Ex Parte Amthor et al

Patent Trial and Appeal Board

Jul 10, 2018

14349333 (P.T.A.B. Jul. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/349,333 04/03/2014 Thomas Erik Amthor
24737 7590 07/12/2018
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.
2011P00832WOUS 6803
EXAMINER
KINNARD, LISA M
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
07/12/2018 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 THOMAS ERIK AMTHOR, FALK UHLEMANN,
SASCHA KRUEGER, STEFFEN WEISS,
RON ALDUS FREDERIK JOHANNES HOL THUIZEN,
DANIEL WIRTZ, and PETER KOKENM
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Application 14/349,333
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
of using a medical apparatus for guiding a catheter and the apparatus itself.
The Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b ). We reverse.
Statement of the Case
Background
High dose rate (HDR) brachytherapy is a very promising
method for treating different kinds of tumors. One or more
catheters are inserted directly into one or several tumor( s) in a
1 Appellants identify the Real Party in Interest as KONINKLIJKE
PHILIPS NV (see App. Br. 2).
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Application 14/349,333
minimally invasive procedure. Through these catheters, small
radioactive seeds can be shifted to pre-defined positions in
order to deposit a high radiation dose precisely in the lesion
with only minimal damage of surrounding healthy tissue
compared to other focal techniques.
(Spec. 1:5-10). "Current treatment planning software optimizes the dose
distribution after the intervention, when the catheters are already placed in
the patient and the positions are fixed" (Id. at 1:13-14). "A disadvantage of
current methods of guiding brachytherapy catheters is that it is very difficult
for a physician to place the catheter in exactly the correction position" (Id. at
2:56).
The Specification teaches:
After a catheter is placed embodiments of the invention may
determine the location of placed catheters using a magnetic
resonance image. The location of the placed catheters is then
used an input for a calculation where the placement of the
remaining catheters is determined. This provides a means of
compensating for catheters which have been placed incorrectly
or a wrong location.
(Spec. 2:12-16).
The Claims
Claims 1-15 are on appeal. Claim 1 is representative and reads as
follows:
1. A medical apparatus (200, 300, 400) comprising:
A magnetic resonance imaging system (202) for
acquiring magnetic resonance data (244, 250) from an imaging
zone (208);
a display (270, 501) for displaying images (252, 500);
a processor (228) for controlling the medical apparatus;
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a memory (234) for storing machine executable
instructions for execution by the processor,
wherein execution of the instructions causes the
processor to receive a brachytherapy treatment plan (240) for
treating a subject (210), wherein execution of the instructions
further causes the processor to acquire (100) planning magnetic
resonance data (244) using the magnetic resonance imaging
system, wherein execution of the instructions further causes the
processor to calculate (102) a catheter placement position (246,
900, 902) and a catheter control command (248) for each of the
multiple brachytherapy catheters using the brachytherapy
treatment plan and the planning magnetic resonance data,
wherein the catheter control command is descriptive of
locations and dwell times for the locations for one of the
multiple brachytherapy catheters,
wherein execution of the instructions causes the
processor, for each catheter placement position, to repeatedly:
acquire (106) guidance magnetic resonance data (250);
reconstruct (108) an image (252, 500) from the guidance
magnetic resonance data;
display (110) the image on the display;
display (112) the catheter placement position on the
image;
receive (114) a catheter inserted signal from a user
interface;
segment ( 116) the image to determine the catheter
placement position after receiving the catheter inserted signal;
recalculate ( 116) the catheter placement positions for
each remaining catheter placement position after receiving the
catheter inserted signal; and
recalculate ( 116) the catheter control command for the
multiple catheters after receiving the catheter inserted signal.
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The Rejections
A. The Examiner rejected claims 1, 2, 4--8, 11, and 13-15 under 35
U.S.C. § I03(a) as obvious over Ford,2 Edmundson, 3 Kindlein, 4 and Cheng5
(Final Act. 2-8).
B. The Examiner rejected claims 3 and 12 under 35 U.S.C. § I03(a) as
obvious over Ford, Edmundson, Kindlein, Cheng, and Whitcomb 6 (Final
Act. 9-10).
C. The Examiner rejected claim 9 under 35 U.S.C. § I03(a) as obvious
over Ford, Edmundson, Kindlein, Cheng, Holdaway, 7 and Palmeri 8 (Final
Act. 10-11 ).
D. The Examiner rejected claim 10 under 35 U.S.C. § I03(a) as obvious
over Ford, Edmundson, Kindlein, Cheng, and Fischer9 (Final Act. 11-12).
A. 35 USC§ 103(a) over Ford, Edmundson, Kindlein, and Cheng
The Examiner finds that Ford teaches an MRI imaging system for
control of catheters in a brachytherapy treatment (Final Act. 2-3) but
acknowledges Ford "does not explicitly disclose details regarding dwell
times, displaying catheter positions, image segmentation or a catheter
inserted signal" (Final Act. 4 ). The Examiner relies upon Kindlein and
2 Ford, J., US 6,846,282 Bl, issued Jan. 25, 2005.
3 Edmundson, G., US 5,391,139, issued Feb. 21, 1995.
4 Kindlein et al., US 2003/0233123 Al, published Dec. 18, 2003.
5 Cheng et al., US 6,438,401 Bl, issued Aug. 20, 2002.
6 Whitcomb et al., US 2010/0056900 Al, published Mar. 4, 2010.
7 Holdaway et al., US 6,217,518 B 1, issued Apr. 17, 2001.
8 Palmeri et al., US 2011/0201931 Al, published Aug. 18, 2011.
9 Fischer et al., US 2011/0077504 Al, published Mar. 31, 2011.
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Cheng to suggest image segmentation and receiving a catheter inserted
signal (Final Act. 4--5).
The Examiner relies upon Edmundson to teach dwell times and
particularly to teach a system that after obtain a catheter placement position,
functions to "recalculate the catheter placement positions for each remaining
catheter placement position" (Final Act. 4). The Examiner also finds Cheng
teaches "recalculating catheter placement positions for each remaining
catheter placement position after receiving the catheter inserted signal"
(Final Act. 5).
The Examiner finds it obvious to "employ a catheter received signal
and recalculate catheter placement positions as disclosed by Cheng, for the
purpose of allowing the system to make error corrections prior to inserting
the next radiation seed" (Final Act. 6).
Appellants contend
Edmundson, at col 5, 11. 10-35 does not recalculate catheter
placement positions for remaining catheter placement positions
after receiving the catheter input signal. To the contrary,
Edmundson displays a dosage profile. Then, if medical
personnel determine that the dosage profile does not cover an
acceptable portion of the anatomical volume, a new (additional)
needle location is chosen, and a dosage profile is determined
and displayed for the new location.
(App. Br. 10). Appellants contend "Edmundson does not calculate or
otherwise determine catheter placement positions for each remaining
catheter as required by the claim. Instead one additional needle placement is
chosen at a time" (App. Br. 10-11).
Appellants also contend
Cheng, at col. 6, 11. 21--4 7 does not recalculate catheter
placement positions for remaining catheter placement positions
after receiving the catheter input signal. To the contrary, Cheng
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calculates the positional error of the actual placement from the
planned location, then recalculates a radiation dose for the
actual placement of the currently inserted needle, not catheter
placements for remaining catheters.
(App. Br. 11 ). Appellants contend "Cheng recalculates the dose for seeds
that are already placed, not for each remaining catheter" (Id.).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that the prior art
suggests "to determine the catheter placement position after receiving the
catheter inserted signal" and then "recalculate (116) the catheter placement
positions for each remaining catheter placement position" as required by
claim 1?
Findings of Fact
1. Ford teaches an "apparatus for and methods in brachytherapy
by which radioactive seeds can be accurately deposited in a patient's body
by calculating dose distribution and displaying the calculated radiation dose
distribution" (Ford 2:25-28).
2. Edmundson teaches a "need for an apparatus and method for
rapidly, reliably and interactively generating a radiation dosage plan based
on real time data associated with a preselected placement of a radiation
source delivery system with respect to the anatomical portion to be treated"
(Edmundson 1:63---68).
3. Edmundson teaches
the displayed dosage profile which is superimposed at window
225 of monitor 211 over the anatomical portion, such as the
prostate gland, to be treated, is viewed by the medical
personnel, and if an acceptable dose profile covers an
acceptable portion of the anatomical volume, then the
procedure advances to step 329. Otherwise, a new needle
location is chosen at step 311 and the steps 313 through 325 are
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reexecuted. The planning system of this invention inherently
accommodates movement of the anatomical portion being
treated, in that the real time output of the scanner is
continuously captured and displayed.
(Edmundson 5: 13-21 ).
4. Edmundson teaches
the reconstruction basic steps comprise reading the input data at
step 401, selecting a next needle at step 403 and a next dwell
position within that needle at step 405. Then at step 407,
utilizing the template and reference positional data, the x,y,z
cartesian coordinate values for the dwell position of interest are
interpolated at step 407, and an initial weight and dwell time in
relative unitless values are assigned. This interpolation process
is repeated for every dwell position in the implant using the
tests at steps 409 and 411, and when all dwell positions have
been modeled, the data is output at step 413.
(Edmundson 6:22-33).
5. Cheng teaches "a technique for rapid and accurate identification
and quantification of needle placement departures from such a treatment
plan" (Cheng 1: 15-17).
6. Cheng teaches:
While the above techniques allow calculation of optimized
dwell time, placement or the like, they do not provide for
detection and correction of errors in needle or seed placement. .
. . It will be apparent from the above that a need exists in the
art to detect and correct errors in implementation of a treatment
plan.
(Cheng 2:59-67).
7. Cheng teaches
Following the insertion of each needle or catheter in step
206, the live ultrasound image 306 of the interface 300 displays
a bright (hyperechoic) spot 332 in step 208. In step 210, the
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operator manually identifies the spot 332, e.g., by clicking on it
with the mouse 108. In step 212, the [] difference in the x-y
plane between the planned location and the actual location of
the needle or catheter is calculated to give errors .!'ix and L'iy,
which are shown both on the grid 302 and on the highlighted
row 330 of the spreadsheet. The positional errors in the x-y
plane of each seed, .!'ix' and L'iy', are calculated in step 214 based
on straight line interpolation at the planned z location of the
seed. The straight line used in the interpolation is constructed
by joining two known points: (a) the actual needle location
shown on ultrasound at the known z plane and (b) the template
coordinate outside the patient body through which the needle is
inserted under precision template guidance. At the template
118, .!'ix and L'iy are assumed to equal zero. The dose is then
recalculated in step 216 by moving the seeds along the activated
needle or catheter in the x and y directions by those amounts
.!'ix' and L'iy', which may be the same or different for every seed.
The dosimetry updated by such feedback of seed placement
errors is redisplayed in step 218 on the series of isodose panels
308.
(Cheng 6:21--44).
Principles of Law
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int 'l 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 the elements in the way the
claimed new invention does." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
While both Edmundson and Cheng teach the selection of needle
(catheter) locations based on dose profiles and anatomical volumes (FF 3, 4,
7), we agree with Appellants that neither reference teaches a processor to
"recalculate (116) the catheter placement positions for each remaining
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catheter placement position after receiving the catheter inserted signal" as
recited in claim 1. That is, Edmundson looks at the volume being treated by
a previous dose, but not at the needle ("catheter" of the claims) location in
the description of the flow diagram of Figure 3 (FF 3). While Figure 4 of
Edmundson discusses the coordinate values of the needle, the focus is on
calculation of the dwell positions of the radioactive sources, not the location
of the needle (catheter) relative to previously inserted needles (FF 4). On
the other hand, the claim requires each catheter position to be recalculated
based on a position in a "brachytherapy treatment plan." As the
Specification explains, this recalculation is done to calculate the dose and
area of the tissue to be treated (Spec. 6:18-27). However, Edmundson
describes choosing new needle (catheter) positions but this location is not
expressly based on a previously placed needle (catheter) position and does
not recalculate the position of a placed needle from its position in a
treatment plan as the claims require.
Similarly, while Cheng recognizes the importance of correct needle
( catheter) placement (FF 5), Cheng teaches using the needle locations to
calculate the location of seeds for dosing within the needle ( catheter) (FF 7).
Indeed, the interpolation to which the Examiner refers (see Ans. 12) is
specifically performed based on the needle location so the "dose is then
recalculated ... by moving the seeds along the activated needle or catheter"
(FF 7). Thus, Cheng also does not teach to "recalculate (116) the catheter
placement positions for each remaining catheter placement position" as
required by claim 1, but rather teaches moving the seed along the needle or
catheter (FF 7).
In addition to the absence of specific teachings in the cited prior art to
recalculate the catheter placement positions based on signals from
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previously inserted catheters as required by claim 1, we note that the
Examiner also fails to provide specific reasoning or logic explaining why
this would have been obvious (see Final Act. 5-6, 12-13; Ans. 12). We are
therefore constrained to reverse this rejection.
Conclusion of Law
The preponderance of the evidence of record does not support the
Examiner's conclusion that the prior art suggests "to determine the catheter
placement position after receiving the catheter inserted signal" and then
"recalculate (116) the catheter placement positions for each remaining
catheter placement position" as required by claim 1.
B.-D. 35 USC§ 103(a)
The Examiner relies upon the rejection over Ford, Edmundson,
Kindlein, and Cheng to address the "recalculate" limitation of claim 1.
Having reversed the obviousness rejection of claim 1 over this rejection for
the reasons given above, we also find that the further combinations with
Holdaway, Palmeri, and Fischer do not render the rejected claims obvious
for the same reason.
SUMMARY
In summary, we reverse the rejection of claims 1, 2, 4--8, 11, and 13-
15 under 35 U.S.C. § 103(a) as obvious over Ford, Edmundson, Kindlein,
and Cheng.
We reverse the rejection of claims 3 and 12 under 35 U.S.C. § 103(a)
as obvious over Ford, Edmundson, Kindlein, Cheng, and Whitcomb.
We reverse the rejection of claim 9 under 35 U.S.C. § 103(a) as
obvious over Ford, Edmundson, Kindlein, Cheng, Holdaway, and Palmeri.
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We reverse the rejection of claim 10 under 35 U.S.C. § 103(a) as
obvious over Ford, Edmundson, Kindlein, Cheng, and Fischer.
REVERSED
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