J. Landon. Gilkey et al.

Patent Trials and Appeals Board

Apr 15, 2020

13650507 - (D) (P.T.A.B. Apr. 15, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/650,507 10/12/2012 J. Landon Gilkey APO-019D1 6974
119800 7590 04/15/2020
Donald K. Jones
Apollo Endosurgery US, Inc.
1120 S. Capital of Texas Hwy
Bldg 1, Suite 300
Austin, TX 78746
EXAMINER
HIGHLAND, RACHEL S
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
04/15/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
USIPDocketing@apolloendo.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte J. LANDON GILKEY, BRETT E. NAGLREITER,
PETER K. KRATSCH, DONALD K. JONES, and
VLADIMIR MITELBERG
____________

Appeal 2019-001519
Application 13/650,507
Technology Center 3700
____________

Before ANTON W. FETTING, MICHAEL C. ASTORINO, and
AMEE A. SHAH, Administrative Patent Judges.

SHAH, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s final decision to reject claims 72–87 and 89–96, which are all of
the pending claims. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real party in interest as
“Apollo Endosurgery US, Inc.” Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The Appellant’s invention “relates to a treatment device which can be
inserted into a body through a natural orifice with an endoscope or other
steerable guide member.” Spec. ¶ 1.
Claims 72, 75, 80, and 90 are the independent claims. Claim 72 is
illustrative of the subject matter on appeal and is reproduced below:
72. A method of suturing tissue of a mammal using an
endoscopic suturing system, comprising the follow steps:
(a) inserting an endoscope into a body with a suturing
device coupled to the endoscope, the endoscope having an
instrument channel extending therethrough;
(b) opening a needle arm of the suturing device having a
removable needle removably coupled to the needle arm;
(c) drawing tissue at a desired suture site between the
needle and a distal end of the endoscope;
(d) closing the needle arm of the suturing device such that
the needle axially aligns with the instrument channel of the
endoscope;
(e) piercing the tissue with the needle;
(f) recovering the needle within the distal end of the
endoscope by using a needle capture device extended through the
instrument channel of the endoscope;
(g) opening the needle arm to disengage the needle arm
relative to the needle;
(h) closing the needle arm; and
(i) removing the suturing device from the body.
Appeal Br. 18 (Claims App.).

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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Yamamoto et al.
(“Yamamoto”)
US 2003/0181924 A1 Sept. 25, 2003
Saadat et al.
(“Saadat”)
US 2005/0065401 A1 Mar. 24, 2005
Baker et al.
(“Baker”)
US 2008/0086148 A1 Apr. 10, 2008
REJECTIONS
Claims 72–75, 78, 80, 83, 85, 87, and 89–96 stand rejected under pre-
AIA 35 U.S.C. § 103(a) as being unpatentable over Yamamoto and Saadat.
Claims 76, 77, 79, 81, 82, 84, and 86 stand rejected under pre-AIA
35 U.S.C. § 103(a) as being unpatentable over Yamamoto, Saadat, and
Baker.
OPINION
Each of the independent claims 72, 75, 80, and 90 sets forth a method
“of suturing tissue of a mammal using an endoscopic suturing system.” See
Appeal Br. 18–23 (Claims App.). Claims 72 and 75 recite closing the needle
arm of the suturing device such that the needle, or needle clip, axially aligns
with the instrument channel of the endoscope. Id. at 18–19 (Claims App.).
Claim 90 recites “(e) positioning the needle in alignment with the instrument
channel of the endoscope.” Id. at 23 (Claims App.). We refer to these
recitations as the “alignment limitations.”
Claims 72 and 75 recite recovering the needle or grasping the needle
clip by using a needle capture device extended through the instrument
channel of the endoscope. Id. at 18–19 (Claims App.). Claim 80 recites
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“(f) engaging the needle with a needle capture device passed through the
endoscope; [and] (g) recovering the needle with the needle capture device
within the instrument channel.” Id. at 20–21 (Claims App.). Claim 90
recites “(f) mechanically engaging the needle with an instrument extending
through the instrument channel of the endoscope.” Id. at 23 (Claims App.).
We refer to these recitations as the “needle capture device limitations.”
Common to each of the independent claims is a method using an
endoscope with an instrument channel and a suturing device that includes a
needle arm, a needle clip, a needle and/or a needle capture device.
The Examiner relies on the combination of Yamamoto and Saadat to
teach the alignment and needle capture device limitations. See Final
Act. 3–4, 6–11; Ans. 2–4. The Appellant presents the same arguments for
each of the independent claims. See Appeal Br. 15–16. After careful review
of the Briefs, Final Action, and Answer, we agree with the Appellant that the
Examiner does not adequately explain how the combined teachings of
Yamamoto and Saadat would have resulted in the subject matter of the
alignment and needle capture device limitations. See Appeal Br. 10–12;
Reply Br. 3–6.
The Examiner finds that Yamamoto teaches a method using an
endoscope with instrument channel 6 extending therethrough and suturing
device 3, and suturing device 3 that may include needle arm 16, needle clip
154/157, needle 34/157, and needle capture device 147/153/161/171/178.
Final Act. 3–4, 6–11. The Examiner finds that Yamamoto “does not teach
that the needle [or needle clip] axially aligns with the instrument channel of
the endoscope” (id. at 3–4, 6), “the needle capture device is passed through
the instrument channel of the endoscope” (id. at 8–9), or “that the needle is
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positioned in alignment with the instrument channel of the endoscope” (id.
at 11). However, the Examiner finds that Yamamoto teaches “a separate
external tube (35/160) for the needle to move into,” and that the suturing
device and endoscope can be removably fixed or structurally integrated with
each other (id. at 3–4, 6–7, 9, 11 (citing Yamamoto ¶ 150, Figs. 46–50,
57–59)2). Put simply, the Examiner finds that Yamamoto teaches aspects of
the alignment and needle capture device limitations, but not the entirety
thereof.
The Examiner relies on Saadat to teach the remainder of the alignment
and needle capture device limitations. Specifically, The Examiner finds that
Saadat “teaches an endoscopic suturing device where the tissue grasper,
needle arm, and needle capture device are each contained within the outer
endoscopic tool (10),” and that “the needle arm can be bent such that the
needle aligns axially with an instrument channel of the endoscope.” (Id.
at 4, 7, 9, 11 (citing Saadat Figs. 7, 15, 20, 37, and 42).
The Examiner determines
[i]t would have been obvious to one of ordinary skill in the art at
the time of invention as a matter of design choice to have the
needle be moved into the instrument channel (as taught by
Saadat) instead of an external auxiliary channel (as taught by
Yamamoto) so as to make the device more compact.
Id.

2 Figures 46–50 and 57–59 are figures that represent two different
embodiments of Yamamoto’s invention. More specifically, Figures 46–49
represent a sixth embodiment and Figures 57–59 represent an eighth
embodiment. See Yamamoto ¶¶ 234, 263. Figure 50 “show[s] a state in
which a tissue is sutured while the tissue is pulled by a grasping forceps,”
and is common to many embodiments of Yamamoto’s invention. Id. ¶ 66;
see also id. ¶¶ 188, 245.
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For the needle capture device limitations, the Examiner relies on
Yamamoto as modified by Saadat. Id. In the Answer at page 4, the
Examiner clarifies that Yamamoto teaches the alignment limitations, but
does not “explicitly depict” the arrangement of the tissue capture device,
needle, needle arm, and needle capture device being “integrally contained
within one outer tube,” i.e., the needle capture device limitations. The
Examiner relies on Saadat solely “for the teaching of having all the various
parts within one outer tube.” Id. at 3–4. In other words, the Examiner does
not rely on Saadat to teach any instruments (structure), only the relative
positioning of Yamamoto’s structure. Accordingly, it appears that the
Examiner’s position is that one of ordinary skill in the art would place
needle capturing device 147/178 within instrument channel 6 without any
further modification to the device of Yamamoto.
Yamamoto discloses an endoscopic suturing system comprising, in
relevant part, endoscope 12, suturing device 3, instrument channel 6, light
guides 8 and 9, camera 10, and washing nozzle 11. Yamamoto, Title,
¶¶ 149, 150, Figs. 2,3 50. “[T]he suturing device 3 is removably fixed at a
distal end of the endoscope 12 by a fixing member 40, [but] the suturing
device 3 and the endoscope 12 may be structured integrally with each other
instead thereof.” Id. ¶ 150 (emphasis omitted), Fig. 8. Suturing device 3
comprises, in relevant part, flexible tube 73, holding member 18 formed of
two support plate portions, hole 19 with push rod 20, and channel
member 35 fixed to member 18 via an L-shaped supporting member. Id.
¶¶ 151, 160, Figs. 3–11. Push rod 20 has, in part, arm members 24 and 25 at

3 Figs. 1–11 refer to Yamamoto’s first embodiment. See Yamamoto
¶¶ 14–22, 148.
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a proximal end, members 24 and 25 integrally formed with actuating
members 16 and 17 rotatably linked with support plate portion 18 via pins
28 and 29, and having needles 34, 41, and 42 fixed to their distal ends. Id.
¶¶ 151, 158, 159. Channel 35 can contain needle fixing means 147 in a sixth
embodiment (id. ¶¶ 236, 241, Figs. 47–49), and actuating member 15 can
have fixed to its distal end needle holder 178 in an eighth embodiment (id.
¶ 265, Fig. 57). Figure 50 is illustrative and is reproduced below.

Figure 50 shows endoscope 12 with instrument port 6 having grasping
forceps 152 inserted therethrough, light guides 8 and 9, camera 10,
nozzle 11, support plate 18, pin 28, actuating arms 16 and 17, and
needles 34, 41, and 42. See id. ¶¶ 149–154, 245.
Saadat discloses an endoluminal tool deployment system comprising,
in relevant part, main body 10 including guide lumens through which
tools 40 having tool arms 30 are inserted. Saadat, Title, ¶¶ 60–62, 68, 113,
Figs. 7A, 7B.
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To the extent the Examiner relies on Yamamoto as teaching the
alignment limitations, i.e., needle arm 16 aligning with endoscope 12’s
instrument channel 6, the Examiner does not adequately explain how
Yamamoto’s “separate external tube (35/160) for the needle to move into”
and the suturing device and endoscope being removably fixed or structurally
integrated with each other (Final Act. 3–4, 6–7, 9, 11) teaches needle arm 16
aligning with channel 6. The Examiner further does not adequately explain
how Yamamoto teaches “closing the needle arm such that it aligns with a
channel of the endoscope” by depicting in Figures 30, 37, and 38 (second
and fourth embodiments of Yamamoto (see Yamamoto ¶¶ 190, 208) “how
the needle is captured by the needle capture device which is within the outer
cover.” Ans. 3. In other words, the Examiner does not explain how the
drawings depict such an alignment. The Examiner also does not explain
how Saadat cures the deficiency of the finding concerning the alignment
limitations.
To the extent the Examiner relies on the combined teachings of
Yamamoto and Saadat to result in the needle capture device limitations, the
limitations do not require a tissue grasper, needle arm, and needle capture
device to be contained within one channel. The Examiner determines that
Saadat modifies Yamamoto’s capture device so as to be extended through
Yamamoto’s channel 6 by combining various tools in one tube. However,
the Examiner does not adequately explain how combining elements into one
tube would modify Yamamoto’s channel 35 comprising tubular member 151
with needle fixing means 147 to fit into Yamamoto’s channel 6 comprising
grasping forceps 152 that pulls the tissue thereby closing member 16 and 17
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(located on device 3 outside of channel 6) to puncture the removable needle
into the tissue.
To the extent the Examiner is modifying Yamamoto’s needle holder
178 fixed to needle arm 16 connected to suturing device 3 with holding
member 18 and pin 28, to fit within Yamamoto’s channel 6 with forceps 152
as one tube, as taught by Saadat’s body 10 with tools 40 (see Final Act. 4,
6–7, 9, 11; Ans. 3–4), the Examiner does not adequately explain how
Yamamoto’s arm 16 would be disconnected from device 3 to be combined
in one tube with forceps 16.
To the extent the Examiner is modifying Yamamoto’s channel 6 to
contain suturing device 3 with holding member 18 and pin 28, arm 16, and
needle capture device 147 or needle holder 178 in one tube, as taught by
Saadat’s body 10 with tools 40 (see Final Act. 4, 6–7, 9, 11; Ans. 3–4), the
Examiner does not explain such a modification would be made to device 3.
At best, the Examiner explains that Saadat teaches combining multiple tools
into one tube member 10, but does not explain how such a tube would be
able to encompass a support plate with a rotatable arm, needle, and
connected channel with a needle capture device, how the support plate with
an arm, needle, and channel/capture device would be modified to be
encompassed within a tube, and how the modified tube would have a needle
aligned with channel 6. Moreover, the Examiner does not explain how such
a modification would make the device more compact.
In sum, the Examiner does not adequately explain how, and in what
way(s), Yamamoto is being modified by Saadat to teach the alignment and
needle capture device limitations as recited in the independent claims.
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Thus, based on the record before us, we are persuaded of Examiner
error, and we do not sustain the rejection over Yamamoto and Saadat of
independent claims 72, 75, 80, and 90. We also do not sustain the rejection
of dependent claims 73, 74, 78, 83, 85, 87, 89, and 91–96, under the same
ground of rejection. The rejection of claims 76, 77, 79, 81, 82, 84, and 86 as
obvious over Yamamoto, Saadat, and Baker is also not sustained, as it fails
to include additional findings and/or reasoning that cures the deficiency in
the rejection of the independent claims, from which they ultimately depend.
CONCLUSION
The Examiner’s decision to reject claims 72–87 and 89–96 is not
sustained.

In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
72–75, 78,
80, 83, 85,
87, 89–96
103(a) Yamamoto, Saadat 72–75, 78,
80, 83, 85,
87, 89–96
76, 77, 79,
81, 82, 84, 86
103(a) Yamamoto, Saadat,
Baker
76, 77, 79,
81, 82, 84, 86
Overall
Outcome
72–87, 89–96

REVERSED