Recor Medical, Inc., Otsuka Medical Devices Co., Ltd. v. Medtronic Ireland Manufacturing Unlimited Co.

N OTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
RECOR MEDICAL, INC., OTSUKA MEDICAL
DEVICES CO., LTD.,
Appellants
v.
MEDTRONIC IRELAND MANUFACTURING
UNLIMITED CO.,
Appellee
______________________
2023-2251
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2022-
00431.
______________________
Decided: March 27, 2025
______________________
G ABRIEL K. BELL , Latham & Watkins LLP, Washing-
ton, DC, argued for appellants. Also represented by
ASHLEY N. F INGER, A SHLEY M. F RY , MATTHEW J. MOORE;
ROGER J. CHIN, San Francisco, CA.
J AMES L AWRENCE D AVIS , J R., Ropes & Gray LLP, East
Palo Alto, CA, argued for appellee. Also represented by
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RECOR MEDICAL, INC. v.
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ALLEN S. CROSS , D OUGLAS HALLWARD-D RIEMEIER, Wash-
ington, DC.
______________________
Before L OURIE, MAYER, and P ROST , Circuit Judges.
P ROST , Circuit Judge.
Recor Medical, Inc. and Otsuka Medical Devices Co.
Ltd. (collectively, “Recor”) appeal the final written decision
of an inter partes review (“IPR”) of U.S. Patent No.
8,845,629 (“the ’629 patent”), holding all challenged claims
were not shown unpatentable. Recor Med., Inc. v. Med-
tronic Ir. Mfg. Unlimited Co., No. IPR2022-00431, 2023
WL 5167837, at *16 (P.T.A.B. July 14, 2023) (“Final Writ-
ten Decision”). We vacate and remand for further proceed-
ings consistent with this opinion.
BACKGROUND
The ’629 patent is titled “Ultrasound Apparatuses for
Thermally-Induced Renal Neuromodulation” and “relates
to methods and apparatus[es] for achieving renal neuro-
modulation via thermal heating and/or cooling mecha-
nisms.” ’629 patent col. 1 ll. 43–44. Renal
neuromodulation is the process of surgically disrupting or
destroying the renal nerves. The ’629 patent discusses how
renal neuromodulation may be used to treat certain dis-
eases such as heart failure, renal failure, and hypertension.
Id. at col. 1 ll. 48 to col. 2 ll. 21.
More specifically, the ’629 patent relates to using a
catheter to perform renal neuromodulation by applying
thermal energy to the target neural fibers. The catheter
contains a positioning element (e.g., a ballon), which may
be used to center or position the electrodes that deliver the
thermal energy within the blood vessel to the targeted tis-
sue. See id. at col. 7 ll. 34–55. While various forms of ther-
mal energy may be used for neuromodulation, “such as
through application of a ‘thermal’ electric field, of high-
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intensity focused ultrasound, of laser irradiation, etc.,” id.
at col. 4 ll. 61–63, the claims of the ’629 patent are directed
to ultrasound. Claim 1 is illustrative:
1. An ultrasound apparatus for thermally-induced
renal neuromodulation, the apparatus comprising:
a catheter sized and shaped for delivery within a
blood vessel to a vicinity of neural fibers that con-
tribute to renal function;
an ultrasound transducer carried by the catheter,
wherein the ultrasound transducer is configured to
transmit ultrasound energy waves to target renal
neural fibers outside of the blood vessel to ther-
mally induce modulation of target neural fibers
while protecting non-target tissue in the blood ves-
sel wall from thermal injury; and
an expandable member carried by a distal region of
the catheter,
wherein the expandable member is configured to
vary between a reduced configuration for delivery
and retrieval and an expanded deployed configura-
tion, and
wherein the ultrasound transducer is positioned on
a shaft of the catheter and within the expandable
member.
Id. at claim 1.
In 2022, Recor filed a petition for IPR of the ’629 patent,
challenging claims 1–4 and 8–12. Relevant here are Re-
cor’s four grounds based on obviousness of the ’629 patent,
including two grounds involving Levin1 in view of Acker2
1 U.S. Patent App. Pub. No. 2003/0216792 (“Levin”),
J.A. 2102–26.
2 U.S. Patent No. 6,669,655 (“Acker”), J.A. 2127–40.
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and two grounds involving Acker in view of the knowledge
of a person of ordinary skill in the art. For the Levin-Acker
grounds, Recor argued that it would have been obvious to
combine the renal neuromodulation method of Levin with
Acker’s catheter. See J.A. 1035 (“Levin teaches using a
catheter-based approach within a renal artery to modulate
renal nerves lying on the external surface of the arterial
wall. While Levin does not teach using ultrasound, Acker
does. Specifically, Acker provides an ultrasound catheter
for ablating tissue lying outside a blood vessel.”). The
Board disagreed, finding that there was no motivation to
combine Levin with Acker and that it would not have been
obvious to try ultrasound energy for renal neuromodula-
tion. See Final Written Decision, 2023 WL 5167837,
at *7–12.
As to Acker in view of the knowledge of a person of or-
dinary skill in the art, Recor argued that “Acker teaches an
ultrasound ablation catheter,” and a person of ordinary
skill in the art “would have understood from Acker that its
catheter was appropriate for selectively ablating tissue, in-
cluding nerve tissue.” J.A. 1069. The Board disagreed
“[f]or the same reasons discussed . . . in the context of the
asserted ground based on Levin and Acker”—i.e., “the com-
plete record does not support that one of ordinary skill in
the art at the time of the invention in the ’629 patent would
have been motivated to use Acker’s ultrasound catheter for
renal neuromodulation applications.” Final Written Deci-
sion, 2023 WL 5167837, at *15. Based on these findings
(and others), the Board held that Recor had not demon-
strated by a preponderance of the evidence that the chal-
lenged claims would have been obvious.
Recor appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A).
D ISCUSSION
“Whether a claimed invention would have been obvious
is a question of law, based on factual determinations
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regarding the scope and content of the prior art, differences
between the prior art and the claims at issue, the level of
ordinary skill in the pertinent art, the motivations to mod-
ify or combine prior art, and any objective indicia of non-
obviousness.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064,
1073 (Fed. Cir. 2015). “We review the Board’s legal deter-
mination of obviousness de novo and its factual findings for
substantial evidence.” Outdry Techs. Corp. v. Geox S.p.A.,
859 F.3d 1364, 1367 (Fed. Cir. 2017) (internal citation
omitted). “Substantial evidence is such relevant evidence
as a reasonable mind might accept as adequate to support
a conclusion.” Intel Corp. v. PACT XPP Schweiz AG, 61
F.4th 1373, 1378 (Fed. Cir. 2023) (internal citation omit-
ted).
On appeal, Recor makes two main arguments: (1) that
the Board committed legal error by failing to consider
Acker “for everything it teaches,” Belden, 805 F.3d at 1076
(emphasis omitted); and (2) that the Board erred in con-
cluding that it would not have been obvious to try ultra-
sound energy to ablate renal nerves. We address each
argument in turn.
I
“[A] reference must be considered for everything it
teaches by way of technology and is not limited to the par-
ticular invention it is describing and attempting to pro-
tect.” Id. (emphasis omitted) (quoting EWP Corp. v.
Reliance Universal Inc., 755 F.2d 898, 907 (Fed. Cir. 1985)).
We agree with Recor that the Board violated this principle
here.
Recor relied on Acker’s catheter in both its Levin-Acker
grounds and its Acker-in-view-of-a-person-of-ordinary-skill
grounds. The use of such a catheter in the renal neuromod-
ulation context in all of these grounds was based on obvi-
ousness arguments, including Levin’s use of a catheter in
the renal neuromodulation context and the knowledge of a
person of ordinary skill in the art. One of Recor’s
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arguments was that Acker itself provides a basis for using
its ultrasound catheter in any “blood vessel” or “tubular an-
atomical structure,” which when combined with Levin or
the person of ordinary skill in the art would render obvious
the claimed invention of the ’629 patent. The Board disa-
greed, concluding that Acker primarily discloses more spe-
cific uses for ultrasound catheters in pulmonary veins. See
Final Written Decision, 2023 WL 5167837, at *8–9.
But the Board was required to consider Acker “for eve-
rything it teaches.” Belden, 805 F.3d at 1076. And Acker
teaches using a catheter with an ultrasonic transducer “to
provide ultrasonic energy in a ring-like zone surrounding a
blood vessel.” J.A. 2127 abstract (emphasis added); see also
J.A. 2135 col. 2 ll. 23–25 (“[T]he catheter is positioned
within a circulatory vessel with a central axis of the emit-
ting element substantially aligned with an axis of the cir-
culatory vessel.” (emphasis added)); J.A. 2139 claim 10
(“said catheter is positioned within a circulatory vessel
with a central axis of the emitting element substantially
aligned with an axis of the circulatory vessel”). While
Acker includes specific embodiments where the catheter is
placed into a pulmonary vein, Acker clearly contemplates
a wider use for its catheter to ablate other tissues with ul-
trasonic energy: “Although the invention has been de-
scribed above with reference to ablation of blood vessel
walls, the same techniques can be used to ablate ring-like
regions around other tubular anatomical structures.”
J.A. 2138 col. 8 ll. 15–18. These disclosures in Acker,
among others, explicitly contemplate the use of Acker’s
catheter in various blood vessels. And they should not be
disregarded simply because Acker has a preferred embodi-
ment involving a more specific use in pulmonary veins.
Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed.
Cir. 1989) (“In a section 103 inquiry, the fact that a specific
embodiment is taught to be preferred is not controlling,
since all disclosures of the prior art, including unpreferred
embodiments, must be considered.” (cleaned up)).
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And although the Board recognized that “Acker does,
in certain passages cited by Petitioner, use broader phrases
such as ‘blood vessel’ and ‘tubular anatomical structures,’”
Final Written Decision, 2023 WL 5167837, at *8, the
Board’s justification for disregarding these teachings was
unsound: “[T]he record does not support that one of ordi-
nary skill in the art would have understood from these
broader statements that Acker’s ultrasound catheter could
have been used effectively on any anatomical structures
near any human blood vessel, including, more specifically,
on renal nerves near renal arteries.” Id. (emphasis altered
from original). Whether the Board’s narrow interpretation
of Acker is read as a requirement that the prior art actually
operate to perform the claimed invention or that the prior
art be enabled, neither inquiry is correct under our obvi-
ousness standard. See, e.g., Beckman Instruments, Inc. v.
LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989)
(“Even if a reference discloses an inoperative device, it is
prior art for all that it teaches.”); In re Etter, 756 F.2d 852,
859 (Fed. Cir. 1985) (en banc) (explaining that the test for
obviousness is “not whether the references could be physi-
cally combined but whether the claimed inventions are ren-
dered obvious by the teachings of the prior art as a whole”).
Instead, the question is whether “a skilled artisan
would have been motivated to combine the teachings of the
prior art references to achieve the claimed invention.” Al-
lied Erecting & Dismantling Co. v. Genesis Attachments,
LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016) (quoting Pfizer,
Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)).
KSR explained that “‘[a] person of ordinary skill is also a
person of ordinary creativity, not an automaton,’ so the fact
that it would take some creativity to [arrive at the claimed
invention] does not defeat a finding of obviousness.” Face-
book, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321,
1343 (Fed. Cir. 2020) (quoting KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 421 (2007)). By failing to consider Acker “for
everything it teaches,” the Board disregarded the
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“expansive and flexible approach” to obviousness inquiries
expressed in KSR. 550 U.S. at 415. We, therefore, con-
clude that the Board legally erred in dismissing Acker’s
broader teachings and vacate the Board’s holdings as to all
four of Recor’s obviousness grounds that rely on Acker in
combination with Levin or the knowledge of a person of or-
dinary skill in the art.
II
Recor also argues that the Board erred in concluding
that it had not shown that it would have been obvious to
try ultrasound to ablate renal nerves.3 Recor frames its
argument as a legal error, but we agree with Medtronic
that the question here is one of fact reviewed for substan-
tial evidence under the circumstances before us.4
“To prove obviousness under an obvious to try theory,
[Recor] must show (1) a design or market need to solve a
particular problem, and (2) that ‘there are a finite number
of identified, predictable solutions’ that would lead to an
expectation of success.” Grunenthal GMBH v. Alkem Labs.
Ltd., 919 F.3d 1333, 1345 (Fed. Cir. 2019) (emphasis omit-
ted) (quoting KSR, 550 U.S. at 421). Here, Recor argues
that it would have been obvious to combine Levin’s method
of renal neuromodulation with Acker’s ultrasound catheter
because both Levin and Acker use thermal energy, and a
3 Medtronic argues that Recor forfeited this argu-
ment. Appellee’s Br. 47. We disagree. Recor’s petition
raised and preserved this issue. See J.A. 1037–38.
4 There may be circumstances where obvious-to-try
arguments are rooted in a legal question. For example, if
there are no underlying facts in dispute regarding the “fi-
nite number of identified, predictable solutions,” the appli-
cation of the obvious-to-try rationale may be purely a
question of law. See Uber Techs. Inc. v. X One, Inc., 957
F.3d 1334, 1341 (Fed. Cir. 2020). That is not the case here.
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person of ordinary skill in the art would have “understood
ultrasound to be a known and predictable alternative to us-
ing electrical current as suggested by Levin.” J.A. 1037.5
Specifically, Recor asserts that there are a finite number of
thermal energy sources for ablation, including electrical,
ultrasound, radiofrequency, cryogenics, microwave, laser,
chemical, induction, radiation, and mechanical methods.
See Appellant’s Br. 36–39.
Aside from its forfeiture argument, Medtronic responds
that on the merits “Acker’s particular ultrasound trans-
ducer that forms a ring-shaped lesion was not a predictable
source of thermal energy for [renal neuromodulation],” Ap-
pellee’s Br. 47, and “while several sources list ultrasound
as a thermal source, it is among many different options and
none of the references suggests ultrasound is an option for
renal denervation,” id. at 51 (emphasis omitted). In other
words, Medtronic argues that ultrasound catheters were
not part of a finite number of predictable solutions for renal
neuromodulation.
“Absolute predictability . . . is not required.” Valeant
Pharms. Int’l, Inc. v. Mylan Pharms. Inc., 955 F.3d 25, 34
(Fed. Cir. 2020). “Common sense teaches, however, that
familiar items may have obvious uses beyond their primary
purposes, and in many cases a person of ordinary skill will
be able to fit the teachings of multiple patents together like
pieces of a puzzle.” KSR, 550 U.S. at 420. The Board
should therefore have considered, under the obvious-to-try
rationale, whether “a person of ordinary skill has good rea-
son to pursue the known options within his or her technical
grasp.” Id. at 421. On that question, Recor provided ample
5 Based on Recor’s argument in its petition and its
opening brief, we understand its obvious-to-try argument
to apply only to the two Acker-Levin grounds raised in its
petition. See J.A. 1036–38; Appellant’s Br. 36.
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evidence, including Levin, Acker, Diederich,6 and Huang.7
For example, Levin teaches renal neuromodulation, includ-
ing ablation, using a catheter with electrical energy.
J.A. 2114, ¶ 2; J.A. 2119 ¶ 64 (“Ablation can be performed
by introduction of a catheter into the venous system in
close proximity of the sympathetic renal nerve subsequent
ablation of the tissue.”). And Acker teaches ablation of tis-
sue using an ultrasound catheter. J.A. 2127 abstract. Both
Diederich and Huang teach a limited universe of thermal
energy sources for the ablation of tissues. See J.A. 2164–65
(Diederich) (listing DC current, AC current, radiofre-
quency, microwave, heating elements, light emitting ele-
ments, and ultrasound as possible “energy emitting”
ablation elements); J.A. 3962 (Huang) (listing a similar
and overlapping list as Diederich of ten thermal energy
sources). This is a sufficiently finite universe of options to
support an obvious-to-try theory. See Valeant Pharms.,
955 F.3d at 34 (concluding a set of ten variables was finite).
And these thermal energy sources’ known use for ablation
renders them reasonably predictable. See In re Copaxone
Consol. Cases, 906 F.3d 1013, 1025–27 (Fed. Cir. 2018).
Based on these prior-art references, “a person of ordinary
skill [would have] good reason to pursue [these] known op-
tions.” KSR, 550 U.S. at 421. We therefore conclude that
substantial evidence does not support the Board’s rejection
of Recor’s obvious-to-try theory.
6 PCT App. No. WO 99/02096 (“Diederich”),
J.A. 2141–2257.
7 S. Huang & D. Wilber, Radiofrequency Catheter
Ablation of Cardiac Arrhythmias, Basic Concepts and Clin-
ical Applications (Futura Publishing Co. 2d ed. 2000)
(“Huang”), J.A. 3959–70.
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CONCLUSION
For the reasons above, we vacate and remand to the
Board for further proceedings consistent with this opinion.
VACATED AND REMANDED
COSTS
Costs to Appellants.
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