Ex Parte Kalloo et al

Board of Patent Appeals and Interferences

Mar 18, 2010

09815336 (B.P.A.I. Mar. 18, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ANTHONY NICOLAS KALLOO and
SERGEY VENIAMINOVICH KANTSEVOY
____________

Appeal 2009-006379
Application 09/815,336
Technology Center 3700
____________

Decided: March 18, 2010
____________

Before LINDA E. HORNER, KEN B. BARRETT, and
FRED A. SILVERBERG, Administrative Patent Judges.

HORNER, Administrative Patent Judge

DECISION ON APPEAL
Appeal 2009-006379
Application 09/815,336

2
STATEMENT OF THE CASE
Anthony Nicolas Kalloo and Sergey Veniaminovich Kantsevoy
(Appellants) seek our review under 35 U.S.C. § 134 (2006) of the
Examiner’s decision rejecting claims 1, 2, 4-19, 21, 22, and 36. We have
jurisdiction under 35 U.S.C. § 6(b) (2006).
SUMMARY OF DECISION
We REVERSE.
THE INVENTION
Appellants’ claimed invention is a procedure for accessing and
examining and/or conducting surgical procedures in a body cavity. Spec.
1:6-7. Claim 1, reproduced below, is representative of the subject matter on
appeal.
1. A method for accessing an interior of a cavity of a
mammal, said method comprising:
positioning an elongated flexible conduit to extend from
an exterior of the mammal through a natural orifice into and
along at least a portion of the digestive tract to a target wall
segment in the digestive tract;
forming an incision in said target wall segment;
advancing a distal end of said flexible conduit so that the
distal end of said conduit extends through said wall;
after forming said incision and advancing the distal end of
said flexible conduit through said wall, anchoring said distal end
with respect to said wall;
advancing an endoscope through said conduit so that a
distal end of said endoscope is disposed adjacent or distal to said
distal end of said conduit;
Appeal 2009-006379
Application 09/815,336

3
viewing at least one of a tissue and an organ within said
cavity;
releasing said anchor;
withdrawing said conduit and said endoscope through
said wall; and
closing said incision,
further comprising, after said forming an incision and
before said advancing said conduit, dilating said incision to
facilitate passage of said conduit therethrough, wherein said
dilating comprises dilating with an inflatable balloon.
THE EVIDENCE
The Examiner relies upon the following evidence:
Wilk US 5,297,536 Mar. 29, 1994
McNeely US 5,458,583 Oct. 17, 1995
Laufer US 6,030,365 Feb. 29, 2000
THE REJECTIONS
Appellants seek review of the following rejections:
1. The Examiner rejected claims 1, 2, 4, 5, 7-13, 15-19, 21, 22, and 36
under 35 U.S.C. § 103(a) as being unpatentable over Wilk and
McNeely.
2. The Examiner rejected claims 6 and 14 under 35 U.S.C. § 103(a) as
being unpatentable over Wilk, McNeely, and Laufer.
ISSUE
The Examiner found Wilk teaches the method of claim 1, relying on
Wilk’s endoscope sheath to meet the claimed flexible conduit, except that
Wilk does not specifically mention dilating the opening after it is made or
the use of balloons. Ans. 3-5. The Examiner found that McNeely teaches a
Appeal 2009-006379
Application 09/815,336

4
method of dilating a stomach wall using a balloon. Ans. 3. The Examiner
determined that it would have been obvious to employ the dilation steps of
McNeely in the method of Wilk. Ans. 3.
Appellants argue that “[e]ven if the sheath is provided as a part of the
endoscope in Wilk and that sheath is advanced through the incision, such a
sheath does not read on the claimed flexible conduit which is not only
advanced through the incised target wall segment but is then anchored to the
wall segment and an endoscope is thereafter passed through it.” Reply Br. 2.
The issue presented by this appeal is:
Would the combination of Wilk and McNeely, as proposed by the
Examiner, have resulted in the claimed method including the steps of
anchoring a distal end of a flexible conduit with respect to a wall in the
digestive tract and advancing an endoscope through the flexible conduit?
FINDINGS OF FACT
We find that the following enumerated findings are supported by at
least a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849 F.2d
1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for
proceedings before the Office).
1. Wilk discloses an endoscopic assembly 20 comprising an outer
tube 22 and an endoscopic insertion member 32. Wilk, col. 4, ll.
34-36 and 43-44; fig. 4.
2. Wilk discloses that tube 22 and endoscopic insertion member 32
may be inserted together through a natural body opening into an
organ, and that upon selection of a suitable entry site, endoscopic
Appeal 2009-006379
Application 09/815,336

5
insertion member 32 is withdrawn at least partially from 22 to
facilitate formation of a negative-pressure connection between the
distal end of tube 22 and the wall of the organ. Wilk, col. 4,
ll. 59-68.
3. Wilk discloses that prior to incising the wall of a natural body
cavity or organ, a distal end of the tube 22 is brought into
engagement with the wall, and suction is applied to connect the
tube 22 to the wall. Wilk, col. 4, ll. 54-58; fig. 5A.
4. Wilk discloses that once the tube 22 is connected to the wall, a
needle is inserted through a biopsy channel 52 in the endoscopic
insertion member 32 to pierce the wall of the cavity, the abdominal
cavity is insufflated, the needle is removed, an endoscopic incising
instrument is passed through the biopsy channel 52 to perforate the
wall of the cavity, a distal end of the endoscope 32 is moved
through the tube 22 and through the perforation, the endoscope is
used to visually inspect internal body tissues, and then a surgical
operation is executed on the internal body tissues by manipulating
an endoscope surgical instrument passed along the endoscope and
through the perforation into the abdominal cavity. Wilk, col. 2,
ll. 43-52 and col. 5, ll. 1-18.
5. Wilk discloses in one embodiment, endoscopic insertion member
32 is provided with a sheath having an expandable channel, and the
incising instrument is inserted through this channel upon insertion
of the endoscope through the natural body opening and into the
Appeal 2009-006379
Application 09/815,336

6
natural body cavity, and the surgical instrument is inserted through
the sheath channel prior to executing a surgical operation. Wilk,
col. 2, ll. 15-22, col. 3, ll. 52-61.
6. Wilk does not disclose anchoring the distal end of its sheath with
respect to the wall of the digestive tract.
7. McNeely discloses a method of placing a gastrostomy catheter into
the interior of a patient’s stomach through the secured walls of the
patient’s stomach and abdomen. McNeely, col. 1, ll. 64-67.
8. McNeely discloses using a balloon on a dilatation catheter to dilate
a passageway formed through the abdominal and stomach walls,
then deflating the balloon and advancing the gastrostomy catheter
over the dilatation catheter. McNeely, col. 3, ll. 2-8 and ll. 22-28.
9. In McNeely, once the distal end of the gastrostomy catheter is
disposed well within the interior of the stomach, the dilatation
catheter is removed, and the distal end of the gastrostomy catheter
is secured within the stomach by inflating a balloon on the distal
end of the gastrostomy catheter, withdrawing the catheter until the
inflated balloon is urged snugly against the interior of the stomach
wall, and then advancing distally a sealing ring on the shaft of the
gastrostomy catheter until it is pressed against the exterior of the
abdominal wall. McNeely, col. 3, ll. 29-40.
ANALYSIS
We cannot find in the Examiner’s Answer any specific discussion or
findings as to how the combination of Wilk and McNeely would have
Appeal 2009-006379
Application 09/815,336

7
resulted in the sheath of Wilk being anchored to the wall segment, or any
discussion or findings as to how the combination of Wilk and McNeely
would have resulted in the endoscope of Wilk being passed through the
sheath. While the Examiner explains why one would have substituted the
sealing method of McNeely for the sealing method of Wilk, the Examiner is
referring in this explanation to Wilk’s use of suction to seal the tube 22 to
the wall segment. Ans. 5-7. Even if one were to make the substitution
suggested by the Examiner, this modification would not result in Wilk’s
endoscope sheath (i.e., the flexible conduit) being anchored to the wall
segment as called for in claim 1, since Wilk discloses that the endoscope and
sheath pass through the tube 22 (Facts 4, 5).
Further, we find no disclosure in Wilk of anchoring the sheath to the
wall segment (Facts 1-6). While McNeely discloses securing its
gastrostomy catheter within the stomach, McNeely’s catheter is a permanent
or semi-permanent feeding tube which has to be anchored to the stomach
wall to prevent the tube from being pulled out inadvertently (Facts 7-12).
The Examiner has not articulated any persuasive reasoning why one having
ordinary skill in the art would have been led to anchor Wilk’s sheath to the
wall segment in view of McNeely’s teaching to secure a feeding tube to the
stomach wall. Also, Wilk appears to disclose that the sheath is part of the
endoscope such that the two are advanced simultaneously (Fact 5). Thus,
Wilk does not appear to disclose the step of advancing an endoscope
through the flexible conduit as claimed. As such, the Examiner has not
made sufficient findings and has not provided adequate reasoning to explain
Appeal 2009-006379
Application 09/815,336

8
why one having ordinary skill in the art would have arrived at the method of
claim 1 in view of Wilk and McNeely. The rejection of claims 2, 4, 5, 7-13,
15-19, 21, 22, and 36 based on Wilk and McNeely likewise fails by virtue of
their dependence from claim 1.
Claims 6 and 14 also depend from claim 1. The rejection of claims 6
and 14 based on Wilk, McNeely, and Laufer likewise fails because the
Examiner relies on Laufer to teach the use of a cauterizing incision
instrument and the use of balloons to seal the conduit in the organ wall and
does not rely on Laufer to cure the deficiencies noted above in the
combination of Wilk and McNeely. Ans. 4.
CONCLUSION
The combination of Wilk and McNeely, as proposed by the Examiner,
would not have resulted in the claimed method including the steps of
anchoring a distal end of a flexible conduit with respect to a wall in the
digestive tract and advancing an endoscope through the flexible conduit.
DECISION
The decision of the Examiner to reject claims 1, 2, 4-19, 21, 22, and
36 is reversed.
REVERSED

Vsh

NIXON & VANDERHYE PC
901 NORTH GLEBE ROAD
11TH FLOOR
ARLINGTON VA 22203