Boston Scientific Neuromodulation Corp.

Patent Trials and Appeals Board

Jan 19, 2021

IPR2019-01341 (P.T.A.B. Jan. 19, 2021)

Trials@uspto.gov Paper No. 42
571-272-7822 Entered: January 19, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

NEVRO CORP.,
Petitioner,
v.
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION,
Patent Owner.

IPR2019-01341
Patent 8,682,447 B2

Before MICHAEL W. KIM, Vice Chief Administrative Patent Judge,
ROBERT A. POLLOCK, and JASON W. MELVIN, Administrative Patent
Judges.
MELVIN, Administrative Patent Judge.

JUDGMENT
FINAL WRITTEN DECISION
Determining Some Challenged Claims Unpatentable
35 U.S.C. § 318(a)

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I. INTRODUCTION
Petitioner, Nevro Corp., filed a Petition (Paper 2, “Pet.”) requesting
inter partes review of claims 1, 3, 5–7, and 9 (“the challenged claims”) of
U.S. Patent No. 8,682,447 B2 (Ex. 1001, “the ’447 patent”). Patent Owner,
Boston Scientific Neuromodulation Corp.,1 timely filed a Preliminary
Response. Paper 6. We instituted review of the challenged claims. Paper 7.
Patent Owner filed a Response. Paper 21 (“PO Resp.”). Petitioner
filed a Reply. Paper 30 (“Pet. Reply”). Patent Owner filed a Sur-Reply.
Paper 32 (“PO Sur-Reply”). We held a hearing on November 10, 2020, and
a transcript appears in the record. Paper 41 (“Tr.”).
This is a final written decision as to the patentability of the challenged
claims. For the reasons discussed below, we determine Petitioner has shown
by a preponderance of the evidence that claim 1, 3, 5, 6, and 9 are
unpatentable, but has now shown that claim 7 is unpatentable.
A. THE ’447 PATENT
The ’447 patent relates to neurostimulation systems, such as for
spinal-cord stimulation. Ex. 1001, 1:15–16. It addresses the need for
verifying the position of electrode leads. Id. at 1:20–52. The ’447 patent
describes two techniques for determining orientation of an electrode on one
lead relative to electrodes on another lead—measuring interelectrode
impedance and measuring field potentials. Id. at 1:44–52, 3:9–14. Figure 1
of the ’447 patent is reproduced below:

1 Patent Owner is a wholly owned subsidiary of Boston Scientific Corp.,
which Patent Owner identifies as a real party in interest. Paper 4, 2.
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Figure 1 depicts a neurostimulation system, as used in the ’447 patent,
containing implantable pulse generator (IPG) 40 connected to first
implantable lead 20 with a series of in-line electrodes, E1 through E8, and
second implantable lead 30 with a series of in-line electrodes, E9 through
E16. Id. at 3:15–37. Each electrode may be individually selected to receive
an electrical stimulus from the IPG. Id. at 3:38–58. The IPG may source or
sink current having a desired amplitude through a given electrode, and also
may measure an electrode’s voltage, regardless of whether current is flowing
through the electrode. Id. at 4:50–65.
To measure electrode relative locations, the described system can
measure impedance vectors—the impedance values between pairs of
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electrodes in the body. Id. at 6:23–39. The ’447 patent also describes an
alternative technique for determining relative electrode positions, using
electric field measurements of the electrodes. Id. at 7:51–9:8. Once
determined, relative electrode locations “may be used to track lead
migration, to setup stimulation configurations and parameters for nominal
stimulation and/or navigation, and to automatically adjust stimulation energy
to a previously-defined optimal potential field in the case of lead migration
or postural changes.” Id. at 9:8–13.
B. CHALLENGED CLAIMS
Challenged claim 1 is independent and is reproduced below:
1. A method, comprising:
determining, using circuitry, a relative two-dimensional
orientation of first and second multiple-electrode leads
implanted within a user;
conveying electrical stimulation energy from a pulse
generator implanted within the user into tissue of the
user via the first and second multiple-electrode leads;
and
displaying the relative two-dimensional orientation of the
first and second multiple-electrode leads.
Id. at 10:51–59. Claims 3, 5–7, and 9 each directly depend from claim 1. Id.
at 10:66–11:38.
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C. PRIOR ART AND ASSERTED GROUNDS
Petitioner asserts the following grounds of unpatentability:
Claims Challenged 35 U.S.C. § References
1, 3, 5, 9 1032 Barreras,3 Swanson4
6, 7 103 Barreras, Swanson, Meadows5
Pet. 4. Petitioner also relies on the Declaration of Dr. Mark Kroll (Ex. 1003).
See generally Pet. 2–57 (citing Dr. Kroll’s Declaration throughout).
II. ANALYSIS
A. LEVEL OF ORDINARY SKILL IN THE ART
Petitioner submits that a person of ordinary skill in the art at the time
of invention would have had “(1) at least a bachelor’s degree in electrical
engineering, biomedical engineering, or equivalent coursework, and (2) at
least one year of experience researching or developing implantable medical
devices.” Pet. 15 (citing Ex. 1003 ¶¶ 15–18). Petitioner further submits that
such a person “would have had general knowledge of implantable medical
devices and various related technologies as of December 4, 2001.” Id. (citing
same). Patent Owner adopts Petitioner’s definition of a skilled artisan.
PO Resp. 6. We agree that Petitioner’s definition of the level of ordinary

2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
(2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became
effective after the filing of the application that led to the ’447 patent.
Therefore, we apply the pre-AIA version of 35 U.S.C. § 103.
3 US 5,895,416, issued Apr. 20, 1999 (Ex. 1005).
4 US 5,876,336, issued Mar. 2, 1999 (Ex. 1006).
5 WO 02/09808 A1, published Feb. 7, 2002, filed July 26, 2000 (Ex. 1007).
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skill in the art reflects the disclosures of the ’447 patent and the prior art at
issue, and therefore adopt it.
B. CLAIM CONSTRUCTION
For an inter partes review petition filed after November 13, 2018, we
construe claim terms “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).
Petitioner asserts that the terms in the challenged claims should
receive their plain meaning and that none requires an express construction.
Pet. 15–16. Patent Owner agrees that no term requires express construction.
PO Resp. 6–7. We agree that no express constructions are required to
resolve the unpatentability issues before us. See Nidec Motor Corp. v.
Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017);
Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
1999).
C. DECLARATION SUPPORT
Patent Owner criticizes Petitioner’s reliance on a declaration that
follows the language of the Petition. PO Resp. 19–21. We do not agree that
the declaration should be afforded no weight simply because it and the
Petition contain the same assertions. Rather, such a declaration lends the
declarant’s credibility to factual assertions. To be sure, a declaration
inadequately supporting a particular assertion will not automatically help
establish that assertion. See 37 C.F.R. § 42.65(a) (“Expert testimony that
does not disclose the underlying facts or data on which the opinion is based
is entitled to little or no weight.”). Thus, our determinations regarding the
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contested issues include determining whether the record supports
Petitioner’s and its declarant’s contentions.
D. UNPATENTABILITY OVER BARRERAS AND SWANSON
Barreras describes a method and apparatus for electrically stimulating
nerve tissue using implanted electrodes. Ex. 1005, 1:8–27. Barreras includes
embodiments with multiple leads, each with multiple electrodes. Id. at 5:6–
30, Figs. 5, 6. An implanted stimulator can assign individual electrodes as
positive (an anode) or negative (a cathode) to create the desired stimulation
field. Id. at 5:6–30. Barreras refers to that approach as field steering. Id. at
code (57), 1:7–27. Further, Barreras discloses a technique of measuring
electrode impedance and using it to determine the applied voltage, thus
maintaining a desired stimulation pattern. Id. at 2:60–65, 8:22–34.
Barreras additionally describes a mechanical steering system, used by
a physician to achieve the desired positioning when implanting the
electrodes. Ex. 1005, 2:18–31, 3:15–24. The system allows the physician to
guide a lead’s distal end to navigate away from obstacles and achieve the
desired final implantation position. Id.
Swanson describes “systems and methods for guiding or locating
diagnostic or therapeutic electrode elements in the interior regions of the
body.” Ex. 1006, 1:13–15. To guide an electrode such as an ablation probe
relative to another electrode, such as one that is part of a mapping probe
having electrodes 24, Swanson uses “processing element 48 electrically
coupled to the mapping probe 14 and the ablation probe 16.” Id. at 6:61–63.
Swanson’s processing element “collects and processes information regarding
the location of the ablation probe 16 within the space 22 defined by the
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basket structure 20, in term of its position relative to the position of the
electrodes 24.” Id. at 6:63–67. Swanson’s Figure 1 is reproduced below:

Swanson’s Figure 1 depicts system 10 with processing element 48
electrically coupled to ablation probe 16 and mapping probe 14, which has
electrodes 24 making up basket structure 20. Ex. 1006, 6:61–67, Fig. 1.
Swanson discloses multiple modes of operation to determine the
relative position of the ablation and mapping probes. Petitioner relies on
Swanson’s impedance-sensing mode, in which the processor measures the
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impedance between the ablation electrode and the electrodes on the mapping
probe. Id. at 15:27–16:41.
1. Claim 1
Petitioner relies on Barreras’s stimulation system, modified to use
Swanson’s method of determining and displaying lead orientation. Pet. 30–
40. Petitioner notes that Barreras includes a mechanical steering system to
help position the electrode leads during implantation. Id. at 27 (citing
Ex. 1005, 2:18–31, 3:14–24). Thus, reasons Petitioner, “[a] physician
engaged in attempting to mechanically steer the leads upon initial insertion
would thus clearly benefit from knowing the relative orientation of the
second lead to be implanted relative to first implanted lead.” Id. at 27–28
(citing Ex. 1003 ¶¶ 66–67).6 In light of the similarities between Barreras’s
need for guiding an electrode lead and Swanson’s ability to help guide such
leads, Petitioner asserts that skilled artisans would have improved Barreras’s
system with Swanson’s method. Id. at 28–29 (“The use of Swanson’s
method for determining and displaying the relative two-dimensional
orientation of an implanted, multi-electrode cardiac ablation lead relative to
a plurality of implanted, multi-electrode, mapping leads would have been
applicable in improving Barreras’s mechanical steering embodiment.”).
a. Reason to combine
Patent Owner challenges whether skilled artisans considering
Barreras’s device would have had reason to incorporate Swanson’s teachings

6 Petitioner argues further that “a physician adjusting the programming
would benefit from knowing whether and how the leads had shifted over
time, allowing more precise programming of the device.” Id. at 28 (citing
Ex. 1003 ¶¶ 67–68).
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as asserted by Petitioner. PO Resp. 18–50. Patent Owner asserts that
“Barreras itself contains no teaching, motivation, or suggestion to modify its
device to use circuitry to determine lead orientation.” PO Resp. 21. In
particular, Patent Owner contends that, without any identified deficiency in
Barreras, Petitioner has no support for the contention that the combination
would have improved Barreras. Id. at 21–22. Patent Owner focuses on
Barreras’s constant-current approach, which maintains the desired
stimulation field without measuring impedance, and points out that Barreras
does not measure electrode impedance in order to maintain the stimulation
field. See id. at 23–28. Petitioner asserts, however, that capability in Barreras
is not required. See Pet. Reply 11. Rather, Petitioner notes that Barreras
recognizes the significance of impedance on field measurements. Pet. 27
(citing Ex. 1005, 2:13–17, 2:60–65, 8:22–34). Petitioner points to Barreras’s
recognition that correctly placing leads during implantation poses a
challenge to physicians. Id. (citing Ex. 1005, 2:18–31). Thus, reasons
Petitioner, “knowing the relative orientation of the second lead to be
implanted relative to [the] first implanted lead” would have offered a distinct
benefit to physicians. Id. at 27–28. In Petitioner’s asserted combination, that
benefit would have come from using Swanson’s measurement system. See
id. at 28–29.
Barreras need not have identified the claimed solution, which is
disclosed in Petitioner’s asserted combination. As set forth by Petitioner,
Barreras’s disclosures support Petitioner’s reasoning because Barreras
identifies both the relationship of impedance to lead positioning and the need
for accuracy in initial lead placement. Ex. 1005, 2:6–31. Petitioner contends
that Swanson’s method for determining relative lead orientation “would
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have been applicable in improving Barreras’s mechanical steering
embodiment.” Pet. 29.
Patent Owner challenges Swanson’s applicability, reasoning that
Swanson’s cardiac-ablation electrodes, designed for a homogeneous blood
pool, would not have worked in the heterogeneous spinal tissues targeted
with Barreras’s device. PO Resp. 29–44. Petitioner, on the other hand,
contends that the challenged claims do not require any degree of precision,
and that any positioning uncertainty therefore would not impact how the
claims read on the proposed combination. Pet. Reply 8–9. Petitioner points
out that Patent Owner’s declarant confirmed during his deposition that,
within the heterogeneous epidural space, Swanson’s approach would permit
general, relative positioning, due to impedance between two electrodes
decreasing as they get closer together. Pet. Reply 6–9 (citing Ex. 1010,
107:6–113:13). Patent Owner characterizes that view as overly simplified
and failing to recognize the complexity introduced by heterogeneous tissue.
PO Sur-Reply 8–9.
Patent Owner contends that the ’447 patent corrects for the
confounding effects of heterogeneous tissue. PO Resp. 34 (citing Ex. 1001,
6:35–7:34, 7:66–8:3). Significantly, however, that description includes
measuring monopolar impedances to correct bipolar impedances. Ex. 1001,
6:65–7:9 (“The monopolar impedances are used to ‘correct’ the bipolar
impedances for the first factor of bulk impedance, the strongly-weighted
impedance near the electrode”). Although the ’447 patent’s Specification
discloses using monopolar impedances to measure and correct for
heterogeneous tissues, that technique does not appear in the challenged
claims. See Pet. Reply 10. Thus, we agree with Petitioner that the claims do
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not incorporate the Specification’s description of correcting for
heterogeneous tissue.
Although the claims do not require correcting for heterogeneous
tissue, the differences between Barreras’s and Swanson’s applications may
demonstrate that skilled artisans would not have made the asserted
combination. See Intelligent Bio-Sys. Inc. v. Illumina Cambridge Ltd., 821
F.3d 1359, 1368 (Fed. Cir. 2016) (holding that a difference between prior art
references, although not within a claimed requirement, may nonetheless
show a lack of motivation to combine). Indeed, Patent Owner stresses that,
even though the claims do not require a particular degree of precision, the
differences between Barreras’s and Swanson’s applications are important
considerations that would have counseled against the asserted combination.
PO Sur-Reply 5. In Patent Owner’s view, Swanson’s techniques could not
have improved Barreras’s device because those techniques were limited to
operating in a blood pool. PO Resp. 35–39; PO Sur-Reply 10.
We are persuaded by Petitioner’s position. As an initial note, Patent
Owner does not contend that Swanson is nonanalogous art. See Tr. 30:16–
26, 33:8–17. The disputed issue therefore relates to how Swanson’s
teachings would have benefited Barreras’s device. Although Swanson
describes operation in a blood pool, Petitioner has established that
Swanson’s technique would have been able to determine relative electrode
position when applied to Barreras’s device. See Ex. 1003 ¶¶ 67, 69, 72, 81;
Ex. 1010, 110:6–18, 112:9–113:9. Stated otherwise, the uncertainty
introduced by heterogeneous tissue does not undermine Swanson’s
technique, which would still have provided a benefit during implantation of
Barreras’s device.
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We agree with Petitioner that Barreras’s emphasis on the importance
of placing its electrodes during implantation would have given skilled
artisans reason to look at techniques to improve the implantation process.
See Ex. 1005, 2:24–31. Swanson teaches a method of determining relative
electrode position and we find any constraints of that method would not
have overcome motivation for skilled artisans to use Swanson’s teachings in
Barreras.
We note that Patent Owner at times makes a distinction that the
challenged claims require determining electrode position in an “implanted”
device. See PO Sur-Reply 6. Petitioner takes the position that Barreras’s lead
is “implanted” once placed in a patient’s body, while being advanced to the
final position. See Tr. 6:1–25. And Patent Owner agrees that the term does
not exclude initial implantation. Id. at 26:3–18 (agreeing that the claim
language does not rule out Petitioner’s motivation-to-combine argument
based on initial implantation). Indeed, the ’447 patent expressly
contemplates positioning during initial implantation. Ex. 1001, 2:19–25
(“verify the position of the leads at numerous times during the lifetime of the
implanted leads, e.g., during initial implantation and programming”). Thus,
any distinction Patent Owner draws based on whether Barreras’s device has
been fully implanted or is merely within a patient’s body is not persuasive.
Patent Owner contends that the use of mechanical steering by both
Barreras and Swanson is insufficient reason to combine their teachings.
PO Resp. 48–50. We agree that the common ability for mechanical steering
by itself may not be sufficient to show that skilled artisans would have made
the combination. But that was not all Petitioner relied on. Rather, as
discussed above, the desire to place Barreras’s electrodes with accuracy
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would have motivated using techniques that could have improved that aspect
of Barreras. Barreras’s emphasis on steering is significant not simply
because it is a parallel capability to Swanson, but because it expressly
highlighted an area that would have benefited from improvement. We
conclude that Petitioner has established that skilled artisans would have had
reason to address Barreras’s need for accurate initial placement by
supplementing Barreras’s system with Swanson’s teachings.
b. Expectation of success
Patent Owner challenges additionally whether skilled artisans would
have had a reasonable expectation of success, with the “determining” step,
when combining Barreras and Swanson as Petitioner asserts. PO Resp. 29–
48. In ways, the argument blends with Patent Owner’s challenge to whether
skilled artisans would have had reason to combine the references. Patent
Owner agrees, however, that a reasonable expectation of success must be
shown only to the extent of the claim scope. See Tr. 23:20–22, 25:18–21.
Thus, Petitioner need show only that skilled artisans would have had a
reasonable expectation of achieving what is claimed—“determining, using
circuitry, a relative two-dimensional orientation of first and second multiple-
electrode leads implanted within a user.”
Patent Owner contends Swanson’s teachings would not have worked
in the heterogeneous tissue targeted by Barreras. See PO Resp. 43. As
addressed above, Petitioner has established that Swanson’s locating
technique would have benefited Barreras’s device. Ex. 1003 ¶¶ 67, 69, 72,
81. That benefit is consistent with testimony by Patent Owner’s declarant
that Swanson’s approach would have been able to determine general
positioning, even in heterogeneous tissue. See Pet. Reply 6–8; Ex. 1010,
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110:6–18, 112:9–113:9. Thus, Patent Owner’s argument that Swanson’s
approach would not work “in the heterogeneous environment of the epidural
space” (PO Resp. 36) is not persuasive.
Patent Owner contends also that encapsulation—a body’s
inflammatory response to foreign objects—would also have hindered
applicability of Swanson’s method in Barreras’s device. Id. at 44–48.
Against Petitioner’s assertion that encapsulation is irrelevant to the initial
implantation (see Pet. Reply 3–4), Patent Owner argues that initial
implantation is insufficient to measure whether skilled artisans would have
expected success with the proposed combination. Tr. 25:22–26:2, 44:15–
45:18. But Patent Owner agrees that the “implanted” claim language does
not exclude the initial implantation phase, i.e., when the device is being
steered while inserted into the body. Id. at 26:3–18; accord Ex. 1010, 75:5–
21. Encapsulation does not occur for some time after initial implantation.
Ex. 1010, 95:17–96:5. Because Petitioner need only show a reasonable
expectation of success commensurate with the claim language, we agree that
potential encapsulation does not undermine that skilled artisans would have
had a reasonable expectation of success with the asserted combination.
Accordingly, we find that Petitioner has shown that skilled artisans
would have had a reasonable expectation of success of achieving the claimed
invention with the combination of Barreras and Swanson.
c. Disclosure of claim limitations
Petitioner explains how the combination of Barreras and Swanson
discloses “determining, using circuitry, a relative two-dimensional
orientation of first and second multiple-electrode leads implanted within a
user.” Pet. 30–37. Other than as discussed above, Patent Owner does not
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contest Petitioner’s showing in this regard. See Paper 8, 7 (“Patent Owner is
cautioned that any arguments for patentability not raised in the response may
be deemed waived.”). We agree with Petitioner that the combination of
Barreras and Swanson renders obvious the “determining” limitation.
Petitioner relies on Barreras as disclosing “conveying electrical
stimulation energy from a pulse generator implanted within the user into
tissue of the user via the first and second multiple-electrode leads.” Pet. 38.
Patent Owner does not contest Petitioner’s showing in this regards. See
Paper 8, 7. We agree with Petitioner that Barreras discloses the “conveying”
limitation. Pet. 38.
Petitioner explains how Swanson’s techniques include “displaying the
relative two-dimensional orientation of the first and second multiple-
electrode leads,” and that skilled artisans would have incorporated such
display functionality along with Swanson’s measurement techniques.
Pet. 29, 39–40. Patent Owner does not contest Petitioner’s showing in this
regard. See Paper 8, 7. We agree with Petitioner that the combination of
Barreras and Swanson renders obvious the “displaying” limitation. See
Pet. 27–29, 38–40.
d. Summary
Based on the foregoing, we determine Petitioner has shown by a
preponderance of the evidence that claim 1 would have been obvious over
Barreras and Swanson.
2. Dependent claims
For claims 3, 5, and 9, which each depend from claim 1, Petitioner
identifies disclosures in Barreras and Swanson that Petitioner asserts render
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obvious the additional limitations. Pet. 41–50. Other than as discussed above
regarding the limitations of claim 1, Patent Owner does not contest
Petitioner’s assertions for claims 3, 5, or 9. See Paper 8, 7.
We have reviewed Petitioner’s contentions regarding claims 3, 5, and
9, and agree that those claims would have been obvious over Barreras and
Swanson, as explained by Petitioner.
E. OBVIOUSNESS OVER BARRERAS, SWANSON, AND MEADOWS
Claims 6 and 7 each depend from claim 1 and further recite a
comparing step. Claim 6 requires comparing the displayed relative two-
dimensional orientation (recited in claim 1) “with a display of a previously
measured” orientation, while claim 7 requires comparing the displayed
orientation “with a display of a previously entered” orientation. Ex. 1001,
11:17–28. Petitioner asserts that, in order “to ascertain relative motion
between two leads,” a physician practicing prior-art methods had to
“compar[e] the displayed orientation to a previously obtained orientation
(whether measured or entered).” Pet. 51 (citing Ex. 1003 ¶¶ 122–123).
Petitioner contends further that Meadows shows the state of the art at the
time, and that it would have been obvious to perform a comparison. Id.
at 51, 53–54, 56.
1. Meadows’s status as prior art
Patent Owner argues that Meadows does not qualify as prior art under
§ 102(e), and even if it did, could not be used as part of a § 103 obviousness
challenge because it is co-owned with the ’447 patent. PO Resp. 52–54.
Petitioner responds that it does not rely on Meadows as prior art but as
“evidence of the state of the art at the relevant time.” Pet. Reply 18. Thus,
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Petitioner concedes that Meadows does not qualify as prior art under
§ 102(e) and cannot be used as an obviousness reference per se.
2. Meadows’s impact in Petitioner’s challenge
Petitioner contends that Meadows provides “evidence of the state of
the art at the relevant time” and can inform our analysis notwithstanding its
unavailability as an obviousness reference. Pet. Reply 18; accord id. at 21–
23; Pet. 53 (“The state of the art at the time of invention shown in Meadows
confirms that it would have been obvious for the device to also perform a
comparison with a previously measured and saved value.”).
Patent Owner argues that even considering Meadows together with
Barreras and Swanson does not benefit Petitioner’s case, because Meadows
does not disclose impedance measurements for determining lead orientation.
PO Resp. 54–56. Patent Owner points out that Meadows discloses
comparing currently measured impedance values to previously measured
values only for electrical diagnosis, not for positioning information. Id.
at 55–56. In our view, Patent Owner’s distinction is not significant.
Petitioner does not assert that Meadows shows comparing position
measurements; only that Meadows shows that skilled artisans understood the
benefit of comparing a measured value with a previously measured value.
Pet. 53.
That said, to the extent Meadows informs Petitioner’s obviousness
analysis, it does so by disclosing evidence of a claim limitation not disclosed
by the other references. See Pet. 51 (“Swanson and Barreras do not expressly
disclose a comparison, either with previously measured or previously
entered orientations.”). The Federal Circuit has recognized that evidence
unavailable as a prior-art reference “can be relied on for their proper
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supporting roles, e.g., indicating the level of ordinary skill in the art, what
certain terms would mean to one with ordinary skill in the art, and how one
with ordinary skill in the art would have understood a prior art disclosure.”
Yeda Research v. Mylan Pharms., Inc., 906 F.3d 1031, 1041
(Fed. Cir. 2018) (quoting Dominion Dealer Sols., LLC v. AutoAlert, Inc.,
IPR2014-00684, Paper 9, 8 (PTAB Oct. 6, 2014)); accord Ariosa
Diagnostics v. Verinata Health, Inc., 805 F.3d 1359, 1365 (Fed. Cir. 2015)
(“Art can legitimately serve to document the knowledge that skilled artisans
would bring to bear in reading the prior art identified as producing
obviousness.”). That is not the role that Meadows plays in Petitioner’s
assertions. Petitioner asserts that “Meadows confirms the state-of-the-art” as
including the claimed comparisons. Id. (citing Ex. 1003 ¶ 124). But we read
that as asserting Meadows shows the art included a claim element, not as
asserting Meadows shows how skilled artisans would have understood the
disclosure of another reference. Petitioner may not rely on a reference that
was not prior art to the challenged claims in order to prove the obviousness
of a particular limitation of those claims. Thus, we do not consider
Meadows.
3. Obviousness over Barreras and Swanson
Petitioner contends that it has shown claims 6 and 7 are obvious over
Barreras and Swanson, without Meadows. Tr. 18:11–21:22, 40:3–41:2.
Patent Owner disputes whether Petitioner adequately raised the issue in the
Petition. Id. at 27:9–12, 35:24–36:5.
“[I]nherency may supply a missing claim limitation in an obviousness
analysis.” Par Pharm., Inc. v. TWi Pharms., Inc., 773 F.3d 1186, 1194–95
(Fed. Cir. 2014). To support such an approach, a challenger must show “that
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the natural result flowing from the operation as taught would result in the
performance of the questioned function.” Id. at 1195 (quoting In re Oelrich,
666 F.2d 578, 581 (CCPA 1981)). The Petition asserts facts supporting that
the claimed comparison is part of performing the method with the
combination of Barreras and Swanson.
Petitioner asserts that a physician using claim 1’s method “must
complete some comparison of a prior orientation to a new orientation,
otherwise the currently measured information is useless.” Pet. 51 (arguing
also that “the physician would not be able to ascertain relative motion
between two leads” without comparing the displayed orientation to a
previous orientation (citing Ex. 1003 ¶¶ 122–123)). Petitioner asserts that the
claimed comparison need not “be performed by any device or circuitry.”
Pet. 52. Thus, reasons Petitioner, using Swanson’s “real time display”
satisfies the requirement for a comparison. Id. at 52; Tr. 19:3–25.
Patent Owner argues that, by stating that “Swanson and Barreras do
not expressly disclose a comparison” (Pet. 51), Petitioner has conceded that
it must rely on Meadows. PO Sur-Reply 19; Tr. 35:24–36:5. We do not
agree, because Petitioner’s assertions of inherent disclosure are consistent
with a lack of express disclosure. The Petition asserts that claim 6’s and 7’s
comparing steps were either (1) inherent in the combination of Barreras and
Swanson or (2) expressly disclosed when additionally considering Meadows.
Our determination that Petitioner cannot rely on Meadows to show the
comparing step does not foreclose Petitioner from showing the steps were
inherently disclosed by Barreras and Swanson.
We conclude that Petitioner has made the requisite showing.
Swanson’s real-time display results in a comparison between prior
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Patent 8,682,447 B2

21
measurements and the current measurement. Ex. 1002 ¶¶ 58, 123, 126–127;
Ex. 1006, 15:42–46. Thus, Petitioner has shown that the subject matter of
claim 6 would have been obvious over Barreras and Swanson.
As to the “previously entered” orientation in claim 7 versus the
“previously measured” orientation in claim 6, we reach a different
conclusion. At the hearing, Petitioner took the view that there is no
meaningful difference in claim scope. See Tr. 21:4–22. That position,
however, is not consistent with the Petition, which states that “[t]he Board
should preserve the difference between an ‘entered’ orientation and a
‘measured’ orientation.” Pet. 55; see also id. at 57 (arguing that “to the
extent ‘entered’ is interpreted more broadly to also encompass a previously
measured orientation” then we should reach the same conclusion for claim 7
as for claim 6). We decline to take a view of claim scope for which
Petitioner has not argued. Additionally, Petitioner does not assert that a
comparison to a “previously entered” orientation would have been inherent
to the combination of Barreras and Swanson. See Pet. 55–57. Thus, we
conclude that Petitioner has not shown that the prior art rendered obvious all
limitations of claim 7.
III. CONCLUSION7
For the reasons discussed above, we conclude:

7 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue
application or a request for reexamination of the challenged patent, we
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Patent 8,682,447 B2

22
Claims

35
U.S.C.
§
Reference(s)/Basis
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1, 3, 5, 9 103 Barreras, Swanson 1, 3, 5, 9
6, 7 103 Barreras, Swanson, Meadows8 6 7
Overall
Outcome 1, 3, 5, 6, 9 7

IV. ORDER
Accordingly, it is
ORDERED that claims 1, 3, 5, 6, and 9 of the ’447 patent are
unpatentable;
FURTHER ORDERED that Petitioner has not shown claim 7 of the
’447 patent to be unpatentable; and
FURTHER ORDERED that, because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

remind Patent Owner of its continuing obligation to notify the Board of
any such related matters in updated mandatory notices. See 37 C.F.R.
§ 42.8(a)(3), (b)(2).
8 Although the ground as listed includes Meadows, our unpatentability
conclusion for claim 6 does not depend on Meadows in any way.
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Patent 8,682,447 B2

23
PETITIONER:
Jon E. Wright
Ian Soule
KESSLER, GOLDSTEIN & FOX P.L.L.C.
jwright-ptab@sternekessler.com
isoule-ptab@sternekessler.com

Ching-Lee Fukuda
Thomas A. Broughan, III
Sharon Lee
SIDLEY AUSTIN LLP
clfukuda@sidley.com
tbroughan@sidley.com
sharon.lee@sidley.com

PATENT OWNER:
David A. Caine
Wallace Wu
ARNOLD & PORTER KAYE SCHOLER LLP
david.caine@apks.com
wallace.wu@apks.com