Rex Medical, L.P.

Patent Trials and Appeals Board

Mar 26, 2021

IPR2020-00152 (P.T.A.B. Mar. 26, 2021)

Trials@uspto.gov Paper 35
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.
REX MEDICAL, L.P.,
Patent Owner.

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Before GEORGE R. HOSKINS, MICHAEL L. WOODS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
WOODS, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining Some Challenged Claims Unpatentable
35 U.S.C. § 318(a)

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I. INTRODUCTION
Petitioner, Intuitive Surgical, Inc., filed a Petition (Paper 2, “Pet.”)
requesting inter partes review of claims 4–24 (“the challenged claims”) of
U.S. Patent No. 9,439,650 B2 (Ex. 1001, “the ’650 patent”).1 Pet. 3. We
issued a decision to institute an inter partes review of these claims. Paper 9
(“Institution Decision” or “Inst. Dec.”).
After institution, Rex Medical, L.P. (“Patent Owner”) filed a Patent
Owner Response (Paper 13 (“PO Resp.” or “Response”)), to which
Petitioner replied (Paper 21 (“Pet. Reply” or “Reply”)). Patent Owner also
filed a Sur-Reply to Petitioner’s Reply. Paper 25 (“PO Sur-Reply” or “Sur-
Reply”).
Oral argument, or hearing, was held on January 27, 2021, and the
transcript of the hearing has been entered as Paper 34.
We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden
of proving unpatentability of the challenged claims, and the burden of
persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l
Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner
must prove unpatentability by a preponderance of the evidence. See 35
U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued
pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons that
follow, we determine that Petitioner has shown that claims 4, 5, 9–18, 20,
and 22–24 of the ’650 patent are unpatentable. Petitioner has not shown that
claims 6–8, 19, and 21 of the ’650 patent are unpatentable.

1 Petitioner identifies itself as the only real party in interest. Pet. 1.
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A. Related Proceedings
The parties identify the following two related cases as pending before
the U.S. District Court for the District of Delaware: Rex Medical, L.P. v.
Intuitive Surgical, Inc., Intuitive Surgical Operations, Inc., and Intuitive
Surgical Holdings, Inc., 1:19-cv-00005-MN (Del.), filed January 2, 2019,
and Rex Medical, L.P. v. Covidien LP, 1:19-cv-01092-MN (Del.), filed June
13, 2019. Pet. 1–2; Paper 5, 2. Petitioner also identifies U.S. Pat. No.
10,136,892 and pending U.S. Patent Application Nos. 16/185,506 and
16/564,543 as related to the ’650 patent. See Pet. 1–2.

B. The ’650 Patent (Ex. 1001)
The ’650 patent is titled “Apparatus and Method for Resectioning
Gastro-Esophageal Tissue” and describes a system for stapling tissue. Ex.
1001, codes (54), (57). To illustrate an embodiment of the ’650 patent’s
stapling apparatus, we reproduce its Figure 3, below:

Figure 3 depicts a perspective view of an illustrative embodiment of the ’650
patent’s stapling system. Id. at 2:7–10, 2:19–20. In particular, Figure 3
depicts stapling apparatus 10 with proximal handle portion 12, elongated
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flexible body portion 14 that extends from handle portion 12, and C-shaped
stapling assembly 16 at the distal end of flexible body portion 14. Id. at
3:55–59. Stapling apparatus 10 also includes actuation cable 44 and
actuation knob 38 that, together, operate jaws 17. Id. at 4:61–63. The ’650
patent further describes that in at least one embodiment, an I-beam member
is used for bringing jaws 17 together. See id. at 2:57–59. To illustrate the I-
beam, we reproduce Figure 14, below:

Figure 14 depicts I-beam member 70 with upper beam portion 82a and lower
beam portion 82b, connected via central web portion 84. Id. at 5:45–47. As
shown, leading edge 84a of central web portion 84 may include a cutting
blade for incising tissue as I-beam member 70 moves distally. Id. at 5:47–
50. To illustrate the location of I-beam member 70 within the distal portion
of the stapling apparatus, we reproduce Figure 15, below:
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Figure 15 depicts the jaws as closed by operation of actuation cable 44. Id.
at 5:36–50, Fig. 3. Once the jaws are closed to hold tissue between them,
I-beam 70 is moved distally along the jaws, during which upper portion 82a
of the I-beam rides in a channel in the upper jaw and lower portion 82b of
the I-beam rides in a channel of the lower jaw. Id. at 5:36–50. I-beam 70 is
driven by pusher 80, and when the I-beam is driven distally, a sloped leading
edge of upper portion 82a (shown above) contacts, sequentially, each of a
plurality of staple pushers 118, driving the staples through their respective
staple slots out of staple carrying portion 40, through the tissue, and into
staple forming pockets 122 of staple forming portion 50. Id. at 6:26–40.

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C. Illustrative Claims
Of the challenged claims, claims 4 and 13 are independent. Ex. 1001,
8:4–10:9. We reproduce these claims, below, and add brackets with
numbers that correspond to Petitioner’s reference numbers of the claimed
limitations (see, e.g., Pet. 19–29):
4. [4.0] An apparatus for stapling tissue, comprising:
[4.1] a first jaw and a second jaw, at least one of the first
jaw and the second jaw being movable with respect to the other
of the first jaw and the second jaw from a first configuration in
which the first jaw and the second jaw are separated from each
other at a first distance to receive tissue and a second
configuration in which the first jaw and the second jaw are
clamped together at a second distance to hold tissue
therebetween for stapling,
[4.2] a staple carrying portion of the first jaw defining slots
through which staples are configured to pass;
[4.3] an anvil surface defined on the second jaw opposing
the first jaw;
[4.4] at least one of a gear and a cable operatively coupled
to at least one of the first jaw and the second jaw and configured
to move at least one of the first jaw and the second jaw from the
first configuration to the second configuration such that the first
jaw and the second jaw are in alignment; and
[4.5] a staple pusher configured to cause a staple to move
from a first position at least partially within the staple carrying
portion to a second position entirely outside the staple carrying
portion, [4.6] the second distance and the alignment being
maintained by a beam configured to engage the first and second
jaws from within the first and second jaws while tissue is stapled
from a proximal location to a distal location.
Id. at 8:4–33 (bolded and bracketed portions added).

13. [13.0] An apparatus, comprising:
[13.1] a head portion having a first jaw and a second jaw
configured to move between a first configuration for receiving
tissue and a second configuration for stapling tissue,
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[13.1.1] the first jaw defining a cavity configured to
receive a plurality of staples and a plurality of slots
configured to pass staples therethrough;
[13.1.2] the second jaw having a staple-forming
surface; and
[13.2] a beam whose opposite end portions are connected
by a central web portion and are configured to clamp and align
the first and second jaws from therewithin when in the second
configuration as the beam moves distally along a channel defined
in a tissue contacting surface of each of the first and second jaws;
and
[13.3] a control handle configured to actuate receiving,
clamping and stapling of tissue, and
[13.4] a shaft coupling the control handle to the head
portion.
Id. at 8:63–9:14 (bolded and bracketed portions added).
The other challenged claims depend, directly or indirectly, from claim
4 or 13. See id. at 8:34–8:62, 9:15–10:9.

D. References Relied Upon
Petitioner’s challenges rely on the following references (Pet. 4–5):
Name Reference Ex. No.
Green 209 US Pat. No. 5,645,209, issued July 8, 1997 1004
Green 695 US Pat. No. 4,429,695, issued Feb. 7, 1984 1005
Knodel US Pat. No. 5,465,895, issued Nov. 14, 1995 1006
Rothfuss US Pat. No. 4,605,001, issued Aug. 12, 1986 1007
McGuckin US Pat. No. 5,868,760, issued Feb. 9, 1999 1012

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E. Alleged Grounds of Unpatentability
Petitioner contends that claims 4–24 of the ’650 patent are
unpatentable under the following grounds:
Ground Claims
Challenged
35 U.S.C.
§ References/Basis
1A 4, 5, 9–18, 20, 22–
24 103
Green 209, Green 695,
Knodel
1B 4, 5, 9–18, 20, 22–
24 103
Green 695, Green 209,
Knodel
2 4–8, 10–24 103 Rothfuss, Green 209, Knodel
3 4–24 103 McGuckin, Green 695
Pet. 3. Petitioner also relies on the Declaration testimony of Dr. Bryan
Knodel (Exs. 1003, 1025). See, e.g., Pet. Reply iv–v, 7 (referencing Dr.
Knodel’s testimony under Exs. 1003, 1025). Patent Owner submits the
competing testimony of Dr. Michael Dolgin (Ex. 2001) and Mr. Albert
Juergens (Ex. 2002). See, e.g., PO Resp. iv (Exhibit List, referencing Ex.
2002); see also, e.g., id. at 29 (referencing Dr. Dolgin’s testimony).

II. ANALYSIS
A. Level of Ordinary Skill in the Art
In determining whether an invention would have been obvious at the
time it was made, we consider the level of ordinary skill in the pertinent art
at the time of the invention. Graham v. John Deere Co. of Kansas City, 383
U.S. 1, 17 (1966).
Factors pertinent to a determination of the level of ordinary skill in the
art include: (1) educational level of the inventor; (2) type of problems
encountered in the art: (3) prior art solutions to those problems; (4) rapidity
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with which innovations are made; (5) sophistication of the technology, and
(6) educational level of workers active in the field. Environmental Designs,
Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing
Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376,
1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every
case, and one or more of these or other factors may predominate in a
particular case. Id. Moreover, these factors are not exhaustive but are
merely a guide to determining the level of ordinary skill in the art. Daiichi
Sankyo Co. Ltd, Inc. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).
In determining a level of ordinary skill, we also may look to the prior
art, which may reflect an appropriate skill level. Okajima v. Bourdeau, 261
F.3d 1350, 1355 (Fed. Cir. 2001).
Petitioner’s expert, Dr. Knodel, testifies that:
A person of ordinary skill in the art [(“POSITA”)] at the
time of the alleged invention would have 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. Additional education in a relevant field, such
as mechanical engineering, or industry experience may
compensate for a deficit in one of the other aspects of the
requirements stated above.
Ex. 1003 ¶ 26 (emphasis added).
Patent Owner’s expert, Mr. Juergens, testifies that:
The relevant technical field for the ’650 patent is medical
staplers. Based on this, and the four factors above, in my opinion
a person of ordinary skill in the art as of January 2001 would hold
a bachelor’s degree or the equivalent in mechanical engineering
(or equivalent degree or experience) and at least two years of
additional product development experience in the area of
medical staplers, other regulated products or equivalent work
experience.
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Ex. 2002 ¶ 14 (emphasis added).
Based on the sophistication of the technology, as reflected in the prior
art, we are not persuaded that product development experience—as opposed
to graduate-level research in medical staplers, for example—is necessary to
qualify a person as a POSITA, as Patent Owner’s expert testifies. Id.
Rather, we find Petitioner’s definition to more accurately reflect the level of
ordinary skill in the art, as it does not require “at least two years of
additional product development experience.” Compare id., with Ex. 1003
¶ 26. Petitioner’s definition is flexible in that it provides that “[a]dditional
education in a relevant field, such as mechanical engineering, or industry
experience may compensate for a deficit in” the stated work experience. See
Ex. 1003 ¶ 26.
For this reason, we adopt Petitioner’s proposed level of ordinary skill
in the art (id.). We also consider Petitioner’s expert—Dr. Bryan Knodel
(Exs. 1003, 1025)—and Patent Owner’s experts—Dr. Michael Dolgin
(Ex. 2001) and Mr. Albert Juergens (Ex. 2002)—as being POSITAs under
our definition. These experts have established, through their own testimony,
that they possessed the appropriate education and work experience in the
relevant art at the time of the invention. See Ex. 1003 ¶¶ 6–14 (Dr. Knodel’s
qualifications); see also Ex. 2001 ¶¶ 3–11 (Dr. Dolgin’s qualifications); see
also Ex. 2002 ¶¶ 3–11 (Mr. Juergens’s qualifications).

B. Claim Construction
In an inter partes review proceeding for a petition filed on or after
November 13, 2018, a patent claim shall be construed using the same claim
construction standard that would be used to construe the claim in a civil
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action under 35 U.S.C. § 282(b). See 37 C.F.R. § 42.100(b) (2019). This
rule adopts the same claim construction standard used by Article III federal
courts (see id.), which follow Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
Cir. 2005) (en banc) and its progeny. Under the Phillips standard, the words
of a claim are generally given their “ordinary and customary meaning,”
which is the meaning the term would have to a person of ordinary skill at the
time of the invention, in the context of the entire patent including the
specification. See Phillips, 415 F.3d at 1312–13. “[W]here a party believes
that a specific term has meaning other than its plain meaning, the party
should provide a statement identifying a proposed construction of the
particular term and where the disclosure supports that meaning.” Office
Trial Practice Guide, 77 Fed. Reg. 48,756, 48,764 (Aug. 14, 2012).

1. District Court Claim Construction Order
Patent Owner directs our attention to a related District Court Claim
Construction Order (“Order”) that issued after our Institution Decision was
entered. PO Resp. 1 (“A claim construction order issued in the
corresponding litigation on May 5, 2020.” (citing Ex. 2003)).
Patent Owner “adopts those claim constructions” in this proceeding.
Id.
Petitioner does not address the Order in its Reply. See, generally, Pet.
Reply.
We have considered the Order, Patent Owner’s Response, Petitioner’s
Reply, and Patent Owner’s Sur-Reply, and determine that the only limitation
that requires express construction for purposes of this Final Written Decision
is 4.4 of independent claim 4. See Nidec Motor Corp. v. Zhongshan Broad
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Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only
construe terms ‘that are in controversy, and only to the extent necessary to
resolve the controversy’”) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).

2. 4.4 “at least one of a gear and a cable operatively coupled to at
least one of the first jaw and the second jaw and configured to move
at least one of the first jaw and the second jaw from the first
configuration to the second configuration such that the first jaw
and the second jaw are in alignment”
In our Institution Decision, we expressly construed this limitation.
See Inst. Dec. 10–11. The District Court also construed this limitation. See
Order 1–2.
At the institution phase, we determined that under the plain and
ordinary meaning of the claim, the limitation may include structure in which
the gear and/or the cable is operatively coupled to the first jaw and/or the
second jaw through a series of intermediary structures that ultimately move
the first jaw and the second jaw from the first configuration to the second
configuration. See Inst. Dec. 11.
Neither Petitioner nor Patent Owner disagrees with our initial
proposed construction. See, generally, Pet. Reply; see also PO Resp. 1 (“PO
does not object to the Board’s interpretation of the ‘gear and cable’
limitation of claim 4.”).
The District Court construed “at least one of a gear and a cable
operatively coupled to at least one of the first jaw and the second jaw and
configured to move at least one of the first jaw and the second jaw from the
first configuration to the second configuration” to mean “at least one of a
gear or a cable operatively coupled to at least one of the first jaw or the
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second jaw and configured to move at least one of the first jaw or the second
jaw from the first configuration to the second configuration.” Order 1–2
(emphases on the three words “or”).
The District Court’s claim construction is consistent with the
construction that we adopted in our Institution Decision. Compare id., with
Inst. Dec. 11. In particular, both constructions provide that the claimed gear
or cable are operatively coupled to the first jaw or second jaw.
Absent any argument that our initial construction was in error, and as
doing so would be consistent with the District Court’s claim construction,
we conclude that limitation [4.4] may include structure in which the gear
and/or the cable is operatively coupled to the first jaw and/or the second jaw
through a series of intermediary structures that ultimately move the first jaw
and/or the second jaw from the first configuration to the second
configuration.

3. Other Claim Terms
There are no other terms that require express construction for
purposes of this Decision. See Nidec, 868 F.3d at 1017.

C. Principles of Law
“In an . . . [inter partes review], the petitioner has the burden from the
onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
Cir. 2016). This burden never shifts to Patent Owner. Dynamic Drinkware,
LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
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Petitioner’s challenges are based on obviousness. Pet. 3. A claim is
unpatentable as obvious under 35 U.S.C. § 103(a) 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 said subject matter pertains.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of
obviousness 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) where in evidence, so-called secondary considerations.
Graham, 383 U.S. at 17–18.

D. Ground 1A: Green 209, Green 695, and Knodel
Petitioner submits that claims 4, 5, 9–18, 20, and 22–24 are
unpatentable over Green 209 in view of Green 695 and Knodel. Pet. 9.
Petitioner alternatively contends that these same claims are unpatentable
over Green 695 in view of Green 209 and Knodel. Id. We address
Petitioner’s first challenge under this heading, “Ground 1A,” and address
Petitioner’s second, alternative challenge under the heading “Ground 1B.”
See infra Part II.E.
Under Ground 1A, Petitioner relies on Green 209 for disclosing the
majority of the claimed limitations. See Pet. 10–44.

1. Green 209 (Ex. 1004)
Green 209 is a U.S. Patent titled “Self Contained Gas Powered
Surgical Apparatus.” Ex. 1004, code (54). Green 209 discloses that its
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“invention relates to surgical stapling apparatus, and more particularly to
surgical apparatus which are powered by [self-]contained relatively low
pressure gas systems to perform sequential operations such as tissue
clamping, staple forming and/or tissue cutting.” Id. at 1:20–24.
Petitioner submits that Green 209 discloses an apparatus for stapling
tissue, providing an annotated version of Green 209’s Figure 1 (Pet. 10),
which we reproduce, below:

Figure 1 is a “perspective view of a self contained gas powered endoscopic
surgical instrument.” Ex. 1004, 6:4–6. According to Petitioner’s
annotations, this figure depicts surgical stapling instrument 50 with frame
portion 52, elongated portion 54, anvil member 56, articulating cartridge
assembly 58, and articulating handle 62. Pet. 10 (citing Ex. 1004, 11:21–
35). Petitioner further provides annotated versions of Green 209’s Figures 2
and 15 (Pet. 11), both of which we reproduce, below:
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Figure 2 is an “exploded perspective view of the frame and pneumatic
assembly of the surgical instrument of” Figure 1. Ex. 1004, 6:7–9. Figure
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15 is an “exploded perspective view of the elongated portion of the surgical
instrument of” Figure 1. Id. at 6:47–47. Petitioner’s annotations to Figure 2
include highlighting in yellow clamp tube 70 and articulating handle 62.
According to Petitioner, the surgeon presses down upon articulating handle
member 62 to close the jaws. Pet. 12 (citing Ex. 1004, 19:50–20:2). When
the tissue is clamped within the jaws, the instrument can be fired to staple
and cut tissue. Id. (citing Ex. 1004, 12:40–42). Petitioner also submits an
annotated version of Green 209’s Figure 9 (Pet. 13), which we also
reproduce, below:

Figure 9 is a “side plan view in cross section showing the frame and
pneumatic assembly of the present invention in the clamped and fired
position.” Ex. 1004, 6:31–33. Petitioner’s annotation to Figure 9 includes
highlighting in yellow gas container 88, firing trigger 96, pneumatic cylinder
100, and piston 104. According to Petitioner, Green 209’s instrument also
includes firing trigger 96. Pet. 12 (citing Ex. 1004, 12:40–42). After the
tissue is clamped between the jaws, depressing firing trigger 96 dispenses a
gas to propel a surgical knife in the distal direction via piston 104. See id.
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(citations omitted). Petitioner also submits an annotated version of Green
209’s Figure 16 (Pet. 14), which we reproduce below:

Figure 16 is an “exploded perspective view of the articulating cartridge
assembly of the surgical instrument” of Figure 1. Ex. 1004, 48–49.
Petitioner’s annotation to Figure 16 includes highlighting in yellow cam bars
286, 288, knife 240, and cam bar adapter 300. According to Petitioner, knife
240 cuts tissue upon depression of firing trigger 96. Pet. 12 (citations
omitted). Petitioner acknowledges, however, that knife 240 “is not an I-
beam.” Id. at 14.

2. Green 695 (Ex. 1005)
Green 695 is a U.S. Patent titled “Surgical Instruments.” Ex. 1005,
code (54). Green 695 describes its invention as relating to “an instrument
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for use in applying surgical fasteners such as staples, clips and the like to
living tissue.” Id. at 1:8–10.
Petitioner submits that Green 695 utilizes an I-beam (knife blade
assembly 30) to maintain distance and alignment between jaws of a stapler.
Pet. 14 (citations omitted). Petitioner submits an annotated version of Green
695’s Figure 3 (id. at 15), which we reproduce, below:

Figure 3 is a “side view of the instrument in an open condition.” Ex. 1005,
2:63. Petitioner’s annotations include identifying in red elongate upper jaw
16, openings 55, upper shoe 56, elongate lower jaw 20, lower shoe 54, and
knife blade assembly 30. According to Petitioner, Green 695’s knife blade
assembly 30 includes upper shoe 56 and lower shoe 54 that fit within
passageways to ensure vertical spacing is maintained when upper and lower
frame members (12 and 14) are held. See Pet. 14–15 (citations omitted).
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Petitioner also submits an annotated version of Green 695’s Figure 6 (id. at
16), which we reproduce, below:

Figure 6 is a section line of the side view of the surgical instrument in an
assembled and closed condition. Ex. 1005, 2:59–60, 2:68. Petitioner’s
annotations include highlighting in yellow passageway for lower shoe 54
and passageway for upper shoe 56. According to Petitioner, this figure
depicts Green 695’s upper passageway 52 and lower passageway 48 (both
shown in yellow), which receive upper shoe 56 and lower shoe 54,
respectively. See Pet. 15 (citing Ex. 1005, 4:37–60).

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3. Knodel (Ex. 1006)
Knodel is a U.S. Patent titled “Surgical Stapler Instrument.”
Ex. 1006, code (54). Knodel discloses that its “invention relates in general
to surgical stapler instruments which are capable of applying lines of staples
to tissue while cutting the tissue between those staple lines.” Id. at 1:5–7.
Petitioner asserts that Knodel discloses a closing trigger with gear
system. See Pet. 26 (citations omitted). In support of this assertion,
Petitioner submits an annotated version of Knodel’s Figure 3 (Pet. 27),
which we reproduce, below:

Figure 3 is an “exploded view showing the handle portion, the firing trigger,
the closure trigger, the spring, the motion transfer mechanism, the yoke and
the release button of the instrument.” Ex. 1006, 4:47–50. Petitioner’s
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annotations include calling out multiplier 170, closure trigger 150, gear
segment section 150b, gear rack 154d, and closure yoke 154. According to
Petitioner, Knodel discloses closure trigger 150 with gear segment section
150b in meshing engagement with gear track 154d. Pet. 26 (citations
omitted).
Knodel further discloses firing multiplier 170, which comprises first
and second integral pinion gears 170a, 170b, which are shown in Figures 6
and 12. Id.

4. Independent Claim 4
For ease of reference, we map the limitations of claim 4 as Petitioner
has done in its Petition. See Pet. 19–29; see also supra Part I.C.
a) “[4.0] An apparatus for stapling tissue,
comprising:”
Petitioner submits that Green 209 discloses an apparatus for stapling
tissue, submitting an annotated version of Green 209’s Figure 1. Pet. 19
(citing in part Ex. 1004, Fig. 1). We reproduce Green 209’s Figure 1, as
annotated by Petitioner (id. at 20), below:
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As shown above in annotated Figure 1, Petitioner submits that Green 209’s
surgical apparatus 50 is an apparatus for stapling tissue. Id. at 19.

b) “[4.1] a first jaw and a second jaw, at least one of
the first jaw and the second jaw being movable with
respect to the other of the first jaw and the second jaw
from a first configuration in which the first jaw and the
second jaw are separated from each other at a first
distance to receive tissue and a second configuration in
which the first jaw and the second jaw are clamped
together at a second distance to hold tissue therebetween
for stapling”
Petitioner asserts that Green 209 discloses this limitation, providing
another annotated version of Green 209’s Figure 1. Pet. 20–21 (citations
omitted). We reproduce Petitioner’s annotated Figure 1, below:
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As shown in the above annotated Figure 1, Petitioner submits that Green 209
depicts first jaw (shown in yellow) and second jaw (shown in blue) that are
moveable with respect to each other from a first/open configuration (shown
in Green 209’s Figure 29) to receive tissue to a second/closed configuration
(shown above) to hold tissue for stapling. Pet. 21 (citing in part Ex. 1003
¶ 65).
c) “[4.2] a staple carrying portion of the first jaw
defining slots through which staples are configured to
pass”
Petitioner asserts that Green 209 discloses this limitation, submitting
an annotated version of Green 209’s Figure 16. Pet. 22 (citations omitted).
Below, we reproduce Petitioner’s annotated Figure 16:
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As shown above in annotated Figure 16, Petitioner submits that Green 209
discloses stapling carrying portion (cartridge 280, and highlighted in yellow)
of first jaw defining slots (shown in Green 209’s Figures 16, 18) through
which staples 285 pass. Id. (citations omitted).
d) “[4.3] an anvil surface defined on the second jaw
opposing the first jaw”
Petitioner asserts that Green 209 discloses this limitation, submitting
annotated versions of Green 209’s Figures 17 and 30. Pet. 22–23 (citations
omitted). We reproduce annotated Figures 17 and 30, below:

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As shown above in annotated Figures 17 and 30, Petitioner submits that
Green 209 discloses an anvil surface (staple forming plate 234) defined on
the second jaw (anvil member 56) and in opposition to the first jaw (housing
portion 270). See Pet. 23 (citations omitted).

e) “[4.4] at least one of a gear and a cable
operatively coupled to at least one of the first jaw and the
second jaw and configured to move at least one of the
first jaw and the second jaw from the first configuration
to the second configuration such that the first jaw and the
second jaw are in alignment”
Petitioner relies on Green 209, when modified based on Knodel’s
teachings, for satisfying this limitation. See Pet. 23, 26. Petitioner submits
an annotated version of Green 209’s Figure 16 to support its assertions
(Pet. 24), a copy of which we reproduce, below:

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Petitioner calls out pulley 248, anchor cable 427, and cable 404 from
Green’s Figure 16. As also shown above, Petitioner submits that Green 209
discloses a cable (cable 404) that is:
(1) operatively coupled to the first jaw by anchor cable 427;
(2) operatively coupled to the second jaw by pulley 248; and
(3) configured to move at least one of the first jaw and the second jaw
(anvil member 56) from the first/open configuration to the
second/closed configuration such that the first and second jaws are
aligned in the closed position to allow for stapling.
Pet. 23 (citing Ex. 1004, 18:1–41, Figs. 15, 16). Petitioner also submits an
annotated version of Green 209’s Figure 2 (id. at 25), which we reproduce,
below:

In the above-annotated Figure 2, Petition highlights handle member 62 and
clamp tube 70. Petitioner asserts that Green 209’s jaws are closed by
pressing down on articulating handle member 62, driving clamp tube 70
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distally. Id. at 24 (citations omitted). Petitioner acknowledges that Figure 2
depicts a “palm grip configuration” instead of a “pistol grip configuration.”
Id. at 26.
Petitioner cites to Green 209’s disclosure that its “handle portion . . .
may have a palm grip configuration or a pistol grip configuration depending
on the needs of the surgeon.” Pet. 25 (quoting Ex. 1004, 5:53–56, Fig. 90).
Petitioner reasons that it would have been obvious to use a pistol grip
configuration instead of a palm grip configuration to address the “needs of
the surgeon” and to provide the surgeon with “increased range of
operability.” Pet. 26 (citing in part Ex. 1003 ¶ 71; Ex. 1004, 5:53–56,
36:14–35).
As to Knodel’s teachings, Petitioner submits an annotated version of
Knodel’s Figure 3 (id. at 27), which we reproduce, below:
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In annotated Figure 3, Petitioner calls attention to closure yoke 154, gear
rack 154d, gear segment section 150b, closure trigger 150, and multiplier
170. Petitioner submits that this figure depicts Knodel’s closure trigger 150
with gear segment section 150b in meshing engagement with gear track
154d. Pet. 26 (citations omitted). Petitioner further submits that Knodel
discloses firing multiplier 170 with first and second pinion gears 170a, 170b
identified in Figures 6 and 12. Id.
In combining Green 209 with Knodel, Petitioner reasons that a skilled
artisan would have been motivated to modify Green 209 to use Knodel’s
gears to increase design flexibility. Pet. 27 (citing Ex. 1003 ¶ 74; Ex. 1006,
11:16–25). Dr. Knodel testifies that “increasing the drive system’s
mechanical advantage would, for example, permit a given input force to
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produce a larger output force, which may be advantageous for clamping
certain tissues with a surgical stapler.” Ex. 1003 ¶ 74. In support of this
testimony, Knodel discloses,
Because the size of each of the pinion gears 170a and 170b may
be varied, the motion transfer mechanism 220 of the present
invention is easily modifiable for use in stapler instruments
having different staple line lengths and/or staple firing force
requirements so as to permit, for a given instrument, the length
of the stroke of the firing trigger and the force required to move
it to be set at ergonomically preferred values.
Ex. 1006, 11:16–25; see also Ex. 1003 ¶ 74 (quoting the same).

f) “[4.5] a staple pusher configured to cause a staple
to move from a first position at least partially within the
staple carrying portion to a second position entirely
outside the staple carrying portion”
Petitioner asserts that Green 209 discloses this limitation, submitting
an annotated version of Green 209’s Figure 16. Pet. 28–29 (citations
omitted). Below, we reproduce the annotated version of Figure 16:
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As shown above in annotated Figure 16, Petitioner identifies in red cam bars
286, 288, staples 285, and staple pusher elements 284. Petitioner submits
that Green 209 discloses staple pusher (pusher elements 284) configured to
cause staples (285) to move from a first position (in which staples 285 are
within cartridge 280) to a second, ejected position. Pet. 28 (citations
omitted).

g) “[4.6] the second distance and the alignment
being maintained by a beam configured to engage the
first and second jaws from within the first and second
jaws while tissue is stapled from a proximal location to a
distal location”
Petitioner relies on Green 209, as modified based on Green 695’s
teachings, for satisfying this limitation. See Pet. 29–30. In particular,
Petitioner proposes to modify Green 209’s knife 240 to include an I-beam
like that disclosed in Green 695, including Green 695’s knife blade carrier
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32, lower shoe 54, and upper shoe 56, configured to engage the first and
second jaws from within when the jaws are in the second/closed position.
Id. at 29–30 (citations omitted). Petitioner submits an image to illustrate the
resultant structure (id. at 30), which we reproduce, below:

As shown in the above annotated Figure 6, Petitioner submits that Green
209’s modified knife 240 includes knife blade carrier 32 with upper shoe 56
and lower shoe 54. See id. Upper shoe 56 fits within passageway 52 of jaw
16, and lower shoe 54 fits within passageway 48 of opposing jaw 20 when
jaws 16, 20 are closed. See id.
In modifying Green 209, as shown above, Petitioner reasons that a
skilled artisan would have been motivated to make the modification “to
provide . . . optimum alignment and stabilization of the jaws . . . during
application and securing of the fasteners” and to “enable the use of
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lightweight disposable materials for manufacture of the jaws.” Pet. 17
(citations omitted).
Dr. Knodel testifies that “a POSITA reading both Green 209 and
Green 695 would have been motivated to improve the alignment and
clamping capability of Green 209 by using the I-beam disclosed in Green
695.” Ex. 1003 ¶ 51.
Green 695 discloses:
By utilizing the aforementioned shoes [on an I-beam]
locally to support the jaws and provide both lateral and vertical
stabilization in the region of the pusher bar cams and knife blade
as these elements ride along the jaws, the adverse effects of the
previously mentioned forces are substantially minimized and the
jaws themselves can therefore be made of light-weight
construction so that an instrument designed in accordance with
the invention lends itself to manufacture in disposable materials.
Ex. 1005, 2:48–56.

h) Patent Owner’s Arguments
Patent Owner argues that a skilled artisan would not have combined
Green 209 with Green 695 as Petitioner has done. PO Resp. 2. In support of
this argument, Patent Owner presents the following interrelated arguments
(id. at 2–25):
1. “Adding an I-beam to Green-209’s stapler results in a
serious safety issue and would have rendered Green-209’s stapler
unsatisfactory for its intended purpose of endoscopic use” (id. at
5).
2. “Adding an I-beam to Green-209 is unnecessary and adds
duplicative functionality” (id. at 11).
3. “Adding an I-beam to Green-209’s stapler would increase
the complexity and cost to manufacture and commercialize the
stapler” (id. at 14).
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4. “Adding an I-beam to Green-209’s stapler would require
a substantial redesign, which is not accounted for in the Petition”
(id. at 20).
5. “Petitioner’s motivations to combine Green-209 and
Green-695 are unavailing” (id. at 22).
We address each of Patent Owner’s arguments separately, below.
i) Analysis
(1) “Adding an I-beam to Green-209’s stapler
results in a serious safety issue and would have
rendered Green-209’s stapler unsatisfactory for its
intended purpose of endoscopic use”
Patent Owner argues that adding an I-beam to Green 209’s stapler
would create a safety issue. PO Resp. 5. Specifically, Patent Owner
contends that adding an I-beam eliminates an inherent safety feature of
Green-209’s stapler. See id. at 5–6.
As explained by Patent Owner, Green 209’s stapler includes return
springs 140, 142 for retracting the knife to its start position after firing. See
id. at 7 (citations omitted). With Green 209’s stapler, if springs 140, 142 fail
to return the knife to its retracted position, “the surgeon can simply open the
stapler to release the tissue [and] remove the stapler from the patient.” Id.
Patent Owner contends that this “failure does not pose any safety issues to
Green-209’s design as-is.” Id.
Turning to the proposed modification, Patent Owner contends that the
addition of an I-beam creates a “serious problem.” Id. Patent Owner
explains that if Green 209’s device failed, the presence of an I-beam “would
prevent the jaws of Green-209’s stapler from opening to release the tissue,
and the device would literally be stuck inside the patient and need to be
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manually excised via an incision.” See id. at 8 (citing Ex. 2002 ¶¶ 54–56)
(emphasis omitted).
Importantly, Patent Owner’s argument is premised on a failure of
Green 209’s retraction mechanism. That is, Patent Owner’s safety issue only
arises if Green 209’s stapler fails in some way. Patent Owner does not
argue that Petitioner’s proposed modification (adding an I-beam to Green
209’s stapler) in and of itself prevents Green 209’s retraction springs 140,
142 from working. Rather, Patent Owner’s argument is premised on one of
many possible failures of Green 209’s retraction mechanism. In particular,
Patent Owner’s expert, Mr. Juergens, testifies,
Several different conceivable failures would result in an
I-beam preventing the jaws of Green-209’s stapler from opening.
For example, Green-209 includes a counter mechanism that
“indicate[s] to a user the number of times the instrument has been
operated or, alternatively, the number of remaining firings
available.” Green-209, 5:34-45. But, like all mechanical and
electrical features, there is a potential for failure. For example,
the counter could fail to advance so that the surgeon does not
know how many firings s/he has left and, as a result, the stapler
could potentially run out of gas midway through a firing. The
venting valve could malfunction. It is also possible[] that the
stapler may be used to grab more tissue than can be handled by
the jaws given the fixed spacing of the I-beam. In this case, the
cutter/stapler mechanism could advance part way or even all the
way through the cut but not have enough force in the return
springs 140, 142 to overcome stiction between the I-beam and
the jaws to push the I-beam back out of the jaws. Failures like
these (and others not mentioned) can have catastrophic effects
during surgery, which is why medical device companies
regularly validated the designs of their staplers. Here, where
Green-209’s stapler is gas powered, there is an increased risk of
failure because the pushing and pulling of the I-beam is at the
mercy of a part that cannot be manually controlled and is subject
to inherent failures.
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Ex. 2002 ¶ 55 (emphases added). In summary, Mr. Juergens identifies three
possible points of failure: (1) the stapler could “run out of gas” midway
through firing; (2) the “venting valve could malfunction”; and (3) return
springs 140, 142 may lack sufficient force to overcome the stiction between
the I-beam and jaws. See id.
Before addressing each of these possible points of failure, we provide
a detailed discussion of Green 209’s pneumatic system, starting by
reproducing Green 209’s Figure 9, below:

Figure 9 “is a side plan view in cross section showing the frame and
pneumatic assembly of the present invention in the clamped and fired
position.” Ex. 1004, 6:30–32. Green 209 discloses,
Pneumatic system 68 is wholly contained within housing
members 64 and 66 and includes a container 88 of relatively low
pressure gas longitudinally slidably mounted therein. The
pressure of the gas in container 88 during operation of the stapler
is typically less than about 200 p.s.i.g. and preferably in the range
of about 80 p.s.i.g. to about 160 p.s.i.g. . . . . Container 88
dispenses the relatively low pressure gas through stem 90, valve
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92, and gas tube 94 when the firing trigger 96 is depressed.
Spring 97 is positioned between container 88 and valve 92 and
functions to hold the container 88 in position spaced from valve
92. Valve 92 is fixed within housing members 64 and 66 and is
longitudinally adjustable by means of set screw 93 (see FIG. 11).
This feature permits the position of valve 92 to be longitudinally
changed to compensate for manufacturers’ variations in length
among containers 88 between a distal end and the proximal end
of stem 90. A pneumatic actuator 98 is disposed above container
88 within housing members 64 and 66. Actuator 98 includes a
pneumatic cylinder 100 which is held in place by opposed pins
99. Cylinder 100 is substantially closed at the proximal end
thereof but for a ferrule 102 extending therethrough and is open
at its distal end, wherein a pneumatic piston 104 is mounted for
reciprocal motion therein on an axis which is parallel to the
longitudinal axis of elongated portion 54.
Ex. 1004, 12:1–29. Green 209 further discloses,
When the instrument is in the clamped configuration,
depression of firing trigger 96 moves trigger rod 112 distally in
the longitudinal direction causing piston slide 144 to engage and
pivot rocking lever 120 which, in turn, engages pusher disk 136
and moves container 88 into contact with valve 92 to dispense
gas and propel piston 104 in the distal direction (see FIGS. 9–
11).
As piston 104 moves distally, rocking lever 120 remains
in its pivoted firing position by contact with the bottom surface
of piston 104. A gap 138 is formed in the bottom surface of
piston 104 adjacent the proximal end thereof which effectively
allows rocking lever 120 to disengage from piston 104 and return
to a position wherein container 88 is released from engagement
with valve 92, thereby stopping the flow of gas into pneumatic
cylinder 100.
A pair of return springs 140 and 142 disposed in elongated
portion 54 drive piston 104 back to its initial prefired position.
Ex. 1004, 13:28–38; see also id. at Figs. 9–11 (depicting side cross-sectional
views of Green 209’s pneumatic firing assembly).
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Turning back to Patent Owner’s argument, Patent Owner’s expert
speculates that (1) “the stapler could potentially run out of gas midway
through the firing,” (2) the “venting valve could malfunction,” or (3) that
retraction springs 140, 142 may lack the spring force to overcome the
friction between the I-beam and jaws. Ex. 2002 ¶ 55. Having reviewed the
evidence of record, however, we are not persuaded with Patent Owner’s
theories on failure. After weighing the competing expert testimony, we
agree with and credit the testimony of Petitioner’s expert, Dr. Knodel. In
particular, even if Patent Owner’s problems exist, we agree with Dr. Knodel
that they are within a skilled artisan’s abilities to account for. See Ex. 1025
¶ 18.
As to the first possible point of failure, Mr. Juergens speculates that
Green 209’s gas cylinder may “run out of gas midway through the firing.”
Ex. 2002 ¶ 55. Mr. Juergens’s testimony presumes, however, that Green
209’s gas cartridge cannot be recharged or replaced, and once the pressure of
working gas in container 88 falls below a certain pressure, the I-beam may
remain stuck in Green 209’s jaws. This argument is not persuasive for at
least two reasons.
First, Green 209 describes gas staplers that use replaceable gas
supplies. Specifically, Green 209 suggests that gas containers 88 are
replaceable, as Green 209 discloses that “the position of valve 92 [may] be
longitudinally changed to compensate for manufacturers’ variations in
length among containers 88.” See id. at 12:17–20 (emphasis added); see
also id. at 2:61–63 (“[E]ven if the gas supply is replaceable, it undesirably
increases the frequency with which the gas supply must be replaced.”).
Because Green 209 teaches that its gas containers 88 are replaceable, we do
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not envision a problem arising if the stapler “runs out of gas midway,”
which Patent Owner argues would require the surgeon to perform another
incision to excise the stapler from the patient. See PO Resp. 7–8. Indeed,
Green 209’s gas containers 88 are located at the proximal end of the device,
near the surgeon, and even if container 88 “ran out of gas,” we do not see
why this would require the surgeon to perform an invasive surgical
procedure to excise the device from the patient, rather than simply replacing
or recharging container 88.
Second, the pressurized gas is used to urge the piston and I-beam from
a proximal position to a distal position, not the other way around. See supra
pp. 34–36. If container 88 “runs out of gas,” we understand that the gas
within cylinder 100 will fail to drive piston 104 distally. In this event, the
force from springs 140, 142, which are biased to keep the assembly in a
retracted position, will be unopposed by a contrary distally-directed force on
piston 104. As a result, the springs will maintain piston 104 in a retracted
position, and the I-beam will not be stuck within the jaws.
As to Patent Owner’s second possible “failure,” Mr. Juergens
speculates that Green 209’s “venting valve could malfunction.” Ex. 2002 ¶
55. Absent a more detailed explanation, we assume that Patent Owner is
referring to valve 92. Having reviewed Green 209, however, we do not
envision how malfunction of valve 92 would create the problem that
Mr. Juergens testifies to.
Patent Owner’s argument presumes that valve 92 will “malfunction”
(Ex. 2002 ¶ 55), thus preventing the I-beam from being retracted and
requiring the surgeon to perform an invasive incision to excise the device
from the patient (see PO Resp. 7–8). Yet, we do not see how a
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“malfunction” of valve 92 would result in a scenario where the I-beam
remains stuck in Green 209’s jaws. Specifically, forces from springs 140,
142 urge piston 104 to remain in the retracted position, and we do not see
how failure of valve 92 would result in a scenario where the I-beam is stuck
within Green 209’s jaws. If, for the sake of argument, Mr. Juergens believes
that container 88 fails to disengage from valve 92, thereby locking pressure
within cylinder 100, we do not see why the surgeon would not simply
manually slide container 88 longitudinally to disengage container 88 from
valve 92, thereby releasing pressurized gas from cylinder 100, and retracting
the I-beam from the jaws. As with Mr. Juergens’s first speculated failure
(loss of gas pressure), Mr. Juergens’s second speculated failure (malfunction
of valve 92) is located at the proximal end of Green 209’s stapler, and a
surgeon would presumably have access to valve 92 to disengage container
88 from the valve.
As to Patent Owner’s third hypothesized failure, in which return
springs 140, 142 lack sufficient force to retract the I-beam, Patent Owner’s
argument has some merit. Ex. 2002 ¶ 55. In support of this argument,
Patent Owner cites to Dr. Knodel’s cross-examination testimony from a
different inter partes review challenging a different patent. See PO Resp. 8
(referencing Dr. Knodel’s cross-examination testimony in IPR2019-00880,
filed as Ex. 2005 in this proceeding, at 47:1–8). In this other inter partes
review, Dr. Knodel testified in response to the following questions:
Q. Okay. And what’s your experience with respect to
retraction springs and how often they don’t work?
A. In the case of a – of endocutters, it is a common issue
with endocutters, and you can check the MDR records of the
FDA that clamping on too thick of tissue is a continual problem,
has been over the entire life of endocut – endoscopic linear
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stapling; and when that occurs, you can bind – you can bind the
jaw so that the spring will not have sufficient force to pull it back,
and, therefore, you – because it would be locked on the tissue,
you have to provide some kind of manual retraction because it’s
not just reliable enough for such a critical function. To leave this
device clamped on tissue is a huge – this – and we’re not talking
about one more step of an operation, we’re taking about, you
know, cutting a person open to re- -- to be able to get the device,
you know, cut out of their body.
So, and by – in my opinion, they, the Swayze and Shelton
II references that – that have automatic and – but with lots of
provisions for why there’s a manual backup, it’s very, very clear
that that is because the automatic system does not work all the
time.
Q. Okay. But that’s not something you addressed in
designing the EZ 45 or the ETS 45?
A. In the EZ 35 or EZ 45, there’s no E-beam and no
I-beam; therefore, it doesn’t matter if the firing system doesn’t
retract because you’re not locked on tissue; that’s the beauty of
it. You can unclamp an EZ 45 and EZ 35 even if the firing
system has not retracted, and that is a safety feature that was lost
with the introduction of I-beams and E-beams.
Ex. 2005, 45:18–47:8.
We agree with Patent Owner that Petitioner’s proposed modification
may make retraction of Green 209’s knife/I-beam seemingly more difficult if
the forces from springs 140, 142 fail to overcome the frictional forces
imposed between Green 209’s jaws and the I-beam. See, e.g., Ex. 2002
¶ 54. Indeed, Dr. Knodel’s cross-examination testimony in related IPR2019-
00880 provides some support for this finding. See Ex. 2005, 45:18–47:8.
When reviewing the entirety of Dr. Knodel’s testimony, however,
including his supplemental declaration (Ex. 1025), we are persuaded by
Dr. Knodel that Patent Owner fails to fully appreciate the cross-examination
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testimony from the related proceeding, as the testimony addresses a skilled
artisan’s proclivity—to add an I-beam to a spring-loaded retraction
mechanism—during a different time of invention. See Ex. 1025 ¶¶ 20, 21.
In particular, to clarify his cross-examination testimony in IPR2019-00880
(Ex. 2005), Dr. Knodel explains that at the time of the ’650 patent, “a spring
alone was considered sufficient for I-beam retraction,” whereas, the
testimony in IPR2019-00880 addresses a skilled artisan’s knowledge as of
“2005 (more than four years after the alleged priority date of the ’650 patent)
[when it became mandatory] to add a backup manual retraction mechanism
to a spring return.” Id. ¶ 21. Having clarified this point, we agree with
Dr. Knodel’s testimony that a “spring alone was considered sufficient for
I-beam retraction at the time of the ’650 patent.” Id.
We further agree with Dr. Knodel’s testimony that at least U.S. Patent
No. 5,507,426 to Young (Ex. 1009, “Young”) disclosed a system with a
spring-loaded retraction mechanism and an I-beam. Ex. 1025 ¶ 16 (citing
Ex. 1009, Figs. 2, 5, 6). Indeed, Figure 2 of Young depicts “I-beam” (54,
56, 80) and Figures 5 and 6 depict spring 112 within chamber 100 and
biased to return piston 98 to return to its proximal direction. See Ex. 1009,
5:37–44; see also id. at 6:44–46 (“further comprising a coiled return spring
disposed within the piston chamber to bias the piston in a proximal
direction”). Dr. Knodel testifies, correctly, that: “Under [Patent Owner’s]
theory . . . [,] Young’s stapler, which uses only a spring to retract the I-beam,
would have suffered the same safety issues as the proposed combinations of
Green-209 and Green-695. Yet that did not deter the inventors of Young.”
Ex. 1025 ¶ 16. We credit Dr. Knodel’s testimony that “Young confirms that
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a spring alone was considered sufficient for I-beam retraction at the time of
the ’650 patent.” Id. at ¶ 21.
Moreover, and even if a spring, by itself, was insufficient for
retraction at the time of the ’650 patent, we credit Dr. Knodel’s testimony
that “the selection of an alternative retraction mechanism (e.g., a manually
operated mechanical slide or a reversible motor) would have been well
within a POSITA’s abilities.” Id. ¶ 18. We are not persuaded that the use of
a spring-loaded retraction mechanism with an I-beam would have been so
problematic that it would have discouraged a skilled artisan from adding an
I-beam to Green 209’s stapler, considering the benefits that the I-beam
would have provided. See Pet. 17 (identifying multiple benefits to adding an
I-beam, including improved alignment and stabilization of the stapler’s
jaws).
In summary, even if the addition of an I-beam to Green 209’s stapler
may have made it more difficult to retract the I-beam from the jaws (in the
unlikely event that springs 140, 142 fail to retract the I-beam from the bound
jaws), this concern would not have discouraged a skilled artisan from adding
an I-beam to Green 209’s spring-loaded retraction mechanism, considering
the benefits that adding an I-beam would have provided (see id.).
(2) “Adding an I-beam to Green-209 is
unnecessary and adds duplicative functionality”
Patent Owner asserts that “Green-209’s stapler is stable and aligned
without an I-beam.” PO Resp. 11–12 (citing Ex. 2002 ¶¶ 59–71). Patent
Owner explains: “Adding an I-beam to Green-209’s stapler therefore does
not solve any problem or improve the stapler’s functionality. Rather, adding
the I-beam creates problems for the stapler.” Id. at 12. In explaining why
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Green 695 used an I-beam, Patent Owner states that Green 695 had an
“unstable pivot point” that would result in its jaws “eventually becom[ing]
misaligned due to acting forces as soon as the stapling function was
activated.” Id. (citing Ex. 2002 ¶¶ 61–64). In differentiating Green 209’s
stapler, Patent Owner asserts: “None of these issues, however, are present in
Green-209.” Id. at 12–13.
Patent Owner’s argument is not persuasive. Having reviewed Green
695, Green 209, and the testimony of Dr. Knodel and Mr. Juergens, we
credit Dr. Knodel’s testimony that if “a POSITA used a longer anvil and/or a
lightweight material having a thickness that is not sufficient to withstand the
clamping and firing forces, then an I-beam (or a similar structure) would
have been required to stabilize and align the jaws.” Ex. 1025 ¶ 5.
As to Patent Owner’s assertion that Green 695 has an unstable pivot
point, which explains why Green 695 used an I-beam (see PO Resp. 11–13),
we disagree. Rather, we agree with and credit Dr. Knodel’s testimony that
“nothing in Green-695 suggest[s] that the pivot point was unstable or that an
I-beam was added to stabilize the pivot mechanism.” Ex. 1025 ¶ 6. In
comparing the stability of Green 695’s pivot point with Green 209’s pivot
point, we further agree with Dr. Knodel that “Green 695’s pivot point is
more stable than Green 209’s pivot point,” because, “unlike Green 209’s
pivot point, which moves up and down in slot 260 during operation,
Green-695[’s] pivot point is fixed during operation.” Id. ¶ 7 (citing Ex.
1005, Figs. 1, 2; citing also Ex. 1004, 15:40–48, Figs. 16, 28).
Green 695 further identifies a problem that existed in the prior art with
surgical staplers, namely, distortion of the jaws when clamping tissue. See
Ex. 1005, 1:49–57. Specifically, Green 695 discloses,
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With stapling instruments of the type described, relatively
large forces are involved in clamping the tissue to be fastened
and in ejecting the individual staples, causing these to penetrate
the gripped tissue and to be closed against the anvil. Such forces
tend both to separate the jaws vertically and to laterally distort
the jaws, thereby hindering accurate stapling. This problem is of
course accentuated if relatively light-weight disposable materials
are to be used for manufacture of the jaw frames.
Id. Green 695 further discloses that if the jaw frames are manufactured from
light-weight materials, the problem of jaw distortion is exacerbated. See id.
As to Patent Owner’s argument that Green 209’s jaws are already
manufactured from light-weight materials (see PO Resp. 14 (citing Ex. 1005,
2:40–43)), we disagree.
Although Green 209 discloses that “[u]se of a relatively low pressure
gas is advantageous to enable a stapler to be made of lighter construction
and less expensive materials” (Ex. 1004, 2:40–43 (emphasis added)), Green
209 does not disclose or suggest that its jaws are made from light-weight
materials (see Ex. 1025 ¶¶ 9, 10 (confirming the same)). We agree with and
credit Dr. Knodel’s understanding of this disclosure that a “POSITA would
have understood that the use of a relatively low pressure gas would enable
the pneumatic system (e.g., the air tanks and the components actuated by
them) to be made of lighter construction and less expensive materials.” Id.
¶ 10.
Petitioner’s reasoning that a POSITA would have added an I-beam to
Green-209’s stapler to improve alignment and stabilization of the jaws
during application and securing of the fasteners, and to enable use of
lightweight disposable materials for the manufacture of the jaws, is
reasonably supported by the testimony of Dr. Knodel (see e.g., Ex. 1003 ¶¶
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51, 52) and the express teachings of Green 695 (see e.g., Ex. 1005, 1:49–62,
2:48–56).

(3) “Adding an I-beam to Green-209’s stapler
would increase the complexity and cost to
manufacture and commercialize the stapler”
Patent Owner argues that Petitioner’s proposed modification of adding
passageways in Green 209’s upper and lower jaws for receiving an I-beam,
would have been impractical. See PO Resp. 14–16. Patent Owner’s expert,
Mr. Juergens, testifies: “In my opinion, the modifications that would be
required to implement Green-695’s passageways 48, 52 in Green 209’s
stapler would have been extremely difficult to implement cost effectively.”
Ex. 2002 ¶ 77. Mr. Juergens explains: “[B]ecause these complex and
expensive modifications would not result in any positive benefit to
Green-209’s stapler, a POSITA would not have been motivated to combine
Green-209 with Green-695 in the manner suggested.” Id. Mr. Juergens
further explains that the T-slot passageways that Petitioner proposes to
include in Green 209’s jaws are “one of the more difficult cuts to make on a
machine because it requires cutting into a thick piece of metal and milling an
opening having different widths at different depths to form the ‘T’ shape
therein.” Id. ¶ 82 (citation omitted). Mr. Juergens testifies, “Implementing
the T-slots in a very small device . . . would have been very difficult to do
and that would have weighed heavily on a POSITA’s mind and deterred
them from making the combination.” Id. ¶ 86.
Although we agree that the proposed modification would have likely
added costs to the proposed stapler, in that the modified stapler would have
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required T-shaped slots in its jaws and an I-beam to engage those slots,
nevertheless, it is well established that tradeoffs regarding costs or
manufacturability do not necessarily obviate a proposed modification.
See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir.
2006) (“[A] given course of action often has simultaneous advantages and
disadvantages, and this does not necessarily obviate motivation
to combine.”). Patent Owner’s argument and Mr. Juergens’s testimony
assumes that the proposed modification provides no benefit. See, e.g.,
Ex. 2002 ¶ 77 (“because these complex and expensive modifications would
not result in any positive benefit to Green-209’s stapler, a POSITA would
not have been motivated to combine Green-209 with Green-695 in the
manner suggested”). We disagree with this assumption. Rather, we agree
with Petitioner’s reasoning that the proposed modification would have
improved alignment and stabilization of Green 209’s jaws, allowing the use
of light-weight disposable materials and longer staple cartridges, which may
further reduce the number of cartridges used in a procedure. See Pet. 17
(citing Ex. 1003 ¶¶ 51, 52). We find that the additional cost incurred from
the proposed modification would not have deterred a skilled artisan from
making the proposed combination, in light of the extensive improvements
realized from the modification. See Ex. 1025 ¶ 25 (testifying that the
additional cost of adding an I-beam did not deter the inventor of Green 695
from adding an I-beam to a prior art stapler).

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(4) “Adding an I-beam to Green-209’s stapler
would require a substantial redesign, which is not
accounted for in the Petition”
Patent Owner further argues that “[a]dding an I-beam to Green-209’s
stapler would require a complete redesign of the pulley system.” PO Resp.
20. To support this assertion, Patent Owner submits an annotated version of
Green 209’s Figure 28 (id.), which we reproduce, below:

Figure 28 “is an enlarged perspective view, partially cut-away, of the distal
end of the elongated portion of the subject invention showing the mechanism
provided therein.” Ex. 1004, 7:12–14. Patent Owner’s annotations highlight
Green-209’s pulley system. Patent Owner explains that the system
highlighted in yellow “is responsible for closing Green-209’s jaws and
serves as the jaws’ pivot point.” PO Resp. 20 (citing Ex. 1004, 15:23–48,
18:1–19:11). Patent Owner submits that adding an I-beam “would not clear
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this system because it is much taller than the original knife 240 and must
extend past the anvil’s staple forming plate 234 to reach the channel formed
therein.” Id. at 21 (citing Ex. 2002 ¶¶ 96–98). Patent Owner submits that
“the system will block the I-beam from moving into the jaws and entering
the channels.” Id. (emphasis omitted).
Patent Owner’s argument that the proposed modification “would
require a substantial redesign” (PO Resp. 21) is not persuasive for at least
two reasons.
First, the test for obviousness “is not whether the features of a
secondary reference may be bodily incorporated into the structure of the
primary reference, . . . but rather whether ‘a skilled artisan would have been
motivated to combine the teachings of the prior art references to achieve the
claimed invention’.” Allied Erecting & Dismantling Co. v. Genesis
Attachments, LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016); see also Pet.
Reply 15 (arguing the same).
Second, we disagree with Patent Owner’s assertion that adding an
I-beam “would not clear this system because it is much taller than the
original knife 240.” PO Resp. 21. Instead, we agree with Dr. Knodel’s
testimony that Patent Owner’s argument incorrectly assumes that cable
separation block 424 must sit on top of the staple cartridge. Ex. 1025 ¶ 33;
see also Ex. 1004, Figs. 16, 28. To illustrate this point, Dr. Knodel submits
an annotated version of Green 209’s Figure 16 (Ex. 1025 ¶ 33), which we
reproduce, below:
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Figure 16 “is an exploded perspective view of the articulating cartridge
assembly of the surgical instrument.” Ex. 1004, 6:48–49. Dr. Knodel
testifies that “a POSITA would have understood that cable separation block
424 rests on the lowered portion at the proximal end of forward housing
portion 270’s sidewalls (highlighted in yellow . . .), which is proximal of the
cutting portion of knife 240 positioned in the raised portion of slot 282.”
Ex. 1025 ¶ 33. We agree with Dr. Knodel that “pulley 248 is clearly
proximal of the cutting portion of knife 240” (id. ¶ 34) and credit his
testimony that “the I-beam . . . replaces only the distal-most portion of knife
240 that is distal to cable separation block 424 and pulley 248, [and] would
not have been blocked by the pulley system” (id. ¶ 35). Accordingly, we
disagree with Patent Owner’s assertion that the proposed modification would
have required a “substantial redesign” of Green 209’s stapler. PO Resp. 20.
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(5) “Petitioner’s motivations to combine
Green-209 and Green-695 are unavailing”
In rehashing several of the arguments addressed above, Patent Owner
contends that “each and every one of Petitioner’s motivations to combine
Green-209 with Green-695 fails.” PO Resp. 25; see also id. at 22–25. For
the reasons discussed above, we disagree with Patent Owner.
Petitioner has established by a preponderance of the evidence that a
skilled artisan would have been motivated to modify Green 209’s stapler so
that knife 240 includes an I-beam, the jaws include internal passageways for
receiving the I-beam, and Green 209’s anvil member 56 includes an opening
that allows the I-beam to enter the channel as the instrument is closed. See
Pet. 14. Having fully considered the evidence of record, including Green
209 and Green 695, and having weighed the competing testimony of Mr.
Juergens and Dr. Knodel, we credit Dr. Knodel’s testimony that “A POSITA
would have been motivated to make this modification for the reasons
provided in Green 695” and that “a POSITA reading both Green 209 and
Green 695 would have been motivated to improve the alignment and
clamping capability of Green 209 by using the I-beam disclosed in Green
695.” Ex. 1003 ¶ 51. Indeed, Green 695 discloses that an object of its
invention is “to provide . . . optimum alignment and stabilization of the jaws
. . . during application and securing of the fasteners” (Ex. 1005, 1:58–62),
and we find that this teaching would have motivated a POSITA to
incorporate Green 695’s I-beam into Green 209’s stapler. See also id. at
2:48–56 (“By utilizing the aforementioned shoes locally to support the jaws
and provide both lateral and vertical stabilization in the region of the pusher
bar cams and knife blade as these elements ride along the jaws, the adverse
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effects of the previously mentioned forces are substantially minimized.”).
We further find persuasive Petitioner’s reason that the proposed
modification would have improved Green 209’s device in other ways, as
well, including by (1) allowing the use of lightweight disposable materials
for the manufacture of the jaws and (2) allowing for longer staple cartridges,
as the jaws of the modified stapler would be less likely to distort when
clamping tissue. See Pet. 17; see also Ex. 1003 ¶ 52.

j) Summary of Independent Claim 4
We are persuaded by Petitioner’s argument and evidence as discussed
above, and find that Petitioner has established by a preponderance of the
evidence that Green 209 as modified by the teachings of Green 695 and
Knodel satisfies all of the limitations of independent claim 4, for the reasons
stated by Petitioner in the Petition, which we adopt as our own findings, as
further supported by the declarations of Dr. Knodel.

5. Dependent Claim 5
Claim 5 depends from claim 4 and further recites, “wherein the beam
is configured to engage the first and second jaws one of entirely or
substantially from therewithin to maintain the second distance and the
alignment.” Ex. 1001, 8:33–36. In addressing this limitation, Petitioner
submits that Green 209 as modified by Green 695 satisfies this limitation.
See Pet. 31 (citations omitted).
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
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We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 5 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

6. Dependent Claim 9
Claim 9 depends from claim 4 and further requires, “wherein the first
jaw and the second jaw are pivotably coupled at a pivot point, a portion of
the first jaw defining a flange that extends past a surface of the second jaw
when the first jaw and second jaw are in the first configuration and the
second configuration.” Ex. 1001, 8:51–55 (emphasis added).
To address this claim, Petitioner submits that Green 209 and
Green 695 each discloses this limitation. See Pet. 31–33. Petitioner
apparently submits these alternative positions to account for the fact that
Petitioner presents two alternative grounds: (1) Ground 1A—which relies
primarily on Green 209—and (2) Ground 1B—which relies primarily on
Green 695. See id. at 10 (“Green-209 in view of Green-695” (emphasis
omitted)); see also id. at 17 (“Green-695 in view of Green-209” (emphasis
omitted)).
Under Ground 1A, we understand Petitioner’s position to be that
Green 209 discloses this limitation. Whether Green 695 discloses or teaches
this limitation is irrelevant under Ground 1A, as Petitioner does not propose
to modify Green 209 by adding Green 695’s flange. See id. at 14, 31–32.
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In addressing claim 9 under Ground 1A, Petitioner submits an
annotated version of Green 209’s Figure 16 (Pet. 33), which we reproduce,
below:

Figure 16 depicts “an exploded perspective view of the articulating cartridge
assembly of the surgical instrument.” Ex. 1004, 6:48–49. Petitioner submits
that Green 209 discloses a flange, but acknowledges that “Green-209’s
second jaw defines the claimed flange (highlighted in yellow), rather than
the first jaw,” as required by the claim. See Pet. 32–33.
To meet the limitation, Petitioner reasons,
It would have been obvious to move Green-209’s flange
from the second jaw to the first jaw because there were a finite
number of identified and predictable locations for the flange
(e.g., the first jaw, the second jaw, or the shaft housing). . . . A
POSITA making this modification would have reasonably
expected to succeed because moving the location of the flange
from one jaw to the other was well within the level of ordinary
skill in the art.
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Pet. 33 (citing in relevant part Ex. 1003 ¶¶ 83–86).
Patent Owner responds, “If the flange were moved to the bottom jaw
as Petitioner suggests, then a completely different pulley fixation system
would be needed to open and close Green-209’s upper jaw, otherwise the
open and close functionality of Green-209’s stapler would be lost.” PO
Resp. 27 (citing Ex. 2002 ¶¶ 104–108).
Petitioner replies, “The pulley fixation arrangement is the same in the
combination as in Green-209.” Pet. Reply 16 (citing Ex. 1025 ¶ 36).
Petitioner states that “even if a different pulley fixation arrangement would
have been needed (it was not), that would not demonstrate non-
obviousness.” Id.
We disagree with Patent Owner’s assertion that “a completely
different pulley fixation arrangement would be needed to open and close
Green-209’s upper jaw, otherwise the open and close functionality of
Green-209’s stapler would be lost.” PO Resp. 27 (emphasis omitted).
Patent Owner’s argument presumes that the modification requires relocating
the pulley system from the upper jaw to the lower jaw. It does not.
Having reviewed the evidence of record, including Green 209 and the
competing testimony of Dr. Knodel and Mr. Juergens, we credit
Dr. Knodel’s testimony that “the anvil member 56 would still have sidewalls
including apertures for mounting ring pairs 250 and 252 and pulley 248. At
most, a POSITA might reduce the width of proximal anvil portion to sit
inside the relocated flange and/or the length of the sidewalls.” Ex. 1025
¶ 36.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
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Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 9 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

7. Dependent Claim 10
Claim 10 depends from claim 4 and recites, “further comprising one
or more actuators including at least one of an actuator handle, a lever, a
trigger, a knob or a cable.” Ex. 1001, 8:56–58. In addressing this limitation,
Petitioner submits that Green 209 discloses this limitation, identifying
Green 209’s frame 52 (the “handle”), handle member 62 (the “lever”), firing
trigger 96 (the “trigger”), dial member 452 (the “knob”), and cable 404 (the
“cable.”). See Pet. 34 (referencing in part Green 209’s Figure 1).
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 10 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

8. Dependent Claim 11
Claim 11 depends from claim 4 and further recites, “wherein at least a
portion of the apparatus is powered.” Ex. 1001, 8:59–60. In addressing this
limitation, Petitioner submits that Green 209 discloses this limitation, citing
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the fact that Green 209 describes a pneumatically-powered stapler. See
Pet. 35 (citations omitted).
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 11 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

9. Dependent Claim 12
Claim 12 depends from claim 4 and further recites, “wherein at least a
portion of the first jaw and the second jaw is curved.” Ex. 1001, 8:61–62.
In addressing this limitation, Petitioner submits that Green 209 discloses this
limitation, citing the outer surface of Green 209’s anvil member 56 and
flange 366 of forward housing 270. See Pet. 35–36 (citations omitted).
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 12 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

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10. Independent Claim 13
Independent claim 13 is similar to independent claim 4 but further
recites, inter alia, “a control handle configured to actuate receiving,
clamping and stapling of tissue.” Compare Ex. 1001, 8:4–32, with id. at
8:63–9:13.
To address this particular limitation, Petitioner submits that
Green-209’s control handle (frame 52 or handle assembly 1012)
is configured to actuate receiving (via gross manipulation of
frame 52/handle assembly 1012 to position the instrument jaws
relative to tissue), clamping (via handle member 62 or actuation
handle 1018) and stapling of tissue (via firing trigger 96 or 1020).
Pet. 39 (citing in part Ex. 1003 ¶ 96).
Patent Owner argues, “It appears that Petitioner is arguing that simply
pushing the stapler towards the tissue via hand is supposed to satisfy the
‘actuate receiving’ requirement . . . . If PO’s assumption is correct, then
Petitioner has failed to satisfy the limitation because hand movement itself
does not equate to ‘actuating’ anything.” PO Resp. 28.
Patent Owner’s argument is not persuasive. Petitioner and Dr. Knodel
sufficiently explain the following: (1) that gross manipulation of
Green 209’s frame 52 to position the instrument jaws relative to tissue
satisfies the claimed “configured to actuate receiving,” (2) manipulation of
handle member 62 satisfies the claimed “configured to actuate . . .
clamping,” and (3) actuating firing trigger 92 satisfies the claimed
“configured to actuate . . . stapling of tissue.” See Ex. 1003 ¶ 96.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
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the limitations of claim 13 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

11. Dependent Claim 14
Claim 14 depends from claim 13 and further recites, “wherein: the
beam is configured to enable at least one of firing staples and cutting tissue.”
Ex. 1001, 9:15–17. In addressing this limitation, Petitioner references
limitation [4.6] and submits that Green 209 as modified by Green 695
satisfies this limitation. See Pet. 40 (citations omitted).
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 14 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

12. Dependent Claim 15
Claim 15 depends from claim 13 and further recites, “wherein the
slots through which staples are passed are arranged in a first row extending
from a proximal end of the first jaw to a distal end thereof such that two or
more staples are fired in a row orthogonal to a direction of movement of the
beam one of simultaneously or serially.” Ex. 1001, 9:18–23. In addressing
this limitation, Petitioner asserts that Green 209 discloses this limitation,
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submitting an annotated version of Green 209’s Figure 18 (see Pet. 41–42), a
copy of which we reproduce, below:

Figure 18 is a “perspective view of the articulating cartridge assembly of the
surgical instrument.” Ex. 1004, 6:53–54. Petitioner annotates Figure 18 to
highlight the “proximal end of the first jaw,” the “distal end of the first jaw,”
the “direction of movement of the beam,” the “row orthogonal to direction
of beam movement,” and the “first row.”
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 15 for the reasons stated by Petitioner in the Petition,
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which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

13. Dependent Claim 16
Claim 16 depends from claim 15 and further recites, “wherein
additional slots are arranged in a second row substantially parallel to the first
row of slots.” Ex. 1001, 9:23–25. In addressing this limitation, Petitioner
submits that Green 209 discloses this limitation, presenting another
annotated version of Green 209’s Figure 18. See Pet. 42 (citations omitted).
We reproduce Petitioner’s annotated Figure 18, below:

As shown in the annotated figure, Petitioner calls out the “first row” and the
“second row parallel to [the] first row” and submits that Green 209 discloses
additional slots arranged in a second row that is substantially parallel to the
first row of slots. See id.
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
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We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 16 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

14. Dependent Claim 17
Claim 17 depends from claim 13 and further recites, “wherein the
head portion is one of fixedly coupled or movably coupled to the shaft.”
Ex. 1001, 9:27–28. In addressing this limitation, Petitioner asserts that
Green 209 discloses this limitation, submitting an annotated version of
Green 209’s Figure 31 (see Pet. 43 (citations omitted)), a copy of which we
reproduce, below:

Figure 31 “is an enlarged perspective view, partially cut-away, of [a]
cartridge assembly.” Ex. 1004, 7:21–23.
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Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 17 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

15. Dependent Claim 18
Claim 18 depends from claim 13 and further recites, “wherein tissue is
cut between the first row and the second row upon firing of one or more
staples through the slots.” Ex. 1001, 9:29–31. In addressing this limitation,
Petitioner asserts that Green 209, as modified by the teachings of Green 695,
satisfies this limitation. See Pet. 44 (citing in relevant part limitations [4.2],
[4.6], and claims 14 and 16).
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 18 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

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16. Dependent Claim 20
Claim 20 depends from claim 13 and further recites, “wherein the
beam includes a cutting blade and is configured to clamp and align the first
and second jaws one of entirely or substantially from therewithin.”
Ex. 1001, 9:35–38. In addressing this limitation, Petitioner references
elements [4.2] and [13.2], and asserts that Green 209, as modified by Green
695, satisfies this limitation. See Pet. 44.
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 20 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

17. Dependent Claim 22
Claim 22 depends from claim 13 and further recites, “wherein the
control handle includes at least one of an actuation handle, a lever, a trigger,
a knob and a cable.” Ex. 1001, 10:3–5. In addressing this limitation,
Petitioner references the analysis from its claim 10 challenge. See Pet. 44;
see also supra Part II.D.7.
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
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the limitations of claim 22 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

18. Dependent Claim 23
Claim 23 depends from claim 13 and further recites, “wherein at least
a portion of the apparatus is powered.” Ex. 1001, 10:6–7. In addressing this
limitation, Petitioner references the pneumatically-powered stapler cited in
its claim 11 challenge. See Pet. 45; see also supra Part II.D.8.
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 23 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

19. Dependent Claim 24
Claim 24 depends from claim 13 and further recites, “wherein the
apparatus is powered electrically, hydraulically or pneumatically.”
Ex. 1001, 10:8–9. In addressing this limitation, Petitioner relies on
Green 209’s pneumatically-powered stapler cited during the analysis of
claim 11. See Pet. 45; see also supra Part II.D.8.
Patent Owner does not dispute Petitioner’s assertion. See, generally,
PO Resp.
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We are persuaded by Petitioner’s argument and evidence, and find
that Petitioner has established by a preponderance of the evidence that
Green 209 as modified by the teachings of Green 695 and Knodel satisfies
the limitations of claim 24 for the reasons stated by Petitioner in the Petition,
which we adopt as our own findings, as further supported by the testimony
of Dr. Knodel.

20. Summary of Ground 1A
Based on the foregoing, we determine Petitioner has proven by a
preponderance of the evidence that claims 4, 5, 9–18, 20, and 22–24 are
unpatentable in view of Green 209 as modified by the teachings of
Green 695 and Knodel.

E. Ground 1B – Green 695, Green 209, and Knodel
1. Petitioner’s Challenge
Petitioner’s challenge under Ground 1B is similar to Petitioner’s
challenge under Ground 1A in that both challenges rely on the same three
references—Green 209, Green 695, and Knodel—and both challenge the
same claims—namely, claims 4, 5, 9–18, 20, and 22–24. See Pet. 9. As
distinguished from Ground 1A, in which Petitioner proposes to modify
Green 209 in view of Green 695 and Knodel, however, Petitioner proposes
to modify Green 695’s “surgical stapler for use in minimally invasive
surgery to create essentially the same device.” Id.
Petitioner submits that “Green-695’s instrument 10 does not include
an elongated shaft and therefore could not be used for minimally invasive
surgery (‘MIS’).” Id. at 17. Petitioner further submits that Green 695’s
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instrument does not include a power source (separate from the hand-actuated
mechanism) for firing the stapling mechanism. Id. at 17–18. Based on these
perceived shortcomings, Petitioner submits that a skilled artisan would have
been motivated to modify Green 695’s instrument to be used for MIS “to
produce essentially the same device as discussed in the first combination.”
Id. at 18 (citing Ex. 1003 ¶ 55). In explaining how this structure would look,
Petitioner explains, “Green-695’s handles 22, 26 are replaced with Green-
209’s frame 52 and elongated shaft portion 54 . . . [and] Green-695’s jaws
16, 20 are opened and closed using the linkage and cable assembly
controlled by Green-209’s handle 62.” Id. Petitioner further explains that
“Green’s 695’s [sic] pusher bar and knife assembly 30 are driven by Green
209’s pneumatic system.” Id.
Petitioner reasons that a skilled artisan would have been motivated to
modify Green 695 in such a manner “because the benefits of MIS compared
to open surgery (e.g., faster recovery times, less pain, etc.) were well
known.” Id. (citations omitted). As for the modification involving the
addition of Green 209’s pneumatic system, Petitioner reasons that a skilled
artisan would have been motivated to modify Green 695 to include such a
feature “to facilitate fastening and/or cutting tissue.” Id. (citations omitted).

2. Analysis
Patent Owner argues: “The Petition is detrimentally silent as to how
or why Green 695 satisfies the limitations of the challenged claims.” PO
Resp. 28–29. Patent Owner cites to our Institution Decision (see id.), in
which we explained that Petitioner failed to explain adequately its challenge.
See Inst. Dec. 33–34. Despite not being persuaded, we nevertheless
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instituted Ground 1B under SAS Guidance. See Guidance on the Impact of
SAS on AIA Trial Proceedings (Apr. 26, 2018), https://
www.uspto.gov/patents-application-process/patent-trial-and-appeal-
board/trials/guidance-impact-sas-aia-trial (“SAS Guidance”). See Inst. Dec.
34.
Petitioner does not respond to Patent Owner’s argument or otherwise
address our Institution Decision in its Reply. See, generally, Pet. Reply.
We maintain our initial assessment that the Petition fails to clearly set
forth its challenge under Ground 1B.
Although Petitioner submits a detailed claim chart to address the
limitations of the challenged claims under Ground 1A (see Pet. 19–45), this
claim chart fails to support Petitioner’s alternative challenge under
Ground 1B. Indeed, other than its brief summary on pages 9 and 17–18 of
the Petition, Petitioner fails to specify (under Ground 1B) where each
element of the challenged claims are found in the prior art. See 37 C.F.R.
§ 42.104(b)(4) (“The petition must specify where each element of the claim
is found in the prior art patents or printed publications relied upon.”).

3. Summary of Ground 1B
Based on the foregoing, Petitioner has failed to prove by a
preponderance of the evidence that claims 4, 5, 9–18, 20, and 22–24 are
unpatentable over Green 695 in view of Green 209 and Knodel.

F. Ground 2 – Rothfuss, Green 209, and Knodel
Petitioner contends that claims 4–8 and 10–24 are unpatentable as
obvious over Rothfuss in view of Green 209 and Knodel. Pet. 45.

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1. Rothfuss (Ex. 1007)
Rothfuss is a U.S. Patent titled, “Surgical Stapling Instrument with
Dual Staple Height Mechanism.” Ex. 1007, code (54). Rothfuss describes a
“surgical stapling instrument suitable for performing a gastrointestinal
anastomosis.” Id. at code (57).

2. Petitioner’s Challenge
Petitioner produces an annotated version of Rothfuss’s Figure 1
(Pet. 45), which we reproduce, below:

As shown above in annotated Figure 1, Petitioner submits that this figure
depicts linear anastomotic stapling instrument 20, which includes upper and
lower handles 22, 24, upper and lower jaw members 26, 28, and first and
second control buttons 72, 74. Pet. 45 (citations omitted).
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Petitioner explains that two operations are performed in sequence to
complete stapling. Id. at 46. First, and “[a]fter the tissue is clamped, first
control button 72 is actuated to advance actuator assembly 70 [shown below
in Figure 9] longitudinally along jaw members 26 and 28 into staple
cartridge 60 . . . and anvil 80.” Id. (quoting Ex. 1007, 12:37–40). Next,
when “actuator assembly 70 [is] advanced into staple cartridge 60 and anvil
80, its elongated I-beam structure provides support and alignment along the
entire operating length of jaw members 26 and 28.” Id. (quoting Ex. 1007,
12:66–13:2).
Petitioner also submits an annotated version of Rothfuss’s Figure 9,
which depicts Rothfuss’s actuator assembly 70 (Pet. 47), below:

As shown above in annotated Figure 9, Petitioner submits that Rothfuss’s
actuator assembly 70 includes an I-beam with knife blade 100 “having an
inclined front face 102 which is beveled to provide a sharp cutting edge.”
Pet. 47 (quoting Ex. 1007, 8:38–45). Rothfuss further discloses that “upper,
elongated flange member 104 extends along the top of knife blade 100 and a
lower, elongated flange member 106 extends along the bottom of the knife
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blade to complete the I-beam structure.” Id. Rothfuss explains that upper I-
beam flange member 104 is provided with staple pinning bars 108, which
each include forwarding projecting tapered tip 110 and an inclined cam
surface 112. Id. (citing Ex. 1007, 8:45–56).
Petitioner also submits an annotated version of Rothfuss’s Figure 6
(id. at 48), which is an enlarged vertical section through the handle of
Rothfuss’s device (Ex. 1007, 5:40–42), and which we also reproduce, below:

As shown above in annotated Figure 6, Petitioner submits that upper jaw
member 26 includes pair of shoulders 118, which along with upper interior
surface of jaw member 26, define passageway 120 in which upper flange
104 is slidably mounted for longitudinal movement relative to the jaw
member. Pet. 47 (citing Ex. 1007, 8:62–9:3). As with the upper jaw
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member, lower jaw member 28 (along with anvil flanges 82) define
passageway 130 for slidably receiving lower I-beam flange 106. Pet. 48
(citing Ex. 1007, 9:37–40).
In describing the operation of Rothfuss’s stapling, Petitioner submits
an annotated version of Rothfuss’s Figure 12 (Pet. 49), which illustrates the
operation of Rothfuss’s actuator assembly (Ex. 1007, 5:56–58), and which
we reproduce, below:

As shown above in annotated Figure 12, Petitioner submits that as actuator
assembly 70 is advanced, upper I-beam flange 104 slides into passageway
120, and cam surfaces 112 sequentially engage staple drivers 68. Pet. 48
(citing Ex. 1007, 13:7–28). “As a result, staple drivers 68 are sequentially
pushed downward to partially drive each staple 65.” Id. (quoting Ex. 1007,
13:7–28). Next, second control button 74—of staple pusher bar mechanism
75, shown in Figure 11—is actuated to advance staple forming bars 76
longitudinally into staple cartridge. Id. at 50 (citing Ex. 1007, 13:28–30,
Fig. 11). Petitioner also submits an annotated version of Rothfuss’s
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Figure 13 to illustrate the ejection of staples by bars 76 (id. at 51), which we
reproduce, below:

As shown above in annotated Figure 13, Petitioner submits that cam surfaces
78 of staple forming bars 76 push staple drivers 68 downward to complete
ejection of staples 65 from the cartridge and into anvil flanges 82, forming
the staples into a B-shaped configuration. Ex. 1007, 13:29–38.

3. Institution Decision
In our Institution Decision, we determined that Petitioner did not
show a reasonable likelihood of establishing that any of claims 4–8 or 10–24
are unpatentable over Rothfuss in view of Green 209 and Knodel. See Inst.
Dec. 49.
Patent Owner argues that Petitioner’s proposed modification of
Rothfuss is flawed (see PO Resp. 29–36) and requests that we maintain our
initial position (see id. at 29).
Petitioner did not reply to Patent Owner’s arguments or otherwise
address our Institution Decision. See, generally, Pet. Reply.
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For the reasons below, Petitioner has failed to prove by a
preponderance of the evidence that claims 4–8 and 10–24 are unpatentable
over Rothfuss in view of Green 209 and Knodel.

4. Independent Claim 4
a) “[4.0] An apparatus for stapling tissue,
comprising:”
Petitioner submits that Rothfuss discloses an apparatus for stapling
tissue, submitting an annotated version of Rothfuss’s Figure 1 (Pet. 51),
which we reproduce, below:

As shown above in annotated Figure 1, Petitioner submits that Rothfuss’s
linear anastomotic stapling instrument 20 satisfies the claimed “apparatus for
stapling tissue.” Id. (citing Ex. 1007, 6:8–14).
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b) “[4.1] a first jaw and a second jaw, at least one of
the first jaw and the second jaw being movable with
respect to the other of the first jaw and the second jaw
from a first configuration in which the first jaw and the
second jaw are separated from each other at a first
distance to receive tissue and a second configuration in
which the first jaw and the second jaw are clamped
together at a second distance to hold tissue therebetween
for stapling”
Petitioner asserts that Rothfuss discloses this limitation, submitting
annotated versions of Rothfuss’s Figures 2 and 3 (Pet. 53), which we
reproduce, below:
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As shown above in the annotated Figure 2, Petitioner highlights the “first
configuration” (in which the jaws are open), the “first distance between
jaws,” the “second configuration” (in which the jaws are closed), and the
“second distance between jaws.” Petitioner submits that this figure depicts
Rothfuss’s upper/first jaw 26 and lower/second jaw 28 in the first, or open,
position, for receiving tissue. See id. at 52–53 (citations omitted). As also
shown above, Petitioner submits that Rothfuss’s Figure 3 depicts upper/first
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jaw 26 and lower/second jaw 28 in a second, or closed, position to hold
tissue therebetween. See id. (citations omitted).

c) “[4.2] a staple carrying portion of the first jaw
defining slots through which staples are configured to
pass”
Petitioner asserts that Rothfuss discloses this limitation, submitting an
annotated version of Rothfuss’s Figure 15 (Pet. 54), which we reproduce,
below:

As shown above in annotated Figure 15, Petitioner submits that this figure
depicts a staple carrying portion (staple cartridge 60) of the first jaw defining
slots (openings 63) through which staples 65 are configured to pass. Id.
(citing Ex. 1007, 7:22–57).
d) “[4.3] an anvil surface defined on the second jaw
opposing the first jaw”
Petitioner asserts that Rothfuss discloses this limitation, submitting an
annotated excerpt from Rothfuss’s Figure 7 (Pet. 55), which we reproduce,
below:
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As shown above in annotated Figure 7, Petitioner submits that Rothfuss
discloses an anvil surface (anvil 80) defined on the second jaw opposing the
first jaw. Id. at 54 (citing Ex. 1007, 8:14–22).
e) “[4.4] at least one of a gear and a cable
operatively coupled to at least one of the first jaw and the
second jaw and configured to move at least one of the
first jaw and the second jaw from the first configuration
to the second configuration such that the first jaw and the
second jaw are in alignment”
Petitioner relies on Rothfuss, in view of the teachings of Green 209
and Knodel, for satisfying this limitation. Pet. 55. In particular, Petitioner
submits that Rothfuss would include two modifications: (1) modified to be
used for MIS based on Green 209’s teachings; and (2) modified to include
Knodel’s gears and Green 209’s cable which are controlled by Green 209’s
handle. See id. To illustrate the modified structure, Petitioner submits the
following figure (Pet. 56):
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As shown above in the annotated Figure Petitioner submits that Rothfuss’s
upper jaw member 28 is connected to Green 209’s anchor cable 427, with
Rothfuss’s lower jaw member 26 connected to Green 209’s pulley 248. See
id.
As to the proposed modification of Rothfuss for MIS, Petitioner
reasons that a skilled artisan would have been motivated to modify
“Rothfuss’s stapler for use in minimally invasive surgery . . . for the same
reasons a POSITA would have modified Green 695’s stapler for use in
MIS.” Id. at 50 (citing Ex. 1003 ¶ 117). Petitioner explains:
Rothfuss’s handles 22, 24 would be replaced with Green-209’s
frame portion 52 and elongated shaft portion 54 without or
without [sic] Green-209’s articulation and rotation functionality.
Rothfuss’s jaws 26, 28 (reduced in size and modified to resemble
Green-209’s jaws) would be opened and closed using
Green-209’s linkage and cable assembly. And at least Rothfuss’s
staple pusher bar mechanism 75 would be driven by Green-209’s
pneumatic system 68 to gain the benefit of a powered firing
mechanism.
Id. at 50–51.
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f) “[4.5] a staple pusher configured to cause a
staple to move from a first position at least partially
within the staple carrying portion to a second position
entirely outside the staple carrying portion”
Petitioner asserts that Rothfuss discloses this limitation, submitting
annotated versions of Rothfuss’s Figures 12 and 13 (Pet. 57), which we
reproduce, below:

As shown above in annotated Figures 12 and 13, Petitioner calls out “staple
pusher (or staple driver 68), and staple 65 before and after being ejected
from cartridge 60. Petitioner submits that Rothfuss discloses staple pusher
(staple drivers 68) configured to cause staples 65 to move from a first
position within staple carrying portion (shown in Figure 12) to a second
position entirely outside of the staple carrying portion (shown in Figure 13).
Id. at 56 (citations omitted).

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g) “[4.6] the second distance and the alignment
being maintained by a beam configured to engage the
first and second jaws from within the first and second
jaws while tissue is stapled from a proximal location to a
distal location”
Petitioner submits that Rothfuss discloses this limitation, submitting
an annotated version of Rothfuss’s Figure 9 (Pet. 58), which we reproduce,
below:

As shown above in annotated Figure 9, Petitioner calls out upper flange 104,
lower flange 144, knife blade 100, and staple pinning bars 108. Petitioner
submits that Rothfuss discloses that I-beam structure—including knife blade
100—is configured to engage first and second jaws from within
passageways 120, 130 while tissue is stapled from a proximal location to a
distal location. Pet. 57 (citations omitted).
h) Patent Owner’s Argument
In addressing limitation 4.4, Patent Owner argues that “Petitioner has
not provided any explanation as to how control button 72 operates when
upper handle 22 is replaced with Green-209’s frame portion 52 and
elongated shaft portion 54.” PO Resp. 33. Patent Owner explains that “[t]he
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buttons 72, 74 in Rothfuss are manually operated because the device [] is
used in open surgeries.” Id. (citations omitted).
Patent Owner’s argument is persuasive.

i) Analysis
The burden is on Petitioner to clearly set forth the basis for its
challenge in its Petition. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d
1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter
partes review petitions to identify “with particularity . . . the evidence that
supports the grounds for the challenge to each claim”)).
Here, Petitioner proposes to modify Rothfuss by replacing Rothfuss’s
handles 22, 24 with Green 209’s frame portion 52 and elongated shaft
portion 54 for the purpose of making Rothfuss a minimally-invasive surgical
device, yet it is not clear to us how Rothfuss’s buttons 72, 74 would continue
to operate within this construct. See Pet. 50.
Indeed, Rothfuss discloses that its stapling device permits surgeons to
select between two different staple heights to allow the device to be used
with tissue of different thicknesses. Ex. 1007, 2:51–55. Rothfuss achieves
this functionality through control buttons 72, 74. See, e.g., id. at 7:68–8:2
(“first control button 72 is moveable laterally between different control
positions to select the desired staple height to be produced”); see also id. at
8:3–6 (“The stapling instrument includes a second control button 74 which is
actuated after the tissue is initially pinned and cut by actuator assembly 70 to
operate a staple pusher bar mechanism 75”). Rothfuss discloses, “After the
stapling of the tissue is completed, control buttons 72 and 74 are retracted to
allow jaw members 26 and 28 to pivot apart for removal of the stapled tissue
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from the jaw members.” Id. at 8:10–13. Furthermore, Rothfuss’s handles
22, 24 (including notch 152 and flange 153) permit the control buttons to
adjust laterally between their outermost and innermost positions for selection
of the desired staple height. See id. at 10:53–11:3, Figs. 1, 8. Absent any
explanation in the Petition (see Pet. 50–51, 55–57), it is not clear to us how
Petitioner’s proposed removal of handles 22, 24 would allow Rothfuss’s
device to maintain the varying height-adjustable staple functionality of
buttons 72, 74, and we are not persuaded that a skilled artisan would have
been motivated to modify Rothfuss as Petitioner proposes. Petitioner’s
proposed modification leaves the Board to speculate about how Rothfuss’s
control buttons 72, 74 would continue to adjust laterally for selecting staples
of varying heights. See Harmonic, 815 F.3d at 1363.
Absent any meaningful explanation in the Petition, Patent Owner’s
argument that the “proposed modifications to Rothfuss’[s] device render the
height staple selection functionality insufficient or inoperable” is persuasive.
PO Resp. 33.
Petitioner has failed to prove by a preponderance of the evidence that
Rothfuss in view of Green 209 and Knodel satisfies limitation [4.4]. As
such, Petitioner has failed to prove that claim 4 is unpatentable over
Rothfuss in view of Green 209 and Knodel.

5. Independent Claim 13
As with its challenge of claim 4, in addressing the claimed limitation
13.3, “a control handle configured to actuate receiving, clamping and
stapling of tissue,” Petitioner proposes to replace Rothfuss’s handles with
Green 209’s control handle. See Pet. 66; see also id. at 50 (“Rothfuss’s
handles 22, 24 would be replaced with Green-209’s frame portion 52 and
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elongated shaft portion 54 without or without [sic] Green-209’s articulation
and rotation functionality.”).
As with claim limitation [4.4], however, Petitioner has failed to prove
by a preponderance of the evidence that a skilled artisan would have been
motivated to replace Rothfuss’s handles 22, 24, as doing so would also
impact the operation of Rothfuss’s control buttons 72, 74. See supra Part
II.F.4.e. The Petition fails to adequately address how the proposed
modification would maintain the functionality of these buttons, and we are
not persuaded that a skilled artisan would have been motivated to modify
Rothfuss as Petitioner proposes. See id.
Petitioner has failed to prove by a preponderance of the evidence that
claim 13 is unpatentable over Rothfuss in view of Green 209 and Knodel.

6. Dependent Claims 5–8, 10–12, and 14–24
Claims 5–8, 10–12, and 14–24 depend from either claim 4 or 13, and
Petitioner’s challenge to these claims inherit the same infirmity as its
challenge under claim 4. See Pet. 59–70. For the same reasons that
Petitioner has failed to prove by a preponderance of the evidence that a
skilled artisan would have been motivated to modify Rothfuss’s handles,
Petitioner has failed to prove that dependent claims 5–8, 10–12, and 14–24
are unpatentable over Rothfuss in view of Green 209 and Knodel.

7. Summary of Ground 2
Petitioner has failed to prove by a preponderance of the evidence that
claims 4–8 and 10–24 are unpatentable over Rothfuss in view of Green 209
and Knodel.

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G. Ground 3 – McGuckin and Green 695
Petitioner contends that claims 4–24 are unpatentable as obvious over
McGuckin in view of Green 695. Pet. 70.

1. McGuckin (Ex. 1012)
McGuckin discloses a surgical apparatus for resectioning diseased
tissue. Ex. 1012, 1:5–9. Resection is described as the surgical removal of
an organ or structure. Id. at 1:44. To illustrate McGuckin’s apparatus, we
reproduce its Figures 1A and 1B, below:
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Figures 1A and 1B are isometric views of a preferred embodiment of an
apparatus for the removal of malignant or other undesirable tissue. Id. at
9:54–56. In particular, Figure 1A (top) depicts the operating control module
portion of the apparatus and Figure 1B (bottom) depicts “a longitudinally
elongated operating capsule apparatus . . . and the portion of the cable
carrying flexible tubular apparatus not shown in FIG. 1A.” Id. at 9:60–66.
In combination, these figures depict apparatus 10 including longitudinally
elongated operating capsule 12, operating control module 14, and cable
carrying flexible tubular member 16. Id. at 11:62–66.

2. Independent Claim 4
a) “[4.0] An apparatus for stapling tissue,
comprising:”
Petitioner submits that McGuckin discloses an apparatus for stapling
tissue, submitting an annotated version of McGuckin’s Figures 1A and 1B
(Pet. 70), which we reproduce, below:

As shown above in annotated Figures 1A and 1B, Petitioner submits that
McGuckin’s apparatus 10 is an apparatus for stapling tissue. Id. (citations
omitted). McGuckin discloses: “The tissue fastening means portion of the
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apparatus preferably may further include a plurality of suturing staples and
anvils for the fastening, bending or closing of individual suturing staples
serially thereagainst.” Ex. 1012, 4:34–37.
b) “[4.1] a first jaw and a second jaw, at least one of
the first jaw and the second jaw being movable with
respect to the other of the first jaw and the second jaw
from a first configuration in which the first jaw and the
second jaw are separated from each other at a first
distance to receive tissue and a second configuration in
which the first jaw and the second jaw are clamped
together at a second distance to hold tissue therebetween
for stapling”
Petitioner asserts that McGuckin discloses this limitation, submitting
an annotated version of McGuckin’s Figures 14 and 15 (Pet. 72), which we
reproduce below:
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As shown above in Figures 14 and 15, Petitioner identifies a “first distance”
and a “second distance” between “first jaw” 24 and “second jaw” 22.
Petitioner submits that McGuckin discloses first jaw (lower shell 24) and
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second jaw (upper shell 22) being movable with respect to the other from a
first/open configuration in which the jaws are separated from each other at a
first distance (Figure 15) to receive tissue and a second configuration
(closed) in which the jaws are clamped together at a second distance (Figure
14) to hold tissue therebetween for stapling, as further shown in Figure 31.
Pet. 71 (citations omitted).

c) “[4.2] a staple carrying portion of the first jaw
defining slots through which staples are configured to
pass”
Petitioner asserts that McGuckin discloses this limitation, submitting
an annotated version of McGuckin’s Figure 23 (Pet 73), which we
reproduce, below:

As shown above in annotated Figure 23, Petitioner submits that McGuckin
discloses staple carrying portion (lower lip 28) of the first jaw defining slots
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(apertures 108O, 109I) through which staples 104 are configured to pass.
Pet. 73 (citations omitted).

d) “[4.3] an anvil surface defined on the second jaw
opposing the first jaw”
Petitioner asserts that McGuckin discloses this limitation, submitting
an annotated version of McGuckin’s Figure 15 (Pet. 74), which we
reproduce, below:

As shown above in annotated Figure 15, Petitioner submits that McGuckin
discloses anvil surface (upper lip 26) defined on second jaw 22 opposing
first jaw 24. See id. (citations omitted).

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e) “[4.4] at least one of a gear and a cable
operatively coupled to at least one of the first jaw and the
second jaw and configured to move at least one of the
first jaw and the second jaw from the first configuration
to the second configuration such that the first jaw and the
second jaw are in alignment”
Petitioner submits that McGuckin discloses this limitation (see supra
Part II.G.1), and provides annotated versions of McGuckin’s Figures 13 and
14 to support its position. Pet. 75–76. We reproduce Petitioner’s annotated
Figure 14, below:

As shown above in annotated Figure 14, Petitioner highlights threaded shaft
148, bulkhead 120, arm 156, pedestal block 150, pin 158, drive pulley 152,
nut 154, and cable 146. Petitioner submits that McGuckin depicts cable 146
configured to move first jaw 24 and second jaw 22 from the first/open
configuration to the second/closed configuration such that the first and
second jaws are in alignment. See id. at 76.
We also reproduce Petitioner’s annotated Figure 13, below:
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As shown above in annotated Figure 13, Petitioner submits that McGuckin
discloses at least one gear (bevel gears 140, 144, highlighted in yellow) and
cable (146, also highlighted in yellow). Pet. 75 (citations omitted).
Petitioner explains that bevel gears 140, 144 and cable 146 are operatively
coupled to first and second jaws by pulley 142, threaded shaft 148, pedestal
block 150, bulkhead 120, drive pulley 152, nut 154, arm 156, pin 158, and
lift arm 160 (shown in Figure 14). Id.

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f) “[4.5] a staple pusher configured to cause a staple
to move from a first position at least partially within the
staple carrying portion to a second position entirely
outside the staple carrying portion”
Petitioner asserts that McGuckin discloses this limitation, submitting
an annotated version of McGuckin’s Figure 24 (Pet. 77), which we
reproduce, below:

As shown above in annotated Figure 24, Petitioner submits that this figure
depicts staple pusher (staple support block 168) configured to cause staple
(104) to move from a first position at least partially within a staple carrying
portion to a second position entirely outside of the staple carrying portion.
Id. (citations omitted).

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g) “[4.6] the second distance and the alignment
being maintained by a beam configured to engage the
first and second jaws from within the first and second
jaws while tissue is stapled from a proximal location to a
distal location”
Petitioner submits that McGuckin, when modified based on
Green 695’s teachings, satisfies this limitation. See Pet. 77–78. In
particular, Petitioner proposes to modify McGuckin’s knife portion 76 to
include the upper portion of an I-beam, and to modify McGuckin’s first and
second jaws to include an internal passageway and opening. See id. at 78.

h) Patent Owner’s Argument
Patent Owner argues that a POSITA would not have modified
McGuckin based on Green 695’s teachings. See PO Resp. 40–45. Patent
Owner explains that the McGuckin stapler is “very different” from the
staplers described in Green 695 and Green 209 and Petitioner “ignor[es]
existing features of McGuckin . . . already providing alignment and
stability.” Id. at 41. Specifically, Patent Owner identifies McGuckin’s
hinges as creating a solid anchor point whereby longitudinal distortion of the
jaws is prevented. Id. at 43 (citing Ex. 2002 ¶ 133); see also PO Sur-Reply
17 (“In McGuckin, longitudinal movement is restricted by two hinges 44
along the length of the shells. . . . Having two pivot points is significant.”).
We agree.

i) Analysis
Having reviewed the evidence of record, namely, McGuckin, Green
695, and the competing testimony of Mr. Juergens and Dr. Knodel, we credit
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Mr. Juergens’s testimony that a POSITA would not have modified
McGuckin by adding an I-beam taught by Green 695. See Ex. 2002 ¶ 132.
To illustrate this point, Mr. Juergens produces an annotated version of
McGuckin’s Figure 15 (id. ¶ 133), a copy of which we reproduce, below:

Figure 15 depicts a “partially sectioned side view of the operating capsule
apparatus manifesting aspects of the invention with the operating capsule
illustrated in the open position.” Ex. 1012, 10:50–52. Specifically,
Figure 15 discloses upper shell portion 22 and lower shell portion 24
“longitudinally aligned and movable relative to one another about hinges 44
[highlighted in yellow] . . . so that upper and lower shell portions 22, 24 can
move, thereby to open shell 18.” Id. at 13:29–34.
We credit Mr. Juergens’s testimony that McGuckin’s hinges 44 “are
widely spaced by virtue of being on the long side of the shell. This makes
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them particularly stable as they define a pivot line that is long when
compared to the length of the rotating shell.” Ex. 2002 ¶ 135 (emphasis
added).
Although we agree with Petitioner’s similar reasoning for modifying
Green 209 based on Green 695’s I-beam (see supra Part II.D.4.i), we find
that the differences between Green 209’s stapler and McGuckin’s
resectioning apparatus would have led a POSITA to different results.
Green 209’s stapler includes elongated jaws (56, 58) with a pivot
point located at one end of the elongation. See, e.g., Ex. 1004, Fig. 1.
McGuckin’s device, on the other hand, is not elongated like Green
209’s and Green 695’s staplers, and McGuckin’s shell pivots along the
longitudinal side of the shell. See, e.g., Ex. 1012, Figs. 15, 18; see also PO
Sur-Reply 16 (“McGuckin’s jaws pivot longitudinally”). We agree with
Mr. Juergens’s testimony that the “hinges 44 in McGuckin . . . are widely
spaced by virtue of being on the long side of the shell [and that this] makes
them particularly stable as they define a pivot line that is long when
compared to the length of the rotating shell.” Ex. 2002 ¶ 135.
The record supports our legal conclusion that Green 209’s elongated
jaws, but not McGuckin’s relatively short jaws, would have benefited from
adding an I-beam. We credit Mr. Juergens’s testimony that McGuckin’s
hinges “are disposed along the length of jaws 22, 24, creating a solid anchor
and pivot point [axis] about which jaws 22, 24 can rotate but longitudinal
movement is prevented.” Ex. 2002 ¶ 133. Indeed, even Dr. Knodel’s
testimony confirms our understanding that a longer anvil, or longer jaws,
“would have been required to stabilize and align the jaws.” See Ex. 1025 ¶ 5
(“If, however, a POSITA used a longer anvil . . . then an I-beam (or a similar
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structure) would have been required to stabilize and align the jaws.”). Yet,
McGuckin’s jaws are not elongated like Green 209’s jaws or Green 695’s
jaws.
Furthermore, we are not persuaded by Dr. Knodel’s testimony that “a
POSITA would have understood that McGuckin’s jaws could have various
lengths.” Ex. 1025 ¶ 42. Petitioner’s attempt to reconstruct the shape and
length of McGuckin’s jaws for the purpose of supporting its proposed
modification is a bridge too far; this is precisely the type of impermissible
hindsight reconstruction that we have been cautioned to avoid. See Grain
Processing Corp. v. Am.-Maize Prods. Co., 840 F.2d 902, 907 (Fed. Cir.
1988) (“Care must be taken to avoid hindsight reconstruction by using ‘the
patent in suit as a guide through the maze of prior art references, combining
the right references in the right way so as to achieve the result of the claims
in suit.’” (quoting Orthopedic Equip. Co. v. United States, 702 F.2d 1005,
1012 (Fed. Cir. 1983))).
For the foregoing reasons, Petitioner has failed to prove by a
preponderance of the evidence that a skilled artisan would have been
motivated to modify McGuckin to include an I-beam in view of Green 695’s
teachings. As such, Petitioner has failed to prove that claim 4 is
unpatentable over McGuckin in view of Green 695.

3. Independent Claim 13
As with its challenge of claim 4, Petitioner relies on the same
unsupportable modification of adding an I-beam to McGuckin based on
Green 695’s teachings. See Pet. 91 (referencing limitation [4.6] in
addressing “a beam . . . configured to clamp and align the first and second
jaws . . . .”). For the same reasons that Petitioner has failed to prove by a
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preponderance of the evidence that a skilled artisan would have been
motivated to modify McGuckin to include an I-beam in view of Green 695’s
teachings, Petitioner has failed to prove that independent claim 13 is
unpatentable over McGuckin in view of Green 695.

4. Dependent Claims 5–12 and 14–24
Claims 5–12 and 14–24 depend from claim 4 or 13, respectively, and
Petitioner’s challenge to these claims inherit the same infirmity as its
challenge under claim 4. See Pet. 83–98. For the same reasons that
Petitioner has failed to prove by a preponderance of the evidence that a
skilled artisan would have been motivated to modify McGuckin to include
an I-beam in view of Green 695’s teachings, Petitioner has failed to prove
that claims 5–12 and 14–24 are unpatentable over McGuckin in view of
Green 695.

5. Summary of Ground 3
Petitioner has failed to prove by a preponderance of the evidence that
claims 4–24 are unpatentable over McGuckin in view of Green 695.

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III. CONCLUSION
Weighing the evidence of the disclosure of the references, the
competing testimony, and the reasoning to combine the references, we
determine that Petitioner has shown by a preponderance of the evidence that
claims 4, 5, 9–18, 20, and 22–24 of the ’650 patent are unpatentable.
Petitioner has not shown that claims 6–8, 19, and 21 of the ’650 patent are
unpatentable.

Claims 35 U.S.C. § Reference(s)/Basis
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
4, 5, 9–
18, 20,
22–24
103 Green 209, Green
695, Knodel
(Ground 1A)
4, 5, 9–18, 20,
22–24

4, 5, 9–
18, 20,
22–24
103 Green 209, Green
695, Knodel
(Ground 1B)
4, 5, 9–18, 20,
22–24
4–8, 10–
24
103 Rothfuss, Green
209, Knodel
4–8, 10–24
4–24 103 McGuckin, Green
695
4–24
Overall
Outcome
4, 5, 9–18, 20,
22–24
6–8, 19, 21
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IV. ORDER
Accordingly, it is:
ORDERED that claims 4, 5, 9–18, 20, and 22–24 of the ’650 patent
have been shown to be unpatentable;
FURTHER ORDERED that claims 6–8, 19, and 21 of the ’650 patent
have not been shown to be unpatentable; and
FURTHER ORDERED that any party seeking judicial review must
comply with the notice and service requirements of 37 C.F.R. § 90.2.2

2 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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For PETITIONER:
Steven Katz
John Phillips
Ryan O’Connor
FISH & RICHARDSON P.C.
katz@fr.com
phillips@fr.com
oconnor@fr.com

For PATENT OWNER:
Erik Milch
Jennifer Volk-Fortier
Frank Pietrantonio
Joseph Van Tassel
COOLEY LLP
emilch@cooley.com
jvolkfortier@cooley.com
fpietrantonio@cooley.com
jvantassel@cooley.com