Ex Parte Kravitz et al

Patent Trials and Appeals Board

Jul 3, 2019

13545473 - (D) (P.T.A.B. Jul. 3, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/545,473 07/10/2012
27049 7590 07/08/2019
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.
151947 1094
EXAMINER
LANDAU, SHARMILA GOLLAMUDI
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
07/08/2019 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, DAVID
PETTINATO, RICHARD K. BUCK, JOHN STARK, and ROBERT J.
ALLEN
Appeal2018-002877
Application 13/545,473 1
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and DAVID
COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
apparatus for perfusing, transporting, and/or storing an organ or tissue. The
Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a).
We affirm.
1 According to Appellants, the real party in interest is Lifeline Scientific, Inc.
App. Br. 1.
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Application 13/545,473
STATEMENT OF THE CASE
The Specification discloses that "[a] problem with conventional organ
or tissue perfusion machines ... is that the temperature sensor does not
accurately monitor temperature and/or may cause damage to the organ or
tissue during the monitoring of the temperature of the organ or tissue."
Spec. ,r 5. According to the Specification "a need exists for monitoring the
temperature of an organ in a storage and/ or transport apparatus such as an
organ perfusion machine through minimally or noninvasive means." Id. ,r 7.
The claimed apparatus addresses this need by providing "an organ container
and a temperature sensor that allow for accurate and non-invasive
monitoring of temperature of an organ." Id. ,r 8.
Claims 1-9, 33-35, and 37--42 are on appeal. Claim 1 is illustrative
and reads as follows:
1. An apparatus for perfusing, transporting, and/ or storing an
organ or tissue, comprising:
a coolant container configured to contain coolant and
define a compartment to hold another container; and
a first non-contact temperature sensor configured to
measure a temperature of perfusate within the container and a
second non-contact temperature sensor configured to measure a
temperature of the organ or tissue when disposed in the
container, the first non-contact temperature sensor and the
second non-contact temperature sensor being disposed exterior
to the coolant container.
Claim App'x A-1.
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Application 13/545,473
The Examiner rejected claims 1-9, 33-35, and 37--42 under 35 U.S.C.
§ I03(a) as obvious over the combination of Fahy, 2 Gorbach, 3 and Fujita. 4
ANALYSIS
Appellants argue claims 1-9, 33-35, and 37--42 together. We
designate claim 1 as representative.
In rejecting claim 1 as obvious, the Examiner found that Fahy
disclosed "an apparatus for perfusing, transporting or storing an organ or
tissue." Final Act. 3. 5 Fahy's organ container is depicted in Figure 3
(reproduced below). Fahy, col. 3, 11. 33--43.
247
23:3/
225
226· ,
291 -----r::::r--........... =t"".'.':"'r"'""'~~~~
ti (
235
337
According to the Examiner, element 200 in the above figure, which Fahy
describes as an organ "shipping box" (id. at col. 8, 11. 58-59), corresponds to
2 Fahy, US Patent No. 5,586,438, issued Dec. 24, 1996 ("Fahy").
3 Gorbach et al, Assessment of Cadaveric Organ Viability During Pulsatile
Perfusion Using Infrared Imaging, 87 (8) Transplantation 1163-1166 (2009)
("Gorbach").
4 Fujita et al, US Patent Publication No. 2012/0178076 Al, published July
12, 2012 ("Fujita").
5 Office Action mailed February 9, 2017 ("Final Act.").
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Appeal2018-002877
Application 13/545,473
the claimed "coolant container," and element 11, which Fahy describes as an
"organ container" (id. at col. 8, 1. 45), corresponds to the "container" held
within the claimed "coolant container." Ans. 3. The Examiner found that
Fahy disclosed temperature sensors mounted on the inside of the coolant
container. Id. at 5 (citing Fahy claims 17 and 18). The Examiner
acknowledges, however, that Fahy did not disclose non-contact temperature
sensors or temperature sensors disposed exterior to the coolant container.
Final Act. 4.
The Examiner found that Gorbach disclosed an "organ perfusion
system comprising a compartment to hold a perfusion fluid." Id. The
Examiner found that Gorbach's system included a non-contact temperature
sensor, such as an infrared temperature sensor, that was "separate from the
organ" but "configured to measure a temperature of the organ." Id.
The Examiner found that Fujita referenced Gorbach's teachings (Ans.
8) and disclosed an "organ perfusion system comprising a compartment to
hold a perfusion fluid and a non-contact temperature sensor, such as an
infrared temperature sensor" that is "disposed exterior to the compartment."
Final Act. 4.
The Examiner concluded that "because each of Gorbach and Fujita
disclose a useful temperature sensor that may be combined with a similar
apparatus, the sensor of Gorbach and Fujita could have been included in the
apparatus of Fahy ... with a reasonable expectation of success." Id. at 4--5.
With respect to the location of the temperature sensor, the Examiner
concluded that it would have been obvious to dispose a sensor exterior to the
container because Fujita's teaching of a sensor disposed outside the
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Application 13/545,473
container "provides motivation to configure the non-contact sensor such that
the probe is disposed outside of the container." Id.
We agree with the Examiner that claim 1 would have been obvious
over cited art. We address the Appellants arguments below.
Appellants argue that "[a]lthough Fujita teaches that the energy may
be in the infrared range, Fujita fails to teach optical apparatus 740 as
measuring a temperature of object 720 [i.e. the organ]." App. Br. 9. Thus,
according to Appellants, "the Figure 7 embodiment of Fujita fails to teach a
temperature sensor disposed exterior to a coolant container." Id. We are not
persuaded.
Fujita teaches that infrared imaging may be used to analyze the
viability of an organ in its perfusion apparatus. Fujita ,r,r 25, 38. In addition,
Fujita cites Gorbach, which teaches that infrared imaging may be used to
measure the temperature of an organ disposed within a tissue container. Id.
,r,r 23-24; Gorbach, Abstract, 3. Accordingly, we agree with the Examiner
that "it is evident from the teachings of the prior art that the IR imaging
elements of Fujita and Gorbach are used to sense temperature and may
therefore be interpreted as non-contact temperature sensors." Ans. 8.
Appellants argue that Fahy "fails to clearly teach that the alleged
temperature sensors (thermal wells 18, 19, 112) are disposed exterior" to the
claimed "coolant container." App. Br. 7. We are not persuaded because the
Examiner does not rely on Fahy as disclosing temperature sensors exterior to
the coolant container. Ans. 4. Rather, the Examiner contends that "this
feature of the claims is rendered obvious over Fahy in view of Gorbach and
Fujita." See In re Keller, 642 F.2d 413,426 (CCPA 1981) ("one cannot
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Application 13/545,473
show nonobviousness by attacking references individually where, as here,
the rejections are based on combinations of references").
Appellants contend that Fujita is "silent regarding a 'coolant
container,"' and thus Fujita "fails to teach placing temperature sensors
relative to the location of a 'coolant container."' App. Br. 8. Appellants
argue that "[a]lthough Fujita teaches that spectrum elements 140 (the alleged
'temperature sensors') are disclosed exterior to the organ chamber 110,"
because Fujita "fails to teach spectrum elements 140 are disposed exterior to
a 'coolant container"' the combination of Fahy, Gorbach, and Fujita "would
not have resulted in 'the first non-contact temperature sensor and the second
non-contact temperature sensor being disposed exterior to the coolant
container,' as recited in claim 1." Id.
We are not persuaded because the Examiner does not rely on Fujita as
disclosing a coolant container. Ans. 6 ("Fujita is not relied upon as teaching
a coolant container"). 6 Rather, the Examiner finds that it would have been
obvious to use the sensors disclosed in Fujita and Gorbach in connection
with Fahy's coolant container system. Id.
Appellants argue that the temperature sensors in Fahy are disposed
interior to the coolant container. App. Br. 8-9. Thus, according to
Appellants, the "the combination of Fahy and Fujita fails to have rendered
obvious a non-contact temperature sensor that is disposed 'exterior to the
coolant container."' Id. at 9. We are not persuaded.
6 The Examiner notes that Fujita "does not appear to specifically teach a
coolant container." As discussed infra, we find that Fujita does disclose a
"coolant container," and that this provides an additional basis for affirming
the Examiner's rejection.
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Application 13/545,473
Fujita discloses that, "one issue with contact based systems [like
Fahy's temperature sensor] was the impact on the local environment (e.g.,
perfusion, metabolic activity) that the contact created." Fujita ,r 42. Fujita
teaches that to address this issue "the optical probe 144 is positioned to
remain at least a predetermined distance away from the organ 120." Id. In
addition, Fujita discloses sensors that are disposed exterior to the organ
container and exterior to a "perfusion apparatus." Id. ,r 50, Fig. 7.
Accordingly, we agree with the Examiner that the ordinary artisan would
have recognized that a "non-contact sensor need not be placed immediately
adjacent to the organ and could instead be placed in a position that is distinct
from the organ or organ container" (Ans. 7), and that this would have been
advantageous because it would have avoided impacting the local
environment. It would have been obvious to place the sensor exterior to the
Fahy's coolant container because Fujita teaches to place a sensor exterior to
a perfusion apparatus containing a chamber that houses an organ. See, Fujita
Figs. 7 and 9.
Appellants argue that in Figures 1 and 7 of Fujita, "spectrum elements
140 ( the alleged temperature sensors) [are] disposed exterior of an organ
chamber but still interior of outer apparatus 100/700." Reply Br. 4.
Appellants thus contend that in view of the combination of Fujita and Fahy,
the skilled artisan would "at best, have modified the location of thermal
wells 18, 19, 112 of Fahy (the alleged temperature sensors) so that they are
disposed exterior of an organ chamber but still interior of an outer
apparatus." Id. We are not persuaded.
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Figure 7 of Fujita is reproduced below.
f ~~::~~,..-·:..1] ,\ff:O~l!':~t~~ 1 l ...... ••, .. , .......... ':!(: ........................ 1
1 ................................................................................ .
"FIG. 7 illustrates an embodiment of an apparatus 700 that includes ... an
optical apparatus 740 configured to operate in a non-NMR spectrum."
Fujita ,r 50. The optical apparatus "appl[ies] electromagnetic energy to an
object 720 positioned in a perfusion apparatus 705, and a data logic 760 ...
provide[s] object viability data based on the spectral data." Id.
As can be seen, although the optical sensor 7 40 is positioned within
apparatus 700, it is exterior to the perfusion apparatus 705 and to the organ
chamber 710 within the perfusion apparatus. This provides support for the
Examiner's position that it would have been obvious to position a non-
contact temperature sensor outside of Fahy's perfusion apparatus.
Accordingly we affirm the Examiner's rejection over the combination of
Fahy, Fujita, and Gorbach.
In addition, and alternatively, we find that Fujita alone renders the
apparatus of claim 1 obvious. In finding claim 1 obvious, the Examiner did
not rely on Fujita as teaching a coolant container, noting that Fujita "does
not appear to specifically teach a coolant container." Ans. 6. However,
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Application 13/545,473
Appellants have not defined the term "coolant container" to have a special
meaning, and the claim requires only that the container be "configured to
contain coolant and ... hold another container." Fujita teaches that
"perfusion apparatus 705" in Figure 7 may be a "hypothermic pulsatile
perfusion apparatus." Fujita ,r 51. Given that element 705 is described as
"hypothermic" and as being used for "perfusion" (which involves the use of
a perfusate) we find that perfusion apparatus 705 is a "coolant container"
within the meaning of claim 1. Moreover, in Figure 7 of Fujita the optical
sensor 740, which, as discussed above, corresponds to the claimed "non-
contact temperature sensor," is positioned exterior to the chamber 710 for
housing the organ and exterior to the coolant container 705. See, id. at Fig.
7. Accordingly, we find that Figure 7 of Fujita anticipates claim 1. We do
not designate this as a new ground of rejection because "anticipation is the
epitome of obviousness" and because we also affirm the Examiner's
decision based on the rationale employed in the Examiner's rejection. In re
McDaniel, 293 F3d. 1379, 1385 (Fed. Cir. 2002) (quoting Connell v. Sears
Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)); see also, In re Bush,
296 F.2d 491,496 (CCPA 1961) (holding that the Board may rely on fewer
than all of the references relied on by the Examiner in an obviousness
rationale without designating it as a new ground of rejection).
Accordingly, we affirm the Examiner's rejection of claim 1 as
obvious over Fujita. Because they were not argued separately, claims 2-9,
33-35, and 37--42 fall with claim 1.
SUMMARY
For the reasons set forth herein, and those set forth in the Examiner's
Answer and Final Office Action, we affirm the Examiner's rejection of
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Application 13/545,473
claims 1-9, 33-35, and 37--42 under 35 U.S.C § 103(a) as obvious over
Fahy, Fujita, and Gorbach.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED
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