Ex Parte Paolini et al

Board of Patent Appeals and Interferences

Jul 10, 2009

10500324 (B.P.A.I. Jul. 10, 2009)

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.
10/500,324 06/28/2004 Francesco Paolini 07552.0031 8942
22852 7590 07/13/2009
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON, DC 20001-4413
EXAMINER
WIEST, PHILIP R
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
07/13/2009 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 FRANCESCO PAOLINI, FRANCESCO FONTANAZZI, and
MASSIMO ZACCARELLI
__________

Appeal 2009-002683
Application 10/500,324
Technology Center 3700
__________

Decided:1 July 10, 2009
__________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and STEPHEN
WALSH, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
and apparatus for extracorporeal blood treatment. The Examiner has

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
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rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification discloses control equipment and control methods
that regulate temperature in extracorporeal blood circuits.
Claims 26 and 28-50 are on appeal. Claims 26 and 45 are
representative and read as follows:
Claim 26: An apparatus for control of an extracorporeal blood circuit
connected to a blood purification machine, said extracorporeal blood circuit
comprising
an access branch, having one end connected to at least one blood
treatment element inlet and another end connected to a patient,
a return branch, having one end connected to an outlet of said at least
one blood treatment element and another end connected to a patient;
said apparatus comprising:
a sensor located in the access branch upstream of all blood treatment
elements for measuring a first temperature of blood leaving a patient along
the access branch upstream of said at least one blood treatment element;
a temperature regulating device for regulating said blood temperature
in the extracorporeal blood circuit, said temperature regulating device
comprising a line conveying a fluid, said line being coupled to a portion of
the return branch downstream of all blood treatment elements to form a heat
exchanger directly before blood is returned to the patient;
and a control unit connected to said temperature regulating device for
controlling the blood temperature by controlling the temperature of the fluid
conveyed in said line as a function of said first temperature and of a
reference temperature.

Claim 45: [A control method for an extracorporeal blood circuit for
the circulation of blood in a blood purification machine, the extracorporeal
blood circuit comprising
an access branch and a return branch, said access branch and return
branch being connected to at least one blood treatment element,
the control method comprising the steps of:
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connecting the access branch to a patient and to an inlet of said blood
treatment element;
connecting the return branch to the patient and to an outlet of said
blood treatment element;
measuring a first temperature of the blood in correspondence of said
access branch upstream of all blood treatment elements; and
regulating a blood temperature in the extracorporeal blood circuit as a
function of the first temperature and of a reference temperature, the blood
temperature in the extracorporeal blood circuit being regulated along a
portion of the return branch and downstream of all blood treatment elements,
directly before blood is returned to the patient,
wherein a fluid is conveyed along said temperature regulating device,
said fluid having a fluid temperature that varies within a specified range
about 37° C,]
wherein blood is conveyed along the extracorporeal blood circuit by
means of a pump, a state of operation of the pump being detected, the fluid
temperature being regulated as a function of the first temperature and of the
reference temperature, and the fluid temperature being kept equal to the
reference temperature when the pump is not in operation.

OBVIOUSNESS
Issue
The Examiner has rejected claims 26 and 28-50 under 35 U.S.C.
§ 103(a) as being obvious in view of Weitzel,2 Polaschegg,3 and Derek.4
Claim 45 was argued separately. Claims 28-44 and 46-50 have not been
argued separately and therefore stand or fall with claim 26. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner finds that Weitzel discloses an extracorporeal blood
circuit apparatus that comprises an access branch, a return branch, and a

2 Weitzel et al., US 6,561,997 B1, May 13, 2003
3 Polaschegg, US 4,894,164, Jan. 16, 1990
4 Derek et al., US 6,582,387, June 24, 2003
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blood treatment element, and that allows for precise control over fluid
temperature in the circuit (Ans. 4). The Examiner also finds that Weitzel
discloses a heat exchanger that “functions to keep the blood at a
physiological temperature” (id.).
The Examiner finds that Polaschegg discloses “a blood treatment
apparatus comprising a temperature sensor 206 located in the access branch
220 and upstream of all blood treatment devices” (id.). The Examiner
concludes that “it would have been obvious to one skilled in the art … to
combine the apparatus of Weitzel et al. with the temperature sensor
placement of Polaschegg in order to measure the true temperature of blood
leaving the body for use as a reference temperature for controlling the heat
exchanger 8” (id. at 4-5).
The Examiner finds that Derek “discloses a blood treatment apparatus
wherein a heat exchanger may be placed within the return tube …, which is
downstream of all blood treatment elements” (id.). The Examiner concludes
that “it would have been obvious to one skilled in the art … to modify the
blood treatment apparatus of Weitzel et al. with the heat exchanger
placement of Derek et al. in order to minimize temperature change before
blood reenters the body” (id.).
Appellants contend that the Examiner erred in finding that the cited
references suggest a heat exchanger downstream of all blood treatment
elements, and directly before blood is returned to the patient, that regulates
the blood temperature as a function of temperature in the access branch and
a reference temperature (Appeal Br. 17). Appellants also contend that the
Examiner erred in finding that one of skill in the art would have been
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motivated to combine the cited references to arrive at the invention of claim
26 (id. at 21).
The issues presented are: Does the evidence of record support the
Examiner’s findings that (i) the cited references suggest a heat exchanger
downstream of all blood treatment elements and directly before blood is
returned to the patient that regulates the blood temperature as a function of
temperature in the access branch and a reference temperature and (ii) that
one of skill in the art would have been motivated to combine the cited
references to arrive at the invention of claim 26?
Findings of Fact
1. Weitzel discloses “extracorporeal circuits for use in treating a body
fluid … adapted to provide precise control of flow rate, temperature, and
pressure through the circuit” (Weitzel, col. 1, ll. 51-54).
2. Weitzel discloses that the body fluid may be blood (id. at col. 4, ll.
40-42).
3. Weitzel discloses that the circuit comprises “an inlet for receiving
a body fluid from a patient, a first pump, a first treatment device for
processing the body fluid, a second pump, an outlet for returning processed
body fluid to the patient and a shunt” (id. at col. 1, l. 65 to col. 2, l. 3).
4. Weitzel’s circuit also includes a heat exchanger upstream of the
treatment device (id. at col. 6, ll. 11-14).
5. Weitzel discloses that the “heat exchanger can be … a water bath
at least partially surrounding any portion of the intake line” (id. at col. 6, ll.
19-21).
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6. Polaschegg discloses an apparatus “for treating blood in an
extracorporeal circuit for hemodialysis or hemofiltration and a method …
for withdrawing heat from blood in an extracorporeal circuit wherein blood
is brought into contact along a membrane with a treatment solution which
has been heated to a temperature” (id. at col. 3, ll. 5-11).
7. Polaschegg discloses that “the blood temperature, which correlates
to the body temperature of the patient, is measured and compared with a
predetermined value or a number of predetermined values, the temperature
of the dialysis solution or the substitution solution being adjusted in
accordance with the comparison result” (id. at col. 3, ll. 16-21).
8. Polaschegg’s apparatus includes a temperature sensor 206
upstream of all blood treatment elements (id. at col. 7, l. 1; Fig. 1).
9. Polaschegg discloses that “[i]f only one temperature sensor 206 is
disposed in the extracorporeal blood circuit the arterial blood temperature
thereof is taken as reference temperature for the evaluating and control unit
208” (id. at col. 7, ll. 1-4).
10. Polaschegg discloses that “[i]f a temperature sensor 207 is
additionally disposed in the venous blood path of the extracorporeal circuit
the difference between the arterial temperature sensor 206 and venous
temperature sensor 207 can also be selected as reference value” (id. at col. 7,
ll. 4-8).
11. Polaschegg discloses that
evaluating and control unit 208 receives the signals of the
temperature sensors 206 and 207 and a signal from the blood
pump 201 proportional to the blood pump flow. A signal line
leads … to the temperature regulating unit 106. … The
temperature of the dialysis solution or substitution solution is
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thereby raised or lowered to a temperature value calculated by
the evaluating and control unit 208.
(Id. at col. 7, ll. 10-19.)
12. Polaschegg discloses that the “flowing past of the two media
dialysis solution and blood plasma results in an exchange of heat taking
place in the dialyzer. . . . The body temperature of the patient or his blood
temperature is brought to a normal value or a value selected by the
physician.” (Id. at col. 7, ll. 22-24.)
13. Derek discloses a system that “is adapted to withdraw blood from
a patient, combine the blood with a[n] oxygen-supersaturated physiologic
fluid, and deliver the oxygen-enriched blood back to the patient” (Derek,
col. 7, ll. 56-59).
14. Derek discloses that
if it is desirable to control the temperature of the incoming
blood in the draw tube 34 or the outgoing gas-enriched blood in
the return tube 50, an appropriate device, such as a heat
exchanger, may be operatively coupled to one or both of the
tubes 34 and 50. Indeed, not only may the heat exchanger (not
shown) be used to warm the fluid as it travels through the
system 10, it may also be used to cool the fluid.

(Id. at col. 10, ll. 4-14).
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15. Figure 2 of Derek is shown below:

Figure 2 shows a block diagram of a system for producing gas-
enriched fluid (id. at col. 5, ll. 30-33).
16. Derek discloses that the “blood is pumped through the draw tube
34 in the direction of the arrow 52 into an oxygenation device 54” (id. at col.
8, ll. 53-54) and the “oxygen-enriched blood is taken from the third chamber
64 of the oxygenation device 54 by the return tube 50” (id. at col. 9, ll. 13-
15).
Principles of Law
“[W]hen the question is whether a patent claiming the combination of
elements of prior art is obvious,” the answer depends on “whether the
improvement is more than the predictable use of prior art elements according
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to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
417 (2007).
The obviousness analysis “can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418.
Analysis
Claim 26 is directed to an extracorporeal blood treatment apparatus
comprising a sensor in the access branch, upstream of all blood treatment
elements, for measuring the temperature of blood leaving the patient and a
temperature regulating device (heat exchanger) coupled to the return branch,
downstream of all blood treatment elements, to regulate the temperature of
the blood. Claim 26 also requires a control unit that is connected to the
temperature regulating device and that controls the temperature of the fluid
in the heat exchanger as a function of the blood temperature and a reference
temperature.
Weitzel discloses an extracorporeal blood treatment device that
includes a heat exchanger for regulating the temperature of blood entering
the treatment component of the device. Polaschegg discloses a temperature
sensor in the access branch of an extracorporeal blood treatment device.
Polaschegg also discloses the desirability of adjusting the temperature of
treated blood in the apparatus as a function of the temperature of the blood
in the access branch or as a function of the difference between the
temperature of the blood in the access and return branches. Derek discloses
an extracorporeal blood treatment device with a heat exchanger on the return
branch of the circuit.
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In view of these disclosures, it would have been obvious to one of
skill in the art to modify Weitzel’s extracorporeal blood treatment apparatus
to include a temperature sensor upstream of the treatment device, as
disclosed by Polaschegg, and a temperature regulating device in the return
branch, as disclosed by Derek. Polaschegg discloses monitoring blood
temperature in the access branch and using the obtained temperature
information to appropriately adjust the temperature of blood that is returned
to the patient. One of skill in the art would have understood that a heat
exchanger in the return branch, as disclosed by Derek, would also achieve
the temperature regulation suggested in Polaschegg. Such a combination is
no more than the predictable use of prior art elements according to their
established functions.
Appellants argue that the cited references do not suggest a heat
exchanger downstream of all blood treatment elements (Appeal Br. 17).
Appellants argue the Examiner’s reliance on Derek is misplaced because
“the cited passage in Derek is unclear and Derek fails to provide details
about the components present on return tube 50 or the structure of the tube
itself,” and thus Derek does not disclose a heat exchanger downstream of all
blood treatment elements and directly before the blood is returned to the
patient (id.).
This argument is not persuasive. Derek describes the heat exchanger
as being located on either or both of the draw tube and the return tube (FF
14). Figure 2 shows the return tube 50 as being downstream of chambers
58, 62, and 64 of the blood treatment device. Thus, Derek reasonably
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appears to suggest a heat exchanger that is downstream of all blood
treatment elements and directly before the blood is returned to the patient.
Appellants also argue that the cited references do not disclose the
claimed heat exchanger that regulates temperature as a function of the
temperature of blood in the access branch and a reference temperature
(Appeal Br. 17).
This argument is not persuasive. As discussed above, Polaschegg
discloses the desirability of regulating temperature as a function of the
temperature in the access branch (i.e., the first temperature) and a reference
temperature (i.e., the temperature desired for blood returned to the patient;
FF 12). Polaschegg, Derek, and Weitzel all disclose that the temperature of
blood in the circuit can be regulated by a heat exchanger (FFs 5, 12, 14). As
discussed above, Derek teaches locating the heat exchanger in the return
branch. Thus, using a heat exchanger to regulate temperature in the return
branch as a function of the blood temperature and a reference temperature is
simply the use of prior art elements for their established functions.
With regard to claim 45, Appellants argue that the cited references do
not disclose or suggest “the fluid temperature being regulated as a function
of the first temperature and of the reference temperature, and the fluid
temperature being kept equal to the reference temperature when the pump is
not in operation” (Appeal Br. 19).
This argument is not persuasive. Polaschegg discloses that heat is
exchanged between blood and dialysis solution, and that the temperature of
the dialysis solution is adjusted based on, among other thing, the rate of flow
through the blood pump. It would have been recognized by those of
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ordinary skill in the art that when the blood is not flowing, it will remain in
contact with the dialysis solution and the blood and dialysis solution will
come to temperature equilibrium (i.e., the same temperature). Therefore, it
would have been obvious to maintain the solution in a heat exchanger at the
desired reference temperature at times when the pump is not operating (and
therefore blood is not flowing).
CONCLUSIONS OF LAW
The evidence of record supports the Examiner’s conclusions that (i)
the cited references suggest a heat exchanger downstream of all blood
treatment elements and directly before blood is returned to the patient that
regulates the blood temperature as a function of temperature in the access
branch and a reference temperature and (ii) that one of skill in the art would
have been motivated to combine the cited references to arrive at the claimed
invention.
SUMMARY
We affirm the rejection claims 26 and 28-50 under 35 U.S.C. § 103(a)
as being obvious in view of Weitzel, Polaschegg, and Derek.
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

lp
Appeal 2009-002683
Application 10/500,324

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FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON DC 20001-4413