Case: 22-1451 Document: 46 Page: 1 Filed: 07/10/2023
United States Court of Appeals
for the Federal Circuit
______________________
AXONICS, INC.,
Appellant
v.
MEDTRONIC, INC.,
Appellee
______________________
2022-1451, 2022-1452
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2020-
00715, IPR2020-00679.
______________________
Decided: July 10, 2023
______________________
WILLIAM P. NELSON, Tensegrity Law Group LLP, Red-
wood Shores, CA, argued for appellant. Also represented
by MATTHEW D. POWERS; AZRA HADZIMEHMEDOVIC,
SAMANTHA A. JAMESON, AARON MATTHEW NATHAN,
McLean, VA.
CHETAN BANSAL, Paul Hastings LLP, Washington, DC,
argued for appellee. Also represented by STEPHEN BLAKE
KINNAIRD, NAVEEN MODI.
______________________
Before LOURIE, DYK, and TARANTO, Circuit Judges.
Case: 22-1451 Document: 46 Page: 2 Filed: 07/10/2023
2 AXONICS, INC. v. MEDTRONIC, INC.
TARANTO, Circuit Judge.
Medtronic, Inc., owns U.S. Patent Nos. 8,626,314 and
8,036,756 (together, the Medtronic patents), which de-
scribe and claim a neurostimulation lead and a method for
implanting and anchoring the lead. Axonics, Inc., having
been sued by Medtronic for infringement, challenged vari-
ous claims of the Medtronic patents for obviousness in inter
partes reviews (IPRs) under 35 U.S.C. §§ 311–319. In both
IPRs, the Patent and Trademark Office’s Patent Trial and
Appeal Board concluded that Axonics had failed to prove
any of the challenged claims unpatentable. Axonics ap-
peals. Because the Board erred in its obviousness analysis,
and because the errors cannot be regarded as harmless, we
vacate and remand.
I
A
The ’314 patent is a grandchild of the ’756 patent, so
we hereafter cite only the ’314 specification. The “Field of
the Invention” section of the specification states:
This invention relates generally to a method
and apparatus that allows for stimulation of body
tissue, particularly sacral nerves. More specifi-
cally, this invention relates to an implantable med-
ical 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 med-
ical electrical lead electrodes in operative relation
to a selected sacral nerve to allow for stimulation.
’314 patent, col. 1, lines 34–44. An extended discussion of
“Related Art” follows, id., col. 1, line 45, through col. 5, line
44, which is focused on medical problems addressable by
Case: 22-1451 Document: 46 Page: 3 Filed: 07/10/2023
AXONICS, INC. v. MEDTRONIC, INC. 3
electrical stimulation of the sacral nerves, e.g., id., col. 1,
line 46, through col. 4, line 23, but includes discussion of
electrostimulation devices for other parts of the body, e.g.,
id., col. 4, line 24, through col. 5, line 33. That section ends
by identifying a “need in the art for a permanently implant-
able electrical sacral nerve stimulation lead” with certain
properties. Id., col. 5, lines 34–44.
In the “Summary of the Invention” section, id., col. 5,
line 46 (full-phrase capitalization altered), the specification
then describes the “present invention” in terms that are not
confined to the sacral nerves, id., col. 5, line 48. “The pre-
sent invention provides a solution to the problems associ-
ated 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 tech-
niques.” Id., col. 5, lines 48–53; see also, e.g., id., col. 5, line
65, through col. 6, line 19. Application to “sacral nerve
stimulation” is one “preferred embodiment.” Id., col. 5,
lines 53–64.
The patents describe and show the features key to the
present appeal: at least two electrodes at the distal end of
the lead, with “a plurality M of tine elements arrayed . . .
along a segment of the lead proximal to the stimulation
electrode array.” Id., col. 6, lines 5–8. For example, Figure
2 shows four “ring-shaped electrodes 25, 30, 35, and 40 in
an electrode array 20 extending proximally from the lead
distal end 45,” id., col. 9, lines 25–34 (emphases omitted),
and four “tine elements” (125, 130, 135, and 140) attached
“proximally toward the lead proximal end,” id., col. 10,
lines 25, 32–35:
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4 AXONICS, INC. v. MEDTRONIC, INC.
Id., Fig. 2 (annotated version in Medtronic’s Br. at 14).
Claim 1 of the ’314 patent is illustrative of the claims
at issue here:
1. A system comprising:
an implantable medical lead comprising:
a lead body extending between a
proximal end and a distal end;
a plurality of conductors within
the lead body;
a plurality of electrodes, wherein
each electrode is electrically con-
nected to a conductor of the plural-
ity of conductors; and
a plurality of tine elements ex-
tending from the lead body,
wherein all tine elements of the
plurality of tine elements are posi-
tioned between a most proximal
electrode of the plurality of elec-
trodes and the proximal end of the
lead body, each tine element com-
prising a plurality of flexible, pliant
tines, each tine having a tine width
and thickness and extending a tine
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AXONICS, INC. v. MEDTRONIC, INC. 5
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 support-
ing the tine extending outwardly of
the lead body and proximally to-
ward the lead proximal end,
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 intro-
ducer is withdrawn to release the
plurality of tines, wherein the plu-
rality of tine elements is separate
from and axially displaced from the
plurality of electrodes.
Id., col. 13, line 51, through col. 14, line 11. No claim of the
two patents either mentions or is limited to sacral nerves.
The same is true of the titles of the two patents: “Implant-
able Medical Lead Including a Plurality of Tine Elements,”
’314 patent, col. 1, lines 1–3 (capitalization removed); “Im-
plantable Medical Electrical Stimulation Lead Fixation
Method and Apparatus,” ’756 patent, col. 1, lines 1–3 (cap-
italization removed).
B
On March 16, 2020, Axonics petitioned for IPRs of
claims 1, 2, 4, 7, 10–12, 14, and 18–24 of the ’314 patent
and of claims 1, 2, 5, 7, 13–15, and 18 of the ’756 patent.
The Board instituted both IPRs on September 15, 2020—
IPR2020-00679 for the ’314 patent and IPR2020-00715 for
the ’756 patent. On September 13, 2021, the Board issued
final written decisions in both IPRs.
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6 AXONICS, INC. v. MEDTRONIC, INC.
1
In its petition concerning the ’314 patent, Axonics ar-
gued, among other things, that the challenged claims of the
’314 patent are unpatentable under 35 U.S.C. § 103 for ob-
viousness over Young (Ronald F. Young, M.D., Electrical
Stimulation of the Trigeminal Nerve Root for the Treatment
of Chronic Facial Pain, 83 Journal of Neurosurgery 72
(1995)) in view of Gerber (U.S. Patent No. 6,055,456) and
Lindegren (PCT App. No. WO 98/20933). 1 Axonics specifi-
cally argued that a relevant artisan would have been moti-
vated “to replace the one electrode of Young with multiple
electrodes at the distal end distal to the anchoring mecha-
nism, as taught in Gerber, in order to provide more flexi-
bility in activation of a wider area and provide the
possibility for bipolar electrical stimulation, as taught in
Young.” J.A. 208 (Axonics’s petition). Only the Board’s
findings about the combination of Young and Gerber are
presented for review in this appeal.
Young describes a clinical study of patients who re-
ceived percutaneous implantations of an electrical neu-
rostimulator to treat chronic facial pain resulting from
injury to the trigeminal nerve or nerve root. J.A. 2405–06
(Young at 72–73). The “study was undertaken . . . to ex-
tend the application of electrical stimulation,” which had
previously “been used successfully with spinal cord and
deep brain stimulation, to the trigeminal system and
chronic facial pain.” Id. The implanted neurostimulator
used in the study “consisted of a monopolar . . . lead with
two sets of four ‘tines’ located” a short distance proximal to
the single electrode at the distal tip of the lead. J.A. 2406
(Young at 73). The tines “prevent[ed] the electrode from
1 The version of 35 U.S.C. § 103 applicable to both
patents at issue here is the one pre-dating the amendments
made by the Leahy-Smith America Invents Act, Pub. L. No.
112-29, 125 Stat. 284, 287–88 (2011).
Case: 22-1451 Document: 46 Page: 7 Filed: 07/10/2023
AXONICS, INC. v. MEDTRONIC, INC. 7
becoming dislodged after implantation.” Id. Young states
that the neurostimulator “could be improved” by adding
“multiple active stimulation sites,” i.e., additional elec-
trodes, “near the tip[,] . . . which would permit greater flex-
ibility in activation of a wider area of the trigeminal nerve
root” and would “provide the possibility for bipolar electri-
cal stimulation, which in other neurostimulation settings
(such as [those] involving spinal cord and brain) has proved
to be more effective than monopolar stimulation.” J.A.
2410 (Young at 77).
Gerber describes “an implantable medical lead having
at least one electrode contact wherein the lead is implanted
near the sacral nerves for stimulation” and a “method of
implantation and anchoring of the medical lead near the
sacral nerve.” Gerber, col. 1, lines 9–14. Gerber also dis-
closes that existing leads for sacral nerve stimulation “have
four small discrete electrodes built into the distal end of the
lead.” Id., col. 1, lines 57–58. Gerber’s implantable lead
includes “a distal end” (25) with “at least one electrode con-
tact” (20) and “a proximal end” (35), id. col. 3, lines 21–22,
42–46, and may include an “anchoring mechanism” (50) to
keep the lead near the targeted sacral nerve, id., col. 4,
lines 13–31, as shown in Figure 2:
The anchoring mechanism may have holes for suture fixa-
tion (50 in Figure 2) or may “allow the medical lead . . . to
fibrose in naturally using the human body’s reaction to a
foreign body or healing.” Id., col. 4, lines 13–31.
In arguing that a relevant artisan would have been mo-
tivated to combine the teachings of Young and Gerber, Ax-
onics asserted that Young and Gerber “reasonably
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8 AXONICS, INC. v. MEDTRONIC, INC.
address[] the similar problems of leads adequately stimu-
lating the nerves while limiting electrode migration”—a
problem that Axonics contended the ’314 patent also ad-
dresses. J.A. 206 (Axonics’s petition, citing Young at 73;
Gerber, col. 1, line 64, through col. 2, line 13). Young, Ger-
ber, and the ’314 patent, according to Axonics, are also
“from the same field”: “neurostimulation with implantable
medical leads with electrode(s) at the distal end of the lead
and a proximal anchoring mechanism.” Id. (citing Young
at 73; Gerber, col. 3, line 39, through col. 4, line 52). Ax-
onics argued that a relevant artisan “would have been mo-
tivated to combine references that solve the same problem
as the ’314 [p]atent in the same field.” Id. (citing Tokai
Corp. v. Easton Enterprises, Inc., 632 F.3d 1358, 1371 (Fed.
Cir. 2011)). Axonics also argued that Young expressly pro-
vides a motivation to make the asserted combination when
it states that the neurostimulator used in the clinical study
“could be improved to provide multiple active stimulation
sites near the tip.” J.A. 207 (quoting Young at 77). Gerber,
urged Axonics, “discloses multiple electrodes on implanted
leads for sacral nerve stimulation” and an “anchoring
means that fixes by fibrosis.” Id. Axonics added that, at
the priority date, there were a “limited number of devices
available . . . to anchor by fibrosis,” tines being the predom-
inant one. Id.
In its final written decision, the Board held all the chal-
lenged claims of the ’314 patent not unpatentable for obvi-
ousness. J.A. 2. The Board began by defining the relevant
art and a relevant artisan, in agreement with Medtronic on
the point of relevance here, as focused on sacral-nerve stim-
ulation specifically. The Board found that “the relevant art
is medical leads specifically for sacral neuromodulation,”
J.A. 13; see J.A. 15, relying on the “field of the invention”
statements to narrow the field in that way even though the
claims are not limited to sacral nerves. J.A. 13–14. The
Board then concluded that, because the relevant art “is so-
phisticated and requires knowledge of human anatomy of
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AXONICS, INC. v. MEDTRONIC, INC. 9
the sacral area and the surgical procedures involved in sa-
cral neuromodulation,” a relevant artisan is someone with,
among other experience, “at least two years of experience
researching and developing medical leads for sacral neuro-
modulation.” J.A. 15.
The Board then addressed Axonics’s argument that the
claims would have been obvious over Young in view of Ger-
ber and Lindegren. The Board agreed with Axonics that it
had “demonstrated each limitation of independent claim 1
in its proposed combination”—including, as relevant here,
a plurality of electrodes distal to all tines. J.A. 36. Never-
theless, the Board found that Axonics had not demon-
strated that a relevant artisan would have had a
motivation to combine “Young’s lead with Gerber’s plural-
ity of electrodes so the plurality of electrodes is distal to all
of the lead’s tines.” Id. This failure of proof, the Board
said, defeated the challenge to all identified claims, as Ax-
onics “relie[d] on the same reasoning for combining” the
teachings of Young and Gerber for all three independent
claims (1, 11, 18). Id.
In making its decisive determination, the Board first
found that, contrary to the argument of Axonics, Young,
Gerber, and the ’314 patent do not solve the same problem.
The Board reasoned that the ’314 patent “addresses the
need for a percutaneously implantable lead that is properly
and securely positioned to provide sacral nerve stimula-
tion,” J.A. 31 (emphasis added), and Gerber addresses “the
positioning and securement of an electrode that is im-
planted in the sacral area via a non-percutaneous surgical
procedure,” id., but “Young addresses placement of an im-
planted, percutaneously placed electrode system for . . .
stimulation of the trigeminal sensory root for treatment of
chronic facial pain,” id. (emphasis added).
That distinction also was central to the Board’s rejec-
tion of Axonics’s reliance, for motivating the combination
with Gerber, on Young’s statement that “[t]he electrode
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10 AXONICS, INC. v. MEDTRONIC, INC.
could be improved to provide multiple active stimulation
sites near the tip.” J.A. 30, 34–35; see J.A. 2410 (Young at
77). Medtronic and its expert, Dr. Slavin, asserted that
this sentence in Young did not suggest to a relevant artisan
“to include a plurality of electrodes distal to all of the tines”
in the Young neurostimulator “because such an arrange-
ment would not be feasible in the complex anatomy of the
trigeminal nerve region.” J.A. 33. The Board agreed, stat-
ing that the purpose of Young’s lead “is electrical stimula-
tion of the trigeminal sensory root,” so Young’s sentence on
improvement by adding electrodes would not have moti-
vated a relevant artisan to combine Young’s lead with a
plurality of electrodes distal to all of the tines (as taught in
Gerber), because “such an arrangement would not be feasi-
ble in the trigeminal nerve region” given the tight tissue-
related spacing constraints of that particular nerve region.
J.A. 35 (relying on Dr. Slavin’s testimony, reproduced at
J.A. 33). The Board further found that Young “discloses
multiple active sites near the tip, not at the tip or distal to
the tines.” Id. This finding similarly depended entirely on
Dr. Slavin’s testimony regarding the space constraints of
the trigeminal-nerve region. Id. The Board therefore con-
cluded that Axonics failed to prove that a relevant artisan
would have been motivated to combine the teachings of
Young and Gerber. Id.
2
In its petition concerning the ’756 patent, Axonics ar-
gued obviousness over Young in view of Gerber, Lindegren,
and Akerström (U.S. Patent No. 4,407,303). This challenge
relied on the same combination of Young and Gerber as
was decisive for the ’314 patent. J.A. 291 (Axonics’s peti-
tion). The Board rejected the asserted motivation to com-
bine for the ’756 patent—and hence the obviousness
challenge—for the same reasons it did for the ’314 patent.
J.A. 103–04.
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AXONICS, INC. v. MEDTRONIC, INC. 11
3
Axonics timely appealed from both final written deci-
sions on February 4, 2022, within the 63 days allowed by
35 U.S.C. § 142 and 37 C.F.R. § 90.3(a)(1). We have juris-
diction under 35 U.S.C. §§ 141(c), 319 and 28 U.S.C.
§ 1295(a)(4)(A).
II
Obviousness is an issue of law decided based on numer-
ous factual findings, including the scope and content of the
prior art, the level of ordinary skill, and whether a relevant
artisan would have had a motivation to combine references
in the way required to achieve the claimed invention.
Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1331
(Fed. Cir. 2019) (citing Graham v. John Deere Co., 383 U.S.
1, 17–18 (1966)); PAR Pharmaceutical, Inc. v. TWI Phar-
maceuticals, Inc., 773 F.3d 1186, 1196–97 (Fed. Cir. 2014).
Factual findings are reviewed for substantial-evidence sup-
port, which exists when, on the whole record, “a reasonable
fact finder could have arrived at” the finding on review. In
re Gartside, 203 F.3d 1305, 1312 (Fed. Cir. 2000). Whether
the decision on review rests on a failure to apply the correct
legal standards is determined de novo on appeal. Belden
Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015).
The Board in this case rejected Axonics’s obviousness
challenge because it found that Axonics failed to show that
a relevant artisan would have had a motivation to combine
the teachings of Young with those of Gerber, and the Board
rested that finding on its determination that the proposed
combination “would not be feasible in the trigeminal nerve
region.” J.A. 35. We conclude that this rationale is doubly
infected by error. First, even if the Board was correct to
treat the Medtronic patents at issue as limited in the prob-
lem they address to the sacral-nerve context, the Board
committed a fundamental legal error in confining the mo-
tivation inquiry to whether a motivation would exist to
make the proposed combination for use in the Young-
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12 AXONICS, INC. v. MEDTRONIC, INC.
specific trigeminal-nerve context—to which the Medtronic
patents are not limited. Second, the Board was incorrect
in its view that “the relevant art is medical leads specifi-
cally for sacral neuromodulation,” J.A. 13, as the Medtronic
patents’ claims are not limited to the sacral-nerve context
and the shared specification, properly read, is not so lim-
ited either. Unable to characterize these errors as harm-
less, we vacate the Board’s decisions and remand.
A
When an obviousness challenge asserts a combination
of identified prior art, the motivation-to-combine portion of
the inquiry is “whether ‘a skilled artisan would have been
motivated to combine the teachings of the prior art refer-
ences to achieve the claimed invention.’” Allied Erecting &
Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d
1373, 1381 (Fed. Cir. 2016) (internal citations omitted)
(emphasis added); see also Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1361 (Fed. Cir. 2007). The inquiry is not
whether a relevant artisan would combine a first refer-
ence’s feature with a second reference’s feature to meet re-
quirements of the first reference that are not requirements
of the claims at issue. A contrary view would run counter
to established principles, including that the claim defines
the invention whose obviousness is being assessed and that
a skilled artisan may be motivated to combine particular
features of different references, e.g., to secure some bene-
fits at the expense of others, even when bodily incorpora-
tion would be impossible or inadvisable. See, e.g., In re
Yamamoto, 740 F.2d 1569, 1573 (Fed. Cir. 1984); In re Ur-
banski, 809 F.3d 1237, 1243–44 (Fed. Cir. 2016). As Med-
tronic states, “[t]he real question is ‘why a person of
ordinary skill in the art would have combined elements
from specific references in the way the claimed invention
does.’” Medtronic’s Br. at 66 (quoting ActiveVideo Net-
works, Inc. v. Verizon Communications, Inc., 694 F.3d
1312, 1328 (Fed. Cir. 2012) (emphasis in original)).
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AXONICS, INC. v. MEDTRONIC, INC. 13
The Board adopted a legally incorrect framing of the
motivation-to-combine question when it confined the in-
quiry to whether a motivation would exist to make the Ger-
ber-Young combination for use in the Young-specific
trigeminal-nerve context. That context is not part of the
Medtronic patents’ claims. The proper inquiry is whether
the relevant artisan would be motivated to make the com-
bination to arrive at the claims’ actual limitations, which
are not limited to the trigeminal-nerve context. And the
Board made no finding, and the parties have not pointed to
evidence, that the space constraints of that context, on
which the Board relied for finding no motivation to make
the combination for trigeminal-nerve stimulation, are ap-
plicable to other nerve-stimulation contexts covered by the
claims at issue, which include sacral-nerve stimulation.
The Board’s contrary view makes particularly little
sense given the Board’s definition of the relevant artisan
providing the perspective that governs the obviousness
analysis and of the problem addressed by the Medtronic
patents here. The Board, in agreement with Medtronic’s
own position, defined the relevant artisan as a person in
“the relevant art” of “medical leads specifically for sacral
neuromodulation,” J.A. 13, and the Board, while accepting
that Young was prior art that the relevant artisan would
consider, identified the problem addressed by the Med-
tronic patents as sacral-nerve stimulation, J.A. 31. Such
an artisan, focused on such a problem, would hardly be
reading Young only for what it taught or suggested about,
or only how features of Young’s teachings might be com-
bined with Gerber for, the trigeminal-nerve context. Ra-
ther, such an artisan would be considering what Young
taught or suggested about, or how features of Young’s
teachings might be combined with Gerber for, at least the
sacral-nerve context.
The Board thus improperly limited the Young-Gerber
combination analysis to what would work in the trigemi-
nal-nerve area. That legally incorrect framing of its
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14 AXONICS, INC. v. MEDTRONIC, INC.
motivation inquiry was not harmless. The Board did not
find that the critical space limitations of the trigeminal-
nerve area are present elsewhere, including the sacral-
nerve area. And the Board did not rely on any ground for
rejecting the motivation argument of Axonics that is inde-
pendent of the legally erroneous framing. Vacatur and re-
mand is necessary for this reason.
B
Relatedly, we also conclude that the Board erred in its
definition of “the relevant art” as limited to medical leads
for sacral-nerve stimulation. J.A. 31. The parties have
treated this issue as a factual one, subject to substantial-
evidence review. Even under that standard of review, we
conclude that the Board’s ruling on the issue cannot stand.
The Medtronic patent claims make no reference to sa-
cral anatomy or sacral neuromodulation, and they cannot
be properly construed as so limited. Neither the Board nor
Medtronic has cited any authority for treating the relevant
art as limited to a narrow subset of what the claims of a
patent cover—a conclusion that would risk curtailing prior-
art analysis of a claim to less than its exclusive-rights-pro-
tecting scope. And we have repeatedly ruled that what con-
stitutes “analogous art” for section 103 purposes is tied to
“the claimed invention.” See Sanofi-Aventis Deutschland
GmbH v. Mylan Pharmaceuticals Inc., 66 F.4th 1373,
1377–78 (Fed. Cir. 2023) (citing and quoting cases).
In any event, the only reasonable reading of the speci-
fication is contrary to the Board’s narrow definition. The
Board relied on the “Field of the Invention” paragraph, J.A.
13 (quoted supra p. 2), but the language of that paragraph
can readily be understood as identifying examples, not nar-
rowing, even if read alone. And it must be so understood
when not read in isolation. The “Summary of the Inven-
tion,” ’314 patent, col. 5, line 46 (capitalization altered),
like the title of each patent, states the invention in general
terms, not limited to the sacral-nerve context, e.g., id., col.
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AXONICS, INC. v. MEDTRONIC, INC. 15
5, lines 48–53; id., col. 5, line 65, through col. 6, line 19, and
the Summary labels the sacral-nerve stimulation applica-
tion as one “preferred embodiment,” id., col. 5, lines 53–64.
See also id., col. 13, lines 32–39 (stating application to spe-
cific other areas). The expressly broad scope of what was
identified as invented is not negated by the fact that the
specification notes a “need” in the sacral-nerve context that
may have supplied the inventor’s starting point. Id., col. 5,
lines 34–44.
We therefore conclude that substantial evidence does
not support the Board’s limitation of “the relevant art” to
sacral-nerve stimulation. The Board relied on this limita-
tion in rejecting Axonics’s argument for the asserted moti-
vation to combine Young with Gerber. We are unable to
say that this error was harmless.
III
For the foregoing reasons, we vacate the Board’s final
written decisions and remand for further proceedings con-
sistent with this opinion.
Costs awarded to Axonics.
VACATED AND REMANDED