Case: 21-1995 Document: 42 Page: 1 Filed: 05/23/2022
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
ETHICON LLC,
Appellant
v.
INTUITIVE SURGICAL, INC.,
Appellee
______________________
2021-1995, 2021-1997
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2020-
00050, IPR2020-00051.
______________________
Decided: May 23, 2022
______________________
ANISH R. DESAI, Weil, Gotshal & Manges LLP, New
York, NY, argued for appellant. Also represented by ADAM
BANKS, ELIZABETH WEISWASSER; PRIYATA PATEL,
CHRISTOPHER PEPE, Washington, DC.
STEVEN KATZ, Fish & Richardson PC, Boston, MA, ar-
gued for appellee. Also represented by KENTON W.
FREEMAN, JR., Washington, DC; RYAN PATRICK O'CONNOR,
JOHN C. PHILLIPS, San Diego, CA.
______________________
Case: 21-1995 Document: 42 Page: 2 Filed: 05/23/2022
2 ETHICON LLC v. INTUITIVE SURGICAL, INC.
Before NEWMAN, REYNA, and HUGHES, Circuit Judges.
Opinion for the court filed by Circuit Judge REYNA.
Dissenting opinion filed by Circuit Judge NEWMAN.
REYNA, Circuit Judge.
Appellant Ethicon LLC appeals a final written decision
issued in two consolidated inter partes review proceedings
where the Patent Trial and Appeal Board concluded that
the challenged claims are unpatentable as obvious. Ethi-
con contends that the Board committed legal error by plac-
ing the burden of proof on Ethicon, the patent owner.
Ethicon also contends that the Board’s finding of a reason-
able expectation of success in combining the asserted prior
art is unsupported by substantial evidence. 1 We affirm.
BACKGROUND
Ethicon owns U.S. Patent No. 9,844,379 B2 (the
“’379 Patent”), titled “Surgical stapling instrument having
a clearanced opening.” The ’379 Patent relates to an endo-
scopic surgical stapling tool. The purported novelty of the
claimed invention is the use of both an I-beam firing mem-
ber and a no-cartridge safety lockout, such that the lockout
blocks the advancement of an I-beam firing member when
there is no staple cartridge loaded in the stapling assembly.
See Appellant’s Br. 1–3. This safety mechanism is partic-
ularly useful for endoscopic procedures, which require a
1 Ethicon also argued in its opening brief that the
Board’s finding of a motivation to combine is unsupported
by substantial evidence. Appellant’s Br. 56–69. Ethicon
conceded this issue at oral argument, so we do not reach
the question here. Oral Arg. 8:00–8:30. We note, however,
that the absence of that waiver would not affect our dispo-
sition in this case.
Case: 21-1995 Document: 42 Page: 3 Filed: 05/23/2022
ETHICON LLC v. INTUITIVE SURGICAL, INC. 3
surgeon to work with reduced visual and tactile feedback
as compared to open surgery. Id.
On October 16, 2019, Appellee Intuitive Surgical, Inc.
(“Intuitive”) filed two petitions for inter partes review
(“IPR”) of claims 1–3 of the ’379 Patent. Intuitive Surgical,
Inc. v. Ethicon LLC, Nos. IPR2020-00050, IPR2020-00051,
2021 WL 1158290, at *1 (P.T.A.B. Mar. 26, 2021). On
March 31, 2020, the Board instituted the IPRs on the
ground that claims 1–3 are unpatentable as obvious over
U.S. Patent No. 4,429,695 (“Green”) in view of U.S. Patent
No. 5,413,267 (“Solyntjes”). 2 Id.
Green, titled “Surgical instruments,” describes a “sur-
gical stapling instrument” with “upper and lower elongate
jaws for receiving a staple cartridge and an anvil respec-
tively.” J.A. 5157. Green accounts for the majority of the
claimed features in the ’379 Patent, including a frame, a
distal end, a first jaw with a channel, and a channel re-
tainer. See Intuitive Surgical, 2021 WL 1158290, at *6–7.
Solyntjes, titled “Surgical stapler with spent cartridge
sensing and lockout means,” is directed to surgical stapling
instruments “for applying linear parallel rows of staggered
staples through compressed living tissue.” J.A. 5146.
Solyntjes teaches that there are benefits to equipping a
surgical stapler instrument with a locking pin to prevent
the instrument’s firing when it is loaded with an empty sta-
pler cartridge, as doing so “reduces the chances of unneces-
sary tissue trauma, blood loss, inadequate hemostasis, and
squandered time during surgery.” Solyntjes col. 2 ll. 65–
68.
2 The Board also instituted IPR on other grounds.
See Intuitive Surgical, 2021 WL 1158290, at *1. We do not
address those grounds, as they are not at issue on appeal.
Case: 21-1995 Document: 42 Page: 4 Filed: 05/23/2022
4 ETHICON LLC v. INTUITIVE SURGICAL, INC.
BOARD’S FINAL WRITTEN DECISION
During IPR, Ethicon conceded that Green and
Solyntjes disclose all the elements claimed by the chal-
lenged claims. Intuitive Surgical, 2021 WL 1158290, at *7.
Ethicon argued, however, that a person of ordinary skill in
the art (“POSITA”) (1) would not have been motivated to
combine Green with Solyntjes, and (2) would not have had
a reasonable expectation of success in doing so. Id. On
March 26, 2021, the Board issued a consolidated final writ-
ten decision addressing both issues.
Motivation to Combine
With respect to the question of a motivation to combine,
Intuitive relied on testimony from its expert, Dr. Knodel,
to argue that a POSITA would have recognized Solyntjes’s
locking mechanism would make Green’s instrument safer
and more efficient. Id. at *6–8. Ethicon, on the other hand,
relied on testimony from its own expert, Dr. Fronczak, to
argue that there would be no motivation to combine the ref-
erences because Green already provides the user with tac-
tile and visual feedback as to the presence or absence of a
staple cartridge. Id. at *7–8. The Green instrument was
for use in open surgery whereby the instrument was in the
surgeon’s field of vision. See Appellant’s Br. 3.
The Board determined that Dr. Fronczak’s expert opin-
ion relied too much on “speculation as to a user’s awareness
or cognizance during use of Green’s surgical stapler instru-
ment as to the presence or absence of a stapler cartridge.”
Id. at *7. The Board instead found that a POSITA would
have been motivated to combine the references because:
In particular, Solyntjes clearly sets forth that a
locking mechanism is valuable, as the dangers of
firing a surgical stapler instrument without a sta-
pler cartridge being present are significant, includ-
ing the risk of “unnecessary tissue trauma, blood
Case: 21-1995 Document: 42 Page: 5 Filed: 05/23/2022
ETHICON LLC v. INTUITIVE SURGICAL, INC. 5
loss, inadequate hemostasis, and squandered time
during surgery.” [Solyntjes col. 2 ll. 65–68].
[. . .]
It defies reason to conclude that a skilled artisan
would not have recognized readily the benefit of
employing a locking mechanism specifically di-
rected to preventing such firing. That is logically
so even if a user may already have an avenue to
recognize the presence or absence of a staple car-
tridge, such as through visual or tactile feedback,
as mere recognition in that regard is not under-
stood to actually prevent the firing of a cartridge-
less stapler. [Suppl. Decl. of Dr. Knodel ¶¶ 15–20].
Id. The Board also noted that Dr. Fronczak admitted it
would be “catastrophic” and a “hazard” if a user failed to
notice the absence of a stapler cartridge before attempting
to fire the instrument. Id. Accordingly, the Board found
that Intuitive sufficiently established a motivation to com-
bine Green with Solyntjes.
Reasonable Expectation of Success
With respect to the question of a reasonable expecta-
tion of success, Ethicon proffered testimony from
Dr. Fronczak supporting its contention that a POSITA
“would be incapable of implementing a ‘spring-and-pin
lockout mechanism,’ such as that disclosed in Solyntjes,
into a surgical stapler instrument having the particular
structural characteristic of Green’s instrument.” Id. at *8.
The Board discredited this testimony because it was “based
on little evidentiary support in the record” and “instead
largely premised on Dr. Fronczak’s speculation that physi-
cal difficulties or impediments in modifying Green’s instru-
ment would have been insurmountable.” Id.
The Board credited the testimony of Dr. Knodel that a
POSITA would know how to modify Green’s stapler with
the lockout taught in Solyntjes. Id. at *9. The Board found
Case: 21-1995 Document: 42 Page: 6 Filed: 05/23/2022
6 ETHICON LLC v. INTUITIVE SURGICAL, INC.
Dr. Knodel’s testimony “logical and credible,” as “appropri-
ately reflect[ing] the types of design assessments that such
a skilled artisan would have employed in seeking to im-
prove Green’s instrument based on Solyntjes’s teachings as
to a locking pin mechanism so as to harness the benefits of
such a mechanism.” Id. Recalling that “[b]oth parties
agree[d] that the level of ordinary skill in the relevant art
includes someone with a degree in mechanical engineering
and at least three years of design experience in surgical in-
struments,” the Board found that a motivated POSITA
would be able to “account for routine considerations, e.g.,
location, positioning, and robustness of a locking mecha-
nism, as a part of Green’s instrument.” Id.
Ultimately, the Board concluded that Intuitive estab-
lished by a preponderance of the evidence that claims 1–3
of the ’379 Patent are unpatentable as obvious. Id. at *10.
Ethicon appeals. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(4)(A).
STANDARD OF REVIEW
We review the Board’s legal conclusions de novo and its
factual findings for substantial evidence. ACCO Brands
Corp. v. Fellowes, Inc., 813 F.3d 1361, 1365 (Fed. Cir.
2016). Substantial evidence “means such relevant evi-
dence as a reasonable mind might accept as adequate to
support a conclusion.” In re Gartside, 203 F.3d 1305, 1312
(Fed. Cir. 2000) (quoting Consol. Edison Co., Inc. v. NLRB,
305 U.S. 197, 229–30 (1938)).
Obviousness is a question of law with underlying fac-
tual issues relating to the scope and content of the prior
art, differences between the prior art and the claims at is-
sue, the level of ordinary skill in the pertinent art, and any
objective indicia of non-obviousness. Randall Mfg. v. Rea,
733 F.3d 1355, 1362 (Fed. Cir. 2013) (citing KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 406 (2007); Graham v. John
Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966)).
Whether a skilled artisan would have been motivated to
Case: 21-1995 Document: 42 Page: 7 Filed: 05/23/2022
ETHICON LLC v. INTUITIVE SURGICAL, INC. 7
combine references in an obviousness determination is a
pure question of fact, which we review for substantial evi-
dence. Par Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d
1186, 1196 (Fed. Cir. 2014) (quoting Alza Corp. v. Mylan
Lab’ys, Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006)).
Whether a skilled artisan would have had a reasonable ex-
pectation of success in combining references is also a ques-
tion of fact. Id. (citation omitted).
DISCUSSION
On appeal, Ethicon argues that the Board improperly
placed the burden on Ethicon as the patentee to disprove
that a POSITA would have had a reasonable expectation of
success in combining Green and Solyntjes. Appellant’s
Br. 41–51. Ethicon also argues that the Board’s finding of
a reasonable expectation of success is unsupported by sub-
stantial evidence. Id. at 51–56.
I
We first address whether the Board improperly placed
the burden of proof on Ethicon. The fact that the petitioner
bears the burden of proof in a Board proceeding does not
eliminate the patent owner’s burden to proffer opposing ev-
idence against the petitioner’s showing of unpatentability.
See Novo Nordisk A/S v. Caraco Pharm. Lab’ys, Ltd.,
719 F.3d 1346, 1353 (Fed. Cir. 2013). In resolving a claim
of obviousness, the Board should consider the totality of ev-
idence proffered by both parties to resolve any subsidiary
factual inquiries, such as the scope and content of the prior
art, the existence of a motivation to combine, the existence
of a reasonable expectation of success, or the existence of
any objective indicia of non-obviousness. The petitioner
bears the burden to demonstrate by a preponderance of the
evidence that the patent is invalid. See 35 U.S.C. § 316.
And while the unpatentability inquiry must remain fo-
cused on whether the petitioner has borne its burden, that
the Board addresses the patentee’s counterarguments is
not an improper shifting of burdens. See, e.g., Bos. Sci.
Case: 21-1995 Document: 42 Page: 8 Filed: 05/23/2022
8 ETHICON LLC v. INTUITIVE SURGICAL, INC.
SciMed, Inc. v. Iancu, 811 F. App’x 618, 626 (Fed. Cir.
2020) (citing Novo Nordisk, 719 F.3d at 1353).
Here, the Board received competing expert testimony
and found Intuitive’s expert, Dr. Knodel, more credible
than Ethicon’s expert, Dr. Fronczak. The Board found that
Dr. Knodel logically and credibly opined that a POSITA
would have had a reasonable expectation of success in com-
bining Green with Solyntjes because an individual with a
mechanical engineering degree and at least three years of
experience designing surgical instruments would have
been capable of performing routine modifications to imple-
ment Solyntjes’s lockout mechanism in Green’s stapler.
The Board also found Dr. Fronczak’s testimony unsup-
ported by the record and largely speculative. This is not
indicative of a situation where the Board improperly
shifted the burden of proof on the patent owner to establish
non-obviousness in the first instance, as Ethicon argues.
Rather, the Board weighed competing evidence and made
its determination on the record as a whole.
II
We also conclude that substantial evidence supports
the Board’s finding that a POSITA would have had a rea-
sonable expectation of success in combining Green and
Solyntjes. Evidence of a reasonable expectation of success,
just like evidence of a motivation to combine, “may flow
from the prior art references themselves, the knowledge of
one of ordinary skill in the art, or, in some cases, from the
nature of the problem to be solved.” Brown & Williamson
Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125
(Fed. Cir. 2000) (citing Pro-Mold & Tool Co. v. Great Lakes
Plastics, Inc., 75 F.3d 1568, 1573 (Fed. Cir. 1996)).
Here, as discussed above, the Board credited
Dr. Knodel’s testimony that a POSITA would have had a
reasonable expectation of success in modifying the surgical
stapling instrument of Green to include the lockout mech-
anism of Solyntjes. Intuitive Surgical, 2021 WL 1158290,
Case: 21-1995 Document: 42 Page: 9 Filed: 05/23/2022
ETHICON LLC v. INTUITIVE SURGICAL, INC. 9
at *9. The Board acknowledged Ethicon’s argument that
the combination would require some modifications to fit
pieces of the invention together. The Board relied, how-
ever, on Dr. Knodel’s testimony that a POSITA would know
how to account for “routine considerations” such as “loca-
tion, positioning, and robustness of a locking mechanism,
as a part of Green’s instrument.” Id. And although
Dr. Fronczak testified that a POSITA would be “incapable”
of combining the references, the Board discredited his tes-
timony as speculative and unsupported by evidence in the
record. Id. at *8. In view of the foregoing, we conclude that
the Board’s finding of a reasonable expectation of success
is supported by substantial evidence, especially in light of
the parties’ stipulation regarding the relative skill and ex-
perience level of a POSITA in this case.
CONCLUSION
In summary, we hold that the Board did not misplace
the burden of proof on the patentee and that substantial
evidence supports the Board’s finding that a POSITA
would have had a reasonable expectation of success in com-
bining the asserted references. Thus, we affirm the Board’s
final written decision concluding that claims 1–3 of the ’379
Patent are unpatentable as obvious.
AFFIRMED
COSTS
Costs to Appellee.
Case: 21-1995 Document: 42 Page: 10 Filed: 05/23/2022
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
ETHICON LLC,
Appellant
v.
INTUITIVE SURGICAL, INC.,
Appellee
______________________
2021-1995, 2021-1997
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2020-
00050, IPR2020-00051.
______________________
NEWMAN, Circuit Judge, dissenting.
I respectfully dissent. The court reconstructs a novel
surgical device from components of known devices, using
the ’379 patent as a template for the reconstruction. The
court finds that an engineer with at least three years of ex-
perience in designing surgical instruments would have
been capable of designing the claimed device. However, the
patentability question is not whether such an engineer
would be capable of designing the instrument of the ’379
patent. The patentability question is whether the prior art
teaches or suggests the structure of the ’379 instrument as
a whole. Although the court finds that it would have been
obvious to combine the Solyntjes and Green reference
Case: 21-1995 Document: 42 Page: 11 Filed: 05/23/2022
2 ETHICON LLC v. INTUITIVE SURGICAL, INC.
mechanisms, it is not disputed that the Solyntjes’ spring-
and-pin mechanism is not a spent-cartridge lockout, and
that a simple combination does not produce the ’379 instru-
ment.
There is no teaching or suggestion in the prior art of
the ’379 patent’s structure as a whole, although the prior
art shows closely related surgical instruments. No refer-
ence shows or suggests a spring-and-pin lockout within the
jaws of an endoscopic cutting and stapling instrument.
And the inventors’ description in the ’379 specification of
the problem to be solved is not prior art against their solu-
tion. Although my colleagues now find it obvious to make
the ’379 instrument, no one did so despite the advantages
and benefits here achieved.
The ’379 instrument has advantages and benefits not
possessed by prior endoscopic instruments. Such an
achievement is of particular relevance in the field of medi-
cal technology, where afflicted patients may be benefitted
by any technological advantage. Such opportunity for ben-
efit is a purpose of the patent system, thereby serving the
public interest. The purpose of encouraging development
of new technology warrants recognition of the varied attrib-
utes of the myriad fields of technological ecommerce.
The panel majority finds the elements of the ’379 in-
vention in assorted prior art references, which the majority
then plugs into the claims. Such judicial hindsight was ne-
gated in KSR International, where the Supreme Court ob-
served that “inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed dis-
coveries almost of necessity will be combinations of what,
in some sense, is already known.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 418–19 (2007).
From my colleagues’ analysis and conclusion, I re-
spectfully dissent.