Ex Parte Belson et al

Patent Trials and Appeals Board

Jun 27, 2019

13255867 - (D) (P.T.A.B. Jun. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/255,867 03/12/2012
21971 7590 07/01/2019
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
FIRST NAMED INVENTOR
Amir Belson
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.
32138-705.831 9700
EXAMINER
SUL, DOUGLAS YOUNG
ART UNIT PAPER NUMBER
3785
NOTIFICATION DATE DELIVERY MODE
07/01/2019 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):
patentdocket@wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AMIR BELSON, ROBERT M. OHLINE, and NIMROD TZORI
Appeal 2018-007516
Application 13/255,867
Technology Center 3700
Before MICHELLE R. OSINSKI, LISA M. GUIJT, and LEE L. STEPINA,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants1 appeal under 35 U.S.C. § 134(a) from the Examiner's
rejection of claims 1, 2, 8, 26, 32, 33, and 54.2 We have jurisdiction under
35 U.S.C. § 6(b ).
1 Qool Therapeutics, lnc. is identified as the real party in interest Appeal
Br. 3.
2 Appeal is taken from the Final Office Action dated May 30, 2017, as
supplemented by the Advisory Action dated Feb. 22, 2018.
Appeal 2018-007516
Application 13/255,867
We AFFIRM.
CLAIMED SUBJECT MATTER
Claims 1, 2, and 26 are the independent claims on appeal. Claim 1,
reproduced below, is exemplary of the subject matter on appeal, with
disputed limitations emphasized.
1. A therapeutic treatment system, comprising:
a delivery device having a gas inlet and a gas outlet
adapted to deliver a breathing gas mixture to a patient, wherein
the delivery device comprises an endotracheal tube;
an injection device comprising a frozen water ice particle
delivery tube having an outlet positioned near the gas outlet of
the delivery device and having an inlet coupled to a source of
frozen water ice particles; and
a control system coupled to the delivery device and the
injection device;
wherein the control system is adapted to control the
injection device to release the frozen water ice particles from the
frozen water ice particle outlet into the breathing gas mixture
near the gas outlet of the delivery device to form a mist of frozen
water ice particle in the breathing gas mixture.
THE REJECTIONS3
I. Claims 1, 2, 26, 32, and 33 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Jiang (WO 2005/113046 A2; published
3 Although there is no explicit withdrawal of the Examiner's rejection of
claims 26, 32, 33, and 54 under 35 U.S.C. § 112, second paragraph, as
indefinite (see Ans. 8), Appellants' Amendment dated Jan. 17, 2018, which
deletes the claim language "the delivery device," renders the rejection moot.
Final Act. 2-3; Adv. Act. 1 ("After entry of the amendment, claims 1, 2, 8,
26, 32, 33, and 52 are currently subject to appeal.").
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Application 13/255,867
Dec. 1, 2005), Tada (US 5,035,750; issued July 30, 1991), and Kumar (US
2003/0131844 Al; published July 17, 2003).
II. Claims 8 and 54 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Jiang, Tada, Kumar, and Takano (US 2003/0056789 Al;
published Mar. 27, 2003).
ANALYSIS
Rejection I
Appellants argue claims 1, 2, 26, 32, and 33 as a group. Appeal
Br. 7-9. We select claim 1 as representative, with claims 2, 26, 32, and 33
standing or falling with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
Regarding independent claim 1, the Examiner finds Jiang discloses an
endotracheal tube having a gas inlet and a gas outlet adapted to deliver a
breathing gas mixture to a patient, and a device capable of generating mists
containing frozen particles, as claimed. Final Act. 3-4 ( citing Jiang 3 :26-
28, 5:6-8, 5:13-16); see, e.g., Jiang 4:1 (referring to the device capable of
generating mist as a "the mist-generating device").
The Examiner determines that Jiang does not disclose that the mist-
generating device comprises a frozen water ice particle delivery tube having
an outlet and also an inlet coupled to a source of frozen water ice particles,
as claimed, and the Examiner relies on Tada4 for disclosing a frozen water
ice particle delivery tube (i.e., nozzle 11) having an outlet (i.e., outlet of
nozzle 11) and an inlet (i.e., the inlet of nozzle 11) coupled to a source of
frozen water ice particles (i.e., freezing chamber 1 ). Final Act. 4 ( citing
4 Notably, the teachings of Tada are incorporated by reference into Jiang.
See Jiang 3:15-19.
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Application 13/255,867
Tada 4:8-58). The Examiner reasons that it would have been obvious to
modify Jiang' s mist-generating device to include a tube, as taught by Tada,
because "Jiang specifically discloses that suitable device[ s] for forming a
mist with frozen particles are described in Tada." Id. at 4-5 (citing Jiang
5:6-8).
The Examiner also determines that neither Jiang nor Tada disclose
positioning the outlet of Jiang's injection device, as modified by Tada, near
the gas outlet of the endotracheal tube, as claimed, and the Examiner relies
on Kumar for disclosing that it is known to position the outlet of an injection
device (i.e., heliox delivery tube 224) near the gas outlet of a delivery device
(i.e., distal port 220 of endotracheal tube 202). Final Act. 5 ( citing Kumar
,i,i 116, 118, Fig. 3). The Examiner reasons that it would have been obvious
to modify Jiang's injection device, as modified by Tada, such that the outlet
of the injection device (i.e., a frozen water ice particle delivery tube) is
positioned near the gas outlet of the endotracheal tube, "to provide the
cooling substance directly within the patient's body," because "Jiang
specifically discloses that suitable device[ s] for forming a mist with frozen
particles are described in Kumar." Id. ( citing Kumar ,i 56; Jiang 5:6-8).
Appellants argue that "Jiang teaches that frozen ice particles may be
delivered to a patient's lungs through an endotracheal tube ... , but nowhere
teaches or suggests that a 'frozen water ice particle delivery tube' ha[s] an
outlet that delivers such particles into a breathing gas stream as the stream
mixture near[ s] the gas outlet of the delivery device, as required by [ claim
1]." Appeal Br. 5. Appellants submit that Jiang fails to disclose that "the
breathing air and the ice particles are to be delivered through separate tubes
and combined only at the outlet [ o ]f the endotracheal [tube]." Id. at 6.
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Application 13/255,867
Jiang discloses "a mist comprise[ d] [ of] frozen particles suspended in
a physiologically acceptable carrier gas." Jiang 3: 1-2. Jiang also discloses
that "[t]he system also includes a container having a composition comprising
the ... gas and ... liquid from which mists will be generated" and that "the
container ... may ... be part of [a] mist-generating device," wherein "[i]n
general, this means that a passageway must be available leading from the
container to a port or nozzle from which the composition can be expelled."
Jiang 3:30-4:4. Jiang further discloses that "[t]he mist of frozen particles
may be expelled into an endotracheal tube that can be inserted into a
patient." Id. at 5: 13-14. Thus, a preponderance of the evidence supports the
Examiner's finding that Jiang discloses a device, which is separate from the
endotracheal tube and which has a port or nozzle for expelling ( or ejecting)
the mist, for example, into an endotracheal tube, which meets the limitations
of "an injection device," as claimed. In other words, Jiang discloses two
separate devices.
As set forth supra, the Examiner relies on Tada for disclosing that the
injection device is more particularly a frozen water ice particle delivery tube,
with an outlet and an inlet coupled to a source of frozen water ice particles,
as claimed, and on Kumar for disclosing positioning the outlet of tube
positioned near the gas outlet of endotracheal tube, as claimed. Thus,
Appellants' argument does not address the rejection as articulated by the
Examiner, nor does Appellants' argument apprise us of error in the
Examiner's findings with respect to Jiang, Tada, or Kumar.
Appellants also argue that
[ w ]hile the assembly of the tubes 222/224 [ of Kumar] releases
frozen particles at the outlet of an endotracheal tube 202,
nowhere does Kumar teach or suggest providing a "source of
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Application 13/255,867
frozen water ice particles," deliver[ing] the ice particle[s]
through a delivery tube from the ice source, and then releasing
those particles into breathing air from the endoscope.
Appeal Br. 6. However, as set forth supra, the Examiner relies on Tada, not
Kumar, for disclosing a frozen water ice particle tube having an inlet
coupled to a source of frozen water ice particles, as claimed, and on Jiang
for disclosing expelling the mist (i.e., the frozen water ice particles) into the
endotracheal tube, for example, from Jiang' s container via a passageway
(modified to be a tube, in view of Tada) and a nozzle or port. Thus,
Appellants' arguments do not apprise us of error in the Examiner's findings
with respect to Jiang, Tada, or Kumar.
Appellants further argue that
[ w ]hile Tada clearly does teach making frozen ice particles and
connecting a delivery nozzle to a source of such particles, such
teaching would hardly suggest to one of skill in the art to modify
the teachings of Jiang to move the ice particle connection from
an inlet of a breathing line, as taught by Jiang, or an in situ
generation source, as taught by Kumar, to a separate ice particle
injector as required by all independent claims herein.
Appeal Br. 6. Appellants submit that "Tada is not related to therapeutic
treatments and nowhere suggests that such ice particles should be injected
into a breathing gas stream at a downstream location in the lungs." Id. at 7.
Appellants do not provide support for their reliance on Jiang for
disclosing that the mist is expelled at an inlet of the endotracheal tube. As
discussed supra, Jiang merely discloses a container containing the mist, a
passageway, and a port or nozzle from which the composition can be
expelled (see Jiang 4:2-4), and also that the mist of frozen particles may be
expelled into an endotracheal tube (see id. at 5:13-14). Further, as set forth
supra, the Examiner does not rely on Tada for suggesting modification of
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Application 13/255,867
Jiang' s injection device to a position near the gas outlet of the delivery
device.
Appellants also mischaracterize the Examiner's rejection by stating
that the Examiner "concedes that neither Jiang nor Kumar teach or suggest
delivering the ice particles separately and combining them at the respective
outlet ends of the endotracheal tube and the frozen particle injection device."
Appeal Br. 7-8. Rather, as set forth supra, the Examiner recognizes that
Jiang discloses an injection device separate from the endotracheal tube, i.e.,
a "device capable of forming a mist with frozen particles." Final Act. 4.
The Examiner further recognizes, as set forth supra, that Kumar teaches
combining a mist with the breathing gas near the gas outlet of the delivery
device. Again, Appellants' argument does not address the rejection as stated
by the Examiner.
Appellants argue that
Tada nowher[ e] provides any teaching or suggestion that the
frozen particles be combined with the breathing gas at the outlet
end of an endotracheal tube. The natural assumption of one of
skill would be that the Tada source would be connected to deliver
the ice particles into the inlet end of the endotracheal tube, not to
the outlet end as required by all claims herein. Thus, even if Tada
were combined with the teachings of Jiang and Kumar, there
would be no teaching of injecting the frozen water particles into
a breathing gas near an outlet end of an endotracheal [tube].
Appeal Br. 8. However, as set forth supra, the Examiner does not rely on
Tada for the positioning of the outlet of the of the injection device (i.e., the
frozen water particle delivery tube) near the gas outlet of the endotracheal
tube, as claimed. Nor do Appellants provide any evidentiary support in
support of the assumption that Tada' s tube would be connected to an inlet
end of an endotracheal tube. As set forth supra, the Examiner relies on
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Application 13/255,867
Kumar for disclosing positioning a delivery tube near the gas outlet of an
endotracheal tube.
Appellants argue that the Examiner impermissibly relied on hindsight.
Appeal Br. 8. In support, Appellants submit that"[ n Jothing in Jiang teaches
that ice particles are to be delivered to the patient through a separate injector
whose outlet is near the outlet of the endotracheal tube." Id. at 9. However,
as discussed supra, Appellants do not apprise us of error in the Examiner's
reliance on Jiang for disclosing an injector device, separate from the
endotracheal tube, and on Kumar for disclosing the claimed positioning of
the injection device. As recognized by Appellants, Kumar discloses
coaxially locating a tube within the endotracheal tube, such that the outlet of
the tube is positioned near the gas outlet of the endotracheal tube," as
claimed. See Appeal Br. 6 ("Kumar teaches in situ formation by injecting
liquid PFC' s through a 'liquid delivery tube 222' into a heliox stream
flowing through a tube 224 located coaxially over the liquid tube 222").
As set forth supra, the Examiner reasons that positioning the outlet of
an injection device near the gas outlet of the endotracheal tube "provide[ s]
the cooling substance directly within the patient's body." Final Act. 5.
Kumar involves placing a "heliox delivery tube" in the claimed
position, wherein "heliox" is a "helium and oxygen mixture," (Kumar ,i 54),
which is one of the carrier gases disclosed in Jiang into which liquid is
added to form frozen particles. See, e.g., Jiang 3: 1-2 ("the invention is
directed to a mist that comprises small diameter frozen particles suspended
in a physiologically acceptable carrier gas" wherein "[t]he frozen particles
must be formed from a non-toxic, physiologically acceptable liquid"), 3: 10-
12 (disclosing that the "liquid" may be "water" and the carrier gas may be a
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Application 13/255,867
mixture of oxygen and helium). Similar to Jiang, Kumar discloses that
"[b Jody temperature can be further cooled by atomizing and injecting a fluid
into the helium-oxygen gas mixture," such as water, although
perfluorocarbon is preferred. Id. ,i 20; see also id. ,i 58 ("[t]he heliox acts as
the suspension medium for the PFC droplets"). Thus, Kumar discloses
injecting, into an endotracheal tube, the same mist as disclosed in Jiang for
the same purpose, namely, to cool tissue. Kumar teaches to one skilled in
the art that the suspension medium for cooling tissue may be dispensed by
an injector device (i.e., heliox delivery tube 224) at a distal region 221 of
endotracheal tube 202, for example, by positioning the heliox tube coaxially
within the endotracheal tube. See Kumar, ,i,i 115, 116, Fig. 3.
Thus, the Examiner's rationale for detennining that it would have
been obvious to position Jiang's injection device, as modified by Tada,
relative to the endotracheal tube to provide the cooling substance directly
within the patient's body has sufficient factual support in the disclosure of
Kumar. 5
5 Notably, there are only a finite number of places along the endotracheal
tube (i.e., near the distal end, in an intermediate section, or near the proximal
end) to position an injection device to solve the problem of cooling tissue,
such that it would have been obvious to try positioning Jiang's injection
device, as modified by Tada, relative to the endotracheal tube as required by
claim 1, especially in view of Kumar's teaching that near the distal end is an
available option for the same mist for the same purpose. See MPEP §
2143(I)(E) (providing that to reject a claim based on an "obvious to try"
rationale, Office personnel must include "a finding that at the time of the
invention, there had been a recognized problem or need in the art, which
may include a design need or market pressure to solve a problern").
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In sum, we are not persuaded by Appellants' argument that the
Examiner impermissibly relied on hindsight, notwithstanding the
Specification's disclosure that
[p Jositioning the injection device close to the exit port of the
delivery device maximizes that ability of system 100 to deliver a
frozen mist of particles directly to the target tissue of the patient
while maximizing the percentage of particles that exit the device
and make contact with target tissue.
Spec. ,i 41.
For the first time, in the Reply Brief, Appellants argue that Figure 2 of
Kumar depicts the injection device at the "base (proximal end) of an
endotracheal tube ... and not near the distal end as claimed." Reply Br. 3
(citing Kumar, Fig. 2).6 Appellants submit that the Examiner erred by
relying on Kumar for disclosing locating the injection device near the outlet
of the endotracheal tube. Id. at 4.
\Ve ded ine to consider argmnents raised for the first tirne by
Appellants in the Reply Brief, without a demonstration of good cause as to
v.,rhy Appellants' arguments vvere not raised earlier and without the benefit of
a response by the Examiner. See 37 C.F.R. § 41.4l(b)(2) ("Any argument
raised in the reply brief which was not raised in the appeal brief, or is not
responsive to an argument raised in the examiner's answer, ... will not be
considered by the Board for purposes of the present appeal, unfoss good
cause is shown.").
Accordingly, we sustain the Examiner's rejection of claim 1, and
claims 2, 26, 32, and 33 fall therewith.
6 As set forth supra, the Examiner relies on the embodiment disclosed in
Figure 3 of Kurnar, and as discussed supra, Appe11ants have not apprised us
of error with respect to the Examiner's findings with respect to Figure 3.
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Rejection II
Appellants chose not to present arguments for the patentability of
claims 8 and 54 apart from the arguments presented for the patentability of
independent claims 2 and 26. Appeal Br. 9.
Accordingly, for essentially the same reasons as stated supra, we also
sustain the Examiner's rejection of claims 8 and 54.
DECISION
The Examiner's rejections of claims 1, 2, 8, 26, 32, 33, and 54 are
AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
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