Ex Parte Bertolina et al

Patent Trial and Appeal Board

Oct 16, 2017

13735936 (P.T.A.B. Oct. 16, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/735,936 01/07/2013 James A. Bertolina 10860-704.200 1785
66854 7590 10/18/2017
SHAY TtT FNN T T P
EXAMINER
2755 CAMPUS DRIVE GILLMAN, AMELIE R
SUITE 210
SAN MATEO, CA 94403 ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
10/18/2017 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
shayglenn_pair @ firsttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES A. BERTOLINA and
ALEKSANDRA RAKIC
Appeal 2016-005696
Application 13/735,936 1
Technology Center 3700
Before FRANCISCO C. PRATS, JOHN H. SCHNEIDER, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to an ultrasound
therapy system and method of use for treating a prostate. The Examiner
entered final rejections for obviousness. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as HistoSonics, Inc. App. Br.
2.
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Application 13/735,936
STATEMENT OF THE CASE
Background
Histotripsy applies high intensity focused acoustic energy
to homogenize cellular tissues. Histotripsy high intensity
focused ultrasound is pulsed to induce acoustic cavitation in the
target tissue. Acoustic cavitation occurs when rapid cycling
from compression to rarefaction forms cavitation micro-bubbles
which oscillate and collapse violently releasing tremendous
energy as stresses and pressures. The resulting “bubble cloud”
completely homogenizes the tissues.
Spec. 14. “In order to generate an effective bubble cloud through layers of
tissue from an external focused ultrasound transducer, pressures generated
by the transducer must be very high.” Id. 15. The Specification: “generally
relates to applying therapeutic ultrasound to tissue. More specifically, this
disclosure relates to transducer designs well suited to apply Histotripsy
therapy to tissue.” Spec. 13. Specifically:
[a]n ultrasound therapy system for treatment of a prostate
through a perineal window of a patient is provided, comprising
an ultrasound therapy transducer sized and configured to be
positioned adjacent to a perineum of the patient and generate
ultrasound pulses that are minimally blocked by bones of the
perineal window when focused on the prostate, the ultrasound
therapy transducer including an opening disposed along or near
a perimeter of the ultrasound therapy transducer, and a
transrectal imaging transducer disposed in the opening of the
ultrasound therapy transducer.
Id. 19.
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The Claims
Claims 1—18 are on appeal.2 Claims 1 and 17 are illustrative and read
as follows (emphases on elements at issue added):
1. An ultrasound therapy system for treatment of a
prostate through a perineal window of a patient, comprising;
an ultrasound therapy transducer sized and configured to
be positioned adjacent to a perineum of the patient and generate
ultrasound pulses that are minimally blocked by bones of the
perineal window when focused on the prostate, the ultrasound
therapy transducer comprising an opening disposed along or
near a perimeter of the ultrasound therapy transducer; and
a transrectal imaging transducer disposed in the opening
of the ultrasound therapy transducer, wherein the opening of the
ultrasound therapy transducer allows for movement of the
ultrasound therapy transducer with respect to the transrectal
imaging transducer without structural interference from the
transrectal imaging transducer.
17. A method of treating a prostate through a perineal
window of a patient with Histotripsy therapy, comprising;
positioning an ultrasound therapy transducer adjacent to a
perineum of the patient;
positioning a transrectal imaging probe in a rectum of the
patient, and positioning the transrectal imaging probe in an
opening in the ultrasound therapy transducer;
adjusting a linear, pan, or tilt position of the ultrasound
therapy transducer relative to the imaging probe without
structural interference from the transrectal imaging probe;
obtaining an ultrasound image of the prostate with the
transrectal imaging probe; and
generating Histotripsy pulses that are minimally blocked
by bones of the perineal window when focused on the prostate
to treat the prostate.
2 Examiner’s Final Action 1, mailed May 19, 2015 (“Final Act”).
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Application 13/735,936
App. Br. 9, 11 (Claims Appendix).
The Issues
The following rejections are before us to review:
Claims 1, 3, 4, 6, 7, and 16—18 are rejected under pre-AIA
35 U.S.C. § 103(a) as obvious over Roberts3 in view of Okazaki.4
Claim 2 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over
Roberts, Okazaki, and further in view of Vaezy.5
Claims 5, 8, and 9 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Roberts, Okazaki, and further in view of Chopra.6
Claims 10-15 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Roberts, Okazaki, and further in view of Uzgiris.7
I
The Examiner finds that Roberts teaches “a system and method for
treating a prostate through a perineal window of a patient with histotripsy
therapy” comprising positioning an “ultrasound therapy transducer . . .
adjacent a perineum of the patient” and a “transrectal imaging probe ... in a
rectum of the patient.” Final Act. 3. The Examiner finds Roberts teaches
that the “therapy transducer is adjusted relative to the imaging probe without
structural interference from the imaging probe,” and that treatment by
histotripsy pulses is given with the assistance of ultrasound imaging of the
prostate by the imaging probe. Id. The Examiner further finds Roberts
3 US 2011/0054315 Al, published March 3, 2011 (“Roberts”).
4 US 5,165,412, issued November 24, 1992 (“Okazaki”).
5 US 2009/0112098 Al, published April 30, 2009 (“Vaezy”).
6 US 6,589,174 Bl, issued July 8, 2003 (“Chopra”).
7 US 6,470,204 Bl, issued October 22, 2002 (“Uzgiris”).
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Application 13/735,936
teaches movement of the therapy transducer to permit focused therapy of the
ultrasound pulses “in all regions of the prostate without interfering with the
transrectal imaging transducer.” Id.
The Examiner finds that while Roberts does disclose that “an imaging
transducer may be located in the center of an ultrasound therapy system,” it
does not disclose “that the imaging probe is disposed in an opening of the
therapy transducer, wherein the opening allows the movement of the therapy
transducer.” Id. at 4.
The Examiner finds that Okazaki discloses “a shock wave medical
treatment apparatus with exchangeable imaging ultrasonic wave probe” and
that “an imaging probe may disposed in a round opening of a therapy
transducer, wherein the opening allows movement of the therapy
transducer.” Id.
The Examiner concludes that an ordinarily skilled artisan would have
found it obvious
to have modified the invention of Roberts to have the imaging
probe disposed in a round opening of the therapy transducer,
wherein the opening allows the movement of the therapy
transducer, as taught by Okazaki, in order to provide an
arrangement in which the focusing axis of the therapy
transducer is centered in the imaging plane of the imaging
transducer. Such an arrangement would simplify Roberts’
process of maintaining the cavitational bubble cloud produced
by the histotripsy pulses in the field of view of the imaging
transducer.
Id. at 5. Alternatively, the Examiner finds that the skilled artisan would
have found it obvious “to have modified the invention of Roberts to have the
imaging probe disposed in a round opening of the therapy transducer, in
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order to couple the transducers together spatially in a predetermined fashion
that could be easily controlled.” Id.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that Roberts and Okazaki
suggest the claimed subject matter. We select claims 1 and 17 as
representative of the claims subject to this ground of rejection. 37 C.F.R.
§ 41.37(c)(l)(iv).
Findings of Fact
FF1. The Specification discloses Figure 5, reproduced below:
Fig. 5
60S
Figure 5 “is another transducer design having a cutout for an imaging
probe.”
FF2. Roberts discloses a
medical imaging and therapy device is configured [to]
controllably apply ultrasound energy into the prostate by
maintaining a cavitational bubble cloud generated by an
ultrasound therapy system within an image of the prostate
generated by an imaging system. The medical imaging and
therapy device can be used in therapeutic applications such as
Histotripsy.
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Roberts Abstract.
FF3. Roberts discloses:
A trans-rectal (TR) ultrasound imaging system can be inserted
in the patient’s rectum to confirm accurate targeting and
localization of the bubble cloud formed by the therapy system
during treatment, and for imaging of target tissue during the
Histotripsy procedure. The imaging system can be attached to
the micro-manipulator system and repositioned axially and
rotated radially during the procedure to image and track
therapy.
Id. 129. See also Roberts Figures 2A-4B, depicting the process of insertion
of the imaging system and alignment of the transducer adjacent a perineum
of the patient for application of therapy. Roberts discloses that “the micro­
manipulator system is adapted and configured to position the imaging
system within a rectum of the patient and to position the ultrasound therapy
system in acoustic contact with the perineum while the imaging system is in
the rectum” (id. 136) and that “the focal point of the ultrasound therapy
transducer can be automatically moved by the micro-manipulator system
through the surgical treatment volume (e.g., of the prostate) to ablate the
treatment volume under real time imaging from the imaging system.” Id.
141.
FF4. Roberts discloses that the imaging system can be “advanced in the
rectum so that its imaging aperture defined by imaging transducer 220 is
adjacent to the prostate and is configured to acquire an image of the prostate
in the transverse plane” or “positioned by rotating radially along the
longitudinal axis of the probe so as to acquire an image of the prostate in the
medial sagittal plane.” Id. 135. Roberts discloses that the micro­
manipulator system is “adapted and configured to position the imaging
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system” (id.) including the ability to “automatically position the micro­
manipulator system, imaging system, and the ultrasound therapy system to
keep the cavitational bubble cloud in the imaging field.” Id. 143. From this
disclosure, the Examiner concludes that the “therapy transducer is adjusted
relative to the imaging probe without structural interference from the
imaging probe (positioning of transrectal imaging system and ultrasound
therapy system).” Final Act. 3.
FF5. Roberts discloses that, once in position, ultrasound imaging of the
prostate is performed with the imaging probe and treatment is provided
through histotripsy pulses that are generated by the transducer. Id. Tflf 40, 33,
and 34. From these disclosures, the Examiner concludes that therapy is
“minimally blocked by bones of the perineal window when focused on the
prostate” and that the “therapy transducer may be moved to position a
therapy focus of the ultrasound pulses in all regions of the prostate without
interfering with the transrectal imaging transducer.” Final Act. 3.
FF6. Okazaki discloses:
A shock wave medical treatment apparatus in which the
imaging ultrasonic wave probe can be changed among those of
different imaging region depths easily. The apparatus includes
a shock wave transducer for generating shock waves with a
focal point inside a body to be treated, having an aperture at a
center; an imaging ultrasonic wave probe for taking images of
the body to be treated containing the focal point of the shock
wave; and a housing pipe, placed on a line joining the focal
point of the shock wave and a center of the aperture of the
shock wave transducer, for exchangeably holding the imaging
ultrasonic wave probe.
Okazaki Abstract.
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FF7. Okazaki discloses:
In this shock wave applicator 17, the imaging ultrasonic wave
probe 16 is housed inside a cylindrical housing pipe 54 made of
stainless steel which has an inner diameter slightly larger than
an outer diameter of the imaging ultrasonic wave probe 16, and
at the central aperture of the shock wave transducer 15a cup
shaped connecting member 43 having a slightly larger inner
diameter than an outer diameter of the housing pipe 54 for
supporting the shock wave transducer 15 with respect to the
housing pipe 54 is provided around the housing pipe 54.
Id. at 4:19-29.
FF8. Okazaki discloses Figure 4, reproduced below:
FIG. 4
Figure 4 “is a detailed cross sectional view of a shock wave transducer in the
apparatus of FIG. 3. Id. at 3:4—5.
FF9. Okazaki discloses that “between the connecting member 43 and the
housing pipe 54, there is provided a driver unit 36 for moving the shock
wave transducer 15 in a direction E with respect to the housing pipe 54.” Id.
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Application 13/735,936
at 4:63—66. The position of the shock wave transducer with respect to the
housing pipe is detected by position detection unit 90 and signaled to
position controller 30, “which in turn controls rotation angle of the driving
axis of the motor 36c such that the position of the shock wave transducer 15
with respect to the imaging ultra-sonic wave probe 16 is controlled in a
desired manner.” Id. 5:8—22. Okazaki discloses that the “imaging ultrasonic
wave probe 162 can be fixed, or made free to rotate.” Id. 8:29-30 and
Figure 9.
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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
We adopt the Examiner’s findings regarding the scope and content of
the prior art (Final Act. 2—5; FF1—9) and agree that the claimed device
would have been obvious over the teachings of Roberts and Okazaki. We
address Appellants’ arguments below.
Appellants argue that Okazaki teaches that its “therapy transducer
cannot be moved with respect to the Okazaki imaging transducer because the
two are fixed in place relative to another with the Okazaki tilting
mechanism.” App. Br. 4. Accordingly, Appellants argue, the Examiner fails
to identity in the prior art
an “opening of the ultrasound therapy transducer [that] allows
for movement of the ultrasound therapy transducer with respect
to the transrectal imaging transducer without structural
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Application 13/735,936
interference from the transrectal imaging transducer”, as
required by claim 1, and . . . “positioning the transrectal
imaging probe in an opening in the ultrasound therapy
transducer, [and] adjusting a linear, pan, or tilt position of the
ultrasound therapy transducer relative to the imaging probe
without structural interference from the transrectal imaging
probe” as required by claim 17.
Id. at 5. We are not persuaded. As the Examiner explains, Okazaki teaches
that “the shock wave transducer 15 is movable in a direction E with respect
to the housing pipe [and thus is] movable with respect to imaging transducer
16 located inside the housing pipe.” Ans. 2; FF9. Okazaki teaches that the
position controller controls the driving axis, thereby controlling the rotation
angle of the transducer and imaging probe. Ans. 2; FF9. Okazaki also
teaches that the probe itself can be “made free to rotate.” Ans. 2; FF9.
Accordingly, we agree with the Examiner that Okazaki teaches the
limitations at issue in claim 1 and 17.
Appellants next argue the Examiner has not provided “<2 rational basis
for combining Roberts and Okazaki” because “Roberts already allows for
movement of the therapy transducer without interference from the imaging
probe.” App. Br. 5—6. According to Appellants, the Examiner has not
established why modification is necessary where the “benefits are already
achieved by the original Roberts design.” Id. at 6. Appellants further argue
Okazaki “does not provide any teaching on how to position an imaging
transducer within an opening of a therapy transducer while allowing for
relative movement between the transducers.” Id. Finally, Appellants argue
that the proposed combination of Roberts and Okazaki changes the principle
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Application 13/735,936
of operation of both references, is not explained by the Examiner, and goes
against “the main teachings of Okazaki.” App. Br. 6-7.
We are unpersuaded. Appellants’ argument regarding Okazaki’s
failure to teach positioning fails to address the combination of references.
Nonobviousness cannot be established by attacking the references
individually when the rejection is predicated upon a combination of prior art
disclosures. In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986);
see also In re Keller, 642 F.2d 413, 426 (CCPA 1981) (finding “one cannot
show nonobviousness by attacking references individually where, as here,
the rejections are based on combinations of references” (citations omitted)).
Appellants have provided no evidence or persuasive argument to explain
why Okazaki’s teachings regarding positioning of a transducer within a
housing and under the control of a driver for directing movement of the
transducer with respect to an imaging probe (FF6—9) teach away from the
combination or otherwise fail to suggest the claimed subject matter. Rather,
we agree with the Examiner that
while Roberts’ system allows extensive relative motion
between the imaging and therapy transducers, Roberts also
appreciates that the entire range of motion may not be necessary
or desirable in all circumstances. The proposed modification
would provide an arrangement that constrains the movement of
the imaging transducer to be within a range accommodated by
the dimensions of the opening of the therapy transducer. This
would reduce unnecessary or undesired relative motion in the
system and consequently reduce the amount of manipulation
required by the micromanipulator to initially position and
ultimately maintain the therapy transducer in the field of view
of the imaging transducer.
Ans. 4. Appellants have not provided arguments or evidence that, when
considered together with the Examiner’s reasonable fact-based conclusions,
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render the claims non-obvious. We affirm the rejection of claims 1 and 17.
Claims 3, 4, 6, 7, 16, and 18 were not separately argued and fall with claims
1 and 17. 37 C.F.R. § 41.37(c)(l)(iv).
II
Appellants do not separately argue the rejection of claim 2 as obvious
over Roberts, Okazaki, and Vaezy; claims 5, 8, and 9 as obvious over
Roberts, Okazaki, and Chopra, or claims 10-15 as obvious over Roberts,
Okazaki, and Uzgiris, but rather state for each respective rejection that the
additionally cited reference “fails to make up for the deficiency of Roberts
and Okazaki.” App. Br. 7. Such arguments do not suffice as separate
arguments for patentability of these claims. In re Lovin, 652 F.3d 1349,
1357 (Fed. Cir. 2011) (noting that separately arguing a claim requires “more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
found in the prior art.”). Accordingly, Appellants have waived arguments
directed to Vaezy, Chopra, and Uzgiris. We, therefore, also affirm the
rejections of claim 2 as obvious over Roberts, Okazaki, and Vaezy; claims 5,
8, and 9 as obvious over Roberts, Okazaki, and Chopra, or claims 10—15 as
obvious over Roberts, Okazaki, and Uzgiris. See Hyatt v. Dudas, 551 F.3d
1307, 1314 (Fed. Cir. 2008) (“In the event of such a waiver, the PTO may
affirm the rejection of the group of claims that the examiner rejected on that
ground without considering the merits of those rejections.”).
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SUMMARY
We affirm the rejection of claims 1,3,4, 6, 7, and 16—18 under pre-
AIA 35 U.S.C. § 103(a) as obvious over Roberts and Okazaki.
We affirm the rejection of claim 2 under pre-AIA 35 U.S.C. § 103(a)
as obvious over Roberts, Okazaki, and further in view of Vaezy.
We affirm the rejection of claims 5, 8, and 9 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Roberts, Okazaki, and further in view of Chopra.
We affirm the rejection of claims 10—15 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Roberts, Okazaki, and further in view of Uzgiris.
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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