Ex Parte Krivitski et al

Patent Trial and Appeal Board

Jul 31, 2013

11370721 (P.T.A.B. Jul. 31, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte NIKOLAI KRIVITSKI and
NAVEEN THURAMALLA
____________

Appeal 2012-002102
Application 11/370,721
Technology Center 3700
____________

Before ERIC GRIMES, LORA M. GREEN, and ULRIKE W. JENKS,
Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal
1
under 35 U.S.C. § 134 involving claims directed to
a method of determining cardiac output by measuring blood parameters in an
extracorporeal closed fluid system. The Examiner has rejected the claims as
lacking written descriptive support, anticipation, and obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm the prior art rejections.

1
Appellants state that the real party in interest is Transonic Systems, Inc.
(App. Br. 2).
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STATEMENT OF THE CASE
Claims 1-27 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief (App. Br. 32-39). Claims 1, 22, and 25 are illustrative of
the claims on appeal, and read as follows (emphasis added):
1. A method for determining cardiac output comprising the
steps of:
a) establishing an extracorporeal closed fluid circuit
between an arterial cannula and a venous cannula in a patient;
b) establishing a constant fixed flow of blood through the
extracorporeal closed fluid circuit from the arterial cannula to
the venous cannula, using a pump;
c) injecting an indicator intravenously;
d) taking a reading of a blood parameter in the
extracorporeal closed fluid circuit after the indicator has flowed
at least once through the cardiopulmonary circulatory system of
the patient to which the arterial and venous cannula are
attached; and
e) determining cardiac output from the read blood
parameter independent of the constant fixed flow of blood
through the extracorporeal fluid circuit.
22. A system for determining cardiac flow in a patient
comprising:
a) a closed fluid circuit connecting an arterial cannula
and a venous cannula in a patient;
b) a least one sensor on the closed fluid circuit positioned
to sense a physical parameter of a fluid flowing in the closed
fluid circuit from the arterial cannula to the venous cannula, the
physical parameter corresponding to passage of an indicator
through a cardiopulmonary circulatory system of the patient;
c) at least one closable access port on the closed fluid
circuit, the access port configured to allow fluid access to the
closed fluid circuit;
d) at least one flow regulator to establish a constant fixed
flow of blood through the closed fluid circuit; and
e) a processor connected to the at least one sensor
configured to receive signals from the at least one sensor and
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determine cardiac flow when blood flows from the arterial
cannula to the venous cannula with the indicator that has been
injected into the at least one closable access port and passed at
least once through the cardiopulmonary circulatory system of
the patient.
25. A method of determining a cardiac output of a patient, the
method comprising:
(a) establishing a predetermined constant flow in a closed
extracorporeal circuit withdrawing blood from an arterial
portion of a patient cardiopulmonary system and returning the
withdrawn blood to a venous portion of the patient
cardiopulmonary system; and
(b) determining a cardiac output of the patient
independent of the predetermined constant flow, the cardiac
output corresponding to a sensed change in a blood parameter
in the closed extracorporeal circuit, the sensed change resulting
from a dilution indicator passing through the patient
cardiopulmonary system and a portion of the dilution indicator
passing into the closed extracorporeal circuit.
The Examiner has rejected the claims as follows:
I. claims 1, 3, 22, and 27 under 35 U.S.C. § 112 first paragraph as
lacking written descriptive support;
II. claim 25 under 35 U.S.C. § 102(e) as being anticipated by
Krivitski;
2

III. claims 1-21 and 26 under 35 U.S.C. § 103(a) as being
unpatentable over Krivitski and Mohl;
3

IV. claims 22-24 and 27 under 35 U.S.C. § 103(a) as unpatentable
over Krivitski in view of Buckberg
4

2
Nikolai M. Krivitski et al., US 2004/0158133 Al, published Aug. 12, 2004.
3
Werner Mohl, US 6,506,146 Bl, issued Jan. 14, 2003.
4
Gerald D. Buckberg et al., US 5,011,469, issued Apr. 30, 1991.
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I. The Issue: New Matter
The Examiner takes the position that the Specification does not
provide support for the limitations of “constant fixed flow” or “independent
of constant fixed flow of blood” (Ans. 5). Furthermore, the Examiner takes
the position that “[a] standard rate does not equate to constant or fixed” (id.
at 11).
Appellants contend that “the original disclosure stated the pump
caused the blood to flow at a predetermined rate. Appellant respectfully
submits such disclosure is sufficient to reasonably convey to one of ordinary
skill in the art that the blood flow in the extracorporeal circuit was a constant
fixed rate.” (App. Br. 14.)
The issue is: Has the Examiner shown that the disclosure as originally
filed does not provide descriptive support for the limitation of “constant
fixed flow”?
Findings of Fact
FF 1. Original claim 3 provides “wherein the step of establishing the
regulated blood flow comprises the step of starting a pump to cause the
blood to flow at a predetermined rate.” (Spec. 17-18.)
FF 2. The Specification provides that cardiac output is calculated
based on the following equation:

“Q represents the rate of cardiac output, V represents the volume of the
indicator and S represents the area under the dilution curve.” (Spec. 8-
9: ¶ 0026.)
FF 3. The Specification also provides, as a preferred embodiment, the
following equation:
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Q, V, and S are the same as above (FF 2). “K is a calibration constant
designed to relate the voltage signal received from the sensor to the
concentration of indicator in the blood as it passes the sensor.” (Spec.
10: ¶ 0028.)
Analysis
With respect to the limitation “constant fixed flow” we agree with the
Appellants‟ position that the original disclosure of setting the pump to a
predetermined flow provides descriptive support for the presently claimed
recitation of “constant fixed flow.” While the Examiner is correct that the
specific language of the claims was not disclosed ipsis verbis in the
Specification, ipsis verbis support is not required. Fujikawa v. Wattanasin,
93 F.3d 1559, 1570 (Fed. Cir. 1996). Here, the Specification as originally
filed recites setting the blood flow to a predetermined rate. Furthermore,
Appellants contend that the disclosed dilution principles support and are
consistent with constant flow as recited in the claims (App. Br. 15).
Appellants assert that one of ordinary skill in the art would “immediately
recognize this equation implies a regulated – constant – flow” (id.). Given
the totality of the disclosure (FFs 1-3) we agree with Appellants that the
Specification sufficiently supports the “constant fixed flow” limitation as
recited in the pending claims.
With respect to the limitation “independent of the constant fixed flow
of blood,” Appellants contend that the Specification provides “three
examples of determining cardiac output independent of the flow rate through
the extracorporeal circuit.” (App. Br. 19.) Appellants point to three
equations in the Specification as providing descriptive support for
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determining cardiac output independent of the constant fixed flow rate (App.
Br. 17-19). According to Appellants the same equation that provides
support to establish constant fixed flow through the extracorporeal circuit, Q
= V/S (FF 2; App. Br. 15), also provides support for the limitation
“independent of the constant fixed flow of blood.” Appellants are correct
that literally these equations as written do not list flow volume as one of the
measured parameters (FFs 2-3). As the equations do not list flow volume as
one of the measured parameters, it appears that these equations are
seemingly independent of flow parameters. The Examiner reiterates “that
the term regulated is not an equivalent term to constant fixed” and that “[a]
standard rate does not equate to constant fixed.” (Ans. 11.) What is missing
from the Answer, however, is an explanation from the Examiner as to why
Appellants‟ reliance on these equations would not provide descriptive
support for the claimed limitation of “independent of the constant fixed flow
of blood.” Accordingly, the Examiner has not shown that the Specification
fails to sufficiently support the “independent of constant fixed flow of
blood” limitation as recited in the pending claims.
We reverse the new matter rejections.

II. The Issue: Anticipation of Claim 25 by Krivitski
Claim 25 is directed to a method of determining cardiac output similar
to that of claim 1, except that claim 25 does not require allowing the
indicator to pass at least once through the patient‟s cardiopulmonary system
before assessing a change in a blood parameter. The Examiner takes the
position that “Krivitski discloses a method for determining cardiac output
including the steps of establishing an extracorporeal closed fluid circuit
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between an arterial cannula and a venous cannula in a patient.” (Ans. 5.)
An extracorporeal circuit is established in a “tubing system where blood
flows, as well as disclosed as usable with dialysis which also meets the
claim limitation of creating a constant flow in a closed fluid circuit.” (Id. at
11.)
The issue is: Does the preponderance of the evidence of record
support the Examiner‟s finding that Krivitski anticipates claim 25?
Findings of Fact
FF 4. Krivitski disclosed a method comprising “connecting an arterial
tubing portion of a dialysis system to withdraw blood from a patient and
connecting a venous tubing portion of the dialysis system to deliver filtered
blood to the patient.” (Krivitski, 6: claim 1.)
FF 5. Krivitski disclosed that “[d]ialysis machines of some brands
turn ultrafiltration off during dialysis session several times to conduct
internal self-calibration. Advantageously, these self-calibrating procedures
can be used for calibration of the sensitivity optical probe to the relative
concentration change.” (Krivitski, 4-5: ¶ 0069.)
FF 6. Krivitski disclosed that cardiac output may be determined by
dilution technique measuring photometric properties:
The measurement may be made in an extracorporeal blood
system in which optical measuring probes are secured, for
example, to tubing leading to exterior blood treatment
equipment such as hemodialysis machine, extracorporeal
artery-vein passive shunt, or the like. Thereafter, a bolus, or
known volume, of an indicator material is injected into the
bloodstream, and measurements are made of changes in the
photometric properties of the blood to determine the passage of
the bolus past the optical probe 10.
(Krivitski, 5: ¶ 0074; Ans. 6.)
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FF 7. Krivitski disclosed that cardiac output of a patient‟s heart may
be calculated as follows:

CO is the cardiac output; “Vind is total volume of injected indicator; Sb-ind is
the area under a dilution curve representing the total optical density changes
in the blood column over a time period; and Ks is the calibration coefficient
for a particular set of tubing and probe” (Krivitski, 5: ¶¶ 0077-0078;
Ans. 6).
FF 8. The Examiner finds that “Krivitski teaches that an
extracorporeal circuit is established in the prior art of record as can be seen
in paragraphs 0020-0021 where there is tubing system where blood flows, as
well as disclosed as usable with dialysis which also meets the claim
limitation of creating a constant flow in a closed fluid circuit.” (Ans. 11.)
FF 9. The Examiner finds that “Krivitski inherently uses a pump in
the device in order to maintain the system as it is used to provide dialysis to
patients, and provides a constant fixed flow.” (Ans. 11-12.)
Principle of Law
To anticipate a reference must expressly or inherently disclose “within
the four corners of the document not only all of the limitations claimed but
also all of the limitations arranged or combined in the same way as recited in
the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371
(2008).
Analysis
Appellants contend that Krivitski does not disclose each and every
element of the claim. Specifically, that Krivitski does not disclose
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“„establishing a predetermined constant flow in a closed extracorporeal
circuit.‟” (App. Br. 22.)
We are not persuaded by Appellants‟ contention that Krivitski does
not disclose all the limitations of claim 25. The Examiner reasons that
Krivitski disclosed a tubing system “usable with dialysis which also meets
the claim limitation of creating a constant flow in a closed fluid circuit”
(FF 8). The Examiner concluded that a dialysis system inherently provides
constant flow (FF 9) and thereby meets the claim limitation of
“predetermined constant flow” as required by claim 25. See In re Best, 562
F.2d 1252, 1254-55 (CCPA 1977):
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to
require the applicant to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.
… Whether the rejection is based on “inherency” under 35
U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. §
103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO's inability to
manufacture products or to obtain and compare prior art
products.
Appellants have not provided persuasive rebuttal evidence that the
system of Krivitski, used to provide dialysis to a patient, would not provide a
“predetermined constant flow” as found by the Examiner (Ans. 11).
The Examiner‟s finding of inherency for the “predetermined constant
flow” limitation is additionally supported by the finding that Krivitski
disclosed the use of a closed extracorporeal circuit for “determining cardiac
output from [a] measured blood parameter” (Ans. 5). As the Examiner
points out, Krivitski disclosed that the cardiac output of a patient can be
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calculated based on the total volume of the injected dilution indicator (Ans.
6; FF 6), by using the area under the dilution curve in conjunction with the
use of a calibration coefficient for a particular tubing (FFs 6, 7).
Here, Krivitski calculates the cardiac output using the same measured
parameters and equations (FFs 6-7) as those disclosed in the Specification
(FFs 2-3). Appellants concede that the examples and methods of calculating
cardiac output as disclosed in the Specification (FFs 2-3) using the equation
the equation Q= V/S provides support for the limitation of “determining
cardiac output of the patient independent of the predetermined flow through
the extracorporeal system” (App. Br. 19), and that one “of ordinary skill in
the art would immediately recognize this equation (FF 2) implies a regulated
- constant – flow” (id. at 15, see also Reply Br. 3). Krivitski uses essentially
the same equation to determine cardiac output (FF 7), thus, the reference
disclosed “constant flow.”
The “very essence of inherency is that one of ordinary skill in the art
would recognize that a reference unavoidably teaches the property in
question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366,
1383 (Fed. Cir. 2009) (emphasis added). Based on the evidence, we find
that the Examiner has met the burden of presenting a prima facie case of
anticipation. We affirm the rejection of claim 25.

III. The Issue: Obviousness over Krivitski in view of Mohl
The Examiner takes the position that Krivitski disclosed methods of
determining cardiac output by
calculating blood flow using the equation Q=KV/S wherein Q
represents cardiac blood flow, V represents the amount of
indicator injected, K equals a calibration coefficient and S is
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representative of the integral of the time rate of change (area
under a dilution curve) in concentration of blood to indicator
(saline solution) injected when the indicator is detected as
present in the blood.
(Ans. 6.) The Examiner concedes that Krivitski fails to specifically recite a
pump, however, the Examiner finds that “Krivitski inherently uses a pump in
the device in order to maintain the system as it is used to provide dialysis to
patients, and provides a constant fixed flow” (id. at 11-12). The Examiner
relies on Mohl “to positively claim the use of a pump within a [blood flow]
system” (id. at 12).
The issue is: Does the preponderance of evidence of record support
the Examiner‟s conclusion that the combination of Krivitski and Mohl
renders the claims obvious?
Principle of Law
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of
the references would have suggested to those of ordinary skill
in the art.
In re Keller, 642 F.2d 413, 425 (CCPA 1981).
Analysis
Appellants assert that Mohl teaches away from the combination with
Krivitski because it would lead one of ordinary skill in the art to use
“variable flow as opposed to the claimed constant fixed” flow in the
combined device leaving the device inoperable. (Reply Br. 8.)
We are not persuaded. The Examiner finds that “Krivitski inherently
uses a pump in the device in order to maintain the system as it is used to
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provide dialysis to patients, and provides a constant fixed flow” (Ans. 11-12;
FFs 4-7). See In re Best, 562 F.2d at 1254-55. Appellants have not provided
persuasive rebuttal evidence that the system of Krivitski, used to provide
dialysis to a patient, would not provide constant flow through the use of a
pump as found by the Examiner.
The Examiner‟s finding of inherency for the limitation of
“predetermined constant flow” is also supported by the finding that Krivitski
calculates cardiac output using the general formula CO = K ∙ V/S (FF 7)
where CO is cardiac output. Appellants concede that the examples and
methods of calculating cardiac output as disclosed in the Specification (FFs
2-3) using the equation the equation Q = K ∙ V/S not only shows constant
flow; the same equation also provides support for the limitation
“independent of the constant fixed flow” (App. Br. 18), and also that one “of
ordinary skill in the art would immediately recognize this equation (FF 2)
implies a regulated - constant – flow” (id. at 15, see also Reply Br. 3).
Krivitski uses this same equation to determine cardiac output (FF 7), thus,
the reference disclosed the limitations of “constant fixed flow” and
“independent of the constant fixed flow.”
The Examiner looks to Mohl for the positive recitation of using a
pump in an extracorporeal blood flow system (Ans. 12). Even though Mohl
is primarily directed to providing extracorporeal blood flow on a
discontinuous or pulsed basis, Mohl also provides for continuous flow by
suggesting “optionally one continuously conveying external suction means
or pump being used” (Mohl, col. 3, ll. 13-14). We find that Mohl disclosed
the use of a pump in an extracorporeal circulatory system that can be
configured to run continuously. The Examiner finds that Krivitski
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inherently uses a pump in the device (Ans. 11-12; see also FF 5). The mere
substitution of one pump for another pump would be obvious to one of
ordinary skill in the art. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). Appellants have not pointed to any persuasive evidence that
suggests that dialysis systems generally, or specifically the system of
Krivitski, does not utilize a pump for the blood filtration process.
We are also not persuaded by Appellants‟ contention that Mohl
teaches away from the combination. Mohl not only suggests applying
variable flow to the extracorporeal system but also optionally provides for
continuous flow by conveying continuous external suction or pump (Mohl,
col. 3, ll. 13-14). It is well settled that disclosed examples and preferred
embodiments do not constitute a teaching away from a broader disclosure or
even non-preferred embodiments. See In re Susi, 440 F.2d 442, 446 n.3
(CCPA 1971).
We find that the preponderance of the evidence of record supports the
Examiner‟s conclusion of obviousness and we affirm the rejection of claim 1
under 35 U.S.C. § 103(a) over Krivitski in view of Mohl. As claims 2-21
and 26 have not been argued separately, they fall together with claim 1. 37
C.F.R. § 41.37(c)(1)(vii).

IV. The Issue: Obviousness over Krivitski in view of Buckberg
Claim 22 is directed to a system comprising components suitable for
carrying out a method like that of claim 1; claim 22 additionally requires a
“closable access port” and a “flow regulator.” The Examiner takes the
position that “Krivitski [disclosed] a system for a closed fluid circuit
between an arterial cannula and a venous cannula in a patient . . . but fails to
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teach a flow regulator to establish and regulate the flow of blood through the
closed circuit.” (Ans. 9.) “Buckberg teaches a regulated flow of blood
through the closed circuit from the arterial cannula to the venous cannula . . .
using a flow regulator.” (Id. at 10.) The Examiner finds that “Krivitski
inherently uses a pump in the device in order to maintain the system as it is
used to provide dialysis to patients, and provides a constant fixed flow.
Buckberg is relied upon to show that it is known to use a flow regulator
within an extracorporeal system and not used to illustrate a constant fixed
flow.” (Id. at 12.)
The issue is: Does the preponderance of evidence of record support
the Examiner‟s conclusion that the combination of Krivitski and Buckberg
renders the claims obvious?
Findings of Fact
FF 10. Buckberg disclosed a peripheral cardiopulmonary bypass
system. “The peristaltic pump 118 is desirable in that the pumping
mechanism does not actually contact the blood, thus eliminating a source of
contamination and allowing reuse of the pump.” (Buckberg, col. 12, ll. 7-
10; Ans. 10.)
FF 11. Buckberg disclosed that:
To accommodate possible fluctuations in the volume of
the flow required, and to regulate the blood volume of the
patient, a reservoir, preferably compliant, is provided bridging
the pump, with an inlet to the reservoir being connected to the
pump outlet, and an outlet from the reservoir being connected
between the venous catheter connection and the pump. Inflow
and outflow valves in the connections permit circulating blood
volume and therefore blood flow rates to be controlled.
(Buckberg, col. 4, ll. 33-41.)
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Analysis
Appellants assert that “Krivitski is recognized as failing to disclose
the constant flow through the extracorporeal circuit, and Buckberg does not
cure this deficiency.” (App. Br. 28.) “[D]etermining a cardiac output
cannot be predicated upon bypassing all the blood flow around the heart, and
then attempting to measure cardiac output.” (Id. at 29.) Appellants assert
that “neither of the cited references disclose or suggest the limitation of
„establishing a constant fixed flow through the closed fluid circuit.‟” (Id. at
30.)
We are not persuaded. The Examiner finds that “Krivitski inherently
uses a pump in the device in order to maintain the system as it is used to
provide dialysis to patients, and provides a constant fixed flow” (Ans. 11-12;
FFs 4-7). See In re Best, 562 F.2d at 1254-55. Appellants have not provided
persuasive rebuttal evidence to show that the system of Krivitski, used to
provide dialysis to a patient, would not provide constant flow through the
use of a pump found by the Examiner.
The Examiner‟s finding of inherency for the limitation of “constant
fixed flow” is further supported in that Krivitski teaches two major ways of
calibrating a conventional hemodialysis system. One such method relies on
the dilution method (FFs 5-7) and the other relies on changing the rate of
ultrafiltration by a known amount. “When the ultrafiltration rate is altered,
the venous flow rate becomes greater by ultrafiltration rate change QUF. The
change in the ultrafiltration rate produces a decreasing hemoglobin
concentration.” (Krivitski 4: ¶ 0061.) The ability to change the flow
through the ultrafiltration system further supports the Examiner‟s position
that Krivitski inherently discloses a dialysis system having a pump. In
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addition, the Examiner finds that Krivitski calculates cardiac output using
the general formula CO = K ∙ V/S (FF 7) where CO is cardiac output. As
conceded by Appellants, the general formula Q= K ∙ V/S shows constant
flow (App. Br. 15-19). Because Krivitski‟s cardiac output calculation relies
on constant fixed flow (FF 7) in conjunction with an extracorporeal circuit
(FF 4), we are not persuaded by Appellants‟ contentions that the references
do not disclose the limitation “constant fixed flow.”
We agree with the Examiner‟s finding that Buckberg disclosed the use
of a pump (FF 10) as well as the use of flow regulators (FF 11) to control the
blood flow in a closed extracorporeal circuit. Buckberg disclosed the use of
a peristaltic pump and teaches that the use of such a pump is desirable
because the pumping mechanism does not make direct contact with blood
and therefore the pump can be utilized multiple times without the fear of
contamination (FFs 10-11).
“The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference,” but what the combined teachings of the references suggest. In re
Keller, 642 F.2d at 425. The Examiner relies on Krivitski for teaching an
extracorporeal circuit and measuring cardiac output while “Buckberg is
relied upon to show that it is known to use a flow regulator within an
extracorporeal system and not used to illustrate a constant fixed flow.”
(Ans. 12.) We are not persuaded by Appellants‟ contention that the
combination does not teach “a constant fixed flow of blood though the
extracorporeal closed fluid circuit” (App. Br. 30) because we agree with the
Examiner‟s finding that Krivitski provides this limitation by calculating the
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cardiac output using the general formula CO = K ∙ V/S (FF 7) in the closed
extracorporeal dialysis system (FF 4).
We find that the preponderance of the evidence of record supports the
Examiner‟s conclusion of obviousness and we affirm the rejection of claim
22 under 35 U.S.C. § 103(a) over Krivitski in view of Buckberg. As claims
23, 24, and 27 have not been argued separately, they fall together with claim
22. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We reverse the rejection of claims 1, 3, 22, and 27 under 35 U.S.C.
§ 112 first paragraph as lacking written descriptive support.
We affirm the rejection of claim 25 under 35 U.S.C. § 102(e) as being
anticipated by Krivitski.
We affirm the rejection of claims 1-21 and 26 under 35 U.S.C. §
103(a) as being unpatentable over Krivitski and Mohl.
We affirm the rejection of claims 22-24 and 27 under 35 U.S.C. §
103(a) as unpatentable over Krivitski in view of Buckberg.
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

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