Ex Parte Dalal et al

Patent Trial and Appeal Board

Feb 8, 2018

13126188 (P.T.A.B. Feb. 8, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/126,188 04/27/2011 Sandeep Dalai 2008P01186WOUS 1539
24737 7590 02/12/2018
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue PARK, PATRICIA JOO YOUNG
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Valhalla, NY 10595 ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
02/12/2018 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):
patti. demichele @ Philips, com
marianne. fox @ philips, com
katelyn.mulroy @philips .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SANDEEP DALAL,
BALASUNDARA RAJU, and AJAY ANAND
Appeal 2017-001680
Application 13/126,188
Technology Center 3700
Before JEFFREY N. FREDMAN, ELIZABETH A. LaVIER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to an
ultrasound therapy method. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“Ultrasound therapy for tissue ablation includes insonifying a tissue of
interest with high intensity ultrasound that is absorbed and converted into
heat, raising the temperature of the tissues. As the temperature rises above
1 Appellants identify the real party in interest as KONINKLIJKE PHILIPS
N.V. (see App. Br. 3).
Appeal 2017-001680
Application 13/126,188
55°C, coagulative necrosis of the tissues occurs resulting in immediate cell
death” (Spec. 12). “The ultrasound lesion sizes depend not only on the
ultrasound beam characteristics, but also on the sonication time” {id. 13).
“In order to optimally treat tumors that are larger than the size of a
single ultrasound lesion, the ultrasound beam needs to be repositioned in
different parts of the tumor” {id. 14). “In practice, doctors treat an
additional small margin encompassing the tumor to also treat microscopic
cancerous tissue that may not be visible in the diagnostic imaging scans of
the tumor. The tumor and margin is also knows as the Planned Target
Volume (PTV)” (id. 14). “If the PTV is larger than one ablation, which is
frequently the case, a sequence of multiple overlapping ablations, called a
‘composite ablation’, has to be created” {id. 14).
The Claims
Claims 1, 4, 5, 7—9, 11, 13—15, and 17—20 are on appeal. Claim 1 is
representative and reads as follows:
1. An ultrasound therapy method comprising acts of:
obtaining a first image of a region of interest;
graphically delineating a planned target volume (PTV)
using the first image;
selecting ablation shapes of ultrasound beams from a
library to completely cover the PTV, the library comprises the
ablation shapes pre-computed by a thermal acoustic modeling
tool and obtained through experiments;
until the PTV is fully ablated repeating
performing an ultrasound ablation on the PTV
using an ultrasound transducer that applies energy based
on the selected ablation shapes;
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Application 13/126,188
obtaining a latest image of the region of interest
after performing the ultrasound ablation;
determining remaining areas of the PTV that have
not been ablated by comparing ablation lesions from the
latest imaging and estimated ablation lesions from the
library; and
selecting and modifying, based on a feedback, one
or more ablation shapes of ultrasound beams from the
library to completely cover the determined remaining
areas while avoiding covering ablated portions of the
PTV based on the latest image.
The issues
A. The Examiner rejected claims 1, 4, 9, 11, 15, and 17 under 35 U.S.C.
§ 103(a) as obvious over Shahidi,2 Diederich,3 Dodd III,4 and Freundlich5
(Final Act. 6—12).
B. The Examiner rejected claims 5, 7, 8, 13, 14, and 18—20 under 35
U.S.C. § 103(a) as obvious over Shahidi, Diederich, Dodd III, Freundlich,
andNields6 (Final Act. 12—15).
A. 35 U.S.C. § 103(a) over Shahidi, Diederich, Dodd III, and Freundlich
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Shahidi, Diederich, Dodd III, and
Freundlich render the rejected claims obvious?
2 Shahidi, US 2009/0221999 Al, published Sept. 3, 2009.
3 Diederich et al., US 2007/0255267 Al, published Nov. 1, 2007.
4 Dodd III, et al., US 2007/0055225 Al, published Mar. 8, 2007.
5 Freundlich et al., US 6,618,620 Bl, issued Sept. 9, 2003.
6 Nields et al., US 2008/0033420 Al, published Feb. 7, 2008.
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Application 13/126,188
Findings of Fact
1. Shahidi teaches “achieving a curative outcome in unresectable
cases by use of minimally invasive in situ ablation techniques including . . .
high-frequency focused ultrasound” (Shahidi 1 6). Shahidi teaches the
invention “is not limited to IFM probe design, but may easily be applied to
the design of other probe types, such as . . . ultrasound (‘US’) probes”
(Shahidi 132).
2. Shahidi teaches “images of the patient are used to construct a
mapping of the anatomical structures of the site where the thermal therapy is
intended” (Shahidi 134).
3. Shahidi teaches “this mapping is morphed to the specific
volumetric and spatial relationships among the anatomical structures
appearing in the image. From this process a patient-specific site model is
produced for near-real-time monitoring of the thermal ablation or ablation
planning” (Shahidi 134).
4. Figure 1 of Shahidi, graphically delineating a target volume, is
reproduced below:
0 5 10 15 20 25 30 0 5 10 IS 20 25 30 0 5 10 15 20 25' 30
distance jmm) distance dstaiice (ronj}.-
<»; id)
FIG. 1
Figure 1 illustrates “power patterns in a homogeneous media . . . from a
microwave energy source” (Shahidi 140).
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5. Shahidi teaches: “In order to create an arbitrary shape suited for
targeted thermal therapy, the integrated EM/thermal model is needed to
determine the exact antenna geometries and excitation characteristics
(frequency, amplitude, phasing) that can produce a desired shape for a hot
spot” (Shahidi 166).
6. Shahidi teaches “a set of antenna and frequency configurations
may be found that create predefined ablation volume elements. This
information can be stored in a library” (Shahidi 197). Shahidi further
teaches a “thermal therapy tool provided on computer-readable media
includes a library of generalized site models” (Shahidi 119).
7. Shahidi teaches:
Shape modeling algorithms may be used to process volumetric
information obtained from an image-guidance part of the
planning tool, e.g., as discussed earlier in connection with
images 516, which can proceed with breaking a pathology into
multiple sub-segments of known geometries that would match a
library of preset antenna signal configurations designed to
encompass each sub-segment.
(Shahidi 197).
8. Shahidi teaches: “For large tumors, multiple ablation
applications may be necessary to encompass the entire volume, with probe
placements for these multiple ablations currently based on the operator’s
estimates” (Shahidi 178).
9. Shahidi teaches computations “may factor in safety margins (to
account for such things as image quality relied on to perform an anatomic
atlas mapping, discussed below, variations of tissue type, the presence of
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nearby vascular bodies microcirculation, etc.) in order to protect adjacent
tissue” (Shahidi 1 88).
10. Shahidi teaches an “integral part of the system is the heat feed­
back and monitoring mechanism. This mechanism allows the caregiver to
adjust the shape, amount and depth of the energy being implemented. These
parameters may be adjusted dynamically based on the displayed ultrasound
guidance image and heat-monitoring feedback received during the
procedure” (Shahidi 1110).
11. Diederich teaches the “ultrasound system and methods of the
present invention allow directional control and deep penetration of energy
patterns for directed thermal arterial occlusion/coagulation” (Diederich
119).
12. Diederich teaches the “quality and pattern of the ultrasound
energy output may be assessed with acoustic beam distributions . . . These
results may also be correlated to shapes of thermal coagulation produced
during heating trials” (Diederich 1115).
13. Diederich teaches: “Biothermal acoustic models were
developed by our group to study ultrasound applicators for hyperthermia and
thermal therapy ... In order to improve accuracy, the model incorporates
dynamic tissue changes in response to accumulation of thermal dose”
(Diederich 1116).
14. Diederich teaches the “dynamic approach has been used to
model transurethral 67 and interstitial ultrasound applicators and shown to
be in excellent agreement with experiment” (Diederich 1116).
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15. Figure 12 of Diederich is reproduced below:
FSG. 12A FIG. 128 FIG. 12C
FIG. 12 illustrates maximum temperature contours and lesion
shapes for r-z simulations of an interstitial ultrasound applicator
heating in vivo thigh muscle for 3 min with (a) one, (b) two, (c)
three active transducers. The solid black contour lines represent
simulated lesion shapes, and the dashed contour lines represent
experimental in vivo measurements of lesions.
(Diederich 1118).
16. Dodd III teaches ablation controllers “may take various forms
. . . The controller may also be manipulated dynamically during an ablation
procedure to change shape and size of an ablation under process. For
example, via a concurrent imaging process, it may be determined that
ablation should expand in a particular direction” (Dodd III 120).
17. Dodd III teaches
the ablation procedure may be performed while also performing
an imaging procedure .... Based on at least some of this
information it may be determined whether a change in the size
or shape of the ablation is desired (diamond 150). For example,
based on imaging feedback it may be determined that the
targeted tissue has not been fully ablated and ablation should
continue in a particular direction or a size of the ablation should
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Application 13/126,188
be increased .... it may be determined whether ablation is
complete. If so, method 100 ends. If instead it is determined
that ablation is not completed, control passes back.
(Dodd III 1124—26).
18. Dodd III teaches “by tailoring the shape and size of an
ablation zone, tumors or other tissue may be treated with greater accuracy
and precision. Likewise, the sparing of surrounding non-targeted tissue and
organs can be improved” (Dodd III 131).
19. Freundlich teaches the “purpose of the treatment plan is to
ensure complete ablation of target mass 104 by planning a series of
sonications that will apply a series of thermal doses at various points within
target mass 104, resulting in a composite thermal dose sufficient to ablate
the entire mass” (Freundlich 7:59-63).
20. Freundlich teaches an imager “provides real-time temperature
sensitive magnetic resonance images of target mass 104 after some or all of
the sonications. The planner 108 uses the images from the feedback imager
502 to construct an actual thermal dose distribution 600 comparing the
actual composite thermal dose to the predicted composite thermal dose”
(Freundlich 10:34-40).
21. Freundlich teaches
Planner 108 uses thermal dose distribution 600 to automatically
adjust the treatment plan, in real-time, after each sonication or
uses the thermal dose distribution 600 in some of the points to
adjust for the neighboring points. Planner 108 can adjust the
treatment plan by adding treatment sites, removing treatment
sites, or continuing to the next treatment site. Additionally, the
thermal dose properties of some or all remaining treatment sites
may automatically be adjusted by planner 108 based on real­
time feedback from feedback imager 502.
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(Freundlich 10:49-58).
22. Freundlich teaches
Multiple shapes of the focal spot can be created by controlling
the relative phases and amplitudes of the em[]itted energy from
the array, including steering and scanning of the beam, enabling
electronic control of the focused beam to cover and treat
multiple of spots in the defined zone of a defined tumor inside
the body.
(Freundlich 2:8—13)
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 6—12; FF 1—22) and agree that
the claims are obvious over Shahidi, Diederich, Dodd III, and Freundlich.
We address Appellants’ arguments below.
Claims 1 and 4
Appellants contend
Shahidi fails to teach or suggest that ablation shapes from a
library are specifically selected to completely cover a PTV.
Instead, in Shahidi, the pathology is broken into multiple sub-
segments in order to match sub-segments of the pathology to a
predetermined ablation shape from the library. Shahidi does
not specifically teach that the sub-segments cumulatively cover
the entire pathology.
(App. Br. 12). Appellants contend “Shahidi does not teach selecting
ablation shapes of ultrasound beams from a library to completely cover a
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PTV. In fact, Shahidi is completely silent with respect to these features” (id.
at 13).
We find this argument unpersuasive because Shahidi teaches: “For
large tumors, multiple ablation applications may be necessary to encompass
the entire volume, with probe placements for these multiple ablations
currently based on the operator’s estimates” (FF 8). This teaching to use
multiple applications to treat an entire tumor volume reasonably suggests
selecting ablation placements and shapes that completely cover the planned
treatment volume, particularly when combined with Shahidi’s teaching of
“breaking a pathology into multiple sub-segments of known geometries that
would match a library of preset antenna signal configurations designed to
encompass each sub-segment” (FF 7).
Moreover, the Examiner’s obviousness determination is not based on
Shahidi alone, but includes Dodd Ill’s teach of dynamic manipulation
“during an ablation procedure to change shape and size of an ablation under
process” (FF 16) because “based on imaging feedback it may be determined
that the targeted tissue has not been fully ablated and ablation should
continue in a particular direction or a size of the ablation should be
increased” (FF 17). Freundlich also suggests the “purpose of the treatment
plan is to ensure complete ablation of target mass 104 by planning a series of
sonications that will apply a series of thermal doses at various points within
target mass 104, resulting in a composite thermal dose sufficient to ablate
the entire mass” (FF 19).
Thus, Shahidi in combination with Dodd III and Freundlich
reasonably suggests the use of multiple ablation shapes to fully ablate the
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planned treatment volume and ablate the entire mass (FF 7, 8, 16, 17, 19).
“Non-obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants contend
Diederich fails to teach or suggest at least performing acoustic
modeling in order to pre-compute ablation shapes. Therefore, a
person with ordinary skill in the art would have no teaching or
suggestion when viewing the teachings of Diederich to utilize
thermal acoustic modeling to pre-compute ablation shapes in
the Shahidi system.
(App. Br. 13-14).
We find this argument unpersuasive because Diederich teaches the
“quality and pattern of the ultrasound energy output may ... be correlated to
shapes of thermal coagulation produced during heating trials” (FF 12) and
therefore “[bjiothermal acoustic models were developed by our group to
study ultrasound applicators for hyperthermia and thermal therapy” (FF 13).
Diederich is reasonably understood as teaching that biothermal acoustic
models were developed to improve the quality, pattern, and shape of
ultrasonic ablation, consistent with the Examiner’s finding it obvious for
Shahidi to “incorporate [Diederich’s] ‘acoustic thermal models’ into
[Shahidi’s] ‘thermal modeling tool’ [in order to] improve accuracy in the
modeling for ultrasound ablation” (Ans. 15).
Appellants contend “Dodd, III is completely silent with respect to at
least the step of ‘determining remaining areas of the PTV that have not been
ablated by comparing ablation lesions from the latest imaging and estimated
ablation lesions from the library’ as recited in the method of claim 1”
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(App.Br. 15). Appellants contend “[t]here is no teaching or suggestion in
Dodd, III of determining remaining areas of the PTV that have not been
ablated specifically by comparing ablation lesions from a latest imaging with
estimated ablation lesions from a library” (Id.). Appellants also contend “the
disclosure of Dodd, III is completely silent with respect to selecting ablation
shapes of ultrasound beams from a library to completely cover determined
remaining areas to be ablated” (Id. at 16).
We find these arguments unpersuasive because the “test [for
obviousness] is what the combined teachings of the references as a whole
would have suggested to those of ordinary skill in the art.” In re Keller, 642
F.2d 413, 425 (CCPA 1981). The test is not whether a single reference such
as Dodd III teaches every element of the claim.
Dodd III teaches that “based on imaging feedback it may be
determined that the targeted tissue has not been fully ablated and ablation
should continue in a particular direction or a size of the ablation should be
increased” (FF 17). Dodd Ill’s teaching, in combination with Shahidi’s
teaching to employ “a library of preset antenna signal configurations
designed to encompass each sub-segment” to ablate an entire tumor (FF 7),
renders obvious the step of “comparing ablation lesions from the latest
imaging and estimated ablasion lesions from the library” in order to utilize
configurations that will complete the ablation process (FF 8, 17, 19) but
“factor in safety margins ... in order to protect adjacent tissue” as suggested
by Shahidi (FF 9). Dodd III also teaches “by tailoring the shape and size of
an ablation zone, tumors or other tissue may be treated with greater accuracy
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and precision. Likewise, the sparing of surrounding non-targeted tissue and
organs can be improved” (FF 18).
Appellants contend “Freundlich solely discloses that the planner
compares a predicted composite thermal dose and an actual thermal dose.
The disclosure of Freundlich is completely silent with respect to performing
a comparison which includes estimated ablation lesions from a library”
(App. Br. 17). Appellants contend the “cited portions of Freundlich are
completely silent with respect to selecting and modifying ablation shapes in
order to cover a determined remaining area” (Id.)
We find these arguments unpersuasive because, as already noted, they
fail to address the teachings of Shahidi, Diederich, Dodd III, and Freundlich
in combination. Merck, 800 F.2d at 1097; Keller, 642 F.2d at 425. As
particularly addressing the limitation “determining remaining areas of the
PTV that have not been ablated by comparing ablation lesions from the
latest imaging and estimated ablation lesions from the library” in claim 1,
Freundlich teaches real time feedback that “uses the images from the
feedback imager 502 to construct an actual thermal dose distribution 600
comparing the actual composite thermal dose to the predicted composite
thermal dose” (FF 20). Freundlich explains that the planner can adjust the
treamtent plan based on the thermal dose properties at treatment sites based
on real time feedback (FF 21). Freundlich’s teachings to compare actual and
predicted (i.e. estimated) ablation lesion volumes, when combined with
Shahidi’s teaching of ablation lesion volume libraries for particular
configurations of the ablation device (FF 6—7), renders obvious the
comparison of imaging and estimated lesions to identity which configuration
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of the ablation device stored in the library should be used “to adjust the
shape, amount and depth of the energy being implemented” as suggested by
Shahidi (FF 10).
Claims 9, 11, 15, and 17
Appellants recite the limitations of claims 9 and 11 and contend:
For the reasons stated with respect to the method of
independent claim 1 and dependent claim 4, the disclosures of
Shahidi, Diederich, Dodd, III and Freundlich, taken both singly
and in combination, do not teach or suggest the non-transitory
computer-readable storage medium of independent claim 9 or
dependent claim 11.
(App. Br. 18). Appellants make similar statements regarding claims 15 and
17 (see App. Br. 19-20).
We find these arguments unpersuasive for the reasons already given
above. We note that Shahidi teaches the use of computer readable media
(FF 6), and Appellants do not specifically identify any other alleged error in
the Examiner’s rejection. “A statement which merely points out what a
claim recites will not be considered an argument for separate patentability of
the claim.” 37 C.F.R. § 41.37(c)(iv). See In re Lovin, 652 F.3d 1349, 1357
(Fed. Cir. 2011) (the Board reasonably interpreted 37 C.F.R. § 41.37(c) as
requiring “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”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Shahidi, Diederich, Dodd III, and Freundlich render the rejected claims
obvious.
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B. 35 U.S.C. § 103(a) rejection over Shahidi, Diederich, Dodd III,
Freundlich, and Nields
This rejections relies upon the underlying obviousness rejection over
Shahidi, Diederich, Dodd III, and Freundlich. The Examiner provides
sound, fact-based reasoning for combining Nields with Shahidi, Diederich,
Dodd III, and Freundlich (Final Act. 12—15). Having affirmed the rejection
of claim 1 over Shahidi, Diederich, Dodd III, and Freundlich for the reasons
given above, we find the further combination with Nields renders the
rejected claims obvious for the reasons given by the Examiner.
SUMMARY
In summary, we affirm the rejection of claims 1, 4, 9, 11, 15, and 17
under 35 U.S.C. § 103(a) as obvious over Shahidi, Diederich, Dodd III, and
Freundlich.
We affirm the rejection of claims 5, 7, 8, 13, 14, and 18—20 under 35
U.S.C. § 103(a) as obvious over Shahidi, Diederich, Dodd III, Freundlich,
and Nields.
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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