Ex Parte COLLINS et al

Patent Trial and Appeal Board

Apr 28, 2016

13025938 (P.T.A.B. Apr. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/025,938 02/11/2011 KENNETH A. COLLINS
24955 7590 05/02/2016
ROGITZ & AS SOCIA TES
Jeanne Gahagan
750B STREET
SUITE 3120
SAN DIEGO, CA 92101
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.
1156-41DV.CON 3768
EXAMINER
A VIG AN, ADAM JOSEPH
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
05/02/2016 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):
Noelle@rogitz.com
eofficeaction@appcoll.com
J ohn@rogitz.com
PTOL-90A (Rev. 04/07)
lJ1..JITED STATES PATENT AND TRADE~vfARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENNETH A. COLLINS and WILLIAM J. WORTHEN
Appeal2014-002940
Application 13/025,938
Technology Center 3700
Before LINDA E. HORNER, THOMAS F. SMEGAL, and
PAUL J. KORNICZKY, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
uECISION ON APPEAL
STATEMENT OF THE CASE
Kenneth A. Collins and William J. Worthen (Appellants)1 seek our
review under 35 U.S.C. § 134 of the Examiner's decision rejecting claims
1-6, 9-13, 15-19, and 24-27. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 According to Appellants, the real party in interest is Zoll Circulation, Inc.
Appeal Br. 2.
Appeal2014-002940
Application 13/025,938
CLAIMED SUBJECT MATTER
Appellants' claimed subject matter "relates generally to therapeutic
hypothermia." Spec. 1. Claims 1, 12, and 24 are independent claims.
Claim 1 is illustrative of the subject matter on appeal and is reproduced
below.
1. A system for controlling patient temperature,
compnsmg:
a closed loop heat exchange catheter configured for
placement in the circulatory system of a patient to exchange heat
with the patient;
a heat exchange system engageable with the catheter,
wherein the heat exchange system includes at least one coolant
loop having a coldwell, the catheter being associated with a
catheter working fluid loop including a catheter coil disposable
in the coldwell, the coldwell being at a highest location in the
heat exchange system.
EVIDENCE
The Examiner relied upon the following evidence:
White book US 6,581,403 B2 June 24, 2003
Lennox US 2003/0130651 Al July 10, 2003
Daoud US 6,719,779 B2 Apr. 13, 2004
Dobak, III ("Dobak") US 6,740,109 B2 May 25, 2004
Cobb US 2004/0153132 Al Aug. 5, 2004
Abreu US 2004/0242976 Al Dec. 2, 2004
Radons US 7,179,279 B2 Feb.20,2007
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Appeal2014-002940
Application 13/025,938
REJECTIONS
Appellants appeal from the Final Action, dated June 20, 2013, which
contained the following rejections:
1. Claims 1, 5, 6, 9-13, 15, 19, and 24-27 under 35 U.S.C. § 103(a)
as unpatentable over Lennox, Daoud, and Whitebook.
2. Claims 2 and 16 under 35 U.S.C. § 103(a) as unpatentable over
Lennox, Daoud, Whitebook, and Cobb.
3. Claims 3 and 17 under 35 U.S.C. § 103(a) as unpatentable over
Lennox, Daoud, Whitebook, and Abreu.
4. Claims 4 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Lennox, Daoud, Whitebook, and Dobak.
5. Claims 4 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Lennox, Daoud, Whitebook, and Radons.
ANALYSIS
Claims 1 and 12
Claim 1 calls for "a closed loop heat exchange catheter configured for
placement in the circulatory system of a patient to exchange heat with the
patient." Appeal Br. 8 (Claims App.). Claim 12 calls for "at least one heat
exchange catheter" having a working fluid that circulates through the
catheter, "the working fluid not being a body fluid." Appeal Br. 10 (Claims
App.). Each of the rejections of independent claims 1and12 relies on a
proposed modification of Lennox "by substituting the intravascular cooling
means taught by both Whitebook and Daoud for the ventricle-cooling
catheter means taught by Lennox in order to achieve the predictable result of
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Application 13/025,938
a means for cooling the brain." Final Act. 4. Appellants argue that
"Lennox, in circulating [cerebral spinal fluid], teaches away from not
circulating cerebral spinal fluid." Appeal Br. 5. Appellants further argue
that the proposed modification to Lennox to use an intravascular cooling
system "utterly changes the way Lennox is intended to work with an entirely
different concept." Reply Br. 3.
Lennox is directed to a way to selectively cool the brain without
inducing systemic hypothermia. Lennox, paras. 8-11 (discussing
disadvantages of systemic hypothermia). Lennox further teaches that prior
art catheters that are placed into the carotid artery to cool the blood entering
the head results in systemic hypothermia. Id., para. 10. Lennox's invention
focuses on "inducing selective cerebral hypothermia" by "placing a cooling
device(s) into one or both lateral ventricles of the brain and applying a
surface-cooling device to the head, then cooling the ventricle(s) with the
ventricle-cooling device(s) and cooling the surface of the head with the
surface-cooling device." Id., para. 16. In some embodiments, Lennox adds
a body-heating device to heat the body simultaneously with cooling the
brain. Id. Lennox lists an object and advantage of its invention is to
"provide selective cerebral hypothermia to a brain at risk of secondary injury
to the degree that offers maximum clinical benefit without clinically
significant temperature gradients within the brain and without inducing
hypothermia in the rest of the body." Id., para. 18. Thus, the focus of
Lennox is directed to selective cooling of parts of the brain while keeping
the rest of the body from experiencing the effects of hypothermia.
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Appeal2014-002940
Application 13/025,938
Daoud discloses a heat transfer catheter 24 having a heat transfer
element 48 which "may be placed in the vasculature of the patient to absorb
heat from or deliver heat to surrounding blood flowing along the heat
transfer element 48." Daoud, col. 8, 11. 8-11. Daoud teaches that this
catheter can be used to cool the brain by placing it "into the common carotid
artery or into both the common carotid artery and the internal carotid artery"
to "draw heat from the surrounding blood flow." Id., col. 8, 11. 23-29.
As noted by Appellants, the Examiner's proposed modification of
Lennox to replace the ventricle-cooling catheter with an intravascular heat
exchange catheter, such as the catheter of Daoud, defeats the purpose of
Lennox's method to achieve selective cooling of the brain and would result
in the systemic hypothermia that the invention of Lennox is designed to
avoid. As such, the Examiner has failed to articulate adequate reasoning
based on rational underpinnings for the proposed modification of Lennox
with the intravascular heat exchange catheter of Daoud so as to render
obvious the subject matter of independent claims 1 and 12. The rejections of
dependent claims 2-6, 9-11, 13, and 15-19 rely on the same proposed
modification of Lennox, and thus are not sustainable for the same reasons
discussed above for claims 1 and 12.
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Appeal2014-002940
Application 13/025,938
Claims 24-27
Appellants present arguments directed to independent claim 24 and
dependent claim 25. Appeal Br. 4-7.2 We address each claim separately
argued claim below. Dependent claims 26 and 27 stand or fall with claim
24. See 37 C.F.R. § 41.37(c)(l)(iv).
Independent claim 24 is reproduced below:
24. System comprising:
housing including a coldwell through which heat exchange
fluid can flow;
first heat exchange element disposable in the coldwell in
thermal but not in fluid contact with the heat exchange fluid, such
that working fluid flowing through the first heat exchange
element exchanges heat with the heat exchange fluid;
working fluid pump pumping the working fluid; and
second heat exchange element disposable in the coldwell
in thermal but not in fluid contact with the heat exchange fluid,
such that working fluid flowing through the second heat
exchange element exchanges heat with the heat exchange fluid.
2 Appellants raise for the first time in the Reply Brief a separate argument
for patentability of dependent claim 26. Reply Br. 4 (arguing that the
separate argument was made "in response to the examiner's further
explanations contained in the Answer of the rejection [of claim 24 ]"). The
statement of the rejection set forth in paragraph 22 of the Final Action
explained the Examiner's proposed modification of Lennox with the
teachings of Daoud and White book so that "both the catheter cooling loop
and the helmet cooling loop have been modified to include heat exchange
coils disposed in the coldwell." Final Act. 7. The Board will not consider
the argument as to claim 26, because Appellants have not demonstrated
good cause as to why the argument was not presented in the Appeal Brief.
37 C.F.R. § 41.4l(b)(2).
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Application 13/025,938
Appeal Br. 11 (Claims App.).
In this rejection, as we understand it, the Examiner proposes to
modify Lennox to use the coldwell configuration of White book in place of
the heat pump and reservoir configuration of Lennox. Final Act. 7; see also
id. at 4 (the proposed modification achieves the predictable result of a means
for exchanging heat with a working fluid loop). The Examiner found that
Lennox, as modified to use the coldwell configuration of White book, would
result in "both the catheter cooling loop and the helmet cooling loop
hav[ ing] been modified to include heat exchange coils disposed in the
coldwell." Id. 3 The Examiner further explained that Lennox, as modified by
White book, would provide each of its two separate fluid circuits with its
own heat exchanger, and would continue to use one coldwell for cooling the
two fluid circuits, which would result in the use of one coldwell for cooling
the two heat exchangers. Id. Appellants contend that the proposed
modification of Lennox is based on improper hindsight using claim 24 as a
template to arrive at the claimed subject matter. Reply Br. 4.
We agree with the Examiner's finding that Whitebook discloses that it
was well known at the time of Appellants' invention to cool a working fluid
in a working fluid loop using a coldwell that is in thermal, but not in fluid
contact, with the working fluid. Final Act 3. Further, we agree with the
3 The only mention of Daoud in this rejection appears to be cumulative of
White book for the teaching of a coldwell configuration. Final Act. 7.
Notably, the Examiner does not appear to propose to modify Lennox to
replace its ventricle catheter with an intravascular catheter of either
Whitebook or Daoud.
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Application 13/025,938
Examiner that modifying the means used to cool the working fluid of
Lennox to use the coldwell configuration ofWhitebook would have been
obvious to one of ordinary skill in the art as a mere substitution of one
known means for cooling for another known means for cooling to yield
predictable results. Id. at 4, citing KSR Int'l Co. v. Teleflex Inc., 550 U.S.
398, 416 (2007).
Appellants contend that in making such a modification, one would not
have arrived at two heat exchange elements disposed in the same coldwell
absent resort to improper hindsight reconstruction. Reply Br. 4. We are not
persuaded that the Examiner relied on improper hindsight. As noted by the
Examiner, Lennox discloses cooling two separate working fluid circuits (one
that feeds cooling cap 8 and another that cools cooling catheter 24) using a
single reservoir 65. Ans. 5; see also Lennox, Fig. 6. As the Examiner noted,
the reservoir 65 of Lennox "directly feeds the two cooling loops." Ans. 5.
The Examiner proposes to use, instead, the known technique of cooling
these same two loops through coiled heat exchangers disposed in the
coldwell. Id. We agree with the Examiner's reasoning and findings as to
how one of ordinary skill in the art would have been led by the prior art to
implement the proposed modification. For these reasons, we are not
persuaded that the Examiner erred in rejecting claim 24, or claims 26 and 27,
under 35 U.S.C. § 103(a).
Claim 25 depends from claim 24 and further recites a third heat
exchange element disposable in the coldwell. Appeal Br. 11-12. The
Examiner determined that further modification of the system of Lennox to
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Application 13/025,938
include a third heat exchange element as called for in claim 25 would be a
"mere duplication of essential working parts" that involves only routine skill
in the art. Final Act. 8.
Appellants contend that the Examiner improperly determined that the
subject matter of claim 25 is a mere duplication of parts. Appeal Br. 7
(referring to same argument presented for claim 24). Appellants argue, with
respect to claim 24, that were one skilled in the art to duplicate parts in light
of the prior art teachings, "two heat exchange elements along with their
respective cold wells" would be duplicated. Appeal Br. 6 (emphasis
omitted). Appellants further argue that the Examiner fails to proffer a
"teaching, suggestion, or motivation to modify the references to use only one
cold well to engage either one of two heat exchange elements (such as
coils)" and further fails to articulate what inferences or creative steps a
person of ordinary skill in the art would have employed to arrive at the
claimed invention. Id. at 6-7.
Appellants' argument is premised on the same argument that we
found was not persuasive of error for claim 24, namely that one having
ordinary skill in the art would not have been led to modify Lennox with the
teachings of White book in the manner claimed. For the reasons provided
above in our discussion of claim 24, we agree with the Examiner that the
modification of Lennox with the teaching of White book would have resulted
in a system in which each cooling loop would have a heat exchange element
disposed in thermal, but not in fluid contact, with the fluid in the coldwell.
Further, we agree that the addition of a third cooling loop to the system of
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Application 13/025,938
Lennox, would likewise result in a third heat exchange element disposed in
the same coldwell. See Lennox, para. 57 (disclosing that "[t]he selective
brain cooling system consists of at least one ventricle-cooling catheter"). In
other words, the use of the coldwell as a means for cooling a third heat
exchange element would result in predictable results. An addition of a third
heat exchange element to the teachings of the prior art would have involved
only routine skill in the art, and does not evidence a patentable distinction
over the prior art. In re Harza, 274 F.2d 669, 671 (CCPA 1960) ("mere
duplication of parts has no patentable significance unless a new and
unexpected result is produced").
DECISION
The decision of the Examiner to reject claims 1-6, 9-13, and 15-19 is
REVERSED.
The decision of the Examiner to reject claims 24-27 is 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-IN-PART
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