Ex Parte Bonutti

Board of Patent Appeals and Interferences

Jun 26, 2008

10662923 (B.P.A.I. Jun. 26, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PETER M. BONUTTI
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Appeal 2007-4107
Application 10/662,923
Technology Center 3700
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Decided: June 26, 2008
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Before ERIC GRIMES, RICHARD M. LEBOVITZ, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to an
apparatus for separating tissue layers. The Examiner has rejected the claims
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Appeal 2007-4107
Application 10/662,923

STATEMENT OF THE CASE
The Specification describes a retractor including “a fluid-operated
portion such as a balloon or bladder to retract tissue” (Spec. 3:8-9). The
Specification also describes using “a pair of retractors . . . together to create
a working space” (id. at 19:14-15). In addition, the Specification describes
passing the leading end of a scope through the retractor into the working
space (id. at 15:15-17).
Claims 2-5, 7-9, and 11-13 are pending and on appeal. Except for
claim 13, the claims subject to each rejection have not been argued
separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii).
We will focus on claims 2 and 13, which are representative and read as
follows:
2. An apparatus for separating layers of tissue comprising:
a first tubular member having an open proximal end and an open
distal end defining a first bore therethrough;
a first inflatable member disposed on the distal end of the first tubular
member, the first inflatable member having an uninflated state and an
inflated state wherein the first inflatable member has an open proximal end
and an open distal end defining a first aperture therethrough, the first
aperture and the first bore being configured and dimensioned for receiving a
surgical instrument therethrough;
a second tubular member having an open proximal end and an open
distal end defining a second bore therethrough, the second tubular member
being configured and dimensioned for receiving the first tubular member
and the first inflatable member in the uninflated state; and
a second inflatable member disposed on the distal end of the second
tubular member, the second inflatable member having an uninflated state
and an inflated state, wherein the first and second inflatable members are
longitudinally spaced apart to define a working space therebetween, and
when the first and second members are in the inflated state, movement of the
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first inflatable member towards the second inflatable member is capable of
capturing body tissue therebetween.
13. The apparatus of claim 2, wherein movement of the first tubular
member towards the second tubular member being capable of separating a
first layer of body tissue from a second layer of body tissue when the first
and second inflatable members are in the inflated state.
Claims 2, 5, 7-9, and 13 stand rejected under 35 U.S.C. § 103(a) as
obvious over Daniels (US 4,655,746, Apr. 7, 1987) in view of Kontos
(US 5,180,367, Jan. 19, 1993) (Ans. 3). Claims 3 and 4 stand rejected under
35 U.S.C. § 103(a) as obvious over Daniels in view of Kontos and Evard
(US 4,981,478, Jan. 1, 1991) (id. at 5). Claims 11 and 12 stand rejected
under 35 U.S.C. § 103(a) as obvious over Daniels in view of Kontos and
Mecca (US 4,690,140, Sep. 1, 1987) (id. at 6).
The Examiner relies on Daniels for disclosing “first tubular
member 68 having an open proximal end, first inflatable member 72, second
tubular member 16 having an open proximal end and an open distal end
defining a bore 18 therethrough . . . and second inflatable member 30”
(Ans. 3). The Examiner relies on Kontos for teaching “that the tubular
member of the inner, pilot balloon can have an open distal end so that it can
slidably receive the guidewire instead of being fixed to the guidewire” (id. at
3-4). The Examiner relies on Evard and Mecca for features of claims that
depend from claim 2 (id. at 5-6).
The Examiner finds:
One of the advantages of having a catheter slidable on a
guidewire as opposed to being fixed to the guidewire is . . . [i]f,
after the guidewire and catheter (which is slidable on the
guidewire) have been inserted into the body, it is determined
that a different catheter (e.g. one with a different sized balloon)
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is needed, the guidewire may remain in the body while the
catheter is replaced. The insertion of the second catheter over
the guidewire is relatively quick and easy because the path to
the target site has already be[en] made and is maintained by the
pre-inserted guidewire.
(Id. at 4.) The Examiner concludes that it “would have been obvious to
make the distal end of the first inflatable member 72 and first tubular
member 68 of Daniels . . . open so that they can slidably receive a guidewire
so that it too would have this advantage” (id. at 4-5).
The Examiner also finds that “[m]ovement of the first inflatable
member 72 towards the second inflatable member 30 is inherently capable of
capturing body tissue therebetween” (id. at 5). In addition, the Examiner
finds that “the Daniels balloons can be first inflated and then one balloon can
be moved toward the other balloon to separate tissue” (id. at 9-10).
Appellant contends that the Examiner erred in concluding that
claims 2 and 13 would have been obvious over Daniels and Kontos.
ISSUES
The issues are whether Appellant has shown that the Examiner erred
in concluding that claims 2 and 13 would have been obvious over Daniels
and Kontos.
FINDINGS OF FACT
1. Daniels describes a catheter device that “includes a first
catheter having a tube with distal and proximal ends, an inflatable balloon
carried on the distal end of the tube, a channel extending through the tube,
and a fluid conduit for supplying fluid to the balloon” (Daniels, col. 2, ll. 10-
14).
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2. Daniels also describes a “second catheter in the device also
[having] a tube with distal and proximal ends, an inflatable balloon carried at
the tube’s distal end, and a fluid conduit for supplying fluid to the balloon”
(id. at col. 2, ll. 15-18).
3. Daniels states that a “central region of the tube [of the second
catheter] . . . is slidably carried within the channel of the first-catheter tube,
to allow relative axial shifting of the tubes, to place the two balloons in the
device a selected axial distance from one another” (id. at col. 2, ll. 19-23).
4. In particular, Daniels describes a second catheter including
tube 68 with central bore 70 extending therethrough and inflatable
balloon 72 “formed integrally with the walls of the tube” (id. at col. 4, ll. 28-
42).
5. Daniels also describes a “guide wire 74 extending through the
bore in tube 68 [that] is used to guide the tube . . . into a blood vessel” (id. at
col. 4, ll. 52-56).
6. Daniels states that this guide “wire is attached at its distal end
to a flexible spring 76, which in turn is secured in the end of bore 70. . . .
Thus, the wire is securely anchored to the distal end of the tube 68 but can
otherwise twist or rotate with respect to the tube along the tube’s length.”
(Id. at col. 4, ll. 54-59.)
7. Kontos describes a system in which a pilot catheter is inserted
in the vascular system to begin the enlarging process. Thereafter, the pilot
catheter “remain[s] resident in the vascular system . . . while feeding [a]
second, larger diameter . . . catheter over the pilot catheter.” (Kontos, col. 1,
l. 47, to col. 2, l. 57.)
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8. Kontos describes a pilot catheter having an inflatable balloon
membrane at or near its distal end (id. at col. 4, ll. 53-56).
9. Kontos states that the application of fluid under pressure causes
the balloon membrane to expand (id. at col. 4, ll. 64-68).
10. Kontos also describes using “an indwelling guide wire 72 to
facilitate placement of the pilot catheter” (id. at col. 8, ll. 8-10).
11. To utilize an indwelling guide wire, Kontos describes using a
catheter having a guide wire lumen (id. at col. 8, ll. 10-13).
12. Kontos states that the “insertion of the guide wire can precede
insertion of the pilot catheter, the two can be inserted together as a unit, or
the guide wire can be inserted after the pilot balloon is in the vascular
system, all in accordance with well known techniques” (id. at col. 8, ll. 15-
19).
13. Based on how the guide wire may be used with the pilot
catheter, the guide wire lumen must have a distal opening (id. at Fig. 9;
Ans. 3-4; Br. 7).
ANALYSIS
Daniels describes a catheter having a guide wire that is secured to a
tube of the catheter at the distal end (Findings of Fact (FF) 1-6). Kontos
describes a catheter including a guide wire lumen having a distal opening for
receiving a guide wire (FF 8-13). We agree with the Examiner that it would
have been obvious to modify Daniels’ catheter to include a guide wire lumen
having a distal opening, as described in Kontos, to permit the use of a guide
wire that is separate from the catheter.
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Appellant argues, however, that “modifying the inner inflatable
balloon of Daniels to have an open distal end as disclosed in Kontos has no
reasonable expectation of success” (Br. 7). Specifically, Appellant argues:
Modifying the inner inflatable balloon of Daniels to have an
open distal end as disclosed in Kontos would necessitate the
removal of the flexible spring that would eliminate a pressure
boundary for the inflatable balloon and the attachment point for
the guide wire. Without a pressure boundary at its distal end,
the inner inflatable balloon would be incapable of retaining
pressurized fluid and would not inflate upon introduction of the
pressurized fluid. In addition, without an attachment point for
the guide wire, the inner inflatable balloon would not rotate
when the guide wire is rotated from the manifold. This
modification, as proposed by the Examiner, renders the catheter
disclosed in Daniels inoperable for its intended purpose.
(Id. at 8.)
We are not persuaded by this argument. Kontos describes an
inflatable member that has an open distal end and that inflates upon
introduction of pressurized fluid (FF 8, 9, & 13). Therefore, as noted by the
Examiner, “[m]aking the distal end of the balloon 72 of Daniels et al. open
to slidably receive a guidewire as taught by Kontos . . . would not prevent
the balloon from retaining pressurized fluid since the balloon itself would be
sealed while the guidewire lumen passing through the balloon would have an
open distal end” (Ans. 7).
In addition, Appellant has not adequately explained why the failure of
the inner inflatable balloon to rotate when the guide wire is rotated from the
manifold would render Daniels’ device inoperable for its intended purpose.
In particular, Appellant has not explained why the Examiner is incorrect in
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his position that “rotation of the balloon is not necessary for the guiding of
the assembly into the body” (Ans. 9).
Appellant additionally argues that “Daniels fails to teach or suggest
moving an inflated balloon towards another inflated balloon to capture tissue
therebetween and separate a first layer of tissue from a second layer of tissue
as recited in claim 13” (Br. 11-12). In particular, Appellant argues that
“Daniels fails to disclose or suggest that either of the inflatable balloons
should be moved when in the inflated state” (id. at 10-11). In fact, Appellant
argues that “[m]oving one inflatable balloon towards the other inflatable
balloon would be contrary to Daniels’ disclosure about providing a
hemostatic seal with the vessel” (id. at 11).
We are not persuaded by this argument. Claims 2 and 13 are each
directed to an apparatus. Claim 2 requires that movement of the inflatable
members be capable of capturing body tissue. Claim 13 additionally
requires that movement be capable of separating body tissue.* However,
being apparatus claims, claims 2 and 13 do not require that the inflatable
members be moved. Thus, the applied references need not teach or suggest
moving the inflatable members to render apparatus claims 2 and 13 obvious.
We conclude that the Examiner has set forth a prima facie case that
claims 2 and 13 would have been obvious over Daniels in view of Kontos,
which Appellant has not rebutted. We therefore affirm the rejection of

* Claim 13 recites “movement of the first tubular member towards the
second tubular member” (emphasis added). However, in view of
Appellant’s argument, it appears that he may have intended to refer to
movement of the first inflatable member towards the second inflatable
member.
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claims 2 and 13 under 35 U.S.C. § 103(a). Claims 5 and 7-9 fall with
claim 2.
Claims 3, 4, 11, and 12 directly or indirectly depend from claim 2.
Appellant does not argue that claims 3 and 4 would not have been obvious
over Daniels in view of Kontos and Evard or that claims 11 and 12 would
not have been obvious over Daniels in view of Kontos and Mecca (Br. 4).
We therefore affirm the rejections of these claims under 35 U.S.C. § 103(a).
CONCLUSION
The Examiner’s position is supported by the preponderance of the
evidence of record. We therefore affirm the rejection of claims 2-5, 7-9, and
11-13 under 35 U.S.C. § 103(a).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc

Patent Counsel
U.S. Surgical, A Division of
TYCO HEALTHCARE GROUP LP
150 Glover Avenue
Norwalk CO 06856
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