Ex Parte Hamadeh

Patent Trial and Appeal Board

Apr 12, 2016

11767281 (P.T.A.B. Apr. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111767,281 06/22/2007
23446 7590 04/14/2016
MCANDREWS HELD & MALLOY, LTD
500 WEST MADISON STREET
SUITE 3400
CHICAGO, IL 60661
FIRST NAMED INVENTOR
Mohamed Ali Hamadeh
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.
219614-NV (18083US01) 1015
EXAMINER
BRUTUS, JOEL F
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
04/14/2016 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):
mhmpto@mcandrews-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MOHAMED ALI HAMADEH
Appeal2014-000637
Application 11/767,281
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(a) from the
Examiner's rejection of claims 1-3, 5, 7, 10-17, 19, and21-26. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification discloses "a system and method for verifying the
accuracy of a surgical navigation system" (Spec. 2, i-f 4). The Specification
explains that "[ c ]urrently, an operating surgeon can assess the accuracy of
1 Appellant identifies the Real Party in Interest as General Electric Company
(App. Br. 2).
Appeal2014-000637
Application 11/767,281
the surgical navigation system in a subjective manner ... [and] visually
compare the 'predicted location' of the navigation instrument with the
'actual location' of the same instrument on the intra-operative navigated
images acquired during surgery" (id. at 3, i-f 7). "Using this technique to
determine whether a navigation system is sufficiently accurate may vary
from surgeon to surgeon" (id. at 4, i-f 10).
Claim 1, reproduced below, is representative of the claims on appeal
(emphasis added):
Issue
1. A method for assessing an accuracy of a surgical
navigation system, the method comprising: acquiring an X-ray
image capturing a surgical instrument tip; tracking a tracked
location of the surgical instrument tip; segmenting the surgical
instrument tip in the X-ray image to determine an imaged
location of the surgical instrument tip; and computing a
distance between the tracked location of the surgical instrument
tip and the imaged location of the surgical instrument tip to
form a navigation error of the surgical navigation system.
(App. Br. 28, Claims Appendix.)
The Examiner has rejected claims 1-3, 7, 10-16, 19, and 21-26 under
35 U.S.C. § 103(a) as obvious over Shachar,2 Heigl, 3 and Simon4 (Ans. 2-7).
Additionally, the Examiner also rejects claims 5 and 17 as obvious over
Shachar, Heigl, Simon, Melkent,5 and Seeley6 (Ans. 7-8). The same issue is
dispositive for both rejections, therefore, we will consider them together.
2 Yehoshua Shachar, US 2005/0096589 Al, published May 5, 2005.
3 Benno Heigl et al., US 2005/0203386 Al, published Sept. 15, 2005
4 David A. Simon et al., US 6,470,207 Bl, issued Oct. 22, 2002.
5 Anthony J. Melkent et al., US 2003/0208122 Al, published Nov. 6, 2003.
6 Teresa Seeley et al., US 6,484,049 Bl, issued Nov. 19, 2002.
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Application 11/767,281
The issue is: Does the preponderance of the evidence of record
support the Examiner's conclusion that the combination of references
comprises the step of "computing a distance between the tracked location of
the surgical instrument tip and the imaged location of the surgical instrument
tip to form a navigation error of the surgical navigation system" as claimed?
Findings of Fact
1. Shachar teaches:
Catheter Guidance and Imaging (CGI) system 503 ... includes
a controller 501 and an imaging and synchronization module
701. The Figure illustrates the overall relationship between the
various functional units and the operator interface 500, the
auxiliary equipment 502, and the patient 390. In one
embodiment, the GCI System Controller 501 calculates the
Actual Tip (AT) position of a distal end of a catheter ...
[ u] sing data from the virtual tip (VT) 405 and the imaging and
synchronization module 701, the GCI system controller 501
determines the position error, which is the difference between
the actual tip position (AP) and the Desired tip Position (DP).
(Shachar 3, i-f 54)
2. Shachar teaches that embodiments of the invention "are useful
for accommodating imaging technologies such as X-ray, CAT-Scan, PET-
Scan, Ultrasound, etc." (Shachar 4, ,-r 61).
3. Shachar teaches that the radar system provides the "position co-
ordinates and orientation of the catheter tip 377" (Shachar 6, i-f 72).
4. Shachar teaches:
[C]onnection of the GCI apparatus 501 to cineoangiographic
equipment 502 . ... For convenience in the present description
... the image will be referred to herein as a fl[ uo ]roscopy
image, it being understood that the image can be generated by
any technology that can generate images of the body structures,
including ... X-ray imaging, Fluoroscopy, ultrasonic imaging,
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Application 11/767,281
MRI, CAT-Scan, PET-Scan, radar imaging, etc. The display of
these images is synchronized by the use of the 6-DOF [6-
Degrees of Freedom] sensor and its accompanying fiduciary
markers ... located on the patient's body 390 ... [to] enable[]
the synchronization 701 of the image 702 shown on video
monitor 325, with the position of the catheter tip 377.
(Shachar 7, i-f 75.)
5. Shachar teaches that the "controller 501 calculates an error
position (PE) 983 which is the difference between the actual position (AP)
981 and the desired position (DP) 982 of the catheter tip 377, also denoted as
curve 'C'985 ... and represented by expression (PE=[ AP-DP])." (Shachar 9,
,-r 103).
6. Heigl teaches a "method for calibrating an x-ray imaging device
... with at least two separate recording systems arranged for different
recording angles, during an intervention with for example an endoluminal
instrument, especially a catheter" (Heigl 1, i-f 13). Heigl discloses that, "at
any number of different positions of the instrument[,] a 2D image is
recorded with the two recording systems at the same time or immediately
adjacent in time" (Heigl 1, i-f 13)
7. Heigl teaches:
For the calibration[,] the doctor ... moves a catheter to
different spatial positions within the area under examination.
At the different positions a 2D x-ray image is recorded
practically simultaneously with both recording systems of the
area under examination in which the catheter tip is
recognizable. Subsequently an extraction of the catheter tip
with an image processing algorithm is undertaken in both the
recorded images. The points or coordinates obtained in the two
images by this algorithm are assigned to each other. If enough
assignments of different positions of the catheter are already
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Application 11/767,281
available[,] the relative imaging geometry of the two recording
systems is calculated.
(Heigl 3, i-f 28.)
Analysis
The Examiner finds that Sacher calculates the navigation error.
Specifically, the Examiner finds that "Sachar discloses the distance between
the actual position (AP) 981 of the catheter tip 377 is marked by Pl and the
desired position (DP) 982, set by the surgeon and is marked by P2. The
difference between the two co-ordinates P 1 and P2 is a position error (PE)
983 (or the navigation error)." (Final Act. 3 (citing Sacher, i-fi-165, 103, 104,
and fig 2L ); FF 5)
In the Answer, the Examiner explains that claim 1 describes "the
synchronization of two systems---one a tool position tracking system and the
other an imaging system ... [and it is] obvious to synchronize two different
positioning systems in order to perform proper operations without
endangering lives" (Ans. 8). ). The Examiner submits that, in Shachar,
the methodology of synchronizing the catheter tip 377 position
relative to the stereotactic framing formed by the fiduciary
markers 700Ax through 700Bx allow[s] the GCI controller 501
to provide ... [a] modality whereby the surgeon can set the
desired position P2 [may be considered as both predicted and
ultimately imaged positions/ relative to actual position P 1.
(Ans. 10.) The Examiner reasons that the synchronization "of the two
systems implicitly suggests the computation of navigation errors between
actual and imaged positions along the way" (Ans. 10). The Examiner
reasons that the synchronization of the two systems "would ultimately result
in the capturing of P2 as an imaged position that is to be computed with the
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Application 11/767,281
actual position P 1 of the catheter tip to form the navigation error of the
surgical navigation system" (Ans. 10-11).
Appellant contends that "Shachar defines the desired position as the
position that is set by the surgeon" (App. Br. 11 (emphasis removed)).
Appellant argues that "computing a distance between a radar-detected
position and a position set by a surgeon, as taught by Shachar, is different
than computing a distance between a tracked location and an imaged
location of a surgical instrument tip ... [because] a position set by a surgeon
is neither a tracked location nor an imaged location" (id.). Appellant argues
that, "[i]nstead of assessing an accuracy of a surgical navigation system,
Shachar merely discloses determining whether a catheter is in a desired
position set by a surgeon by comparing the desired position to a radar-
detected position of the catheter" (id. at 12). Appellant argues that Shachar
is "unrelated to assessing the accuracy of a surgical navigation system by
computing a navigation error as set forth in the Appellant's claims" (id.).
Appellant argues that Heigl and Simon fail to remedy the deficiencies of
Shachar (id. at 12-13).
We agree with Appellant that the Examiner has not adequately
explained how the cited references would have made obvious the method of
claim 1 that comprises the step of "computing a distance between the
tracked location of the surgical instrument tip and the imaged location of the
surgical instrument tip to form a navigation error of the surgical navigation
system." The Examiner points to Shachar's disclosure of determining an
error that is the difference between the actual position (AP) 9 81 of the
catheter tip and the desired position (DP) 982 of the catheter tip (Final Act.
3; Ans. 3; see FF 1 and 5). However, this disclosure in Shachar is not
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Application 11/767,281
related to determining the error of the navigation system in assigning a
location for the catheter tip relative to the actual location of the catheter tip,
but rather relates to relying on the navigation system as providing the actual
location of the catheter tip and then determining the distance between the
location provided by the navigation system and the location desired by the
physician.
The Examiner also points to Shachar's disclosure regarding the
synchronization of the cineoangiographic image of patient anatomy (e.g. X-
ray imaging, Fluoroscopy, ultrasonic imaging, MRI, CAT-Scan, PET-Scan,
and radar imaging) with the radar-determined position of the catheter tip
wherein the position of catheter tip 377 is superimposed onto the image
(Final Act. 6, Ans. 6; see FF 4). However, this disclosure in Shachar is not
related to determining the error of the navigation system in assigning a
location for catheter tip relative to the actual location of the catheter tip, but
rather relates to relying on the navigation system as providing the actual
location of the catheter tip and then, based on the indicated location,
superimposing the location of the catheter tip on the imaged anatomy (FF 4).
The Examiner also points to Heigl as disclosing the use of an X-ray
imaged catheter tip to calibrate X-ray images obtained by two different
systems (Final Act. 3, Ans. 3; see FF 7). However, the Examiner has not
adequately explained how Heigl's disclosure of the calibration of X-ray
images using an imaged catheter tip would have suggested to one of skill in
the art the use of an imaged catheter tip to determine an error of a navigation
system. Thus, we agree with Appellant that the Examiner has not
adequately explained how the combination of Shachar, Heigl, and Simon
would have made obvious the method of claim 1, and we reverse the
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obviousness rejection of independent claim 1 and dependent claims 2, 3, 7,
21, and 22.
Independent claim 10 also stands rejected as being obvious over
Shachar, Heigl, and Simon. As discussed above, the Examiner has not
adequately explained how the cited references would have made obvious the
limitation of computing the distance between a tracked location and the
imaged location of a surgical instrument. Accordingly, we also reverse the
obviousness rejection of independent claim 10 and dependent claims 11, 12,
23, and 24.
Independent claim 13 also stands rejected as being obvious over the
combination of Shachar, Heigl, and Simon. As discussed above, the
Examiner has not adequately explained how the cited references would have
made obvious the limitation of computing the distance between a tracked
location and the imaged location of a surgical instrument. Accordingly, we
also reverse the obviousness rejection of independent claim 13 and
dependent claims 14--16, 19, 25, and 26.
The Examiner has also rejected claims 5 and 17 as obvious over
Shachar, Heigl, Simon, Melkent, and Seeley (Ans. 7-8). The Examiner
relies on Melkent and Seeley only to supply dependent claim limitations.
However, as discussed above, the Examiner has not adequately explained
how the combination of Shachar, Heigl, and Simon would have made
obvious the limitation of computing the distance between a tracked location
and the imaged location of a surgical instrument. Thus, we also reverse the
rejection of claims 5 and 17 as being obvious over Shachar, Heigl, Simon,
Melkent, and Seeley for the reasons discussed above.
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Application 11/767,281
SUMMARY
We reverse the rejection of claims 1-3, 5, 7, 10-17, 19, and 21-26
under 35 U.S.C. § 103(a).
REVERSED
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