Ex Parte Lindsay et al

Patent Trial and Appeal Board

Feb 6, 2013

11245751 (P.T.A.B. Feb. 6, 2013)

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.
11/245,751 10/07/2005 Erin Jessica Lindsay 0097Pa(16977) 5300
46909 7590 02/07/2013
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
ATTN: GAEL DIANE TISACK
6200 JACKSON ROAD
ANN ARBOR, MI 48103
EXAMINER
WIEST, PHILIP R
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
02/07/2013 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 ERIN JESSICA LINDSAY, ARTHUR D. GERSHOWITZ, and
DANIEL W. VIITALA
____________________

Appeal 2010-006034
Application 11/245,751
Technology Center 3700
____________________

Before: JOHN C. KERINS, BRETT C. MARTIN, and
JEREMY M. PLENZLER, Administrative Patent Judges.

PLENZLER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s
decision rejecting claims 1-4 and 6-25. Claim 5 has been cancelled. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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CLAIMED SUBJECT MATTER
Claims 1 and 22 are independent. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. An air removal device for removing air from
blood flowing in a perfusion system, comprising:
a chamber having a blood flow region at a
lower end thereof and having an air collection
region at an upper end thereof, said chamber
further having an inlet, a blood outlet, and an air
outlet vertically higher than said inlet;
a vertical guide structure in said air
collection region;
a float disposed for vertical movement
following said vertical guide structure, wherein
said float has an effective density less than the
density of said blood;
a lever arm having a first end for following
vertical movement of said float and having a
second end pivotally mounted at a pivot point
stationary with respect to said vertical guide
structure;
a valve coupled to said air outlet and to an
intermediate point of said lever arm between said
first and second ends for closing said air outlet
when said float is at its vertically highest position;
and
a vacuum port coupled to said air outlet for
coupling to a vacuum source, such that vacuum
supplied to said air outlet tends to resist downward
motion of said float.

REJECTIONS
1. Claims 1-3, 6-8, and 20-23 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Wright (US 5,429,595; iss. July 4,
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1995), Nuter (US 3,599,659; iss. Aug. 17, 1971), and Tamari (US 6,337,049
B1; iss. Jan. 8, 2002)1;
2. Claim 4 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wright, Nuter, Tamari, and Klaber (US 2,937,014; iss.
May 17, 1960);
3. Claims 9-17, 24, and 25 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Wright, Nuter, Tamari, and Weinstein (US
5,484,474; iss. Jan. 16, 1996); and
4. Claims 18 and 19 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Wright, Nuter, Tamari, and Raneri (US 5,849,186;
iss. Dec. 15, 1998).
OPINION
Claims 1-3, 7, 8, 20, 22, and 23
Claim 1
Claim 1 is directed to an “air removal device for removing air from
blood flowing in a perfusion system” and recites “a float,” “a lever arm
having a first end for following vertical movement of said float,” “a valve
coupled to . . . an intermediate point of said lever arm between said first and
second ends for closing said air outlet when said float is at its vertically
highest position,” and “a vacuum port coupled to said air outlet for coupling
to a vacuum source.” The Examiner cites Wright as teaching each of the
features of claim 1, but notes that “Wright, however, does not specifically
disclose that the float is connected to a lever arm that opens and closes the
air outlet valve, nor does Wright specifically teach the use of a suction

1 Claims 6 and 21 were added as a new ground of rejection in the
Examiner’s Answer. See Ans. 10.
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source [to] assist in the removal of air for the chamber.” Ans. 4. The
Examiner cites Nuter as teaching a lever arm and reasons that
it would have been an obvious engineering choice to one of
ordinary skill in the art at the time of invention to modify the
gas removal device of Wright with the lever arm-actuated air
purge valve of Nuter in order to provide a well-known, alternate
means for opening and closing an outlet valve in response to the
level of fluid inside the device.
Ans. 5-6. The Examiner additionally cites Tamari as teaching vacuum assist
and further reasons that
[i]t would have been obvious to one of ordinary skill in the art
at the time of invention to modify the device of Wright and
Nuter with the vacuum-assisted air purge port of Tamari in
order to enable the air within the air outlet to be evacuated,
thereby improving the speed and efficiency of the air removal.
Doing so would reduce the time the air purge valve would need
to be open and improve the ability of air to be removed from
the chamber.
Ans. 5.
Appellants explain that “[w]hen ball valve 44 is closed [in Wright], a
column of fluid is maintained above ball valve 44 within air exit line 50”
and “[w]hen air enters the chamber, it is the weight of the fluid in air exit
line 50 from the continuous bypass flow that causes ball valve 44 to drop,
thereby opening the ball valve.” App. Br. 6. Appellants contend that “the
inclusion of a lever arm [in Wright] would presumably destroy its operation
since the lever arm would interfere with Wright’s ability to respond to the
weight of the fluid.” Id. However, Appellants do not explain why the lever
arm would necessarily interfere with Wright’s ability to respond to the
weight of the fluid.
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Wright discusses the use of a column of fluid above the valve to
ensure that the valve reopens when the fluid level below the valve is
reduced. See col. 7, ll. 15-19. Wright further explains that “other
mechanical means of continued resistance can be utilized” including
“mechanical spring devices or any other device that can offer resistance and
allow opening of the valve as solution empties in perfusate chamber 12.”
Col. 7, ll. 21-25. A lever arm of the type disclosed in Nuter would be
understood to be an “other mechanical means.” As explained by the
Examiner, “[t]he increased mechanical advantage allows the valve to resist
vacuum forces that result from high pressure differences between the
chamber and its surroundings.” Ans. 12.
Because Appellants have failed to persuasively explain why the lever
arm would necessarily interfere with Wright’s ability to respond to the
weight of the fluid, we are not apprised of Examiner error.
Appellants additionally contend that because “there is no use in Nuter
of vacuum pressure for pulling air through a valve, and therefore no suction
force to be overcome[,] . . . one skilled in the art would not associate the
mechanism of Nuter with the problem of overcoming vacuum pressure.”
App. Br. 6. We disagree. Nuter specifically discusses the use of the lever
arm
over a continuum of design pressure ranges merely by
lengthening the distance between the pivotal connection of the
lower lever arm to the cradle bracket and the pivotal connection
of the metallic float to the free end of the lower lever arm thus
affording a greater mechanical advantage for the higher design
pressure ranges.
Col. 1, ll. 66-71. As the use of suction pressure at the air outlet provides a
different pressure range for the system, we are not convinced that one skilled
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in the art would not look to the mechanism of Nuter to assist in overcoming
vacuum pressure.
Appellants further note that the valve 40 in Nuter “is not attached at a
point on the lever arm between float pin 47 and arm pins 33 or 34; instead it
is at the distal end of lever arm 30 in every embodiment shown.” App. Br. 7.
The Examiner explains that “Figure 4 [of Nuter] illustrates an embodiment
wherein the lever arm comprises a distal end 147 where the floating ball is
attached [and] a hinge point 136 from where the lever arm pivots” with
“[t]he valve activation means 121 [] attached at point 140, which is disposed
horizontally between the distal end and the proximal hinge point (i.e. along
an intermediate point of the lever arm), such that a mechanical advantage is
provided, such that the valve may be opened with maximum torque.” Ans.
13. We agree. In Nuter, point 140 is at a location between horizontal ends
(147, 136) of the lever.
With regard to the Examiner’s modification of Wright to additionally
include vacuum assist based on the disclosure of Tamari, Appellants contend
that “the rejection fails to provide any motivation to combine a vacuum
assist with a lever arm.” Appellants argue that “[t]he rejection fails to
establish any real motivation for combining a lever arm with a float in an air
removal device for a perfusion system as claimed” because “[i]t argues that
speed and efficiency of air removal would be improved, but fails to establish
any reasons why such alleged improvements would have been apparent from
the references without hindsight use of appellant’s disclosure.” App. Br. 7.
The Examiner’s proposed modification includes a substitution of one
known air removal mechanism for another. “[W]hen a patent claims a
structure already known in the prior art that is altered by the mere
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substitution of one element for another known in the field, the combination
must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex, Inc.,
550 U.S. 398, 416 (2007). Wright and Tamari each include an air removal
system for a blood reservoir including an air outlet in an extracorporeal
circuit. A lower pressure (vacuum assist) at the air outlet would further
facilitate removal of air from the within system. Therefore, the Examiner
has a reasonable basis for finding that the vacuum assist of Tamari would
have been a suitable substitute for the air outlet of Wright and has not based
the proposed modifications on impermissible hindsight. Appellants provide
no persuasive reason why a person of ordinary skill in the art could not have
implemented such a substitution or why the results of the substitution would
have been unpredictable.
Appellants further contend that “the fact that elements from one
reference would be contrary to the functioning of another reference with
which the rejection would combine them is an important and relevant point
because it demonstrates the lack of motivation for the alleged combination.”
App. Br. 7. It is unclear which elements (and from which reference)
Appellants consider being contrary to elements of another reference. Based
on Appellants’ arguments, we are not apprised of any contradiction between
the references and, accordingly, are not apprised of any further error by the
Examiner.
For the reasons set forth above, we sustain the rejection of claim 1.
Claims 2, 3, 6-8, 20, and 21 depend from claim 1 and have not been argued
separately. Therefore, claims 2, 3, 6-8, 20, and 21 fall with claim 1.

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Claim 22
Appellants note that “[c]laim 22 is directed to a method corresponding
to the system of claim 1,” “includes essentially the same limitations as are
relied on in responding to the rejection of claim 1,” and “is allowable for the
same reasons.” App. Br. 8. We disagree for the reasons set forth above.
Accordingly, we sustain the rejection of claim 22. Claim 23 depends
from claim 22 and has not been argued separately. Therefore, claim 23 falls
with claim 22.

Claim 4
Appellants rely on the dependence from claim 1 for the patentability
of claim 4, and maintain that the additional Klaber reference fails to correct
alleged deficiencies in the references cited in rejecting claim 1. App. Br. 8.
Because we disagree that those references are deficient in rendering claim 1
unpatentable, as discussed above, we sustain the rejection of claim 4.

Claims 9-17, 24, and 25
Claims 9-17
Claim 9 depends from claim 1 and additionally recites “an arcuate
manifold providing an arcuate blood flow path outside of said portion of said
chamber having an upstream end and a downstream end” with “a slit
aperture between said arcuate manifold and said portion of said chamber.”
The Examiner acknowledges that “Wright, Tamari, and Nuter . . . do not
specifically disclose that the blood inlet comprises an arcuate manifold
having a slit aperture.” Ans. 8. The Examiner finds that Weinstein teaches
“an arcuate flow path 34” and “[a] slit aperture (the opening between the
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arcuate flow path 34 and the chamber 12)” and reasons that “it would have
been obvious . . . to modify the device and method of Wright, Tamari, and
Nuter with the arcuate manifold and slit aperture . . . in order to improve the
separation of gas and blood within the manifold.” Ans. 9.
Appellants contend that “the toroidally-shaped housing cover 14 of
Weinstein does not provide an arcuate flow path outside the cylindrical
chamber, nor is it joined to the chamber by a slit aperture as recited in claim
9.” Ans. 8-9. The Examiner has provided a broad, but reasonable,
interpretation of the arcuate manifold and slit aperture recited in claim 9.
Appellants have not provided any argument regarding why the Examiner’s
characterization of the “arcuate manifold” and “slit aperture” in Weinstein is
incorrect. Thus, we are not apprised of Examiner error and we sustain the
rejection of claim 9.
Claims 11, 13, 16, and 17 each depend from claim 9. Claims 11 and
13 each recite the arcuate manifold including a channel defining an end
ramp. Claim 16 recites that “said arcuate manifold has a cross-sectional area
that is generally decreasing from said upstream end to said downstream end”
and claim 17 recites “said arcuate manifold comprises a channel having a
depth that generally decreases from said upstream end to said downstream
end.” The Examiner finds that Weinstein teaches that “[t]he channel of the
arcuate manifold has a depth that decreases from the inlet end to the outlet
end, thereby forming an end ramp.” Ans. 8; see also Weinstein, Figures 2
and 4. Again, Appellants simply contend that these features are not present
in Weinstein and have not provided any argument regarding why the
Examiner’s characterization of the “arcuate manifold” and corresponding
channel features in Weinstein is incorrect. App. Br. 9. Thus, we are not
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apprised of Examiner error and we sustain the rejection of claims 11, 13, 16,
and 17.
Claims 10, 12, 14, and 15 depend from claim 9 and have not been
argued separately. Thus, claims 10, 12, 14, and 15 fall with claim 9.

Claims 24 and 25
Appellants rely on the dependence from claim 22 for the patentability
of claims 24 and 25. Appellants do not contend that Weinstein corrects any
alleged deficiencies in the references cited in rejecting claim 22. App. Br. 9.
Because we disagree that those references are deficient in rendering claim 22
unpatentable, as discussed above, we sustain the rejection of claims 24 and
25.
Claims 18 and 19
Appellants rely on the dependence from claim 1 for the patentability
of claims 18 and 19, and maintain that the additional Raneri reference fails
to correct alleged deficiencies in the references cited in rejecting claim 1. Id.
Because we disagree that those references are deficient in rendering claim 1
unpatentable, as discussed above, we sustain the rejection of claims 18 and
19.
DECISION
We AFFIRM the Examiner’s decision to reject claims 1-4 and 6-25.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED
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