Ex Parte Mantle

Board of Patent Appeals and Interferences

May 6, 2010

10523857 (B.P.A.I. May. 6, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte ROSS E. MANTLE
____________________

Appeal 2009-006617
Application 10/523,857
Technology Center 3700
____________________

Decided: May 6, 2010
____________________

Before LINDA E. HORNER, MICHAEL W. O’NEILL, and
FRED A. SILVERBERG, Administrative Patent Judges.

SILVERBERG, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Ross E. Mantle (Appellant) seeks our review under 35 U.S.C. § 134 of
the final rejection of claims 1-13 and 18-37. We have jurisdiction under 35
U.S.C. § 6(b) (2002).

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SUMMARY OF DECISION
We AFFIRM-IN-PART.

THE INVENTION
Appellant’s claimed invention is directed to processes and devices for
automated liquid recirculation to and from a body cavity (Spec. 1: 7-11 and
Spec. 7: 15-30).
Claims 1, 18, 28 and 32, reproduced below, are representative of the
subject matter on appeal.
1. Apparatus for modulating the temperature
and pressure within a body cavity by means of
recirculation of a biological or biocompatible
liquid within the cavity, but outside of blood
vessels, which comprises: (a) first pump means for
infusing liquid at a controlled temperature and
flow rate into the cavity; (b) means for monitoring
the temperature within the cavity; (c) means for
monitoring the pressure within the cavity; and (d)
second pump means for withdrawing liquid at a
controlled flow rate from the cavity.

18. Apparatus for modulating introduction and
removal of a liquid within a cavity of a patient's
body, the cavity comprising a cavity outside of
blood vessels, the apparatus comprising:
a catheter configured for insertion into the
cavity and introduction and removal of liquid from
the cavity;
one or more sensors positionable in the
patient's body so as to sense a condition of liquid
in the cavity; and
a controlled pumping system operatively
coupled to both the catheter and the one or more
sensors, the controlled pumping system configured
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to control introduction and removal of liquid from
the cavity so as to maintain a selected liquid
condition value.

28. A feedback-controlled apparatus for
introduction and removal of a liquid within a
cavity of a patient's body, the cavity comprising a
cavity outside of blood vessels, the apparatus
comprising:
a catheter configured for insertion into the
cavity and introduction and removal of liquid from
the cavity;
one or more sensors positionable so as to
sense a biological parameter of a patient's body;
and
a controlled pumping system operatively
coupled to both the catheter and the one or more
sensors, the controlled pumping system configured
to modulate a property of the liquid in response to
signals received from the one or more sensors and
to maintain the biological parameter of the
patient's body within a selected range.

32. A method of maintaining a liquid condition
parameter within a body cavity other than a blood
vessel within a patient's body, the method
comprising:
pumping liquid into the cavity;
pumping liquid out of the cavity;
monitoring a parameter of liquid within the
cavity from a sensor disposed within the patient's
body; and
controlling at least one of liquid
temperature, liquid pressure, and liquid flow rate
in response to a liquid condition value measured in
the monitoring step.

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THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Leonard US 3,927,980 Dec. 23, 1975
Osterholm US 4,450,841 May 29, 1984
Gutierrez-Collazo US 5,562,821 Oct. 8, 1996
Ginsburg US 6,497,721 B2 Dec. 24, 2002
Maginot US 6,743,218 B2 Jun. 1, 2004

The following rejections by the Examiner are before us for review:
1. Claims 1-9, 11-13, 18-231, 25-30, 32-34 and 37 are rejected under 35
U.S.C. § 103(a) as being unpatentable over Osterholm in view of
Leonard and Ginsburg.
2. Claim 10 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Osterholm in view of Leonard and Ginsburg, and further in view
of Gutierrez-Collazo.
3. Claims 24, 31, 35 and 36 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Osterholm in view of Leonard and Ginsburg,
and further in view of Maginot.

1 Claims 20, 25 and 26, which are part of this appeal (App. Br. 2), were not
listed in the Grounds of Rejection section of the Examiner’s Answer, as
being rejected over the prior art of record (Ans. 3). However, a discussion
of the rejections of claims 20, 25 and 26 were included in paragraphs [13]
and [14], respectively (Ans. 8-9), which are subparagraphs under paragraph
2 containing the rejection of claim 18 (Ans. 3). Claims 20 and 25 depend
from claim 18, and claim 26 depends from claim 25. Appellant
acknowledges the Examiner’s intentions to reject claims 20, 25, and 26. See
App. Br. 4, fn. 2. Accordingly, we will consider claims 20, 25 and 26 in this
appeal as having been rejected along with claim 18 over Osterholm in view
of Leonard and Ginsburg.
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ISSUES
The issues before us are:
(1) whether the Examiner erred in finding that the combined teachings
of Osterholm, Leonard and Ginsburg would have led a person having
ordinary skill in the art to (a) means to monitor the temperature and pressure
within a cavity, and (b) a pump to withdraw liquid out of space from which
it was injected as called for in claim 1 (Reply Br. 2-3, App. Br. 6-7);
(2) whether the Examiner erred in finding that Osterholm describes “a
catheter configured for insertion into the cavity and introduction and
removal of liquid from the cavity” as called for in independent claims 18 and
28 (App. Br. 7-8); and
(3) whether the Examiner erred in finding that the combined teachings
of Osterholm, Leonard and Ginsburg would have led a person having
ordinary skill in the art to the steps of “monitoring a parameter of liquid
within the cavity from a sensor disposed within the patient's body; and
controlling at least one of liquid temperature, liquid pressure, and liquid flow
rate in response to a liquid condition value measured in the monitoring step,”
as called for in claim 32 (App. Br. 8).

FINDINGS OF FACT
We find that the following enumerated findings are supported by at
least a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849 F.2d
1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for
proceedings before the Office).
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The Examiner’s Findings
1. The Examiner finds that Osterholm describes all of the limitations
called for in independent claims 1, 18, 28 and 32, except that
Osterholm does not describe “that the monitoring means monitor
temperature and pressure within the cavity, nor does it teach a
second pumping means for withdrawing liquid at a controlled rate
from the cavity,” as called for in claim 1 (Ans. 4).
2. The Examiner finds that Osterholm describes an apparatus
comprising a first pump means 18 for infusing a liquid at a
controlled temperature and flow rate into a cavity; means for
monitoring the temperature of the fluid 14, 40; and means for
monitoring the pressure of the fluid 18, 38 (Ans. 4).
3. The Examiner finds that Osterholm’s means for monitoring
temperature and pressure is done within a storage chamber and not
within the body (Ans. 5).
4. The Examiner finds, regarding claims 18 and 28, that “Osterholm
clearly teaches a catheter (i.e. fluid flow line) that is adapted to
introduce and remove fluid from the cavity.” (Ans. 12-13).
5. The Examiner finds that Leonard describes “an extracorporeal
system comprising a first pump 36 capable of infusing a liquid and
a second pump 40 capable of withdrawing a liquid at a controlled
flow rate (see Figure 1).” (emphasis added) (Ans. 4).
6. The Examiner finds that “Leonard generally teaches that the use of
two pumps (one inlet, one outlet) to control the flow of fluid
through a fluid system allows for improved control over pressure
and flow rate.” (Answer 11-12).
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7. The Examiner finds that “Ginsburg generally teaches the use of
body-implanted sensors to monitor temperature and pressure
within a cavity (Column 5, Lines 58-65, Column 14, Lines 49-59,
and Abstract).” (Ans. 12).
The Board’s Findings
8. Osterholm describes withdrawing fluid through a catheter 30 from
the cisterna magna 24, continuously monitoring various chemical
and physical characteristics of the fluid (e.g., temperature,
oxygenation, pressure) by an output monitor (fig. 1), sterilizing and
reconstituting the fluid at step 32, adjusting the temperature to a
preselected temperature 14, 40, controlling the oxygenation 16, 36
and adjusting the pressure 18, 38, (col. 13, l. 30-col. 14, l. 54 and
col. 15, ll. 3-21 and fig. 1).
9. Osterholm describes injecting the fluid through an injection
catheter 120 to the lateral ventricle of the human brain 24 (col. 12,
ll. 30-32 and figs. 1, 13).
10. Osterholm describes using a delivery pump 107 for establishing
the final injection rate (col. 12, l. 13 and fig. 13).
11. In Osterholm, the lateral ventricle 20 of the human brain and the
cisterna magna 24 comprise a cavity as a person having ordinary
skill in the art would understand because the ventricle is in fluid
communication with other portions of the cerebrospinal pathway
and they collectively form a hollow space.2 (See col. 11, ll. 15-35).
12. Leonard describes using two pumps, a first arterial pump 36 and a
second venous pump 40, to aid in protecting an extracorporeal

2 See STEDMAN'S MEDICAL DICTIONARY (27th ed. 2000).
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oxygenator 20 and a heat exchanger 30 from overpressurization
(col. 3, ll. 24-60 and fig. 1).
13. Ginsburg describes (1) that an aspect of the invention is to control
the internal body temperature of a patient, and (2) that feedback
from temperature sensors located within a patient’s body allow for
the control of the heat transfer from the catheter to automatically
control the temperature of the patient or of the target region within
the patient (Abstract).
14. Ginsburg describes that:
[t]he TE cooler and the pump are responsive to
a controller unit 344. The control unit receives
data input through electrical connections
345,346, 347 to numerous sensors, for example
body temperature sensors 348, 349 that may
sense temperatures from a patient’s ear . . . or
other appropriate location as desired by the
operator who places the sensors. Likewise, a
sensor 350 may monitor the temperature of the
heat exchange balloon, and other sensors (not
shown) may be provided as desired to monitor
the blood temperature at the distal tip of the
catheter, at the proximal tip of the catheter, or
other desired location.
(emphasis added) (col. 22, ll. 36-47 and fig. 16).
15. Additional findings as necessary appear in the Analysis portion of
this opinion.

PRINCIPLES OF LAW
Obviousness
“Section 103 forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
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that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.’” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). See
also KSR, 550 U.S. at 407 (“While the sequence of these questions might be
reordered in any particular case, the [Graham] factors continue to define the
inquiry that controls.”).
In KSR, the Supreme Court held that “if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize
that it would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.” KSR, 550
U.S. at 417.
In KSR, the Supreme Court stated that:
Often, it will be necessary for a court to look to
interrelated teachings of multiple patents; the
effects of demands known to the design
community or present in the marketplace; and the
background knowledge possessed by a person
having ordinary skill in the art, all in order to
determine whether there was an apparent reason to
combine the known elements in the fashion
claimed by the patent at issue.

Id. at 418. The Court noted that “[t]o facilitate review, this analysis should
be made explicit.” Id. (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
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(“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.”)). However, “the analysis need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR, 550 U.S. at 418.
In KSR, the Supreme Court stated that “[c]ommon sense teaches,
however, that familiar items may have obvious uses beyond their primary
purposes, and in many cases a person of ordinary skill will be able to fit the
teachings of multiple patents together like pieces of a puzzle. . . . A person
of ordinary skill is also a person of ordinary creativity, not an automaton.”
Id. at 420-421.

ANALYSIS
Rejection of claims 1-9 and 11-13 over Osterholm, Leonard and Ginsburg;
and the rejection of claim 10 over Osterholm, Leonard, Ginsburg and
Gutierrez-Collazo
Appellant argues claims 1-9 and 11-13 as a group (App. Br. 5). As
such, we select claim 1 as representative of the group, and claims 2-9 and
11-13 will stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii) (2009).
Claim 1
Appellant agrees with the Examiner’s finding that Osterholm does not
describe (1) means to monitor the temperature and pressure within a cavity,
and (2) a pump to withdraw liquid out of space from which it was injected as
called for in claim 1. (See Fact 1).
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Appellant contends, however, that Leonard does not describe injecting
and withdrawing liquid from the same cavity as called for in claim 1 (App.
Br. 5). Appellant contends that Ginsburg does not describe means for
monitoring temperature and pressure within a cavity as called for in claim 1
(App. Br. 6). Appellant further contends that the combined teachings of
Osterholm, Leonard and Ginsburg do not describe (1) means to monitor the
temperature and pressure within a cavity, and (2) a pump to withdraw liquid
out of space from which it was injected as called for in claim 1. (Reply Br,
2-3, App. Br. 6-7).
Appellant contends that the Examiner ignored the claim limitation
“outside of blood vessels,” as set forth in the preamble of claim 1. (Reply
Br. 2-3).
The Examiner found that Osterholm describes an apparatus
comprising a first pump means 18 [sic 107] for infusing a liquid into a
cavity; means for monitoring the temperature of the fluid 14, 40; and means
for monitoring the pressure of the fluid 18, 38 (Fact 2), wherein the means
for monitoring the temperature and pressure is done within a storage
chamber and not within the body (Fact 3). (See also Facts 8-10).
The Examiner found that Leonard describes a first pump 36 capable
of infusing a liquid and a second pump 40 capable of withdrawing a liquid
(Fact 5), wherein the use of two pumps allows for improved control over the
pressure of the liquid (Fact 6). In particular, Leonard’s two pumps 36, 40
aid in protecting an extracorporeal oxygenator 20 and a heat exchanger 30
from overpressurization (Fact 12).
The Examiner found that Ginsburg describes body-implanted sensors
to monitor temperature and pressure within a cavity (Fact 7). The Examiner
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concluded that Ginsburg’s internal sensors would improve the accuracy of
the monitoring of the temperature and the pressure (Fact 7).
In particular, Ginsburg describes controlling the internal body
temperature of a patient, wherein feedback from temperature sensors located
within a patient’s body allow for the control of the heat transfer from the
catheter to automatically control the temperature of the patient or of the
target region within the patient (Fact 13, see also Fact 14).
Claim 1 calls for, inter alia, “(b) means for monitoring the
temperature within the cavity; (c) means for monitoring the pressure within
the cavity; and (d) second pump means for withdrawing liquid at a
controlled flow rate from the cavity.”
Claim 1 is drafted in such a manner that there is no interaction
between the claimed elements. The recitation “but outside of blood vessels”
is not limiting because the claimed apparatus is structurally complete within
the claim body. See, e.g., Catalina Mktg. Int’l, Inc. v. Coolsavings.com,
Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)(stating that a preamble is not
limiting where a structurally complete apparatus is recited in the body of the
claim and the preamble merely states an intended use of the apparatus).
Therefore, we find that the combined teachings of the prior art need only
describe the individual elements called for in claim 1 to render obvious the
claimed invention. See KSR, 550 U.S. at 420-421.
We find that in Osterholm, the lateral ventricle 20 of the human brain
and the cisterna magna 24 are a cavity as a person having ordinary skill in
the art would understand that term (Fact 11).
While Osterholm describes using a pump 107 to inject the fluid into
the body cavity, and describes injecting and withdrawing liquid from the
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same cavity (Facts 8, 9), Osterholm does not describe using a pump to
withdraw the fluid (Fact 1).
Leonard does not describe injecting and withdrawing liquid from the
same cavity, but does describe using a first pump to withdraw fluid and a
second pump to inject fluid to prevent overpressurization of an oxygenator
20 (Facts 5, 6, 12).
Monitoring and controlling the pressure of the fluid is a concern of
Osterholm (Facts 2, 8).
Therefore, we agree with the Examiner’s analysis and conclude that it
would have been obvious to a person having ordinary skill in the art to
combine the teachings of Osterholm, Leonard and Ginsburg by providing
Osterholm with a second pump, that is, a pump to withdraw fluid from the
body cavity as taught by Leonard at 40, and to internally monitor both the
temperature and pressure as taught by Ginsburg.
We conclude that providing Osterholm with a pump to withdraw fluid
from the body cavity would not be beyond the level of skill of an artisan in
order to improve a similar device and to yield the predictable result of aiding
in the protecting against overpressurization. See id. at 417.
Additionally, we conclude that providing Osterholm with internal
sensors to measure the temperature and pressure of the fluid could have been
reasonably predicted to yield the result of improving the accuracy of the
monitoring of the temperature and pressure. See id.
Therefore, we conclude that the Examiner has not erred in rejecting
claim 1 over Osterholm, Leonard and Ginsburg. Likewise, the Examiner has
not erred in rejecting claims 2-9 and 11-13 which stand or fall with claim 1.

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Claim 10
Appellant does not present any separate arguments for the
patentability of dependent claim 10 apart from independent claim 1, other
than Gutierrez-Collazo does not overcome the deficiencies of Osterholm,
Leonard and Ginsburg (App. Br. 9).
Therefore, for the reasons set forth in our discussion of the rejection
of independent claim 1, supra, we conclude that the Examiner has not erred
in rejecting claim 10 over Osterholm, Leonard, Ginsburg, and Gutierrez-
Collazo.

Rejection of claims 18-23 and 25-30 over Osterholm, Leonard and
Ginsburg
Appellant contends that Osterholm does not describe “a catheter
configured for insertion into the cavity and introduction and removal of
liquid from the cavity” as called for in independent claims 18 and 28 (App.
Br. 7-8).
The Examiner found that Osterholm clearly teaches a catheter that is
adapted to introduce and remove fluid from the cavity (Fact 4).
Claims 18 and 28 call for, inter alia, a catheter configured for the
introduction and removal of liquid from the cavity. As such, we construe
that the claimed catheter is required to be able to both introduce and remove
liquid.
Osterholm describes injecting fluid via a first catheter 120 and
withdrawing fluid via a second catheter 30. (Facts 8-9). Therefore,
Osterholm describes two different catheters for the introduction and removal
of fluid.
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Accordingly, Osterholm does not describe a catheter configured for
the introduction and removal of liquid from the cavity as called for in
independent claims 18 and 28.
The Examiner has not relied on either Leonard or Ginsburg for any
teaching that would remedy this deficiency in Osterholm. (Ans. 3, 13).
Therefore, we conclude that the Examiner has erred in rejecting
independent claims 18 and 28 over Osterholm, Leonard and Ginsburg.
Likewise, the Examiner has erred in rejecting claims 19-23, 25-27, 29 and
30, which depend from claims 18 and 28, respectively.

Rejection of claims 32-34 and 37 over Osterholm, Leonard and
Ginsburg
Appellant contends that the combined teachings of Osterholm,
Leonard and Ginsburg do not describe the steps of “monitoring a parameter
of liquid within the cavity from a sensor disposed within the patient's body;
and controlling at least one of liquid temperature, liquid pressure, and liquid
flow rate in response to a liquid condition value measured in the monitoring
step,” as called for in claim 32 (App. Br. 8-9).
The Examiner found (1) that Osterholm describes monitoring pressure
and temperature outside the body (Facts 1-3), and (2) that Ginsburg’s body
implanted sensors allow more accurate monitoring of the pressure in the
body. (Fact 7).
The Examiner concluded that “the cited art reasonably suggests teh
[sic the] device as claimed.” (Ans. 14).
We conclude that the Examiner’s analysis is flawed. The Examiner’s
explanation of the rejection improperly sets forth a “reasonable suggestion”
standard as the basis for a proper legal conclusion of obviousness. The
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determination as to whether there was an apparent reason to combine the
known elements of Osterholm and Ginsburg in the manner claimed requires
an analysis regarding the teachings of Osterholm and Ginsburg, and the
knowledge of a person having ordinary skill in the art. However, the
Examiner has not provided an adequate analysis as to how the known
elements of Osterholm and Ginsburg would be combined by a skilled artisan
in the manner called for in independent claim 32. Further, the Examiner has
not adequately articulated a rationale as to why a person having ordinary
skill in the art would have combined the teachings of Osterholm and
Ginsburg in the manner claimed. See id. at 418.
The Examiner has not relied on Leonard for any teaching that would
remedy the deficiency in Osterholm and Ginsburg. (Ans. 3, 13).
Therefore, we conclude that the Examiner has erred in rejecting
independent claims 32 over Osterholm, Leonard and Ginsburg. Likewise,
the Examiner has erred in rejecting claims 33, 34 and 37, which depend from
claim 32.
Rejection of claims 24, 31, 35 and 36 over Osterholm, Leonard,
Ginsburg and Maginot
The Examiner has not relied on Maginot for any teaching that would
remedy the deficiency in the combination of Osterholm, Leonard and
Ginsburg (Ans. 10). We thus conclude that the Examiner also erred in
rejecting claims 24, 31, 35 and 36 over Osterholm, Leonard, Ginsburg and
Maginot.

CONCLUSIONS
The Examiner has not erred in finding that the combined teachings of
Osterholm, Leonard and Ginsburg would have led a person having ordinary
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skill in the art to (1) means to monitor the temperature and pressure within a
cavity, and (2) a pump to withdraw liquid out of space from which it was
injected as called for as called for in claim 1.
The Examiner has erred in finding that Osterholm describes “a
catheter configured for insertion into the cavity and introduction and
removal of liquid from the cavity” as called for in independent claims 18 and
28.
The Examiner has erred in finding that the combined teachings of
Osterholm, Leonard and Ginsburg would have led a person having ordinary
skill in the art to the steps of “monitoring a parameter of liquid within the
cavity from a sensor disposed within the patient's body; and controlling at
least one of liquid temperature, liquid pressure, and liquid flow rate in
response to a liquid condition value measured in the monitoring step,” as
called for in claim 32.

DECISION
The decision of the Examiner to reject claims 1-13 is affirmed. The
decision of the Examiner to reject claims 18-37 is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2007).

AFFIRMED-IN-PART
Klh

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