Arc Medical Design Limited

Patent Trials and Appeals Board

Sep 17, 2021

IPR2021-00707 (P.T.A.B. Sep. 17, 2021)

Trials@uspto.gov Paper 17
571-272-7822 Date: September 17, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
________________________________________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________________________________
MEDIVATORS INC.,
Petitioner,
v.
ARC MEDICAL DESIGN LIMITED,
Patent Owner.
________________________________________
IPR2021-00707
Patent 9,808,142 B2
________________________________________

Before JOHN G. NEW, ZHENYU YANG, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
35 U.S.C. § 314(a), 37 C.F.R. § 42.4

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I. INTRODUCTION
Petitioner Medivator Inc. (“Petitioner”) has filed a Petition (Paper 1,
“Pet.”) seeking inter partes review of claims 1–5, 8, and 9 of US Patent
9,808,142 B21 (Ex. 1002, the “’142 patent”). Patent Owner Arc Medical
Design Limited (“Patent Owner”) timely filed a Preliminary Response.
Paper 6 (“Prelim. Resp.”). Petitioner subsequently filed a Reply to Patent
Owner’s Preliminary Response (Paper 12), and Patent Owner filed a Sur-
Reply. (Paper 13).
Under 35 U.S.C. § 314, the Board “may not authorize an inter partes
review to be instituted unless … the information presented in the petition …
and any response … shows that there is a reasonable likelihood that the
petitioner would prevail with respect to at least 1 of the claims challenged in
the petition.” Upon consideration of the Petition and Preliminary Response,
Petitioner’s Reply (Paper 13), Patent Owner’s Sur-Reply (Paper 14), and the
evidence of record, we determine that the evidence presented fails to
demonstrate a reasonable likelihood that Petitioner would prevail in
establishing the unpatentability of at least one challenged claim of the ’142
patent.

1 US 10,722,103 B2 (the “’103 patent”) is a continuation of the “’142
patent.” Petitioner has also filed a Petition to institute inter partes review
of the ’103 patent. See IPR2021-00706, Paper 1.
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II. BACKGROUND
A. Related Matters
The ’142 patent has been asserted in pending civil action Arc Medical
Design Ltd. and Keymed (Medical and Industrial Equipment) Ltd. v.
Medivators Inc. and Cantel Medical Corp., 4:21-CV-929 (S.D.
Tex.). Pet. 1; Paper 4 at 1. The complaint was filed March 22, 2021. Id.
B. The Asserted Grounds of Unpatentability
Petitioner contends that claims 1–5, 8, and 9 of the ’142 patent are
unpatentable, based upon the following grounds:

Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–5, 8, 9 103 Hitoshi2
1–5, 8, 9 103 Hitoshi, Reydel3

Petitioner also relies upon the Declaration of Dr. James East (the
“East Declaration,” Ex. 1001).

C. The ’142 Patent
The ’142 patent is directed to a covering or sheath having external
projections for use with a medical device, and in particular for use with

2 Hitoshi (JP2003-339631A, December 2, 2003) (“Hitoshi”) (Ex. 1004).
Hitoshi was originally published in Japanese and is provided with a
certified English translation. See Ex. 1004, 19. All page numbers cited
from Hitoshi are from the provided certified English translation.

3 Reydel (WO 99/29362 A1, June 17, 1999) (“Reydel”) (Ex. 1006).
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flexible medical scoping devices such as endoscopes or enteroscopes. Ex.
1002, col. 1, ll. 16–19. Specifically, the ’142 patent discloses:
[A] cover comprising an elongate tubular member and being
arranged for application over the medical scoping device shaft
with the cover extending along at least a part of the length of a
distal end of the shaft, the tubular member comprising an inner
surface at least a part of which grips the shaft and acts to hold the
cover in place and an outer surface comprising a plurality of
spaced projecting elements having a tip and a base that are
moveable between a resting position to a position wherein the tip
of the projecting element is substantially parallel to a
longitudinal axis of the medical scoping device and to a position
that is at an angle that is approximately perpendicular to the
longitudinal axis of the medical scoping device shaft so that the
said projecting elements are fanned out to contact with and
provide support for and to dilate a lumen wall of a body passage
into which the medical scoping device has been inserted.

Id. at col. 3, ll. 33–48. Figure 1 of the ’142 patent depicts an embodiment of
the device.

Figure 1 of the ’142 patent depicts a view of an embodiment of
the claimed cover

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The ’142 patent explains that:
[W]hen advancing the medical scoping device into the patient’s
bowel or small intestine and the distal end encounters a bend or
loop in the patient's bowel or small intestine, the medical scoping
device is withdrawn towards its proximal end causing the
projecting elements to splay or fan out and to dilate the lumen of
the bowel or small intestine whilst holding the medical scoping
device in position … so said projecting elements engage with and
grip the body passage wall, the medical scoping device is then
further withdrawn towards the proximal end causing it to
straighten and the body passage wall to concertina along the shaft
of the scope proximal to the bend or loop whilst the lumen ahead
of the distal end opens up, the medical scoping device is then
advanced towards its distal end and the bend or loop is navigated.

Id. at col. 4, ll. 22–39. Furthermore, the invention of the ’142 patent
provides:
[A] method of improving endoscopic visualisation … wherein
the projecting elements open a lumen and evert[,] thereby
flattening colonic folds for inspection during withdrawal
whereby visualisation is further enhanced as colonic folds revert
to their normal anatomical position permitting light from the
medical scoping device to play across the mucosa, thus enabling
careful visualisation of the surface of the mucosa that was
hitherto hidden or difficult to view.

Id. at col. 4, ll. 41–50. Figures 12C and 12D depict the claimed invention
deployed in the colon as described in this passage:
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Figures 12C and 12D depict schematic anatomical through
sections of a medical scoping device with a cover of the present
invention in the course of a medical scoping procedure. Figure
12C shows controlled withdrawal, flattening of the colonic wall
and improved visualisation and; Figure 12D shows air suction
causing the colon wall to collapse or wrap around the device
and to grip the cover and device

D. Illustrative Claims
Independent claims 1 and 8 of the ’142 patent are representative of the
claims at issue. Claim 1 recites:
1. [1.1] A method of endoscopic visualization of a bowel
and/or small intestine, the method comprising:

[1.2] inserting a medical scoping device shaft having an air
suction conduit for removing air from a body passage into
the bowel or small intestine of a patient under
investigation, [1.3] the medical scoping device farther
comprising a cover releasably attached to the medical
scoping device shaft and covering at least a part of the
shaft at its distal end, wherein the cover includes a member
having an inner surface for gripping the shaft and an outer
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surface from which a plurality of projecting elements
project radially outwardly;

[1.4] advancing the medical scoping device in the direction of its
distal end within the patient's bowel or small intestine,
wherein the projecting elements deflect to a first radially
inward position to facilitate advancing the medical
scoping device;

[1.5] partially withdrawing the medical scoping device toward its
proximal end, such withdrawal causing the projecting
elements to deflect to a second radially outward position
in which at least some tips of the projecting elements
extend distally further than a distal end of the cover [1.6]
and the distal end of the medical scoping device in
response to contact with a lumen wall to dilate a lumen of
the bowel or small intestine while holding the medical
scoping device in position for visualization of the lumen
and to evert and engage colonic folds that are more distal
than the distal end of the cover and the medical scoping
device whereby visualization is allowed as the colonic
folds revert to their normal anatomical position permitting
a light from the medical scoping device to emit across a
mucosa of the bowel or small intestine providing
visualization of at least a portion of a surface of the
mucosa; and

[1.7] withdrawing the medical scoping device wherein the
projecting elements deflect so that the tips of the
projecting elements extend distally further than the distal
end of the cover and the distal end of the medical scoping
device to facilitate withdrawal of the medical scoping
device.

Ex. 1002, cols. 16–17, ll. 31–3. Claim 8 recites:
8. [8.1] A method of endoscopic visualization of a bowel
and/or small intestine, the method comprising:

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[8.2] inserting a medical scoping device shaft having air suction
for removing air from a body passage into the bowel or
small intestine of a patient under investigation, [8.3] the
medical scoping device further comprising a cover
releasably attached to the medical scoping device shaft
and covering at least a part of the shaft at its distal end,
wherein the cover grips the shaft and comprises a plurality
of projecting elements that project radially outwardly;

[8.4] advancing the medical scoping device in the direction of its
distal end within a lumen of the patient's bowel or small
intestine or bowel and small intestine, wherein the
projecting elements deflect to a first radially inward
position to facilitate advancing the medical scoping
device;

[8.5] partially withdrawing the medical scoping device toward its
proximal end, such withdrawal causing the projecting
elements to deflect to a second radially outward position
at which at least some tips of the projecting elements
extend distally further than a distal end of the cover [8.6]
and the distal end of the medical scoping device in
response to contact with a lumen wall to dilate the lumen
while holding the medical scoping device in position for
visualization of the lumen and to evert and engage colonic
folds that are more distal than the distal end of the cover
and the medical scoping device whereby visualization is
allowed as the colonic folds revert to their normal
anatomical position permitting a light from the medical
scoping device to emit across a mucosa of the lumen
providing visualization of at least a portion of a surface of
the mucosa; and

[8.7] withdrawing the medical scoping device wherein the
projecting elements deflect so that at least some of the tips
of the projecting elements extend distally further than the
distal end of the cover and the distal end of the medical
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scoping device to facilitate withdrawal of the medical
scoping device.

Ex. 1002, cols. 17–18, ll. 28–30.

E. Prosecution History of the ’142 Patent
The ’142 patent was filed as U.S. Application No. 13/699,172 A1 (the
“’172 application”) on November 20, 2012 and claims priority to
PCT/GB2011/050981, filed May 24, 2011. Ex. 1002, Codes (21), (22), (86).
The claims were allowed on June 20, 2017. Id. at 15 (citing Ex. 1030, 1).

III. ANALYSIS
A. Claim Construction
The Board applies the same claim construction standard that would be
used to construe the claim in a civil action under 35 U.S.C. § 282(b). See 37
C.F.R. § 100(b) (2020). Under that standard, claim terms “are generally
given their ordinary and customary meaning” as understood by a person of
ordinary skill in the art at the time of the invention. Phillips v. AWH Corp.,
415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). “In determining the
meaning of the disputed claim limitation, we look principally to the intrinsic
evidence of record, examining the claim language itself, the written
description, and the prosecution history, if in evidence.” DePuy Spine, Inc.
v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006)
(citing Phillips, 415 F.3d at 1312–17). Extrinsic evidence is “less significant
than the intrinsic record in determining ‘the legally operative meaning of
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claim language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc. v. U.S.
Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)).
Neither Petitioner nor Patent Owner proposes, at this stage of the
proceeding, any claim construction, agreeing that the claim terms should be
given the ordinary and customary meaning that they would have to a person
of ordinary skill in the art at the time of the invention. Pet. 16; Prelim. Resp.
14.

B. A Person of Ordinary Skill in the Art
Petitioner contends that a person of ordinary skill in the field of the
‘142 patent would be “a physician specializing in gastroenterology or a GI
surgeon having an interest in colonoscopy or bowel cancer prevention. The
POSA may be such a person working with members of a development team
for devices to be used with colonoscopes.” Pet. 16 (citing Ex. 1001 ¶ 17).
Patent Owner does not contest this definition in its Preliminary Response,
and we consequently adopt Petitioner’s definition for the purposes of this
Decision.

C. Ground I: Alleged Obviousness of Claims 1–5, 8, and 9 over Hitoshi

1. Overview of Hitoshi
Hitoshi was published in December, 1993 and on this record is prior
art to the ’142 patent. Ex. 1004, 1. Hitoshi is directed to an “endoscope
insertion assistance tool,” designed to enable an endoscope insertion portion
to be easily advanced, without requiring any special actions by the operator,
when performing a pressing-in operation and to hold the position of the
endoscope insertion portion by increasing the resistance when a pulling
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operation is performed, thereby improving ease of insertion of the endoscope
insertion portion. Id. at Abstr.
Specifically, Hitoshi claims:
An endoscope insertion assistance tool comprising:

a fixed portion integral with or releasably fixed to an endoscope
insertion portion; and one or more flexible thin fin-shaped
projections connected with said fixed portion in a
condition in which they project distally or in inclined
fashion distally with respect to the direction of insertion
into a body cavity;

wherein the position of said endoscope insertion portion in a
body cavity passage is held by contact of said fin-shaped
projections with the body cavity passage wall, when a
pulling operation is performed on this endoscope insertion
portion within the body cavity passage, in a condition in
which said fixed portion is fixed to said endoscope
insertion portion;

characterised in that at least part of the circumferential portion of
said fin-shaped projections is softer than part of the portion
where said fin-shaped projections are connected with said
fixed portion.

Ex. 1004, 1 (claim 1). Figure 2 of Hitoshi depicts a detail of an embodiment
of the invention:
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Figure 2 of Hitoshi is a perspective view of the claimed
endoscope insertion assistance tool

Hitoshi’s Figure 2 comprises a fixed portion 31 and four fin-shaped
projections 32. Ex. 1004 ¶ 21. The fixed portion 31 is formed in cylindrical
shape and is mounted on the endoscope insertion portion. The four fin-
shaped projections 32 are of a soft and flat thin shape and project from the
outside surface of the aforementioned fixed portion 31 with a prescribed
distally inclined angle with respect to the direction of insertion into the body
cavity passage. Id. at ¶ 22. Furthermore, Hitoshi teaches that the fin-shaped
projection can be deformed so as to contact the endoscope insertion portion,
in a condition with the aforementioned endoscope insertion assistance tool
attached to the endoscope insertion portion. Id. at ¶ 59, Fig. 15.
Figure 8 of Hitoshi depicts the claimed invention fitted to the distal
end of an endoscope 21 deployed in a colon:
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Figure 8 of Hitoshi illustrates straightening of a bend in the
colon via the operator performing a further pulling operation
and a bending operation

With respect to Figure 8, Axon teaches that the s-shaped colon 41 and
the descending colon 42 can be made to assume a substantially linear
condition by the operator performing a further pulling operation and a
bending operation. Ex. 1004 ¶ 41.

2. Obviousness of claims 1–5, 8, and 9 over Hitoshi
a. Independent claim 1
Petitioner identifies how the teachings of Hitoshi, in combination with
Axon, teaches each of the limitations of independent claim 1. Pet. 23–37.
Because we find limitations [1.5] and [1.7] to be dispositive of our decision
to deny institution with respect to claim 1 on Ground 1, we focus our
analysis on those limitations.

i. [1.5] “partially withdrawing the medical scoping device
toward its proximal end, such withdrawal causing the
projecting elements to deflect to a second radially outward
position in which at least some tips of the projecting
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elements extend distally further than a distal end of the
cover”

Petitioner points to Figure 7 of Hitoshi, which depicts withdrawal of
the endoscope within the colon, causing the projecting fins of the cover to
engage with the colon walls. Pet. 37. Figures 7 and 8 of Hitoshi are
reproduced below:

Figure 7 Figure 8

Figures 7 and 8 of Hitoshi illustrate how the endoscope
insertion portion 11 is inserted from the S-shaped colon of the
large intestine 41 into the descending colon 42

Petitioner contends that Figures 7 and 8 of Hitoshi demonstrate that
engagement of the fins with the colon wall causes the walls behind the distal
end of the scope to concertina around the colon itself to straighten. Pet. 37–
38. Petitioner asserts that Hitoshi thus teaches that when the endoscope
insertion portion 11 is pulled, the fin-shaped projection 32 is in contact with
the wall of the colon at the peripheral portion of the fin-like projection 32,
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and is deflected to a radially outward position. Pet. 39 (citing Ex. 1004 ¶ 27;
Ex. 1001 ¶ 113).
Petitioner argues further that Hitoshi teaches an embodiment where
the tips of the projecting elements extend distally further than the distal end
of the endoscope cover in Figure 21, extending past projection 26. Pet. 39–
40 (citing Ex. 1001 ¶ 114). Figure 21 of Hitoshi is reproduced below:

Figure 21 of Hitoshi depicts how an endoscope insertion
assistance tool attached to the endoscope insertion portion is
deformed when subjected to external force from a lumen of the
intestinal wall or the like

According to Petitioner, a person of ordinary skill in the art would
envisage that the endoscope insertion tool of Hitoshi is adapted for one or
more of the tips of the projecting elements to be sized and configured to
extend distally further than the distal end of the cover and endoscope. Pet.
40 (citing Ex. 1001 ¶ 115). Petitioner contends that Hitoshi teaches that the
projecting fins are described as being flexible, with a soft portion 34 that can
easily be deformed, and which gently contacts the intestinal wall 43. Id.
(citing Ex. 1004 ¶ 43; Ex. 1001 ¶ 115). Petitioner asserts that Hitoshi also
discloses that the fin-shaped projections may be connected with the distal
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end of an endoscope cover, or alternatively the proximal end or middle of
the fixed portion of the endoscope cover. Id. (citing Ex. 1004 ¶ 87; Ex. 1001
¶ 115).
Petitioner contends that a person of ordinary skill in the art, upon
viewing Figures 7 and 8, would have understood that given the disclosed
length and flexibility of the projecting elements 32 of the hood, as well as
the teaching of positioning the projecting elements in any position along the
endoscope cover, the device of Hitoshi could readily be adapted such that at
least some of the projecting elements 32 of the distal ring extend further
distally than the end of hood 31. Pet. 40–41 (citing Ex. 1001 ¶ 115).

ii. [1.7] “withdrawing the medical scoping device wherein the
projecting elements deflect so that the tips of the projecting
elements extend distally further than the distal end of the
cover and the distal end of the medical scoping device to
facilitate withdrawal of the medical scoping device.”

Petitioner argues that Hitoshi teaches that the projecting fins readily
deform to lie against the scope, which means the resistance on intubation
with the cover is scarcely increased compared to intubation with an
endoscope without a cover. Pet. 47 (citing Ex. 1004 ¶ 35; Ex. 1001 ¶ 123).
Petitioner notes that the projecting fins are described as being flexible, with
a soft portion 34 that can easily be deformed, and which gently contacts the
intestinal wall 43. Id. (citing Ex. 1004 ¶ 43; Ex. 1001 ¶ 123). Petitioner
asserts that a person of ordinary skill in the art would understand that the
distally-located projecting fins of Hitoshi would be capable of deflecting in
such a manner that their tips extend distally further than the distal end of the
cover and endoscope as shown in Hitoshi’s Figure 21. Id. at 47–48 (see Ex.
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1004, Fig. 21 supra; Ex. 1001 ¶ 123). Furthermore, argues Petitioner, the
fins can be mounted at any point along the longitudinal axis of the cuff, and
can be of varying length. Id. at 48. Therefore, Petitioner reasons, if a long
protrusion was mounted on the cuff near the endoscope tip, a skilled artisan
would have understood that the tip of such a protrusion would fall into the
visual field when “turned over” on withdrawal. Id. (citing Ex. 1004 ¶ 87;
Ex. 1001 ¶ 123).
Petitioner also argues that, for the reasons explained with respect to
limitation [1.5] supra, a skilled artisan, upon viewing Figure 7 of Hitoshi,
would understand that, given the disclosed length and flexibility of the
projecting elements 32 of the hood, the use of such a device in a colon
having a relatively narrow diameter would result in at least some of the
projecting elements 32 extending further distally than the end of hood 31.
Id. (citing Ex. 1001 ¶ 124).

b. Patent Owner’s preliminary response
Patent Owner notes that independent claim 1 recites that, during
partial withdrawal, “at least some tips of the projecting elements extend
distally further than a distal end of the cover and the distal end of the
medical scoping device.” Prelim. Resp. 16 (citing Ex. 1002, claim 1)
(emphasis omitted). Specifically, Patent Owner points out, the projecting
elements must extend distally further than both “a distal end of the cover”
and “the distal end of the medical scoping device.” Id. Patent Owner asserts
that the significance of this feature cannot be understated, because this
feature was the last feature that was amended into the independent claims
before allowance during prosecution. Id. Patent Owner notes that the
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Examiner expressly identified this feature as being one of the reasons for
allowance, and that Hitoshi was specifically evaluated against this feature
during prosecution. Id. (citing, e.g., Exs. 1028–1030).
Patent Owner asserts that Petitioner does not address whether Hitoshi
purportedly renders obvious that projecting elements extend distally further
than “the distal end of the medical scoping device.” Specifically, argues
Patent Owner, Petitioner partitions the feature of claim 1 that recites that “at
least some tips of the projecting elements extend distally further than a distal
end of the cover and the distal end of the medical scoping device.” Id. at 17
(citing Pet. Sections VII.E.5 and VII.E.6.6).
Patent Owner argues that Petitioner alleges that Hitoshi renders
obvious that “at least some tips of the projecting elements extend distally
further than a distal end of the cover,” as recited in claim 1. Prelim. Resp.
17 (citing Pet. Section VII.E.5). Patent Owner contends that Petitioner fails
to address whether Hitoshi purportedly renders obvious that “at least some
tips of the projecting elements extend distally further than . . . the distal end
of the medical scoping device,” as also recited in claim 1. Id. at 17–18.
According to Patent Owner, Hitoshi teaches that element 21, as depicted in
the figures of Hitoshi that Petitioner cites, is the “leading end portion 21” of
the “endoscope insertion portion 11” that is also shown in the figures of
Hitoshi that Petitioner cites. Id. at 18 (citing Ex. 1004 ¶ 15).
Patent Owner therefore asserts that “leading end portion 21” of
Hitoshi can be interpreted to be the “distal end of the medical scoping
device” of claim 1. Prelim Resp. 18. Patent Owner contends that, despite
Hitoshi’s mention of “leading end portion 21,” Petitioner never addresses
whether the projecting elements of Hitoshi extend distally further than
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“leading end portion 21” (the equivalent of the “distal end of the medical
scoping device” recited in claim 1), or allege that such a relationship would
be obvious. Id.
Similarly, Patent Owner argues, Petitioner fails to address whether
the projecting elements of Hitoshi extend distally further than “leading end
portion 21” of Hitoshi, which Patent Owner contends is the equivalent of the
claim term “distal end of the medical scoping device” recited in claim 1,
such a relationship would be obvious. Prelim. Resp. 18–19.
Patent Owner further points to Petitioner’s statement that “[a] POSA
would immediately envisage that the hood of Hitoshi is adapted for one or
more of the tips of the projecting elements to be sized and configured to
extend distally further than the distal end of the cover and endoscope given
the Figures and disclosure.” Prelim Resp. 19 (quoting Pet. 40). However,
Patent Owner argues, that single sentence merely states “endoscope”
generally, and plausibly could refer to the entire endoscope-operating
portion 12, the endoscope insertion portion 11, the part of the endoscope
before the proximal end of the endoscope insertion assistance tool 3, or
various other parts of the endoscope 2. Id. at 19–20. Patent Owner asserts
that Hitoshi neither discloses nor suggest that the projecting elements extend
beyond leading end portion 21. Id. at 20.

c. Analysis
We conclude that Petitioner has not established a reasonable
likelihood of prevailing at trial because Hitoshi neither teaches nor suggests
the limitations [1.5] and [1.7] of independent claim 1 reciting “wherein the
projecting elements deflect so that the tips of the projecting elements extend
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distally further than the distal end of the cover and the distal end of the
medical scoping device to facilitate withdrawal of the medical scoping
device.” Ex. 1002, claim 1. Petitioner relies upon Figure 21 of Hitoshi,
which we again reproduce below, as teaching this limitation:

Scrutiny of Figure 21 does not show that “the one or more of the tips
[34] of the projecting element are sized and configured to extend distally
further than the distal end of the cover and the distal end of the medical
scoping device shaft [21].” We note here that Hitoshi teaches that “[i]n the
construction of the aforementioned endoscope insertion portion 11, from the
leading end side, a leading end portion 21, a bendable portion 22 and a soft
portion 23 are sequentially linked.” Ex. 1004 ¶ 15. We thus find that the
“leading end portion” of Hitoshi’s endoscope insertion portion would be
understood by a person of ordinary skill in the art to correlate to “the distal
end of the medical scoping device shaft,” as recited in claim 1.
However, and more importantly, the text of Hiroshi supporting Figure
21 reveals that the situation depicted in the Figure is not a desirable or
intended feature of the device, but in fact represents an undesirable situation,
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that should be avoided, and which can be ameliorated by certain structural
refinements. Specifically, Hitoshi teaches that:
As described above, the aforementioned fin-shaped projections
32 are formed of thin flexible resilient members and are
deformed by being pressed against the intestinal wall 43
accompanying a pulling operation of the aforementioned
endoscope insertion portion 11: as shown in Fig. 20, the intestinal
wall 43 is thereby folded up (in the direction of the arrow C) on
the distal side of the aforementioned endoscope insertion
assistance tool 3, and the intestinal tract is thereby compressed.
…
However, if the external force G[4] is excessively large or if for
example the external force G is applied to the vicinity of the root
portion of the aforementioned fin-shaped projections 32 (i.e.[,]
the vicinity of the portion connected with the fixed portion 31),
the deformed portion may extend beyond the aforementioned fin-
shaped projections 32 so that rolling-back takes place from the
aforementioned fixed portion 31, with the result that, as shown
in Fig. 21, the fin-shaped projections 32 remain in a condition in
which they are folded up towards the leading-end portion 21 of
the insertion portion. In the condition shown in Fig. 21, there
was a risk that during a pulling operation the effect of the
aforementioned endoscope insertion assistance tool 3 in pressing

4 Although this and the succeeding quoted paragraphs recite “external force
G,” we find that this is either a typographical error on the part of the author
or a translational error by the translator. As defined in the preceding
paragraph “Force C” is a “pulling operation,” i.e., a backward- or
proximally-directed force, that causes the fin-shaped projections 32 to
grasp and retract the intestinal wall. See Hitoshi Fig. 20. “Force G,” on
the other hand, is a pushing or forward force, i.e., in the distal direction.
See Hitoshi Figs. 19, 20. Only a pulling (i.e., proximally directed) force,
i.e., “Force C,” could cause the over-deflection of the fin-shaped
projections 32 such that they point forward towards the distal end of the
endoscope device 21. Consequently, we conclude that, as used in this
passage, “Force G” can logically only be interpreted as meaning “Force
C.”
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on the intestinal wall would be lost and, furthermore, even in the
case of insertion by a pressing-in operation, ease of insertion
would deteriorate, due to increase in diameter of the insertion
portion.
…

To deal with this, in the third embodiment shown in Fig. 17 and
Fig. 18, when a pulling operation in the body cavity passage is
performed on the aforementioned endoscope insertion portion 11
with the aforementioned endoscope insertion assistance tool 203
attached, even if an external force G as shown in Fig. 19 is
applied to the aforementioned fin-shaped projections 32, the
aforementioned endoscope insertion assistance tool 203 is so
constructed that the aforementioned fixed portion 231 is not
easily deformed, by making the connection portion of the
aforementioned fixed portion 231 with the aforementioned fin-
shaped projections 32 of increased thickness: consequently,
folding back of the aforementioned fixed portion 231 cannot
occur.
…
Also, in the third embodiment shown in Fig. 17 and Fig. 18,
thickening is applied solely in the vicinity of the connection
portion of the aforementioned fin-shaped projections 32 and the
aforementioned fixed portion 31, so the increase in the external
diameter of the portion that is inserted into the body cavity is
suppressed to the minimum: ease of insertion cannot therefore be
much impaired by increase in external diameter.

Hitoshi ¶¶ 77–80 (emphases added). As explained, Figure 19 of Hitoshi
depicts the increased thickness at the connection portion of the fin-shaped
projections and the fixed position, which Hitoshi teaches is specifically
designed to avoid or ameliorate the situation depicted in Figure 21:
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Figure 21 depicts how thickening at the point where the fin-
shaped projection is joined to the fixed position [31] is designed
to resist the type of deformation depicted in Figure 21

Figure 22 depicts another embodiment of the same concept:

Figure 22 of Hitoshi depicts another embodiment of the concept
described in Figure 19, with a thickening at the base of the fin-
shaped projections [255] to prevent deformation of the
projections [32] in a distal direction

In sum, Hitoshi teaches that the situation depicted in Figure 21, in
which the fin-shaped projections are deflected so as to “point towards a
distal end of the cover,” as recited in claim 1, is one to be avoided because
“during a pulling operation the effect of the aforementioned endoscope
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insertion assistance tool 3 in pressing on the intestinal wall would be lost
and, furthermore, even in the case of insertion by a pressing-in operation,
ease of insertion would deteriorate, due to increase in diameter of the
insertion portion.” Hitoshi ¶ 78.
We conclude that a person of ordinary skill in the art would
consequently be “discouraged from following the path set out in the
reference.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). As such, we
conclude that Hitoshi teaches away from the third position in which:
[O]ne or more of the tips of the projecting elements of the distal
ring point towards a distal end of the cover, and wherein, when
coupled to the medical device shaft and in the third position, the
one or more of the tips of the projecting element are sized and
configured to extend distally further than the distal end of the
cover and the distal end of the medical scoping device shaft,
as recited in claim 1.
The testimony of Petitioner’s Declarant, Dr. East, fails to squarely
address this teaching away by Hitoshi. Dr. East attests merely that “Hitoshi
discloses an embodiment where the tips of the projecting elements extend
distally further than the distal end of the endoscope cover in Figure 21,
extending past projection 26” and that:
A POSA would immediately envisage that the hood of Hitoshi is
adapted for one or more of the tips of the projecting elements to
be sized and configured to extend distally further than the distal
end of the cover and endoscope given the Figures and
disclosure.… A POSA viewing Figures 7 and 8 would
understand that given the disclosed length and flexibility of the
projecting elements 32 of the hood, as well as the teaching of
positioning the projecting elements in any position along the
endoscope cover, the device of Hitoshi could readily be adapted
such that at least some of the projecting elements 32 of the distal
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ring extend further distally than the end of hood 31 and the distal
end of the medical scoping device 21.

East Decl. ¶¶ 182–183. Dr. East does not mention that Hitoshi teaches that
the situation depicted in Figure 21, in which the fin-like projections are
deflected to point distally, is a situation that Hitoshi expressly warns is to be
avoided, and to which Hitoshi teaches preventative structural elements. See
Hitoshi ¶ 80. Nor does Petitioner, or Dr. East, point to any teaching in Axon
that would negate this teaching away in Hitoshi.
Consequently, because Hitoshi teaches away from this limitation, we
conclude that Petitioner does not have a reasonable likelihood of prevailing
at trial with respect to claim 1 upon this ground.

d. Independent claim 8
With respect to claim 8, Petitioner incorporates and repeats the
arguments presented supra with respect to the limitations of claim 1. Pet.
53–55.
As we have explained with respect to limitations [1.5] and [1.7] of
claim 1 supra, Hitoshi expressly teaches that deflection of the fin-shaped
projections toward the distal end of the endoscope is as undesirable
situation, and one to be avoided, and, further, teaches structural elements to
prevent such an occurrence from happening.
The teachings of Hitoshi would thus discourage a person of ordinary
skill in the art from arriving at the limitation of claim 8 in which “the
projecting elements deflect so that at least some of the tips of the projecting
elements extend distally further than the distal end of the cover and the distal
end of the medical scoping device.” Because Hitoshi expressly teaches
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away from this limitation, we conclude that Petitioner has not established a
reasonable likelihood of prevailing at trial.

e. Dependent claims 2–5, and 9
Claims 2–5 depend from claim 1 of the ‘142 patent and claim 9
depends from claim 8. Petitioner’s arguments with respect to these claims
consequently suffer from the same defects as claims 1 and 8, viz., Hitoshi’s
teaching away from the limitation reciting “the projecting elements deflect
so that the tips of the projecting elements extend distally further than the
distal end of the cover and the distal end of the medical scoping device.”
The same applies with respect to the claims that depend from those claims.
Consequently, and for these same reasons, we conclude that Petitioner
has not succeeded in establishing a reasonable likelihood of prevailing at
trial upon Ground I of the Petition.

D. Ground II: Alleged Obviousness of Claims 1–5, 8, and 9 over Hitoshi
and Reydel

1. Overview of Reydel
Reydel was published on June 19, 1999, and is prior art to the ‘142
patent. Reydel is directed to “[a] medical device for intrusion of body
cavities and canals, such as the gastrointestinal, urinal, vaginal and vascular
tracts, … with unconventional surface structure, namely one having a
bidirectional coefficient of friction upon ingress and egress into a body
cavity, such surface replacing conventional slippery low friction surfaces.”
Ex. 1006, Abstr. Specifically, Reydel teaches that:
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If a flexible endoscope is advanced along this pathway provided
with the different bidirectional surface characteristics of this
invention, the human tissue along the intestinal wall will tend to
grab and hold on upon egress, while the ingress orientation is
favorably comparable with prior art lubricated instrumentation
along the desired ingress route.…Thus, an endoscope-catheter
distal end can be jiggled or inch-wormed back and forth during
the ingress to create pleating or accordioning of the walls of the
intestine tract onto the scope. In this “pleating” procedure when
feeding the device and/or instrument into the intestine, the zig-
zag incremental feeding using the interface surface texture with
the intestine walls moves a pleat outwardly and straightens out
the canal walls inwardly into a relatively straight increment for
ingress of the instrumentation, such as the endoscope.
Ex. 1006, 7.
Pertinently, Reydel teaches that:
[S]mooth device surfaces that will contact human tissue in the
insertion and removal process can be surface texturized, for
example, to produce angled crests of a multi-peaked or fibrous
surface texture with the crests forming barb-like tips slanting at
an angle toward the proximal end of a catheter, thereby to
encourage the ingress of the device into the work site, and
impede withdrawal.… Thus, the instruments have the
characteristic of grabbing or clinging to the tissue of the canal
walls. In general, the textured surface can occur along the
catheter length.
Ex. 1006, 4. Reydel’s Figure 15 provides an example:

Figure 15 of Reydel is a side view sketch of a removable plastic
sleeve embodiment of the invention
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Reydel teaches, with respect to Figure 15, that “the sheath 110
employs a different bidirectional surface texture 111, which can be obtained,
for example, by brushing or milling the surface of a polymer such as
polyiden to give the generally macroscopic bidirectional characteristic.” Ex.
1006, 20. Figures 16–18 depict additional embodiments of the surface
structures providing the bidirectional frictional properties:

Figures 16–18 of Reydel are different section view fragments of
adhesive plastic film embodiments of the invention having
different surface geometry patterns

2. Obviousness of claims 1–5, 8, and 9 over Hitoshi and Reydel

a. Independent claim 1
Petitioner identifies how the teachings of Hitoshi, in combination with
Reydel, teaches each of the limitations of independent claim 1. Pet. 23–37.
Because we find limitations [1.5] and [1.7] to be dispositive of our decision
to deny institution with respect to claim 1 on Ground 1, we focus our
analysis on those limitations.
i. [1.5] “partially withdrawing the medical scoping device
toward its proximal end, such withdrawal causing the
projecting elements to deflect to a second radially outward
position in which at least some tips of the projecting
elements extend distally further than a distal end of the
cover”

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Petitioner argues that Reydel teaches that the projecting elements
(textured surface 75) impede egress (i.e., withdrawal) because of friction
with the wall tissue of the colon 70 wherein the “barbs” contact the walls
during egress as shown by arrow 76 in Figure 10B of Reydel. Pet. 62–63
(citing Ex. 1006, 19, Fig. 10B; Ex. 1001 ¶ 145). Figure 10B of Reydel is
reproduced below:

Fig 10B of Reydel depicts a portion of a colon during ingress of
an endoscope illustrating the improved “inchworm” incremental
back and forth method of pushing an endoscope into the small
intestine

Petitioner contends that Reydel teaches that the surface films of the
invention containing the projecting elements may be made of a thin semi-
stretchable plastic. Pet. 63 (citing Ex. 1006, 21; Ex. 1001 ¶ 146). According
to Petitioner, a person of ordinary skill in the art would have understood that
a semi-stretchable plastic would bend outwardly when it meets the colon
wall during a pulling motion, or “egress,” where the endoscope is being
moved in a proximal direction. Id. (citing Ex. 1001 ¶ 146).
Petitioner argues further that a skilled artisan would also envisage that
the projecting elements could extend distally further than a distal end of the
cover. Pet. 63. Petitioner refers to Figure 10B as demonstrating that the
projecting elements of Reydel can protrude from the most distal end of the
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scoping device cover. Id. (citing Ex. 1001 ¶ 147). Petitioner notes that
Reydel teaches that:
Either microscopic or macroscopic surface size can be provided,
depending upon the work missions required and the
characteristics of the tissue or canals to be invaded. The surface
texture pattern and the geographical distribution can be custom
designed for particular medical procedures. Thus, the
instruments have the characteristic of grabbing or clinging to the
tissue of the canal walls.

Id. at 63–64 (quoting Ex. 1006, 4; Ex. 1001 ¶ 147) (bracketed alteration and
internal quotation marks omitted).
Petitioner therefore contends that a person of ordinary skill in the art
would understand that Reydel contemplates that the projecting elements of
the invention could be sized for a given medical application such that they
cling to the tissues of the canal walls. Pet. 64 (citing Ex. 1001 ¶ 147).
Petitioner asserts that the skilled artisan would therefore understand that the
stretchable protrusions located at the distal end of the scoping device cover
could be provided with such a length that they would bend outwardly such
that some of the protrusions would extend past the distal end of the cover on
egress. (Ex. 1001 ¶ 147).

ii. [1.7] “withdrawing the medical scoping device wherein the
projecting elements deflect so that the tips of the projecting
elements extend distally further than the distal end of the
cover and the distal end of the medical scoping device to
facilitate withdrawal of the medical scoping device.”

Petitioner repeats the argument presented with respect to limitation
[1.5] supra, that the textured surface projections of Reydel are flexible, and a
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skilled artisan would understand that the tips of at least some of the
projections of Reydel could extend distally further than the distal end of the
cover and scoping device upon egress for the reasons explained above. Pet.
68 (citing Ex. 1001 ¶ 153).
Additionally, argues Petitioner, Reydel recites “a catheter of a length
reaching from outside a body into a work site adapted for entry into,
movement along and withdrawal from a body canal for supporting medical
surveillance and therapy at a work site inside the body.” Pet. 68–69 (quoting
Ex. 1006, claim 31; Ex. 1001 ¶ 153). Therefore, Petitioner argues, an
express purpose of the surface structure device of Reydel is to aid in
withdrawal from a body canal and supporting medical surveillance. Id. at 69
(citing Ex. 1001 ¶ 153). Petitioner notes that Reydel teaches that the
different bidirectional coefficient of friction, which impedes the spontaneous
withdrawal of the device and/or instrument, is not extreme enough to
traumatize the canal walls, and therefore egress is not significantly more
uncomfortable than with conventionally surfaced devices and/or
instruments. Id. (citing Ex. 1006, 8; Ex. 1001 ¶ 153).
Petitioner argues that this limitation is obvious in light of Hitoshi.
Pet. 69. Petitioner reasons that a person of ordinary skill in the art would
have understood that the projections on the hood of Hitoshi would facilitate
withdrawal of the endoscope while enabling the necessary function of
visualizing colonic folds during withdrawal. Id. at 69–70 (citing Ex. 1001
¶ 154). According to Petitioner, the projecting fins are described as being
flexible, with a soft portion 34 that can easily be deformed and which gently
contacts the intestinal wall 43, and a skilled artisan would understand that
projecting fins of Hitoshi would be capable of deflecting such that their tips
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extend distally further than the distal end of the cover and endoscope. Id. at
70 (citing Ex. 1004 ¶ 43; Ex. 1001 ¶ 155).

b. Patent Owner’s preliminary response
Patent Owner points out that claim 1 recites “at least some tips of the
projecting elements extend distally further than a distal end of the cover and
the distal end of the medical scoping device.” Prelim. Resp. 21 (emphasis in
original). Patent Owner contends that the projecting elements must thus
extend distally further than both “a distal end of the cover” and “the distal
end of the medical scoping device,” and not just one or the other. Id. at 21–
22. However, Patent Owner argues, Petitioner arbitrarily partitions the
limitation of claim 1 that recites that “at least some tips of the projecting
elements extend distally further than a distal end of the cover and the distal
end of the medical scoping device” in a manner that causes the feature to
span two different sections of the Petition. Id. (citing Pet. 62–64, 68–70).
According to Patent Owner, Petitioner alleges that Reydel renders
obvious that “at least some tips of the projecting elements extend distally
further than a distal end of the cover,” as recited in claim 1. Prelim. Resp.
23 (citing Pet. 63). However, Patent Owner argues, nowhere does Petitioner
argue that the projecting elements of Reydel extend distally further than the
“distal end of the medical scoping device,” recited in claim 1. Id.
Furthermore, Patent Owner argues, Petitioner proffers an
interpretation of Reydel that is not supported by the evidence cited by the
Petitioner, rather, Patent Owner contends, Petitioner impermissibly relies
upon hindsight analysis. Prelim. Resp. 44.

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c. Analysis
As an initial matter, we have already explained why we find
unpersuasive Petitioner’s argument that Hitoshi teaches or suggests the
limitation of claim 1 reciting “the projecting elements deflect so that the tips
of the projecting elements extend distally further than the distal end of the
cover and the distal end of the medical scoping device to facilitate
withdrawal of the medical scoping device.” Indeed, we have explained why
we find that Hitoshi, in fact, teaches away from this limitation. We
incorporate that reasoning here with respect to Ground II.
With respect to the teachings of Reydel as supporting this limitation,
we find Petitioner’s argument to be almost entirely devoid of any factual
basis in the evidentiary record. Nowhere does Reydel expressly teach that
the apparently hair-like protrusions of its surface film are capable of
extending distally further than the distal end of the cover and the distal end
of the medical scoping device to facilitate withdrawal of the medical scoping
device. Indeed, Figures 15–18 appear to demonstrate that the textured
coating is such that the projections imparting the directionally-dependent
frictional properties are not long enough to project distally past the end of
either the cover or the medical scoping device, but serve only to create a
bidirectional coefficient for the device. Moreover, Patent Owner’s argument
that that Reydel’s teaching that “the different bidirectional coefficient of
friction which impedes the spontaneous withdrawal of the device and/or
instrument is not extreme enough to traumatize the canal walls, and
therefore egress is not significantly more uncomfortable than with
conventionally surfaced devices and/or instruments” (see Pet. 69), somehow
teaches that the projections of the bidirectional coating are capable of
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extending distally beyond the end of the cover or the scoping device, is
similarly without factual basis. To the contrary, Reydel teaches that:
The patient’s comfort is also an objective of this invention, which
is enhanced by simpler and less traumatic ingress methods. The
different bidirectional coefficient of friction which impedes the
spontaneous withdrawal of the device and/or instrument is not
extreme enough to traumatize the canal walls, and therefore
egress is not significantly more uncomfortable than with
conventionally surfaced devices and/or instruments.

Ex. 1006, 8. The plain language of this passage states merely that, due to the
properties of the instrument cover, there are different coefficients of friction
for distal and proximal movement of the endoscope, but that the difference
between the frictional coefficients is not so great as to damage or traumatize
the walls of the colon. Petitioner’s contention that this is caused by forward
deflection of the projections of the cover in the distal direction, such that
they extend beyond the end of the cover or of the scoping device, is mere
conjecture and attorney argument to which we accord little probative weight.
See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
In short, we conclude that Petitioner has failed to meet the burden of
demonstrating a reasonable likelihood of prevailing at trial because neither
Reydel nor Hitoshi teaches or suggests the limitations of claim 1 reciting
“the projecting elements deflect so that the tips of the projecting elements
extend distally further than the distal end of the cover and the distal end of
the medical scoping device to facilitate withdrawal of the medical scoping
device.”

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d. Independent claim 8
Regarding claim 8, Petitioner expressly relies upon the same
arguments made with respect to claim 1. See Pet. 74–75. In addressing
limitation [8.7] of claim 37, Petitioner expressly repeats the same arguments
made with respect to limitation [1.7] in Ground II and, by incorporation,
limitation [1.7] in Ground I. Pet. 75 (“This element is obvious over Reydel
for the reasons set forth regarding Ground 2, element 1.7 above”). For the
reasons we have explained, we do not find this argument persuasive and, for
those reasons, we conclude that Petitioner has failed to establish a
reasonable likelihood of prevailing at trial with respect to independent claim
8.

e. Dependent claims 2–5 and 9
Petitioner’s arguments with respect to claims 2–5 and 9 consequently
suffer from the same defects as claims 1 and 8, viz., neither Reydel nor
Hitoshi teach or suggest the limitations of independent claims 1 and 8
reciting “the projecting elements deflect so that the tips of the projecting
elements extend distally further than the distal end of the cover and the distal
end of the medical scoping device.” The same applies with respect to the
claims which depend from those claims.
Consequently, and for these same reasons, we conclude that Petitioner
has not succeeded in establishing a reasonable likelihood of prevailing at
trial upon Ground II of the Petition.

IV. CONCLUSION
For the reasons we have explained, we conclude that Petitioner has
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failed to establish a sufficiently persuasive showing that the cited prior art
references disclose, teach, or suggest the elements of at least one of claims
1–5, 8 or 9 of the ’142 patent. Furthermore, because we so conclude, we
need not reach Patent Owner’s additional arguments. Petitioner has thus
failed to establish a reasonable likelihood of prevailing at trial with respect
to at least one of claims 1–5, 8, or 9 of the ’142 patent over the cited prior art
set forth in the asserted Grounds I and II. 35 U.S.C. § 314. Furthermore,
and for the reasons set forth, we need not reach a decision whether to
exercise our discretion under 35 U.S.C. § 325(d) to deny institution of inter
partes review.

V. ORDER
In consideration of the foregoing, it is hereby:
ORDERED, pursuant to 35 U.S.C. § 314(a), that the Petition for inter
partes review of claims 1–5, 8, or 9 of US 9,808,142 B2 is DENIED with
respect to all grounds in the Petition; and
FURTHER ORDERED that no inter partes review is instituted.

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For PETITIONER:

Erik Swenson
Matthew Goggin
CARLSON, CASPERS, VANDENBURGH & LINDQUIST, P.A. Capella
eswenson@carlsoncaspers.com
mgoggin@carlsoncaspers.com

For PATENT OWNER:

Katherine Vidal
Michael R. Rueckheim
WINSTON & STRAWN LLP
kvidal@winston.com
mrueckheim@winston.com
Winston-IPR-ArcMedical@winston.com