DETAILED ACTION
This Office action is responsive to communications filed on 10/15/2025. Claims 1-6, 8-13, 15-19 have been amended. Presently, Claims 1-20 remain pending and are hereinafter examined on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Previous rejections under 35 USC § 101 is withdrawn in view of the amendments filed on 10/15/2025.
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 10/15/2025.
Previous claim objections are withdrawn in view of the amendments filed on 10/15/2025.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on Dunbar et al (US 2015/0359991 A1) in view of Fichtinger et al (US 2016/0242855 A1) as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on Masumoto (US 2024/0407755 A1) in view of Bharat et al (US20190159752A1) in view of Jiang et al (Kalman filter-based EM-optical sensor fusion for needle deflection estimation. Int J Comput Assist Radiol Surg. 2018 Apr;13(4):573-583. doi: 10.1007/s11548-018-1708-8. Epub 2018 Feb 7) in view of Dunbar et al (US 2015/0359991 A1).
Specification
The disclosure is objected to because of the following informalities and should recite:
¶0032: line 2, “instrument [[102]]122”.
¶0055: line 2 & 5, “instrument [[102]]122”.
¶0065: line 3, “sensors 126 and [[136]]138”.
¶0070: line 1, “the elongated shaft [[118]]148”.
Appropriate correction is required.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1:
lines 11-12, “receiving a second signal from a second tracking sensor positioned at an end of a trocar, the trocar disposed in a wall of the object[[,]] and the end of the trocar is outside of the subject;”. Appropriate correction is required.
lines 16-17, “the transducer array”. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 7:
line 2, “the trocar”. Appropriate correction is required.
Claim 8:
line 1, “A non-transitory computer readable medium”. See MPEP 2106.03. Appropriate correction is required.
lines 13-14, “receive a second signal from a second tracking sensor positioned at an end of a trocar, the trocar disposed in a wall of the object[[,]] and the end of the trocar is outside of the subject”.
lines 18-19, “the transducer array”. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 10:
line 4, “interest
Claim 14:
line 3, “the trocar”. Appropriate correction is required.
Claim 17:
line 4, “interest
Claims 9-14:
line 1, “The non-transitory computer readable medium”. See MPEP 2106.03. Appropriate correction is required.
Claim 15:
lines 15-17, “receive a second signal from a second tracking sensor positioned at an end of a trocar, the trocar disposed in a wall of the object[[,]] and the end of the trocar is outside of the subject;”
line 22, “the transducer array”. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 20:
line 2, “the trocar”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-12, 14-18, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Masumoto (US 2024/0407755 A1) in view of Bharat et al (US20190159752A1) in view of Jiang et al (Kalman filter-based EM-optical sensor fusion for needle deflection estimation. Int J Comput Assist Radiol Surg. 2018 Apr;13(4):573-583. doi: 10.1007/s11548-018-1708-8. Epub 2018 Feb 7) in view of Dunbar et al (US 2015/0359991 A1).
Claim 1: Claim 8, Claim 15, Masumoto teaches, a method, computer readable medium, and a system to/comprising: (Claim 20, ¶Abstract, processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081),
transmitting an ultrasound signal, during an ultrasound image-guided examination of a subject, with a transducer array of an ultrasound probe, wherein a portion of the ultrasound probe that includes the transducer array is in a cavity of an object of the subject; (¶0045-0047, ¶0049-0050, ¶0056-0057, ¶0075, ¶0119-0120, ¶0154-0155)
receiving an echo signal, with the transducer array of the ultrasound probe; (¶0045-0047, ¶0049-0050, ¶0056-0057, ¶0075, ¶0119-0120, ¶0154-0155)
generating an image of an interior of the cavity, including a region of interest in the cavity, based on the echo signal; (¶0045-0047, ¶0049-0050, ¶0056-0057, ¶0075, ¶0119-0120, ¶0154-0155)
(FIG. 2, ¶0045-0047, ¶0049-0050, ¶0056-0057, ¶0075, ¶0119-0120, ¶0154-0155 – The ultrasound probe has insertion part inserted into the body of the patient (i.e., the subject) via trocars, the trocars within a wall of the subject where an end of the trocar is outside the subject. The trocars (17) are used to insert the ultrasound probe 14 into the subject. The ultrasound transducer 14B transmits ultrasound waves to the target area. The reflected waves, reflected from the target are received. The image generation processing is based on these reflected waves (i.e., echo signals). The ultrasound image is generated that illustrates the internal structure of the target.)
Masumoto discloses, an end of a trocar, which is disposed in a wall of the object, outside the subject, (FIG. 2, trocar 17 for the tool 18)
Masumoto discloses, a medical device (18), wherein a first part of a shaft of the medical device is outside the subject and includes a handle, a second part of the shaft is in the trocar or the cavity and outside of a field of view of the transducer, an instrument is disposed at an end region of the second part of the shaft that is in the cavity, (see Highlighted FIG. 2 of Masumoto below)
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processing marker signals, (processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081)
displaying the image (¶0045, ¶0051, ¶0053);
Masumoto fails to disclose:
receiving a first signal from a first tracking sensor disposed on the portion of the ultrasound probe in the cavity;
However, Bharat in the context of tracking of interventional instruments in ultrasound guided interventions discloses, receiving a first signal (¶0034, ¶0044) from a first tracking sensor (EM sensors 35) disposed on the portion of the ultrasound probe (12, FIG. 1) in the cavity (¶0024, ¶0034);
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the portion of the ultrasound probe of Masumoto to include a first tracking sensor to receive a first signal as taught by Bharat for the advantage of tracking the position and orientation of the probe within a three-dimensional space, as suggested by Bharat, ¶0034.
Masumoto fails to disclose:
receiving a second signal from a second tracking sensor positioned at an end of a trocar;
receiving a third signal from a third tracking sensor of a medical device (FIG. 1), the third tracking sensor is on the first part of the shaft proximate the handle, and the first part of the shaft is deflected between the third sensor and the second sensor;
determining a value of an arc length of the deflected first part of the shaft to estimate a first location of the instrument in the cavity relative to the region of interest;
However, Jiang in the context of needle deflection tracking discloses:
receiving a second signal from a second tracking sensor (FIG. 1, EM sensor) positioned at an end of a trocar (FIG. 1-depth stopper);
receiving a third signal from a third tracking sensor (optical sensor) of a medical device (FIG. 1), the third tracking sensor is on the first part of the shaft proximate the handle (FIG. 1 & FIG. 7), and the first part of the shaft is deflected between the third sensor and the second sensor;
-Jiang discloses, the optical sensor is mounted to the needle base while the EM sensor is attached to the depth stopper, FIG. 1. While FIG. 3 depicts the angular springs model where the needle is modeled as connected rigid rods. In this diagram, the section of the needle between Popt (i.e., the optical sensor position) and PEM (i.e., the EM sensor position) is shown as a curved, segmented line consisting of deflection signals (q1 & q2) indicating that the needle bends in this region, see Angular springs model second on pages 5-7. Jiang defines specific variables that quantify the deflection between these two sensors. For instance dEM is defined as the deviation of the EM sensor form the optical sensor. This deviation confirms that the shaft section between the base of the optical sensor and the EM sensor does not remain straight relative to the base orientation, see pages 6-7 of the Angular springs model section.
determining a value of an arc length of the deflected first part of the shaft to estimate a first location of the instrument in the cavity relative to the region of interest;
Jiang discloses, using the estimated parameters of the aforementioned model to estimate the needle posture (i.e., the tip) from the measured dEm. See pg. 6-7 of the Angular springs model section.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the end of the trocar of modified Masumoto to include a second tracking sensor to receive a second signal positioned at the end of the trocar as taught by Jiang. The motivation to do this yield predictable results such as to significantly improve the maneuvering of the needle and accuracy of the needle place as suggested by Jiang, [pg. 9 second paragraph], ‘This result indicates that by maneuvering the needle in the x–y plane, the accuracy of needle placement can be significantly improved.’
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the first part of the shaft proximate the handle of modified Masumoto to include a third tracking sensor to receive a third signal as taught by Jiang. The motivation to do this yield predictable results such as to significantly improve the maneuvering of the needle and accuracy of the needle place as suggested by Jiang, [pg. 9 second paragraph], ‘This result indicates that by maneuvering the needle in the x–y plane, the accuracy of needle placement can be significantly improved.’
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the method and apparatus of modified Masumoto such that first part of the shaft is deflected between the sensors and to determine a value of an arc length of the deflected part of the shaft to estimate a location of the instrument in the cavity relative to the region of interest as taught by Jiang. The motivation to do this yield predictable results such as to significantly improve the maneuvering of the needle and accuracy of the needle place as suggested by Jiang, [pg. 9 second paragraph], ‘This result indicates that by maneuvering the needle in the x–y plane, the accuracy of needle placement can be significantly improved.’
Masumoto fails to disclose:
processing the first, second and third signals
superimposing, based on the estimated first location, indicia over the image that indicates a current location of the instrument in the cavity relative to the region of interest.
However, Dunbar in the context of image guiding ultrasound procedures discloses: processing the first, second and third signals, (¶0042-0045, ¶0054-0055, ¶0066)
superimposing, based on the estimated first location, indicia over the image that indicates a current location of the instrument in the cavity relative to the region of interest. (¶Abstract, ¶0010, ¶0023, ¶0073, ¶0080, ¶0087, see FIGs 3(A)-3(E).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify processing of modified Masumoto that it processes the first, second, and third signals, and to include superimposing, based on the estimated first location, indicia over the image that indicates a current location of the instrument in the cavity relative to the region of interest as taught by Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 2: & Claim 9: & Claim 16: modified Masumoto discloses all the elements above in claim 1, claim 8, claim 15, Matsumoto fails to disclose: wherein the indicia includes first graphical indicia representing the instrument.
However, Dunbar is relied upon above discloses, wherein the indicia includes first graphical indicia representing the instrument. (Abstract, ¶0001, ¶0010, ¶0014, ¶0024, ¶0060)
-The image serves as the anatomical map for the procedure, (Abstract, ¶0001, ¶0010, ¶0014, ¶0025, ¶0044, ¶0047, ¶0060, ¶0073).
-The calculated position of the tool is then forwarded to the processor 3 and superimposed on the ultrasound image. The indicia representing the tool is displayed as a line (17) on the ultrasound image. If the tool (5) is detected as being in the imaging plane of the ultrasound transducer (2), it is displayed as a solid line, ¶0073. This directly address the “location where the instrument is in a plane of the image” as required by the claim. If the tool is not in the ultrasound image plane, the system still displays a projected position of the needle onto the ultrasound image plane. To indicate that this projected position a dotted and/or different colour is shown, ¶0073, Claims 7-9. Differentiating the display based on whether the tool is in or out of the plane represents the instrument’s location relative to the image plane.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the indicia of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 3: & Claim 10: & Claim 17: modified Masumoto discloses all the elements above in claim 2, claim 9, claim 15, Matsumoto fails to disclose: wherein the indicia includes second graphical indicia representing a trajectory from the instrument to the region of interest.
However, Dunbar is relied upon above discloses, wherein the indicia includes second graphical indicia representing a trajectory from the instrument to the region of interest. (¶0080, ‘FIG. 3(A), therefore, illustrates the impedance value being displayed as a chart along the tool path, trajectory. It can be seen that although the impedance values vary continuously along the path, there are larger step-like changes associated with the tip of the tool crossing tissue boundaries visible in the ultrasound image. These step-like changes therefore act as confirmations that the tool tip is crossing these different tissue types.’; ¶0081, ‘FIG. 3(B) illustrates the measured impedance values colour-coded and displayed as an overlay on the tool position/trajectory, and again colour changes can be seen to align with the tissue boundaries visible in the ultrasound image itself.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the indicia of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 4: & Claim 11: & Claim 18 modified Masumoto discloses all the elements above in claim 1, claim 8, claim 15, Matsumoto fails to disclose: wherein the indicia includes graphical indicia representing a trajectory from the instrument to the region of interest.
However, Dunbar is relied upon above discloses, wherein the indicia includes graphical indicia representing a trajectory from the instrument to the region of interest.(Abstract, ¶0001, ¶0010, ¶0014, ¶0024, ¶0060)
-The image serves as the anatomical map for the procedure, (Abstract, ¶0001, ¶0010, ¶0014, ¶0025, ¶0044, ¶0047, ¶0060, ¶0073).
-The calculated position of the tool is then forwarded to the processor 3 and superimposed on the ultrasound image. The indicia representing the tool is displayed as a line (17) on the ultrasound image. If the tool (5) is detected as being in the imaging plane of the ultrasound transducer (2), it is displayed as a solid line, ¶0073. This directly address the “location where the instrument is in a plane of the image” as required by the claim. If the tool is not in the ultrasound image plane, the system still displays a projected position of the needle onto the ultrasound image plane. To indicate that this projected position a dotted and/or different colour is shown, ¶0073, Claims 7-9, which represents the trajectory. Differentiating the display based on whether the tool is in or out of the plane represents the instrument’s location relative to the image plane.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the indicia of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 5: modified Masumoto discloses all the elements above in claim 1, Matsumoto fails to disclose: further comprising: determining a change in a location of the medical device based on the third sensor; and estimating a subsequent location of the instrument in the cavity based on the change in the position.
However, Dunbar is relied upon above discloses, further comprising:
-The processor and display are adapted to display the change of the measured bio-electrical property as the tissue-penetrating medical tool is moved through the subjects body, ¶0026-0027, Claims 10-13. This directly links the measured changes in tissue impedance based on the third sensor, electrode 11’. determining a change in a location of the medical device based on the third sensor; and estimating a subsequent location of the instrument in the cavity based on the change in the position. (¶Abstract, ¶0001, ¶0010, ¶0014, ¶0025, ¶0047, ¶0060, ¶0073, ¶0080)
-The system continuously tracks and displays the tool’s position. The ability to display a projection position if the tool is out of the imaging plane and to differentiate it visually (e.g., dotted line or different color), represents a dynamic prediction of the tool movement relative to the imaging plane, ¶0073 & ¶0080. This expected needle track, ¶0073-0075, constitutes a continuous estimation of the tool’s future locations based on its current trajectory.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the determining of the location of the medical device based on the third sensor of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 7: modified Masumoto discloses all the elements above in claim 1, Matsumoto fails to disclose: further comprising: receiving a fourth signal from the second tracking sensor at the cannula disposed in the wall of the object; receiving a fifth signal from the third tracking sensor of the medical device, and processing the fourth and fifth signals to determine a second estimated location of the instrument in the cavity relative to the region of interest.
However, Dunbar is relied upon above discloses, further comprising: receiving a fourth signal from the second tracking sensor at the cannula disposed in the wall of the object; receiving a fifth signal from the third tracking sensor of the medical device, and processing the fourth and fifth signals to determine a second estimated location of the instrument in the cavity relative to the region of interest. (¶Abstract, ¶0001, ¶0010, ¶0014, ¶0025, ¶0047, ¶0060, ¶0073, ¶0080)
-The system continuously tracks and displays the tool’s position. The ability to display a projection position if the tool is out of the imaging plane and to differentiate it visually (e.g., dotted line or different color), represents a dynamic prediction of the tool movement relative to the imaging plane, ¶0073 & ¶0080. This expected needle track, ¶0073-0075, constitutes a continuous estimation of the tool’s future locations based on its current trajectory. This continuous tracking would receive multiple signals or subsequent signals that further constitute a fourth and fifth signal which amount to the tool’s future locations (i.e., a second estimated location).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify second tracking sensor of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 12: modified Masumoto discloses all the elements above in claim 8, Matsumoto discloses: wherein the instructions further cause the processor to: (processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081)
Matsumoto fails to disclose:
determine a change in a location of the medical device based on the third sensor; and
estimate a subsequent location of the instrument in the cavity based on the change in the position.
However, Dunbar is relied upon above discloses, Dunbar discloses: wherein the instructions further cause the processor to: (base unit/station 14 & processor 3, ¶0044)
determine a change in a location of the medical device based on the third sensor; and
-The processor and display are adapted to display the change of the measured bio-electrical property as the tissue-penetrating medical tool is moved through the subjects body, ¶0026-0027, Claims 10-13. This directly links the measured changes in tissue impedance based on the third sensor, electrode 11’.
estimate a subsequent location of the instrument in the cavity based on the change in the position. (¶Abstract, ¶0001, ¶0010, ¶0014, ¶0025, ¶0047, ¶0060, ¶0073, ¶0080)
-The system continuously tracks and displays the tool’s position. The ability to display a projection position if the tool is out of the imaging plane and to differentiate it visually (e.g., dotted line or different color), represents a dynamic prediction of the tool movement relative to the imaging plane, ¶0073 & ¶0080. This expected needle track, ¶0073-0075, constitutes a continuous estimation of the tool’s future locations based on its current trajectory.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the determining of the location of the medical device based on the third sensor of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 14: modified Masumoto discloses all the elements above in claim 8, Matsumoto fails to disclose: wherein the instructions further cause the processor to: (processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081)
Matsumoto fails to disclose:
receive a fourth signal from the second tracking sensor at the cannula disposed in the wall of the object; receive a fifth signal from the third tracking sensor of the medical device, and process the fourth and fifth signals to determine a second estimated location of the instrument in the cavity relative to the region of interest.
However, Dunbar is relied upon above discloses:
wherein the instructions further cause the processor to: (base unit/station 14 & processor 3, ¶0044) receive a fourth signal from the second tracking sensor at the cannula disposed in the wall of the object; receive a fifth signal from the third tracking sensor of the medical device, and process the fourth and fifth signals to determine a second estimated location of the instrument in the cavity relative to the region of interest. (¶Abstract, ¶0001, ¶0010, ¶0014, ¶0025, ¶0047, ¶0060, ¶0073, ¶0080)
-The system continuously tracks and displays the tool’s position. The ability to display a projection position if the tool is out of the imaging plane and to differentiate it visually (e.g., dotted line or different color), represents a dynamic prediction of the tool movement relative to the imaging plane, ¶0073 & ¶0080. This expected needle track, ¶0073-0075, constitutes a continuous estimation of the tool’s future locations based on its current trajectory. This continuous tracking would receive multiple signals or subsequent signals that further constitute a fourth and fifth signal which amount to the tool’s future locations (i.e., a second estimated location).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claim 19: modified Masumoto discloses all the elements above in claim 15, Masumoto discloses: wherein the processor is further configured to: (processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081)
Masumoto fails to disclose: determine a change in a location of the medical device based on the third sensor; determine a bend in a portion of the shaft between the second and third sensors based on the second and third signals; and estimate a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft.
However, Shlomo in the context of bend-response catheter apparatus discloses: determine a bend in a portion of the shaft between the second and third sensors based on the second and third signals; and (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
estimate a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft. (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor that processes the second and third sensors of modified Dunbar to include determining a bend based on the second and third signals and estimating a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft as taught by Shlomo. The motivation to do this yields predictable results such achieving the desired accuracy of determination of the plurality of points along the length of the instrument, [Col 9 l.5-8] of Shlomo.
Claim 20: modified Masumoto discloses all the elements above in claim 15, Masumoto discloses:
wherein the processor is further configured to: ( (processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081)
Masumoto fails to discloses: wherein the processor is further configured to: receive a fourth signal from the second tracking sensor at the cannula disposed in the wall of the object; receive a fifth signal from the third tracking sensor of the medical device, and process the fourth and fifth signals to determine a second estimated location of the instrument in the cavity relative to the region of interest.
Dunbar discloses: wherein the processor is further configured to: (base unit/station 14 & processor 3, ¶0044) receive a fourth signal from the second tracking sensor at the cannula disposed in the wall of the object; receive a fifth signal from the third tracking sensor of the medical device, and process the fourth and fifth signals to determine a second estimated location of the instrument in the cavity relative to the region of interest. (¶Abstract, ¶0001, ¶0010, ¶0014, ¶0025, ¶0047, ¶0060, ¶0073, ¶0080)
-The system continuously tracks and displays the tool’s position. The ability to display a projection position if the tool is out of the imaging plane and to differentiate it visually (e.g., dotted line or different color), represents a dynamic prediction of the tool movement relative to the imaging plane, ¶0073 & ¶0080. This expected needle track, ¶0073-0075, constitutes a continuous estimation of the tool’s future locations based on its current trajectory. This continuous tracking would receive multiple signals or subsequent signals that further constitute a fourth and fifth signal which amount to the tool’s future locations (i.e., a second estimated location).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the determining of the location of the medical device based on the third sensor of modified Masumoto in view of the teachings of Dunbar. The motivation to do this yield predictable results such improving the tracking of the position and orientation of individual parts of the tool during an operation, as suggested by Dunbar, ¶0079, to visually allow the user to see the visual alignment between tissue boundaries in the ultrasound image, as suggested by Dunbar, ¶0084.
Claims 6, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Masumoto (US 2024/0407755 A1) in view of Bharat et al (US20190159752A1) in view of Jiang et al (Kalman filter-based EM-optical sensor fusion for needle deflection estimation. Int J Comput Assist Radiol Surg. 2018 Apr;13(4):573-583. doi: 10.1007/s11548-018-1708-8. Epub 2018 Feb 7) in view of Dunbar et al (US 2015/0359991 A1), as applied to claim 5, 12, and 15, in further view of Shlomo (US 6,272,371 B1).
Claim 6: modified Masumoto discloses all the elements above in claim 5, Masumoto fails to disclose further comprising: determining a portion of the shaft between the second and third sensors includes a bend based on the second and third signals; and estimating the subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft.
However, Shlomo in the context of bend-response catheter apparatus discloses: determining a portion of the shaft between the second and third sensors includes a bend based on the second and third signals; and (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
estimating the subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft. (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the second and third sensors of modified Masumoto to include determining a bend based on the second and third signals and estimating a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft as taught by Shlomo. The motivation to do this yields predictable results such achieving the desired accuracy of determination of the plurality of points along the length of the instrument, [Col 9 l.5-8] of Shlomo.
Claim 13: modified Masumoto discloses all the elements above in claim 12,
Masumoto discloses: wherein the instructions further cause the processor to: (processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081)
Masumoto fails to disclose: determine a portion of the shaft between the second and third sensors includes a bend based on the second and third signals; and estimate the subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft.
However, Shlomo in the context of bend-response catheter apparatus discloses:
determine a portion of the shaft between the second and third sensors includes a bend based on the second and third signals; and (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
estimate the subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft. (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor that processes the second and third sensors of modified Dunbar to include determining a bend based on the second and third signals and estimating a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft as taught by Shlomo. The motivation to do this yields predictable results such achieving the desired accuracy of determination of the plurality of points along the length of the instrument, [Col 9 l.5-8] of Shlomo.
Claim 19: modified Masumoto discloses all the elements above in claim 15, Masumoto discloses: wherein the processor is further configured to: (processor 41, ¶0005, ¶0060, ¶0070, ¶0078-0081)
Masumoto fails to disclose: determine a change in a location of the medical device based on the third sensor; determine a bend in a portion of the shaft between the second and third sensors based on the second and third signals; and estimate a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft.
However, Shlomo in the context of bend-response catheter apparatus discloses: determine a bend in a portion of the shaft between the second and third sensors based on the second and third signals; and (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
estimate a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft. (¶Abstract, ‘First and second sensors (28, 30) are fixed to the distal portion of the probe (20) in known positions relative to the distal end (22), which sensors generate signals responsive to bending of the probe. Signal processing circuitry (36) receives the bend responsive signals and processes them to find position and orientation coordinates of at least the first sensor (28), and to determine the locations of a plurality of points along the length of the distal portion of the probe.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor that processes the second and third sensors of modified Dunbar to include determining a bend based on the second and third signals and estimating a subsequent location of the instrument in the cavity based on the change in location and the bend in the portion of the shaft as taught by Shlomo. The motivation to do this yields predictable results such achieving the desired accuracy of determination of the plurality of points along the length of the instrument, [Col 9 l.5-8] of Shlomo.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798