Ex Parte Weng et al

Patent Trial and Appeal Board

Oct 6, 2016

13245689 (P.T.A.B. Oct. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/245,689 09/26/2011 Lee Weng
84561 7590 10/11/2016
Vista IP Law Group, LLP
2160 Lundy Avenue, Suite 230
San Jose, CA 95131
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.
KONA.023C8 8908
EXAMINER
KISH, JAMES M
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
10/11/2016 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):
docketing@viplawgroup.com
ttn@viplawgroup.com
ev@viplawgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LEE WENG, DAVID M. PEROZEK,
and JIMIN ZHANG1
Appeal2014-009129
Application 13/245,689
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
for delivering energy to a vascular treatment site which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Kona Medical, Inc. (Br.
3.)
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Application 13/245,689
STATEMENT OF THE CASE
Appellants' "invention generally relates to methods and apparatus for
sealing vascular punctures and wounds, and more particularly, to a device
that may be used to deliver ultrasound energy to a vascular puncture site to
arrest bleeding." (Spec. i-f 2.) More specifically, Appellants disclose that a
"control automatically controls the ultrasonic transducer applicator so that
the ultrasonic energy produced by the ultrasonic transducer applicator is
focused at the site and is administered at a sufficient intensity and duration
to denature tissue at the puncture, closing and sealing the puncture." (Id. at
,-r 12.)
Claims 1-30 are on appeal. Claim 1 is illustrative:
1. A system for delivering energy to a vascular treatment site,
the system comprising:
a first ultrasonic transducer configured to deliver
ultrasound therapy to the vascular treatment site;
a second ultrasonic transducer configured to send and
receive a downstream pulsed Doppler line, send and receive an
upstream pulsed Doppler line, and provide an output signal based
on the downstream pulsed Doppler line and the upstream pulsed
Doppler line; and
a control unit having a processor configured to receive the
output signal from the second ultrasonic transducer and to
automatically determine an alignment of the first ultrasonic
transducer relative to the vascular treatment site based on the
received output signal, wherein the control unit is configured to
control the first ultrasonic transducer based at least in part on the
automatically determined alignment of the first ultrasonic
transducer relative to the vascular treatment site.
(Br. 16 (Claims App'x).)
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Application 13/245,689
The claims stand rejected as follows:
I. Claims 1-3, 6, 8, 10-15, 18, 20-24, 27, and 30 are rejected
under 35 U.S.C. § 103(a) over Driscoll,2 Jackson,3 and Kantorovich.4
II. Claims 9, 19, 28, and 29 are rejected under 35 U.S.C. § 103(a)
over Driscoll, Jackson, Kantorovich, and either one of, Suzuki,5 Watkins,6
and Iger.7
III. Claims 4, 5, 7, 16, 17, 25, and 26 are rejected under 35 U.S.C.
§ 103(a) over Driscoll, Jackson, Kantorovich, and Martin. 8
REJECTION!
Claims 1-3, 6, 8, 10, 20-24, 27, and 30:
Appellants argue the patentability of the claims together. We select
claim 1 as representative. Claim 1 requires, among other things, "an output
signal based on the downstream pulsed Doppler line and the upstream pulsed
Doppler line," and a control unit configured to
automatically determine an alignment of the first ultrasonic
transducer relative to the vascular treatment site based on the
received output signal, wherein the control unit is configured to
control the first ultrasonic transducer based at least in part on the
automatically determined alignment of the first ultrasonic
transducer relative to the vascular treatment site.
(Br. 16 (Claims App'x).)
2 Driscoll, Jr. et al., US 5,882,302, issued Mar. 16, 1999.
3 Jackson et al., US 6,193,660 Bl, issued Feb. 27, 2001.
4 Kantorovich, US 6,261,233 Bl, issued July 17, 2001.
5 Suzuki et al., US 5,553,618, issued Sept. 10, 1996.
6 Watkins et al., US 5,769,790, issued June 23, 1998.
7 Iger et al., US 6,206,843 Bl, issued Mar. 27, 2001.
8 Martin et al., US 6,007,499, issued Dec. 28, 1999.
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Application 13/245,689
The Examiner finds that Driscoll teaches '"[a]n apparatus for
producing remote hemostasis comprising a focused therapeutic ultrasound
radiation surface and a sensor for identifying a site of internal bleeding, with
a registration means coupled to the radiating surface and the sensor to bring
a focal target and the bleeding site into alignment.'" (Final Act. 7.) The
Examiner finds that "Driscoll fails to teach that the system automatically
determines a therapy volume (or region of interest)." (Id.)
The Examiner, however, turns to Jackson and finds it "teaches 'a
method and [ultrasound] system for determining the location of a region of
interest. .. [.] The system, in response to user input or automatically,
identifies a region of interest associated with anatomy represented in an
image (see Abstract)."' (Id. (quoting Jackson) (emphasis added by
Examiner).) The Examiner concludes that it would have been obvious to
"incorporate an automatic determination of a region of interest, as taught by
Jackson, with the system and methods of Driscoll in order to fully automate
the Driscoll system because manually identifying anatomy in real time can
be time consuming (see [Jackson] column 1, lines 20-21)." (Id. at 7-8.)
The Examiner finds that "Driscoll does not go into great detail of the
arrangement of pulses used and Jackson, while stating that its system
includes a Doppler processor for representing tissue motion and blood flow
... , neither reference explicitly teaches that upstream and downstream
information is gathered." (Id. at 8.)
The Examiner, however, turns to Kantorovich and finds it "teaches a
method of determining a velocity of a flowing material including irradiating
the conduit with ultrasonic waves, detecting Doppler-shifted reflections of
the waves, which first reflections have a positive Doppler-shift and second
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Application 13/245,689
reflections have a negative Doppler-shift." (Id.) The Examiner concludes
that it would have been obvious to
provide upstream and downstream pulsed Doppler imaging (i.e.,
positive and negative Doppler-shifts), as taught by Kantorovich,
with the system of Driscoll and Jackson in order to align the
transducers with respect to the flow of the blood vessel as an aid
in the process of automatically determining a treatment site (as
taught by Jackson) located on the vessel.
(Id. at 8-9.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Driscoll, Jackson, and
Kantorovich would have rendered claim 1 obvious?
Findings of Fact (FF)
1. Driscoll teaches
An apparatus for producing remote hemostasis comprises
a focused therapeutic ultrasound radiating surface and a sensor
for identifying a site of internal bleeding, with a registration
means coupled to the radiating surface and the sensor top bring
a focal target and the bleeding site into alignment. The sensor
generally comprises a Doppler imaging display. Hemostasis
enhancing agents may be introduced to the site for actuation by
the ultrasound energy.
(Driscoll Abstract; see also Final Act. 7, Ans. 4--5, 7.)
2. Driscoll teaches "the identifying step comprises Doppler
imaging a section of the patient body with a pulsed ultrasound transducer,
typically using colorflow imaging techniques." (Driscoll 4:26-28; see also
Final Act. 7.)
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3. Driscoll teaches that "[p ]referably, the radiating surface and an
ultrasound imaging transducer array are carried within a single housing."
(Driscoll 4:49-51; see also Final Act. 9, Ans. 7.)
4. Driscoll teaches that "[t]he controller automatically linearly and
angularly positions the transducer so that the active surface is focused at the
target tissue." (Driscoll 7:50-52; see also Final Act. 7.)
5. Jackson teaches " [a] method and system for determining the
location of a region of interest throughout a sequence of images is provided.
The system, in response to user input or automatically, identifies a region of
interest associated with anatomy represented in an image." (Jackson
Abstract; see also Final Act. 7.)
6. Jackson teaches that "proper placement of the region of interest
to identify anatomy in real time is not provided, and manual adjustment may
be time consuming." (Jackson 1 :20-22; see also Final Act. 8.)
7. Jackson teaches that
the system ... automatically determines the region of interest.
For example, the control processor ... or another processor
applies an algorithm to data associated with the image, such as
detected or scan converted ultrasound data. In one embodiment,
the algorithm identifies edges associated with structure
boundaries based on intensity or movement differences. For
example, the region of interest or associated anatomical feature
is preferably identified using one of various metrics, such as
gradient, entropy or texture content. For gradient based
identification, the location or locations associated with a frame
of data corresponding to the maximum gradient or change in
ultrasound data amplitude is selected as the feature. For
example, a location or locations associated with an edge of an
imaged structure is selected. Other selection processes may be
used, including selecting a plurality of locations associated with
gradient values above a threshold.
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(Jackson 5:3-18; see also Ans. 4.)
8. Kantorovich teaches
A method of determining the velocity of a flowing
material, suspended in a liquid and flowing in a conduit,
including irradiating the conduit with ultrasonic waves, detecting
first Doppler-shifted reflections of the waves from the material,
which first reflections have a positive Doppler-shift, and
detecting second Doppler shifted reflections of the waves from
the material, which second reflections have a negative Doppler-
shift. The flow velocity is estimated based on the extent of the
positive and negative Doppler-shifts. The first and second
reflections may be summed to form a composite signal and the
range of Doppler-shifts in the composite signal is used to
estimate the flow velocity.
(Kantorovich Abstract; see also Final Act. 8.)
9. Kantorovich teaches that "the transducers include phased-array
scanners having electronically controlled ultrasonic orientations and the
controller directs the orientations of the transducers towards the flow.
Preferably; the controller directs the orientations of the transducers with
respect to each other." (Kantorovich 11 :20-25; see also Final Act. 8, Ans.
7.)
10. Kantorovich teaches "transducers ... can be phased-array
scanners which automatically scan tissue ... to find Doppler-shifting flow."
(Kantorovich 24:1-3; see also Final Act. 8, Ans. 6.)
DISCUSSION
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 6-14; Ans. 2-9; FF 1-10) and
agree that claim 1 would have been obvious over Driscoll, Jackson, and
Kantorovich. We address Appellants' arguments below.
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Appellants contend that
Jackson does not disclose any form of therapy or treatment
and merely discloses producing a digital image outlining
anatomy in real time for use in diagnostics by an operator
viewing the image. . . . Thus, as in Driscoll, Jackson merely
provides an imaging transducer output signal to a display and not
to an ultrasound control unit. At most, the combination of
Driscoll and Jackson would only provide an operator with more
detailed information within an ultrasound image such that the
operator could better select the treatment area and/ or treatment
volume. However, the operator would still nonetheless have to
look at an image for selection of a treatment and therefore the
combination would not "automatically determine an alignment
of the first ultrasonic transducer relative to the vascular treatment
site based on the received output signal" as recited by Claim 1.
Accordingly, Appellant disagrees with the Examiner's assertion
that "the combination of Driscoll in view of Jackson now
provides for full automation of Driscoll." . . . In fact, the
combination of Driscoll with Jackson does not substantively alter
the graphical representation of the teachings of Driscoll depicted
above. The only change would be in the information provided to
the user on the display.
(Br. 8.)
This argument is unpersuasive.
[E]vidence of a motivation to combine need not be found in the
prior art references themselves, but rather may be found in "the
knowledge of one of ordinary skill in the art or, in some cases,
from the nature of the problem to be solved." ... When not from
the prior art references, the "evidence" of motive will likely
consist of an explanation of the well-known principle or
problem-solving strategy to be applied.
Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1366 (Fed. Cir. 2006) (emphases in original, quoting In re
Dembiczak, 175 F.3d 994, 999 (Fed. Cir. 1999)).
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Appeal2014-009129
Application 13/245,689
Driscoll teaches "[a]n apparatus for producing remote hemostasis
comprises a focused therapeutic ultrasound radiating surface and a sensor for
identifying a site of internal bleeding, with a registration means coupled to
the radiating surface and the sensor top bring a focal target and the bleeding
site into alignment." (FF 1.) Driscoll also teaches that "[t]he controller
automatically linearly and angularly positions the transducer so that the
active surface is focused at the target tissue." (FF 4.) Driscoll further
teaches that "[p ]referably, the radiating surface and an ultrasound imaging
transducer array are carried within a single housing." (FF 3.)
Jackson teaches that "proper placement of the region of interest to
identify anatomy in real time is not provided, and manual adjustment may be
time consuming." (FF 6.) To remedy this, Jackson teaches "[a] method and
system for determining the location of a region of interest throughout a
sequence of images is provided. The system, in response to user input or
automatically, identifies a region of interest associated with anatomy
represented in an image." (FF 5 (emphasis added).) Jackson teaches that the
system ... automatically determines the region of interest. For example, the
control processor ... or another processor applies an algorithm to data
associated with the image, such as detected or scan converted ultrasound
data." (FF 7 (emphasis added).)
The Examiner reasons that "'broadly providing an automatic means to
replace manual activity which was accomplished the same result involves
only routine skill in the art.'" (Ans. 4.) The Examiner, however,
acknowledges that "modifying a system to automatically determine a region
of interest (ROI) from ultrasound data could arguably require particular
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technical knowhow in computer processing/coding." (Id.) Thus, as the
Examiner explains,
Jackson is introduced as a teaching reference, explicitly
illustrating that it is possible, prior to the current application, that
an ultrasound system may be configured to automatically
determine an ROI without user input []. Therefore, Jackson
teaches an ultrasound system having the capability to provide an
automated ROI localization step - "The system, in response to
user input or automatically, identifies a region of interest
associated with anatomy represented in an image["] (see the
Abstract of Jackson).[] Jackson's Abstract also provides
obviousness that a system may utilize user input or automatically
determine a ROI within an ultrasound image. The incorporation
of Jackson removes the need for displaying the image of Driscoll
to the user and removes the need for user input.
(Id. at 4--5.)
To further illustrate, the Examiner annotates the figure from
Appellants' brief, which Appellants argued depicted the teachings of
Driscoll. (Br. 7.) When the teachings of Driscoll and Jackson are combined;
the Examiner reasons that the skilled artisan would have automated the
display and user input steps as shown below:
(Id. at 5 (annotating figure from Br. 7).) The Examiner further explains that
"[t]herefore, it can be seen that the combination provides automatic
determination of a ROI of interest, and when this teaching is incorporated
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within Driscoll, the above 'Display' and 'User Input' sets are insignificant
due to the automation." (Id. at 6; see also Ans. 8 ("By incorporating Jackson
and/or Kantorovich for automatic ROI/blood vessel localization, there is no
further need for Driscoll to display the ultrasound image in order to the user
to provide ROI input since this step is found obvious to be automatic.").)
We agree with the Examiner. Appellants' contentions to the contrary are
unpersuasive.
Appellants also argue that
Furthermore, the automatic determination in Jackson is
not based on pulsed Doppler. The disclosure of Doppler in
Jackson is with reference to analyzing a frame of image or
displaying data related to Doppler information. . . . Therefore,
in all, the combination would not provide guidance for arriving
at the claimed invention because the combination would still
suffer from the disadvantage of requiring operator judgment for
treatment selection even if the image is better defined as a result
of Jackson's invention.
(Br. 8.)
This argument is unpersuasive as well. As the Examiner explains,
"Kantorovich was explicitly incorporated with this limitation [regarding
pulsed Doppler] in mind." (Ans. 6; see also Ans. 6-8, FF 8-10.) "Non-
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references []. [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole." In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants argue that "Kantorovich fails to disclose any relationship
to therapy or treatment." (Br. 9.) This argument is unpersuasive because it
fails to recognize Driscoll's and Jackson's teachings as discussed above.
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Here again, Appellants' argument amounts to an attack on the individual
teachings of the reference, and does not persuasively overcome the
Examiner's proposed combination of Driscoll, Jackson, and Kantorovich.
Appellants contend that
Even if one were to automate Driscoll using any of the
principles described in Jackson or Kantorovich, automation of
alignment determination is the solution provided by the
application. Using the solution provided by claims to provide a
rationale for the combination relies on impermissible hindsight
bias. Rationale for automation as claimed is not found in the
cited references. The alleged rationale in Jackson for automation
is limited solely to imaging, which still requires user analysis and
input.
(Br. 14.)
This argument is not persuasive.
Kantorovich teaches that "the transducers include phased-array
scanners having electronically controlled ultrasonic orientations and the
controller directs the orientations of the transducers towards the flow.
Preferably, the controller directs the orientations of the transducers with
respect to each other." (FF 9.) We thus agree with the Examiner that
Driscoll, Jackson, and Kantorovich provide motivations and teachings in
order to arrive at the claimed invention, as discussed above. Moreover, even
if the prior art does not provide explicit motivation, we conclude that the
Examiner has sufficiently explained why one skilled in the art would have
predictably combined the teachings from Driscoll, Jackson, and Kantorovich
based on "the knowledge of one of ordinary skill in the art or, in some cases,
from the nature of the problem to be solved." (See Ans. 8-9.) See Dystar,
464 F.3d at 1366.
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Appellants also argue that "a claim is nonobvious if the problem
which had suggested use of the method had been previously unknown." (Br.
14.) This argument is unpersuasive for the reasons discussed above. We
thus agree with the Examiner that "the problem solved, and particularly the
solution currently being claimed, is a matter of obviousness based on the
current references of record." (Ans. 9.)
Claims 11-15, and 18:
Appellants similarly argue that "[t]here is no teaching or suggestion to
'automatically determine an alignment of the first ultrasonic transducer
relative to the vascular treatment site' based on an 'output signal
based on the downstream pulsed Doppler line and the upstream pulsed
Doppler line."' (Br. 12.) We are not persuaded for the reasons discussed
above.
REJECTION II
Claims 9, 28, and 29:
Appellants contend that "Suzuki does not teach a system for
delivering ultrasound therapy to a vascular treatment site and does not cure
the deficiencies pointed out in regards to Driscoll, Jackson, and
Kantorovich." (Br. 10.) Appellants also argue that "Watkins does not
disclose the claimed invention and does not cure the deficiencies pointed out
in regards to Driscoll, Jackson, and Kantorovich." (Id. at 10-11.)
Appellants further argue that "Iger does not disclose the claimed invention
and does not cure the deficiencies pointed out in regards to Driscoll,
Jackson, and Kantorovich." (Id. at 11.) Having affirmed the rejection of the
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parent claim for the reasons given above, we thus atlirm the rejection of
claims 9, 28, and 29.
Claims 19:
Appellants contend that "[ c ]laim[] 19 depends directly from Claim 11.
Appellant respectfully submits that this claim is allowable pursuant to its
dependency on an allowable base claim." (Id. at 13.) Having affirmed the
rejection of the parent claim for the reasons given above, we thus affirm the
rejection of claim 19.
REJECTION III
Appellants contend that "Martin does not teach a system for
delivering ultrasound therapy to a vascular treatment site and does not cure
the deficiencies pointed out in regards to Driscoll, Jackson, and
Kantorovich." (Id. at 10, 12-13.) Having affirmed the rejection of the
parent claim for the reasons given above, we thus affirm the rejection of
claims 4, 5, 7, 25, and 26.
CONCLUSION OF LAW
We affirm the rejection of claims 1-3, 6, 8, 10-15, 18, 20-24, 27, and
30 under 35 U.S.C. § 103(a) over Driscoll, Jackson, and Kantorovich.
We affirm the rejection of claims 9, 19, 28, and 29 under 35 U.S.C.
§ 103(a) over Driscoll, Jackson, Kantorovich, and either one of, Suzuki,
Watkins, and Iger.
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We atlirm the rejection of claims 4, 5, 7, 16, 17, 25, and 26 under
35 U.S.C. § 103(a) over Driscoll, Jackson, Kantorovich, and Martin.
AFFIRMED
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