Ethicon LLC

Patent Trials and Appeals Board

Mar 26, 2021

IPR2020-00051 (P.T.A.B. Mar. 26, 2021)

Trials@uspto.gov Paper 53
571-272-7822 Date: March 26, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

INTUITIVE SURGICAL, INC.,
Petitioner,

v.

ETHICON LLC,
Patent Owner.
____________

IPR2020-00050
IPR2020-000511
Patent 9,844,379 B2
____________

Before JOSIAH C. COCKS, FRANCES L. IPPOLITO, and
MATTHEW S. MEYERS, Administrative Patent Judges.

COCKS, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
Granting Parties’ Motions to Seal
35 U.S.C. § 318(a)

1 As set forth herein, we exercise our discretion under 35 U.S.C. § 315(d) to
consolidate the two proceedings.
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I. INTRODUCTION
A. Consolidation
Pursuant to 35 U.S.C. § 315(d):
[D]uring the pendency of an inter partes review, if another
proceeding or matter involving the patent is before the Office,
the Director may determine the manner in which the inter partes
review of other proceeding or matter may proceed, including
providing for stay, transfer, consolidation, or termination of any
such matter or proceeding.
Here, each of IPR2020-00050 and IPR2020-00051 involves
challenges to claims 1–3 (“the challenged claims”) of U.S. Patent No.
9,844,379 B2 (Ex. 1001 (both proceedings), “the ’379 patent”). We exercise
our discretion to consolidate the proceedings and enter a single final written
decision pertaining to both proceedings.2
B. Background
Intuitive Surgical, Inc. (“Petitioner”) filed a Petition (IPR2020-00050,
Paper 3, “’050 Pet.”; IPR2020-00051, Paper 3, “’051 Pet.”) in each
proceeding to institute an inter partes review of the challenged claims. See

2 During a conference call on September 18, 2020, Petitioner requested that
the two proceedings be consolidated into a single proceeding with a single
final written decision. See IPR2020-00051, Ex. 1026, 7–10. At the time, the
panel and Patent Owner contemplated that there may be logistical issues,
including, for instance, concerns as to the effect of consolidation on briefing
submitted during trial, were the cases to then be consolidated. See id. At
this advanced stage of the proceedings, the panel considers entry of a single
final written decision to be appropriate.
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35 U.S.C. § 311. We instituted trial in each proceeding, to determine
whether the challenged claims were unpatentable as follows:
Claim(s) Challenged 35 U.S.C. § References/Basis
1–3 102 Shelton ’5623
IPR2020-00050, Paper 15 (“’050 Dec. on Inst.”).
Claim(s) Challenged 35 U.S.C. § References/Basis
1–3 102 Shelton ’8184,5

3 Shelton ’562, US 2005/0263562 A1 published Dec. 1, 2005 (IPR2020-
00050, Ex. 1004).
4 Shelton ’818, US 7,000,818 B2 issued Feb. 21, 2006 (IPR2020-00051, Ex.
1014).
5 Petitioner contends that Shelton ’818 incorporates by reference the entirety
of another document that Petitioner identifies as “U.S. Patent Application
Publication No. 2004/0232195 (‘Shelton ’195,’ [Ex. 1013]).” ’051 Pet. 19
(citing Ex. 1014, 1:8–26, 9:35–38). Shelton ’818, itself, does not reference
the particular application publication number that Petitioner terms “Shelton
’195,” and instead incorporates by reference four applications identified by
their titles and the names of their inventors. IPR2020-00051, Ex. 1014,
1:13–26. Petitioner relies on the Declaration testimony of Dr. Bryan Knodel
(Ex. 1003) to support that Shelton ’195 constitutes subject matter of one of
those four applications. ’051 Pet. 19 (citing Ex. 1003 ¶ 57, n.2). On the
record before us, we discern no reason to doubt Petitioner’s and Dr.
Knodel’s contention that one of the patent applications identified expressly
in Shelton ’818 is Shelton ’195 and is incorporated by reference in its
entirety as a part of Shelton ’818’s disclosure. Patent Owner also does not
contest that Shelton ’195 is incorporated by reference. Petitioner relies on
content of Shelton ’195 as a part of its proposed ground of anticipation based
on Shelton ’818.
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Claim(s) Challenged 35 U.S.C. § References/Basis
1–3 103 Green,6 Solyntjes7
IPR2020-00051, Paper 15 (“’051 Dec. on Inst.”).8
In IPR2020-00050, Ethicon LLC, (“Patent Owner”) timely filed a
Patent Owner’s Response. Paper 21 (“’050 PO Resp.”).9 Petitioner filed a
Reply. Papers 28, 29 (“’050 Pet. Reply”).10 Patent Owner subsequently
filed a Sur-Reply (Paper 38, “’050 Sur-Reply”) and Petitioner filed a Sur-
Sur-Reply (Paper 46, “’050 Sur-Sur-Reply”).11 A consolidated oral hearing
for both IPR2020-00050 and IPR2020-00051 occurred on January 12, 2021.

6 Green, US 4,429,695 issued Feb. 7, 1984 (IPR2020-00051, Ex. 1015).
7 Solyntjes, US 5,413,267 issued May 9, 1995 (IPR2020-00051, Ex. 1011).
8 Prior to our Decisions on Institution, and as was authorized by the panel
(Paper 9 in each proceeding), Patent Owner filed a “Motion Requesting
Leave to Petition the Director for a Certificate of Correction” (Paper 10 in
each proceeding). Although Petitioner opposed (Paper 11 in each
proceeding), we granted the Motion (Paper 13 in each proceeding). During
trial, on April 21, 2020, the Director issued a Certificate of Correction. See
Ex. 2004 (each proceeding).
9 Along with the Response, Patent Owner filed a “Motion to Seal and For
Entry of a Protective Order.” Paper 20.
10 Paper 28 is a version of the Reply designated “Protective Order Material -
Confidential.” IPR2020-00050, Paper 28; see also Paper 27 (Petitioner’s
Motion to Seal). Paper 29 is a redacted, public version.
11 Petitioner’s Sur-Sur-Reply was authorized by the panel. Paper 46.
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A transcript of the oral hearing appears in the record. IPR2020-00050,
Paper 49, Ex. 2102; IPR2020-00051, Paper 50, Ex. 2102.12
In IPR2020-00051, Patent Owner timely filed a Patent Owner’s
Response. Papers 21, 22 (“’051 PO Resp.”). Petitioner filed a Reply.
Papers 29, 30 (“’051 Pet. Reply”).13 Patent Owner subsequently filed a Sur-
Reply (Papers 39, 40, “’051 Sur-Reply”)14 and Petitioner filed a Sur-Sur-
Reply (Paper 47, “’051 Sur-Sur-Reply”).15
We have jurisdiction under 35 U.S.C. § 6. This Final Written
Decision is issued pursuant to 35 U.S.C. § 318(a). For the reasons that
follow, we determine that Petitioner has shown by a preponderance of the
evidence that the challenged claims of the ’379 patent are unpatentable.

12 The parties had represented that confidential material may be discussed
during the oral hearing. Accordingly, the hearing was closed to the public.
A non-public version of the transcript of the hearing was entered into the
record. IPR2020-00050, Paper 49; IPR2020-00050, Paper 50. The parties
were invited to submit jointly a public, redacted version of the transcript.
IPR2020-00050, Paper 50; IPR2020-00051, Paper 51. They did so
(IPR2020-00050, Paper 51; IPR2020-00051, Paper 52), and the parties’ joint
submission now appears in the record (IPR2020-00050, Ex. 2012; IPR2020-
00051, Ex. 2102).
13 Paper 29 is a version of the Reply designated “Protective Order Material -
Confidential.” Paper 29; see also Paper 28 (Petitioner’s Motion to Seal).
Paper 30 is a redacted, public version.
14 Paper 39 is a version of the Sur-Reply designated “Protective Order
Material.” Paper 39; see also Paper 38 (Patent Owner’s second Motion to
Seal). Paper 40 is a redacted, public version.
15 Petitioner’s Sur-Sur-Reply was authorized by the panel. Paper 46.
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C. Related Matters
The parties identify Ethicon LLC et al. v. Intuitive Surgical, Inc. et al.,
C.A. No. 1:18-cv-01325-LPS (D. Del.) as a proceeding in which Patent
Owner moved to amend its complaint to assert the ’379 patent against
Petitioner. Paper 6, 2 (each proceeding); see Pet. 2 (each proceeding).
Patent Owner explains that “[o]n July 17, 2019, Patent Owner’s motion was
denied without prejudice in light of the parties’ joint stipulation to stay that
litigation.” Paper 6, 2. The parties also refer to a United States International
Trade Commission proceeding alleging infringement of the ’379 patent by
Petitioner. Pet. 2; Paper 6, 2 (identifying Certain Reload Cartridges for
Laparoscopic Surgical Staplers, Inv. No. 337-TA-1167). Petitioner further
identifies several other inter partes review (“IPR”) proceedings involving
other U.S. patents that Patent Owner has asserted against Petitioner in
district court. Pet. 2–3. Patent Owner additionally references numerous
other U.S. patents and patent applications that it contends “claim priority to
one of more of the same applications(s) to which the ’379 patent claims
priority.” Paper 6, 3–7.
D. The ’379 Patent
The ’379 patent is titled “Surgical Stapling Instrument Having
Clearanced Opening,” and relates to “surgical instruments that are suitable
for endoscopically inserting an end effector that is actuated by a
longitudinally driven firing member.” Ex. 1001, code (54); 1:51–54. The
Abstract of the ’379 patent sets forth the following:
A stapling assembly comprising a first jaw and a second jaw,
wherein the first jaw is rotatable relative to the second jaw. The
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stapling assembly comprises a detachable cartridge portion
comprising a plurality of staples and an anvil configured to
deform the staples. The stapling assembly comprises a staple
firing member comprising a first cam configured to engage the
first jaw and a second cam configured to engage the second jaw
when the staple firing member is advanced from an initial
position, and wherein the first jaw comprises a clearanced
opening configured to receive the first cam when the staple firing
member is in the initial position such that the first cam is not
engaged with the first jaw when the staple firing member is in
the initial position.
Id. at code (57).
Figure 1 of the ’379 patent is reproduced below.

Figure 1 above shows “a perspective view of an endoscopic surgical
stapling instrument for surgical stapling and severing in an open,
unarticulated state.” Id. at 3:44–46. Surgical stapling instrument 10
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includes handle 14 and staple applying assembly 12 spaced from the handle
by elongate shaft 16. Id. at 4:58–61.
Figure 2 of the ’379 patent is reproduced below.

Figure 2 above “is a left front perspective view of an open staple
applying assembly of the surgical stapling instrument of FIG. 1 with a right
half portion of a replaceable staple cartridge included in a staple channel.”
Id. at 3:47–50. Staple receiving assembly 12 includes staple channel 18 for
receiving staple cartridge 20. Id. at 4:61–63. “Pivotally attached to the
staple channel 18 is an anvil 22 that clamps tissue to the staple cartridge 20
and serves to deform staples 23 [not shown in Figure 2] driven up from
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staple holes 24 in the staple cartridge 20 against staple forming recesses [not
shown in Figure 2] in an anvil undersurface 28 into a closed shape.” Id. at
4:63–5:1. “An E-beam 102 is the distal portion of the two-piece knife and
firing bar 90, which facilitates separate closure and firing as well as spacing
of the anvil 22 from the elongate staple channel 18 during firing.” Id. at
6:28–31.
Figure 6 of the ’379 patent is reproduced below.

Figure 6 above “is a left side view [ ] taken in longitudinal cross
section along a centerline line 6-6 of the staple applying assembly of FIG.
2.” Id. at 3:60–63. In Figure 6, surgical stapling instrument is shown in an
open state with E-Beam 102 fully retracted. Id. at 6:61–62. “E-beam 102 is
retracted with the top pins 110 thereof residing with an anvil pocket 150 near
the pivoting proximal end of the anvil 22.” Id. at 7:29–31.
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Figure 8 of the ’379 patent is reproduced below.

Figure 8 above “is a front view in elevation taken in cross section
along line 8-8 of the staple applying assembly of FIG. 2 depicting internal
staple drivers of the staple cartridge and portions of the two-piece knife and
firing bar.” Id. at 4:1–4. “Longitudinally aligned and parallel plurality of
downwardly open wedge slots 202 (FIG. 8) receive respective wedges 204
integral to the wedge sled 126.” Id. at 7:44–47.
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Figures 13 and 14 of the ’379 patent are reproduced below.

Figure 13 above is a left view cross-sectional view in elevation of a
closed staple applying assembly “after firing of the staple cartridge and
retraction of the two-piece knife.” Id. at 4:22–23. Figure 14 above is “a left
side cross-sectional detail view in elevation of the staple applying assembly
of FIG. 13 with the two-piece knife allowed to drop into a lockout position.”
Id. at 4:25–27. After firing, firing bar 90 is retracted leaving wedge sled 126
in a distal position. Id. at 8:18–19. The ’379 patent further states the
following:
In FIG. 14, the middle pin 112 is allowed to translate down
into a lockout recess 240 formed in the staple channel 18 . . .
Thus, the operator would receive a tactile indication as the
middle pin 112 encounters the distal edge of the lockout recess
240 when the wedge sled 126 (not shown in FIG. 14) is not
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proximally positioned (i.e., missing staple cartridge 20 or spent
staple cartridge 20).
Id. at 8:20–26.
E. Illustrative Claim
Each of claims 1–3 is independent. Claim 1 is illustrative and is
reproduced below.
1. A stapling assembly, comprising:
a frame;
a distal end;
a first jaw comprising a channel;
a channel retainer, wherein said channel is slidably
attachable to said channel retainer;
a second jaw extending from said frame;
a plurality of staples;
a staple firing member comprising a first cam configured
to engage said first jaw and a second cam configured to engage
said second jaw when said staple firing member is advanced from
an unadvanced position toward said distal end, wherein one of
said first jaw and said second jaw comprises a clearanced
opening configured to permit said firing member to be
unengaged with one of said first jaw and said second jaw when
said firing member is in said unadvanced position; and
a lockout configured to block the advancement of said
staple firing member when said channel is not attached to said
channel retainer.
Ex. 1001, 8:60–9:11.
II. ANALYSIS
A. Claim Construction
In an inter partes review, a claim “shall be construed 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).
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Under this standard, claim terms are given their ordinary and customary
meaning as would have been understood by a person of ordinary skill in the
art at the time of the invention and in the context of the entire patent
disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
2007). We determine that it is unnecessary to provide an explicit
construction of any additional claim term in order to resolve the issues in
dispute in this proceeding. Nidec Motor Corp. v. Zhongshan Broad Ocean
Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that claim
terms need to be construed “only to the extent necessary to resolve the
controversy” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
795, 803 (Fed. Cir. 1999))).
B. Proposed Ground of Obviousness Based on Green and Solyntjes
1. Principles of Law
A claim is unpatentable under 35 U.S.C. § 103 if the differences
between the claimed subject matter and the prior art are “such that the
subject matter as a whole would have been obvious at the time the invention
was made to a person having ordinary skill in the art to which such subject
matter pertains.” 35 U.S.C. § 103(a). The question of obviousness under
35 U.S.C. § 103 is resolved on the basis of underlying factual
determinations, including: (1) the scope and content of the prior art; (2) any
differences between the claimed subject matter and the prior art; (3) the level
of skill in the art; and (4) objective evidence of nonobviousness, i.e.,
secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17–
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18 (1966).16 “While the sequence of these questions might be reordered in
any particular case, the factors continue to define the inquiry that controls.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407 (2007).
2. Level of Ordinary Skill in the Art
Patent Owner expresses the following as to the level of ordinary skill
in the art:
Patent Owner’s expert, Dr. Fronczak, has opined that a
person of ordinary skill in the art (“POSITA”) with respect to the
379 Patent would include someone who has a Bachelor’s degree
in Mechanical Engineering or an equivalent branch of
engineering, as well as 3 years of experience in the design and
analysis of minimally invasive surgical instruments or
comparable surgical devices. [IPR2020-00051,] Ex. 2094 ¶ 33.
Petitioner’s expert, Dr. Knodel, has opined that a POSITA would
include someone who had the equivalent of a Bachelor’s degree
or higher in mechanical engineering with at least 3 years working
experience in the design of comparable surgical devices.
[IPR2020-00051,] IS1003 ¶¶ 25–26. Accordingly, there does not
appear to be a material dispute between the parties regarding the
level of ordinary skill in the art.
’051 PO Resp. 15.
Petitioner does not challenge Patent Owner’s explanation of the
parties’ positions with respect to the level of ordinary skill in the art. We
agree that there is no material dispute between the parties’ experts in that
respect, and adopt the proposed assessments. We also discern that the
applied prior art reflects the appropriate level of skill at the time of the

16 Neither party has submitted or relied on any objective evidence of non-
obviousness.
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claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
Cir. 2001).
3. Overview of Green
Green is titled “Surgical Instruments.” IPR2020-00051, Ex. 1015,
code (54). Green describes “[a] surgical stapling instrument [that] has upper
and lower elongate jaws for receiving a staple cartridge and an anvil
respectively.” Id. at code (57).
Green’s Figures 1 and 2 are reproduced below:

Figures 1 and 2 above illustrate a surgical stapling instrument in a
closed position (Figure 1) and an open position (Figure 2). Id. at 2:59–62.
Surgical stapling instrument 10 includes upper frame 12 defining elongate
upper jaw 16 and lower frame 14 defining elongate lower jaw 20. Id. at
3:23–27. Handle 26 operates to open and close the frames about pivot
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means 24, 28. Id. at 3:34–37.
Green’s Figure 3 is reproduced below:

Figure 3 depicts an “exploded view of the instrument.” Id. at 2:63.
The surgical stapler instrument includes sliding pusher bar and knife
assembly 30 with knife 42 that is situated to the rear of pusher bar cams 38
and 40. Id. at 3:40–47 Green explains the following:
In use, a disposable staple cartridge 44, containing four
laterally spaced longitudinal rows of staples is inserted into the
lower jaw 20 while two anvil members 72 having staple shaping
depressions in their outer surfaces, complimentary to the
positioning of the individual staples in the staple cartridge, are
placed on the upper jaw 16. The instrument is inserted into a
patient’s body and manipulated such that tissue to be cut and
sutured is inserted between the jaws, and incision to receive one
of the jaws having previously been made in the tissue if required.
The jaws are then closed and locked by handle 26 to firmly grip
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the tissue between the opposing staple cartridge and anvil
surface. The pusher bar and knife assembly, which is initially in
a rearward position relative to the jaws, is then pushed forward
causing the pusher bar cams to enter longitudinal slits in the
staple cartridge, in which slits are accommodated rows of
individual stapler pushers. The pusher bar cams cooperate
sequentially with camming surfaces on the individual staple
pushers to force the staples successively from the cartridge,
through the gripped tissue and into engagement with the anvil
depressions which thereby, in conjunction with the cams,
produce staple-closing forces.
Id. at 3:48–4:3.
4. Overview of Solyntjes
Solyntjes is titled “Surgical Stapler with Spent Cartridge Sensing and
Lockout Means.” IPR2020-00051, Ex. 1011, code (54). Solyntjes’s
Abstract reads as follows:
A stapler is disclosed that includes a mechanism for
sensing whether the stapler is loaded with a fire cartridge housing
and for preventing the stapler from being closed or fired when
loaded with the fired cartridge. The mechanism also prevents the
stapler from firing or clamping on tissue when the stapler is not
loaded with a stapler cartridge.
Id. at code (57).
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Solyntjes’s Figures 2 and 3 are reproduced below:

Figures 2 and 3 above illustrate operation of stapler 10 in an open
position (Figure 2) and a closed position (Figure 3). Id. at 8:13–18.
Actuation means 50 operates to transition cartridge assembly 32 from an
open to a closed position. Id.
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Solyntjes’s Figures 12 and 13 are reproduced below:

Figures 12 and 13 above illustrate enlarged views of the distal end of
a stapler in a pre-fired position (Figure 12) and a fired position (Figure 13).
Id. at 6:8–13. The stapler includes a means for preventing cartridge
assembly 32 from moving from an open to a closed position. Id. at 10:64–
66. That means comprises anvil frame 12 defining safety aperture 81 and
locking plate or pin 82 residing in the safety aperture. Id. at 10:66–11:2.
Locking pin 82 is biased by coil spring 86 to move into the path of ram 48 to
block movement of cartridge assembly 32 when the assembly is not loaded
with a ready-to-fire staple cartridge. Id. at 10:48–11:18. In that regard,
Solyntjes describes that “pin 82 prevents firing of the stapler 10 should the
fired cartridge housing be replaced with another fired cartridge.” Id. at
12:67–13:3. Solyntjes also specifies that “pin 82 will not only prevent the
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stapler 10 from firing when loaded with a spent cartridge, but will also
prevent the firing of the stapler 10 when the stapler is not loaded with a
cartridge housing 40 at all.” Id. at 12:62–66.
Solyntjes summarizes the benefits of its means for preventing
cartridge assembly movement as follows:
The means for preventing the cartridge assembly from moving
from the open to the closed position (1) prevents approximation
and clamping of living tissue between anvil and cartridge
components of the stapler when the stapler is loaded with a spent
stapler cartridge, (2) prevents the user from attempting to refire
the stapler, and (3) provides a stapler that reduces the chances of
unnecessary tissue trauma, blood loss, inadequate hemostasis,
and squandered time during surgery.
Id. at 2:59–68.
5. Discussion
Petitioner proposes that Green and Solyntjes disclose all the features
of the challenged claims. ’051 Pet. 59–86. More specifically, Petitioner
contends that the stapling assembly of Green accounts for the majority of the
claim features including a frame, a distal end, a first jaw with a channel, a
channel retainer, a second jaw, a plurality of staples, and a staple firing
member. See generally id. Petitioner points to Solyntjes as teaching the
claim element of “a lockout” that is “configured to block the advancement of
said staple firing member when said channel is not attached to said channel
retainer.” Id. at 69–75. Petitioner contends that a person of ordinary skill in
the art would have had multiple reasons to implement a Solyntjes’s locking
mechanism in Green’s surgical stapling device as one of ordinary skill in the
art would have recognized that such a locking mechanism “would
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advantageously prevent the inadvertent severing of tissue when the device is
loaded with a spent cartridge or no cartridge,” and “would have made
Green’s instrument safer and more efficient.” Id. at 75–77. Petitioner also
reasons that a skilled artisan would have recognized Green’s stapling
instrument as being “ready for improvement to yield predictable results.” Id.
at 77–78 (citing KSR, 550 U.S. at 417). Petitioner supports its position as to
its proposed combination of Green and Solyntjes with citation to the
testimony of Dr. Knodel. Id. at 75–78 (citing Ex. 1003 ¶¶ 157–171).
Patent Owner does not dispute that all of the features required by the
challenged claims are found in the prior art teachings of Green and
Solyntjes. Rather, Patent Owner takes the position that a person of ordinary
skill in the art neither would have been motivated to combine those
teachings nor would have had a reasonable expectation of success in doing
so. ’051 PO Resp. 57–85; ’051 Sur-Sur-Reply 3–38. Patent Owner offers a
variety of arguments in support of its position, but for the reasons that follow
we find them all unpersuasive.
For instance, Patent Owner argues that Green “already provides the
user with tactile and visual feedback as to the presence or absence of a staple
cartridge.” ’051 PO Resp. 59. Thus, in Patent Owner’s view, a skilled
artisan would have regarded Green’s disclosure as “negat[ing] the need for a
no-cartridge lockout in Green[.]” Id. at 62. Patent Owner bases that view
almost entirely on the testimony of Dr. Fronczak. Id. at 59–64 (citing Ex.
2094 ¶¶ 258–265). In reviewing that testimony, we discern that it is
generally premised on Dr. Fronczak’s speculation as to a user’s awareness or
cognizance during use of Green’s surgical stapler instrument as to the
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presence or absence of a stapler cartridge. We find that speculation
unpersuasive.
In that respect, Dr. Fronczak does not explain persuasively why the
prospect that a user might happen to recognize that a stapler instrument is
missing a staple cartridge eliminates motivation to employ a locking
mechanism, as in Solyntjes, which is an assembly dedicated to preventing
the instrument’s firing in the very circumstance of the absence of a cartridge.
Solyntjes’s teachings as to the safety benefit of a locking mechanism as a
part of a stapler instrument are unambiguous. In particular, Solyntjes clearly
sets forth that a locking mechanism is valuable, as the dangers of firing a
surgical stapler instrument without a staple cartridge being present are
significant, including the risk of “unnecessary tissue trauma, blood loss,
inadequate hemostasis, and squandered time during surgery.” IPR2020-
00051, Ex. 1011, 2:65–68. Indeed, as noted by Petitioner (’051 Sur-Sur-
Reply 2), on cross examination, Patent Owner’s own declarant, Dr.
Fronczak, himself expressed that firing of an instrument in that scenario
would be “catastrophic” and presents a “hazard.” See, e.g., Ex. 1019,
101:20–102:56; Ex. 1027, 21:11–22:1. It defies reason to conclude that a
skilled artisan would not have recognized readily the benefit of employing a
locking mechanism specifically directed 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 cartridge, such as through visual or tactile
feedback, as mere recognition in that regard is not understood to actually
prevent the firing of a cartridge-less stapler. See, e.g., Ex. 1025
(Supplemental Declaration of Dr. Knodel) ¶¶ 15–20) (Dr. Knodel testifying
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that Green’s visual or tactile feedback indications do not prevent a user from
firing a stapler that does not have a staple cartridge). We credit Dr.
Knodel’s testimony on this matter.
Patent Owner also contends that combining Solyntjes’s teachings of a
locking mechanism with Green would require “substantial modifications”
because the two references disclose “fundamentally different architectures.”
See, e.g., ’051 PO Resp. 65; ’051 Sur-Reply 14–15. At the outset, we
observe that the stapler instruments of Green and Solyntjes hardly seem
“fundamentally different,” as even a casual review of the two references
reveals that they include similar structures to accomplish a staple firing
operation, and perform similar functions of stapling tissue. For example,
both devices include jaw portions with anvil surfaces that operate by virtue
of a pivoting lever to bring the jaws from an open to a closed position for the
purpose of firing staplers from a staple cartridge into tissue. Compare, e.g.,
IPR2020-00051, Ex. 1011, 8:14–52, Figs 2, 3, with IPR2020-00051, Ex.
1015, 3:23–4:9, Figs. 1, 2. Nevertheless, even considering that some
modification of Green’s instrument is necessary to implement Solyntjes’s
teachings of a locking mechanism, such modification is not an anathema to
the obviousness inquiry.
A showing of obviousness does not require that references be
physically combinable, without change. In re Sneed, 710 F.2d 1544, 1550
(Fed. Cir. 1983). Indeed, “[c]laims may be obvious in view of a
combination of references, even if the features of one reference cannot be
substituted physically into the structure of the other reference.” Orthopedic
Equipment Co., Inc. v. U.S., 702 F.2d 1005, 1013 (Fed. Cir. 1983). Thus,
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the obviousness inquiry does not turn on whether modifications to a surgical
stapling instrument, such as Green’s, in view of Solyntjes’s teachings of a
locking mechanism, may require something more than direct physical
insertion of one structure into another. Furthermore, Patent Owner does not
assert that any necessary change to the structure or arrangement of Green’s
surgical stapling instrument, even if substantial, is beyond the skill or ability
of one of ordinary skill in the art. It is well settled that a person of ordinary
skill in the art is also a person of ordinary creativity. KSR, 550 U.S. at 421.
A skilled artisan of ordinary creativity reasonably would appreciate
necessary design modifications or adjustments to implement a known safety
component for a surgical implement, i.e., Solyntjes’s locking mechanism,
into a surgical implement, as in Green, that is missing such a component but
is ripe for its implementation. We credit Dr. Knodel’s testimony to that
effect. See, e.g., IPR2020-00051, Ex. 1003 ¶¶ 154–171.
Patent Owner additionally argues that a person of ordinary skill in the
art would have lacked a reasonable expectation of success in combining
Green and Solyntjes. ’051 PO Resp. 79–87; ’051 Sur-Reply 21–38.
Generally, Patent Owner bases that argument on two theories, as follows:
First, a [person of ordinary skill in the art] would not expect there
to be sufficient space to add a spring-and-pin lockout mechanism
to Green’s stapler jaws. Ex. 2094 ¶ 290. Second, a [person of
ordinary skill in the art] would not expect a spring fitted into
Green’s stapler’s jaws, if it could be made to work at all, to be
able to withstand user applied force. Ex. 2094 ¶ 296.
’051 PO Resp. 80.
We do not find either of Patent Owner’s theories persuasive. The
general assumption underscoring those theories is that a skilled artisan in the
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area of surgical staplers 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 characteristics of Green’s
instrument. In offering that assumption, Patent Owner relies extensively on
the testimony of Dr. Fronczak. ’051 Pet. 79–87 (citing Ex. 2094 ¶¶ 288–
302). That testimony, however, is based on little evidentiary support in the
record, and is instead largely premised on Dr. Fronczak’s speculation that
physical difficulties or impediments in modifying Green’s instrument would
have been insurmountable for a skilled artisan to produce a functional
instrument that incorporates Solyntjes’s locking pin mechanism. What a
reference teaches, however, must be taken in the context of the knowledge,
skill and reasoning ability of one with ordinary skill in the art. Syntex
(U.S.A) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005).
Moreover, a skilled artisan is presumed to know something about the art
apart from what the reference expressly discloses. See In re Jacoby, 309
F.2d 513, 516 (CCPA 1962); see also DyStar Textilfarben GmbH & Co. v.
C.H. Patrick Co., 464 F.3d 1356, 1360 (Fed. Cir. 2006) (explaining that “the
prior art” includes basic principles unlikely to be restated in cited
references). We are not persuaded that Dr. Fronczak’s speculation
adequately takes into account what a skilled artisan in the art of surgical
stapler devices would have appreciated from the teachings of the prior art.
“[I]f a technique has been used to improve one device, and a person of
ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill.” KSR, 550 US at 417. In this case,
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Solyntjes is unmistakable in its teachings that there are notable, recognized
benefits in equipping a surgical stapler instrument with a particular locking
pin assembly for preventing the firing of the instrument when a staple
cartridge is either empty or absent. See, e.g., IPR2020-00051, Ex. 1011,
2:59–68. For example, as noted above, those benefits include “prevent[ing]
the user from attempting to refire the stapler” and “provid[ing] a stapler that
reduces the chances of unnecessary tissue trauma, blood loss, inadequate
hemostasis, and squandered time during surgery.” Id. at 2:64–68. It follows
readily that a person of ordinary skill in the art would have appreciated that
such benefits would also be desirable in other types of stapler instruments
that involve firing staples from a staple cartridge into tissue, but do not
provide for the prevention of such firing in the circumstance of a missing
staple cartridge, e.g., Green’s surgical stapler instrument.
Both parties agree 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 instruments. See, e.g., ’051 PO Resp.
15; IPR2020-00051, Ex. 2094 ¶ 33; IPR2020-00051, Ex. 1003 ¶¶ 25–26.
Dr. Knodel testifies that a person with such a background would be guided
by the teachings of Solyntjes to modify Green’s stapler so as to result in an
instrument that accounts for the challenged claims. See, e.g., IPR2020-
00051, Ex. 1003 ¶¶ 154–206. In our view, Dr. Knodel’s testimony is logical
and credible and appropriately reflects the types of design assessments that
such a skilled artisan would have employed in seeking to improve Green’s
instrument based on Solyntjes’s teachings as to a locking pin mechanism so
as to harness the benefits of such a mechanism. We are not persuaded that
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such design assessments would be deficient or inadequate to account for
routine considerations, e.g., location, positioning, and robustness of a
locking mechanism, as a part of Green’s instrument. We determine that
Dr. Knodel’s testimony on the matter is more persuasive than the
countervailing testimony of Dr. Fronczak, and we therefore credit Dr.
Knodel’s testimony over that of Dr. Fronczak.17
We have considered all of Patent Owner’s arguments challenging the
ground of unpatentability of the challenged claims based on Green and
Solyntjes, but find them unavailing. We conclude that the record before us
reflects that Petitioner has made the requisite showing that the challenged
claims would have been unpatentable for obviousness.
C. Proposed Grounds of Anticipation
Petitioner proposes grounds of anticipation to the challenged claims
based on each of Shelton ’818 and Shelton ’562. Because we conclude
above that all of the challenged claims of the ’379 patent are unpatentable

17 Patent Owner contends that Dr. Knodel’s testimony is unreliable. ’051
PO Resp. 87–88. That contention is based on testimony from Dr. Knodel, at
his deposition on June 3, 2020, in which he apparently characterized a type
of “ETS 45 stapler” that he had designed while an engineer for Ethicon in
the 1990s as including a no-cartridge lockout. Id. Patent Owner challenges
the accuracy of that testimony. In a supplemental declaration (Ex. 1025),
Dr. Knodel testifies that during his deposition he confused one type of
stapler he had previously designed, the “ETS 45 stapler,” with another “EZ
45 stapler” that he had also designed, and which he testifies includes a “no-
cartridge lockout.” IPR2020-00051, Ex. 1025 ¶ 36. We find Dr. Knodel’s
explanation in his supplemental declaration sufficient and credible and
conclude that Dr. Knodel’s testimony is reliable.
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based on Green and Solyntjes, we determine that it is unnecessary to reach
the merits of either of the proposed anticipation grounds.
III. MOTIONS TO SEAL
A. Listing of the Motions
Both parties have filed Motions to Seal. Neither party has filed an
opposition to any of the Motions. The Motions to Seal are summarized
below.
Petitioner’s Motions To Seal
Proceeding and Paper No. Documents sought to be sealed
IPR2020-00050, Paper 27 Paper 28 (Petitioner’s Reply);
Exhibit 1012
IPR2020-00051, Paper 28 Paper 29 (Petitioner’s Reply);
Exhibit 1025

Patent Owner’s Motions To Seal
Proceeding and Paper No. Documents sought to be sealed
IPR2020-00050, Paper 20 Exhibit 2094
IPR2020-00051, Paper 20 Exhibits 2012–2014, 2017–2050,
2052–2070, 2072–2085, 2094, 2095
IPR2020-00051, Paper 38 Paper 39 (Patent Owner’s Sur-
Reply); Exhibit 2099

B. Consideration of the Motions
There is a strong public policy in favor of making information filed in
an inter partes review open to the public, especially because the proceeding
determines the patentability of claims in an issued patent and, therefore,
affects the rights of the public. Under 35 U.S.C. § 316(a)(1) and 37 C.F.R.
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§ 42.14, the default rule is that all papers filed in an inter partes review are
open and available for access by the public; a party, however, may file a
concurrent motion to seal and the information at issue is sealed pending the
outcome of the motion. It is, however, only “confidential information” that
is protected from disclosure. 35 U.S.C. § 316(a)(7); see Trial Practice
Guide, 77 Fed. Reg. at 48,760. The standard for granting a motion to seal is
“for good cause.” 37 C.F.R. § 42.54(a). The party moving to seal bears the
burden of proof in showing entitlement to the requested relief, and must
explain why the information sought to be sealed constitutes confidential
information. 37 C.F.R. § 42.20(c).
We have reviewed all the parties’ Motions to Seal. On the record
before us, we conclude that both parties have shown that the documents
sought to be sealed contain confidential information.
We further note that in the Scheduling Order of each proceeding, we
expressed to the parties the following: “[r]edactions to documents filed in
this proceeding should be limited to the minimum amount necessary to
protect confidential information, and the thrust of the underlying argument
or evidence must be clearly discernible from the redacted versions.”
See, e.g., IPR2020-00050, Paper 16, 2–3; IPR2020-00051, Paper 16, 2–3.
We discern that the parties have largely complied with that requirement. To
that end, the record as a whole provides a clear and understandable basis for
an adequate appreciation of the issues that were developed and resolved
during the course of this inter partes review, without the need to make
public any of the material that the parties seek to be maintained under seal.
We conclude that the parties have established sufficiently good cause
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30
to grant the Motions to Seal that are before us. Furthermore, in each of
IPR2020-00050 and IPR2020-00051, as a part of Paper 20, Patent Owner
expresses that “[b]y agreement of the parties, Patent Owner also requests
entry of the Proposed Protective Order (Attachment 1). In each case,
Attachment 1 to Paper 20 is titled “[Stipulated] Protective Order.” There is
also an “Attachment 2” to Paper 20 in each case that is a redlined version of
the Stipulated Protective Order showing the proposed variations from the
Board’s default Protective Order (see Office Patent Trial Practice Guide, 77
Fed. Reg. 48,756, App. B (Aug. 14, 2012)). Attachment 1 and Attachment 2
of Paper 20 in each of IPR2020-00050 and IPR2020-00050 are identical.
We grant each of the parties’ Motions to Seal and enter the Stipulated
Protective Order (each proceeding, Paper 20, Attachment 1). Furthermore,
until further notice from the Board, the record will be preserved in its current
form.
IV. CONCLUSION18
For the foregoing reasons, we conclude that Petitioner has shown by a
preponderance of the evidence that claims 1–3 of the ’379 patent are
unpatentable for obviousness based on Green and Solyntjes. We do not

18 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 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).
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reach the merits of the anticipation grounds based on Shelton ’818 or
Shelton ’562.
In summary,
Claims
35
U.S.C.
§ Reference(s)/Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1–3 103 Green, Solyntjes 1–3
1–3 102 Shelton ’81819
1–3 102 Shelton ’562
Overall Outcome 1–3
V. ORDER
It is
ORDERED that Petitioner has established by a preponderance of the
evidence that claims 1–3 of U.S. Patent 9,844,379 B2 are unpatentable;
FURTHER ORDERED that Petitioner’s Motions to Seal (IPR2020-
00050, Paper 27; IPR2020-00051, Papers 28) are granted;
FURTHER ORDERED that Patent Owner’s Motions to Seal
(IPR2020-00050, Paper 20; IPR2020-00051, Papers 20, 38) are granted; and

19 As noted above, because we conclude that all of the challenged claims of
the ’379 patent are unpatentable based on Green and Solyntjes, we do not
reach the merits of either of the proposed anticipation grounds.
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FURTHER ORDERED because this is a final written decision, the
parties to this proceeding seeking judicial review of our Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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PETITIONER:

John Phillips
Steven Katz
Ryan O’Connor
Jennifer Huang
Kenton Freeman
FISH & RICHARDSON P.C.
phillips@fr.com
katz@fr.com
oconnor@fr.com
jjh@fr.com
kfreeman@fr.com

PATENT OWNER:

Anish Desai
Elizabeth Weiswasser
Adrian Percer
Christopher Marando
Christopher Pepe
Ian Moore
WEIL, GOTSHAL, & MANGES LLP
anish.desai@weil.com
elizabeth.weiswasser@weil.com
adrian.percer@weil.com
christopher.marando@weil.com
christopher.pepe@weil.com
imoore2048@gmail.com