Ex Parte Tillander et al

Patent Trial and Appeal Board

Sep 14, 2018

14241552 (P.T.A.B. Sep. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/241,552 02/27/2014 Matti Oskari Tillander
24737 7590 09/18/2018
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
2011P01483WOUS 4426
EXAMINER
OUYANG,BO
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
09/18/2018 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 MATTI OSKARI TILLANDER,
MAX OSKAR KOHLER, and
SHUNMUGA VELU SOKKA 1
Appeal2017-009138
Application 14/241,552
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims relating to a medical apparatus for
generating focused ultrasonic energy for sonicating within a target volume
of a subject. The Examiner rejected the claims as obvious under 35 U.S.C.
§ 103. Appellants appeal the rejection pursuant to 35 U.S.C. § 134. We
have jurisdiction under 35 U.S.C. § 6(b). The rejections are reversed.
1 The Appeal Brief ("Appeal Br.") 1 lists KONINKLJJKE PHILIPS, N.V. as
the real party in interest.
Appeal2017-009138
Application 14/241,552
STATEMENT OF THE CASE
Claims 1-7, 9, 10, and 12-17 stand rejected by the Examiner as
unpatentable under pre-AIA 35 U.S.C. § I03(a).
The Examiner rejected claims 1, 7, 9, 10, 12, and 15-17 under pre-
AIA 35 U.S.C. § I03(a) as obvious in view of Vortman et al. (U.S. Publ.
Pat. App. No. 2010/0241036 Al, published Sept., 23, 2010) ("Vortman")
and Novak et al. (U.S. Publ. Pat. App. No. 2008/0058648 Al, published
Mar. 6, 2008) ("Novak"). Final Office Action ("Final Act.") 3.
Dependent claims 2, 3, 4, 5, 6, 13, and 14 stand rejected by the
Examiner over the combination of Vortman and Novak, and additionally
cited publications to reach the limitations recited in the dependent claims.
Final Act. 9, 10, 12, and 13.
Claims 1, 12, 15, and 17 are the independent claims on appeal.
Claims 1 and 12 are illustrative and are reproduced below.
1. A medical apparatus comprising:
high intensity focused ultrasound system configured for
generating focused ultrasonic energy for sonicating within a
target volume of a subject, wherein the high intensity focused
ultrasound system comprises an ultrasonic transducer with a
controllable focus;
a memory containing machine executable instructions for
controlling the medical apparatus;
a processor configured for controlling high intensity
focused ultrasound system based on the instructions to:
cause ultrasonic cavitations at multiple cavitation
locations on a rear surface of the target volume to form an
acoustically reflective shield, wherein the multiple cavitation
locations are targeted by adjusting the controllable focus; and
sonicate multiple sonication locations within the target
volume in front of the acoustically reflective shield and below a
threshold which induces cavitation, wherein the multiple
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sonication locations are targeted by adjusting the controllable
focus.
12. A method of operating a medical apparatus,
wherein the medical apparatus comprises a high intensity
focused ultrasound system configured for generating focused
ultrasonic energy for sonicating within a target volume of a
subject, wherein the high intensity focused ultrasound system
comprises an ultrasonic transducer with a controllable focus,
wherein the method comprises the steps of:
creating an acoustic shield by causing ultrasonic
cavitations at multiple cavitation locations at a rear of the target
volume using the high intensity focused ultrasound system,
wherein the multiple cavitation locations are targeted by
adjusting the controllable focus; and
sonicating multiple sonication locations within the target
volume using the high intensity focused ultrasound system and
below a threshold which induces cavitation, wherein the
multiple sonication locations are targeted by adjusting the
controllable focus, wherein the acoustic shield prevents acoustic
propagation into tissue behind the acoustic shield during the
sonicating.
CLAIMS
Claim 1 is directed to a medical apparatus comprising ( 1) a high
intensity focused ultrasound system ("HIFU") for generating focused
ultrasonic energy, (2) a memory containing executable instructions for
controlling the apparatus, and (3) a processor configured for controlling the
high intensity ultrasound system. The processor contains the following
instructions:
(a) "cause ultrasonic cavitations at multiple cavitation locations on a
rear surface of the target volume to form an acoustically reflective shield";
and
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(b) "sonicate multiple sonication locations within the target volume in
front of the acoustically reflective shield and below a threshold which
induces cavitation".
Claim 12 is directed to a method of operating a medical apparatus that
comprises a high intensity ultrasound system for generating focused
ultrasonic energy. The method comprises steps of (a) "creating an acoustic
shield by causing ultrasonic cavitations at multiple cavitation locations at a
rear of the target volume" and (b) "sonicating multiple sonication locations
within the target volume using the high intensity focused ultrasound system
and below a threshold which induces cavitation." Steps (a) and (b)
correspond to the instructions (a) and (b) of claim 1. Claim 12 further
requires "wherein the acoustic shield prevents acoustic propagation into
tissue behind the acoustic shield during the sonicating."
CLAIM INTERPRETATION
The Specification defines "cavitation" as the "formation of empty
cavities or bubbles in a liquid by using ultrasound and the immediate
implosion of them also by using ultrasound." Spec. 7:6-7. The
Specification further explains that reference "in the claims to causing
cavitation in a target using ultrasound may be interpreted as a sonication
performed with sufficient ultrasound intensity to induce the formation of
bubbles and subsequent cavitation of them." Id. at 7:9--12.
Claim 1 recites processor instructions to control the system to (a)
"cause ultrasonic cavitations at multiple cavitation locations on a rear
surface of the target volume to form an acoustically reflective shield" and to
(b) "sonicate multiple sonication locations within the target volume in front
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of the acoustically reflective shield and below a threshold which induces
cavitation." (Emphasis added.) We interpret such recited instructions to
require the processor to control the apparatus to carry out each step
separately to achieve (a) cavitation and (b) sonication below the cavitation
threshold at the recited multiple locations, i.e., the process instructs the
system to achieve cavitation and has a separate instruction telling the system
to achieve sonication below cavitation. See Spec., Figs. 1-5 showing flow
charts with separate/steps instructions for each.
The claims require an "acoustically reflective shield." This term is
not expressly defined in the Specification. However, the Specification
teaches that the cavitation locations "may be beneficial because the multiple
cavitation locations may form a shield or a block which reduces the amount
of ultrasound which goes through it." Spec. 10:26-28. The Specification
also discloses:
In another embodiment ultrasonic cavitations at multiple
cavitation locations form an acoustic barrier. The bubbles
generated by the ultrasonic cavitations make it difficult for
ultrasound to pass the region with the bubbles. In this way
forming cavitations at the multiple cavitation locations may
form an acoustic barrier which blocks or partially blocks
ultrasound from traveling through it.
Spec. 10:32-11:2.
Based on these disclosures, we interpret an "acoustically reflective
shield" to reduce or partially block ultrasound from traveling through it, but
not necessarily to completely prevent the ultrasound from going through it.
Claims 1 and 12 both comprise instructions or steps of (a) producing
cavitations to form an acoustic shield at the rear of the target and (b)
sonicating in front of the shield. Thus, we interpret the claims to require that
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both the shield and the sonicating occur at the same time, namely at least
overlapping in time.
REJECTIONS BASED ON VORTMAN AND NOV AK
The Examiner found that V ortman describes a medical apparatus
comprising (1) HIFU as in claims 1 and 12, and (2) a memory; and (3) a
processor as in claim 1. Final Act. 3--4, 6. The Examiner found that
Vortman does not describe causing ultrasonic cavitations that form an
acoustically reflective shield as required by both claims. Id. at 4, 6.
However, the Examiner found that Novak teaches cavitations that generate
an acoustic shield. Id. at 4, 6-7. The Examiner determined that it would
have been obvious to one of ordinary skill in the art "to use the cavitations to
form a shield, as taught by Novak. This would help to protect untargeted
tissue from treatment." Id. at 4; see also id. at 7.
Appellants dispute the Examiner's finding that Novak describes
utilizing an acoustically reflective shield in its method to protect untargeted
tissue. Appeal Br. 6.
Discussion
We focus our discussion on Novak because the content and teachings
of that publication is in dispute.
Novak teaches an ultrasonic surgical instrument for wound treatment.
Novak ,r 9. Novak teaches that the device comprises a probe that operates at
three different amplitude settings.
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High amplitude setting
Novak teaches that when the device operates at high amplitude
settings, tissue debridement occurs when cavitation is induced and also that
cavitation produces an acoustic shield:
FF 1. Novak describes a surgical device that comprises a vibrating tip
that creates acoustical energy in the form of "cavitation." Novak ,r 17.
Novak teaches that this "energy breaks up tissue and emulsifies it into the
irrigant fluid, which can be aspirated from the wound site by standard
means." Id.
FF2. Novak further teaches that "for this effect to take place, the
amplitude of vibration of the tip must be high enough to create sufficient
acoustic energy to induce cavitation. This is called the Cavitation
Threshold." Id. at ,r 18.
FF3. Novak teaches: "Once a cavitation bubble is induced, enough
energy exists at the probe wound interface to not only destroy tissue but to
cause pain if the wound is debrided too deeply." Id. at ,r 18.
FF4. Novak further teaches:
On the higher amplitude setting, the cavitation energy is
substantially more aggressive with greater debridement evident.
The acoustic wall created by the cavitation is so great that the
low frequency waves are not present. The cavitation and
microstreaming are removing devitalized tissue.
Id. at i123.
FF5. Novak also teaches that the cavitation produces a bubble field
that attenuates transmission of acoustic waves, producing an acoustic or
bubble shield:
Once cavitation is induced, the resulting bubble shield will
attenuate the transmission of acoustic waves into the body.
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This is due to the gaseous nature of the bubble cloud. It is well
known that gas presents a high or infinite impedance to acoustic
waves in the low ultrasound region.
Id. at ,I 19.
Thus, Novak teaches that the device can operate on a setting that
produces an acoustic shield as recited in the claims.
Moderate amplitude setting
FF6. Novak teaches that, when the device operates at moderate
amplitude settings, the following occurs:
On moderate settings, i.e., at or very near the cavitation
threshold, the acoustic energy results in moderate debridement
of the wound, but the acoustic shield developed is not so great
as to impede the majority or a substantial amount of the low
amplitude waves from reaching the affected area. There is
biofilm being destroyed and a significant amount of bacterial
cell destruction taking place at these settings.
Id. at ,I 22.
Low amplitude setting
Novak also teaches low amplitude settings for the probe.
FF7. Novak teaches that applying energy at a low amplitude setting,
less than that which produces cavitation, can be used to stimulate healing:
If the probe operating face or energy director vibratory
amplitude is less than that needed to induce cavitation, all of the
acoustic energy is transmitted into the wound bed much the
same way as an underwater speaker transmits sound waves. In
this case, the tissues are being stressed by the compression and
rarefaction waves. This movement stimulates the natural
healing mechanisms of the body and increases the healing rate.
Id. at ,I 20.
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FF8. Further, as described in Novak:
For instance, the low amplitude sonic waves (minimally or not
occluded by the acoustic shield created by cavitation) has a
benefit of repolarizing the cells, decongesting the wound bed,
and disrupting the biofilm. The low acoustic energy also has
been described as decongesting the wound and allowing factors
critical to wound healing to reach the affected areas. In
addition, this low frequency ultrasound appears to arrest the
inflammation process minimizing the subsequent edema.
Id. at,I2I.
Claim 12
While Novak teaches that an acoustic shield is produced when the
amplitude is sufficient to produce cavitation (FF5, FF6, FF8), the issue in
the rejection of claim 12 is whether the combination of Vortman and Novak
suggest creating an acoustic shield by causing ultrasonic cavitations at the
rear surface of a target volume, "wherein the acoustic shield prevents
acoustic propagation into tissue behind the acoustic shield during the
sonicating," and then sonicating in front of the shield at thresholds below
those amplitudes that cause cavitation.
As discussed above, Novak teaches applying settings that produce
both cavitations at a high amplitude (FF5, FF6, FF8) and sonicating at low
amplitude at a setting that does not produce cavitations (FF7, FF8) as
required by claim 12. The high amplitude waves that produce cavitation are
applied to debride and break up tissue (FFl, FF3, FF4, FF6) and the low
amplitude waves are used to stimulate tissue healing (FF7, FF8).
Novak generally teaches applying the two different waves, but at
different times:
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FF9.
In order to take advantage of this therapeutic effect of low
amplitude waves, the present invention contemplates wound
debridement with the electronic generator of the system set at
an output that will give amplitudes of vibration significantly
above the cavitation threshold. This will provide the most
efficient debridement. Once the wound bed is debrided, the
practitioner will reduce the amplitude of vibration of the system
by turning the output signal lower, to a point below the
cavitation threshold. The probe will then be rubbed on the
debrided wound bed to allow the acoustic energy to flow into
the wound without further debridement or tissue ablation.
Novak ,r 24 (emphasis added).
FFlO
The surgeon or surgeons use the debridement probe on a trauma
site for a time adequate to remove necrotic tissue from the site
and then use the therapy instrument on the debrided tissue to
stimulate a healing response. The duration or interval that the
therapy instrument's working tip is in contact with the debrided
tissue surface may be timed by a timer.
Id. at ,r 101 ( emphasis added).
Thus, in neither of these disclosures in which Novak describes the
normal operation of its device does Novak describe creating an acoustic
shield at the rear of a target and sonicating in the target volume in front of
the shield at the same or overlapping times and "below a threshold which
induces cavitation" where "the acoustic shield prevents acoustic propagation
into tissue behind the acoustic shield during the sonicating" as in claim 12.
Rather, in the above-mentioned disclosures (FF9, FFlO), Novak describes
sequential application of the different waves, but not both at the same time
as required by claim 12. These disclosures also do not teach that shield
prevents acoustic propagation behind the shield when sonicating.
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In the moderate setting, Novak describes circumstances in which
cavitation occurs ("at ... the cavitation threshold") and "low amplitude
waves." FF6. However, Novak expressly teaches the acoustic shield
produced by the cavitation "is not so great as to impede the majority or a
substantial amount of the low amplitude waves from reaching the affected
area." FF6. Thus, Novak does not teach the limitation of claim 12 where
"the acoustic shield prevents acoustic propagation into tissue behind the
acoustic shield during the sonicating." Novak does not suggest the
limitation either because Novak describes the acoustic shield as being used
to debride tissue (FFl, FF3, FF4, FF6) and to be applied before the low
amplitude wave (FF9--FF 11 ). Thus, while the ability of the acoustic shield
to attenuate the transmission of acoustic waves is recognized by Novak
(FF5), it was not used for this purpose.
The Examiner did not provide a reason as to why one of ordinary skill
in the art would have utilized the acoustic shield to "prevent[ ] acoustic
propagation into tissue behind the acoustic shield during the sonicating"
when Novak does not use the shield for this purpose and desires to limit its
development from not being "so great as to impede the majority or a
substantial amount of the low amplitude waves from reaching the affected
area" (FF6).
For the foregoing reasons, the obviousness rejection of claim 12 is
reversed. The rejections of dependent claims 13 and 14 are also reversed for
the same reasons.
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Claim 15
Claim 15 is directed to non-transitory computer readable medium
carrying software "which controls one or more processors to: control a high
intensity focused ultrasound system which includes at least one ultrasound
transducer to form a bubble cloud by causing ultrasonic cavitations at
multiple cavitation locations within the target volume," and "wherein the
bubble cloud is configured to prevent acoustic propagation." We interpret a
bubble cloud produced by cavitations to be same as the acoustic shield of
claim 12. Spec. 2:20-23, 26. Thus, as for claim 12, the combination of
V ortman and Novak does not disclose or suggest a processor configured
produce a bubble cloud "configured to prevent acoustic propagation." The
rejection of claim 15 is reversed.
Claim 17
Claim 1 7 is directed to medical apparatus comprising a processor
configured "control the high intensity focused ultrasound system to cavitate
tissue in a target volume to create an acoustically reflected barrier," and "the
acoustically reflective barrier prevents the high intensity focused ultrasound
applied during the sonication from propagating through the barrier to tissue
on another side of the acoustically reflective barrier." As explained for
claim 12 the combination of Vortman and Novak does not disclose or
suggest a processor configured to produce an acoustically reflected barrier
that prevents propagation of ultrasound across it as required by claim 1 7.
The rejection of claim 17 is reversed.
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Claim 1
Claim 1 requires instructions to "cause ultrasonic cavitations at
multiple cavitation locations on a rear surface of the target volume to form
an acoustically reflective shield" and to "sonicate multiple sonication
locations within the target volume in front of the acoustically reflective
shield and below a threshold which induces cavitation." Unlike claim 12,
claim 1 does not expressly require the shield to "prevent" acoustic
propagation into the tissue behind the shield. As explained in the "Claim
Interpretation" section, an acoustic shield or barrier does not require
ultrasound to be completely blocked; the Specification also discloses that it
may "partially block[] ultrasound from traveling through it" (Spec. 11: 1-2).
Thus, because Novak discloses an acoustic shield that impedes some - albeit
not all and not a substantial amount (FF6)- we find the limitation to have
been met in Novak.
The Examiner stated:
In the combination ofVortman and Novak, as the target area is
filled with cavitation bubbles, the rear surface of the target area
would also have these bubbles given the target area itself is
filled with bubbles. This would shield tissue beyond the target
area via the attenuation of ultrasound by the bubbles, while
simultaneously heating the tissue due to absorption of the
ultrasound energy that was attenuated.
Ans. 3.
However, the Examiner did not identify disclosure in either Vortman
or Novak of instructions to:
(a) "cause ultrasonic cavitations at multiple cavitation locations on a
rear surface of the target volume to form an acoustically reflective shield";
and
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(b) "sonicate multiple sonication locations within the target volume in
front of the acoustically reflective shield and below a threshold which
induces cavitation".
As discussed above in the Claim Interpretation section, we construed
these instructions to be separate instructions. The Examiner did not provide
adequate evidence that Vortman or Novak, alone or combined, disclose or
suggest separate instructions (a) for causing ultrasonic cavitations to form an
acoustic shield and (b) for sonicating at multiple locations. See Appeal Br.
8. Rather, Novak teaches one moderate setting that produces both
cavitation and low amplitude waves (FF6), with no guidance for performing
the steps separately.
In addition to this, claim 1 requires that the cavitations/shield is
formed at the rear and that the sonicating is performed in front of the shield.
The Examiner's interpretation of the claim that such limitations are satisfied
by producing the cavitations and sonications at the same locations ( as in
Novak's moderate setting (FF6)) ignores the "rear" and "front" limitations
of the claim. All limitations of a claim must be considered when making a
patentability determination. In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir.
1983). See Spec. 15:11-17 (shown in Fig. 9) describing an acoustic shield
622 at rear "form[ing] a shield or barrier which obstructs or greatly
attenuates the ultrasound 612. This confines the ultrasound 612 to the
remainder of the target volume 620." The Examiner has therefore not
established that Vortman and Novak render these "rear" and "front"
locations obvious.
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For the foregoing reasons, the obviousness rejections of independent
claim 1, and dependent claims 2-7, 9, 10, and 16 are reversed.
REVERSED
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