Ex Parte Facundus et al

Board of Patent Appeals and Interferences

Mar 29, 2012

10966903 (B.P.A.I. Mar. 29, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/966,903 10/15/2004 Edward C. Facundus CELESKIPAT1 7259
20115 7590 03/30/2012
PATENT SERVICES
915 Merchant Walk
Suite D
HUNTSVILLE, AL 35801
EXAMINER
SONNETT, KATHLEEN C
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
03/30/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte EDWARD C. FACUNDUS and DANIAL C. CELESKI
__________

Appeal 2010-011217
Application 10/966,903
Technology Center 3700
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims relating to
an apparatus for use in stomach reduction surgery. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification discloses “a multifunction instrument used in
gastric bypass surgical procedures” (Spec. 1:7-8). The Specification
Appeal 2010-011217
Application 10/966,903

2
discloses that the “tool integrates a template balloon for forming and sizing a
small gastric pouch with a gastric sump tube having one or more lumens”
(id. at 1:8-10). The Specification discloses that the lumens are “adapted for
the functions of draining and collapsing the stomach, …filling the balloon
with air or a fluid to define a gastric pouch and filling the completed
[gastric] pouch with air… in order to determine integrity of suture and staple
lines and to test the pouch for leakage” (id. at 1:10-14).
Claims 1-24 are on appeal. Claim 1 is representative and reads as
follows:
1. A combined template, leak and integrity testing apparatus for
sizing and forming a gastric pouch and testing integrity of a newly-formed
gastric pouch during stomach reduction surgery comprising:
a gastric tube selectively sealable at a proximal end thereof, said
gastric tube configured to extend from within a stomach of a patient at a
distal end and out through a patient’s mouth at a proximal end, said distal
end of said gastric tube having a plurality of openings,
a balloon attached to said gastric tube proximate to said distal end of
said gastric tube, said balloon inflatable to serve as a template for forming a
gastric pouch,
a port at said proximal end of said tube for receiving an inflating
medium for said balloon, and a balloon tube communicating between said
port and said balloon,
a suction coupling mounted to a proximal end of said gastric tube,
said suction coupling and said gastric tube configured to communicate with
at least some of said openings to an interior of a stomach of a patient,
a pressure tube configured to be coupled to a pressure-developing
device and respective pressure monitor at said proximal end of said gastric
tube, said pressure tube communicating with at least one of said openings in
said distal end of said gastric tube,
whereby said balloon is inflated and a source of suction is applied to a
stomach to withdraw contents therefrom and deflate the stomach around an
inflated said balloon to define size of a gastric pouch, and after formation of
a gastric pouch is completed, pressure is applied to an inside of the gastric
Appeal 2010-011217
Application 10/966,903

3
pouch by said pressure-developing device to pressurize a newly-formed
gastric pouch so that integrity thereof may be determined.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1-3, 5, 7-10, 12 and 14 in view of Hakki1 and Stark;2
• Claims 4 and 11 in view of Hakki, Stark and Siegmund;3
• Claims 6 and 13 in view of Hakki, Stark and Greelis;4
• Claims 1-3 and 5 in view of Moss5 and Stark;
• Claims 15-18, 23 and 24 in view of Freeman,6 Kraemer7 and Black;8
• Claims 19 and 21 Freeman, Kraemer, Black and Siegmund;
• Claims 20 and 22 Freeman, Kraemer, Black, Siegmund and Greelis.
I.
The Examiner has rejected claims 1-3, 5, 7-10, 12 and 14 under 35
U.S.C. § 103(a) as being obvious in view of Hakki and Stark. The Examiner
has also rejected, under 35 U.S.C. § 103(a), claims 4 and 11 in view of
Hakki, Stark and Siegmund and claims 6 and 13 in view of Hakki, Stark and
Greelis. Since the same issue is dispositive for all three rejections, we will
consider them together.
The Examiner finds that “Hakki discloses an apparatus capable of
sizing a gastric pouch and testing integrity of a newly formed gastric pouch

1 Hakki, US 5,188,592, issued February 23, 1993
2 Stark et al., US 3,448,739, issued June 10, 1969
3 Siegmund, US 4,598,698, issued July, 08,1986
4 Greelis et al., US 5,336,183, issued August 09, 1994
5 Moss, US 4,642,092, issued February 10, 1987
6 Freeman, US 6,543,456 B1, issued April 08, 2003
7 Kraemer et al., US 2005/0080444 A1, published April 14, 2005
8 Black et al., US 6,245,083 B1, issued June 12, 2001
Appeal 2010-011217
Application 10/966,903

4
during stomach reduction surgery” (Answer 3). The Examiner finds that the
Hakki apparatus comprises a gastric tube (10) having a proximal suction
coupling and distal end openings which communicate via the gastric tube
(id. at 3-4). The Examiner finds that the Hakki apparatus further comprises
an inflatable “balloon (50) attached proximate to the distal end of the gastric
tube which “serve[s] as a template for a… gastric pouch” and a balloon tube
communicating between an inflation port and the balloon (id. at 3). The
Examiner finds that the Hakki apparatus further comprises a pressure-
developing device connected to a pressure tube that communicates with
openings in the gastric tube (id. at 4). The Examiner finds that Stark
discloses a pressure gauge coupled to a pressure-developing device to allow
pressure monitoring of the organ or vessel pressurized by the pressure
developing device (id.). The Examiner concludes that it would have been
obvious to one skilled in the art to modify Hakki’s apparatus to further
include a pressure gauge, as disclosed by Stark, “in order to be able to
monitor pressure… to ensure the correct amount of suction and inflation is
occurring” (id.).
Appellants contend, among other things, that the cited references
would not have made obvious the claim 1 apparatus with “a balloon
inflatable to serve as a template for forming a gastric pouch,” as required by
claim 1, because “the balloon of Hakki is far too small to be of any use… in
forming a gastric pouch” (Appeal Br. 17). Appellants argue that the Hakki
balloon “is only inflatable to a maximum diameter of between 3mm and 20
mm… [and] [i]t is well known in the art of gastric reduction surgery that
stomach pouches are 3-4 times this size” (id. at 16).
Appeal 2010-011217
Application 10/966,903

5
The Examiner responds that sizes of the balloon and the gastric pouch
formed by the balloon are not claimed and “therefore the device must only
be capable of sizing a gastric pouch of any size in order to meet this
functional limitation” (Answer 10). The Examiner further responds that the
apparatus and balloon of Hakki “is capable of being used to size a gastric
pouch” (id. at 11).
We agree with the Appellants that the Examiner has not adequately
explained how the cited references would have made obvious the apparatus
of claim 1 with “a balloon inflatable to serve as a template for forming a
gastric pouch.” Hakki discloses a “multi-tubed catheter for physically
dislodging and removing material from a lung by suction and simultaneously
aerating the lung with oxygen” (Hakki, abstract). Hakki discloses that the
“catheter comprises an oxygen tube for conveying oxygen into the lung, a
suction tube adapted to remove material from the lung and an inflation tube
for inflating a small balloon for separating the flow of oxygen from the
suction” (id.). Hakki discloses that the “balloon… may be designed to have
a maximum diameter of between 3.0 mm. and 20.0 mm” (id. at col. 7, ll. 17-
20). Hakki discloses that the “balloon 18 will generally be fully inflated
with less than 10.0 cc. of a gas such as air” (id. at col. 7, ll. 20-21).
The Specification discloses that in “gastric reductions, [the] capacity
of the stomach is greatly reduced… from a capacity of about 800 cc to
1100cc… [to] about 15 ml to about 200 ml” i.e. about 15 cc to about 200 cc
(Spec. 2:13-15). Since Hakki discloses balloons with a maximum capacity
of less than 10 cc and the Specification discloses that a minimum gastric
pouch size is about 15 cc, the Examiner has not adequately explained how a
Appeal 2010-011217
Application 10/966,903

6
balloon that has a maximum volume less than the smallest acceptable size
for a gastric pouch would be capable of sizing a gastric pouch. The
Examiner’s reasoning that claim 1 does not specify the size of the balloon is
not persuasive because claim 1 does specify that that the balloon must be
capable of sizing a gastric pouch.
Thus, we reverse the rejection of independent claim 1 and dependent
claims 2, 3, 5, 7, and 8 as being obvious in view of Hakki and Stark.
Independent claim 9 is directed to “a tubular surgical implement for
use during a stomach reduction surgery to form and test a newly-formed
gastric pouch” and is similar to claim 1 in requiring “a balloon of a size
selected to define a size of a gastric pouch.” Thus, we also reverse the
rejection of independent claim 9 and dependent claims 10, 12 and 14 as
being obvious in view of Hakki and Stark.
The Examiner has also rejected, under 35 U.S.C. § 103(a), dependent
claims 4 and 11 in view of Hakki, Stark and Siegmund and claims 6 and 13
in view of Hakki, Stark and Greelis. For these rejections, the Examiner
relies on Hakki and Stark, as discussed above, and the Examiner relies on
Siegmund and Greelis to supply dependent claim limitations. Thus, we also
reverse these rejections.
II.
The Examiner has rejected claims 1-3 and 5 under 35 U.S.C. § 103(a)
as being obvious in view of Moss and Stark.
The Examiner finds that “Moss discloses an apparatus capable of
sizing a gastric pouch and testing integrity of a newly formed gastric pouch
during stomach reduction surgery” (Answer 6). The Examiner finds that the
Appeal 2010-011217
Application 10/966,903

7
Moss apparatus comprises a gastric tube (12) which comprises a suction
coupling and distal openings which communicate via the gastric tube (id.).
The Examiner finds that the Moss apparatus further comprises a balloon
attached to the gastric tube and a balloon tube (26) communicating between
an inflation port and the balloon (id.). The Examiner finds that the Moss
apparatus further includes a feeding tube, “which can be considered a
pressure-developing device” (id. at 7). The Examiner finds that Stark
discloses a pressure gauge coupled to a pressure-developing device to allow
pressure monitoring of the organ or vessel pressurized by the pressure
developing device (id.). The Examiner concludes that it would have been
obvious to one skilled in the art to modify the Moss apparatus to include a
pressure gauge, as taught by Stark, “in order to be able to monitor
pressure… to ensure the correct amount of suction and irrigation” (id.). The
Examiner finds that the Moss balloon is “nearer to the proximal end of the
device then the distal end” (id.). The Examiner concludes that one skilled in
the art would have been motivated “to increase the length of the… tube
proximal of the balloon in order to have more clearance outside of the
body... [or] to be able to deliver the device to the stomach through a patient’s
mouth” (id.). The Examiner reasons that this modification would have
resulted in “a balloon that is proximate the distal end of the device” (id.).
Appellants contend, among other things, that the cited references
would not have made obvious the testing apparatus of claim 1 with a gastric
tube and “a balloon attached to said gastric tube proximate to said distal end
of said gastric tube,” as required by claim 1, because the Moss balloon is
located closer to the proximal end (Appeal Br. 33).
Appeal 2010-011217
Application 10/966,903

8
The Examiner responds that, with an increase in length at the
proximal end to allow for more clearance, “the balloon can be considered
positioned on the distal end of the gastric tube” (Appeal Br. 15).
We agree with Appellants that the Examiner has not adequately
explained how the cited references would have made obvious the testing
apparatus of claim 1 with a gastric tube and “a balloon attached to said
gastric tube proximate to said distal end of said gastric tube.” Moss
discloses “an aspirating and feeding device for insertion into a patient’s
body” (Moss, abstract). Figures 1 and 2 of Moss are shown below,
respectively.

Appeal 2010-011217
Application 10/966,903

9
Figure 1 is said to show “an elevational view of the gastrointestinal device”
and Figure 2 is said to show the device “disposed within a patient’s body”
(id. at col. 3, ll. 40-43). Moss discloses that the portions of the device are
“the external end portion 28 which is outside of the body; the midportion
30…; and the internal end portion 36 which extends from the pyloric
sphincter to the internal end 35 of the device in the proximal segment of the
small bowel” (id. at col. 4, ll. 10-16). Moss discloses that a balloon 14 is
attached around the main elongated tube 12 (id. at col. 3, 50-58).
As can be seen from Moss’s Figures 1 and 2 and the accompanying
description, Moss’s balloon is not located proximate the distal end of the
gastric tube. The Examiner’s reasoning that extending the proximal portion
of the device would result in the balloon being proximate the distal end of
the gastric tube is not persuasive since such a modification would not change
the relative positions of the balloon and the distal end. Thus, we reverse the
rejection of independent claim 1 and dependent claims 2, 3 and 5, as being
obvious in view of Moss and Stark.
III.

The Examiner has rejected claims 15-18, 23 and 24 under 35 U.S.C. §
103(a) as being obvious in view of Freeman, Kraemer and Black. The
Examiner has also rejected, under 35 U.S.C. § 103(a), claims 19 and 21 in
view of Freeman, Kraemer, Black and Siegmund and claims 20 and 22 in
view of Freeman, Kraemer, Black, Siegmund and Greelis. Since the same
issue is dispositive for all three rejections, we will consider them together.
Appeal 2010-011217
Application 10/966,903

10
Claim 159 is directed to a method for performing gastric reduction
surgery that comprises, among other things, using the apparatus of claim 1 to
form a gastric pouch smaller than a stomach, connecting the newly-formed
gastric pouch to the small bowel of a patient, and leak testing a newly
formed gastric pouch by using the apparatus of claim 1 to pressurize the
newly-formed gastric pouch to a selected pressure.
The Examiner finds that Freeman discloses a gastric reduction surgery
method that comprises “forming a gastric pouch smaller than the patient's
stomach and connecting the… gastric pouch” to the small bowel (Answer 7-
8). The Examiner finds that Kraemer discloses “an apparatus for evacuating
and sizing a stomach comprising a gastric tube,” with an attached balloon
(id. at 8). The Examiner finds that Kraemer discloses evacuating stomach
contents “through the working channel of tube portion (82)… and discloses
collapsing the stomach around the balloon (72) to size the gastric pouch”

9 Claim 15 is as follows: A method for performing gastric reduction surgery
comprising:
withdrawing stomach contents of a patient by using the combined
template, leak and integrity testing apparatus of claim 1,
collapsing a stomach of a patient around the combined template, leak
and integrity testing apparatus of claim 1,
using an inflated said balloon of claim 1 to ascertain size of a gastric
pouch,
forming a gastric pouch smaller than a stomach,
connecting a newly-formed gastric pouch to a small bowel of a
patient,
leak testing a newly formed gastric pouch by using the combined
template, leak and integrity testing apparatus of claim 1 to pressurize the
newly-formed gastric pouch to a selected pressure.

Appeal 2010-011217
Application 10/966,903

11
(id.). The Examiner concludes that it would have been obvious to one
skilled in the art to have modified Freeman’s method to include Kraemer’s
device “in order to be able to evacuate the stomach and size the gastric
pouch” (id.). The Examiner finds that “anastomotic leak after gastric bypass
surgery is a well known complication” (id.). The Examiner finds that Black
discloses a device for “testing the integrity of an anastomosis by applying
fluid to a vessel and monitoring the pressure” (id.). The Examiner concludes
that it would have been obvious to include a pressure-developing and
monitoring device as taught by Black… on the [Kraemer] device… so that
the integrity of the pouch can be checked without having to remove the
sizing device and insert a separate ” device (id.).
Appellants argue that the cited references would not have made
obvious the combination of Black’s integrity testing device with Kraemer’s
pouch sizing and formation device into a single apparatus for use in
Freeman’s gastric reduction surgery method (Appeal Br. 37-38).
We agree with Appellants that the Examiner has not adequately
explained how the cited references would have made obvious the claim 15
method for performing gastric reduction surgery. In particular, we agree
with Appellants that the Examiner has not adequately explained why one of
skill in the art would have modified the Kraemer’s pouch sizing apparatus to
contain an integrity testing component for use in Freeman’s method because
Freeman discloses that gastric pouch formation is followed by an
anastomosis step that is performed with a transorally inserted anastomosis
instrument. Thus, a different instrument is required between the pouch
Appeal 2010-011217
Application 10/966,903

12
sizing and formation step and the step where integrity testing would be
performed.
Freeman discloses a “method to perform a gastric bypass procedure…
using surgical tools and anastomosis members inserted transorally”
(Freeman, col. 2, ll. 22-24). Figure 4 of Freeman is shown below:

Figure 4 is said to show “anastomosis of the drainage loop to the jejunum of
a patient” (id. at col. 2, ll. 56-57). Freeman discloses that “[t]wo
anastomosis members [anvils 14 and 18] are placed transorally and passed
into the distal small intestine” (id. at col. 2, ll. 24-26). Freeman discloses
that the “small intestine is transected… to create a drainage loop [44]” (id. at
col. 2, ll. 26-28). Freeman discloses that an “anastomosis instrument is
inserted transorally to join the most distal anastomosis member [anvil 14] to
the drainage loop [44]” (id. at col. 2, ll. 28-30). Freeman discloses that the
“stomach is then transected to form a small gastric pouch. An anastomosis
Appeal 2010-011217
Application 10/966,903

13
instrument… is inserted transorally to join the more proximal anastomosis
member [anvil 18] to the gastric pouch” (id. at col. 2, ll. 31-33).
The Examiner’s reasoning is that Kraemer’s apparatus would be used
to size and form the gastric pouch in Freeman’s method. However, an
anastomosis instrument would be required to be inserted transorally after
pouch formation, and any integrity testing would be conducted after
anastomosis. Thus, the Examiner has not explained why it would have been
obvious to add Black’s integrity testing components to Kraemer’s pouch
sizing and formation components since the two sets of components would be
required at different points in the procedure, i.e. before and after the use of a
different anastomosis device. Thus, we reverse the rejection of claim 15 and
the rejection of claims 16-18, 23 and 24, which depend from claim 15
directly or indirectly, as being obvious in view of Freeman, Kraemer and
Black.
The Examiner has also rejected, under 35 U.S.C. § 103(a), claims 19
and 21 in view of Freeman, Kraemer, Black and Siegmund and claims 20
and 22 in view of Freeman, Kraemer, Black, Siegmund and Greelis. For
these rejections, the Examiner relies on Freeman, Kraemer, and Black, as
discussed above, and the Examiner relies on Siegmund and Greelis to supply
dependent claim limitations. Thus, we also reverse these rejections.
SUMMARY
We reverse the rejections of claims 1-24 under 35 U.S.C. § 103(a).

REVERSED
Appeal 2010-011217
Application 10/966,903

14

dm