Ex Parte Vortman et al

Patent Trial and Appeal Board

Sep 27, 2017

12910622 (P.T.A.B. Sep. 27, 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.
12/910,622 10/22/2010 Kobi Vortman INS-061/7300942001 8522
23517 7590 09/29/2017
MORGAN, LEWIS & BOCKIUS LLP (BO)
1111 PENNSYLVANIA AVENUE, N.W.
WASHINGTON, DC 20004
EXAMINER
SANTOS RODRIGUEZ, JOSEPH M
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
09/29/2017 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):
kcatalano@morganlewis.com
patents @ morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KOBI VORTMAN, SHUKI VITEK, and YOAV LEVY
Appeal 2016-006976
Application 12/910,622
Technology Center 3700
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
for ultrasound treatment of two distinct target regions within a tissue. The
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm-in-part.
Statement of the Case
Background
“One way to apply thermal energy to internal body tissue is to focus
high-intensity ultrasound waves into the tissue .... Such treatment can
1 Appellants identify the Real Party in Interest as InSightec, Ltd. (see App.
Br. 2).
Appeal 2016-006976
Application 12/910,622
reduce or even eliminate the need for invasive surgery to remove the tissue”
(Spec. 12). “[I]t is important to avoid painful or damaging heat build-up in
healthy tissues surrounding the target tissue” (id.). “Non-target tissues can
often be protected by allowing cooling periods between successive
sonications. Such cooling periods, however, tend to significantly prolong
the total treatment time” (id. 13). “To eliminate or reduce the need for
cooling periods, non-target tissues can sometimes be actively cooled” (id.).
The Claims
Claims 12—20, 22, 23, 26, and 35—38 are on appeal. Claim 19 is
representative and reads as follows:
19. A method for ultrasound treatment of two distinct target
regions within a tissue, a first target region being proximate a
first, non-coolable non-target tissue and a second target region
being proximate a second, coolable non-target tissue, cooling of
the second non-target tissue also causing cooling of the second
target region and, to a lesser extent, cooling of the first target
region, and heating of either target region also causing heating
of at least a tissue region surrounding the respective target
region and the non-target tissue proximate thereto, the method
comprising:
using an ultrasound transducer, directing an ultrasound
focus first into the first target region so as to heat the first target
region while cooling the second non-target tissue;
using a thermal imaging device, monitoring a
temperature of the first non-target tissue relative to a
temperature of the tissue region surrounding the first target
region; and
when the temperature of the first non-target tissue
exceeds the temperature of the tissue region surrounding the
first target region by a specified threshold as a result of a
combined effect of the ultrasound focus and the cooling,
interrupting ultrasound treatment of the first target region so as
to avoid overheating of the first non-target tissue and re-
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directing the ultrasound focus into the second target region so
as to heat the second target region, whereby prior cooling of the
second non-target tissue avoids overheating thereof.
The Issue
The Examiner rejected claims 12—20, 22, 23, 26, and 35—38 under
35 U.S.C. § 103(a) as obvious over Salomir,2 Chomas,3 and Chopra4 (Final
Act. 2-7).
The Examiner finds Salomir teaches ultrasonically “heating a target
tissue . . . monitoring a temperature field in a region encompassing target
tissue and non-target tissue using MRI thermometry . . . and, based on the
temperature field actively adjusting temperature in a non-target region”
(Final Act. 2—3). The Examiner interpreted “active adjustment to include
moving ultrasound focus as well as changing the ultrasound intensity” (id. at
3).
The Examiner acknowledges Salomir does “not expressly disclose
plural non-target portions where active cooling is applied to one non-target
portion but not to at least one non-target portion and adjusting the
temperature of the first non-target portion based on the thermal responses of
plural non-target portions” (id.).
The Examiner finds Chomas teaches “active cooling at the skin
surface to help dissipate temperature increases both at the skin surface as
well as non-target portions beneath the skin surface” (id.). The Examiner
interprets skin as “a plurality of tissue regions, including multiple non-target
2 Salomir et al., US 6,823,216 Bl, issued Nov. 23, 2004.
3 Chomas et al., US 2010/0106063 Al, published Apr. 29, 2010.
4 Chopra et al., US 2006/0206105 Al, published Sept. 14, 2006.
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Application 12/910,622
tissue regions as well as a non-coolable region (interpreted as being below
the skin surface such that it is not directly accessible for cooling)” (id.).
The Examiner finds Chopra teaches “actively cooling non-target
tissue while heating a target tissue ([0011]), and redirecting ultrasound when
a temperature difference reaches a specified threshold, for heating an
additional target tissue” (id. at 4).
The Examiner finds it obvious to
modify the teaching of ultrasound therapy systems as disclosed
by Salomir(’216) and the use of tissue surface cooling as
disclosed by Chomas(’063) with the use of changing ultrasound
focus as disclosed in Chopra(’ 105) in order to protect the
neighboring skin surface as well as the underlying tissue
portions not targeted during focused ultrasound therapy.
(Final Act. 4—5).
The issues with respect to this rejection are: Does the evidence of
record support the Examiner’s conclusion that Salomir, Chomas, and Chopra
render claims 19, 20, 26, and 36 obvious?
Findings of Fact
1. Salomir teaches “local hyperthermia treatment by focused
ultrasound, controlled by MRI” where “mapping means 200 make it possible
to measure and record the spatial temperature distribution” (Salomir 4:20—
46).
2. Salomir teaches:
a step 1 for estimating the heat diffusion coefficient (ai)
and the absorption coefficient (012) of the focused ultrasound in
the biological tissue 410;
a step 2 for defining by the user, a temporal change
profile of the desired temperature;
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Application 12/910,622
a step 3 for acquiring an MRI image;
a step 4 for calculating the spatial distribution of the
phase at the focal point 460 and in its surroundings;
a step 5 for establishing the spatial temperature
distribution at the focal point 460 and its surroundings;
a step 6 for evaluating the temperature gradients of the
focal point 460 and in its surroundings;
a step 7 for determining the new power having to be
delivered by the generator 120; and
a step 8 for changing the energy level applied by the
generator 120.
Steps 3 to 8 are carried out in a loop, in order to reach
and to follow the temporal change profile of the desired
temperature, defined in step 2.
(Salomir 6:18—36).
3. Chomas teaches an “ultrasound generator supplying ultrasound
at a pressure and frequency which will heat subcutaneous tissue” and that
“may include means for actively cooling the ultrasound transducer or the
skin of the patient which contacts the transducer” (Chomas 113).
4. Chomas teaches:
Active cooling at the skin interface may be used in any of the
embodiments disclosed herein to prevent or minimize surface
level heating of the skin. Active cooling can be achieved by
many ways, including flowing a cooling medium such as water
or the like over the transducer, flowing a cooling medium (gas
or liquid) through the transducer, pre-cooling the transducer,
pre-cooling the tissue, or any other method to draw heat away
from the skin and transducer interface. Active cooling may be
utilized while the subcutaneous tissue is being insonated with
ultrasound. Active cooling may be used before or after the
tissue is insonated or between treatments.
(Chomas 140).
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5. Chopra teaches “ultrasound energy is delivered to tissue
volume 105 to generate a localized spatial heating pattern while tissue
temperature measurements are acquired to determine and control the spatial
heating pattern” (Chopra 139).
6. Figure 2 of Chopra is reproduced below:
The heating applicator can be rotated about its axis to a desired
angular position 208 .... The angular position 208 and angular
scan rate 209 of the heating applicator 204 determine, at least in
part, the spatial energy deposition. The target volume 201 can
be identified in anatomical/fimctional imaging information
acquired prior to treatment. A treatment volume boundary 202
is chosen so that it substantially encompasses the target volume
201 while generally sparing the surrounding or nearby tissue
structures 207. The surrounding or nearby tissue structures 207
may be sensitive or critical structures that cannot or should not
be damaged by the thermal therapy. The target volume 201 in
201
Fig. 2
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Application 12/910,622
this plane is treated by rotating the heating applicator across the
entire region.
(Chopra 148).
7. Chopra teaches:
MR thermometry information is used to control the output
parameters of heating applicator 106. This control allows
adequate heating of the target boundary without overheating the
areas near the transducer surface. For example, heating may be
carried out until the temperature along the entire target
boundary volume 105 is elevated beyond a threshold
temperature, or thermal dose, sufficient to achieve a desired
therapeutic outcome.
(Chopra 145).
8. Chopra teaches: “Upon completion of the therapy, the error
function is evaluated and heating re-applied to any regions of the target
volume that were insufficiently heated” (Chopra 1 64).
9. Chopra teaches “a temperature control system is also available
wherein coolant is provided to the heating applicator, which can be used to
heat or cool the immediately adjacent tissue, as well as remove heat from the
transducers” (Chopra 111).
Principles of Law
Although we apply the broadest reasonable interpretation during
examination, “[ajbove all, the broadest reasonable interpretation must be
reasonable in light of the claims and specification.” PPC Broadband, Inc. v.
Corning Optical Commc’ns RF, LLC, 815 F.3d 747, 755 (Fed. Cir. 2016).
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Analysis
Claims 19 and 26
Appellants contend: “Critically, claims 19 and 26 further require
separate heating of the first and second target regions” (App. Br. 9).
Appellants contend “Chomas heats only a single target” (id. at 10) while
“Chopra . . . does not interrupt heating of one target to heat another target”
(id. at 12).
The Examiner responds “Chopra specifically discloses (as seen in Fig.
2 []) that a treatment lesion 203 can be made using the transducer 205.
Then, the transducer can be rotated (see 206) such that additional treatment
lesions can be made in a pattern and the whole treatment region 202 is
completely treated” (Ans. 9).
We find that Appellants have the better position. While Chopra
teaches, regarding Figure 2, that the “target volume 201 in this plane is
treated by rotating the heating applicator across the entire region” (FF 6), we
agree with Appellants that Chopra does not suggest the rotation is performed
to separately heat a second target region to avoid overheating of “non-
coolable” non-target tissue nor does Chopra suggest the redirection of the
rotation is towards tissue adjacent to cooled tissue. (Reply Br. 6.) The
Examiner provides no reason, based on teachings in the prior art, to perform
these steps as required by claims 19 and 26.
Instead, Chopra treats the entire regions 201 and 202 as a single target
region as shown in Figure 2, and identifies only region 207 as non-target
tissue (FF 6). Therefore, Chopra lacks a teaching or suggestion to redirect
rotation for overheating, much less a teaching that when the redirection
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occurs, the heating should focus on a target region adjacent an already
cooled, second non-target tissue as required by claims 19 and 26. The
Examiner also does not identify any teachings in Salomir or Chomas
suggesting that when redirecting heating by ultrasound occurs, that such
redirection should focus on targets adjacent already cooled non-target tissue.
Claims 20 and 36
Appellants contend “Chopra also fails to disclose or suggest a
differential response to cooling, nor does Chopra disclose or suggest a cycle
of cooling, treatment, and deactivating cooling” (App. Br. 14—15).
We note that claim interpretation is “a question of law reviewed de
novo.” Pfizer, Inc. v. leva Pharmaceuticals, USA, Inc., 429 F.3d 1364,
1372 (Fed. Cir. 2005).
Claim 20 recites a method “comprising at least one treatment cycle”
and system claim 36 recites “at least one control cycle.” We interpret “at
least one” as encompassing the situation where a single treatment cycle is
performed. Thus, because claims 20 and 36 do not require repetition of the
treatment cycles, we are not persuaded that the proposed combination fails
to disclose a single cycle comprising the three recited steps.
Chopra suggests using equipment for active cooling to “cool the
immediately adjacent tissue” (FF 9), where the adjacent tissue is non-target
tissue. Chopra teaches using ultrasound “to generate a localized spatial
heating pattern” (FF 5). Chomas teaches that “[ajctive cooling may be
utilized while the subcutaneous tissue is being insonated with ultrasound.
Active cooling may be used before or after the tissue is insonated or between
treatments” (FF 4). Thus, Chopra and Chomas reasonably render obvious a
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method that comprises performing at least a single cycle in which non-target
tissue is cooled (FF 9), subsequently using ultrasound to heat target tissue
(FF 5), and stopping cooling of non-target tissue at some point after heating
has occurred (FF 4).
We recognize, but find unpersuasive, Appellants’ argument that the
“notion of cooling activation and de-activation cycles — much less the
notion of doing so to limit applied energy levels and avoid overheating — is
utterly outside the disclosure of Chomas” (Reply Br. 7). While we agree
that performing the process over multiple cycles is not suggested by the
combination of Salomir, Chomas, and Chopra, claims 20 and 36 encompass
the embodiment where a single cycle is performed. See In re Self, 671 F.2d
1344, 1348 (CCPA 1982) (“[Ajppellanf s arguments fail from the outset
because . . . they are not based on limitations appearing in the claims.”).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Salomir, Chomas, and Chopra render claims 19 and 26 obvious.
The evidence of record supports the Examiner’s conclusion that
Salomir, Chomas, and Chopra render claims 20 and 36 obvious.
SUMMARY
In summary, we reverse the rejection of claims 15, 19, 26, 37, and 38
under 35 U.S.C. § 103(a) as obvious over Salomir, Chomas, and Chopra.
We affirm the rejection of claims 20 and 36 under 35 U.S.C. § 103(a)
as obvious over Salomir, Chomas, and Chopra. Claims 12—14, 16—18, 22,
23, and 35 fall with claims 20 and 36.
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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-IN-PART
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