Ex Parte Roberts et al

Patent Trial and Appeal Board

Jul 17, 2017

12868768 (P.T.A.B. Jul. 17, 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.
12/868,768 08/26/2010 WILLIAM W. ROBERTS 10860-500.200 / UM-4271 6572
66854 7590 07/19/2017
SHAY TtT FNN T T P
EXAMINER
2755 CAMPUS DRIVE AKAR, SERKAN
SUITE 210
SAN MATEO, CA 94403 ART UNIT PAPER NUMBER
3786
NOTIFICATION DATE DELIVERY MODE
07/19/2017 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):
info@ shayglenn.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM W. ROBERTS, TIMOTHY L. HALL, CHARLES A.
CAIN, J. BRIAN FOWLKES, ZHEN XU, MICHAEIL THOMAS
KUSNER, JR., and DEJAN TEOFILOVIC
Appeal 2016-002766
Application 12/868,7681
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
imaging therapy system and method of using such a system to ablate tissue
in a prostate, which have been rejected as indefinite and/or obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Histotripsy is a non-invasive tissue ablation process that uses high
peak intensity pulsed ultrasound generated from transducers to create micro
1 Appellants identify the Real Party in Interest as The Regents of the
University of Michigan and Histosonics Inc. (Appeal Br. 2.)
Appeal 2016-002766
Application 12/868,768
bubbles and mechanically damage target tissue through cavitation of those
micro bubbles. (Spec. 4, 6.) The present invention relates to an imaging
system and ultrasound therapy system connected to a micro-manipulator
system for ablating target tissue using histotripsy and the method of using
such a system. (Spec. 1|12, 15, 18.)
Claims 1—27 are on appeal. Claim 1 is representative and reads as
follows:
1. An imaging and therapy system comprising:
a micro-manipulator system;
an ultrasound therapy system attached to the micro­
manipulator system, the ultrasound therapy system configured
to generate a cavitation bubble cloud in a target tissue; and
an imaging system attached to the micro-manipulator
system apart from the ultrasound therapy system and
configured to generate one or more images of the target tissue
and to monitor the cavitation bubble cloud in the target tissue
with real time imaging; and
a controller configured to control movement of the
ultrasound therapy system and the imaging system to maintain
the cavitation bubble cloud within a treatment volume defined
in the controller to ablate the target tissue within the treatment
volume.
(Appeal Br. 10.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1—15 and 26 under 35 U.S.C. § 112, second paragraph as
being indefinite.
2
Appeal 2016-002766
Application 12/868,768
Claims 1—9, 15—24, 26, and 27 under 35 U.S.C. § 103(a) as
unpatentable over Chauhan2 and Cain.3
Claims 3 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Chauhan, Cain, and Vaezy.4
Claims 10-14 under 35 U.S.C. § 103(a) as unpatentable over
Chauhan, Cain, and Zvuloni.5
Claim 25 under 35 U.S.C. § 103(a) as unpatentable over Chauhan,
Cain, and Seip.6
DISCUSSION
I
112, second paragraph: Claims 1 and 26
The Examiner finds that claims 1 and 26 are indefinite because “it is
not clear how the treatment volume is defined in the controller.” (Final
Action 4.)
Appellants contend that one of ordinary skill in the art would
understand this phrase in the context of the rest of the claim limitation and in
light of the Specification describing how a treatment volume may be
determined from images stored in the controller and retrieved by surgical
planning software, the subsequent marking up of the images to identify a
desired ablation volume and the software creating the surgical plan within
2 Chauhan, US 2008/0312561 Al, published Dec. 18, 2008.
3 Cain et al., US 2007/0083120 Al, published Apr. 12, 2007.
4 Vaezy et al., WO 2007/035529 A2, published Mar. 29, 2007.
5 Zvuloni et al., US 2008/0262486 Al, published Oct. 23, 2008
6 Seip et al., US 2007/0219448 Al, published Sept. 20, 2007.
3
Appeal 2016-002766
Application 12/868,768
the target tissue volume and the transducer can be automatically moved by
the software through that treatment volume. (Reply Br. 2.)
We understand Appellants’ position to be that one of ordinary skill in
the art would understand from the Specification that the controller as
claimed includes software and that software stores the information that
defines the treatment volume as determined in the surgical planning stage
from images of the target tissue. The Examiner provides no reasoning why
the foregoing would not be the case, just that because the claims merely
recite “treatment volume defined in the controller” and not something
additional, the phrase would not be definite to one of ordinary skill in the art.
We disagree with the Examiner. The question is whether one of ordinary
skill in the art would be informed with reasonable certainty about the scope
of the invention “in light of the claim language when viewed in light of the
Specification and prosecution history.” Nautilus, Inc. v. Biosig Instruments,
Inc., 134 S. Ct. 2120, 2124 (2014). Appellants have pointed out how the
Specification would inform one of ordinary skill in the art of the scope of the
invention where the controller is configured as claimed, i.e., “to maintain the
cavitation bubble cloud within a treatment volume defined in the controller.”
For the foregoing reason, therefore, we reverse the Examiner’s
rejection of claims 1 and 26 for indefmiteness.
112, second paragraph: Claim 15
The Examiner contends that claim 15 is indefinite “since it is not clear
how the functions [of the control system] are performed with the
algorithm/program.” (Final Action 5.) This rejection is based on the
Examiner’s conclusion that “control system” recited in claim 15 invokes
4
Appeal 2016-002766
Application 12/868,768
112, sixth paragraph and that the originally filed Specification “fails to
disclose the corresponding algorithm or the program.” (Id.)
Appellants argue that this element of claim 15, which performs a
particular function is not a means-plus-fimction limitation invoking 35
U.S.C. § 112, sixth paragraph. (Appeal Br. 4—5.)
We agree with Appellants. As Appellants point out (Appeal Br. 4),
the fact that the claim language does not use the phrase “means for” creates
a strong presumption that § 112, sixth paragraph does not apply. See e.g.,
Inventio Ag v. Thyssenkrupp Elevator Americas, 649 F. 3d 1350, 1356 (Fed.
Cir. 2011). We agree with the Appellants that the Examiner has not
provided sufficient evidence to rebut the presumption. Rather, we find that
the claim as properly construed recites sufficiently definite structure to avoid
§ 112, sixth paragraph. Indeed, we find this case analogous to Inventio
where our reviewing Court found that the term “modernizing device” was
not a means-plus-function recitation in the limitation
installing at least one modernizing device and connecting the at
least one modernizing device to said floor terminals and said at
least one computing unit for reading the destination signal, for
converting the destination signal into at least one call report and
for controlling the elevator control by way of the call report.
Id. at 1354. In particular, the Court found that the claims “delineate [d] the
components that the modernizing device is connected to, describe[d] how
the modernizing device interacts with those components, and describe[d] the
processing that the modernizing device performs” and “[t]he written
descriptions additionally show that the modernizing device conveys
structure to skilled artisans.” Id. at 1359. The Court also found that the term
“computing unit” was not a means-plus function recitation in the limitation
5
Appeal 2016-002766
Application 12/868,768
installing at least one computing unit and connecting the at least one
computing unit to said floor terminals for at least one of evaluating the
destination call reports and association of destination floors with
recognized ones of the identification codes, and for the output of at
least one destination signal.
Id. at 1353. The Court found that the claims recited the components the
computing unit is connected to, how the computing unit interacts with the
components, and the processing it performs and that the written description
indicates that the phrase “connotes structure to skilled artisans.” Id. at 1359
(“The claims elaborate that the computing unit is connected to the floor
terminals of the elevator system, and evaluates incoming call reports,
destination floors, and identification codes to generate the destination signal
for processing by the modernizing device.”)
Here, the claim recites that the “control system” automatically
controls the micro-manipulator system to maintain the cavitation bubble
cloud generated by the ultrasound therapy system within the image
generated by the imaging system. Thus, the claim delineates the component
that the control system is connected to, i.e., a micro-manipulator system,
describes how the control system interacts with that system, i.e.,
automatically control it, and how processing that the device needs to
perform to achieve that automatic control, i.e., maintain the bubble cloud
generated by the ultrasound system and maintain it within a particular image
generated by the imaging system. The written description provides
significant detail about the structure of the control system, e.g., a controller
that can be a computer having hardware and software, an input that can be a
keyboard and mouse or a joystick and display that can be an electronic
display or a graphical user interface. (Spec. 132.) The written description
6
Appeal 2016-002766
Application 12/868,768
further indicates that the “[m]ovement of the micro-manipulator system,
imaging of the target tissue with the imaging system, and treatment of the
target tissue with the ultrasound therapy system can be managed, observed,
and controlled with [the] control system.” (Spec. 137; see also ^fl[ 38, 41,
43.) As in Inventio, “[t]his is not a case where a claim nakedly recites a
‘device’ [or system] and the written description fails to place clear structural
limitations on the ‘device’ [or system].” Id.
Thus, we disagree with the Examiner that claim 15 invokes § 112,
sixth paragraph. Because that is the underlying premise for the Examiner
rejecting claim 15 as being indefinite, we reverse the Examiner’s rejection of
claim 15 for indefiniteness.
II
1. Obviousness: System Claim 1
The Examiner finds that Chauhan teaches an imaging and therapy
system that includes an ultrasound therapy system 84 and an imaging system
86 both separately attached to a micro-manipulator system 10 and a
controller configured to control movement of the ultrasound therapy system
and imaging system. (Final Action 7.) According to the Examiner, the
treatment system taught by Chauhan includes high intensity focused
ultrasound (“HIFU”) transducers and the imaging system is “configured to
generate one or more image of the target tissue [0055] with real time
imaging [0058].” (Id.) The Examiner further notes that Chauhan teaches a
tumor treatment volume is defined in the controller and that the HIFU
transducers and imaging system are moved within that treatment volume by
the controller. (Id.)
7
Appeal 2016-002766
Application 12/868,768
The Examiner indicates that Chauhan “does not seem to teach
ultrasound therapy system configured to generate a cavitation bubble cloud,
maintain cavitation bubble cloud and monitor the cavitation bubble cloud in
the target tissue.” {Id. at 8.) However, the Examiner contends that such a
treatment system is taught by Cain and that it would have been obvious to
one of ordinary skill in the art to substitute such a system into Chauhan as a
“beneficial noninvasive alternative” in the surgical field described by
Chauhan. {Id. at 8—9.) The Examiner explains that Cain teaches that such
pulsed cavitational ultrasound therapy involves feedback of the process,
including detecting and monitoring the bubble cloud, “in order to optimize
the process based on observed spatial-temporal bubble cloud dynamics.”
{Id. at 8.) The Examiner further indicates that Cain teaches the ultrasound
imaging device can “be used to detect and monitor the bubble cloud while
simultaneously actuating the transducer [0016].” (Id. at 9.)
We agree with the Examiner’s factual findings and conclusion that the
claimed imaging and therapy system recited in claim 1 would have been
obvious from Chauhan and Cain.
Appellants do not disagree that Cain describes a pulsed cavitational
ultrasound therapy system, i.e., a histotripsy system “that uses ultrasound
image feedback to provide information on bubble cloud formation and
maintenance.” (Appeal Br. 7). Nor do Appellants disagree with the
Examiner that Chauhan teaches real time monitoring. (Reply Br. 2.)
However, Appellants contend that the combination of Chauhan and Cain
does not teach the claimed system because “both Chauhan and Cain fail to
disclose the claimed limitation of controlling movement of the ultrasound
therapy system and the imaging system to maintain the cavitation bubble
8
Appeal 2016-002766
Application 12/868,768
cloud within a treatment volume defined in the controller.” (Appeal Br. 8;
Reply Br. 3.) That is so, assert the Appellants, because
a) Chauhan “lacks at least an ultrasound system configured to
generate a bubble cloud, an imaging system configured to monitor the
bubble cloud, and a controller configured to control movement of the
ultrasound therapy system and the imaging system to maintain the bubble
cloud within a treatment volume defined in the controller,” and
b) “Cain does not control movement of the imaging system and
ultrasound therapy system to maintain the bubble could within a treatment
volume defined in the controller.” (Appeal Br. 6—7.)
Thus, according to Appellants, even assuming one of ordinary skill in
the art would have found it obvious to include Cain’s histotripsy system and
imaging system in Chauhan, the combination “would still lack a controller
configured to control movement of the ultrasound system and the imaging
system to maintain the bubble cloud within the defined treatment volume
using the real time bubble cloud imaging information.” (Id.)
Appellants further argue that the Examiner has not provided a
sufficient rationale for adding the “missing subject matter to the combined
disclosures of Chauhan and Cain.” (Appeal Br. 7; Reply Br. 3.) According
to Appellants, the Examiner’s only reasons for combination “is that the two
references are ‘in the same field of endeavor.’” (Id.) We do not find
Appellants’ arguments persuasive.7
7 Appellants belatedly argue in their Reply Brief that modifying or replacing
Chauhan’s HIFU therapy modality “upon which the entire Chauhan
disclosure is based, with the Histotripsy therapy of Cain, would require a
change in the basic principle under which Chauhan is designed to operate.”
9
Appeal 2016-002766
Application 12/868,768
a. Alleged Missing Elements
Appellants’ first argument concerns a missing element, assuming it
would have been obvious to combine Chauhan and Cain. We note that in
contrast to Appellants’ argument, claim 1 does not require the controller to
control movement of the ultrasound therapy system and the imaging system
to maintain the cavitation bubble cloud within a treatment volume defined in
(Reply Br. 3.) The term “Reply Brief’ is exactly that, a brief in reply to new
rejections or new arguments set forth in an Examiner’s Answer. As stated in
Ex parte Borden, consideration by the Board of new arguments presented for
the first time in the Reply Brief that could have been presented earlier would
“vitiate the force of the requirement in Board Rule 37(c)(l)(vii) that ‘[a]ny
arguments or authorities not included in the brief... will be refused
consideration by the Board, unless good cause is shown.’” Ex parte Borden,
93 USPQ2d 1473, 1474 (BPAI 2010) (informative).
Appellants have not demonstrated any specific Examiner findings
presented for the first time in the Answer necessitating this specific new
argument in rebuttal in the Reply Brief. Nor do we find any substantial
differences in the Examiner’s initial findings and the Examiner’s findings
stated in the Answer that would warrant the new arguments presented in the
Reply Brief for the first time. And in any event, we do not find that
Chauhan requires a specific ultrasound therapy to be used with the described
“mechanical manipulator for HIFU transducers” (Chauhan Title), in order
for the described system to be able to function. Moreover, “[cjlaims may be
obvious in view of a combination of references, even if the features of one
reference cannot be substituted physically into the structure of the other
reference.” Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1013
(Fed. Cir. 1983). “There is a distinction between trying to physically
combine the two separate apparatus disclosed in two prior art references on
the one hand, and on the other hand trying to learn enough from the
disclosures of the two references to render obvious the claims in suit.” Id.
As discussed herein, there does not appear to be any “mismatch between [the
technologies of Chauhan and Cain]” that would counsel against the
obviousness of the combination. Id.
10
Appeal 2016-002766
Application 12/868,768
the controller “using the real time bubble cloud imaging information”
(Appeal Br. 7). Rather, claim 1 requires an imaging system that is
configured to monitor the cavitation bubble cloud, and separately requires
the controller to be configured simply to control movement of the therapy
system and imaging system to maintain the bubble cloud within the
treatment volume to ablate the target tissue within the treatment volume.
Thus, we agree with the Examiner that claim 1 does “NOT require
‘placement of therapy and imaging transducers based on real time
monitoringf.]’” (Ans. 5 (emphases in original).)
Regarding what is claimed, i.e., a controller that is configured to
control movement of the ultrasound therapy system and the imaging system
to maintain treatment within a treatment volume defined in the controller
such that target tissue is ablated within the treatment volume, we note that
Chauhan teaches that there are separate ultrasound probes used for therapy
and imaging and the movement of both probes is controlled by a system
controller. (Chauhan ^[62—65 (describing system control of the treatment
probes and imaging probes).)
Chauhan explains that in the pre-planning phase,
images of target tissue are captured in a given direction with a
given index. Tumor boundary points are defined (using a
mouse cursor) and the tumor volume is calculated for defining
dosage parameters.
(Id. 1 59.) Chauhan explains that the manner of carrying out treatment
includes exposing a target area to the HIFU beam at one spot with
subsequent probe movement “following a scanning motion of the probes” to
expose a different treatment spot “until the entire volume of the lump is
covered in a three-dimensional manner.” (Id. at 157.)
11
Appeal 2016-002766
Application 12/868,768
While Chauhan does not teach the use of bubble clouds for ultrasound
therapy (Appeal Br. 6), it does teach the use of a controller configured to
control movement of an ultrasound therapy system and the imaging system,
which controller maintains the treatment within a treatment volume defined
in the controller, i.e., the volume for treatment determined in the preplanning
phase. (See, e.g., Chauhan 1 65 (“The data that are managed by the control
module includes the robot initialization, positional information, such as the
position of treatment modules and diagnostic module at a given instant.”).)
Regarding the claim requirement of an imaging system that is capable
of monitoring with real time imaging, as the Examiner noted, Chauhan
teaches the diagnostic ultrasound probe is used for “tumor localization,
registration and volume calculation and real-time imaging.” (Chauhan 1 58;
see also Chauhan Abs., and 1 55 (describing arrangement for “trans­
perineum and supra-pubic access or for a trans-rectal diagnostic module to
provide multiple route applications or for the prostrate”).) Chauhan further
explains that “[o]nce the surgical protocol is decided in the preplanning
phase,” with certain images, the surgeon can control the robot positioning of
the transducers manually using subsequently taken “2-D images.” (Id.
64—66.) In the manual mode, where “subsequent 2-D images” are used to
select target areas, the surgeon “selects the location of making a lesion on
the on-line image with the help of a cursor selection,” which selection is
automatically translated to robot coordinates using information collected in
the pre-planning phase, then the surgeon confirms positioning and prompts
positioning of the treatment transducers, and repeats the sequence “for all
the desired target points in a 2D frame one by one and then in consequent
frames, thus ablating a given target volume in 3-D.” (Id. at 1 66.)
12
Appeal 2016-002766
Application 12/868,768
In light of the foregoing, while images with the Chauhan system may
be obtained from the patient prior to therapy to plan the therapy “and the
coordinates of the desired therapy locations in the images are used to control
the movement of the micromanipulator during the therapy” (Appeal Br. 6),
the imaging system of Chauhan is taught to be configured so as to be able to
include real time imaging with a diagnostic ultrasound probe and appears to
be able to be used, at least in manual mode, for monitoring treatment during
surgery. And Appellants agree that Chauhan teaches real time monitoring.
(Reply Br. 2.) While the monitoring is of tissue, Cain is relied upon by the
Examiner for teaching monitoring of the treatment modality (Final Action
8—9), as well as using monitoring of the bubble cloud to control the
treatment process. Thus Chauhan’s deficient teaching with respect to claim
1 surrounding the bubble cloud, i.e., a therapy system that generates a
cavitation bubble cloud as claimed, an imaging system to monitor that
bubble cloud, and a controller to control movement of the therapy system
and imaging system to maintain a bubble cloud within a treatment volume, is
remedied by the teachings of Cain as will be discussed below. The test for
obviousness is what the combined teachings of the prior art would have
suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413,
425 (CCPA 1981).
That Chauhan does not teach real time imaging for monitoring a
cavitation bubble cloud in the target tissue (Reply Br. 2) does not render the
Examiner’s rejection in error. Chauhan describes a therapeutic modality that
employs ultrasound transducers for focused ultrasound tissue ablation. (See,
e.g., Chauhan || 32—37, 71—73.) Cain’s histotripsy process uses ultrasound
transducers as well. (See, e.g., Cain 173.) The difference between the two
13
Appeal 2016-002766
Application 12/868,768
is the creation of a bubble cloud by the high intensity ultrasound in Cain that
is then used for mechanically induced tissue destruction, rather than using
high intensity ultrasound for thermally induced tissue destruction that
appears to be taught by Chauhan.
The Examiner recognized that Chauhan does not specifically teach a
therapy system that uses cavitation bubble clouds and thus does not teach
real time imaging of such bubbles to monitor them or keeping them within a
treatment volume. (Ans. 5; Final Action 8.) The Examiner relied upon Cain
for teaching an ultrasound therapy system that employs cavitation and
explained why it would have been obvious to one of ordinary skill in the art
to substitute such an ultrasound therapy system for the described Chauhan
ultrasound therapy system and to include feedback monitoring of that
treatment modality. (Ans. 5—6; Final Action 8—9.)
The ultrasound therapy system taught by Cain appears to employ the
same type of transducers (HIFU) that Chauhan contemplates for use in the
therapeutic tissue ablation with ultrasound. (Compare Cain 176 (noting
initiation of the cavitation nuclei can be accomplished “with a therapy
transducer using acoustic energy, usually high intensity pulses, at the same
frequency as the sustaining and therapy processes”) and 1 85 (noting that
“[t]he therapy transducer(s) can also be used, as outlined herein, as sources
of initiation and/or maintenance processes and procedures”) with Chauhan
12 (noting that the invention “relates to a mechanical manipulator for high
intensity focused ultrasound (HIFU) transducers”), 17 (describing devices
that employ HIFU for treating prostate diseases), and Tflf71—72 (describing
the ability to manipulate HIFU probes for treating prostate tumors). Indeed,
Appellants do not contend otherwise.
14
Appeal 2016-002766
Application 12/868,768
In addition, regarding the controller in Cain for the HIFU treatment
system, we note that Cain describes the controller as being configured such
that the cavitation bubble can be maintained within a treatment volume
defined in the controller using feedback obtained from the monitoring
transducer. (See, e.g., Cain 173 (describing the use of feedback on the
bubble cloud presence or absence), 174 (noting feedback and monitoring
“allows for various parameters of the pulsed cavitational ultrasound process
to be varied in real time”), 176 (noting the ultrasound imaging transducer
can initiate the therapy and can obtain feedback information “on the
histotripsy process or feedback on the therapy itself’), 1 80 (using the
ultrasound imaging transducer in initiation), 181 (using feedback to predict
“optimum characteristics or parameters for the next therapy pulse”), 1 83
(using the feedback from ultrasound imaging transducer in maintenance),
11 89-90 (using therapy transducers with imaging transducers to enhance
effects and/or to provide direct imaging of the therapy pulse beam pattern).)
That Cain does not control movement of the imaging system and the
ultrasound therapy system to maintain the bubble cloud within a treatment
volume defined in the controller (Appeal Br. 7) (emphasis added) is not
determinative, as Chauhan teaches a controller configured to control
movement of both the imaging system and therapy system. Cain teaches an
imaging system and therapy system where both are configured to be moved
in order to treat tissue. Cain teaches a three axis positioning system (see,
e.g., Figure 1 at 106) that is controlled by a controller (112) which controls
movement of the ultrasound therapy transducer (102) and monitoring
transducer (104). (Cain H 68.) Substitution into Chauhan of Cain’s therapy
system and ultrasound feedback monitoring of that therapy—which are
15
Appeal 2016-002766
Application 12/868,768
taught by Cain to be moveable, would have the control of Chauhan, which
would maintain the bubble cloud therapy within the treatment volume as
required by claim 1.
b. Reason To Combine An Ultrasound Therapy System Configured to
Generate a Cavitation Bubble Cloud in a Target Tissue and Real
Time Imaging of That Cloud
We agree with the Examiner’s findings and conclusion regarding the
obviousness of substituting Cain’s ultrasound therapy system and the
feedback mechanism teachings into Chauhan—a system that includes an
imaging system that could be configured for such feedback in the manner
taught by Cain.
Cain teaches that pulsed cavitational ultrasound therapy is
advantageous because collateral injury such as is caused by thermal effects
of high intensity ultrasound is able to be reduced. (Cain H 236—38.) This
teaching supports the Examiner’s position that “ultrasound therapy system
that generates, maintains and monitors the cavitation bubble cloud in a tissue
as taught by Cain . . . enables beneficial noninvasive alternatives to many
present methods in the surgical field.” (Final Action 9.)
Furthermore, the monitoring and receiving feedback during pulsed
cavitational ultrasound therapy is explained by Cain to be advantageous
because such
would inform a clinician whether the treatment procedure is
progressing adequately according to plan and when it can be
ended. As such, the ability to monitor and adjust the ultrasound
therapy concomitant with treatment would provide significant
advantages over prior ultrasound therapies.
(Cain 113; see also 1101 (noting that the feedback and monitoring methods
readily allow directed parameter adjustments and the effects thereof to be
16
Appeal 2016-002766
Application 12/868,768
observed during the histotripsy process, in real time, and/or permit therapy
progress measurement in stages, where therapy can be reinitiated as desired
or as necessary).)
In view of the foregoing, we agree with the Examiner that Cain
provides a reason to substitute its treatment system using pulsed cavitational
ultrasound, as well as real-time feedback, into Chauhan. Using cavitational
ultrasound would provide the benefits indicated by Cain of avoiding thermal
effects otherwise resulting from ultrasound therapy that is not mechanical in
nature. The use of real-time feedback monitoring would provide the benefits
indicated by Cain of therapy progress measurement and determination of
whether treatment parameters need to be changed or treatment can be
stopped. The substitution of Cain’s ultrasound therapy system, including the
feedback control for such a system, into Chauhan that already teaches the
use of ultrasound therapy and using a separate ultrasound transducer for
imaging would, thereby, achieve all of the imaging and therapy system
requirements of claim 1, including a controller that would control the
movement of both systems such that the cavitation bubble cloud would
remain/be maintained within the treatment volume.
For the foregoing reasons, therefore, Appellants do not persuade us
that the Examiner erred in maintaining the obviousness rejection of claim 1
over Chauhan and Cain.
Claims 2—9, 15 and 26 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
2. Obviousness: Method Claim 16
Method claim 16 is somewhat different from claim 1 in that the
method requires real time imaging of the bubble cloud with the imaging
17
Appeal 2016-002766
Application 12/868,768
system and “controlling movement of the imaging system and the ultrasound
therapy system to maintain the cavitation bubble cloud treatment volume
under the real time imaging to treat at least a portion of the prostate.”
(Claim 16 (emphasis added).)
The Examiner contends that this claim does not “require ‘placement
of therapy and imaging transducers based on real time monitoring[.]”’
(Ans. 5 (Emphasis in the original).) We disagree somewhat with the
Examiner. While there is no step of “placement” of the imaging system an
ultrasound system based on real time monitoring, the plain language of the
claim requires movement of these systems to maintain the cavitation bubble
cloud treatment based on (or in the words of the claim “under”) real time
imaging.
However, while we disagree with the Examiner’s claim interpretation,
we nevertheless agree with the Examiner that the combination of Chauhan
and Cain renders the claimed process obvious for the reasons discussed
above. That is, Chauhan teaches controlling movement of an imaging
system and ultrasound therapy system based on monitoring tissue in real
time and Cain teaches the benefits of using an ultrasound pulsed cavitational
therapy system and monitoring the bubble cloud created in real time. The
combination of these teachings render obvious the use of cavitational
therapy with real time monitoring of the bubble cloud (Cain) and controlling
movement the imaging system and therapy system under real time imaging
(Chauhan) such that the treatment is maintained in a treatment volume based
on real time imaging. And for the reasons discussed above, we find that the
Examiner’s position that it would have been obvious to one of ordinary skill
in the art to combine Cain’s therapy modality in Chauhan is properly
18
Appeal 2016-002766
Application 12/868,768
rationalized in light of Cain’s teachings of the benefits of such therapy and
monitoring the cavitation bubble cloud. Appellants’ argument that Chauhan
does not teach monitoring the bubble cloud with real time imaging (Reply
Br. 2—3) is not persuasive for the reasons discussed, i.e., that Cain is relied
upon for such a teaching. Moreover, Appellants’ argument that Chauhan
and Cain individually fail to disclose “controlling movement of the imaging
system and the ultrasound therapy system to maintain the cavitation bubble
cloud within treatment volume” (Reply Br. 3) is also unpersuasive as it does
not take into consideration what the combined teachings of the prior art
taken as a whole would have suggested to those of ordinary skill in the art.
See e.g., In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“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.”)
For the foregoing reasons, therefore, Appellants do not persuade us
that the Examiner erred in maintaining the obviousness rejection of claim 16
over Chauhan and Cain.
Claims 17—24 and 27 have not been argued separately and therefore
fall with claim 16. 37 C.F.R. § 41.37(c)(l)(iv).
3. Remaining Obviousness Rejections
Appellants’ Brief on Appeal purports to also separately argue the
patentability of each dependent claims 3 and 18, claims 10—14, and claim 25
19
Appeal 2016-002766
Application 12/868,768
However, Appellants merely indicate that the additional references
relied upon by the Examiner do not cure the alleged deficiencies of Chauhan
and Cain with respect to claims 1 and 16. However, as discussed above, we
disagree with the Appellants that the Examiner’s rejection of claims 1 and
16 under 35 U.S.C. § 103 based on Chauhan and Cain is deficient. Thus, for
the reasons already discussed, we also affirm the Examiner’s rejections of:
claims 3 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Chauhan, Cain, and Vaezy,
claims 10-14 under 35 U.S.C. § 103(a) as unpatentable over Chauhan,
Cain, and Zvuloni, and
claim 25 under 35 U.S.C. § 103(a) as unpatentable over Chauhan,
Cain, and Seip.
SUMMARY
We reverse the rejection of claims 1—15 and 26 under 35 U.S.C.
§112, second paragraph as being indefinite.
We affirm the rejection of claims 1—9, 15—24, 26, and 27 under
35 U.S.C. § 103(a) as unpatentable over Chauhan and Cain.
We affirm the rejection of claims 3 and 18 under 35 U.S.C. § 103(a)
as unpatentable over Chauhan, Cain, and Vaezy.
We affirm the rejection of claims 10-14 under 35 U.S.C. § 103(a) as
unpatentable over Chauhan, Cain, and Zvuloni.
We affirm the rejection of claim 25 under 35 U.S.C. § 103(a) as
unpatentable over Chauhan, Cain, and Seip.
20
Appeal 2016-002766
Application 12/868,768
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
21