Ex Parte Parthasarathy et al

Patent Trial and Appeal Board

Dec 21, 2018

14113035 (P.T.A.B. Dec. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/113,035 03/10/2014 Vijay Parthasarathy
24737 7590 12/26/2018
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.
2011P00078WOUS 9307
EXAMINER
BRUTUS, JOEL F
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
12/26/2018 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 VIJAY PARTHASARATHY,
AMEET KUMAR JAIN, CHARLES RAY HATT III, and
AMISHN.RAVAL 1
Appeal2017-002671
Application 14/113,035
Technology Center 3700
Before MICHAEL J. FITZPATRICK, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
system comprising a multi-planar reformatting imaging module operable to
generate at least two multi-planar reformatting images of an ultrasound
volume image of at least a portion of an interventional tool within an
anatomical region, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as Koninklijke Philips N.V.
( Appeal Br. 3.)
Appeal2017-002671
Application 14/113,035
STATEMENT OF THE CASE
Localization of the tip of an interventional tool is important for
accurate navigation and targeting during interventional procedures such as
cardiovascular interventions. (Spec. 1.) According to the Specification,
however,
visualization of the exact location and orientation of a tip
and a body of an interventional tool is often difficult in 2D
[ ultrasound (US)] or 3D US due to ( 1) image artifacts from
the body of the interventional tool, (2) a limited view of
2D US or 3D US, and (3) out of plane issues involving the
tip of the interventional tool going in and out of the 2D US
image or 3D US image.
(Id.) The Specification explains that, because it is difficult to visualize the
tip of an interventional device in 3D US, "it is also difficult to define multi-
planar reformatting ("MPR") views around the tip of the interventional
device whereby the neighborhood of the tool tip including surrounding
tissue is appropriately visualized." (Id. at 1-2.) Further according to the
Specification, "[t]he present invention provides systems and methods for
accurate real-time localizing of a tool tip in 3D US and for precise
generation of the MPR views of the tool tip and surrounding neighborhood."
(Id. at 2.)
Claims 1-20 are on appeal. Claim 1 is illustrative and reproduced
below:
1. A system, comprising:
an interventional tool having at least one image tracking
point;
an ultrasound imaging system including an ultrasound
probe operable to generate an ultrasound volume image of at
least a portion of the interventional tool within an anatomical
region; and
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Application 14/113,035
a multi-planar reformatting imaging module operable to
generate at least two multi-planar reformatting images of the
ultrasound volume image of the at least a portion of the
interventional tool within the anatomical region, wherein a
generation of the at least two multi-planar reformatting images
includes:
an identification of each image tracking point
within the ultrasound volume image; and
a utilization of each identified image tracking point
as an origin of at least one of the [at] least two multi-
planar reformatting images.
(Appeal Br. 29 (Claims App'x, formatting modified for clarity).)
The Examiner rejects claims 1--4, 8-12, and 16-18 under pre-AIA
35 U.S.C. § 103(a) as being unpatentable over Sun2 and Simopoulos. 3 (Ans.
2.)
The Examiner rejects claim 5 under pre-AIA 35 U.S.C. § I03(a) as
being unpatentable over Sun, Simopoulos, and Roberts. 4 (Ans. 6.)
The Examiner rejects claims 6 and 7 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Sun, Simopoulos, and Yanof. 5 (Ans. 6.)
The Examiner rejects claims 13-15, 19, and 20 under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Sun, Simopoulos, and
Whitmore. 6 (Ans. 7 .)
2 Sun et al., US 2008/0095421 Al, published Apr. 24, 2008.
3 Simopoulos et al., US 2008/0009722 Al, Jan. 10, 2008.
4 Roberts et al., US 2009/0136106 Al, published May 28, 2009.
5 Yanof et al., US 6,064,904, issued May 16, 2000.
6 Whitmore III et al., US 2010/0081920 Al, published Apr. 1, 2010.
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Application 14/113,035
DISCUSSION
Issue
The same issues are dispositive for all of the rejections; we therefore
consider them together.
The Examiner finds that Sun discloses a system comprising "an
interventional tool (catheter) having at least one image tracking point (tip of
the catheter) [and] an ultrasound imaging system including an ultrasound
probe operable for generating an ultrasound volume image of at least a
portion of the [catheter] within an anatomical region," as required by claim
1. (Ans. 2 (citations omitted).) The Examiner finds that Sun discloses that
its ultrasound imaging system can provide real-time 3D location of the
catheter tip. (Id. at 2-3.)
The Examiner finds that Sun does not disclose, as required by claim 1,
[a] multi-planar reformatting imaging module operable for
generating at least two multi-planar reformatting images
of the ultrasound image volume of the at least a portion of
the interventional tool within the anatomical region,
wherein a generation of the at least two multi-planar
reformatting images includes an identification of each
image tracking point within the ultrasound volume image.
(Id. at 3.) However, the Examiner finds that Simopoulos, which teaches "a
medical diagnostic imaging system ... for multi-planar reconstruction from
ultrasound volume data," discloses these limitations. (Id. ( citations
omitted).) In particular, the Examiner finds that Simopoulos teaches
identifying each image tracking point within an ultrasound volume image,
determining the amount and direction of displacement and/or rotation of the
features or 2D image region that defines a plane, adjusting the plane position
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based on tracking, and generating images using the adjusted planes. (Id.)
The Examiner also finds that Simopoulos teaches
determining an orientation of planes in a multi-planar
reconstruction us[ing] a pyramid of ultrasound data sets
that are used to create two or more sets of data with
different resolution and a utilization of each identified
image tracking point as an origin of at least one of the [at]
least two multi-planar reformatting images.
(Id. at 4 ( citations omitted).)
The Examiner concludes that it would have been obvious to a skilled
artisan to combine Sun and Simopoulos to arrive at the claimed invention,
because MPR allows "generation of reformatted images from imaging
volumes in planes other than the plane in which the original images were
acquired," thereby "allowing viewing 2D images and 3D volumes from any
arbitrary direction and an identification of each image tracking point within
the ultrasound volume image; in order to indicate displacement." (Id. at 4
( citation omitted).)
Appellants contend that the cited prior art combination does not
render obvious the claimed MPR imaging module. (Appeal Br. 10-11.) In
particular, Appellants contend that the ultrasound data in Sun is used solely
as "a bridge registration between pre-operative CT /MRI data and
intraoperative fluoroscopy" and not "for guidance purposes of the catheter
within the patient during the procedure." (Id. at 12.) Appellants thus argue
that modifying Sun in view of Simopoulos to arrive at the claimed invention
would improperly violate Sun's operating principle. (Id. at 13.)
The issue with respect to these rejections is whether a preponderance
of evidence of record supports the Examiner's conclusion that it would have
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been obvious to a skilled artisan to combine the cited references to arrive at
the claimed invention.
Findings of Fact
1. Sun teaches that "[ fJluoroscopy is used for real-time monitoring
of the procedure and catheter location visualization" but that "2D
fluoroscopic images lack detailed anatomical information due to the
incapability of X-ray in distinguishing among soft tissues." (Sun ,r 3.)
2. Sun teaches that real-time ultrasound images has a limited field
of view and inferior image quality as compared to high-quality preoperative
volumetric data, such as those acquired by Computed Tomography (CT) or
Magnetic Resonance Imaging (MRI). (Id. ,r 4.)
3. Sun teaches that, while the high-resolution preoperative CT
and/or MRI data may be fused with the real-time 2D fluoroscopy through
2D3D registration techniques, such registration typically require injection of
contrast agent into the patient, which may be undesirable for the patient's
safety. (Id. ,r 5.)
4. Sun teaches a method of providing real-time 3D location of the
catheter, comprising registering "[t]he preoperative volume ... to the 2D
fluoroscopy" by concatenating two registrations: (1) the registration of
"preoperative CT and/or MRI coordinates ... to the ultrasound coordinates
... based on image or data similarities," and (2) the registration of the
ultrasound coordinates to the fluoroscopy coordinates by aligning the
catheter tip locations. (Id. ,r 15; see also id. ,r,r 38, 79.)
5. Sun teaches integrating a sensor with a catheter, which allows
locating the tip or other portion of the catheter. (Id. ,r 3 5; see also id. ,r 71.)
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6. Simopoulos relates to medical diagnostic ultrasound imaging,
particularly multi-planar reconstruction for ultrasound volume data.
(Simopoulos ,r 2; see also e.g., id. ,r,r 6, 30-31.)
7. Simopoulos teaches scanning a volume region with an
ultrasound transducer positioned adjacent, on or within a patient;
determining a first orientation of an object within the volume region while
scanning; orienting a multi-planar reconstruction as a function of the first
orientation of the object; and generating multi-planar reconstruction images
of the object from the data while scanning. (Id. ,r,r 7-9.)
8. Simopoulos teaches that "the position of planes of the multi-
planar reconstruction is located as a function of the object features" where
"[a] feature is any anatomical structure." (Id. ,r,r 42, 66.)
9. Simopoulos teaches that, using its invention, the reconstructed
planes may be positioned relative to the object to "correspond to [a] standard
and/or predetermined view," such that "real-time substantially continuous
display of different specific anatomical planes may be provided regardless of
the orientation of the transducer" and "even where the transducer or imaged
object (e.g., heart or fetus) moves." (Id. ,r,r 18, 52.)
Analysis
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of
ordinary skill in the relevant field to combine [them] in the way the claimed
new invention does." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418
(2007). We find on balance that the Examiner has not established a prima
facie case that the cited references render the claims obvious.
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Application 14/113,035
Independent claim 1 requires ( 1) an ultrasound probe operable to
generate a volume image of an interventional tool having at least one image
tracking point, or a portion thereof, within an anatomical region, and (2) an
MPR imaging module operable to generate at least two MPRs of the
ultrasound volume image by identifying image tracking point( s) in the
volume image and using them as an origin of the MPR image(s).
While Sun teaches an ultrasound system that generates an image of at
least part of an interventional tool within an anatomical region, where the
interventional tool comprises a sensor (FF4, FF5), and while Simopoulos
teaches generating multi-planar reconstruction images of a patient's anatomy
from ultrasound volume data (FF6-FF8), the Examiner has not sufficiently
articulated a reason why a skilled artisan would have combined them to
arrive at the claimed invention, i.e., generating MPR images of an ultrasound
volume image of an interventional tool within the anatomical region wherein
an image tracking point is used as an origin of an MPR image.
The Examiner states that a skilled artisan would have been motivated
to combine Sun and Simopoulos in the manner recited in claim 1
because the process of multiplanar reformatting allows
generation of reformatted images from imaging volumes
in planes other than the plane in which the original images
were acquired. Therefore, a viewer of an imaging volume
may choose to view the source images acquired from the
imaging device and/ or reformatted images, reformatted to
be in a plane that differs from the plane of the source
images; thereby, allowing viewing 2D images and 3D
volumes from any arbitrary direction and an identification
of each image tracking point within the ultrasound volume
image; in order to indicate displacement.
(Ans. 4.) While this statement explains the general benefits of multiplanar
reformatting as articulated in Simopoulos, with respect to imaging a
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patient's anatomy so as to orient the images to a standard or predetermined
view "even where the transducer or imaged object (e.g., heart or fetus)
moves" (FF9), it does not sufficiently explain why a skilled artisan would
have applied Simopoulos' method to identify movement of an interventional
tool in the patient's anatomy. Neither has the Examiner explained why,
based on the combination of Sun and Simopoulos, a skilled artisan would
have used the image tracking point(s) as the origin of the multi-planar
reformatting image( s ), as required by claim 1. 7
In the Answer, the Examiner also states that "an ordinary artisan is not
an automaton who is not capable of modification that would improve the
device." (Ans. 9.) While we agree that an ordinary artisan is not an
automaton, KSR, 550 U.S. at 418, "rejections on obviousness grounds cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." Id. (quoting In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006). What is missing in the Examiner's rationale is an
explanation why a skilled artisan would have believed that the multiplanar
reconstruction disclosed in Simopoulos, which related to imaging of
7 We note that the Examiner cites to paragraph 63 of Simopoulos as
disclosing "a utilization of each identified image tracking point as an origin
of at least one of the [at] least two multi-planar reformatting images." (Ans.
4.) Paragraph 63, however, appears only to describe the relationship
between the Cartesian coordinates of a reconstructed plane and the spherical
coordinates of the 3D volumetric data, and to identify the spherical
coordinates of the perpendicular foot of the origin to the plane. (Simopoulos
,r 63.) The Examiner does not explain how such a relationship and
coordinates suggest utilizing an image tracking point as the origin of the
reformatted image.
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anatomy, would have improved Sun's method relating to real-time
visualization of a tool in an interventional procedure.
"[O]bviousness concerns whether a skilled artisan not only could have
made but 11,,oztld have been nwtivated to make the combinations or
modifications of prior art to anive at the claimed invention." Belden Inc. v.
Berk-TekLLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015); see also In re
Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) ("The mere fact that the prior
art could be so modified would not have made the modification obvious
unless the prior art suggested the desirability of the modification." (citing
cases)). Accordingly, we reverse the Examiner's rejection of claim 1. We
reverse the Examiner's rejection of claim 16, which is the only other
independent claim and contains limitations similar to those in claim 1
discussed above, for the same reasons. We likewise reverse claims 2-15 and
17-20, which depend directly or indirectly from claims 1 and 16. In re Fine,
837 F.2d 1071, 1076 (Fed. Cir. 1988) ("Dependent claims are nonobvious
under section 103 if the independent claims from which they depend are
nonobvious.").
SUMMARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 1-2 0.
REVERSED
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