Ex Parte Abboud et al

Board of Patent Appeals and Interferences

Aug 16, 2011

11074293 (B.P.A.I. Aug. 16, 2011)

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.
11/074,293 03/07/2005 Marwan Abboud 21819-210U 6508
89554 7590 08/16/2011
Christopher & Weisberg, P.A.
200 East Las Olas Boulevard
Suite 2040
Fort Lauderdale, FL 33301
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
08/16/2011 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 Medtronic Cryocath LP
__________

Appeal 2010-004137
Application 11/074,293
Technology Center 3700
___________

Before RICHARD E. SCHAFER, JAMESON LEE, and SALLY C.
MEDLEY, Administrative Patent Judges.

LEE, Administrative Patent Judge.

DECISION ON APPEAL
Medtronic Cryocath LP (“Medtronic”), the real party in interest,
appeals under 35 U.S.C. § 134(a) from a final rejection of claims 1, 5-7, 9,
12, and 14-16. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
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THE INVENTION
Medtronic discloses a “fluid control system for a medical device.”
(Spec., title). The medical device may be, for example, a catheter for a
blood vessel tissue ablation procedure. (Spec. ¶ 4). In such a procedure, a
portion of a catheter is positioned within a targeted blood vessel region.
(Id.). Cryogenic fluid is pumped into the catheter, thereby cooling the noted
catheter portion and the targeted blood vessel region to a low tissue-ablating
temperature. (Id.).
The fluid is pressurized and, if leaked into the vessel, potentially life
threatening. (Spec. ¶ 5). Medtronic’s invention seeks to prevent such leaks.
(Spec. ¶¶ 6-7). Medtronic’s Fig. 1 schematic, reproduced below, shows an
embodiment of the invention. (Spec. ¶ 11).

An intake lumen 12 and exhaust lumen 14 respectively carry
cryogenic fluid, under pressure, to and from a cavity 18 within a first pliable
layer 16. (Spec. ¶¶ 18-20).
As a precaution against the fluid leaking into a patient, the first pliable
layer 16 is enclosed by a second pliable layer 24. (Spec. ¶ 21). For any
fluid to leak from the cavity 18 into the patient, the fluid must initially
breach the first pliable layer 16 and pass into the junction 26 (i.e., space)
between the pliable layers 16, 24. (Id.). In that event, the leaked fluid is
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contained within the junction 26 by the still intact second pliable layer 24.
(Id.).
As another precaution against the fluid leaking into a patient, the
junction 26 is placed under a vacuum (Spec. ¶ 21) and in fluid
communication with a check valve 28, i.e., one way valve. (Spec. ¶ 22).
Leaking of the fluid into the junction 26 increases the pressure inside of the
junction 26. (Id.). A sufficient pressure coaxes the check valve 28 open,
such that some of the fluid and pressure is released from the junction 26 to
prevent a subsequent breach of the second pliable layer 24. (Id.).
Claims 1 and 5 are representative and reproduced below:
1. A medical device, comprising:
a first fluid path including an intake lumen and an
exhaust lumen;
a second fluid path;
a check valve in fluid communication with the first fluid
path and the second fluid path; and
a first pressure sensor in fluid communication with the
second fluid path.

5. A medical device comprising:
an elongate body having a proximal end and a distal end,
wherein the elongate body defines an intake lumen and an
exhaust lumen;
a first pliable element defining a cooling chamber
disposed at a point along the elongate body, the cooling
chamber in fluid communication with the intake lumen and the
exhaust lumen;
a second pliable element at least partially enclosing the
first pliable element, defining a junction between the first and
second pliable element; and
a first check valve in fluid communication with the
junction between the first pliable element and second pliable
element, the first check valve further in fluid communication
with the exhaust lumen.
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THE PRIOR ART
The Examiner relied upon the following prior art references:
Joye Patent 6,648,879 Nov. 18, 2003
Zvuloni Patent 6,875,209 Aug. 5, 2005
The Rejections on Appeal
Claims 5, 7, 9, 12, and 16 were finally rejected, in a final Office
Action mailed April 14, 2009, under 35 U.S.C. § 102 as anticipated by Joye.
(Final Rej. 2:17-18).
Claims 5, 7, 9, 12 and 16 were rejected, in the Examiner’s Answer
and for the first time, under 35 U.S.C. § 103 as unpatentable for obviousness
over Joye. (Ans. 4:17-19).
Claims 1, 6, 14, and 15 were finally rejected, in the final Office
Action, under § 103 as unpatentable for obviousness over Joye and Zvuloni.
(Final Rej. 3:15-16).
Joye
Joye discloses a “safety cryotherapy catheter.” (Joye, title). Like
Medtronic’s catheter (10), Joye’s catheter can be used for a blood vessel
tissue ablation procedure.
Joye’s Figs. 1 and 2, reproduced below, show an embodiment of the
catheter. Fig. 1 shows a perspective view of the catheter 10. (Joye 6:16-18).
Fig. 2 shows a cross-section view, at line 2-2 of Fig. 1, of the catheter 10.
(Joye 6:19-20).
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An intake lumen 18 and exhaust lumen 20 respectively carry
cryogenic fluid, under pressure, to and from a cavity within a first pliable
layer 22. (Joye 6:55-57; 8:27-33).
As a precaution against the fluid leaking into a patient, the first pliable
layer 22 is enveloped by a second pliable layer 24. (Joye 6:55-57; 8:27-33).
For the fluid to leak from the cavity into the patient, the fluid initially
breaches the first pliable layer 22 and passes into the junction 60 between
the pliable layers 22, 24. (Joye Fig. 1). In that event, the leaked fluid is
contained within the junction 60 by the still intact second pliable layer 24.
(Joye 9:26-28).
As another precaution against the fluid leaking into a patient, the
junction 60 is placed under a vacuum (Joye 8:63-65). If the fluid leaks into
the junction 60, the corresponding increase in pressure within the junction
60 is sensed by a vacuum switch 66. (Joye 9:9-16). When a sufficient
increase of pressure is sensed, the vacuum switch 66 outputs a control signal
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to a close a shutoff valve 68 of the intake lumen 18, thereby halting the
supply of the liquid to the cavity within the first pliable layer 22.
(Joye 9:16-26).
ANALYSIS
I. Anticipation
A. The rejection of claims 5, 7, 9, 12, and 16 under § 102 as
anticipated by Joye
Claims 5, 7, 9, 12, and 16 are argued as a group and therefore stand or
fall with claim 5, reproduced supra. 37 C.F.R. § 41.37(c)(1)(vii).
Claim 5 recites a “check valve.” The Examiner and Medtronic agree
that a check valve means a one-way valve, i.e., passes fluid in only one
direction. (Ans. 3:8; Brief 2:13).
The Examiner found that Joye’s shutoff valve 68 constitutes the
recited check valve. (Ans. 6-7). In doing so, the Examiner determined that
an illustrated pathway of arrows within Fig. 10, reproduced below, indicates
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that the shutoff valve 68 is a one-way valve. The Examiner particularly
determined that the pathway of arrows from the fluid supply 72 to the first
balloon 22 indicates a one-way flow of the fluid through the shutoff valve 68
and, thus, the shutoff valve 68 “must” (Ans. 5:26) be a one-way valve.
(Ans. 5:22-6:1). According to the Examiner (id.):
Figure 10 of Joye is a flow diagram. The flow diagram
depicts arrows between the boxes indicating the features of the
automatic fluid shutoff mechanism of Joye’s catheter. It is the
examiner’s position that the arrows indicate the direction in
which the fluid is flowing. For example: the fluid exits from
fluid supply 72 and enters into the fluid supply lumen 18
through the shutoff valve 68 and then enters balloon #1. The
flow diagram depicts fluid flow in one direction only. There is
no indication that fluid flows backward from the balloon to the
fluid supply. Therefore, the shutoff valve must prevent flow of
the fluid in the reverse direction which is the same function that
the presently claimed check valve performs.

Medtronic argues that the flow diagram of Fig. 10 does not illustrate
any structure and, thus, cannot alone support the Examiner’s determination
that the shutoff valve 68 is a one-way valve. (Brief 4:17-19). According to
Medtronic (id.):
Joye’s flow chart fails to show any “structural features;” it
simply illustrates names of components surrounded by boxes.
Fig. 10 of Joye thus fails to disclose or suggest Joye’s shutoff
valve is a check valve.

We agree with the Examiner insofar that Fig. 10, when viewed in light
of the specification, depicts fluid flow in one direction only (Ans. 5:25). We
agree for two reasons. First, the illustrated pathway of arrows between the
fluid supply 72 and pressure relief valve 21 represents a sequence of one-
way communications, as follows: fluid supply 72  shutoff valve 68 
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fluid supply lumen 18  inner balloon 22  exhaust lumen 20  pressure
relief valve 21. Second, Joye’s specification confirms that these one-way
communications are fluid communications. (Joye 6:55-57; 8:60-62; 9:10-
12; 9:28-30). Thus, as determined by the Examiner, Fig. 10 depicts the
fluid as flowing through the shutoff valve 68 in the direction from the fluid
supply 72 to the inner balloon 22 (Ans. 5:23-25), and, there is no
indication that fluid flows backward from the balloon to the fluid supply.
(Ans. 5:25-26).
However, the Examiner has incorrectly determined that the shutoff
valve 68 “must” be (Ans. 5:26), i.e., is inherently, a one-way valve simply
on the basis of the illustrated flow of the fluid. (Ans. 5:26-6:2). Fig. 10
depicts the movement of the fluid when provided by the fluid supply 72 at
high pressure. (Joye 10:1-7). In that circumstance, whether the shutoff
valve 68 is a one-way valve or a two-way valve, the direction of fluid flow
will be the same, in the direction illustrated by the arrows. The structure of
the valve is not described. Either a one-way valve or a two-way valve is
consistent with the illustration shown in Figure 10.
For the foregoing reason, we do not sustain the rejection of claims 5,
7, 9, 12, and 16 under § 102 as anticipated by Joye.
II. Obviousness
A. The rejection of claims 5, 7, 9, 12 and 16 under § 103 as
unpatentable for obviousness over Joye
Claims 5, 7, 9, 12, and 16 are argued as a group and therefore stand or
fall with claim 5. 37 C.F.R. § 41.37(c)(1)(vii).
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1. “check valve”
This § 103 rejection reiterates the Examiner’s findings presented in
the anticipation rejection of claim 5, except here the Examiner reasoned that
in light of the fluid flow described in Joye, it would have been obvious to
one with ordinary skill in the art to implement shutoff valve 68 by a one-way
valve. (Ans. 4:23-5:5). In response, Medtronic simply argues that Joye’s
Fig. 10 does not illustrate structure and thus cannot support the obviousness
conclusion. (Reply 6:14-7:2).
Medtronic’s argument is misplaced, because the rejection is based on
obviousness, not anticipation. As the Examiner explained, Joye describes
fluid flow in only one direction and thus one with ordinary skill in the art
would have known that a one-way valve may be used to implement shutoff
valve 68. The Examiner has articulated a rational basis to support the
obviousness conclusion. Medtronic has not explained why the reasoning is
incorrect. More importantly, Medtronic has not identified any desired fluid
flow that goes in the reverse direction through shutoff valve 68.
 2. “first check valve in fluid communication with the junction
between the first pliable element and second pliable element”
Claim 5 recites the check valve as being “in fluid communication with
the exhaust lumen.” The Examiner found that Joye’s shutoff valve 68
constitutes the recited check valve. (Ans. 4:21). The Examiner found that
Joye’s exhaust lumen 20 constitutes the recited exhaust lumen. (Ans. 4:22).
The Examiner found that the required fluid communication is
disclosed in Joye by the passing of the fluid from the shutoff valve 68 to the
exhaust lumen 20, i.e., by the passing of the fluid through the fluid supply
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lumen 18 and inner balloon 22. (Ans. 6:15-18). According to the Examiner
(id.):
According to Figs. 10 and Fig. 12, they show that the
fluid supply 72 flows through the valve 68 and through the fluid
supply lumen 18 and into first balloon 22 and fluid exits out the
exhaust lumen 20. Therefore, one skill[ed] in the art would
recognize that the check/shutoff valve 68 is in fluid
communication with the exhaust lumen 20.

The Examiner’s explanation is reasonable. Because the applied fluid travels
from the shutoff valve 68 to the exhaust lumen 20, the shutoff valve 68 is in
fluid communication with the exhaust lumen 20.
Medtronic argues that Joye uses the terminology “fluid
communication” only in describing the communications of the shutoff valve
68 with the supply lumen 18 and fluid supply 72. (Joye 9:8-11). The
argument is without merit. Regardless of the terminology used to describe
the connection, the shutoff valve 68 is in fluid communication with the
exhaust lumen 20, as already explained. In determining whether a reference
discloses a claim element, identity of terminology between a reference’s text
and a claim’s language is not required. In re Bond, 910 F.2d 831, 832 (Fed.
Cir. 1990).
3. Conclusion
For the foregoing reasons, we sustain the rejection of claims 5, 7, 9,
12, and 16 under § 103 as unpatentable for obviousness over Joye.
C. The rejection of claims 1, 6, 14, and 15 under § 103 as
unpatentable for obviousness over Joye and Zvuloni
Claims 1, 6, 14, and 15 are argued as a group and therefore stand or
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
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1. “check valve”
Like claim 5, claim 1 recites a “check valve,” i.e., one-way valve. For
the reasons presented in the § 103 rejection of claim 5, the Examiner
determined that it would have been obvious to implement Joye’s shutoff
valve 68 as a check valve. (Ans. 6:2-6:8; 6:23-24).
In responding to this rejection, Medtronic makes the same argument it
presented above in the context of the rejection of claim 5. As discussed
above in the context of claim 5, Medtronic’s argument is without merit.
2. “a check valve in fluid communication with the first fluid
path and the second fluid path”
Claim 1 recites the check valve as being “in fluid communication with
the first fluid path and the second fluid path.” The Examiner found that
Joye’s circulation of the fluid, from the fluid supply 72 to the pressure relief
valve 21, constitutes the first fluid path. (Ans. 6:19-20). The Examiner
found that the connection from Joye’s junction lumen 62 – which conveys
the pressure within the junction 60 to the vacuum switch 66 (Joye 8:65-9:21)
– to the vacuum switch 66 constitutes the second fluid path. (Ans. 3:20).
Thus, the Examiner must show a teaching or suggestion that Joye’s shutoff
valve 68 is in fluid communication with the pathway of the fluid from the
fluid supply 72 to the pressure relief valve (“first path”) and with the
pathway from the junction lumen 62 to the switch 66 (“second path”).
Medtronic does not dispute that Joye’s shutoff valve 68 is in fluid
communication with the pathway of the fluid from the fluid supply 72 to the
pressure relief valve 21. As discussed below, the Examiner and Medtronic
disagree as to whether the shutoff valve 68 is in fluid communication with
the pathway from the junction lumen 62 to switch 66.
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The Examiner found that such fluid communication results from the
entry of the fluid into the junction 60 and, thus, into the junction lumen 62.
(Final Rej. 5:6-15). In other words, that fluid communication results from
passage of the fluid from the shutoff valve 68 into the junction lumen 62
(which trips the vacuum switch 66). According to the Examiner (Final
Rej. 6:10-15):
In other words, the cryogenic fluid 72 flows thru valve 68
and entering through fluid lumen 18 and then entering first
balloon 22. When the first balloon 22 is punctured, the
fluid/blood exits balloon 1 to enter the vacuum space/junction
60. The second balloon 24 also acts to contain any cryogenic
fluid that may have escaped the first balloon 22 (col. 9,
lines 26-28). Therefore, the valve 68 is in fluid communication
with the junction/vacuum space 60 between the first and second
balloon/pliable element.

The Examiner’s reasoning has a rational basis. Because fluid does
travel from the shutoff valve 68 to the junction lumen 62, the shutoff valve
68 is in fluid communication with the second pathway which leads from the
junction lumen 62 to the switch 66.
Medtronic asserts that Joye uses the terminology “fluid
communication” only in describing the connection of the shutoff valve 68 to
the supply lumen 18 and fluid supply 72 and not in describing a connection
of the shutoff valve 68 with a second fluid path. (Reply 8:9-11). On this
basis alone, Medtronic contends that Joye’s shutoff valve 68 is not in fluid
communication with the junction 60 or junction lumen 62, as required. The
argument is misplaced, as we have already explained above. The
determination of whether a reference discloses a claim element is not
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whether the reference uses the identical terminology as does the appellant.
In re Bond, 910 F.2d at 832.
3. Conclusion
For the foregoing reasons, we sustain the rejection of claim 5, 7, 9, 12,
and 16 under § 103 as unpatentable for obviousness over Joye and Zvuloni.
DECISION
The rejection of claims 5, 7, 9, 12, and 16 under § 102 as anticipated
by Joye is reversed.
The rejection of claims 1, 6, 14, and 15 under § 103 as unpatentable
for obviousness over Joye and Zvuloni is affirmed.
The rejection of claims 5, 7, 9, 12 and 16 under § 103 as unpatentable
for obviousness over Joye and Zvuloni is affirmed.
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

ak

John Christopher
Christopher & Weisberg, PA
Suite 2040
200 East Las Olas Blvd.
Fort Lauderdale, FL 33301