Ex Parte Sharareh et al

Patent Trial and Appeal Board

Oct 26, 2018

11644312 (P.T.A.B. Oct. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/644,312 12/22/2006
144837 7590 10/30/2018
Roberts Mlotkowski Safran Cole & Calderon, P.C.
7918 Jones Branch Drive
Suite 500
Mclean, VA 22102
Shiva Sharareh
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. CONFIRMATION NO.
400528-20026 5791
EXAMINER
HUPCZEY, JR, RONALD JAMES
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
10/30/2018 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):
kpredmore@rmsc2.com
docketing@rmsc2.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHIV A SHARAREH and CHAD A. LIEBER 1
Appeal2017-001050
Application 11/644,312
Technology Center 3700
Before DEBORAH KATZ, ELIZABETH A. LA VIER, and
TA WEN CHANG, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
catheter for opto-acoustic tissue assessment, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
According to the Specification, "[ f]or certain types of minimally
invasive medical procedures" such as cardiac ablation for treating atrial
fibrillation, "real time information regarding the condition of the treatment
1 Appellants identify the Real Party in Interest as Biosense Webster, Inc.
(Appeal Br. 1.)
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Application 11/644,312
site within the body is unavailable." (Spec. ,r 2.) The Specification states
that "[l]aser optoacoustic technology can offer ... [i]mprovement in
sensitivity, spatial resolution and interpretation of images" over other
technologies currently used to evaluate the effectiveness of lesions formed
by ablation to treat atrial fibrillation. (Id. ,r 9.) However, further according
to the Specification, application of laser optoacoustic technology "has been
limited due to various factors, including space constraints and integration of
the equipment to provide irradiation and detection of optoacoustic data."
(Id.) The Specification states that, "[t]hus, there is a need for an integrated
electrophysiologic catheter capable of monitoring tissue and performing
lesion assessment, especially for endocardial and epicardial tissue, in real-
time using optoacoustic technology for improved sensitivity and spatial
resolution." (Id. ,r 10.)
Claims 1-16 and 19-32 are on appeal. 2 Claim 1 is illustrative and
reproduced below:
1. A catheter for opto-acoustic tissue assessment,
compnsmg:
a catheter body;
a tip section distal the catheter body, the tip section
comprising a tip electrode adapted to ablate the tissue, the tip
electrode comprising a shell and a plug, the shell comprising a
shell wall that defines a cavity,
an optical waveguide mounted in a first opening in the
shell wall of the tip electrode, the optical waveguide being
adapted to deliver irradiation energy to the tissue during
ablation, wherein the irradiation energy heats the tissue being
ablated to produce an acoustic wave,
2 The Examiner included claim 33 in the obviousness rejection to be
reviewed on appeal. (Ans. 2.) However, claim 33 has been cancelled.
(Appeal Br. 19 (Claims App.); Final Act. 2.)
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at least one acoustic detector mounted in a second
opening in the shell wall of the tip electrode for acoustically
detecting the acoustic wave from the tissue during ablation, the
second opening being from the cavity of the tip electrode
through the shell wall of the tip electrode, wherein the at least
one acoustic detector is configured to generate a signal
representative of a tissue characteristic of the tissue during
ablation, and wherein the first and second openings are
positioned such that the optical waveguide, the tip electrode
adapted to ablate the tissue, and the at least one acoustic
detector are configured to interact with the tissue from a
common orientation, such that the optical waveguide and the at
least one acoustic detector are each generally facing the tissue
such that the direction of irradiation of the tissue and the
direction of acoustic detection of the tissue are generally
opposite to each other.
(Appeal Br. 14 (Claims App.).)
The Examiner rejects claims 1-16 and 19-32 under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Keidar, 3 Oraevsky, 4 Pesach, 5
and Chandrasekaran. 6 (Ans. 2.)
DISCUSSION
Issue
The Examiner finds that Keidar discloses most of the limitations of
claim 1 except that it does not disclose "an optical waveguide mounted in a
separate opening of the shell wall of the tip electrode different from opening
in which the detector is mounted in the tip electrode for delivering
irradiation energy to the tissue, wherein the irradiation energy heats the
3 Keidar et al., US 7,306,593 B2, issued Dec. 11, 2007.
4 Oraevsky et al., US 6,309,352 Bl, issued Oct. 30, 2001.
5 Pesach et al., US 2006/0100489 Al, published May 11, 2006.
6 Chandrasekaran et al., US 6,638,222 B2, issued Oct. 28, 2003.
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Application 11/644,312
tissue to produce an acoustic wave." (Final Act. 2-3.) The Examiner also
finds that Keidar does not disclose "that the acoustic detector is mounted in a
second opening being from an internal portion of the tip electrode to an outer
surface of the tip electrode." (Id. at 3.)
The Examiner finds, however, that Oraevsky discloses a system for
opto-acoustic tissue assessment comprising an ablation element and an
optical waveguide and at least one acoustic detector associated with the
ablation element, wherein the optical waveguide is "adapted to deliver
irradiation energy to the tissue such that the irradiation energy heats the
tissue being ablated to produce an acoustic wave" to be detected by the
acoustic detector, and wherein the acoustic detector is "configured to
generate a signal representative of a tissue characteristic." (Id. at 4.)
The Examiner finds that Oraevsky "fails to specifically recite a
catheter body and a tip section arrangement as claimed." (Id.) However, the
Examiner finds that Chandrasekaran, which discloses "a similar catheter
arrangement" as Keidar, "specifically discloses that the acoustic detector
(transducer 34[)] is located within an opening formed in the shell wall of the
tip electrode ... with the opening being from the cavity of the tip electrode
through the shell wall of the tip electrode." (Id. at 3.) Likewise, the
Examiner finds that Pesach teaches "a similar system as that of Keidar and
Oraevsky comprising a catheter having a distal end functioning to heat and
assess tissue ... containing an optical waveguide ... and at least one
acoustic sensor," wherein the optical waveguide is mounted "within the
distal end of the catheter through an opening in the wall of the distal end/tip
so as to allow for irradiation energy to be applied from the catheter to the
tissue." (Id. at 4.)
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The Examiner concludes that it would have been obvious to a skilled
artisan to combined the cited prior art to arrive at the claimed invention. In
particular, the Examiner concludes that it would have been obvious to a
skilled artisan to "provide an opto-acoustic monitoring system as in
Oraevsky to the catheter of Keidar," in order to "provide precise monitoring
of the progress of the ablative treatment in real-time" and "ensure only a
desired level of treatment is provided to the target tissue." (Id. at 5.)
The Examiner also concludes that it would have been obvious to
mount Oraevsky's optical waveguide "in a first opening in the shell wall of
the tip electrode," as required by claim 1, because Pesach discloses "an
exemplary mounting of an optical fiber within a central lumen in a catheter
and the distal end of the catheter," which would allow the irradiation energy
to be "readily directed to the target tissue being treated." (Id.)
The Examiner further concludes that it would have been obvious to
place at least one acoustic transducer in Keidar's catheter in an "opening in
the shell wall of the tip electrode," as required by claim 1 and taught by
Chandrasekaran, because such a placement is functionally equivalent to the
placement of the acoustic transducer in Keidar, and/or because it would
"reduce[] any issues with attenuation of the signal passing through the tip
electrode thereby allowing for a more accurate representation of the tissue
characteristic to be generated by the detector." (Id. at 5---6.)
Finally, the Examiner finds that the combination of elements
discussed above would result in a system wherein "the optical waveguide
and the at least one acoustic detector are each generally facing the tissue
such that the direction of irradiation of the tissue and the direction of
acoustic detection of tissue are generally opposite to each other," as recited
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in claim 1. (Id. at 6.) The Examiner further finds that the placement of
acoustic transducer as taught by Chandrasekaran "would effectively provide
for the shell, the shell wall, and the cavity" required by claim 1, with the
distal end of the electrode in which the acoustic detector is mounted forming
the shell and shell wall and the proximal end of the electrode forming the
plug. (Id. at 6-7.)
Appellants contend that the cited art combination does not suggest an
acoustic detector "mounted in a[ n] ... opening in the shell wall of the tip
electrode" or the electrode and acoustic detector "configured to interact with
the tissue from a common orientation," as required by the claims. (Appeal
Br. 8-9.) Appellants also contend that the cited prior art combination does
not suggest a single catheter comprising an ablation structure, an optical
waveguide, and an acoustic detector, as required by the claims. (Id. at 12.)
Finally, Appellants contend that a skilled artisan would not have had reason
to modify the cited art to arrive at the claimed invention, that the
modification(s) suggested by the Examiner would render the prior art device
unsuitable for its intended purpose, and that the rejection is based on
impermissible hindsight. (Id. at 9-12.)
The issues with respect to this rejection are (1) whether the cited prior
art combination suggests (a) a catheter comprising an ablation structure, an
optical waveguide, and an acoustic detector, (b) the acoustic detector
mounted in an opening in the shell wall of the tip electrode, and ( c) the
electrode and acoustic detector configured to interact with tissue from a
common orientation; and (2) whether a skilled artisan would have had
reason to combine the prior art to arrive at the claimed invention.
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Findings of Fact
1. Keidar describes treating cardiac arrhythmias by "inserting a
catheter through the patient's vascular system into the heart, ... bringing the
distal tip of the catheter into contact with the cardiac tissue at the site that is
to be ablated," and conducting radio frequency (RF) electrical current
"through [the] wires in the catheter to one or more electrodes at the tip of the
catheter, which apply the RF energy to the myocardium." (Keidar 1 :23-29.)
2. Keidar teaches that "[t]he catheter that is used to perform the
RF ablation may also be used to observe the results of the ablation" and
describes a prior art catheter for "imaging ... and ablating tissue" wherein a
"sonolucent electrode at the tip of the catheter is used to perform RF
ablation" and "[a]n ultrasonic transducer is positioned to transmit ultrasonic
signals through the electrode into the heart tissue, in order to create an
ultrasonic image." (Id. at 2:25-34.)
3. Keidar teaches "devices for prediction and assessment of
ablation treatments applied to cardiac tissue." (Id. at 1:15-18.) In
particular, Keidar teaches a catheter comprising at its distal end an ablation
electrode, a position sensor, and one or more additional physiological
sensors such as ultrasonic transducers. (Id. at 5:53-59, 7:24--30, 33-35; see
also id. at claim 5.)
4. Keidar teaches that the ultrasonic transducers are "typically
arranged in a phased array, aimed in a forward-looking direction along the
axis of catheter" and may be used to produce tissue images for the purposes
of "determin[ing] the thickness and other qualities of tissue ... prior to
ablation, as well as to assess the progress and results of the ablation
procedure." (Id. at 9:48-50, 53---60.)
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5. Keidar teaches that the ultrasonic transducers may be used to
"determine the temperature of the tissue ... as a measure of the extent of
[the] ablation," "observe creation of micro bubbles in tissue ... due to
cavitation during ablation," and "measure the speed of blood flow in a
deeper layer ... of tissue." (Id. at 9:61-10:34; see also id. at 10:52---60,
11: 15-2 0, claims 5-8.)
6. Keidar teaches that, "[a]ltematively or additionally, other
methods for measuring tissue temperature and assessing the extent of ablated
tissue may be used, as are known in the art." (Id. at 10:35--40.)
7. Figure 2 of Keidar is reproduced below:
(Keidar Fig. 2.) Figure 2 of Keidar is "a schematic, pictorial illustration
showing the distal tip of a catheter in contact with endocardial tissue, in
accordance with an embodiment of [Keidar's] invention." (Id. at 5:33-35.)
In particular, Figure 2 depicts a catheter 22 comprising tip electrode 48 and
ultrasonic transducer 46 and in contact with heart tissue 42. (Id. at 7:24--30.)
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8. Oraevsky teaches that "conventional imaging techniques have
limitations such as low contrast (ultrasound and X-ray imaging), high cost
... , [or] poor resolution" and that "[ s Jome of them are not capable of
providing imaging information in real time." (Oraevsky 1 :26-30.)
9. Oraevsky teaches that "[l]aser optoacoustic imaging has
potential to become an imaging technique with high contrast, sensitivity and
resolution, and of moderate cost." (Id. at 3:8-11; see also id. at 9:24--27
( describing advantages of optoacoustic techniques compared to conventional
imaging techniques).)
10. Oraevsky teaches "a method/system ... for monitoring tissue
properties in real time during treatment using optoacoustic imaging system,"
based on the fact that "[ a Jpplication of radiation, heating, or cooling induces
changes in tissue temperature and optical and thermophysical properties"
and "[ o Jptoacoustic technique is sensitive to changes in tissue temperature,
optical properties ... , and [certain] thermophysical parameters" (Id. at
Abstract; see also id. at 1:12-15, 2:1-7, 3:12-22, 4:40-46.)
11. Oraevsky teaches that the technique of its invention "can be
applied if ... radiation (microwave, radiofrequency, ultrasonic, etc.) is used
for tissue heating." (Id. at 3:36-38; see also id. at 5:27-30.)
12. Oraevsky teaches that monitored tissue properties may include,
for example, physical dimension and temperature. (Id. at 1 :59---64, 4:24--27,
claim 2.)
13. Oraevsky teaches obtaining optoacoustic images by irradiating
tissue by laser pulses with short duration, wherein such "[i]nstant heating by
short laser pulses produces acoustic (stress) wave with a profile resembling
distribution of optoacoustic sources in the tissues," which propagates to the
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Application 11/644,312
tissue surface and is detected by an acoustic transducer or transducer array.
(Id. at 5:6-15; see also e.g., id. at 5:46-56, Figs. 2 and 3.)
14. Oraevsky teaches delivering optical pulses for imaging through
a fiber-optic delivery system. (Id. at 4:30-32, claim 3.)
15. Oraevsky teaches placing an optical fiber and acoustic
transducer in an endoscope and positioned inside an organ "such that
irradiation and detection is performed from the same site at the internal
surface of [the] organ." (Id. at claim 12.)
16. Pesach teaches:
A tissue viability monitor (TVM) for determining viability
of a biological tissue comprising: at least one light source
controllable to illuminate the tissue with light that
generates photoacoustic waves therein; at least one
acoustic transducer that generates signals responsive to the
photoacoustic waves; and a controller that receives the
signals and processes the signals to determine at least one
characteristic of the tissue and a measure of viability
responsive to the determined at least one characteristic.
(Pesach Abstract; see also id. ,r,r 16, 25.)
17. Pesach teaches mounting components of a TVM in "a catheter
suitable for percutaneous introduction into a patient's body." (Id. ,r 24; see
also id. ,r 66.) Pesach teaches that "[t]he catheter has a 'probe end' that is
threaded through the patient's vascular system or through a suitable body
orifice to be positioned in a neighborhood of tissue to be diagnosed." (Id.)
Pesach teaches that "[ t ]he tissue is illuminated by light transmitted from the
probe end and, optionally, acoustic energy from photoacoustic waves
generated responsive to the light is received by at least one acoustic
transducer mounted in the probe end." (Id.; see also id. at claim 16.)
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18. Pesach teaches "light source compris[ing] an optic fiber having
an optic end located at the probe end from which optic end light that
illuminates the tissue is radiated." (Id. ,r 30; see also id. at claim 15.)
19. Figure 4 of Pesach is reproduced below:
76 D( lL__ r-----1 CONTROLLER
li'IG.4
(Pesach Fig. 4.) Pesach's Figure 4 "schematically shows a TVM useable for
diagnosing tissue viability percutaneously." (Id. ,r 38.) In particular, Figure
4 depicts a TVM 70 comprising catheter 72 having a probe end 78, wherein
at least one optic fiber 84 extends the length of catheter 72 and transmits
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light to an end 85 (i.e., an optical aperture) of the fiber in probe end 78 and
at least one acoustic transducer 80 is mounted in the probe end. (Id. ,r 67.)
20. Pesach teaches that TVM 70 "tests viability of region 86 by
illuminating the region with at least one pulse of light at a suitable
wavelength to stimulate generation of photoacoustic waves in the region.
Transducer 80 generates signals responsive to the photoacoustic waves."
(Id. ,I 69.)
21. Chandrasekaran relates to "catheter ablation systems for
revascularizing occluded vessels." (Chandrasekaran 1:14--16.) In particular,
Chandrasekaran teaches:
A combination catheter includes an ultrasound transducer
and RF ablation electrode. The ultrasound transducer
transmits ultrasound signals into and receives echo
signals from a vessel ... used to produce an image of the
tissue surrounding the catheter. . . . An RF generator is
electrically coupled to the driveshaft to deliver RF energy
to the electrode at the distal end of the driveshaft to
ablate occluding material in the vessel.
(Id. at Abstract; see also id. at 1:51-55.)
22. Chandrasekaran teaches that the electrode and ultrasound
transducer are located at the distal end of the catheter and that "[t]he
electrode extends out the distal end of [a] non-conductive sheath such that
RF ablation energy is directed from the exposed electrode and into the
occluding material." (Id. at 1 :55-58, 1 :66-2: 1, 2:8-11.)
23. Chandrasekaran teaches that, in one embodiment of the
invention, "the electrode that delivers the RF ablation energy is incorporated
into the steerable sheath, wherein the ultrasound catheter extends through a
hole in the electrode at the distal end of the sheath to obtain images of the
vessel and occluding material." (Id. at 2:29-33.)
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24. Figure 1 of Chandrasekaran is reproduced below:
.JtJ
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I
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kl
00 I C.ENER.4 TOIi
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J4 I 1NFf1:i1(/lf
AJWANl'ER ' r fJLT!Wi'{]l.ll?D
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-----·--·--·.-L. .C! .. CfJN'!ML _}5
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(Id. at Fig. 1.) Chandrasekaran's Figure 1 "illustrates a combination RF
ablation and ultrasound catheter system for crossing total chronic occlusions
according to one embodiment of [its] invention." (Id. at 2:42--44.) As
shown in Figure 1, the combination ultrasound and RF ablation system 10
includes a catheter 12, at the tip of which is "an ultrasound transducer 34
that transmits ultrasound signals into the vessel tissue and receives
corresponding echo signals" to produce an image of the tissue surrounding
the imaging head 16. (Id. at 3:1-13.) In the embodiment depicted in Figure
1, "[ t ]he ultrasound transducer 34 is integrated with a conductive electrode
38 that is secured to the distal end of the conductive shaft 30" and
"positioned in a window 36 on the side of the electrode such that ultrasound
signals are transmitted to and echo signals are received from an area in the
vessel that is adjacent the electrode 38 as well as a region that is just ahead
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Application 11/644,312
or distal to the electrode." (Id. at 3:24--32.) RF energy is delivered to the
electrode 38 to remove occluding material from the vessel. (Id. at 3:41--44.)
25. Figure 3A of Chandrasekaran is reproduced below:
I
70 -- Flg..lA.
(Id. at Fig. 3A.) Figure 3A of Chandrasekaran teaches one embodiment of
RF electrode tip shape, which also shows ultrasound transducer 34
positioned in a window 36 of the electrode. (Id. at 2:48--49, 3:26-32.)
26. Chandrasekaran teaches that "it is possible to use multiple
transducers oriented in different directions so that a desired ... view of the
vessel wall can be created with minimum rotation [ ofJ the ultrasound
catheter." (Id. at 6:16-19.)
Analysis
Appellants do not separately argue for the patentability of individual
claims. We therefore limit our analysis to claim 1 as representative. We
adopt the Examiner's findings of fact and reasoning regarding the scope and
content of the prior art as they relate to claim 1 (Final Act. 2-11, 22-24 see
also Ans. 2-8; FF1-FF26) and agree that claim 1 is obvious over Keidar,
Oraevsky, Pesach, and Chandrasekaran. We address Appellants' arguments
below.
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Appellants contend that the ultrasound transducer in Chandrasekaran
is positioned "in a window ... on the side of the electrode in order to
provide a 360Qview of the vessel in which the catheter is used for ablation";
thus, Appellants contend that "the ultrasound transducer [in Chandrasekaran]
is not mounted in an opening in the tip electrode, let alone an opening from
a cavity of the tip electrode through the shell wall of the tip electrode."
(Appeal Br. 7-8; see also Reply Br. 2, 3--4.)
We are not persuaded. Chandrasekaran teaches an ultrasound
transducer integrated with the electrode and positioned in a window on the
side of the electrode. (FF24, FF25.) The ordinary meaning of window is
"an opening especially in the wall of a building."7 In the present context,
this ordinary meaning suggests that the ultrasound transducer in
Chandrasekaran is positioned in an opening in the electrode from a cavity in
the electrode through the shell wall. Our finding in this regard is supported
by the figures in Chandrasekaran. Figure 3A of Chandrasekaran, for
instance, shows the transducer 34 is in an opening ( window 36) in the
electrode, but does not suggest, as Appellants argue, that the electrode is
solid. (FF25; Reply Br. 2.) Nor have Appellants cited persuasive evidence
that a transducer positioned in a window on the side of the electrode to
provide a 3 60Q view of a blood vessel cannot be "mounted in a[ n] ...
opening in the shell wall of the tip electrode" where the opening is "from the
cavity ... through the shell wall of the tip electrode," as recited in claim 1.
7 "window." l\t1ERRlAivr-\VEBSTER, https://www.merriam-
webster.com/dictionary/window (last visited Oct. 24, 2018) (defining
window as "an opening especially in the wall of a building for admission of
light and air that is usually closed by casements or sashes containing
transparent material (such as glass) and capable of being open and shut").
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Appellants also argue that Chandrasekaran "does not disclose the
electrode and the transducer "interact[ing] with tissue from a common
orientation, as presently recited," because, for instance, Figure 1 of
Chandrasekaran shows the transducer "interact[ing] with tissue from a
different angle ( or orientation) than the part of the electrode 3 8 that exits the
sheath 32." (Appeal Br. 8.)
We are not persuaded. The Examiner does not rely on
Chandrasekaran to teach the limitation relating to "the optical waveguide,
the tip electrode ... , and the ... acoustic detector ... configured to interact
with the tissue from a common orientation." Instead, as the Examiner
explains, this limitation is disclosed by the combination of Keidar and
Pesach, which provides, respectively, a forward-facing acoustic detector and
a forward-facing optical waveguide. (Final Act. 6; see also Ans. 6
( explaining that the claimed orientation of the transducer "is already
provided by the Keidar reference").) "Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references. . . . [The reference] must
be read, not in isolation, but for what it fairly teaches in combination with
the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986).8
8 We note that Chandrasekaran also teaches that "it is possible to use
multiple transducers oriented in different directions so that a desired ...
view of the vessel wall can be created with minimum rotation [ of] the
ultrasound catheter." (FF26.) Thus, Chandrasekaran does suggest that a
transducer from a group of transducers may be configured to interact with
the tissue from a common orientation as the electrode.
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Appellants argue that the Examiner has not provided a reason to
combine Chandrasekaran with other cited prior art to arrive at the claimed
invention. (Appeal Br. 9, 10-12; Reply Br. 3.) In particular, Appellants
contend that "Chandrasekaran highlights the importance of providing a 3 60Q
view of the vessel" and a skilled artisan would have recognized that the
modification suggested by the Examiner would destroy the ability of the
transducer to provide such a view. (Appeal Br. 9, 10-12.) Appellants also
contend that, even if Figure 1 of Chandrasekaran depicted a transducer in an
opening as claimed (i.e., "an opening from the cavity of the tip electrode
through the shell wall of the tip electrode"), the Examiner has not explained
why a skilled artisan "would have selected only that isolated depiction of
Chandrasekaran to modify the Keidar configuration." (Reply Br. 3.)
We are not persuaded. Keidar teaches positioning a transducer within
the electrode to transmit ultrasonic signals through the electrode (FF2, FF7),
while Chandrasekaran teaches positioning a transducer in an opening (i.e., a
window) in the wall of the electrode (FF24, FF25). Because both references
teach a method for affixing an ultrasound transducer for imaging tissue in a
catheter ablation system (FF2, FF21 ), "it would have been prima facie
obvious to substitute one method for the other." In re Fout, 675 F.2d 297,
301 (CCPA 1982). As the predecessor to our reviewing court has explained,
"[ e ]xpress suggestion to substitute one equivalent for another need not be
present to render such substitution obvious." Id.
As to Appellants' argument that the modification suggested by the
Examiner would destroy the ability of Chandrasekaran's transducer to
provide a 360Q view of the vessel, we note that the Examiner's prima facie
case is based on modifying the catheter suggested by the combination of
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Keidar, Oraevsky, and Pesach, by mounting the ultrasound transducer in an
opening in the wall of the electrode, as suggested by Chandrasekaran, rather
than within the electrode, as described in Keidar. In other words, the
rejection is not based on changing the location or orientation of the
transducer in Chandrasekaran 's device itself We are thus not persuaded by
Appellants' apparent contention that the proposed modification would
impermissibly change the principle of operation of Chandrasekaran's device.
Appellants further contend in conclusory fashion that none of the cited
references, either alone or in combination, "teaches or suggests [the claimed]
combination of features in the same catheter." (Appeal Br. 12.) We are not
persuaded. Appellants support their contention only by describing each
reference individually and then reciting claim elements allegedly missing
from that reference. As discussed above, however, "[ n ]on-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references."
Merck, 800 F.2d at 1097. Appellants provide no persuasive argument or
evidence that the Examiner erred in concluding that a skilled artisan, when
reading the references together, would find it obvious to include the claimed
combination of features in the same catheter.
Finally, Appellants contend that the rejection is based on improper
hindsight. (Appeal Br. 9--10, 11; Reply Br. 4.) Appellants similarly contend
that the rejection is based on the Examiner "picking and choosing among
isolated disclosures in the prior art, without fairly considering the disclosures
in their entirety." (Appeal Br. 11.)
We are not persuaded. "Any judgment on obviousness is in a sense
necessarily a reconstruction based upon hindsight reasoning, but so long as it
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takes into account only knowledge which was within the level of ordinary
skill at the time the claimed invention was made and does not include
knowledge gleaned only from applicant's disclosure, such a reconstruction is
proper." In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). As
discussed above, we find the rejection to be based on disclosures from the
cited prior art rather than knowledge gleaned only from Appellants'
disclosure. We also find that the Examiner has sufficiently articulated
reasons why a skilled artisan would combine the prior art disclosures in the
manner described in the rejection to arrive at the claimed invention.
Accordingly, we affirm the Examiner's rejection of claim 1. Claims
2-16 and 19-32, which are not separately argued, fall with claim 1. See 37
C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
For the reasons above, we affirm the Examiner's decision rejecting
claims 1-16 and 19-32.
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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