Ex Parte Chen et al

Patent Trial and Appeal Board

May 7, 2013

10922133 (P.T.A.B. May. 7, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JIANDE CHEN and PANKAJ JAY PASRICHA
__________

Appeal 2012-001058
Application 10/922,133
Technology Center 3700
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of placing a vagus nerve stimulatory device. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.

Appeal 2012-001058
Application 10/922,133

2
Statement of the Case
Background
“The present invention relates generally to gastrointestinal electrical
stimulation, and more particularly to methods for regulating gastrointestinal
action, reducing weight, providing electrical field stimulation to a
gastrointestinal organ” (Spec. 1, ll. 11-15).
The Claims
Claims 13-15, 19, and 21-24 are on appeal. Claim 13 is representative
and reads as follows:
13. A method of placing a vagus nerve stimulatory device
in the gastrointestinal tract of a subject from the exterior of
the subject, the method comprising:
inserting an end of a needle having an interior bore
from the exterior of a subject into the gastrointestinal tract of
the subject, the gastrointestinal tract of the subject having a
center defined by a wall, the wall having a thickness
defining an interior wall adjacent to the center and an
exterior wall, and the end of the needle being inserted
through the thickness of the wall;
inserting a device with an insertion axis through the
interior bore of the needle, wherein the device has an
engaging means comprising a plurality of radially
extendable arms positioned at an axis perpendicular to the
insertion axis, and wherein the device is inserted at least
until the engaging means extends beyond the interior bore of
the needle;
removing the needle; and
retracting the device until the plurality of radially
extendable arms positioned at an axis perpendicular to the
insertion axis engages the interior wall of the gastrointestinal
tract of the subject, thereby placing the device in the
gastrointestinal tract of the subject.

Appeal 2012-001058
Application 10/922,133

3
The issue
The Examiner rejected claims 13-15, 19, and 21-24 under 35 U.S.C. §
103(a) as obvious over Gordon,
1
Edwards,
2
and Dickhudt
3
(Ans. 4-8).
The Examiner finds that “Gordon discloses implanting a gastro-
intestinal stimulator via a laparoscopic procedure, wherein the device is
inserted into or through a wall of the gastro-intestinal tract and retracting the
device to engage a fixation mechanism” (Ans. 5). The Examiner finds that
“Gordon does not explicitly state retracting the device until the engaging
means engages; however the engaging means disclosed is inherently
engaged through retraction of the device due to the backward angled
configuration of the tines” (id. at 5-6). The Examiner finds that “Gordon's
disclosed gastric stimulator is capable of affecting the vagus nerve since the
stomach is well enervated by the vagus nerve” (id. at 6). The Examiner finds
that “Gordon discloses the use of a laparoscopic viewing device to view the
gastrointestinal tract” (id. at 7).
The Examiner finds that “Gordon fails to teach the tines to extend
perpendicularly from the axis of insertion” (id. at 6). The Examiner finds
that “Gordon discloses the use of a laparoscopic viewing device to view the
gastrointestinal tract” (id. at 7).
The Examiner finds that “Dickhundt [sic] teaches that it is known for
fixation tines of an implantable lead to extend perpendicularly from the lead
as set forth in Col. 4, line 13-19 for providing the predictable results of

1
Gordon et al., US 6,542,776 B1, issued Apr. 1, 2003.
2
Edwards, S., US 6,006,755, issued Dec. 28, 1999.
3
Dickhudt et al., US 4,414,986, issued Nov. 15, 1983.
Appeal 2012-001058
Application 10/922,133

4
providing a greater surface area to oppose lead dislodgement” (Ans. 6). The
Examiner finds that “Edwards teaches that it is known to use endoscopy to
view the fixation of an implantable medical device and fixation to the
gastrointestinal tract” (id. at 7). The Examiner “takes the position that
laparoscopic viewing and endoscopic or colonoscopic viewing are
equivalent for their use in the medical art, and the selection of any of these
would be within the level of ordinary skill in the art” (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Gordon, Dickhudt, and
Edwards teach or suggest “retracting the device until the plurality of radially
extendable arms positioned at an axis perpendicular to the insertion axis
engages the interior wall of the gastrointestinal tract” as required by
claim 13?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. Gordon teaches “providing apparatus and methods for attaching
such apparatus to neuromuscular tissue of the viscera, and particularly, the
gastrointestinal tract. The apparatus includes at least four closely spaced
stimulating electrodes electrically connected to a pulse generator that
supplies electrical stimulating pulses to the neuromuscular tissue” (Gordon,
col. 2, ll. 12-18).
2. Gordon teaches
a simple, minimally-invasive installation procedure . . . the
approximate location of the gastrointestinal tissue is located
by the physician. An incision is made in the patient in the
Appeal 2012-001058
Application 10/922,133

5
surface of the skin above the operative site. According to a
preferred embodiment, an obturator device may be used to
provide the incision and install a trocar. The process of
insufflation may be used . . . . A laparoscope or similar
remote viewing apparatus may be inserted through one of
the trocars in order to allow viewing of the process of
attachment of the electrode assembly to the tissue

(Gordon, col. 7, ll. 24-39).
3. Gordon teaches that the “electrode assembly 16 is preferably
passed through the trocar in a compacted form” (Gordon, col. 7, ll. 42-43).
4. Gordon teaches that after “trocar passage, the electrode
assembly may be freed from the sleeve by mechanical means. . . . According
to an alternative embodiment, the electrode assembly is pushed out of the
sleeve by advancing an apparatus, such as a blunt instrument, a plunger, a
blunt dissection device, or a balloon catheter device” (Gordon, col 7, ll. 52-
60).
5. Gordon teaches
First tines 48a may resiliently move towards the undeflected
position . . . and inhibit movement of electrode attachment
member 24a out of the tissue S. Second tines 50a may be
axially spaced from first tines 48a such that they abut the
entrance site V of the tissue S and inhibit further movement
of electrode attachment member 24a into the tissue S. In this
position, the tissue S is located between the two sets of tines
48a and 50a. Moreover, the electrode attachment member
24 is effectively anchored in place by tines 48a and 50a.

(Gordon, col. 8, ll. 17-26.)
6. Dickhudt teaches that “[p]referably the tines extend
substantially perpendicular from the surface of extension 31. Substantially
Appeal 2012-001058
Application 10/922,133

6
here means that the extension is sufficiently parallel and the tines are
sufficiently, flat and sufficiently perpendicular so that the major portion of
the tine surface area opposes motion through the epidural space in a
direction parallel to the axis of the lead” (Dickhudt, col. 4, ll. 13-19).
7. Edwards teaches that:
A variety of other diagnostic methods can be
employed as an adjunct to surface mapping of sphincter wall
26. These method include, but are not limited to, the
following: (i) visualization of the interior surface of the
esophagus via an endoscope or other viewing apparatus
inserted into the esophagus, (ii) visualization of the interior
morphology of the esophageal wall using ultrasonography to
establish a baseline for the tissue to be treated; and, (iii)
impedance measurement to determine the electrical
conductivity between the esophageal mucosal layers and
sphincter mapping and treatment apparatus 10.

(Edwards, col. 12, ll. 35-45.)
Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
Analysis
Appellants contend that
the combination of Gordon in view of Edwards and in view
of Dickhudt does not teach or disclose inserting a device
with a plurality of radially extendible arms positioned at an
axis perpendicular to the insertion axis through a needle and
Appeal 2012-001058
Application 10/922,133

7
retracting the device until the plurality of radially extendible
arms engages the interior wall of the gastrointestinal tract

(App. Br. 16-17).
The Examiner “has acknowledged that Gordon in view of Dickhundt
[sic] is silent to the specific step of retracting the device to engage the
engaging means. Examiner has considered this step to be implicitly
disclosed by Gordon” (Ans. 9).
We find that Appellants have the better position. Dr. Pasricha
4
teaches
that “Gordon does not teach retracting the electrode device, nor is it inherent
or implied. Additionally, Gordon does not teach retracting the assembly after
removing the trocar either” (Pasricha Dec. 3 ¶ 10). The Examiner has not
provided evidence to rebut this teaching or demonstrate this is inherent. The
Examiner has also not provided a reason to modify either Gordon or
Dickhudt to retract the device in order to engage arms/tines with the
gastrointestinal tissue, rather than allow arms/tines to resiliently move
towards the undeflected position as taught by Gordon (FF 5).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Gordon, Dickhudt, and Edwards teach or suggest “retracting the device
until the plurality of radially extendable arms positioned at an axis
perpendicular to the insertion axis engages the interior wall of the
gastrointestinal tract” as required by claim 13.

4
Declaration of Dr. Pankaj Pasricha, filed Apr. 1, 2009.
Appeal 2012-001058
Application 10/922,133

8
SUMMARY
In summary, we reverse the rejection of claims 13-15, 19, and 21-24
under 35 U.S.C. § 103(a) as obvious over Gordon, Edwards, and Dickhudt.

REVERSED

cdc