Ex Parte Kumar et al

Patent Trial and Appeal Board

Oct 22, 2012

11211489 (P.T.A.B. Oct. 22, 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.
11/211,489 08/26/2005 Atul Kumar A8130.0459/P459 6813
24998 7590 10/22/2012
DICKSTEIN SHAPIRO LLP
1825 EYE STREET NW
Washington, DC 20006-5403
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
10/22/2012 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ATUL KUMAR and ALKA KUMAR
__________

Appeal 2011-005662
Application 11/211,489
Technology Center 3700
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
system for distending body tissue cavities by fluid irrigation. The Examiner
has rejected the claims as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in-part.

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STATEMENT OF THE CASE
The Specification describes an apparatus for distending body tissue
cavities in subjects using continuous flow irrigation during an endoscopic
procedure (Spec. 1). Figure 2 in the Specification shows an embodiment:

Figure 2 depicts a schematic diagram of a system for distending tissue
cavities comprising a fluid source container (1), a fluid delivery tube (2), an
inflow pump (3), an inflow tube (4) that carries pressurized irrigation fluid to
tissue cavity (11), an outflow tube (12), a positive displacement pump (14), a
waste fluid carrying tube (15), and a waste fluid collecting container (16)
(id. at 17). The system also comprises a constriction site housing tube
(7), which includes a constriction point (8) (id. at 18). Figure 1 in the
Specification (not shown here) is similar to Figure 2, but also includes a
pressure pulse dampening system (id. at 17).
Claims 1, 3, 5-19, 22-25, and 27-31 are on appeal. Claims 1 and 30
are representative (emphasis added).
1. A system for distending body tissue cavities of subjects by
continuous flow irrigation during endoscopic procedures the system
comprising:
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a fluid source reservoir containing a non viscous physiologic
fluid for continuous flow irrigation during an endoscopic procedure;
a fluid delivery tube connecting the fluid source reservoir to an
inlet end of an inflow dynamic pump an outlet end of the pump being
connectable to a tissue cavity subjected to the endoscopic procedure
through an inflow tube for pumping the fluid at a controlled flow rate
into the cavity to obtain a distended cavity, the rate at which the fluid
from the inflow tube enters into the tissue cavity being termed as the
cavity inflow rate;
a positive displacement outflow pump having an inlet end being
connectable to the tissue cavity through an outflow tube for removing
the fluid from the cavity at a controlled flow rate, the flow rate of the
outflow pump being termed as the cavity outflow rate;
an outlet end of the outflow pump connected to a waste fluid
collecting container via a waste fluid carrying tube; and
a tube having a fixed constriction site provided between the
fluid source reservoir and the inflow tube such that the same by-
passes the inflow pump, the constriction site having a fixed diameter,
wherein the tube provides a route for any excess fluid being pumped
by the inflow pump to bypass the inflow pump and return to the fluid
supply tube or the fluid source reservoir.
30. The system as claimed in claim 1, further comprising an
outflow pressure pulsation dampening means provided between the
cavity and the positive displacement outflow pump, and connected to
the outflow tube for dampening the pressure pulsations inside the
cavity caused by the positive displacement outflow pump, wherein the
pressure dampening means comprises a single outlet syringe
mechanism, a piston of the same being coupled synchronously to the
positive displacement outflow pump through coupling means and the
single outlet end of the syringe mechanism being connected to the
outflow tube.
The claims stand rejected as follows:
(I) claims 1-3, 5-16, 18-19, 22-25, 27-29, and 31 under 35 U.S.C.
§ 103(a) as obvious over Novak (U.S. Pat. No. 6,997,896, issued Feb. 14,
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2006) in view of Nowosielski et al. (U.S. Pat. No. 5,605,545, issued Feb. 25,
1997); and
(II) claim 30 under 35 U.S.C. § 103(a) as being obvious over
Novak in view of Nowosielski and further in view of Takamatsu et al. (U.S.
Pat. No. 6,283,937, issued Sept. 1, 2001).
I.
Findings of Fact
1. Novak discloses an apparatus for controlling the introduction and
removal of a fluid into a body cavity in order to facilitate a surgical
procedure (Novak, col. 1, ll. 9-14). The apparatus “is used for the
endoscopic irrigation of body cavities …” (id. at ll. 18-20). When using the
apparatus, “the pressure and the flow rate can be controlled as independently
from each other as possible” (id. at col. 2, ll. 15-17).
2. In Figure 1, Novak discloses the following embodiment:

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Figure 1 depicts a diagram of an apparatus for irrigating a body cavity (id. at
col. 6, ll. 60-61).
3. As shown in Figure 1 above, “liquid is drawn from a liquid reservoir
through conduit 118 in the direction of arrow 119” (id. at col. 7, ll. 26-27).
The liquid flows into “an irrigation pump 114 connected to the body cavity
112 with irrigation conduit 116” (id. at ll. 24-26). Downstream from
irrigation pump (114), a “flow transducer 121 is associated with the
irrigation conduit 116, which is capable of determining the actual flow (f) of
the liquid through the irrigation conduit 116” (id. at ll. 48-52). In addition,
“pressure sensor 128 is associated with the irrigation conduit 116, which is
capable of determining the actual pressure (p) in the irrigation conduit 116
or in the body cavity 112” (id. at ll. 45-49). Further downstream, a “first
suction conduit 120 extends from the body cavity 112 to a suction pump
124.” At that point, “liquid is then drained off to a sump (not shown) via
conduit 126 in the direction of arrow 127” (id. at ll. 42-45).
4. Novak teaches that an advantage of the disclosed apparatus over those
disclosed in certain prior art is that “an obstruction in the suction conduit …
may be drawn off by virtue of an automatically increasing higher suction
power of the suction pump” (id. at col. 2, ll. 55-59).
5. Novak also teaches that “in case that the obstruction is such that it
cannot be removed despite the increasing suction power, the power of the
irrigation pump is decreased or even reduced to zero, in order to avoid an
excessive pressure in the body cavity and thereby a risk for the patient” (id.
at col. 3, ll. 28-34; see also ll. 34-36).
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6. Nowosielski discloses a “system and method for providing a
pressurized fluid for irrigating or distending an internal body site or organ
that is accessed … in conjunction with a laparoscope, endoscope,
resectoscope or similar device used to perform a surgical procedure”
(Nowosielski, col. 1, ll. 5-12).
7. Figures 4 and 5 in Nowosielski show the following:

Figure 4 depicts a diagram of an irrigation system, including “by-pass 64”
and “pinch valve 70’ (id. at col. 2, ll. 29-30, col. 4, ll. 15-20). Figure 5
depicts “a cross section of a by-pass section of an alternative embodiment”
(id. at col. 2, ll. 31-32).
8. As taught in Nowosielski, “by-pass 64 provides a fluid path around
the pump 16 to reduce the likelihood of high pressure in the tubing 50 and/or
in the patient’s body” (id. at col. 3, ll. 42-47). The apparatus in Nowosielski
endeavors to “avoid problems due to blockages and pressure irregularities”
(id. at col. 1, ll. 60-63).
9. In relation to Figure 5, Nowosielski teaches that the “size of the
orifice or restriction is selected based upon the known size and resistance in
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the second section of tubing 36 and the desired operating pressure” (id. at
col. 3, l. 63 – col. 4, l. 2). To control operating pressure, “if there is an
obstruction or if the physician turns off the flow at the tool, the amount of
flow back through the by-pass will increase” (id. at col. 4, ll. 8-11).
Principles of Law
The Examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). If the Examiner meets that
initial burden, the burden of coming forward with evidence or argument
shifts to the applicant. In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993).
After the applicant submits such evidence or argument, the PTO then
determines patentability “on the totality of the record, by a preponderance of
evidence with due consideration to persuasiveness of argument.” Oetiker,
977 F.2d at 1445. If the Examiner fails to establish a prima facie case of
unpatentability in the first instance, however, the rejection is improper and
must be reversed. Id.; Rijckaert, 9 F.3d at 1532.
Analysis
The Examiner rejects claims 1-3, 5-16, 18-19, 22-25, 27-29, and 31 as
obvious over Novak in view of Nowosielski (Ans. 3). Appellants assert, and
the Examiner acknowledges, that Novak does not disclose an apparatus
comprising a tube with “a fixed constriction site” located between a fluid
source reservoir and an inflow tube, as recited in claim 1 (App. Br. 5; Ans.
5). As noted by the Examiner, however, the by-pass tubing system
presented in Nowosielski in relation to a similar device corresponds to “a
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tube having a fixed constriction site” provided between a fluid source
reservoir and an inflow tube (Ans. 5, 8; FF 7, 9).
Appellants argue that “Novak cannot function at all if a bypass tube
(such as the bypass tube of Nowosielski) is installed in Novak, as the bypass
tube jeopardizes patient’s safety” (App. Br. 5, 7). Appellants assert that the
arrangement in Novak “works only if the entire fluid pumped by the inflow
pump 114 enters into the body tissue cavity 112 via the inflow tube 116,
which becomes impossible the moment the bypass tube of Nowosielski is
installed into the system of Novak” (id. at 7). According to Appellants,
because “a part of the fluid pumped by the inflow pump 114 constantly
escapes at an unknown variable rate into the bypass,” “the fluid flow rate
sensor 121 is never able to gauge the actual fluid pumped by the pump 114
and, thus, the system of Novak becomes erratic” (id.).
We agree with the Examiner (Ans. 5) that it would have been obvious
at the time the invention was made to a person having ordinary skill in the
art to modify the device of Novak so that it included the by-pass tube of
Nowosielski having a fixed constriction site (FF 7, 9). As stated by the
Examiner, the by-pass tubing of Nowosielski would have provided “the
benefit of providing pressure relief to the system so that pressure in the
tubing will not build up distally of the location of the pump and regulating
the flow by maintaining cavity pressure at a stable value” (Ans. 5). Novak
teaches that in a case where “the obstruction is such that it cannot be
removed despite the increasing suction power, the power of the irrigation
pump is decreased or even reduced to zero, in order to avoid an excessive
pressure in the body cavity and thereby a risk for the patient” (FF 5). In
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other words, Novak teaches avoiding exerting excessive pressure in the body
cavity, which can harm a patient, even if increasing suction power might
help remove an obstruction in certain situations.
Based on teachings in both references, we also conclude that it would
have been obvious to make an embodiment having one end of by-pass “tube
64” in Nowosielski (FF 7) upstream of irrigation pump (114) in Novak (FF
2), and the other end downstream of pump (114) but upstream of “flow
transducer 121” (measuring flow) and “pressure sensor 128” (measuring
pressure) (FF 3). Considering the purpose of the by-pass tube (to avoid
excessive pressure and risk to the patient) (FF 5), it would have made sense
to an ordinary artisan to measure flow and pressure at a point beyond the by-
pass tube but before the liquid reaches the body cavity because, based on
flow and pressure measurements, one would have been able to determine
whether to turn off/down the apparatus, or to use an apparatus having a
different sized “fixed constriction site” in the by-pass tube (FF 5, 8, 9).
As noted by the Examiner, Appellants cite no evidence in support of
the notion that Novak’s apparatus cannot function if one includes a bypass
tube, as taught in Nowosielski (Ans. 9). Appellants have not provided any
evidence that a by-pass tube in this embodiment would prevent one from
controlling the irrigation pump of Novak as a function of a flow rate through
a body cavity, or that a by-pass tube would cause “dangerous pressure
fluctuations” inside a body cavity, as asserted by Appellants (App. Br. 7-8).
Arguments of counsel cannot take the place of evidence in the record. In re
Scarbrough, 500 F.2d 560, 566 (CCPA 1974).
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Appellants assert that one would not have been motivated combine the
tube of Nowosielski with the apparatus of Novak, arguing, for example, that
Nowosielski teaches a system for laparoscopy, not endoscopy, as recited in
claim 1 (App. Br. 5; Reply Br. 3). As found by the Examiner, however,
Nowosielski expressly discloses a system for distending an internal body site
accessed in conjunction with an endoscope (Ans. 10; FF 6).
We also disagree with Appellants that adding a by-pass tube to
Novak’s device would “change the principle of operation” of the apparatus
being modified (App. Br. 7). Contrary to Appellants’ assertions, the “crux
of Novak” is not “removal of an obstruction/blockage” (id. at 8). Rather,
Novak describes an apparatus where “the nominal pressure can be
maintained in a particular exact manner in that the suction power of the
suction pump is increased or reduced as a function of the acquired actual
pressure in order to maintain the predetermined nominal pressure in the body
cavity” (Novak, col. 3, ll. 32-37).
As taught in Novak, in certain cases, one may wish to increase suction
to help remove an obstruction, but in other cases an “obstruction is such that
it cannot be removed despite the increasing suction power” (FF 5). In the
latter situation, the “power of the irrigation pump [can be] decreased or even
reduced to zero, in order to avoid an excessive pressure in the body cavity
and thereby a risk for the patient,” as taught in Nowosielski (id.). Thus, the
addition of a by-pass tube helps “avoid problems due to blockages and
pressure irregularities” and ensure patient safety by preventing excessive
pressure in a body cavity (FF 8).
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Appellants have not convinced us that the addition of such a by-pass
tube would prevent appropriate pressure from building in the tubing, or
prevent the suction pump from operating with increased power when
appropriate (App. Br. 8-9), even if the by-pass tube could help avoid
excessive pressure beyond that needed to safely remove an obstruction. The
“resulting arrangement” would not prevent “the purposeful increase in the
cavity pressure when a blockage occurs” (App. Br. 8), although it could
prevent cavity pressure from going excessively high.
For the reasons discussed above, we conclude that a preponderance of
evidence supports the Examiner’s conclusion that independent claim 1 is
obvious over Novak in view of Nowosielski. Because Appellants do not
argue the claims separately, claims 2, 3, 5-16, 18-19, 22-25, 27-29, and 31
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
II.
Additional Findings of Fact
10. Takamatsu teaches “an irrigation/aspiration apparatus which supplies
an irrigation fluid to a surgical site and aspirates the irrigation fluid
therefrom with residual tissue” (Takamatsu, col. 1, ll. 5-8). In this capacity,
Takamatsu describes a “mechanism which is advantageous to damp out or
absorb pulsations caused by a peristaltic suction pump” (id. at ll. 8-10).
11. Takamatsu discloses that “[i]n the field of ophthalmology, this kind of
apparatus is used,” which includes “a peristaltic pump as a pump for
effecting suction of the residual tissue” (id. at ll. 16-19). The peristaltic
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pump “causes pulsations which result in the disadvantage that the suction
pressure varies” (id. at ll. 19-21).
Analysis
The Examiner rejects claim 30 as obvious over Novak in view of
Nowosielski and further in view of Takamatsu (Ans. 6). As noted by
Appellants, Takamatsu discusses its apparatus in the context of ophthalmic
surgeries, while the “system of Novak is used in endoscopic surgery” (App.
Br. 12). Consistently, Takamatsu does not describe cavity distension or
endoscopy, but instead discloses an apparatus that “supplies an irrigation
fluid to a surgical site and aspirates the irrigation fluid therefrom with
residual tissue” (FF 10).
When supplying fluid to the eye during cataract surgery, Takamatsu
indicates that it is important to damp out or absorb pulsations caused by a
peristaltic suction pump in the apparatus (FF 10, 11). By contrast, Novak
and Nowosielski do not mention pulsations, or that pulsations might be
problematic when irrigating a body cavity, especially in a situation where
one might want to increase suction and pressure as a way to remove an
obstruction during an endoscopic procedure.
Moreover, we agree with Appellants that the “eye is a delicate organ
and cannot withstand distension pressure like some other body cavities,”
such as those subjected to endoscopy (App. Br. 12). Takamatsu provides an
apparatus that carefully controls suction pressure, and prevents pulsations
that might cause pressure to vary. Novak and Nowosielski do not suggest,
on the other hand, that variations in suction pressure caused by pulsations
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generated by a suction pump present a disadvantage during endoscopy of a
tissue cavity, or that damping out pulsations might provide an advantage.
The Examiner cites no specific evidence indicating that an ordinary
artisan would have been motivated to add the pulsation damping component
of Takamatsu to the apparatus of Novak in view of Nowosielski. Thus, the
Examiner has not established by a preponderance of the evidence that claim
30 is obvious over Novak in view of Nowosielski in further view of
Takamatsu.
SUMMARY
We affirm the obviousness rejection of claims 1-3, 5-16, 18-19, 22-25,
27-29, and 31 over Novak in view of Nowosielski. We reverse the
obviousness rejection of claim 30 over Novak in view of Nowosielski and
further in view of Takamatsu.

TIME PERIOD FOR RESPONSE
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-IN-PART

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