of
conductors, a plurality of electrodes, and a plurality of tine elements. Id.
at 14:54–15:20. Independent claim 11 additionally recites that the system
comprises an implantable pulse generator, and that the implantable medical
lead is configured to be introduced through and released into body tissue via
an introducer defining an introducer lumen. Id. Independent claim 18
recites a method with similar limitations to those of independent system
claims 1 and 11. Id. at 15:55–16:31.
IPR2020-00679
Patent 8,626,314 B2

10
Claims 2, 4, 7, 10, and 22 depend from independent claim 1. Id.
at 14:12–16, 14:20–25, 14:37–38, 14:52–53, 16:49–51. Claims 12, 14
and 23 depend from independent claim 11 (id. at 15:21–24, 15:28–33,
16:52–54), and claims 19–21 and 24 depend from independent claim 18 (id.
at 16:32–48, 16:56–59).
E. Asserted Grounds of Unpatentability and Evidence
Petitioner asserts that claims 1, 2, 4, 7, 10–12, 14, and 18–24 are
unpatentable on the following three grounds:
Claims Challenged 35 U.S.C. §2 References
1, 2, 4, 7, 10–12,
14, 18–24 103(a) Young
3, Gerber4, Lindegren5
18, 20, 21 103(a) Young, Gerber, Lindegren, Hauser6
1, 2, 4, 7, 10–12,
14, 18–24 103(a) Gerber, Hauser, Akerström
7

2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
Stat. 284, 287–88 (2011), amended certain sections of this statute, including
§§ 102 and 103, and the effective date of the relevant amendment is
March 16, 2013. The ’314 patent was filed on July 14, 2011 (Ex. 1001,
code (22)), and there is no dispute that the challenged claims of the ’314
patent have an effective filing date before March 16, 2013. Accordingly, we
apply the pre-AIA version of the statute.
3 Ronald F. Young, Electrical Stimulation of the Trigeminal Nerve Root for
the Treatment of Chronic Facial Pain, Journal of Neurosurgery 83:72–78
(July 1995) (“Young”) (Ex. 1010).
4 Gerber, US 6,055,456, issued Apr. 25, 2000 (“Gerber”) (Ex. 1012).
5 Lindegren, WO 98/20933, published May 22, 1998 (“Lindegren”)
(Ex. 1013).
6 Hauser et al., US 5,052,407, issued Oct. 1, 1991 (“Hauser”) (Ex. 1014).
7 Akerström, US 4,407,303, issued Oct. 4, 1983 (“Akerström”) (Ex. 1015).
IPR2020-00679
Patent 8,626,314 B2

11
Pet. 16. In support of its asserted grounds of unpatentability, Petitioner
relies on Declarations of Benjamin Pless (Exs. 1003, 1023). Patent Owner
deposed and cross-examined Mr. Pless and submits transcripts of these
depositions (Exs. 2026, 2072).
Patent Owner proffers a Declaration of Dr. Konstantin Slavin
(Ex. 2029), a Declaration of Dr. Steven Siegel (Ex. 2030), and a Declaration
of Charles Thomas Bombeck (Ex. 2035). Petitioner deposed and
cross-examined each of Patent Owner’s declarants and submits transcripts of
Dr. Slavin’s deposition (Ex. 1021), Dr. Siegel’s deposition (Ex. 1022), and
Mr. Bombeck’s deposition (Ex. 1024).
Additionally, Patent Owner provides evidence of objective indicia of
non-obviousness of the claimed invention. Patent Owner identifies this
evidence in its briefing. PO Resp. 60–71; Sur-reply 16–30.

III. ANALYSIS
A. Level of Ordinary Skill in the Art
Petitioner maintains a person of ordinary skill in the art (“POSITA”)
would have had “(1) at least a bachelor’s degree in biomedical engineering,
electrical engineering, mechanical engineering, or equivalent coursework,
and (2) at least two years of experience researching or developing active,
implantable medical devices.” Pet. 12 (citing Ex. 1003 ¶ 52). Patent Owner
proposes its own level of ordinary skill in the art. PO Resp. 14. According
to Patent Owner, a POSITA “would have been a physician with at least two
years of experience in sacral neuromodulation” or “would have been an
implantable medical lead designer with at least three years of experience
designing and researching leads for use in sacral neuromodulation, and
IPR2020-00679
Patent 8,626,314 B2

12
working in close collaboration with a physician having two years of
experience in sacral neuromodulation.” Id. (citing Ex. 2029 ¶¶ 21–22;
Ex. 2030 ¶ 64). Patent Owner further contends “[m]ore education can
substitute for practical experience and vice versa.” Id. (citing Ex. 2029 ¶ 21;
Ex. 2030 ¶ 64).
Patent Owner argues that we should reject Petitioner’s proposed level
of ordinary skill in the art because it requires no understanding of the sacral
anatomy or sacral neuromodulation, which, according to Patent Owner, is
the context of the ’314 patent. PO Resp. 14–15 (citing Ex. 1001, 1:33–44;
Ex. 2029 ¶¶ 23–24; Ex. 2030 ¶¶ 65–66). Patent Owner further argues that
Mr. Pless “does not possess the appropriate skill in sacral neuromodulation
or the requisite knowledge of the sacrum, sacral nerves, and surrounding
tissues” (id. at 15 (citing Ex. 2026, 216:12–21)), and that “Mr. Pless’[s]
testimony in this proceeding is not grounded in the perspective of a
POSITA” (id.). Petitioner replies that the challenged claims do not recite
sacral anatomy or sacral neuromodulation (Reply 2–3 (citing Ex. 1021,
35:24–36:11, 37:10–48:24; Ex. 1022, 92:17–97:22; Ex. 1023 ¶¶ 9–16)), and
that the ’314 patent describes uses of the invention outside of sacral anatomy
(id. at 3 (citing Ex. 1021, 27:5–29:25, 31:4–17, 35:2–37:8; Ex. 1022,
89:8–90:22)).
The level of ordinary skill in the art is “a prism or lens” through which
we view the prior art and the claimed invention. Okajima v. Bourdeau, 261
F.3d 1350, 1355 (Fed. Cir. 2001). The POSITA is a hypothetical person
presumed to have known the relevant art at the time of the invention. In re
GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of
ordinary skill in the art, we may consider certain factors, including the “type
IPR2020-00679
Patent 8,626,314 B2

13
of problems encountered in the art; prior art solutions to those problems;
rapidity with which innovations are made; sophistication of the technology;
and educational level of active workers in the field.” Id.
The parties dispute not only the level of ordinary skill, but also the
relevant art. Beginning with the relevant art, Petitioner’s proposed level of
ordinary skill suggests the relevant art is implantable medical devices
generally (Pet. 12 (citing Ex. 1003 ¶ 52)), whereas Patent Owner’s proffered
level of ordinary skill indicates the relevant art is medical leads specifically
for sacral neuromodulation (PO Resp. 14 (citing Ex. 2029 ¶¶ 21–22;
Ex. 2030 ¶ 64)). We find it is the latter. The Specification of the ’314
patent defines the field of the invention as medical electrical leads for sacral
neuromodulation:
1. Field of the Invention
This invention relates generally to a method and apparatus
that allows for stimulation of body tissue, particularly sacral
nerves. More specifically, this invention relates to an
implantable medical electrical lead having at least one
stimulation electrode adapted to be implanted near the sacral
nerves for stimulation of a bundle of sacral nerve fibers and a
fixation mechanism for providing chronic stability of the
stimulation electrode and lead. Moreover, this invention relates
to the method of implantation and anchoring of the medical
electrical lead electrodes in operative relation to a selected
sacral nerve to allow for stimulation.
Ex. 1001, 1:33–44 (emphases added). Apart from a reference to applications
outside of sacral neuromodulation (id. at 13:37–39), the Specification
describes the invention with respect to the sacral anatomy (see, e.g., id.
at 8:51–9:20 (describing each of the drawings as depicting a sacral nerve
stimulation lead)). Moreover, the claims’ lack of a recitation of sacral
anatomy or sacral neuromodulation does not override the Specification’s
IPR2020-00679
Patent 8,626,314 B2

14
express description of the field of the invention because the claims’ purpose
is not to describe the subject matter of the patent but rather to define the
boundary of the patent monopoly. See, e.g., PSC Comput. Prods., Inc. v.
Foxconn Int’l, Inc., 355 F.3d 1353, 1358 (Fed. Cir. 2004) (“One important
purpose of the written description is to provide notice to the public as to the
subject matter of the patent, while the claim provides notice as to the scope
of the invention.”); In re Vogel, 422 F.2d 438, 442 (CCPA 1970) (“A claim
is a group of words defining only the boundary of the patent monopoly.”).
Turning to the level of ordinary skill, each party’s proposed level of
ordinary skill requires a combination of formal education and experience.
Pet. 12 (citing Ex. 1003 ¶ 52); PO Resp. 14 (citing Ex. 2029 ¶¶ 21–22;
Ex. 2030 ¶ 64). Patent Owner’s proposed level is higher than Petitioner’s
proposed level in that Patent Owner’s proposed level requires a POSITA to
either be a physician with at least two years of experience in sacral
neuromodulation or a sacral neuromodulation lead designer working in close
collaboration with such a physician. PO Resp. 14 (citing Ex. 2029 ¶¶ 21–22;
Ex. 2030 ¶ 64). Drs. Slavin and Siegel testify that this requirement for a
physician with at least two years of experience in sacral neuromodulation is
necessary for the knowledge of human anatomy and surgical procedures
involved in sacral neuromodulation lead placement. Ex. 2029 ¶ 24;
Ex. 2030 ¶ 66. Mr. Pless, however, testifies that a lead designer developing
leads for sacral neuromodulation would have similar knowledge:
[O]ne of the things that engineers who develop products
for implantation in the body pay attention to is the anatomy, and
we had lots of books on anatomy, both, you know, photographic
depictions as well as, you know, more schematic. You know,
Netter was a great resource for that. And occasionally we would
do cadaver studies as well.
IPR2020-00679
Patent 8,626,314 B2

15
Ex. 2026, 24:7–15. Although a physician with at least two years of
experience in sacral neuromodulation would have knowledge of human
anatomy and surgical procedures involved in sacral neuromodulation lead
placement, we disagree with Patent Owner that a POSITA must be a
physician with at least two years of experience in sacral neuromodulation or
a sacral neuromodulation lead designer working in close collaboration with
such a physician to have this knowledge.
In view of the foregoing, the relevant art is medical leads for sacral
neuromodulation. This art is sophisticated and requires knowledge of
human anatomy of the sacral area and the surgical procedures involved in
sacral neuromodulation. Both lead designers and physicians work in this
field. With these considerations, we find a POSITA would have had at least
the following two qualifications: (1) a bachelor’s degree, or coursework
equivalent, in biomedical engineering, electrical engineering, or mechanical
engineering, or a medical degree, and (2) at least two years of experience
researching and developing medical leads for sacral neuromodulation. We
further find that more education can substitute for practical experience and
vice versa.
Regarding Patent Owner’s criticism of Mr. Pless’s testimony as not
being grounded in the perspective of a POSITA, our Trial Practice Guide8
explains that there is no requirement between a declarant’s experience and
the relevant field. TPG 34 (citing SEB S.A. v. Montgomery Ward & Co., 594

8 USPTO, Patent Trial and Appeal Board Consolidated Trial Practice Guide
November 2019, https://www.uspto.gov/TrialPracticeGuideConsolidated
(“TPG”); see also Office Patent Trial Practice Guide, November 2019
Edition, 84 Fed. Reg. 64,280 (Nov. 21, 2019) (notifying the public of the
availability of the Consolidated Trial Practice Guide).
IPR2020-00679
Patent 8,626,314 B2

16
F.3d 1360, 1373 (Fed. Cir. 2010)). We generally permit testimony where
the declarant’s scientific, technical, or other specialized knowledge will help
the Board understand the evidence or to determine a fact in issue. Id. (citing
Fed. R. Evid. 702(a)). Given his education as an electrical engineer and his
experience as a medical lead designer (Ex. 1003 ¶¶ 4–10), we find
Mr. Pless’s testimony helpful in deciding factual issues in this proceeding.
Moreover, when assigning weight to a declarant’s testimony, we consider
the underlying facts or data upon which the testimony is based. TPG 40–41.
In our analysis of the asserted grounds of unpatentability, we weigh
Mr. Pless’s testimony accordingly.
B. Claim Construction
We interpret a claim “using the same claim construction standard that
would be used to construe the claim in a civil action under 35 U.S.C.
282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe
the claim “in accordance with the ordinary and customary meaning of such
claim as understood by one of ordinary skill in the art and the prosecution
history pertaining to the patent.” Id. Furthermore, we expressly construe the
claims to the extent necessary to determine whether Petitioner has proven
that the challenged claims are unpatentable. See Nidec Motor Corp. v.
Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
(“[W]e need only construe terms ‘that are in controversy, and only to the
extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v.
Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
Petitioner argues the claim term “a plurality of tine elements” should
be construed as “at least two or more structures that mount to the lead body,
each structure comprising of multiple tines attached to the structure.”
IPR2020-00679
Patent 8,626,314 B2

17
Pet. 15. Patent Owner disagrees with Petitioner’s proposed construction,
and also asserts the Board can resolve the dispute in this proceeding without
construing the term. PO Resp. 16–18.
We agree with Patent Owner that an express construction of the claim
term “a plurality of tine elements” is unnecessary to resolve the dispute. For
the reasons set forth in our analysis of the asserted grounds of
unpatentability, we determine that no claim term requires an express
construction for us to ascertain whether Petitioner has shown the challenged
claims to be unpatentable.
C. Obviousness Based on Young, Gerber, and Lindegren
Petitioner challenges claims 1, 2, 4, 7, 10–12, 14, and 18–24 under
35 U.S.C. § 103(a), contending the claimed subject matter would have been
obvious over Young, Gerber, and Lindegren. Pet. 17–39; Reply 3–10.
Patent Owner argues Petitioner’s proposed combination of Young, Gerber,
and Lindegren would not have resulted in a system or method comprising all
of the claim limitations. PO Resp. 18–20; Sur-reply 1–5. Patent Owner also
argues that there would not have been a motivation to combine the teachings
of the references as Petitioner proposes. PO Resp. 20–36; Sur-reply 5–10.
We begin our analysis of this asserted ground of unpatentability with
an overview of the references, and then discuss the parties’ contentions for
each of the claims. For the reasons below, Petitioner has not shown, by a
preponderance of the evidence, that the subject matter of claims 1, 2, 4, 7,
10–12, 14, and 18–24 would have been obvious over the combined teachings
of Young, Gerber, and Lindegren.
IPR2020-00679
Patent 8,626,314 B2

18
1. Young
Young details “the author’s experience with the placement of a totally
implanted, percutaneously placed electrode system for chronic electrical
stimulation of the trigeminal sensory root for treatment of chronic facial pain
in 23 patients between 1990 and 1993.” Ex. 1010, 73. The trigeminal
stimulating electrode9 is shown in Figure 1, reproduced below.

Figure 1 is a photograph of the tip of the trigeminal stimulating electrode.
Id. The trigeminal stimulating electrode consists of a monopolar
platinum-iridium lead with two sets of four tines located 5 and 10 mm from
the distal tip of the electrode and a central stylet. Id. The purpose of the
tines is to prevent the electrode from becoming dislodged after implantation.
Id.
The electrode is inserted percutaneously through a No. 14 needle via a
puncture of the foramen ovale. Id. Subsequently, the introducing needle
and central stylet are removed, and the proximal end of the electrode is
tunneled subcutaneously around the mandible and connected to a
percutaneous extension lead. Id. The distal end of the extension lead is

9 The trigeminal stimulating electrode disclosed in Young is Patent Owner’s
Quintatrigeminal electrode. Ex. 1010, 73.
IPR2020-00679
Patent 8,626,314 B2

19
connected to a completely implanted pulse generator system. Id. at 74. The
implanted pulse generator system10 is shown in Figure 3 below.

Figure 3 is a photograph of the complete component system for trigeminal
stimulation, including the electrode, the implanted pulse generator, and an
extension lead. Id.
The patients with the implanted electrode system did not have any
major complications but instead only a few minor problems. Id. at 77.
Nonetheless, “[t]he electrode could be improved to provide multiple active
stimulation sites near the tip,” which “would be particularly useful for
achieving stimulation-induced paresthesias in patients with pain in all three
trigeminal divisions.” Id.
2. Gerber
Gerber discloses “an implantable medical lead having at least one
electrode contact wherein the lead is implanted near the sacral nerves for
stimulation of a bundle of nerve fibers.” Ex. 1012, 1:9–12. An implantable

10 The implanted pulse generator system disclosed in Young is Patent
Owner’s ITREL. Ex. 1010, 74.
IPR2020-00679
Patent 8,626,314 B2

20
medical lead for stimulation of the sacral nerves is shown in Figure 1,
reproduced below.

Figure 1 is a plan view showing implantable medical lead 10 comprising
lead body 15 having at least one electrode contact 20 at distal end 25. Id.
at 3:21–22, 3:40–43. Proximal end 35 of lead body 15 may be coupled to a
pulse generator, and lead body 15 includes at least one conductor wire
within an insulating sheath. Id. at 3:49–51, 4:6–7.
Implantable medical lead 10 may have an anchoring mechanism to
fixate the lead in the desired position, as shown in Figure 2, reproduced
below.

Figure 2 is a plan view of implantable medical lead 10 having anchoring
mechanism 50, which is a molded part, integral to medical lead 10. Id.
at 3:23–25, 4:13–17. A physician can pass sutures through the molded part
to attach medical lead 10 to the human anatomy. Id. at 4:17–19.
Alternatively, anchoring mechanism 50 allows medical lead 10 to fibrose in
naturally using the human body’s natural reaction to a foreign body or
healing. Id. at 4:27–30.
IPR2020-00679
Patent 8,626,314 B2

21
Implantable medical lead 10 may include two electrode contacts, as
shown in Figure 3 below.

Figure 3 is a plan view of implantable medical lead 10 having two electrode
contacts 20, 40 to provide for a bipolar configuration. Id. at 3:26–27,
4:32–33.
The medical lead has a smaller than typical diameter. Id. at 2:64–66.
The smaller diameter allows for less invasive implantation techniques, such
as via a cannula, imparts less trauma to the patient during implantation, and
enables a physician to use local, instead of general, anesthesia. Id.
at 2:66–3:6. When the medical lead is implanted with a cannula, a stylet is
useful to straighten the medical lead for passing through the cannula. Id.
at 5:15–17, 5:26–28.
3. Lindegren
Lindegren discloses an implantable electrode lead with “an electrode
head equipped with external anchoring means, such as tine-like
position-fixation means.” Ex. 1013, 1:6–11. The position-fixation means
consists of a position-fixation groove encircling the exterior of the electrode
head, and the groove is sized to receive a ring-shaped tine-bearing means.
Id. at 5:11–15. Figure 3, reproduced below, shows the ring-shaped means
mounted in the position-fixation groove.
IPR2020-00679
Patent 8,626,314 B2

22

Figure 3 is a perspective view of the distal end section of implantable
electrode lead 2. Id. at 6:30–32, 7:7–8. Received in position-fixation
groove 8, ring-shaped means 10 encircles electrode head 6 and includes four
projections 12 extending at an angle outward and to the rear. Id. at 7:18–23.
From a manufacturing point of view, it is preferable to have projections 12
integral with ring-shaped means 10 and evenly distributed around the
circumference of ring-shaped means 10. Id. at 5:17–22, 7:30–8:1.
Furthermore, ring-shaped means 10 and projections 12 are preferably made
of an elastic material such as silicone rubber. Id. at 5:20–22, 8:5–8.
4. Independent claim 1
a. Undisputed claim limitations (limitations 1.0–1.f and 1.h)
The preamble of independent claim 1, i.e., Petitioner’s designated
limitation 1.0, recites “[a] system.” Ex. 1001, 13:51. Petitioner contends
that, to the extent the preamble is a limitation, Young, Gerber, and
Lindegren disclose a system. Pet. 24.
Independent claim 1 further recites “an implantable medical lead
comprising: a lead body extending between a proximal end and a distal end,”
IPR2020-00679
Patent 8,626,314 B2

23
i.e., limitations 1.a–1.b. Ex. 1001, 13:52–54. Petitioner argues Young’s
lead discloses these limitations. Pet. 24–25 (citing Ex. 1010, 73–74,
Figs. 1–3).
Independent claim 1 next recites “a plurality of conductors within the
lead body,” i.e., limitation 1.c. Ex. 1001, 13:55. Petitioner contends Young
inherently discloses one conductor connecting the electrode to the IPG so
that the electrode can function and stimulate a patient’s nerve. Pet. 25
(citing Ex. 1010, 73–74). Petitioner further contends Gerber teaches “lead
body 15 of the present invention comprises one or more conductor wire(s)
within an insulating sheath.” Id. (quoting Ex. 1012, 4:6–7).
Independent claim 1 also recites “a plurality of electrodes, wherein
each electrode is electrically connected to a conductor of the plurality of
conductors,” i.e., limitation 1.d. Ex. 1001, 13:56–58. Petitioner argues:
“Young discloses one electrode, but states ‘[t]he electrode could be
improved to provide multiple active stimulation sites near the tip.’ Ex. 1010
at 77. Multiple active stimulation sites mean that there will be multiple
electrodes. Ex. 1003 at 68.” Pet. 25–26. Petitioner further argues Gerber
teaches multiple electrodes that are each electrically connected to a
conductor for carrying stimulation pulses from the IPG to the electrode. Id.
at 26 (citing Ex. 1003, 67–6811; Ex. 1012, Abstract, 1:57–58, 2:4–5, 3:52–
56, 4:32–33, claim 1, Fig. 3).

11 In arguing that Gerber teaches limitation 1.d, Petitioner cites to
pages 68–69 of Mr. Pless’s Declaration. Pet. 26. Mr. Pless, however,
discusses this limitation on pages 67–68 of his Declaration. Thus, we
understand that the citation to pages 68–69 is a typographical error, and that
Petitioner is relying on pages 67–68 of Mr. Pless’s Declaration to support its
argument that Gerber teaches limitation 1.d. Moreover, as we note
IPR2020-00679
Patent 8,626,314 B2

24
Independent claim 1 further recites “a plurality of tine elements
extending from the lead body, wherein all tine elements of the plurality of
tine elements are positioned between a most proximal electrode of the
plurality of electrodes and the proximal end of the lead body,” i.e.,
limitation 1.e. Ex. 1001, 13:59–62. Petitioner contends Young’s electrode
includes at least two tine elements located between the electrode and the
lead proximal end. Pet. 26 (citing Ex. 1010, 73, Fig. 1). Petitioner further
contends Gerber teaches an anchoring mechanism located between the most
proximal electrode and the proximal end of the lead body. Id. at 27.
According to Petitioner, Gerber teaches the anchoring mechanism allows the
medical lead to fibrose naturally into the human body, and a POSITA would
have known that tines are a widely used fibrosing anchoring means. Id.
(citing Ex. 1003, 6912; Ex. 1012, 4:13–30, Fig. 3).
Independent claim 1 next recites:
each tine element comprising a plurality of flexible, pliant tines,
each tine having a tine width and thickness and extending a tine
length from an attached tine end to a free tine end, the attached
tine end attached to the lead body from a tine attachment site and
supporting the tine extending outwardly of the lead body and
proximally toward the lead proximal end,
i.e., limitation 1.f. Ex. 1001, 13:63–14:3. Petitioner argues each of Young’s
tines has a width, thickness, and length, and is attached to the lead body so

throughout this Decision, many of Petitioner’s citations to Mr. Pless’s
Declaration are off by one page.
12 Mr. Pless’s testimony regarding an ordinarily skilled artisan’s
understanding that tines are a known fibrosing anchoring means is on
page 69 of his Declaration. We consider Petitioner’s citation to page 70 for
this testimony to be a typographical error, and we understand Petitioner to
have intended to cite page 69.
IPR2020-00679
Patent 8,626,314 B2

25
that one end extends outwardly from the lead body towards the lead
proximal end. Pet. 27–28 (citing Ex. 1010, Fig. 1). Petitioner also argues
Lindegren teaches a plurality of proximally extending tines mounted on
rings. Id. at 28 (citing Ex. 1013, Fig. 3). Petitioner further asserts that
proximally oriented tines were common before 2001, especially for use with
an introducer into which the tine ends enter first, because such an orientation
does not risk damaging the free tine ends. Id.; Ex. 1003 ¶ 32.
The last limitation of independent claim 1 recites “wherein the
plurality of tine elements is separate from and axially displaced from the
plurality of electrodes,” i.e., limitation 1.h. Ex. 1001, 14:9–11. Petitioner
argues Young discloses two sets of tines that are separate from and axially
displaced from the one electrode. Pet. 29 (citing Ex. 1010, Fig. 1).
Petitioner also argues Gerber teaches two electrodes, as well as an anchoring
mechanism located separate from and spaced apart from an electrode. Id.
(citing Ex. 1012, Fig. 2).
Patent Owner does not dispute Petitioner’s contentions with respect to
what Petitioner designates as limitations 1.0–1.f and 1.h. Petitioner’s
arguments and Mr. Pless’s testimony find support in Young, Gerber, and
Lindegren. Young discloses a percutaneously placed electrode system for
chronic electrical stimulation of the trigeminal sensory root to treat chronic
facial pain. Ex. 1010, 73. Young’s electrode system includes an
implantable medical lead having a lead body, an electrode, and plurality of
tine elements made up of a plurality of tines and located proximal to the
electrode. Id. at 73, Fig. 1. Young’s electrode system further includes an
IPG connected to the end of the lead body opposite the electrode so that the
lead body conducts electrical pulses from the IPG to the electrode. Id. at 74,
IPR2020-00679
Patent 8,626,314 B2

26
Fig. 3. Gerber teaches an implantable medical lead having a lead body, a
plurality of conductors, a plurality of electrodes that are each electrically
connected to a conductor of the plurality of conductors, and an anchoring
mechanism located separate and axially displaced from an electrode.
Ex. 1012, Abstract, 3:39–42, 52–56, 4:6–7, 4:13–15, 4:32–33, Figs. 2–3.
Lindegren teaches ring-shaped means including a plurality of proximally
extending, elastic tines. Ex. 1013, 5:17–22, Fig. 3. In view of the foregoing,
Petitioner has persuasively identified what it designates as
limitations 1.0–1.f and 1.h in its proposed combination of Young, Gerber,
and Lindegren.
b. Tines that are adapted to fold inward against the lead body
without overlap and deploy outward when the introducer is
withdrawn (limitation 1.g)
Independent claim 1 further recites
wherein the plurality of tines of the plurality of tine elements are
adapted to be folded inward against the lead body when fitted
into and constrained by a lumen of an introducer without
overlapping one another and deploy outward to engage body
tissue when the introducer is withdrawn to release the plurality
of tines,
i.e., limitation 1.g. Ex. 1001, 14:3–9. In view of Young’s teaching of the
electrode being inserted into a No. 14 needle, Petitioner contends Young
discloses this limitation. Pet. 28–29. In particular, Petitioner asserts:
Since Young’s electrode is “inserted and advanced” in the
needle, the tines are adapted to and do fold inward against the
lead body without overlapping one another. Tines are
purposefully designed to fold inward when constrained in a
lumen because if they did not, they are likely damaged when the
lead is advanced. Ex. 1003 ¶32. In Young Figure 1, the length
of each tine is shorter than the distance between the two sets, i.e.
IPR2020-00679
Patent 8,626,314 B2

27
two tine elements. Thus, the tines cannot overlap one another.
Id. [at 70–71].13
Pet. 29.
Patent Owner argues “[Petitioner’s] assertion that Young discloses
this limitation, in effect, amounts to an unsupported and legally improper
inherency argument that should be rejected because there is no evidence that
Young’s tines necessarily fold inward against the lead body.” PO Resp. 19
(internal quotation omitted). Patent Owner maintains that even if inserting
Young’s lead into a needle causes the tines to fold inwardly, the tines would
not necessarily touch the lead body. Id. at 19–20; Sur-reply 3–5. According
to Patent Owner, Dr. Slavin testifies that whether Young’s tines fold
inwardly against the lead body depends on multiple factors, including the
diameter of the electrode, length and diameter of the tines, diameter of the
needle through which the tined electrode is introduced, and the material of
the tines (PO Resp. 19 (citing Ex. 2029 ¶¶ 48–52)), and Dr. Slavin provides
an example of how a tine can fold inwardly without being against the lead
body (Sur-reply 3–4 (citing Ex. 2029 ¶ 50)). Patent Owner also contends
Mr. Pless admits that he could not say for sure whether Young’s tines would
touch the lead body. PO Resp. 19–20 (citing Ex. 2026, 112:14–113:11);
Sur-reply 4.
Petitioner replies that limitation 1.g recites tines adapted to be folded
against the lead body and thus does not require the tines to actually be folded
against the lead body but simply tines capable of being folded against the

13 Mr. Pless’s testimony regarding limitation 1.g is on pages 70–71 of his
Declaration. We consider Petitioner’s citation to pages 71–72 for this
testimony to be a typographical error, and we understand Petitioner to be
citing pages 70–71.
IPR2020-00679
Patent 8,626,314 B2

28
lead body. Reply 3–4. Petitioner further replies that Mr. Pless’s opinion
regarding Young’s tines being adapted to be folded against the lead body is
based on his measurements of Young’s tines and the inner diameter of a
No. 14 needle. Id. at 4 (citing Ex. 1023 ¶ 24; Ex. 2029, 109:14–110:16).
We agree with Petitioner that limitation 1.g recites tines adapted to be
folded against the lead body and therefore does not require the tines to
actually be folded against the lead body. Consequently, Dr. Slavin’s
testimony that there is insufficient evidence to conclude Young’s tines touch
the lead body when constrained by the needle’s lumen (Ex. 2029 ¶¶ 49–51)
and Mr. Pless’s admission that he could not say for sure whether Young’s
tines would touch the lead body (Ex. 2026, 112:25–113:11) are not
commensurate with the scope of limitation 1.g and thus not probative.
Moreover, contrary to Patent Owner’s argument, Petitioner is not
alleging it is inherent that Young’s tines fold inwardly against the lead body
when fitted into a No. 14 needle. Rather, Petitioner argues that, given the
disclosed dimensions of Young’s tined lead relative to the inner diameter of
a No. 14 needle and Young’s disclosure of inserting the tined lead into a
No. 14 needle, a POSITA would understand that Young teaches tines
capable of folding against the lead body. Pet. 28–29; Reply 4. In particular,
Mr. Pless testifies:
I did look up the size of a No. 14 needle and compared that
against Young’s disclosed dimensions, which were that the tines
were 5 mm apart. Using that as a scale, the diameter of the tines
(tip to tip) appears to be about 4mm. While I couldn’t recall the
dimensions during my deposition, I looked up the size of a
No. 14 needle afterwards. I confirmed that inner diameter of a
No. 14 needle is typically around 1.6 mm. Thus, when the lead
is advanced through the No. 14 needle, it is difficult to see how
that could happen without the tines (which have a considerably
IPR2020-00679
Patent 8,626,314 B2

29
larger span than the inside diameter of the needle) being adapted
to be folded against the lead body.
Ex. 1023 ¶ 24 (footnote omitted).
In view of Young’s disclosure of its tines being spaced 5 mm apart
(Ex. 1010, 73), we credit Mr. Pless’s testimony that, based on the
photograph of the lead shown in Figure 1, the tines extend, tip to tip,
approximately 4 mm. See In re Aslanian, 590 F.2d 911, 914 (CCPA 1979)
(holding that drawings must be evaluated for what they reasonably disclose
and suggest to a POSITA); cf. Hockerson-Halberstadt, Inc. v. Avia Grp.
Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000) (holding that arguments based
on measurements taken from a reference’s drawings are of little value when
the reference does not disclose the drawings are to scale and is silent as to
dimensions). We also credit Mr. Pless’s uncontested testimony that the
inner diameter of a No. 14 needle is approximately 1.6 mm. Given Young’s
disclosure of its tined electrode being inserted through a No. 14 needle,
which has an inner diameter that is less than half the length of the tines
measured tip to tip, Young’s tines must be flexible and bend significantly to
fit in the No. 14 needle and therefore capable of folding inwardly against the
lead body. Accordingly, Petitioner has persuaded us that Young discloses
tines adapted to be folded inwardly against the lead body, as limitation 1.g.
requires, and Petitioner has shown limitation 1.g in its proposed combination
of Young, Gerber, and Lindegren.
c. Reasons for combining the teachings
Petitioner argues a POSITA would have been motivated to combine
the teachings of Young, Gerber, and Lindegren. Pet. 22–24; Reply 7–8.
Petitioner contends a POSITA would have modified Young’s electrode
system to include a lead with multiple electrodes, as Gerber teaches, because
IPR2020-00679
Patent 8,626,314 B2

30
Young teaches that the single electrode could be improved to provide
multiple active stimulation sites near the tip. Pet. 23; Reply 7–8. Petitioner
also contends a POSITA would have modified Young’s electrode system to
include Lindegren’s tine-mounted rings because Lindegren teaches that it
would be preferable for manufacturing to have tines mounted on a
ring-shaped means, like a rubber band encircling the lead body. Pet. 23
(citing Ex. 1003 ¶ 91); Reply 8. Petitioner further asserts “it would have
been easy and feasible to utilize Lindegren’s tine-mounted rings with tines
extending proximally and spaced apart as shown in Young to further prevent
dislodgement after implantation, which is a purpose of the tines stated in
Young.” Pet. 24. Additionally, Petitioner argues a POSITA would have
combined the teachings of Young, Gerber, and Lindegren because each of
these references solve the same problem as the ’314 patent in the same field.
Id. at 22 (citing Ex. 1010, 73; Ex. 1012, 1:64–2:13; Ex. 1013, 1:20–27,
4:32–5:7; Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1371 (Fed.
Cir. 2011)); Reply 8.
Patent Owner maintains Petitioner’s proposed combination of Young,
Gerber, and Lindegren is based on impermissible hindsight. PO
Resp. 20–22. Patent Owner argues there would not have been a motivation
to modify Young’s lead to include Gerber’s multiple electrodes so that the
electrodes are distal to all of the lead’s tines, as limitation 1.e requires. Id.
at 22–28; Sur-reply 6–8. Patent Owner also argues there would not have
been a motivation to combine the teachings of Young’s lead with
Lindegren’s proximally extending tines, as recited in limitation 1.f. PO
Resp. 28–32; Sur-reply 8. Patent Owner additionally argues Petitioner’s
IPR2020-00679
Patent 8,626,314 B2

31
general reasons for combining the teachings of the references are
insufficient. PO Resp. 33–36.
Beginning with Petitioner’s reasoning premised on the references
solving the same problem as the ’314 patent, Patent Owner argues none of
these references solve the same problem as the ’314 patent. PO Resp. 35
(citing Ex. 2029 ¶¶ 76–83). We agree with Patent Owner. Petitioner
characterizes the problem addressed in the ’314 patent as “leads adequately
stimulating the nerves while limiting electrode migration” (Pet. 22), but the
’314 patent describes a more specific problem. According to the ’314
patent:
[T]here remains a need in the art for a permanently
implantable electrical sacral nerve stimulation lead that is
capable of being passed percutaneously over a guide wire,
and/or through the lumen of an introducer from the patient’s skin
to locate stimulation electrodes in casual contact with a sacral
nerve, that provides acute fixation with muscle and tissue layers
posterior to the sacrum, and that can be bent to extend
subcutaneously to the neurostimulator IPG without disturbing
the fixation so that the stimulation electrodes are less likely to be
dislodged during the acute recovery phase and the chronic
implantation period.
Ex. 1001, 5:34–44 (emphasis added). The ’314 patent addresses the need for
a percutaneously implantable lead that is properly and securely positioned to
provide sacral nerve stimulation, whereas the references do not. Young
addresses placement of an implanted, percutaneously placed electrode
system for electrical stimulation of the trigeminal sensory root for treatment
of chronic facial pain. Ex. 1010, 73. Gerber contemplates the positioning
and securement of an electrode that is implanted in the sacral area via a
non-percutaneous surgical procedure. Ex. 1012, 2:9–13. Lindegren
addresses the need for a cardiac lead that can be easily detached from the
IPR2020-00679
Patent 8,626,314 B2

32
anchoring means and allow the lead to be replaced despite the anchoring
means being stuck in the heart. Ex. 1013, 4:16–22. Moreover, the nature of
the problem to be solved is typically pertinent to the motivation for
combining the teachings of simpler mechanical technologies. Tokai, 632
F.3d at 1371 (“We have consistently stated that courts may find a motivation
to combine prior art references in the nature of the problem to be solved, and
that [t]his form of motivation to combine evidence is particularly relevant
with simpler mechanical technologies.” (alternation in original) (citations
and internal quotations omitted)). The technologies in this proceeding
involve medical devices implanted in the body for neurostimulation, not
simple mechanical technologies. See, e.g., Ex. 1001, 1:36–41 (describing
the field of the invention for ’314 patent as “an implantable medical
electrical lead having at least one stimulation electrode adapted to be
implanted near the sacral nerves for stimulation of a bundle of sacral nerve
fibers and a fixation mechanism for providing chronic stability of the
stimulation electrode and lead”). Accordingly, Petitioner’s reasoning
premised on Young, Gerber, and Lindegren solving the same problem as the
’314 patent does not persuade us that a POSITA would have had a reason to
combine the teachings of the references.
Turning to Petitioner’s reasoning for modifying Young’s lead to
include Gerber’s multiple electrodes so that the electrodes are distal to all of
the lead’s tines, Petitioner’s reasoning is premised on Young, which
discloses “[t]he electrode could be improved to provide multiple active
stimulation sites near the tip.” Ex. 1010, 77. Petitioner argues this
disclosure suggests multiple electrodes arranged distal to all of the tines
because “[t]he tip referenced here is the distal tip where Young’s original
IPR2020-00679
Patent 8,626,314 B2

33
electrode was located, which is distal to all of the tines of Young.” Reply 8;
see also Ex. 2026, 168:12–21 (Mr. Pless testifying “I think a person of
ordinary skill in the art would see that Young is recommending multiple
distal electrodes, and at least to me the natural thing would be to add the
electrodes where the current electrode in Young is, which is distal to the
tines”).
Patent Owner argues Young’s disclosure of improving its lead to
provide multiple active stimulation sites, i.e., electrodes, near the tip would
not have suggested to a POSITA to modify Young’s lead to include a
plurality of electrodes distal to all of the tines because such an arrangement
would not be feasible in the complex anatomy of the trigeminal nerve
region. PO Resp. 23 (citing Ex. 2029 ¶¶ 58–65); see also Sur-reply 6–8
(arguing that adding electrodes distal to all of the tines would render
Young’s tines inoperable for their intended purpose). Patent Owner’s
argument is based on Dr. Slavin’s testimony:
If, as Mr. Pless appears to assume, that Young is suggesting
adding electrode(s) distal to the tines in figure 1, then the tines
would have to get pushed back in the proximal direction (i.e.,
towards the foramen ovale) to accommodate the additional
electrode(s). This means the tines would be out of the cistern,
but moving the tines outside the cistern would result in them
being in contact with, for example, the hard tissue of the
trigeminal ganglion. Tines cannot anchor in such hard tissue,
which would have prevented the tines from performing their
intended function of stabilizing the lead electrode within the
cistern.
Ex. 2029 ¶ 62 (footnote omitted). Patent Owner also argues that we should
give no weight to Mr. Pless’s opinion that a POSITA would have been
motivated to combine the teachings of Young with other references because
Mr. Pless lacks an understanding of the trigeminal nerve anatomy pertinent
IPR2020-00679
Patent 8,626,314 B2

34
to Young’s disclosure. PO Resp. 24–26. Patent Owner further argues that
“[e]ven if a POSITA were motivated to try to improve the lead in Young—
they would look to modify Young’s lead to remove tines and would certainly
not consider rearranging them to arrive at the claimed invention.” Id. at 26
(citing Ex. 2029 ¶ 65).
Petitioner replies that it is incorrect for Patent Owner to require
Young’s lead, as modified to include Gerber’s multiple electrodes, to
operate as intended in the trigeminal area. Reply 5–6. According to
Petitioner, the proper inquiry is whether the proposed combination would
achieve what is in the ’314 patent claims. Id. at 6.
Petitioner, however, conflates the obviousness requirements of
motivation to combine and reasonable expectation of success, which are
distinct inquiries. See, e.g., Intelligent Bio–Sys., Inc. v. Illumina Cambridge
Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (explaining “two different legal
concepts—reasonable expectation of success and motivation to combine”).
Reasonable expectation of success contemplates the likelihood of success in
combining the references to meet the limitations of the claimed invention,
and failure to consider the appropriate scope of the claimed invention in
evaluating a reasonable expectation of success constitutes a legal error. Id.
In contrast, motivation to combine considers whether there would have been
a suggestion or motivation to make the proposed combination of references.
Id. at 1368. Although an unclaimed purpose is irrelevant to reasonable
expectation of success, it may be pertinent to motivation to combine. Id.
(“While [the deblocking of the prior art’s azidomethyl group] is irrelevant to
a finding that there was no reasonable expectation of success in meeting the
claims of the ’537 patent, which do not require quantitative deblocking at
IPR2020-00679
Patent 8,626,314 B2

35
all, it is central to a finding of no motivation to combine.”); see also In re
Gordon, 733 F.2d 900, 902 Fed. Cir. 1984) (reversing a determination of
obviousness because the proposed modification would have rendered the
prior art device inoperable for its intended purpose); Trivascular, Inc. v.
Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016) (“We find no error in the
Board’s rejection of TriVascular's argument that it would have been obvious
to substitute the recessed barbs of Samuels ’851 with the protuberances of
Todd, since TriVascular’s proposed substitution would destroy the basic
objective of the barbs, which is to penetrate surrounding tissue.”).
As the purpose of Young’s lead, which is electrical stimulation of the
trigeminal sensory root (Ex. 1010, 73), is relevant to assessing whether there
would have been a motivation to combine, we credit Dr. Slavin’s testimony
that Young’s disclosure of improving its lead to provide multiple active
stimulation sites near the tip would not have suggested to a POSITA to
modify Young’s lead to include a plurality of electrodes distal to all of the
tines because such an arrangement would not be feasible in the trigeminal
nerve region. Moreover, contrary to Petitioner’s argument, Young discloses
multiple active sites near the tip, not at the tip or distal to the tines. In view
of Young simply disclosing multiple active sites near the tip, without any
relation to the tines, and Dr. Slavin’s testimony that a POSITA would not
understand Young to suggest multiple electrodes distal to all of the tines,
Petitioner has not persuaded us that Young’s disclosure of improving its lead
to provide multiple active stimulation sites near the tip would have
suggested to a POSITA to modify Young’s lead to include a plurality of
electrodes distal to all of the tines.
IPR2020-00679
Patent 8,626,314 B2

36
d. Conclusion of independent claim 1
Petitioner has demonstrated each limitation of independent claim 1 in
its proposed combination of Young, Gerber, and Lindegren. Petitioner,
however, has not persuaded us that a POSITA would have had a reason to
combine Young’s lead with Gerber’s plurality of electrodes so the plurality
of electrodes is distal to all of the lead’s tines, as Petitioner proposes. Even
without Patent Owner’s proffered objective indicia of non-obviousness (PO
Resp. 60–71; Sur-reply 16–30), Petitioner has not shown, by a
preponderance of the evidence, that the subject matter of independent
claim 1 would have been obvious over the combined teachings of Young,
Gerber, and Lindegren.
5. Independent claims 11 and 18
Petitioner relies on the same reasoning for combining the teachings of
Young, Gerber, and Lindegren to result in the subject matter of independent
claims 11 and 18 as for combining the teachings of these references to result
in the subject matter of independent claim 1. Pet. 22–24. As discussed
above in section III.C.4.c, Petitioner’s reasoning is not persuasive. Even
without Patent Owner’s proffered objective indicia of non-obviousness (PO
Resp. 60–71; Sur-reply 16–30), Petitioner has not shown, by a
preponderance of the evidence, that the subject matter of independent
claims 11 and 18 would have been obvious over combined teachings of
Young, Gerber, and Lindegren.
6. Dependent claims
For the reasons discussed above in sections III.C.4.c and III.C.5,
Petitioner has not persuaded us that a POSITA would have had a reason to
combine the teachings of Young, Gerber, and Lindegren to result in the
IPR2020-00679
Patent 8,626,314 B2

37
subject matter of independent claims 1, 11, and 18, from which claims 2, 4,
7, 10, 12, 14, and 19–24 depend. Even without Patent Owner’s proffered
objective indicia of non-obviousness (PO Resp. 60–71; Sur-reply 16–30),
Petitioner has not shown, by a preponderance of the evidence, that the
subject matter of dependent claims 2, 4, 7, 10, 12, 14, and 19–24 would have
been obvious over combined teachings of Young, Gerber, and Lindegren.
D. Obviousness Based on Young, Gerber, Lindegren, and Hauser
Petitioner challenges claims 18, 20, and 21 of the ’314 patent under
35 U.S.C. § 103(a), contending the claimed subject matter would have been
obvious over Young, Gerber, Lindegren, and Hauser. Pet. 39–47;
Reply 11–12. Patent Owner argues this asserted ground of unpatentability
fails for the same reasons as the asserted ground based on Young, Gerber,
and Lindegren. PO Resp. 39. Patent Owner also argues that there would not
have been a motivation to combine the teachings of Young, Gerber,
Lindegren, and Hauser as Petitioner proposes. Id. at 40–42; Sur-reply 10.
This asserted ground based on Young, Gerber, Lindegren, and Hauser
is similar to the asserted ground based on Young, Gerber, and Lindegren. In
both of these asserted grounds, Petitioner relies on Gerber’s multiple
electrodes. See Pet. 43–45 (referencing the arguments for the asserted
ground based on Young, Gerber, and Lindegren). Also, Petitioner’s
reasoning for modifying Young’s lead to include Gerber’s multiple
electrodes so that the electrodes are distal to all of the lead’s tines is the
same in both of these asserted grounds. See id. at 42 (referring to the
reasons for combining the teachings of the references with respect to
asserted ground based on Young, Gerber, and Lindegren).
IPR2020-00679
Patent 8,626,314 B2

38
For the reasons discussed above in sections III.C.4.c and III.C.5,
Petitioner has not persuaded us that a POSITA would have had a reason to
combine Young’s lead with Gerber’s plurality of electrodes so the plurality
of electrodes is distal to all of the lead’s tines, as Petitioner proposes. Even
without Patent Owner’s proffered objective indicia of non-obviousness (PO
Resp. 60–71; Sur-reply 16–30), Petitioner has not shown, by a
preponderance of the evidence, that the subject matter of independent
claims 18, 20, and 21 would have been obvious over combined teachings of
Young, Gerber, Lindegren, and Hauser.
E. Obviousness Based on Gerber, Hauser, and Akerström
Petitioner challenges claims 1, 2, 4, 7, 10–12, 14, and 18–24 under
35 U.S.C. § 103(a), contending the claimed subject matter would have been
obvious over Gerber, Hauser, and Akerström. Pet. 47–67; Reply 12–16.
Patent Owner argues that Petitioner’s proposed combination of Gerber,
Hauser, and Akerström would not have resulted in all of the claim
limitations. PO Resp. 43–46; Sur-reply 10–12. Patent Owner also argues
that there would not have been a motivation to combine the teachings of the
references as Petitioner proposes. PO Resp. 46–60; Sur-reply 12–16.
As we discuss Gerber above in section III.C.2, we begin our analysis
of this asserted ground of unpatentability with an overview of Hauser and
Akerström. We then turn to the parties’ contentions for each of the claims.
For the reasons below, Petitioner has not shown, by a preponderance of the
evidence, that the subject matter of claims 1, 2, 4, 7, 10–12, 14, and 18–24
would have been obvious over the combined teachings of Gerber, Hauser,
and Akerström.
IPR2020-00679
Patent 8,626,314 B2

39
1. Hauser
Hauser is directed to “an implantable defibrillation or cardioversion
electrode and a method for placing the electrode on or about the heart to
deliver electrical energy to the heart.” Ex. 1014, 1:12–16. An electrode is
shown in Figure 1, reproduced below.

Figure 1 is a perspective view of the electrode in a partially straightened
position. Id. at 3:9–10. Electrode 10 is thin and elongated, and includes
IPR2020-00679
Patent 8,626,314 B2

40
distal active region 11 and proximal lead region 13. Id. at 3:50–52.
Conductive discharge surface 12 and insulative surface 14 define and extend
the entire length of distal active region 11, and tapered, soft, insulative tip 16
terminates the distal end of distal active region 11. Id. at 3:52–55.
Conductive discharge surface 12 and insulative surface 14 are preformed so
that distal active region 11 adopts a planar spiral patch shape when in its
relaxed state. Id. at 3:62–66, Fig. 6. Conductive element 18 surrounded by
insulator 15 extends the entire length of proximal lead region 13. Id.
at 3:55–57. Conductive element 18 is a lead electrically connecting at one
end with conductive discharge surface 12. Id. at 3:57–60.
Distal insulative tip 16 includes fixation means 17 to anchor and
stabilize electrode 10 relative to the heart. Id. at 3:67–4:1. Electrode 10 is
also provided with proximal fixation means 19 to anchor electrode 10 at the
location of entrance into the pericardial space. Id. at 4:3–8.
IPR2020-00679
Patent 8,626,314 B2

41
The implantation procedure of electrode 10 is shown in Figures 3–5,
reproduced below.

Figures 3–5 are views during various stages of implantation of the electrode.
Id. at 3:12–13, 4:30–32. First, catheter 21, having a cross section only
IPR2020-00679
Patent 8,626,314 B2

42
slightly larger than the cross section of electrode 10, is introduced through
the skin and into the pericardial space, and electrode 10 is inserted into
catheter 21 using stylet 22 through a lumen in the body of electrode 10,
thereby straightening distal active region 11, as shown in Figure 3. Id.
at 4:32–39. With catheter 21 containing electrode 10 and in position in the
pericardial space, distal active region 11 is urged out of catheter 21 with
stylet 22. Id. at 4:39–43. Distal active region emerges from catheter 21 as
stylet 22 is withdrawn, and begins to take a relaxed, coiled shape, as shown
in Figure 4. Id. at 4:41–47. As distal active region 11 continues to emerge
from catheter 21, it assumes more of its relaxed planar spiral shape, as
shown in Figure 5, and deployment continues until the entire distal active
region 11 of electrode 10 is in place in the pericardial space. Id. at 4:47–51.
Stylet 22 and catheter 21 are then removed, and proximal lead region 13 of
electrode 10 is tunneled to the location where it will be connected to a pulse
generator of the defibrillation/cardioversion system. Id. at 4:51–55.
2. Akerström
Akerström relates to an endocardial electrode arrangement having an
elongated electric conductor, an electrode head conductively connected to a
distal end of the conductor for applying stimulation pulses to the heart, and
means for placing the conductor or the electrode head on the heart wall.
Ex. 1015, 1:5–13. The distal end of the endocardial electrode arrangement is
shown in Figure 1, reproduced below.
IPR2020-00679
Patent 8,626,314 B2

43

Figure 1 illustrates the distal end of the endocardial electrode arrangement
that comprises electric conductor 1 provided with electric insulation
sheath 2. Id. at 2:15–16, 2:34–36. At the distal end of conductor 1,
electrode head 3 is disposed. Id. at 2:36–38.
To securely retain the electrode in its position in the heart, the
electrode includes loops 5 into which heart tissue can grow. Id. at 2:46–49.
Loops 5 are located in close proximity to electrode head 3 and mounted on
sleeve 6 slipped over insulation 2 of conductor 1. Id. at 2:46–50. As shown
in Figure 1, loops 5 are attached along a helical-shaped line. Id. at 2:50–51.
The loops can be fabricated from a soft, thin, body-fluid-resistant material,
such as polyester and polypropylene. Id. at 2:66–68. As loops 5 consist of a
soft, thin material, they rest closely against the electrode during insertion of
the electrode into a vein. Id. at 3:8–11.
3. Independent claim 1
a. Undisputed limitations (limitations 1.0–1.f and 1.h)
In regard to what Petitioner designates as limitation 1.0, Petitioner
contends that, to the extent the preamble is a limitation, Gerber, Hauser, and
Akerström disclose a system. Pet. 50. For limitation 1.a, which recites an
implantable medical lead, Petitioner argues Gerber discloses a single and
multi-polar implantable lead for sacral nerve electrical stimulation. Id. at 51
(citing Ex. 1012, Title, Abstract).
IPR2020-00679
Patent 8,626,314 B2

44
For limitation 1.b reciting a lead body, Petitioner argues “Gerber
discloses: ‘An implantable medical lead for stimulation of the sacral nerves
comprises a lead body which includes a distal end and a proximal end . . . .’”
Id. (quoting Ex. 1012, Abstract). In regard to limitation 1.c, which recites a
plurality of conductors within the lead body, Petitioner argues Gerber’s lead
body comprises at least one conductor wire within an insulating sheath. Id.
(citing Ex. 1012, 4:6–7).
Regarding limitation 1.d, which requires a plurality of electrodes, each
electrically connected to a conductor of the plurality of conductors,
Petitioner argues Gerber discloses multiple stimulation electrodes,
particularly two electrodes. Id. (citing Ex. 1012, Abstract, 1:57–58, 2:4–5,
4:32–33, claim 1, Fig. 3). Petitioner also argues that Gerber discloses
stimulation pulses are carried from the pulse generator through the lead body
to the distal having at least one electrode contact, and that each electrode
must be electrically connected to a conductor for there to be stimulation
pulses. Id. (citing Ex. 1003, 86–8714; Ex. 1012, 3:52–56).
For limitation 1.e, which requires a plurality of tine elements
positioned between a most proximal electrode and the proximal end of the
lead body, Petitioner argues Gerber discloses that an anchoring mechanism
is located between the most proximal electrode and the proximal end of the
lead body, and that the anchoring mechanism can provide for fibrosis. Id.

14 Mr. Pless’s testimony regarding limitation 1.d is on pages 86–87 of his
Declaration. We consider Petitioner’s citation to pages 87–88 for this
testimony to be a typographical error, and we understand Petitioner to be
citing pages 86–87.
IPR2020-00679
Patent 8,626,314 B2

45
at 52 (citing Ex. 1003, 8715; Ex. 1012, 4:13–30, Fig. 2). Petitioner further
argues a POSITA knows tines affix by fibrosis. Id. (citing Ex. 1003, 8716).
Petitioner also contends Hauser teaches fixation means 17, 19, which are
made up of multiple sets of tines and can be placed at various locations on
the lead as determined by the surgeon. Id. at 52–54 (citing Ex. 1003,
87–8817; Ex. 1014, Figs. 6, 12). Additionally, Petitioner asserts Akerström
teaches various arrangements of fixation loops, including an arrangement
where the loops are on several collars slipped on the insulation of the
conductor and spaced apart from each other. Id. at 54 (citing Ex. 1015,
2:56–59, Fig. 3). Per Petitioner, Akerström teaches the loops are of
sufficient stiffness to project above the surface of the electrode, and, as the
loops look like tines, a POSITA could arrange tines as shown in Akerström.
Id. (citing Ex. 1003, 9018; Ex. 1015, 3:6–8, 3:29–36, 3:52–55, Fig. 7).
In regard to limitation 1.f, which requires that each tine element
comprises a plurality of flexible, pliant tines extending outwardly of the lead
body and proximally toward the lead proximal end, Petitioner argues
Hauser’s fixation means 19 include a plurality of tine elements each made

15 Mr. Pless’s testimony regarding Gerber’s disclosure of limitation 1.e is on
page 87 of his Declaration. We consider Petitioner’s citation to page 88 for
this testimony to be a typographical error, and we understand Petitioner to be
citing page 87.
16 See supra note 15.
17 Mr. Pless’s testimony regarding Hauser’s disclosure of limitation 1.e is on
pages 87–89 of his Declaration. We consider Petitioner’s citation to
pages 88–89 for this testimony to be a typographical error, and we
understand Petitioner to be citing pages 87–88.
18 This testimony is on page 90 of Mr. Pless’s Declaration, not page 91. We
consider Petitioner’s citation to page 91 to be a typographical error, and we
understand Petitioner to be citing page 90.
IPR2020-00679
Patent 8,626,314 B2

46
up of a plurality of tines extending outwardly and proximally. Id. at 54
(citing Ex. 1003, 90–9119; Ex. 1014, Fig. 12). Petitioner also argues
Akerström teaches flexible, pliant loops extending outwardly and
proximally. Id. at 55 (citing Ex. 1003, 9120).
For limitation 1.h, which recites the plurality of tine elements are
separate from and axially spaced from the plurality of electrodes, Petitioner
argues Gerber’s anchoring mechanism is located separate from and spaced
apart from an electrode. Id. at 55–56 (citing Ex. 1003, 9221; Ex. 1012,
Fig. 2). Petitioner also argues Gerber discloses multiple electrodes. Id. at 56
(citing id. at 51).
Patent Owner does not dispute Petitioner’s contentions with respect to
what Petitioner designates as limitations 1.0–1.f and 1.h. Petitioner’s
arguments and Mr. Pless’s testimony find support in Gerber, Hauser, and
Akerström. Gerber discloses an implantable medical lead having a lead
body, a plurality of conductors, a plurality of electrodes that are each
electrically connected to a conductor of the plurality of conductors, and an

19 Mr. Pless’s testimony regarding Hauser’s disclosure of limitation 1.f is on
pages 90–91 of his Declaration. We consider Petitioner’s citation to
pages 91–92 for this testimony to be a typographical error, and we
understand Petitioner to be citing pages 90–91.
20 Mr. Pless’s testimony regarding Akerström’s disclosure of limitation 1.f is
on page 91 of his Declaration. We consider Petitioner’s citation to page 92
to be a typographical error, and we understand Petitioner to be citing
page 91.
21 Mr. Pless’s testimony regarding limitation 1.h is on page 92 of his
Declaration. We consider Petitioner’s citation to page 93 for this testimony
to be a typographical error, and we understand Petitioner to be citing
page 92.

IPR2020-00679
Patent 8,626,314 B2

47
anchoring mechanism located separate and axially displaced from an
electrode. Ex. 1012, Abstract, 3:39–42, 3:52–56, 4:6–7, 4:13–15, 4:32–33,
Figs. 2–3. Hauser teaches an electrode with proximal fixation means 19
made up of multiple sets of tines extending outwardly and proximally.
Ex. 1014, 4:3–8, Fig. 12. Akerström teaches an electrode arrangement
including flexible, proximally extending loops that are positioned on collars
spaced apart from each other. Ex. 1015, 2:56–59, 3:52–59, Fig. 3. In view
of the foregoing, Petitioner has persuasively identified what it designates as
limitations 1.0–1.f and 1.h in its proposed combination of Gerber, Hauser,
and Akerström.
b. Tines that are adapted to fold inward against the lead body
without overlap and deploy outward when the introducer is
withdrawn (limitation 1.g)
For limitation 1.g, which requires that the plurality of tines are
adapted to fold inwardly against the lead body without overlap when
constrained by a lumen of an introducer and deploy outwardly upon
withdrawal of the introducer, Petitioner contends Hauser’s “fixation
means 19 include pliant tines such that placement of the lead constrained
within the catheter would fold the tines inward against the lead body (Fig. 3)
and [the tines] would deploy laterally outward when released from the
catheter.” Pet. 55. Petitioner acknowledges Hauser does not explicitly teach
that the tines do not overlap, and contends Akerström teaches an
arrangement where the set of loops on the first collar fold inward against the
lead body without overlap. Id. (citing Ex. 1015, Fig. 3); Reply 12–13.
Patent Owner argues that Petitioner assumes Hauser’s fixation
means 19 are tines. PO Resp. 43; Sur-reply 10–11. Patent Owner further
argues that one cannot draw any conclusions about fixation means 19 from
IPR2020-00679
Patent 8,626,314 B2

48
Figures 3–5 because these figures do not show fixation means 19. PO
Resp. 43–44 (citing Ex. 2030 ¶¶ 96–99); Sur-reply 11.
We disagree with Patent Owner that Petitioner assumes Hauser’s
fixation means 19 are tines. Rather, Petitioner’s argument is based on Mr.
Pless’s testimony that fixation means 19 are tines. Pet. 52–53 (citing
Ex. 1003, 87–8822). Moreover, Hauser’s fixation means 19 have a similar
shape to tine elements 125, 130, 135, 140 in the ’314 patent and other tines,
such as Lindegren’s tine-like projections 12. Compare Ex. 1014, Fig. 12,
with Ex. 1001, Figs. 1–2; Ex. 1013, Fig. 3. Like tine elements 125, 130,
135, 140 in the ’314 patent and Lindegren’s tine-like projections 12,
Hauser’s fixation means 19 secure a lead in place in the body. Ex. 1001,
10:12–19; Ex. 1013, 7:18–27; Ex. 1014, 4:3–8. We also disagree with
Patent Owner that a POSITA would not draw inferences regarding Hauser’s
fixation means 19 from Figures 3–5. According to Hauser, Figures 3–5 are
“views during various stages of implantation of the electrode illustrated in
F[igure] 1” (Ex. 1014, 3:12–13), and Figure 1 shows an electrode with
fixation means 19 (id. at 4:3–8, Fig. 1). See also Reply 12 (citing Ex. 1022,
126:1–24 (Dr. Siegel testifying that Hauser’s Figures 3–5 are views of the
electrode of Figure 1)).
Patent Owner argues Petitioner’s proposed combination of the
references would not result in tines adapted to fold inward against the lead
body, as recited in limitation 1.g. PO Resp. 44–45. According to Patent
Owner, Hauser’s lead, which is equipped with fixation means 19 and fits
inside catheter 21, does not suggest that fixation means 19 are “adapted to be

22 See supra note 17.
IPR2020-00679
Patent 8,626,314 B2

49
folded inward against the lead body when fitted into and constrained by a
lumen of an introducer,” as recited in limitation 1g. Id. at 44 (citing
Ex. 2030 ¶¶ 96–99). Patent Owner also maintains that Hauser’s fixation
means would overlap, not fold against the lead body. Id. (citing Ex. 2030
¶ 100). Regarding Akerström, Patent Owner contends that loops and tines
are very different structures, and that loops folding against the lead body is
not the same thing as tines folding against the lead body. Id. at 45 (citing
Ex. 1015, 1:15–32; Ex. 2030 ¶¶ 94–95); Sur-reply 12.
We agree with Patent Owner that Hauser’s fixation means 19 are not
adapted to be folded inwardly against the lead body because the tines would
overlap and thus be folded inwardly against each other, not the lead body.
See Ex. 1014, Fig. 12 (showing the length of the tines of fixation means 19
being longer than the proximal spacing between the tines). In view of
Hauser’s Figure 12, we credit Dr. Siegel’s testimony that “if fixation means
19 were bent or folded, they could not lie against the lead body because
(except for the last two projections) the adjacent projections would interfere
with folding against the lead body.” Ex. 2030 ¶ 100.
Nonetheless, Patent Owner’s argument that Hauser’s fixation
means 19 are not adapted to be folded inwardly against the lead body and its
remaining arguments address Hauser and Akerström individually, whereas
Petitioner is relying on their combined teachings to result in the subject
matter of limitation 1.g. “[T]he test for obviousness is what the combined
teachings of the references would have suggested to those having ordinary
skill in the art.” See In re Mouttet, 686 F.3d 1322, 1333 (Fed. Cir. 2012)
(emphasis added) (citing In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981)).
It matters not whether either Hauser’s fixation means 19 or Akerström’s
IPR2020-00679
Patent 8,626,314 B2

50
loop arrangement teaches tines that are adapted to fold inwardly against the
lead body because Petitioner is relying on its proposed combination of
Hauser and Akerström in which Hauser’s fixation means 19 are arranged
like Akerström’s loops. See Pet. 50 (arguing it would have been obvious to
use “multiple tined anchors, as taught in Hauser, and further to arrange such
tines in accordance with the array design taught in Akerstr[ö]m” (citation
omitted)), 55 (“Akerstr[ö]m[’s] design from Figure 3 can be applied to
Hauser’s tine sets.” (citation omitted)); Reply 12–13 (“[T]he Petition shows
that Akerstr[ö]m teaches a design arrangement where the loops are adapted
to be folded inward against the lead body without overlapping each other,
and that tines of Hauser could be arranged in Akerstr[ö]m’s design array.”
(citations omitted)). Hauser’s fixation means 19 include a plurality of tine
elements. Ex. 1014, Fig. 12. Akerström teaches an arrangement of loops
that rest against the surface of an electrode during insertion of the electrode
in a vein. Ex. 1015, 3:8–11, 3:52–59, Fig. 3. Petitioner has shown that
combining the teachings of Hauser’s fixation means 19 and Akerström’s
loop arrangement would result in a plurality of tine elements that are adapted
to be folded inward against the lead body when the lead is fitted into an
introducer, as limitation 1.g requires.
Patent Owner also argues that Petitioner’s proposed combination of
the references would not result in tines adapted to fold without overlap, as
limitation 1.g requires, because no reference teaches non-overlapping tines.
PO Resp. 54–55. Patent Owner, however, addresses the references
individually when Petitioner relies on their combined teachings. Hauser’s
fixation means 19 include a plurality of tine elements (Ex. 1014, Fig. 12),
and Akerström teaches an arrangement of loops that rest against the surface
IPR2020-00679
Patent 8,626,314 B2

51
of an electrode without overlap. Ex. 1015, 3:8–11, 3:52–59, Fig. 3.
Petitioner has demonstrated that combining the teachings of Hauser’s
fixation means 19 and Akerström’s loop arrangement would result in a
plurality of tine elements that are adapted to be folded without overlap.
After considering the parties’ arguments and evidence, Petitioner has
persuaded us that its proposed combination of Gerber, Hauser, and
Akerström would result in a plurality of tines that are adapted to fold
inwardly against the lead body without overlap when constrained by a lumen
of an introducer and deploy outwardly upon withdrawal of the introducer, as
limitation 1.g requires. Petitioner has shown limitation 1.g was reasonably
suggested by its proposed combination of Gerber, Hauser, and Akerström.
c. Reasons for combining the teachings
Petitioner maintains a POSITA would have modified Gerber’s
multi-electrode lead to have Hauser’s tined anchors arranged on collars
according to Akerström’s array design. Pet. 49–50. Petitioner argues that
Gerber discloses a multi-electrode lead with a proximal anchoring
mechanism that anchors by fibrosis, and that a POSITA would have
considered tines a leading candidate among the limited number of devices
that anchor by fibrosis. Id. at 49 (citing Ex. 1003 ¶ 107). Petitioner also
argues that Akerström’s arrangements of loops for anchoring by fibrosis are
applicable to tines, and that Akerström’s arrangement shown in Figure 3,
which has repeated sets of multiple loops extending from a collar without
overlap, allows for easy manufacturing, adaptation to the needs of the
stimulation site, and a smaller profile which is suited to percutaneous
delivery. Id. (citing Ex. 1003 ¶ 105). Petitioner further maintains “it would
have been obvious to a POSITA to improve anchoring within the soft tissue
IPR2020-00679
Patent 8,626,314 B2

52
near the sacrum to use multiple[] tined anchors, each mounted on collars (i.e.
tine elements) to affix by fibrosis.” Id.
Patent Owner contends Petitioner’s reasoning for combining the
teachings of Gerber, Hauser, and Akerström “is based on a hindsight driven
compilation of claim elements from the prior art references that a POSITA
would have had no reason to combine.” PO Resp. 46 (citing Ex. 2030
¶¶ 101–132). In particular, Patent Owner argues Petitioner has not shown
that a POSITA would have replaced Gerber’s anchoring mechanism with a
plurality of tines as recited in limitation 1.e, much less proximally extending
tines that are adapted to be folded inwardly against the lead body without
overlap as recited in limitations 1.f and 1.g. Id. at 45–46, 48–60;
Sur-reply 12–16.
Regarding the reasoning for replacing Gerber’s anchoring mechanism
with tines, such as those in Hauser, Patent Owner argues Petitioner fails to
provide evidence that the use of tines would improve anchoring of Gerber’s
lead. PO Resp. 49; Sur-reply 14. According to Patent Owner, Gerber’s
disclosure of an implantable electrical lead that allows for some movement
after implantation obviates the need for improved anchoring. PO Resp. 49
(citing Ex. 1012, 2:4–6, 2:9–17, 2:56–63, 3:39–58; Ex. 2030 ¶¶ 70–73);
Sur-reply 15. Patent Owner also argues: “Gerber is not suggesting fibrosis
as a standalone fixation mechanism; it is instead suggesting that the other
disclosed anchoring mechanisms (namely, the bone screws or sutures; see
Ex. 1012, 4:12-31) would become more fixated in the body over time due to
fibrosis.” PO Resp. 50 (citing Ex. 2030 ¶¶ 77–80, 111). Patent Owner
further argues there is no factual support for Petitioner’s allegation that tines
were a leading candidate among the limited number of devices that anchor
IPR2020-00679
Patent 8,626,314 B2

53
by fibrosis. Id.; Sur-reply 14. Per Patent Owner, introducing any foreign
body into a place where fibrosis can occur will result in fibrosis, and
Akerström teaches that loops are better at allowing tissue ingrowth than
tines. PO Resp. 50–51 (citing Ex. 1012, 4:27–30; Ex. 2030 ¶ 108). Patent
Owner additionally contends Petitioner provides no evidence that a POSITA
would have expected tines to work in Gerber’s anatomy. Id. at 51–52;
Sur-reply 14–15. Rather, according to Patent Owner, a POSITA would not
have expected tines to work with Gerber’s implantation procedure because
the periosteum and the soft tissues surrounding the implantation site are
dissected during the procedure, leaving them compromised of structural
integrity and unsuitable for tines to affix thereto. PO Resp. 52 (citing
Ex. 1012, 5:32–6:1, Fig. 6; Ex. 2030 ¶¶ 81, 105–107, 114–115);
Sur-reply 14–15.
In regard to the reasoning for arranging Hauser’s tines according to
Akerström’s arrangement so that the tines extend proximally and are adapted
to be folded inwardly against the lead body without overlap, Patent Owner
argues there would have been no motivation to include, in Gerber’s lead,
such an arrangement of tines. PO Resp. 55–58 (citing Ex. 2030
¶¶ 123–126); Sur-reply 15–16. Patent Owner contends that Petitioner’s
reasoning for applying Akerström’s arrangement—i.e., ease of
manufacturing and a smaller profile for the lead—does not explain why a
POSITA would have combined the teachings of the references to result in
tines that are adapted to be folded inward against the lead body without
overlap. PO Resp. 45–46, 56–57. Patent Owner also contends that Hauser
illustrates fixation means projecting in both the proximal and distal
directions (PO Resp. 58 (citing Ex. 1014, Figs. 1, 12)), and that Hauser
IPR2020-00679
Patent 8,626,314 B2

54
provides no guidance to a POSITA regarding the appropriate orientation for
the tines (id. (citing Ex. 2030 ¶¶ 127–132)).
Petitioner replies that it is incorrect for Patent Owner to consider the
intended purpose of Gerber’s lead. Reply 14. This assertion is similar to
Petitioner’s argument that it is incorrect to consider the intended purpose of
Young’s lead when determining motivation to combine because the proper
inquiry is whether the proposed combination would achieve what is in the
’314 patent claims. See id. (referencing the arguments regarding the
motivation to combine to the teachings of Young, Gerber, and Lindegren).
As we explain above in section III.C.4.c, Petitioner conflates the separate
requirements of motivation to combine and reasonable expectation of
success. Although an unclaimed purpose is irrelevant to reasonable
expectation of success, it may be pertinent to motivation to combine. See
Intelligent Bio–Sys., 821 F.3d at 1367–68 (explaining that, unlike reasonable
expectation of success, motivation to combine does not contemplate the
scope of the claimed invention).
Petitioner also replies that we should give Dr. Siegel’s testimony, on
which Patent Owner’s arguments are based, very little, if any, weight.
Reply 13–14. Per Petitioner, Dr. Siegel never analyzed the claims of the
’314 patent, and his entire Declaration rests on the incorrect premise that the
claims are limited to sacral neuromodulation. Id. (citing Ex. 1022, 94:2–13,
99:5–22, 111:14–19). Petitioner further alleges that Dr. Siegel’s
independence is questionable because he has been a consultant for Patent
Owner in many other proceedings. Id. at 13–14 n.7.
Beginning with Dr. Siegel’s independence, we take into account that
Dr. Siegel has consulted for Patent Owner, but we disagree that Dr. Siegel’s
IPR2020-00679
Patent 8,626,314 B2

55
relationship with Patent Owner depreciates his testimony. Patent Owner
retained Dr. Siegel to testify regarding Petitioner’s asserted obviousness
based on Gerber, Hauser, and Akerström (Ex. 2030 ¶ 1), and Gerber is
assigned to Patent Owner (Ex. 1012, code (73)). Patent Owner also retained
Dr. Siegel to testify regarding Patent Owner’s InterStim system. Ex. 2030
¶ 1. Dr. Siegel’s familiarity with Patent Owner’s technologies is pertinent to
the nature of his testimony. Moreover, Dr. Siegel testifies that “[m]y
compensation is not contingent upon the outcome of this matter or the
specifics of my testimony.” Id. ¶ 2. We also disagree with Petitioner that
we should grossly discount his testimony for lacking an understanding of the
claims of the ’314 patent. Dr. Siegel’s testimony on which Patent Owner
relies regards whether a POSITA would have added tines to Gerber’s lead as
Petitioner proposes. As we explain above, motivation to combine is a
question disparate from the claimed invention. See Intelligent Bio–Sys., 821
F.3d at 1367–68 (explaining that, unlike reasonable expectation of success,
motivation to combine does not contemplate the scope of the claimed
invention).
With this, we turn to Petitioner’s reasoning for combining the
teachings of Gerber, Hauser, and Akerström. With respect to Petitioner’s
reasoning for replacing Gerber’s anchoring mechanism with tines, contrary
to Patent Owner’s arguments regarding improved anchoring, Petitioner does
not contend that a POSITA would have added tines to Gerber’s lead to more
securely affix the lead within the body. Rather, Petitioner contends a
POSITA would have added tines to Gerber’s lead because Gerber suggests
anchoring its lead by fibrosis, for which tines are a leading candidate. See
Pet. 49 (“Gerber discloses a multi-electrode lead with a proximal anchoring
IPR2020-00679
Patent 8,626,314 B2

56
mechanism that anchors by fibrosis instead of the depicted suture sleeve
(Fig. 2). . . . [A] POSITA would have considered tines, a leading candidate
among the limited number of devices that anchor by fibrosis.”); see also Tr.
13:11–14 (Petitioner arguing “Gerber expressly suggests fixation mechanism
by fibrosis and the most predominant use or the common use of that to
actually fixate implantable medical leads by fibrosis was tines by the late
1990s”).
Gerber indeed suggests anchoring its lead by fibrosis. Namely,
Gerber discloses: “Yet another anchoring mechanism 50 is to allow the
medical lead 10 to fibrose in naturally using the human body’s natural
reaction to a foreign body or healing.” Ex. 1012, 4:27–30. Moreover, there
is no dispute that tines secure via fibrosis. Petitioner, however,
acknowledges that any foreign object introduced into the body will cause
fibrosis. Tr. 12:8–13.
Nonetheless, Petitioner maintains that Gerber’s disclosure of securing
its lead by fibrosis would have led a POSITA to choose tines because tines
were a leading candidate among the devices that anchor by fibrosis. Pet. 49
(citing Ex. 1003 ¶ 107) (emphasis added). Petitioner’s argument relies on
Mr. Pless’s opinion that tines were a leading candidate for securement via
fibrosis, and Mr. Pless’s opinion is based his review of the conventional uses
of tines. Tr. 12:18–24 (Petitioner explaining that pages 13–16 of Mr. Pless’s
Declaration provide support for his opinion that tines were most commonly
used for fixation via fibrosis). According to Mr. Pless, “[b]efore 2001, tines
were the most commonly used passive fixation, especially due to the
predominant usage of tines in the cardiac space. Tines help to anchor the
IPR2020-00679
Patent 8,626,314 B2

57
lead immediately after implantation by engaging with the body tissue, and
then by fibrosis.” Ex. 1003, 15.
Gerber’s lead, however, is for sacral nerve stimulation and is
implanted in the sacral area via an open surgical procedure. Ex. 1012,
1:7–15, 5:32–39. We find credible Dr. Siegel’s testimony that Gerber’s
device is implanted via an open surgical procedure in which the periosteum
and soft tissues surrounding the implantation site are dissected,
compromising their structural integrity and rendering tines, which initially
anchor by engaging body tissue, ineffective. Thus, despite the prevalent use
of tines in the cardiac space to secure leads by engaging body tissue and then
by fibrosis, Petitioner has not persuaded us that Gerber’s disclosure of
securing its lead by fibrosis would have led a POSITA to replace Gerber’s
anchoring mechanism with tines.
Regarding Petitioner’s reasoning for positioning tines according to
Akerström’s arrangement, Lindegren attributes a manufacturing preference
to tines integrally formed and evenly spaced on rings, not proximally
extending tines that are adapted to be folded inwardly against the lead body
without overlap. Ex. 1013, 5:17–20 (“From the manufacturing point of
view, having the projections devised as an integral part of a one-piece ring-
shaped means and evenly distributed around the circumference of the
ring-shaped means, should be preferable.”). Moreover, according to
Petitioner, a smaller profile is suited to percutaneous delivery (Pet. 49), but
Gerber’s lead is implanted via an open surgical procedure (Ex. 1012, 1:7–15,
5:32–39). Accordingly, Petitioner has not persuaded us that a POSITA
would have had a reason to include, in Gerber’s lead, Hauser’s tines situated
according to Akerström’s arrangement.
IPR2020-00679
Patent 8,626,314 B2

58
d. Conclusion of independent claim 1
Petitioner has demonstrated each limitation of independent claim 1 in
its proposed combination of Gerber, Hauser, and Akerström. Petitioner,
however, has not persuaded us that a POSITA would have had a reason to
combine the teachings of these references as Petitioner proposes. Even
without Patent Owner’s proffered objective indicia of non-obviousness (PO
Resp. 60–71; Sur-reply 16–30), Petitioner has not shown, by a
preponderance of the evidence, that the subject matter of independent
claim 1 would have been obvious over combined teachings of Gerber,
Hauser, and Akerström.
4. Independent claims 11 and 18
Petitioner relies on the same reasoning for combining the teachings of
Gerber, Hauser, and Akerström to result in the subject matter of independent
claims 11 and 18 as for combining the teachings of these references to result
in the subject matter of independent claim 1. Pet. 48–50. For the reasons
discussed above in section III.E.3.c, Petitioner’s reasons are not persuasive.
Even without Patent Owner’s proffered objective indicia of non-obviousness
(PO Resp. 60–71; Sur-reply 16–30), Petitioner has not shown, by a
preponderance of the evidence, that the subject matter of independent
claims 11 and 18 would have been obvious over combined teachings of
Gerber, Hauser, and Akerström.
5. Dependent claims
For the reasons discussed above in sections III.E.3.c and III.E.4,
Petitioner has not persuaded us that a POSITA would have had a reason to
combine the teachings of Gerber, Hauser, and Akerström to result in the
subject matter of independent claims 1, 11, and 18, from which claims 2, 4,
IPR2020-00679
Patent 8,626,314 B2

59
7, 10, 12, 14, and 19–24 depend. Even without Patent Owner’s proffered
objective indicia of non-obviousness (PO Resp. 60–71; Sur-reply 16–30),
Petitioner has not shown, by a preponderance of the evidence, that the
subject matter of dependent claims 2, 4, 7, 10, 12, 14, and 19–24 would have
been obvious over combined teachings of Gerber, Hauser, and Akerström.

IV. CONCLUSION
Claims
35
U.S.C.
§
References
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1, 2, 4, 7,
10–12, 14,
18–24
103(a) Young, Gerber, Lindegren
1, 2, 4, 7,
10–12, 14,
18–24
18, 20, 21 103(a) Young, Gerber, Lindegren, Hauser 18, 20, 21
1, 2, 4, 7,
10–12, 14,
18–24
103(a) Gerber, Hauser, Akerström
1, 2, 4, 7,
10–12, 14,
18–24
Overall
Outcome
1, 2, 4, 7,
10–12, 14,
18–24

V. ORDER
In consideration of the foregoing, it is:
ORDERED that claims 1, 2, 4, 7, 10–12, 14, and 18–24 of the ’314
patent have not been shown to be unpatentable, and
FURTHER ORDERED that, as this is a Final Written Decision, a
party seeking judicial review of the Decision must comply with the notice
and service requirements of 37 C.F.R. § 90.2.
IPR2020-00679
Patent 8,626,314 B2

60
For PETITIONER:

A. James Isbester
Babak S. Sani
KILPATRICK TOWNSEND & STOCKTON LLP
jisbester@kilpatricktownsend.com
bsani@kilpatricktownsend.com

For PATENT OWNER:

Naveen Modi
Chetan R. Bansal
PAUL HASTINGS LLP
naveenmodi@paulhastings.com
chetanbansal@paulhastings.com