Ex Parte Davie

Patent Trial and Appeal Board

Aug 15, 2017

13451637 (P.T.A.B. Aug. 15, 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.
13/451,637 04/20/2012 Scott W. DAVIE 21819-352U-C2851.USU1 8556
89554 7590 08/17/2017
Christopher & Weisberg, P.A.
200 East Las Olas Boulevard
Suite 2040
Fort Lauderdale, EL 33301
EXAMINER
NGANGA, BONIFACE N
ART UNIT PAPER NUMBER
3769
NOTIFICATION DATE DELIVERY MODE
08/17/2017 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 SCOTT W. DAVIE
Appeal 2016-001307
Application 13/451,6371
Technology Center 3700
Before DONALD E. ADAMS, RACHEL H. TOWNSEND, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a medical
system for the ablation of scarred tissue. The Examiner entered final
rejections for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
1 Appellant identifies the Real Party in Interest as Medtronic CryoCath LP.
App. Br. 3.
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Application 13/451,637
STATEMENT OF THE CASE
Background
The Specification discloses:
a method and system for treating VT [ventricular tachycardia] by
ablating scarred myocardial tissue containing a reentrant VT
circuit. The method includes identifying an area of scarred
myocardial tissue based at least in part on a measurement of
electrical activity at a plurality of sites within a heart. The
electrical activity may be measured by a plurality of electrodes
coupled to a mapping device. Once an area of scarred
myocardial tissue and its border are identified, substantially all
of the scarred area is ablated using an ablation device capable of
radiofrequency ablation (including phased radiofrequency
ablation techniques), ultrasound ablation, microwave ablation,
laser ablation, hot balloon ablation, and/or cryoablation.
Epicardial and/or endocardial tissue may be ablated. Further,
mapping and ablation functions may be performed by the same
medical device. The method may further include displaying a
visual depiction of the electrophysiological anatomy of the
scarred myocardial tissue on a display device in electrical
communication with a computer. The computer may be
programmed to identify optimal ablation sites, such as an isthmus
associated with a reentrant circuit, based at least in part on the
measurement of the plurality of sensors.
Spec. 1 8.
The Claims
Claims 18, 19, 21, 22, and 24—26 are on appeal. App. Br. i. Claim 18
is illustrative and reads as follows:
18. A medical system for the ablation of scarred tissue,
the medical system comprising:
a medical device including:
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an elongate body including a proximal end and a distal
end; and
a plurality of electrical conduction sensors coupled to the
distal end; and
a console in communication with the plurality of
electrical conduction sensors, the console including a computer,
the computer programmed to identify a border of an area
of scarred tissue on a target tissue based at least in part on
signals from the plurality of electrical conduction sensors, and
the computer being programmed to identify optimal ablation
sites, the optimal ablation sites together comprising at least
substantially the entire area of scarred tissue on the target
tissue.
App. Br. (Claims Appendix) 13 (emphasis added).
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The Issues
The following rejections are before us to review2:
Claims 18 and 19 are rejected under pre-AIA 35 U.S.C. § 102(b)
as anticipated by Harlev.3
Claims 21 and 22 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Harlev and Sherman.4
Claim 24 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Harlev and Sherman.
Claims 25 and 26 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Harlev, Sherman, and Ben-Haim.5
Anticipation:
ISSUE
Does the preponderance of evidence on this record support the
Examiner’s finding that Harlev teaches Appellant’s claimed invention?
2 The Examiner withdrew the rejection of claims 18, 19, 21, and 22 under
pre-AIA 35 U.S.C. § 112, second paragraph, following Appellant’s
amendment after the Final Action. See Advisory Action (mailed March 10,
2015) 3. Accordingly, we do not address this rejection (see App. Br. 4—5).
We also do not address Appellant’s argument (App. Br. 3) regarding the
Examiner’s rejection of the Specification as this matter is petitionable to the
Director rather than appealable to the Board. 37 C.F.R. § 1.181.
3 US 2010/0286551 Al, published Nov. 11, 2010 (“Harlev”).
4 US 2008/0281322 Al, published Nov. 13, 2008 (“Sherman”).
5 US 5,954,665, issued Sept. 21, 1999 (“Ben-Haim”).
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FACTUAL FINDINGS (FF)
FF1. Harlev discloses:
a process for generating anatomical information such as a
chamber anatomy is shown. In general, when the catheter is in
the heart, the signals measured by the PME are different from
that of the homogenous case, that is, when the entire domain is
filled with blood. These differences carry the particular
information about the inhomogeneous distribution of the
material property due to the anatomical features around the
catheter. This impedance characterization does not gather
reliable information from great distances due to the smoothing
effect of the Laplace’s equation which governs potential
distribution in the medium: the injected current will not diffuse
substantially into regions far from the catheter. As such, the
system generates information about local anatomical features by
detecting and recognizing differences based on the
inhomogeneous distribution. In order to reconstruct the entire
chamber anatomy, the catheter is moved around the chamber’s
interior and the impedance characterization is repeated in several
locations. Finally, the collected local anatomical information
belonging to the different locations is merged to form the
anatomy of the entire chamber.
Harlev 1131.
FF2. Harlev discloses:
FIG. 4A shows a schematic description of true chamber
boundary 250, a single catheter 254 and a local parameterized
surface 252 reconstructed from the single catheter position. The
local parameterized surface 252 is generated based on
measurements collected by the PME on catheter 254. ... As
shown in FIG. 4B, after the local surface 252 is generated for a
particular catheter location, the system detects and marks regions
of the local parameterized surface 252 that are valid. Valid
regions of the local surface 252 are region(s) that are expected to
lie on the true chamber boundary 250. These regions are detected
and marked as valid patches (e.g., patches 256a and 256b). As
shown in FIG. 4C, the catheter 254 is then moved to another
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location (e.g., moved from location 258a to location 258b) and
the process of construction of local anatomy and detection of
valid patches is repeated. As shown in FIG. 4C, the system
detects another valid patch 256c based on the information
collected by catheter 254 at location 258b. As shown in FIG.
4D, to reconstruct the entire chamber anatomy or portion of
interest (e.g., a portion of the chamber anatomy, but not the entire
chamber anatomy), the catheter is moved to multiple locations,
using the tracking system for position information in each
location. At each location, the system detects additional valid
patches corresponding to additional region(s) that are expected
to lie on the true chamber boundary 250. As shown in FIG. 4E,
once the catheter has been moved around the entire chamber or
the portion of interest, the chamber boundary 260 is
reconstructed by connecting the valid patches.
Id. 1132.
FF3. Harlev discloses:
Electro-Anatomical Map (“EAM”) Construction
The construction of electro-anatomical maps (EAMs) is a
valuable tool for the diagnosis and therapy of a variety of cardiac
related conditions including congestive heart failure, valve
failure and arrhythmia. For the catheter ablation treatment of
arrhythmia the reconstruction of anatomy provides both an
understanding of the anatomical structure as well as the chamber
boundary on which the three dimensional EAM map is
constructed.
Full Chamber Map
The chamber boundary reconstructed using impedance
measurements disclosed herein can be used as the surface onto
which electrical information is projected. This electrical
information may be collected using a contact scheme or non-
contact scheme. ... In the case of a non-contact scheme, both
electrical and anatomical data may be collected simultaneously
by the MEA catheter thus expediting the EAM generation
process. Electrical information displayed on the EAM can
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include any of a number of isopotentials, bipolar maps, local
activation time, voltage map, dominant frequency map, and the
like.
Partial Chamber EAM Map
In some applications, it is necessary to construct only a partial
EAM of the chamber (e.g., construct an EAM of less than the
entire chamber). That is, to save procedure time, only a portion
of the chamber known to participate in the arrhythmogenic
mechanism needs to be provided on the EAM. For example, in
the case of scar related ventricular tachycardia, only the scarred
area and its immediate surrounding tissue may be required for
clinical treatment. Such portion can represent under 25% of total
chamber area and be collected with a limited number of catheter
locations. For example, less than 10 catheter locations may be
used to generate the partial EAM (e.g., 8 catheter locations or
less, 6 catheter locations or less, 5 catheter locations or less, 4
catheter locations). In such case, as shown in FIG. 9, it is
possible to construct a partial anatomy 336 by meshing a closed
surface around the valid patches (e.g., patches 332a, 332b, and
332c). Since the surface 336 is not complete in this case, such
closed mesh also contains areas 334 where no valid patches exist
nearby. However, those are known from the valid patch selection
process described above and marked invalid. Invalid areas 334
in the mesh can be either transparent or rendered differently (e.g.
show only mesh edges and render mesh faces transparent, display
gray, make semi-transparent).
Once the partial chamber anatomy is constructed, electrical
information can then be displayed only on the valid areas (e.g.,
area 336) of the anatomy using either a noncontact or contact
scheme.
Id. 11 156-162.
FF4. Harlev exemplifies the disclosed mapping strategy in Figure 9,
reproduced below:
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True
FIG, 9
Figure 9 “is a schematic diagram of a partial boundary determination.” Id. 1
102.
FF5. Harlev discloses:
In some aspects, the catheter used to generate the anatomical
information and/or generate the EAM information can
additionally include an electrode for delivering ablation energy
for ablating tissue. As such, a single catheter can generate an
EAM map (including generating the anatomical information
used for the EAM map) and perform ablation of identified
regions of the organ. It is believed that this can provide the
advantage of limiting the number of catheters inserted into the
organ of the patient. For example, an ablation procedure can
involve mapping of electrical activity in the heart (e.g., based on
cardiac signals), such as at various locations on the endocardium
surface (“cardiac mapping”), to identify the site of origin of the
arrhythmia followed by a targeted ablation of the site. A single
catheter inserted into the patient’s heart chamber can be used
both to perform such cardiac mapping (including generating the
anatomy of the heart) and to perform the ablation.
Id. 1167.
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FF6. The Specification discloses:
FIG. 2B shows the ablation step of the method . . .
Specifically, an ablation catheter... is positioned within the scar
boundary 24 in contact with the scarred myocardial tissue 10 (at
a first location i) and activated. The ablation device 18 ... is
placed in contact with the tissue in any manner that best suits the
ablation device 18, 20 used and the area of treatment. . . . After
a sufficient ablation time at the first position, the ablation
catheter 18, 20 is moved to a second location ii and activated.
This step is repeated as many times as is necessary to ablate
substantially the entire area of scarred myocardial tissue 10 (for
example, between approximately 75% and 100% of the scarred
area 10). For example, FIG. 2B shows repetition of the ablation
process in six different locations, which are given reference
numbers i, ii, iii, iv, v, and vi. The effective ablation time may
be determined using known methods, such as based on the
desired ablation depth and known ablation characteristics of the
ablation catheter 18, 20. Further, a position at which the ablation
catheter 18, 20 is positioned may overlap the scar boundary 24
or an area that has already been ablated 28.
Spec. 129.
FF7. The Specification exemplifies the disclosed mapping strategy in
Figure 2B, disclosed below:
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Figure 2B “shows a method for ablating the scarred myocardial tissue.” Id.
113.
FF8. The Specification discloses that the computer may be programmed to
identify optimal ablation sites such as an isthmus associated with a reentrant
circuit, based at least in part on the measurement of the plurality of sensors,
or on a target tissue and the location of an isthmus associated with a
reentrant VT circuit within a target tissue, the identification based at least in
part on the measurement of the electrical conduction sensors. The computer
may use time/amplitude morphology data to identify optimal ablation sites
within the heart and to determine the location of an isthmus 11 based on
voltage mapping data (such as electrical conductivity, signal amplitudes, and
monophasic action potentials). Id. H 8, 9, and 31.
ANALYSIS
The Examiner finds that Harlev teaches Appellant’s claimed invention
(Ans. 2—3). In this regard, the Examiner finds that Harlev and Appellant
both disclose a medical system for the ablation of scarred tissue in which the
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computer is “programmed to identify a border of an area of scarred tissue on
a target tissue . . . and . . . programmed to identify optimal ablation sites . . .
comprising at least substantially the entire area of scarred tissue on the target
tissue.” Id.', FF1—5.
We agree with the Examiner’s factual findings and conclusion that
Harlev teaches a computer programmed to identify optimal ablation sites
that comprise “at least substantially the entire area of scarred tissue on the
target tissue” as claimed.
We agree with the Examiner (Ans. 2) that Harlev discloses a medical
system for ablation of scarred tissue. Harlev ^fl[ 108, 109, Figure 1; FF2.
We further agree with the Examiner that the disclosed system comprises:
[A] medical device including an elongate body including a
proximal end and a distal end (catheter 210); and a plurality of
electrical conduction sensors coupled to the distal end (Fig. 2a-
c, [0119], electrodes 118, 119); and a console in communication
with the plurality of electrical conduction sensors where the
source of ablation energy is located is an inherent feature,
including a computer (processing unit 206), the computer
programmed to identify a border of an area of scarred tissue on a
target tissue based at least in part on signals from a plurality of
electrical conduction sensors ([0161-0162] generating partial
electro-anatomical map (EAM) for scarred area and immediate
surroundings, see Fig. 9, [0131-0132] and Figs. 4A-4D details
process).
Ans. 2; FF1-5.
We agree with the Examiner (Ans. 2—3) that the system
disclosed by Harlev identifies “optimal ablation sites” that comprise
“at least substantially the entire area of scarred tissue on the target
tissue” as used in claim 18 through the process disclosed in Figure 9.
See FF1-5.
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Appellant argues that Harlev discloses ‘“methods and systems for the
determination and representation of... anatomical information’” and
“fails to disclose specific methods or strategies for ablating the mapped
tissue, other than broadly disclosing that the tissue may be ablated as part of
a mapping and ablation procedure.” App. Br. 6.
The Examiner responds that, because the “instant claims are directed
to an apparatus and not process claims” and that Appellant has not claimed
“specific methods or strategies for ablating the mapped tissues or a specific
programming of the computer to identify optimal ablation sites,” that
Appellant cannot use this limitation to distinguish the prior art.
The Examiner has the better position. See Super Guide Corp. v.
DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). (“Though
understanding the claim language may be aided by the explanations
contained in the written description, it is important not to import into a claim
limitations that are not a part of the claim.”).6 For this reason, we are also
unpersuaded by Appellant’s argument that the object of the disclosed
invention “‘is to destroy the reentrant VT circuit within an area of scarred
myocardial tissue 10 with a few applications of ablative energy, instead of
necessitating extensive mapping of an isthmus within the scarred area
followed by repeated ablation, induction, and further mapping.” App. Br. 7.
6 We note that Appellant’s Specification recognizes that ablation techniques
are known in the art and, likewise, does not disclose methods or strategies
for ablating mapped tissues. See e.g., Spec, at 129 (“The effective ablation
time may be determined using known methods, such as based on the desired
ablation depth and known ablation characteristics of the ablation catheter.”)
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Claim 18 does not require ablation and does not exclude “extensive
mapping.”
Appellant next argues “nowhere does the Harlev reference disclose
that optimal ablation sites identified by a computer of the system together
comprise at least substantially the entire area of scarred tissue on the
target tissue.'’'’ App. Br. 7. According to Appellant:
The Harlev reference discloses that “an ablation procedure can
involve mapping of electrical activity in the heart... to identify
the site of origin of the arrhythmia followed by targeted ablation
of the site.'” Based on the teachings of the Harlev reference as a
whole, and the fact that the Harlev reference fails to disclose,
teach, or suggest ablation of at least substantially the entire
scarred area, this paragraph of the Harlev reference is interpreted
to mean that a particular site, such as an isthmus, may be targeted
for a precise ablation procedure, and does not include at least
substantially the entire scarred area.
Id. at 7—8. As a result, Appellant argues, Harlev “fail[s] to disclose a
computer programmed to identify optimal ablation sites that together
comprise at least substantially the entire area of scarred tissue.” Id. at 8; See
also Reply Br. at 10-11 (arguing that displaying an area of tissue does not
equate to identifying optimal ablation sites). Appellant further argues that
because Harlev “does not disclose, teach, or suggest the method of
identifying and treating optimal ablation sites,” it cannot inherently disclose
the functional limitations of the claimed invention, including “a computer
programmed to identify optimal ablation sites as claimed.” Reply Br. at 12.
The Examiner responds that “while features of an apparatus may be
recited either structurally or functionally, claims directed to an apparatus
must be distinguished from the prior art in terms of structure rather than
function.” Ans. 9 (citing In re Schreiber, 128 F.3d 1473, 1477—78,
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(Fed. Cir. 1997) “[Apparatus claims cover what a device is, not what a
device does”).
The Examiner further responds that:
[T]he displayed positions or location of the catheter, that
comprise the entire area or the site of scarred tissue that is being
targeted for ablation (process of Fig. 9 detailed in Figs. 4A-4D)
in Harlev, may be described as identified optimal ablation sites
since by displaying the sites on the display 204, the processing
unit identifies sites within boundary/ region 250, and since
Harlev teaches ablation of identified regions of the organ, the
identified sites would constitute substantially the entire area of
scarred tissue (see [0161]) in the case of scar related ventricular
tachycardia, only the scarred area and its immediate surrounding
may be required for clinical treatment.
Ans. 10.
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared with the prior art. The dispute
centers around “optimal ablation site” and “substantially the entire area of
scarred myocardial tissue.”
The Specification does not define “substantially the entire area of
scarred myocardial tissue” but provides that “for example, between
approximately 75% and 100% of the scarred area” practices the invention.
Spec. 129.
The Specification does not define “optimal ablation site,” but
discloses the following about such sites: “The computer may be
programmed to identify optimal ablation sites, such as an isthmus associated
with a reentrant circuit, based at least in part on the measurement of the
plurality of sensors” (Spec. 1 8); “The computer may be programmed to
identify optimal ablation sites on a target tissue and the location of an
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isthmus associated with a reentrant VT circuit within a target tissue, the
identification based at least in part on the measurement of the electrical
conduction sensors” {Id. 19); and “the computer 30 may be programmable
to use time/amplitude morphology data to identify optimal ablation sites
within the heart and to determine the location of an isthmus 11 based on
voltage mapping data (such as electrical conductivity, signal amplitudes, and
monophasic action potentials)” {Id. 131). FF8. The Specification indicates
that an isthmus is a “channel of slowed electrical conduction.” Id. 1 5.
Therefore, we find that a broadest reasonable interpretation of “optimal
ablation site” is “a channel of slowed electrical conduction located using
time/amplitude morphology data.”
Harlev discloses “[mjethods and systems for the determination and
representation of. . . anatomical information.” Harlev Abstract. Harlev
discloses a method of “Electro-Anatomical Maps ‘EAM’ Construction” in
which a map of the full chamber or of a partial chamber can be constructed
using impedance measurements to collect information about the measured
tissue and display that information in “any of a number of isopotentials,
bipolar maps, local activation time, voltage map, dominant frequency map,
and the like.” FF3.
Harlev discloses that its system:
[Generates information about local anatomical features by
detecting and recognizing differences based on the
inhomogeneous distribution. In order to reconstruct the entire
chamber anatomy, the catheter is moved around the chamber’s
interior and the impedance characterization is repeated in several
locations. Finally, the collected local anatomical information
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belonging to the different locations is merged to form the
anatomy of the entire chamber.
FF1. Where only a smaller area of mapping is required, such as “a portion
of the chamber known to participate in the arrhythmogenic mechanism,”
Harlev discloses a partial map embodiment that teaches mapping of “only
the scarred area and its immediate surrounding tissue” to generate the partial
EAM, thereby identifying areas for clinical treatment. Id. See also Harlev
2, 3, and 6, explaining that mapping techniques are used to detect a
change of connectivity (e.g., impedance) at the cardiac chamber boundary,
based on a conductivity contrast between blood and surrounding tissue, and
thereby map heart conditions such as ventricular arrhythmias (e.g., locations
of the heart containing scarred tissue).
Because Harlev teaches mapping the entire area of a boundary to
create a full EAM, Harlev’s method therefore teaches mapping of the
location of all boundary tissue, which would include all scarred tissue,
including every potential optimal site for tissue ablation. FF1, 3. Thus, we
find the full EAM embodiment teaches “programmed to identify optimal
ablation sites, the optimal ablation sites together comprising at least
substantially the entire area of scarred tissue on the target tissue.'1'’
Harlev further teaches creating a partial chamber EAM map to
identify “only a portion of the chamber known to participate in the
arrhythmogenic mechanism ... in the case of scar related ventricular
tachycardia, only the scarred area and its immediate surrounding tissue may
be required for clinical treatment.” FF3. Because Harlev teaches mapping
of the affected area of interest and that all detected scarred tissues are
ablated, and because Appellant has offered no persuasive evidence or
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argument why this falls beneath the 75% threshold, we agree with the
Examiner that Harlev’s partial EAM embodiment also teaches “programmed
to identify optimal ablation sites, the optimal ablation sites together
comprising at least substantially the entire area of scarred tissue on the
target tissue.'1'’
Appellant has not persuasively demonstrated where any error lies in
the Examiner’s interpretation of Harlev as it relates to the elements or
limitations found in claim 18, and we affirm the rejection of claim 18 as
anticipated. Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989)
(“Attorneys’ argument is no substitute for evidence.”).
CONCLUSION OF LAW
The preponderance of evidence supports the Examiner’s conclusion
that Harlev anticipates the subject matter of claim 18. Claim 19 has not been
argued separately and therefore falls with claim 18. 37 C.F.R.
§ 41.37(c)(l)(iv).
Obviousness:
A. Rejection under 35 U.S.C. § 103(a) over Harlev and Sherman
ISSUE
Does the preponderance of evidence on this record support the
Examiner’s finding that Harlev and Sherman suggest the subject matter of
Appellant’s claims 21 and 22?
ANALYSIS
Claims 21 and 22 are rejected as obvious over the combination of
Harlev and Sherman.
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The Examiner finds Harlev “fails to explicitly disclose at least one
thermoelectric cooling element and at least one electrode in communication
with the at least one thermoelectric cooling element.” Ans. 4. The
Examiner finds that Sherman discloses “a substantially similar analogous
device for mapping and ablating tissue, comprising one or more electrodes
that may be used to deliver ablation energy such as cryogenic energy for the
purpose of ablating tissue.” Id. The Examiner finds the ordinarily skilled
artisan would have found it obvious to “include a thermoelectric cooling
element in communication with a corresponding electrode in the device of
Harlev, in order to achieve the predictable result of ablating tissue as
exemplified by Sherman.” Id.
Appellant relies on the same arguments as advanced in connection
with claim 18 and Harlev (App. Br. 8—9); we find those arguments
unpersuasive for the reasons set forth above.
CONCLUSION OF LAW
The preponderance of evidence supports the Examiner’s conclusion
that Harlev and Sherman suggest the subject matter of claims 21 and 22.
B. Rejection under 35 U.S.C. § 103(a) over Harlev and Sherman
ISSUE
Does the preponderance of evidence on this record support the
Examiner’s finding that Harlev and Sherman suggest the subject matter of
Appellant’s claim 24?
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ANALYSIS
Claim 24 is rejected as obvious over the combination of Harlev and
Sherman.
The Examiner finds that the system of Harlev is configured to
“determine site of origin of arrhythmia based on impedance and to determine
an area of scarred tissue [which] is well known in the art [a]is nonconductive
and thus has high impedance compared to a reentrant circuit and/or normal
tissue which are conductive and thus have relatively low impedance.” Ans.
5. The Examiner further finds the Harlev system can locate an isthmus
“based on impedance measurements within a target tissue.” Id. at 5—6. The
Examiner again relies on Sherman to disclose a thermoelectric cooling
element in communication with the console. Id. at 6. The Examiner further
finds Harlev “fails to explicitly disclose at least one thermoelectric cooling
element and at least one conductive material in communication with the at
least one thermoelectric cooling element and the at least one thermoelectric
element being in communication with the console.” Id.
The Examiner again relies on Sherman for an analogous device for
mapping and ablating tissue, including electrodes for delivery of cryogenic
energy as well as a remote controller for making inputs into the system. Id.
The Examiner concludes that “the thermoelectric cooler is necessarily] in
communication with the remote controller” and that it would be obvious to
the skilled artisan “to include a thermoelectric cooling element in
communication with the console and a corresponding electrode in the device
of Harlev, in order to allow setting of ablation energy parameters and ablate
tissue as exemplified by Sherman.” Id.
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Appellant relies on the same arguments as advanced in connection
with claim 18 and Harlev (App. Br. 10); we find those arguments
unpersuasive for the reasons set forth above. Appellant further argues
Sherman does not cure the deficiencies of Harlev. App. Br. 10. For the
reasons discussed above, we are not persuaded. We affirm the Examiner’s
rejection.
C. Rejection under 35 U.S.C. § 103(a) over Harlev, Sherman, andBen-
Haim.
ISSUE
Does the preponderance of evidence on this record support the
Examiner’s finding that Harlev, Sherman, and Ben-Haim suggest the subject
matter of Appellant’s claims 25 and 26?
ANALYSIS
Claims 25 and 26 are rejected as obvious over the combination of
Harlev, Sherman, and Ben-Haim.
The Examiner finds “the combination of Harlev and Sherman
discloses the claimed invention but for position of the thermoelectric cooling
element or the area of conductive material being distal of the plurality of
electrical conduction sensors.” Ans. 7. The Examiner finds Ben-Haim
discloses a “mapping and ablation catheter ... in communication with a
console and an electrode or area of thermoconductivity [and] alternative [ly],
and arrangement. . . wherein the conductive material/electrode [is] located
distal of electrical conduction sensors 27, 31 and 32.” Id. The Examiner
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finds that it would have been obvious to the skilled artisan “configure the
distal end of the catheter of Harlev as taught by Ben-Haim [because] the said
configuration was known in the art and the substitution of one configuration
for another, to perform the same function of ablating cardiac tissue would
have [a] yielded predictable result as evidenced in Ben-Haim.” Id.
Appellant relies on the same arguments as advanced in connection
with claim 18 and Harlev (App. Br. 10-11); we find those arguments
unpersuasive for the reasons set forth above. Appellant further argues,
without elaboration, that the cited art does not disclose the further limitations
of these claims. Id. at 11. Such an argument is not sufficient as a separate
argument for patentability of these claims. In re Lovin, 652 F.3d 1349, 1357
(Fed. Cir. 2011) (noting that separately arguing a claim requires “more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
found in the prior art.”). We affirm the Examiner’s rejection.
SUMMARY
We affirm the rejection of claims 18 and 19 under pre-AIA 35 U.S.C.
§ 102(b) as anticipated by Harlev.
We affirm the rejection of claims 21 and 22 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Harlev and Sherman.
We affirm the rejection of claim 24 is rejected under pre-AIA 35
U.S.C. § 103(a) as obvious over Harlev and Sherman.
We affirm the rejection of claims 25 and 26 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Harlev, Sherman, and Ben-Haim.
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Appeal 2016-001307
Application 13/451,637
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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