Ex Parte Sathyanarayana et al

Patent Trial and Appeal Board

Aug 23, 2016

12563754 (P.T.A.B. Aug. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/563,754 09/21/2009 Shashidhar Sathyanarayana
79292 7590 08/24/2016
Boston Scientific Corporation
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
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.
1362001-2003.2 7035
EXAMINER
AKAR, SERKAN
ART UNIT PAPER NUMBER
3737
MAILDATE DELIVERY MODE
08/24/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHASHIDHAR SATHYANARA YANA and WENGUANG LI
Appeal2014-005837
Application 12/563,754
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134 from the
Examiner's rejection of claims 1-22. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We reverse.
STATEMENT OF THE CASE
The Specification discloses "intravascular ultrasound (IVUS) imaging
systems" and related methods. Spec. 1: 11-12. "An IVUS imaging system
can include a control module (with a pulse generator, an image processor,
1 Appellants identify the Real Party in Interest as Boston Scientific
Corporation (App. Br. 2).
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Application 12/563,754
and a monitor), a catheter, and one or more transducers disposed in the
catheter." Spec. 2:2--4. The catheter "can be positioned in a lumen or cavity
within ... a region to be imaged, such as a blood vessel wall." Spec. 2:4--6.
The control module causes the transducers to generate "acoustic pulses that
are transmitted through patient tissue." Spec. 2:7-8. "Reflected pulses ...
are absorbed by the one or more transducers and transformed [in]to electric
pulses ... [which] are delivered to the image processor and converted to an
image." Spec. 2:8-11.
The Specification discloses a method of evaluating tissue types in an
IVUS image by "providing a tissue classifier comprising a plurality of
detector arrays for each of a plurality of tissue types, where each detector
array comprises a plurality of detectors." Spec. 2: 13-16. The method
comprises comparing "an input IVUS spectrum of a region in the ... image
to the tissue type-assigned IVUS spectra of each of the plurality of detectors
for each of the plurality of detector arrays." Spec. 2: 19-22. "For each of the
plurality of detectors of each of the plurality of detector arrays, it is
determined whether the input spectrum corresponds to the tissue type of the
detector based on the comparisons of the input spectrum to the ... spectra
for that detector." Spec. 2:22-24. "This [process] is repeated for each
region to be characterized in the ... image." Spec. 2:28-29. "A size of at
least one of the tissue types in a selected portion of the ... image is
determined using the tissue characterizations of the regions in the selected
portion." Spec. 2:29-31.
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Claim 1 is representative of the claims on appeal and reads as follows
(emphasis added):
1. A method of evaluating at least one tissue type in at least one
intravascular ultrasound (IVUS) image, the method comprising:
a) providing a tissue classifier comprising a plurality of detector
arrays for each of a plurality of tissue types, wherein each detector array
comprises a plurality of detectors and each detector comprises a plurality of
tissue type-assigned IVUS spectra, wherein a plurality of the tissue type-
assigned IVUS spectra of each detector correspond to a tissue type of the
detector and a plurality of the tissue type-assigned IVUS spectra correspond
to other tissue types;
b) comparing an input IVUS spectrum of a region in the at least one
intravascular ultrasound image to the tissue type-assigned IVUS spectra of
each of the plurality of detectors for each of the plurality of detector arrays;
c) determining, for each of the plurality of detectors of each of the
plurality of detector arrays, whether the input spectrum corresponds to the
tissue type of the detector based on the comparisons of the input spectrum to
the tissue type-assigned spectra for that detector;
d) for each of the plurality of detector arrays, combining results of the
plurality of detectors of the detector array to produce an array result;
e) combining the array results for the plurality of detector arrays to
provide a tissue characterization of the region from the plurality of tissue
types;
t) repeating b) to e) for each region to be characterized in the at least
one intravascular ultrasound image;
g) determining a size of at least one of the tissue types in a selected
portion of the at least one intravascular ultrasound image using the tissue
characterizations of the regions in the selected portion; and
h) displaying one or more of the at least one intra vascular ultrasound
image with an indication of the tissue characterization of one or more
regions of the at least one intra vascular ultrasound image that is displayed
and an indication of the size of at least one of the tissue types in the selected
portion of the at least one intra vascular ultrasound image that is displayed.
Issue
The Examiner has rejected claims 1, 7, 8, 12, 13, and 18-21 under
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35 U.S.C. § 103(a) as obvious in view ofWatson.2 Ans. 2; Final Rejection
(Final Rej.) 2--4. 3 The Examiner has also rejected claims 2-5, 14--16, and 22
in view of Watson and McLeod4, and claims 6, 9-11, and 17 under 35
U.S.C. § 103(a) in view of Watson, McLeod, and Kawaguchi. 5 Ans. 2; Final
Rej. 4--8.
The issue presented is: Does the evidence of record support the
Examiner's conclusion that Watson would have made obvious a method of
evaluating at least one tissue type in at least one intravascular ultrasound
(IVUS) image that comprises "determining a size of at least one of the tissue
types in a selected portion of the at least one intra vascular ultrasound image
using the tissue characterizations of the regions in the selected portion," as
recited in each of independent claims 1, 12, and 18?
Analysis
We have reviewed Appellants' contentions that the Examiner erred in
rejecting claims 1, 7, 8, 12, 13, and 18-21 as obvious over the cited art.
App. Br. 9-11; Reply Br. 2---6. We agree with Appellants that the Examiner
2 Robin J. Watson et al., Classification of Arterial Plaque by Spectral
Analysis of In Vitro Radio Frequency Intravascular Ultrasound Data, 26
Ultrasound in Med. & Biol. 73-80 (2000) ("Watson").
3 Office Action mailed May 22, 2013.
4 Andrew L. McLeod et al., Classification of Arterial Plaque by Spectral
Analysis in Remodelled Human Atherosclerotic Coronary Arteries, 30
Ultrasound in Med. & Biol. 155-159 (2004) ("McLeod").
5 Ren Kawaguchi et al., Usefulness of Virtual Histology Intravascular
Ultrasound to Predict Distal Embolization for ST-Segment Elevation
Myocardial Infarction, 50 Journal of the American College of Cardiology
1641-1646 (2007) ("Kawaguchi").
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Appeal2014-005837
Application 12/563,754
has not adequately explained how Watson would have made obvious the
inventions of the rejected claims. For emphasis, we highlight and address
the following:
FPL Watson discloses that "[i]ntravascular ultrasound (IVUS) is a
useful tool in the examination of coronary arteries, and can provide reliable
measurements of vessel dimensions and the location and severity of
obstructive coronary plaques." Watson 73, left col.
FF2. Watson discloses that, in a study to "test whether radio-
frequency analysis of coronary plaques predicts the histological
classification, r.f. data were collected using ... [an] intravascular ultrasound
scanner." Watson, Abstract.
FF3. Watson discloses that a "pullback scan of length approximately
40 mm was performed on each coronary artery, the catheter position being
controlled by the PC via a stepper motor. Typically, approximately 200
scans, separated by 200 µm, were collected in each pullback." Watson 7 4,
right col.
FF4. "[R]egions-of-interest [ROis] from eight ... coronary arteries
were selected and identified by histology as falling into one of seven
different tissue types." Watson, Abstract. "These are loose fibrous tissue (n
= 78), moderate fibrous tissue (n = 27), dense fibrous tissue (n = 33),
microcalcification (n = 14), calcified plaque (n = 55), lipid/fibrous mixture
(n = 51) and homogeneous areas of lipid pool (n = 29)." Watson, Abstract.
Watson discloses that only 54% of the RO Is were correctly classified using
these categories. Watson, Abstract. When the "data were reclassified using
three broader tissue groups: (1) calcified plaque, (2) lipid pool and (3) a
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mixed fibrous category," 86% of the RO Is were correctly classifieds.
Watson, Abstract.
FF5. Watson discloses that the "results demonstrate the feasibility of
using spectral features of IVUS signals to discriminate between calcified
plaque, mixed fibrous tissue and lipid pools." Watson 78, right col.
Appellants argue that Watson does not teach or suggest "determining
the size of at least one of the tissue types, as recited in claim 1." App. Br.
10. Appellants argue that the instant rejection does not "demonstrate that
Watson discloses 'determining a size of at least one of the tissue types in a
selected portion of the at least one intra vascular ultrasound image using the
tissue characterizations of the regions in the selected portion' as recited in
the claims." App. Br. 10-11.
The Examiner responds that Watson discloses the disputed limitation.
Ans. 5---6. The Examiner finds that Watson "performs 'a pullback scan of
length approximately 40 mm ... on each coronary artery, the catheter
position being controlled by the PC via a stepper motor. Typically
approximately 200 scans, separated by 200 µm were collected in each
pullback'." Ans. 5---6, citing Watson 74, right col., see FF 3. The Examiner
notes that, "while scanning the section of the vessel, the beginning of the
tissue that contains histology is known and the end of the histological
tissue is determined from the scan measurement." Ans. 6. The Examiner
provides the following illustration:
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The illustration shows a blood vessel with a plaque in it and an inserted
IVUS catheter that extends beyond the plaque. Ans. 6. The Examiner states
that, as shown in the illustration, the IVUS device "scans the plaque area of
40 mm, the beginning and the end region of plaque is known therefore the
size is determined." Ans. 6. The Examiner also cites the following
paragraph from Watson as teaching the claim 1 limitation of determining the
size of at least one tissue type:
Two hundred ninety-nine ROis of length 64 sample points
(approx. 0.2 mm) and width five scan-lines (approximately 0.3
mm at a distance of 2 mm from the transducer) were selected
.... These regions were then analyzed in terms of their spectral
content. The size of region was chosen to be sufficiently small
to encompass a homogeneous area of tissue, and sufficiently
large to allow a reasonable signal-to-noise ratio from averaging
adjacent scan-lines
Watson 75, cited by the Examiner at Ans. 6.
We find that Appellants have the better argument. Claim 1 is directed
to a method of evaluating a least one tissue type that comprises providing an
IVUS tissue classifier that provides a plurality of detector arrays for a
plurality of tissue types, and using the classifier to determine tissue
characterizations of a region, i.e., determine tissue types in a region. Claim
1 further requires that a size of least one tissue type is determined from these
tissue characterizations using the IVUS tissue classifier. Although the
Examiner points to Watson's disclosure that a pullback scan of a length of
40 mm was performed on each coronary artery, this portion of Watson
discloses that scans of coronary arteries were obtained to determine regions
interest, but does not suggest that tissue characterizations were obtained
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using an IVUS tissue classifier or that a size of a particular tissue type was
determined using the characterizations. See FF 3. The Examiner also points
to Watson's disclosure, at page 75 (shown above), that relatively small
regions of interest (RO Is) were chosen for spectral analysis so that the tissue
would be homogeneous in the ROI. This portion of Watson also does not
suggest that a size of a particular tissue type was determined using tissue
characterizations of a region that were obtained with an IVUS classifier, as
recited in claim 1. Thus, we agree with Appellants that the Examiner has
not adequately explained how Watson would have made obvious the method
of claim 1 with the step of "determining a size of at least one of the tissue
types in a selected portion of the at least one intra vascular ultrasound image
using the tissue characterizations of the regions in the selected portion."
Thus, we reverse the rejection of independent claim 1 and dependent
claims 7 and 8 under 35 U.S.C. § 103(a) in view of Watson.
The Examiner has also rejected independent claim 12 as obvious in
view of Watson. Independent claim 12 is directed to a computer-readable
medium having instructions that enable a device to "determin[e] a size of at
least one of the tissue types in a selected portion of the at least one
intravascular ultrasound image using the tissue characterizations of the
regions in the selected portion." As discussed above with respect to claim 1,
we have concluded that the Examiner has not adequately explained how
Watson discloses determining the size of at least one tissue type using the
tissue type characterizations.
Thus, we reverse the rejection of independent claim 12 and dependent
claim 13 under 35 U.S.C. § 103(a) in view of Watson.
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The Examiner has also rejected independent claim 18 as obvious in
view of Watson. Claim 18 is directed to a tissue classifier that comprises a
processor that determines "a size of at least one of the tissue types in a
selected portion of the at least one intravascular ultrasound image using the
tissue characterizations of the regions in the selected portion." For the
reasons discussed with respect to claims 1 and 12, we also conclude that the
Examiner has not adequately explained how Watson would have made
obvious the device of claim 18.
Thus, we reverse the rejection of independent claim 18 and dependent
claims 19-21under35 U.S.C. § 103(a) in view of Watson.
The Examiner has also rejected, under 35 U.S.C. § 103(a), dependent
claims 2-5, 14--16, and 22 in view of Watson and McLeod and claims 6, 9-
11, and 17 in view of Watson, McLeod, and Kawaguchi. Ans. 2; Final Rej.
4--8. For these rejections, the Examiner relies on Watson as discussed above
with respect to independent claims 1, 12, and 18. Thus, we also reverse
these rejections.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Watson would have made obvious a method of evaluating at least one
tissue type in at least one intravascular ultrasound (IVUS) image that
comprises "determining a size of at least one of the tissue types in a selected
portion of the at least one intra vascular ultrasound image using the tissue
characterizations of the regions in the selected portion," as recited in
independent claims 1, 12, and 18.
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SUMMARY
We reverse the rejection of claims 1-22 under 35 U.S.C. § 103(a).
REVERSED
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