Ex Parte KRAVITZ et al

Patent Trials and Appeals Board

May 8, 2019

13545281 - (D) (P.T.A.B. May. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/545,281 07/10/2012
27049 7590 05/10/2019
OLIFF PLC
P.O. BOX 320850
ALEXANDRIA, VA 22320-4850
FIRST NAMED INVENTOR
David KRAVITZ
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
151938 9162
EXAMINER
LANDAU, SHARMILA GOLLAMUDI
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
05/10/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
OfficeAction27049@oliff.com
jarmstrong@oliff.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID KRAVITZ, CHRISTOPHER P. STEINMAN,
JEFFREY S. LOUIS, MATTHEW COPITHORNE, BRIAN L. OTTS,
and PETER DEMUYLDER1
Appeal2018-001625
Application 13/545,281
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and DAVID COTTA,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Lifeline Scientific, Inc. as the real parties-in-interest.
App. Br. 1.
Appeal2018-001625
Application 13/545,281
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-25 and 42-49. Specifically, claims
1-25, 42-46, 48, and 49 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Brassil et al. (US
2005/0255442 Al, November 17, 2005) ("Brassil") and Belous et al.
(US 2010/0092939 Al, April 15, 2010) ("Belous").
Claims 44-47 and 49 stand rejected under 35 U.S.C. § 103(a) as being
obvious over the combination Brassil, Belous, and Shuler (US
2011/0054283 Al, March 3, 2011) ("Shuler").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a method and apparatus for
perfusing an organ. Abstract.
REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal
and recites:
1. A method of perfusing an organ or tissue, the method
compnsmg:
connecting a conduit to an organ or tissue, the conduit
comprising a plurality of tubes, and a first end of each of at least
two said tubes being connected to the organ or tissue;
2
Appeal2018-001625
Application 13/545,281
applying a fluid motive force to a perfusion fluid in the at
least two tubes to force the fluid through the at least two tubes
into the organ or tissue to perfuse the organ or tissue;
allowing a flow balance to be established between the at
least two tubes by the fluid motive force and backpressure
generated by the organ or tissue being perfused; and
after the flow balance has been established by the fluid
motive force and the backpressure, then altering the flow balance
between the at least two tubes without altering the fluid motive
force that is applied.
App. Br. Claims App'x A-1.
ISSUES AND ANALYSES
We adopt the Examiner's conclusion that the claims are prima facie
obvious over the combined cited prior art, with the exception of the
Examiner's rejection of claims 43-49. We address the arguments raised by
Appellants below.
A. Rejection of claims 1-25 and 42 under 35 U.S.C. § 103(a)
Issue 1:
Appellants argue that the Examiner erred in finding that the cited prior
art teaches or suggests the limitation of claim 1 reciting: "after the flow
balance has been established by the fluid motive force and the backpressure,
then altering the flow balance." App. Br. 7.
Analysis
The Examiner finds that Brassil teaches a method of perfusing an
organ or tissue comprising connecting a conduit to an organ or tissue (such
3
Appeal2018-001625
Application 13/545,281
as a liver), the conduit comprising a plurality of tubes, and a first end of each
of at least two of said tubes being connected to the organ or tissue. Final
Act. 3 ( citing Brassil Abstr. ,i 72, Fig. l lD). The Examiner finds that
Brassil teaches applying a fluid motive force (such as pneumatic
pressurization) to perfusion fluid in the two tubes to force the fluid through
the two tubes into the organ or tissue to perfuse the organ or tissue. Id.
( citing Brassil ,i 17).
The Examiner finds that, although Brassil does not specifically teach
allowing a flow balance to be established between the two tubes by the fluid
motive force and backpressure generated by the organ or tissue being
perfused, the reference teaches that the single tube is split to be directed into
two or more tubes and, therefore, that a flow balance would be established
between the two tubes by the fluid motive force and backpressure in the
system. Id. ( citing Brassil ,i,i 134-135, Fig. 26). The Examiner finds that a
person of ordinary skill in the art would have realized that altering the flow
balance between the two tubes could be achieved without altering the fluid
motive force that is applied, by using the fine pressure tuning via a pinch
valve, as described by Brassil. Id. at 3-4 ( citing Brassil ,i 17).
The Examiner finds that, although Brassil does not expressly teach
that the flow balance is altered between the at least two tubes without
altering the fluid motive force that is applied after the flow balance is
established, Belous teaches a similar method of perfusion comprising
varying certain parameters, such as flow, by regulating valves on each of the
two tubes. Final Act. 4 ( citing Belous ,i 20, Fig. 1 ).
The Examiner concludes that a person of ordinary skill in the art of
organ perfusion would have been motivated to arrive at the claimed method,
4
Appeal2018-001625
Application 13/545,281
because Belous teaches the step of regulating the valves to control the flow
of fluid into the system, and further teaches that it is desirable to enable an
operator to vary certain parameters, such as flow or pressure, for
experimental purposes. Final Act. 4 ( citing Belous ,i 20). The Examiner
further concludes that a person of ordinary skill would have found it obvious
to combine the teachings of Brassil and Belous to arrive at the claimed
method, and would have had a reasonable expectation of success in doing so
because both references are directed to organ perfusion methods and teach
that the methods may be modified in a number of ways. Id. at 4-5.
Appellants dispute the Examiner's conclusion that: "One of ordinary
skill in the art would have recognized that altering the flow balance between
the two tubes could be achieved ... by using the fine pressure tuning via a
pinch valve, such as are described by Brassil." App. Br. 8 ( quoting Final
Act. 3-4). Appellants contend that even assuming, arguendo, the
Examiner's conclusion is correct- i.e., that Brassil's apparatus could be
used to accomplish the disputed limitation - their method is still patentable
because "new and unobvious uses of old structures and compositions may be
patentable." Id. (quoting MPEP § 2112.02).
Appellants argue further that Belous neither teaches nor suggests the
non-instantaneous reaction of the organ to the flow of the perfusate solution.
App. Br. 8. Appellants therefore argue that a person of ordinary skill in the
art, when given a general teaching to: "vary certain parameters of the
perfusing system 10 to simulate various conditions," (quoting Belous ,i 20)
would have found it obvious to "[allow] a flow balance to be established"
and only "after the flow balance has been established ... then [alter] the flow
balance," as recited in claim 1. Id.
5
Appeal2018-001625
Application 13/545,281
We are not persuaded. Brassil teaches:
Utilizing a single pump 2610 for both vasculature systems
provides a variety of modes that can be used to perfuse a liver.
After each bubble trap 2640, the tubing splits into two directions.
On the hepatic side, hepatic infusion valve 2685 controls the flow
to the hepatic side of the liver and hepatic wash valve 2686
controls the flow into the organ bath. On the portal side, portal
infusion valve 2695 controls the flow to the portal side of the
liver and portal wash valve 2696 controls the flow into the organ
bath.
Brassil ,-J 136. Brassil further teaches that, in a preferred embodiment, the
valves can be altered by the user to employ various modes of operation by
which the hepatic artery or portal vein receive perfusion priority, or by
which priority alternates between the two. Id. at ,-J,-J 13-138.
Similarly, Belous teaches that:
The perfusing system 10 may also be equipped with one or more
sensors or transducers 90a and 90b that are configured to monitor
the pressure, flow rate and/ or temperature in the portal vein 502
and/or the hepatic artery 504 .... This enables an operator to vary
certain parameters of the perfusing system 10 to simulate various
conditions. The valves 40a and 40b may be regulated as well to
control the flow of fluid into the system.
Belous ,-J 20 ( emphasis added). Both Brassil and Belous thus expressly teach
that the valves may be used to regulate the flow of the perfusate throughout
the perfusion process. We agree with the Examiner that a person of ordinary
skill in the art would therefore understand that the flow balance could be
altered after the initial flow balance had been established. We conclude that
using a device in a manner, and for a method, for which the device has been
specifically designed is obvious.
6
Appeal2018-001625
Application 13/545,281
Issue 2
Appellants argue that the Examiner erred in finding that the cited prior
art teaches or suggests the limitation of claim 1 reciting: "the flow balance
between the at least two tubes" [is altered] "without altering the fluid motive
force that is applied." App. Br. 9.
Analysis
Appellants repeat their argument supra that Belous discloses that
various operating and control elements of its perfusing system 10, including
the pump 60, may be varied to simulate various conditions, and that the
valves 40a and 40b may be varied as well. App. Br. 9. Appellants argue
that Belous therefore teaches, at most, varying the valves 40a and 40b in
concert with the pump 60. Id. In other words, contend Appellants, this
reference does not teach varying only the valves 40a and 40b separately
from the pump 60, or varying one valve 40a and 40b separately from the
other valve, which would be required to alter the flow balance between the
at least two tubes without altering the fluid motive force that is applied, as
required by claim 1. Id.
We are not persuaded. Brassil teaches:
Perfusion apparatus 2600 has a single pump 2610, which is
preferably a roller pump or peristaltic pump. The tubing splits
into two or more directions with, for example, three tubes going
toward the portal vein side of the liver (portal tubing 2625) and
one tube going toward the hepatic artery side of the liver (hepatic
tubing 2626).
Brassil ,-J 134. As we have explained supra, Brassil also teaches that each set
of tubes has its own valve, and that the valves can be differentially operated
7
Appeal2018-001625
Application 13/545,281
by the operator according to the desired mode. See Brassil ,i,i 136-138.
Because all of the tubes are operated by a single pump (see, e.g., Brassil Fig.
26; Belous Fig. 1 ), we agree with the Examiner that differential control of
the valves, independent of the motive force generated by the pump, would
have been obvious to a person of ordinary skill in the art. We consequently
affirm the Examiner's rejection of claims 1-25 and 42.
B. Rejection of claims 43 and 44 under 35 U.S.C. § 103(a)
Issue
Claim 43 exemplifies the disputed limitation argued by Appellants,
and recites, in relevant part: "sensing, by a sensor, the presence or absence
of at least one device configured to alter the flow balance between the at
least two tubes without altering the fluid motive force that is applied." App.
Br. Claims App'x A-4. Appellants contend that the Examiner erred in
finding that the combined cited prior art teaches or suggests this limitation.
Id. at 9.
Analysis
Appellants dispute the Examiner's finding that Brassil and Belous
each teach the steps of using: "multiple flow sensors to detect and measure
pressure" and that the:
[P]resence or absence of a closed valve (i.e., a [device]
configured to alter the flow balance between the two tubes)
would be sensed by the pressure sensor. Furthermore, the
presence of an additional device that may alter the flow ... would
be sensed by the sensor. Thus, the combined prior art renders
obvious the sensing, by a sensor, of the presence or absence of
such a device.
8
Appeal2018-001625
Application 13/545,281
App. Br. 9-10 ( quoting Final Act. 7-8).
Appellants contend that, even assuming the Examiner's findings are
correct, the flow sensors would not be able to determine the causes of
changes in the perfusate flow. App. Br. 10. Appellants argue, by way of
example, that a flow sensor in Brassil's apparatus would not be able to
distinguish a reduction of medical fluid flow that is the result of valve 2685
or valve 2695 closing from any other cause of medical fluid flow reduction.
Id. Similarly, Appellants argue, a flow sensor in the apparatus of Belous
would not be able to distinguish a reduction of solution 75 flow that is the
result of valve 40a or valve 40b closing from any other cause of solution 75
flow reduction. Id.
Appellants assert that the teachings of Shuler do not cure these alleged
deficiencies of Brassil and Belous, because the Hall sensor of Shuler (like
the flow sensors of Brassil and Belous) would be unable to determine the
causes of changes in perfusate flow, e.g., "the presence or absence of at least
one device configured to alter the flow balance between the at least two
tubes without altering the fluid motive force that is applied." App. Br. 10.
The Examiner responds that the combined references render obvious a
step of altering the flow balance without altering the fluid motive force that
is applied, such as by regulating a valve. Ans. 4. Because, the Examiner
finds, the references teach the use of a pressure sensor, the sensor would
then detect the presence or absence of a device configured to alter the flow
balance between the tubes (such as a closed valve). Id. The Examiner notes
that the claims are not directed to a specific sensor that detects whether there
is a device present; rather, the claim is interpreted as reading on any sensor
9
Appeal2018-001625
Application 13/545,281
that would detect a change in conditions resulting from the presence or
absence of a device, such as by detecting a transient change in pressure. Id.
We do not find the Examiner's reasoning persuasive. Despite the
Examiner's finding that: "the claims are not directed to a specific sensor that
detects whether there is a device present," we construe the plain language of
claim 43 reciting: "sensing, by a sensor, the presence or absence of at least
one device configured to alter the flow balance between the at least two
tubes" to mean exactly that. That is, what is detected by the claimed sensor
is the presence or absence of the flow-altering device, viz., a valve, and not
merely the downstream effect that such a device might produce. While such
sensors may well be known in the art, the Examiner points to no teaching or
suggestion in the cited prior art that teach such a sensor. We consequently
reverse the Examiner's rejection of claims 43 and 44.
Furthermore, claim 44 is an independent claim, from which claims
43-49 depend. For the reasons explained, we similarly reverse the
Examiner's rejection of those claims and we do not reach Appellants'
additional arguments concerning them.
DECISION
The Examiner's rejection of claims 1-25 and 42 under 35 U.S.C.
§ 103(a) is affirmed.
The Examiner's rejection of claims 43-49 under 35 U.S.C. § 103(a) is
reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
AFFIRMED-IN-PART
10