Ex Parte Wang

Patent Trials and Appeals Board

Feb 5, 2019

11959214 - (D) (P.T.A.B. Feb. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/959,214 12/18/2007
67356 7590 02/07/2019
Marsh Fischmann & Breyfogle LLP
8055 E. Tufts A venue
Suite 450
Denver, CO 80237
FIRST NAMED INVENTOR
Huisun Wang
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.
OB-054400US
(50332-00024)
CONFIRMATION NO.
2357
EXAMINER
WANG, CHANG YU
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
02/07/2019 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):
ptomail@mfblaw.com
ASJM_Patents@abbott.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HUISUN WANG
Appeal2018-000841
Application 11/959 ,214
Technology Center 1600
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2018-000841
Application 11/959 ,214
Appellant1 seeks our review, under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 1, 2, 7-9, 24--29, and 33 (Appeal Brief,
filed May 2, 2016, ("App. Br.") 3, 7.)
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellant's Specification provides a method of determining the
position of a catheter in a patient's body by monitoring a change in blood
gas measurement. (See Spec. ,r,r 7-9.) The change in blood gas
measurement indicates the passage of the catheter from one location in the
patient's body to another location. (See id.)
Appellant argues independent claims 1 and 24 together, as to both
anticipation and obviousness. (See App. Br. 1, 8.) Appellant does not
present separate arguments for the patentability of claims 2, 7-9, 24--29, and
33. (See id.) We focus on claim 1 in our review. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
Appellant's claim 1 recites:
1. A method for use in determining a position of a
catheter a patient's body, comprising the steps of:
transmitting at least one optical signal to tissue from at
least a first optical source disposed proximate to a distal end of
a catheter inserted into the patient's body;
performing a first blood gas measurement using signals
received from an optical detector disposed proximate to said
distal end of said catheter while said distal end of said catheter
is disposed at a first location within the patient's body, wherein
said signals from said optical detector are representative of said
at least one optical signal as applied to the tissue;
1 Appellant reports that the real party in interest is St. Jude Medical, Atrial
Fibrillation Division. (App. Br. 1.)
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Application 11/959 ,214
performing a series of blood gas measurements using
signals received from said optical detector disposed proximate
to said distal end of said catheter while said catheter, said
optical source and said optical detector move from said first
location toward a second location within the patient's body; and
monitoring said series of blood gas measurements as said
distal end of said catheter moves toward said second location of
the patient's body;
identifying a blood gas measurement change, which
exceeds a predetermined threshold, of at least one of said series
of blood gas measurements relative to said first blood gas
measurement; and
generating an output indicating said distal end of said
catheter is located at said second location based on said blood
gas measurement change.
(App. Br. 13, Claims App'x.)
Independent claim 24 is similar to independent claim 1, but includes
the step of performing a medical procedure with the catheter while disposed
at the second location. (App. Br. 14, Claims App'x.)
The Examiner made the following rejections of the claims (Final
Office Action, mailed October 1, 2015, ("Final Act.") 4--24):
Claims References Basis of Rejection
1 and2 Burchman 2 35 U.S.C. § I02(e)
1,2, 7-9,24--29,and Hunter, 3 Burchman, 35 U.S.C. § I03(a)
33 and Hill4
1,2, 7-9,24--29,and Corl, 5 Burchman, and 35 U.S.C. § I03(a)
33 Hill
2 Burchman, US 7,729,735 Bl, issued June 1, 2010.
3 Hunter et al., US 7,599,730 B2, issued October 6, 2009.
4 Hill et al., US 2005/0096707 Al, published May 5, 2005.
5 Corl et al., US 2005/0054905 Al, published March 10, 2005.
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Application 11/959 ,214
1,2, 7-9,24--29,and Claims 19, 22, and 24 N onstatutory
33 of Application No. obviousness-type
12/345,590 double patenting
Findings of Fact
1. Burchman teaches a method for confirming the placement of a
catheter by using a light-emitting array and opposed photodetector to
analyze oxygen saturation in the blood. (See Burchman Abstract.)
2. Burchman teaches "special spectrophotometric oximetry
catheters" that employ fiberoptic wave guides to perform oximetric
monitoring of blood near the catheter's end and thereby allow in vivo
measurement of venous blood oxygenation. (See Burchman 4:32--47.)
3. Burchman teaches a processor and display that indicates
whether the oxygen saturation level comports with venous or arterial blood
based on a measured saturation percentage, where a percentage of about
90% or greater indicates arterial blood and a percentage of about 85% or
lower indicates venous blood. (See Burchman 7:39--49.)
4. Burchman teaches an extended oximetry catheter that is longer
and sufficiently flexible to allow it to be inserted more deeply into a vessel
of the central circulatory system in closer proximity to the cardiopulmonary
system to provide desired data on oxygen saturation. (See Burchman 8:25-
42.)
5. Hunter teaches a catheter carrying multiple location sensors for
identifying the location of the catheter advanced within the cardiovascular
structures of the human body. (See Hunter 2:33-39.)
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Application 11/959 ,214
6. Hunter teaches the location sensors are located near the distal
end of an elongated catheter body. (See Hunter 2:59---60.)
7. Hunter teaches the sensors may provide useful clinical data
related to the catheter position, identify a target tissue site at which medical
therapy will be delivered, or measure physiological signals such as oxygen
saturation. (See Hunter 3 :34--48.)
8. Hunter teaches a method for identifying landmarks within the
heart by measuring oxygen via sensors positioned within the catheter to
provide real time position and orientation information as the catheter is
navigated. (See Hunter 15:21--41; 18:3-17; 22:5-35.)
9. Hunter teaches a method of navigating a catheter to a desired
location by identifying landmarks based upon sensed physiological
conditions and ablating a portion of the cardiac region with the catheter. (See
Hunter 22:5--47.)
10. Corl teaches a probe for in vivo measurement and display of
intravascular parameters such as partial pressure oxygen (P02) and partial
pressure of carbon dioxide (PC02). (See Corl ,r 23.)
11. Corl teaches a single sensor may make multiple readings to
determine a trend in a blood gas parameter, e.g., whether the value is
increasing, decreasing, or stable, where the trend is symbolically indicated
on a display. (See Corl ,r 50.)
12. Corl teaches the oxygen probe can be inserted into the right
atrium of the heart to provide a direct measurement of the oxygen saturation
of mixed venous blood. (See Corl ,r 57.)
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13. Corl teaches advancing a small oxygen sensor mounted on a
probe through a guiding catheter to various locations in the heart and the
great vessels to sample oxygen saturation in vivo. (See Corl ,r 59.)
14. Hill teaches monitoring oxygen in the systemic and/or
pulmonary circulatory systems during a medical procedure. (See Hill ,r 2.)
15. Hill teaches a system for performing a medical procedure,
including a sensor to sense the presence of a gas, concentration of a gas,
presence of oxygen, concentration of oxygen, presence of carbon dioxide,
and/or concentration of carbon dioxide. (See Hill ,r,r 13, 14.)
16. Hill teaches the sensor may be a gas sensor or an optical sensor.
(See Hill ,I 17.)
1 7. Hill teaches the medical procedure may be a cardiac procedure
or an ablation procedure, including ablation of arrhythmias. (See Hill ,r,r 20,
98.)
18. Hill teaches the method for performing the medical procedure
may include sensing a first value of a biological characteristic and sending a
first signal, inhibiting the beating of the heart in response to the first signal,
performing the medical procedure, sensing a second value of the biological
characteristics, and stimulating the beating of the heart in response to the
second signal. (See Hill ,r 21.)
Analysis
35 USC§ 102(e)-Burchman
The Examiner rejected claims 1 and 2 as anticipated by Burchman.
The Examiner finds that Burchman discloses a method of determining
oxygen saturation by measuring absorption of light by blood passing
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Application 11/959 ,214
between a light emitter and a photodetector of a catheter. (See Final Act. 6-
7.) The measured oxygen saturation is used to determine a catheter location
and is compared to a signal from a non-invasive co-oximeter at a different
location. (See Final Act. 7 .)
Appellant argues that the Burchman catheter does not take "a series of
blood gas measurements as the catheter moves from a first position to a
second position or generate an output indicating the distal end of the catheter
is located at the second position based on a change in the blood gas
measurements." (App. Br. 6.) Appellant argues that, therefore, Burchman
does not disclose performing and monitoring a series of blood gas
measurements as the distal end of the catheter moves from a first location to
a second location. (See id.) Moreover, Appellant argues that Burchman
does not teach the limitation of "generating an output indicating said distal
end of the catheter is located at said second location based on said blood gas
measurement change." (See App. Br. 7 .)
We agree with Appellant that the Examiner erred in rejecting
independent claim 1 as anticipated, because we do not find that Burchman
discloses the steps of performing a series of blood gas measurements with a
catheter as the catheter moves from a first to a second location, nor does
Burchman disclose generating an output indicating the catheter is located at
the second location. Although Burchman discloses a method of measuring
blood gas, including using an extended oximetry catheter that can be
inserted into the cardiopulmonary system, the method measures oxygen
saturation with the catheter at one location to determine the presence of
arterial or venous blood. (FF 1--4.) The Examiner cites Burchman claim 11
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for a method of analyzing a signal from a non-invasive co-oximeter. (See
Final Act. 7.) However, this step of measuring at a second location is not
performed by the optical detector located on the catheter as required by the
claims. For this reason we reverse the rejection of claim 1, or claim 2,
which depends on claim 1, as being anticipated under 35 U.S.C. § 102(e) by
Burchman.
35 USC§ 103(a)-Hunter, Burchman, and Hill
The Examiner finds that Hunter teaches a navigable catheter carrying
multiple localization sensors, which measure and monitor blood pressure
and blood oxygen saturation as the navigable catheter moves to different
locations. (See Final Act. 12.) The Examiner finds that Hunter does not
explicitly teach transmitting an optical signal from a source to a detector,
located proximate to the distal end of the catheter. (See id.) The Examiner
finds that Burchman teaches a method for determining location of a catheter
by determining oxygen saturation with a light emitter and photodetector
located proximate to the distal end of the catheter. (See Final Act. 13-14.)
The Examiner finds Hill teaches using a catheter to perform a medical
procedure based on a blood gas measurement. (See Final Act. 16.) The
Examiner determines that it would have been obvious to a person of
ordinary skill in the art to combine the teachings of Hunter, Burchman, and
Hill to perform a medical procedure based on blood gas measurement using
a catheter with a blood gas measurement structure. (See id.)
Appellant argues that "none of the cited references disclose generating
an output indicating that the distal end of the catheter has moved to a second
location based on a change in a blood gas measurement." (App. Br. 11.)
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More specifically, Appellant argues that Hunter fails to disclose using blood
gas measurements for localization purposes or to determine a change in
location. (App. Br. 9.) Likewise, Appellant argues that Hill fails to disclose
identifying a change between blood gas measurements taken as a catheter
moves from a first location and a second location, or generating an output
indicating the catheter is located at the second location. (App. Br. 10.)
We are not persuaded by Appellant's argument that the combination
of prior art as a whole does not teach using blood gas measurements for
location purposes and generating an output indicating a catheter has moved
to a second location using blood gas measurement. See In re Merck & Co.,
800 F.3d 1091, 1097 (Fed. Cir. 1986). Hunter specifically teaches real time
measuring of position and orientation to identify landmarks within the heart
using a catheter with an oxygen sensor. (See FF 7-8.) Burchman teaches a
display that provides an output indicating a desired location based on an
oxygen saturation threshold. (See FF 3.) Both Hunter and Hill teach
performing medical procedures, e.g. ablating cardiac tissue, with the catheter
once the catheter is navigated to a desired location. (See FF 9, 18.) Given
that the prior art teaches navigating a catheter to a desired location from an
initial location using real time monitoring of a blood gas threshold, we find
it would have been within the level of ordinary skill in the art to identify and
generate an output of the desired location based on blood gas measurement
change. See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007) ("[T]he
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.")
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Appellant argues Hunter teaches away from using oxygen saturation
information to determine location "through the incorporation of the
electromagnetic sensors used for localization purposes." (App. Br. 9.) We
are not persuaded by Appellant's argument because Hunter's mere
disclosure of electromagnetic sensors does not constitute teaching away
from oxygen sensors, absent any criticizing, discrediting, or discouraging the
use of oxygen sensors. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004).
Appellant argues "it is unclear why one skilled in the art would
modify the dedicated localization sensor system of Hunter to generate a
system that outputs a position of a distal end of a catheter based on blood gas
measurement absent Appellant's disclosure" and that the Examiner utilized
impermissible hindsight. (App. Br. 12.) We disagree. As discussed above,
the Examiner takes into account only knowledge that was within the level of
ordinary skill in the art at the time the invention was made and provided a
rationale to combine, i.e., to navigate a catheter to a desired location using
blood gas measurements. Therefore, the Examiner properly reconstructs the
prior art. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). We
consequently affirm the Examiner's rejection.
35 US.C. § 103(a)-Corl, Burchman, and Hill
The Examiner finds that Corl teaches a method of measuring blood
gas with a probe to indicate that the probe is positioned at a desired location
and to identify a change in oxygen saturation. (See Final Act. 18.) The
Examiner finds that Corl does not teach an optical signal and detector, nor
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moving a catheter from a first to a second location while taking a series of
blood gas measurements and generating an output indicating the catheter is
located at the second location. (See Final Act. 19.) As discussed above, the
Examiner finds these steps are taught by Burchman and Hill. The Examiner
determines it would have been obvious to combine the teachings of Corl,
Burchman, and Hill to perform a medical procedure based on blood gas
measurements using a catheter having a blood gas measurement structure
that transmits and detects optical signals. (See Final Act. 22.)
Appellant argues that "Corl is directed to a static apparatus for
measuring blood gas parameters of a patient" and "[ t ]he probe 18 of Corl
does not move after insertion." (App. Br. 9.) Thus, Appellant argues the
probe of Corl does not take a series of blood gas measurements as a catheter
moves from a first to a second location. (See id.)
We are not persuaded by Appellant's arguments against the
combination of Corl, Burchman, and Hill. Corl teaches a blood gas probe
that is used to determine trends in a blood gas parameter that can be
indicated on a display (FF 11 ). The probe may be inserted into the atrium to
provide direct measurement of oxygen saturation of mixed venous blood (FF
12). Moreover, Corl teaches advancing a small oxygen sensor mounted on a
probe to various locations in the heart and great vessels to sample oxygen
saturation in vivo. (FF 13) As discussed above, Burchman teaches a display
output that indicates a desired location based on an oxygen saturation
threshold, and Hill teaches performing medical procedures with a catheter
once the catheter is navigated to a desired location. (See FF 3, 18.) Given
that the prior art teaches navigating a catheter to various locations in the
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heart to sample oxygen saturation, we find it would have been within the
level of ordinary skill in the art to identify and generate an output of the
desired location based on blood gas measurement change.
Appellant argues "it is unclear why one would modify the stationary
inter-vascular measurement probe 18 of Corl with the stationary vascular
compartment confirming penetrating catheter of Burchman to arrive at the
claimed subject matter." (App. Br. 12.) We are not persuaded by
Appellant's argument that the combination of Corl and Burchman "is an
exercise of impermissible hindsight." (Id.) As discussed above, Corl is not
limited to a stationary device. (See FF 13.) Moreover, the Examiner takes
into account only knowledge that was within the level of ordinary skill in the
art at the time the invention was made and provided a rationale to combine,
i.e., to navigate a catheter to a desired location using blood gas
measurements. Therefore, the Examiner properly reconstructs the prior art
and we affirm the rejection of the claims. See In re McLaughlin, 443 F.2d at
1395.
Obviousness-Type Double Patenting
The Examiner provisionally rejected claims 1, 2, 7-9, 24--29, and 33
over claims 19, 22, and 24 of pending Application No. 12/345,590. (See
Examiner's Answer 23-24.) Appellant does not argue or otherwise mention
the obviousness-type double patenting rejection in their Appeal Brief. We
consequently summarily affirm the Examiner's rejections on this ground.
See 3 7 C.F .R. § 41.3 7 ( c )(iv) ("[ A ]ny arguments or authorities not included
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in the appeal brief will be refused consideration by the Board for purposes of
the present appeal.").
Conclusion
Upon consideration of the record and the reasons given,
the Examiner's rejection of claims 1 and 2 under 35 U.S.C. § 102( e)
over Burchman is not sustained;
the Examiner's rejection of claims 1, 2, 7-9, 24--29, and 33 under 35
U.S.C. § 103(a) over Hunter, Burchman, and Hill is sustained;
the Examiner's rejection of claims 1, 2, 7-9, 24--29, and 33 under 35
U.S.C. § 103(a) over Corl, Burchman, and Hill is sustained; and
the Examiner's rejections of claims 1, 2, 7-9, 24--29 and 33 on the
basis of obvious-type double-patenting over claims 19, 22, and 24 of US
12/345,590 is sustained;
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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