Ex Parte Burnett et al

Patent Trial and Appeal Board

Jul 19, 2013

11552090 (P.T.A.B. Jul. 19, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DANIEL R. BURNETT, SHANE MANGRUM, and
JARED C. BLANTON
__________

Appeal 2012-003181
Application 11/552,090
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and ULRIKE W. JENKS,
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
for inducing hypothermia, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses that “[h]ypothermia has been shown to
provide distinct medical benefits to stroke and cardiac arrest patients” (Spec.
1, ¶ 0003). The Specification discloses “methods for achieving therapeutic
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hypothermia using minimally invasive access of the peritoneal cavity” (id. at
1, ¶ 0005). The Specification discloses that the
infusion member can also include one or more sensors
configured to sense one or more of flow through the infusion
member, pressure or temperature. In particular embodiments,
the sensor can be a flow or pressure sensor configured to
determine when the tip has entered the peritoneal or other
cavity so as to minimize the chances of injuring a peritoneal
organ.
(Id. at 4, ¶ 0010.)
Claims 5-25 and 27-53 are on appeal. Claim 5, the only independent
claim, reads as follows (emphasis added):
5. A method for inducing hypothermia in a patient, the method
comprising:
inserting an access device a controlled depth into an abdominal wall
of the patient;
determining entry point into the peritoneal cavity utilizing a sensor
output;
advancing an infusion member through the access device and into the
peritoneal cavity of the patient without injuring an organ in the peritoneal
cavity;
monitoring a temperature of the patient at a selected location;
infusing a hypothermic infusate solution into the peritoneal cavity
through the access device or an infusion member positioned within the
access device, wherein an infusion parameter is controlled utilizing the
monitored temperature;
cooling tissue in the peritoneal cavity with the hypothermic solution;
and
reducing the temperature of the patient to a selected temperature.

The Examiner has rejected claims 5-10, 12-24, 27-33, 40-45 and 51
under 35 U.S.C. § 103(a) as obvious in view of Mantle.1 The Examiner has

1 Mantle US 2006/0161107 A1, July 20, 2006.
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also rejected claims 11, 25, 34-39, 46-50, 52 and 53 under 35 U.S.C.
§ 103(a) in view of Mantle and further in view of either Haluck,2 Spears,3
Collins,4 or Klatz.5
The Examiner finds that “Mantle discloses a method for inducing
hypothermia in a patient” (Answer 5) that differs from claim 5 only in that
“Mantle fails to disclose that the infusion member is inserted into a patient
through an access device” (id.). The Examiner finds, however, that “the use
of access devices is known,” and concludes that it would have been obvious
“to use an access device to advance the infusion member, since doing so
would effectively enable the infusion member to be guided in its insertion
into a patient” (id.).
Appellants argue that “Mantle never discloses the affirmative step of
determining entry into the peritoneal cavity using the output of a sensor of
any kind, much less the pressure or temperature sensors” (Appeal Br. 4) and
that “nothing in Mantle points to any kind of need to determine entry into
the peritoneal cavity based on the sensor signal, or any possible benefit from
doing so” (id. at 5).
We agree with Appellants that the Examiner has not adequately
explained how Mantle would have made obvious the disputed limitation.
Mantle discloses “processes and devices for automated extracorporeal
recirculation and chemical manipulation of biological and biocompatible
liquids … in body cavities” (Mantle 1, ¶ 0001). Mantle discloses that a

2 Haluck, US 2004/0138701 A1, July 15, 2004.
3 Spears et al., US 5,693,017, Dec. 2, 1997.
4 Collins, US 6,733,517 B1, May 11, 2004.
5 Klatz et al., US 5,752,929, May 19, 1998.
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“double-barreled catheter is inserted into a body cavity” and liquid is added
to the cavity via one barrel (lumen) and withdrawn via the other barrel
(lumen) (id. at 3, ¶ 0025). Mantle discloses that “a sensor package 21 is
incorporated into the wall of the catheter such that the sensor package 21 can
measure the pressure and temperature of the surrounding tissues” (id. at 3,
¶ 0040) and that “[p]ressure and temperature are continuously monitored by
means of sensors mounted on the primary catheter 8 as described with
respect to sensor package 21” (id. at 5, ¶ 0048).
Claim 5, however, requires “determining [an] entry point into the
peritoneal cavity utilizing a sensor output.” The Specification makes clear
that the claimed step requires using a sensor, such as a pressure or flow
sensor, “to determine when the tip has entered the peritoneal or other cavity”
(Spec. 4, ¶ 0010).
The Examiner reasons that Mantle discloses that pressure and
temperature are continuously monitored by sensors, and that “[i]f the sensor
of the catheter is already monitoring pressure before insertion into the body,
a user monitoring the sensor outputs on the display would notice the change
in pressure prior to insertion of the catheter and after it is placed into the
cavity” (Answer 16-17).
We do not agree that this reasoning supports a conclusion of
obviousness. The Examiner has not pointed to any disclosure in Mantle of
monitoring pressure prior to or during insertion of the sensor into the patient,
nor has the Examiner provided a persuasive reason, based on Mantle’s
disclosure or the knowledge of those skilled in the art, to conclude that doing
so would have been obvious. Mantle’s disclosure that the “sensor package
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… can measure the pressure and temperature of the surrounding tissues”
(Mantle 3, ¶ 0040 (emphasis added)) indicates that the sensors monitor
pressure and temperature within the body cavity, not before or during
insertion of the catheter into the peritoneal cavity.
Thus, we reverse the rejection of independent claim 5 and dependent
claims 6-10, 12-24, 27-33, 40-45 and 51 as being obvious in view of Mantle.
The rejections of dependent claims 11, 25, 34-39, 46-50, 52 and 53
rely on the Examiner’s findings and conclusion with respect to Mantle that
are discussed above. Thus, we also reverse the other rejections on appeal.
SUMMARY
We reverse the rejection of claims 5-25 and 27-53 under 35 U.S.C.
§ 103(a).

REVERSED

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