Ex Parte Stewart et al

Patent Trial and Appeal Board

Aug 4, 2017

13084853 (P.T.A.B. Aug. 4, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/084,853 04/12/2011 Mark T. STEWART 21819B-328U-P0040839.00 1910
89554 7590 08/08/2017
Christopher & Weisberg, P.A.
200 East Las Olas Boulevard
Suite 2040
Fort Lauderdale, EL 33301
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/08/2017 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 @ c wiplaw. com
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK T. STEWART,
SCOTT W. DAVIE, and GILES DESROCHERS
Appeal 2016-004339
Application 13/084,8531
Technology Center 3700
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods that
involve mapping the electrical activity of an anatomical region of interest,
such as the heart, of a patient. The Examiner rejected the claims for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses that “[cjombining imaging capacity with
electrophysiological information in an easily accessible, informative
1 Appellants state that the “real party in interest is Medtronic Ablation
Frontiers LLC.” App. Br. 1.
Appeal 2016-004339
Application 13/084,853
presentation to the physician benefits diagnosis and treatment efforts . . .
Spec. 17. The Specification explains that, under certain circumstances, the
characteristics of the sensed electrophysiological information may “suggest
that the tissue site may include inactive myocardial cells constituting scar
tissue or ablated tissue, or that the contact between the [sensing] medical
device . . . and the tissue site is insufficient.” Id. 142.
Claims 1, 14, and 21, the independent claims on appeal, are
illustrative and read as follows (App. Br. 13, 15—18; emphasis added):
1. A method of displaying electrophysiological information;
comprising:
obtaining a three-dimensional rendering of an
anatomical region;
obtaining a monophasic action potential signal
with a medical device from at least a portion of the
anatomical region;
obtaining an electrocardiogram signal from at least
a portion of the anatomical region;
calculating a value associated with a depolarization
segment of the monophasic action potential signal;
displaying a graphical indicator of the value on the
rendering of the anatomical region;
comparing at least a portion of the monophasic
action potential signal to at least a portion of the
electrocardiogram signal and assessing the contact
between the medical device and the anatomical region
based at least in part on the comparison', and
generating an alert based at least in part on the
comparison.
14. A method of mapping electrophysiological information,
comprising:
receiving imaging information for a tissue region;
receiving a monophasic action potential signal
from the tissue region using a medical device with one or
more mapping electrodes;
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receiving an electrocardiogram signal from the
tissue region using the medical device;
assigning a value corresponding to a depolarization
segment of the monophasic action potential signal;
receiving location information associated with the
monophasic action potential signal;
generating an image based on the imaging
information, the assigned value, and the location
information; and
comparing at least a portion of the monophasic
action potential signal and at least a portion of the
electrocardiogram signal and assessing the quality of the
monophasic action potential signal based at least in part
on the comparison.
21. A medical system, comprising:
a display;
a control unit in communication with the display,
the control unit programmed to:
receive a monophasic action potential signal,
receive three-dimensional location information
associated with the monophasic action potential signal,
receive an electrocardiogram signal;
calculate a value corresponding to a depolarization
segment of the monophasic action potential signal;
generate an image based on the three-dimensional
location information and the calculated value; and
compare at least one of a timing and a waveform
of the monophasic action potential signal to at least one
of a P-wave segment, a QRS complex, and a T-wave
segment of the electrocardiogram signal and assess the
quality of the monophasic action potential signal based
at least in part on the comparison.
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Application 13/084,853
The sole rejection before us for review is the Examiner’s rejection of
claims 1—8 and 10—24 under 35 U.S.C. § 103(a) for obviousness over
Afonso2 and Keidar.3 Final Action 2-4 (entered April 9, 2015).
DISCUSSION
In rejecting claim 1 over Afonso and Keidar, the Examiner found that
Afonso teaches a process having essentially all of the claimed features, but
differing from claim 1 in that “Afonso fails to expressly disclose a step of
comparing the monophasic action potential signal to at least a portion of the
electrocardiogram signal and assess contact between the device and
anatomical region.” Final Action 3.
As evidence that the process of claim 1 would nevertheless have been
obvious, the Examiner found that, in “the same field of endeavor, Keidar
specifies the comparison of the monophasic action potential signal from an
electrode at the tip of a catheter (e.g. 1 [0110]) to an ECG signal generated
by an ECG monitor, and assesses the contact between the device and
anatomical region (e.g. 1 [0121]).” Id. The Examiner also found that,
although neither reference teaches claim 1 ’s step of generating an alarm,
generating of alerts and/or alarms “are common programming options in the
art of implantable medical devices.” Id.
Based on the references’ teachings and the knowledge in the art, the
Examiner concluded:
It would have been an obvious design choice to one of ordinary
skill in the art at the time of the invention to compare the signal
derived from an ablation catheter to at least a portion of an
electrocardiogram and generate an alert based on the
2 US 2007/0073179 A1 (published Mar. 29, 2007).
3 US 2004/0078036 A1 (published Apr. 22, 2004).
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Application 13/084,853
comparison and assessment in order to yield the predictable
results of providing an effective warning step for avoiding
inadvertent contact and ablation during a procedure.
Id.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Ultimately, “[i]n determining whether obviousness is established by
combining the teachings of the prior art, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
Thus, statements lacking a rational underpinning or evidentiary
support are inadequate to support a conclusion of obviousness. See KSR
Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (‘“[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.’”); see also In
re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000) (“Whether the Board relies
on an express or an implicit showing, it must provide particular findings
related thereto. Broad conclusory statements standing alone are not
‘evidence.’” (Citation omitted)).
In the present case, Appellants persuade us that the Examiner has not
adequately articulated an evidence-supported basis for concluding that the
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process recited in claim 1 would have been prima facie obvious to an
ordinary artisan. As Appellants contend, claim 1 requires comparing at least
a portion of a detected monophasic action potential signal to at least a
portion of a detected electrocardiogram signal and assessing the contact
between the medical device and the anatomical region based at least in part
on the comparison. App. Br. 13.
As noted above, the Examiner found that Keidar discloses that
comparison, as well as claim 1 ’s step of assessing the contact between the
medical device and the anatomical region based at least in part on the
comparison. Final Action 3 (citing Keidar || 110, 121). Responding to
Appellants’ arguments, the Examiner explains as follows:
The energy dose information of Keidar is interpreted as meeting
the claimed “at least a portion of the monophasic action
potential signal”. It is important to understand that the “energy
dosage information” includes a plurality of measurements as
noted in []| 27 of Keidar. This includes not only the power
applied at the point of contact between the medical device and
the anatomical region, but also the measure of impedance which
is specifically for measuring the quality of contact between the
tip electrode and tissue during the ablation procedure - see []]f
128. This information is compared to / synchronized using the
ECG signal generated by the ECG monitor as noted in
referenced section of Keidar - specifically []]f 121, where “the
computer uses an ECG signal generated by ECG monitor 34 for
synchronizing the location information with the energy dose
information”. Appellant further asserts that Keidar fails to
teach or suggest using that comparison to “assess the contact
between the medical device and the anatomical region”;
however, the entire purpose of the mapping and ablation
technique in the prior art is to perform this location
determination and comparison of the signals to assess energy
dose information when ablation is performed at the tissue
contact point. Therefore, the energy dose information (i.e.
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measure of impedance) would provide a clear assessment of the
contact between the medical device and the anatomical region.
Ans. 2—3.
We acknowledge Keidar’s disclosure of using impedance as an
indication of the “quality of contact” during ablation between the tip of its
electrode and the tissue. Keidar 1128.
We also acknowledge Keidar’s disclosure that its ablation power
generator “measures one or more of the following: (a) the temperature of the
temperature sensors, (b) power applied to the tissue of the cardiac chamber,
and (c) the measure of impedance. The ablation power generator transmits
this energy dose information to the location system control unit and/or the
ECG monitor.” Id. 127.
We also acknowledge Keidar’s disclosure that, in its process of tissue
ablation, the computer that controls the process “uses an ECG signal
generated by ECG monitor 34 for synchronizing the location information
with the energy dose information. For each cardiac cycle, the computer
preferably associates the location of tip 44 at the annotation point with the
series of measurements, at a synchronization step 72.” Id. 1121.
We are not persuaded, however, that the Examiner has adequately
explained why measuring impedance at the electrode tip, as taught in Keidar,
necessarily equates to obtaining a monophasic action potential, as
Appellants’ claim 1 requires. Nor has the Examiner explained adequately
how or why measuring impedance equates to a disclosure of obtaining a
monophasic action potential, calculating a value associated with a
depolarization segment of the monophasic action potential signal, and then
comparing the obtained value to a distinct ECG signal, and in turn, using
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that comparison as a measure of the contact between the action potential­
sensing device and the evaluated tissue, as claim 1 also requires.
To the contrary, Keidar’s assessment of the quality of contact between
the electrode and tissue rests solely on impedance, and not on a comparison
with an ECG signal. See Keidar 1128. Although the ECG signal
synchronizes the energy dose information (which may include the
impedance measurement) and location information (id. 1121), the Examiner
has not explained adequately how or why the ECG signal is involved in
Keidar’s actual assessment of the contact between the action
potential-sensing device and the evaluated tissue, as Appellants’ claim 1
requires.
In sum, because we are not persuaded that the Examiner has explained
adequately why the combination of Afonso and Keidar teaches or suggests a
process having all the steps and features of Appellants’ claim 1, we reverse
the Examiner’s rejection of that claim, and its dependents, over those
references.
In rejecting claim 14 over Afonso and Keidar, the Examiner stated as
follows: “Afonso compares a portion of the monophasic action potential
signal and at least a portion of the electrocardiogram signal to assess the
quality of the signal based on the comparison (e.g. 1 [44] - where the VI
signal assesses the quality by comparing the events detected).” Final Action
3^4.
Responding to Appellants’ arguments, the Examiner explains further:
[Paragraph] 44 [of Afonso] was cited to meet the claimed step
of comparing at least a portion of the monophasic action
potential signal and at least a portion of the electrocardiogram
signal and assessing the quality based in part on the comparison
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Application 13/084,853
because this section describes the measuring of specific regions
of the heart for peak to peak voltage. Peak to peak
measurements are based on the peaks measured by the ECG
signal itself. The measuring of the peak to peak voltage at
different locations of the heart is the comparison of the
monophasic action potential with a portion of this
electrocardiogram signal. The voltage determined during this
comparison is then assessed to determine the quality of the
signal - whether it is a result of infarct or ischemic tissue.
Ans. 4.
Appellants persuade us that the Examiner has not adequately
articulated an evidence-supported basis for concluding that the process
recited in claim 14 would have been prima facie obvious to an ordinary
artisan. As Appellants contend, claim 14 requires comparing at least a
portion of a monophasic action potential signal and at least a portion of an
electrocardiogram signal and assessing the quality of the monophasic action
potential signal based at least in part on the comparison. App. Br. 16.
Afonso describes a process of generating a three-dimensional map of
the electrical activity of the heart using multiple sensing electrodes. Afonso,
Abstract; see also id. 126. Paragraph 44 of Afonso, cited by the Examiner
as describing the comparing and assessing steps of claim 14, reads as
follows:
The amplitude of the voltage signal ROV corresponding
to the roving electrode 31 is also shown on panel 66 of FIG. 5.
The amplitude of the time-varying signal ROV is located
between two adjustable bands 74 and 76, which can be used to
set selection criteria for the peak-to-peak voltage of the signal
ROV. In practice, regions of the heart with low peak-to-peak
voltage are the result of infarct tissue, and the ability to convert
the peak-to-peak voltage to grayscale or false color allows
identification of the regions that are infarct or ischemic. In
addition, a time-varying signal “VI” is also shown and
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corresponds to a surface reference electrode, such as a
conventional ECG surface electrode. The signal VI, for
example, may orient a user, such as a physician, to the same
events detected on the surface of the patient.
Afonso 144.
We agree with the Examiner that Afonso, thus, discloses that the
peak-to-peak voltage of the roving electrode signal provides an assessment
of the quality of the action potential signal (indicating infarcted or ischemic
tissue). However, rather than teaching or suggesting that the signal sensed
by ECG electrode, when compared to the roving electrode signal, allows
assessment as to whether the tissue is infarcted or ischemic (i.e., an
assessment of the quality of the signal as required by Appellants’ claim 14),
the signal V1 corresponding to the surface reference electrode simply
“orient[s] a user, such as a physician, to the same events detected on the
surface of the patient.” Id.
We are not persuaded, therefore, that the Examiner has explained
adequately how or why a comparison of the roving electrode signal to the
ECG signal sensed by the surface reference electrode provides an
assessment of the quality of the action potential signal, as required by
Appellants’ claim 14. Because we are not persuaded that the Examiner has
explained adequately why Afonso and Keidar teach or suggest a process
having all of the steps and features of claim 14, we reverse the Examiner’s
rejection of that claim, and its dependents, over those references.
In rejecting claim 21 over Afonso and Keidar, the Examiner cited
Afonso as teaching a system having substantially all of the features required
by the claim, and found that Keidar, “[a]s noted above,. . . compares the
timing of the monophasic action potential signal to the position in the
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cardiac cycle, which is necessarily a P, QRS, or T wave segment.” Final
Act. 4. In responding to Appellants’ arguments, the Examiner relies on the
discussion as to claim 14, noted above, and explains further:
With respect to the comparison of a timing and waveform of a
monophasic action potential to at least one of a P-wave, QRS
complex, and T wave segment, the examiner notes that both
Afonso and Keidar specifical[l]y discuss the monitoring and
correlating values throughout the cardiac cycle of the patient.
The P segment, QRS complex, and T-wave segment together
form the entire cardiac cycle; accordingly, the comparison must
occur during at least one of the 3 segments.
Ans. 4—5.
Similar to claims 1 and 14 discussed above, Appellants’ claim 21
recites a medical system with a control unit programmed to compare at least
one of a timing and a waveform of a monophasic action potential signal to at
least one of a P-wave segment, a QRS complex, and a T-wave segment of an
electrocardiogram signal, and to assess the quality of the monophasic action
potential signal based at least in part on the comparison. App. Br. 17.
As discussed above in relation to claim 1, we are not persuaded that
the Examiner explained adequately how or why measuring impedance as
taught in Keidar necessarily equates to obtaining a monophasic action
potential, which the system of Appellants’ claim 21 is programmed to do.
Nor are we persuaded that the Examiner explained adequately how or why
Keidar teaches or suggests programming a system to (a) obtain a
monophasic action potential, (b) compare that signal to a distinct ECG
signal, and, in turn, (c) use that comparison as a measure of the quality of the
monophasic action potential signal, as claim 21 also requires.
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As discussed above in relation to claim 14, we are also unpersuaded
that the Examiner explained adequately how or why Afonso’s comparison of
its roving electrode signal to the ECG signal sensed by its surface reference
electrode provides an assessment of the quality of the action potential signal,
as required by Appellants’ claim 21. Accordingly, because we are not
persuaded that the Examiner has explained adequately why the combination
of Afonso and Keidar teaches or suggests a process having all the features of
Appellants’ claim 21, we reverse the Examiner’s rejection of that claim, and
its dependents, over those references.
SUMMARY
We reverse the Examiner’s rejection of claims 1—8 and 10—24 under
35 U.S.C. § 103(a) for obviousness over Afonso and Keidar.
REVERSED
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