Ex Parte Browning et al

Patent Trial and Appeal Board

Sep 28, 2016

12376317 (P.T.A.B. Sep. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/376,317 0210412009 Theodore J. Browning
24737 7590 09/30/2016
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.
2006P01897WOUS 5665
EXAMINER
HOFFA, ANGELA MARIE
ART UNIT PAPER NUMBER
3768
NOTIFICATION DATE DELIVERY MODE
09/30/2016 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):
marianne.fox@philips.com
debbie.henn@philips.com
patti. demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THEODORE J. BROWNING, WILLIAM SHI, JEFFRY E.
POWERS, MICHALAKIS A VERKIOU,
and THOMAS GAUTHIER
Appeal2014-008872
Application 12/376,317
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134 from the
Examiner's rejection of claims 1-20. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We reverse.
STATEMENT OF THE CASE
The Specification discloses "ultrasound systems which perform
imaging and therapy for stroke victims" (Spec. 1 ).
1 Appellants identify the Real Party in Interest as Koninklijke Philips
Electronics N.V. (App. Br. 3).
Appeal2014-008872
Application 12/376,317
Claim 1 is representative of the claims on appeal and reads as follows
(emphasis added):
1. A stroke therapy system for treating cranial vascular obstructions
compnsmg:
a transducer array headset adapted to maintain an ultrasonic transducer
array in acoustic contact with a head of a subject;
a two dimensional array of transducer elements, located in the headset,
the elements configured to steer both imaging beams and therapeutic beams
over a volumetric region in the head of the subject;
a microbeamformer, located in the headset and coupled to the elements
of the two dimensional array of transducer elements;
a transmit controller, coupled to the array of transducer elements, and
configured to cause the elements to transmit beams in either an imaging mode
or a therapy mode;
an image processor, coupled to the microbeamformer, which is
configured to produce harmonic images of micro bubbles in the blood flow in
the cranium of the subject when the elements are steering imaging beams over
an imaged region of the cranium in the imaging mode;
an image display, coupled to the image processor, which is configured to
produce an image of the cranial vasculature; and
a user control which is adapted to be manipulated by a user to aim a
therapeutic beam vector on the image display at a location of an obstruction
site in the image of the cranial vasculature,
wherein the elements are caused to transmit a therapeutic beam of a
duty cycle of 50% or less which is aimed along the therapeutic beam vector
and focused at the obstruction site in the cranium of the subject to vibrate or
break the microbubbles at the obstruction site when operated in the therapy
mode.
Claims 5 and 14, the other independent claims, include limitations that
are substantively the same as those highlighted above for claim 1.
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Application 12/376,317
Issue
The Examiner has rejected claims 1-20 under 35 U.S.C. § 103(a) as
obvious in view ofUnger2 and Averkiou3 (Ans. 3-12).
The issue presented is: Does a preponderance of the evidence support
the Examiner's conclusion that the combination of Unger and A verkiou
would have made obvious stroke therapy system that comprises
a user control which is adapted to . . . aim a therapeutic beam
vector on the image display at a location of an obstruction site in
the image . . . wherein the [transducer] elements are caused to
transmit a therapeutic beam ... aimed along the therapeutic beam
vector and focused at the obstruction site,
as required by claim I (emphasis added)?
Findings of Fact
1. Unger discloses an apparatus and a method to treat cerebral
ischemia or ischemic stroke. "The method supplies an ultrasound emitting
device 100 comprising a plurality of ultrasound transducers (180f (Unger)
Abstract), T'lie method "locates using [a] first ultrasound energy an
occlusion disposed in ... cerebral blood vessels. The method then emits
second ultrasound energy)' to 1yse the occlusion (id.).
2. Unger discloses that~ by monitoring a display device; a medical
provider determines '"when sufficient injected microbubb1es have reached
the occlusion site ... [and then] causes the plurality of therapeutic
ultrasound emitters to produce ultrasound energy;' to rupture the
microbubbles (id.~! 134).
2 Unger, US 2008/0262350 Al, published October 23, 2008.
3 A verkiou et al., US 6, 171,246 B 1, issued January 9, 2001.
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Appeal2014-008872
Application 12/376,317
3. Unger discloses that, afrer 1ocating the occlusion site) the
ultrasound emitting device is positioned on the patient's scalp such that the
ultrasound energy waves are directed to the occlusion site (id. ir 163). Unger
discloses that the ultrasound emitting device can be positioned by hand or
"using the head band apparatus .. , or head frame apparatus'' (id.).
4. Averkiou discloses that ''bloodf1ow in organs, tissue and vessels
is imaged in realtirne with the enhancement of a microbubbk contrast agenC
(Averkiou, col. 2, 11. 9----11),
5. Averkiou discloses "an ultrasonic diagnostic imaging system .
. . . A probe 10 which includes an array transducer 12 transmits ultrasonic
energy into the body and receives echoes returned from tissue, ce11s and
flowing substances in the body, including ultrasonic contrast agents)' (id. at
coL L !L 43-49). "[C]ontrolled timing of transmission enables the wave
transmitted by the entire anay to be steered in a given direction) that is,
along a predetermined scanline, and to be fr1cused at the desired depth of
f' " ' "d ' 1 '1 11 <'.·') t. ' ocus (Z . at co , L, , o...,----,)6).
6, A verkiou discloses that; in prior art techniques,
a microbubble contrast agent is imaged by transmitting high
power pulses to elicit the strong echoes of microbubble
destruction. Since the contrast agent is locally destroyed by the
high energy pulses, an intervening time of no pulses or low
power pulses is used to allow a reinfusion of new microbubbles
into the image area, whereupon the contrast agent can be imaged
agam.
(Id. at col. 5, 11. 2-9.)
7, Averkiou discloses that in its invention,
exactly the opposite approach is taken. A high power pulse or
pulses may be initially transmitted to disrupt or destroy the
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Appeal2014-008872
Application 12/376,317
microbubble contrast agent in the region being imaged.
Thereafter the micro bubbles are imaged in rea!time by low
power transmit pulses, and the reinfusion of the blood vessel or
tissue vasculature is observed in realtime.
(id. at col. 5, 11. 13----16.)
8. Averkiou states that '"[s]uch realtime images can reveal areas of
tissue such as the myocardium which do not reperfuse as rapidly as
surrounding tissue or do not reperfuse at all, indications of an infarct" (id. at
col. 5, 11. 20-23).
Analysis
The Examiner finds that Unger discloses "a stroke therapy system for
treating cranial vascular obstructions" comprising all of the limitations of
claim 1 except for a user control that is manipulated to aim a therapeutic
beam vector on an image display, and a therapeutic beam that is transmitted
along the therapeutic beam vector (Ans. 3--4).
The Examiner finds that A verkiou discloses that "ultrasound beams
are aimed, steered, and focused at a desired area within the cranium ... in
order to disrupt microbubbles and monitor perfusion" (id. at 4). "The
desired area is further monitored with ultrasound to produce images in real
time" (id.). According to the Examiner, Averkiou discloses that "non-
ablating ... beams are focused at the desired area to vibrate or destroy the
microbubbles" (id. at 5). The Examiner concludes it would have been
obvious to modify Unger's system, as a "matter of design choice[,] to
provide a graphical user interface to position a therapeutic beam vector at
the occlusion site ... [to] aid[] the user in treating the occlusion site with a
focused ultrasound beam ... as taught by Averkiou" (id.).
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Application 12/376,317
Appellants argue that Unger "does not use a directed therapeutic beam
... [and] does not have a therapeutic beam vector on the image display
which can be manipulated by the clinician to aim the beam at the obstruction
site" (App. Br. 11 ). Appellants argue that, instead, Unger discloses
manually positioning the ultrasound device "by adjusting his head band or
head frame apparatus on the head of the patient to direct the ultrasonic
energy waves toward an occlusion site." (Id.).
Appellants argue that Averkiou is directed to "contrast-mediated
imaging and not therapy" and does not disclose a "therapeutic beam vector
... which can be manipulated over a displayed image" (id. at 12).
Appellants argue that there "is no focused beam therapy in A verkiou ...
because there is no therapy" (id.).
With regard to Appellants' argument that the references do not teach
manipulating a therapeutic beam vector on a displayed image, the Examiner
"agrees that the references do not expressly teach such a feature. However,
the Examiner believes that image-guidance of the focused beam would be
obvious to one of ordinary skill in the art at the time of the invention" (Ans.
14). The Examiner also states that "[t]he motivation would be to provide
real-time treatment and monitoring of an imaged area," as taught in Unger
(id.).
According to the Examiner, the system made obvious by the cited
references
must somehow know where to aim the beam in order for the
therapy to be initiated in a meaningful location. Either an
automated response or a user-controlled response can be used to
communicate the desired region of interest (ROI) to the system,
and such a process is considered routine in the imaging art.
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Application 12/376,317
Choosing an ROI from an image does not produce any critical or
unexpected result.
(id.).
\Ve agree with Appellants that the Examiner has not adequately
explained how the cited references would have made obvious a stroke
therapy system that comprises a user control for "aim[ing] a therapeutic beam
vector on the image display at a location of an obstruction site in the image ...
wherein the [transducer] elements are caused to transmit a therapeutic beam
... aimed along the therapeutic beam vector and focused at the obstruction
site," as required by claim I (emphasis added). "In rejecting claims under 35
U.S.C. § 103, the examiner bears the initial burden of presenting aprirna
facie case of obviousness." In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir.
1993). A proper § 103 analysis requires "a searching comparison of the
claimed invention-including all its limitations-with the teaching of the
prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
Here, the Examiner acknowledges that neither reference discloses
aiming a therapeutic beam vector on the display or transmitting a therapeutic
beam along such an aimed vector (Ans. 14). The Examiner, however, reasons
that Unger's goal is to provide real-time treatment and monitoring of an imaged
area (id.) and that Averkiou discloses that ultrasound beams are aimed, steered,
and :focused at a desired area (id. at 4).
'fhe Examiner~s reasoning is not persuasive, however, because Unger
discloses the manual positioning of ultrasound transducers to target a desired
area (FF 3). There is nothing in Unger to suggest steering of a therapeutic
ultrasound beam with a user interface that allows for positioning a steering
vector on an image display. Averkiou discloses genera11y that ultrasound
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Application 12/376,317
waves can be directed in a particular direction along a predetennined scan
line to arrive at a desired depth, but, as Appellants point out (App. Br. 12----
13), Averkiou's system is only for diagnosis, not therapy (FF5----FF8). The
Examiner has not explained why this disclosure would suggest aiming a
therapeutic beam vector on an image display and transmitting a therapeutic
ultrasound beam along the vector. Although the Examiner states that using a
user-controlled response to communicate a desired reQ:ion-of-interest to an
<>
ultrasound system is considered routine in the art (Ans. 14 ), she has not
provided evidence to support that statement. "In reviewing the examiner's
decision on appeal, the Board must necessarily weigh all of the evidence and
argument." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "[T]he
conclusion of obviousness vel non is based on the preponderance of
evidence and argument in the record." Id. at 1446.
Because the rejection is not supported by a preponderance of the
evidence, we reverse the rejection of independent claim 1 and dependent
claims 2--4, 6, 8-11, and 13 under 35 U.S.C. § 103(a) in view of Unger and
Averkiou. As noted above, claims 5 and 14 are the only other independent
claims and include limitations substantively the same as those discussed for
claim 1. Thus, we also reverse the rejection of independent claims 5 and 14,
and dependent claims 7, 12, and 15-20 under 35 U.S.C. § 103(a) in view of
Unger and A verkiou.
SUMMARY
We reverse the rejection of claims 1-20 under 35 U.S.C. § 103(a).
REVERSED
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