DETAILED ACTION
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
Applicant’s arguments with respect to claim(s) 1-10, & 12-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 7 & 20 objected to because of the following informalities:
Claim 7 recites “and/or”, should instead recite “and” or “or”
Claim 20 recites “and/or”, should instead recite “and” or “or”
. 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 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.
Claims 1, 3-7, 13-14, & 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US20200367972A1; hereinafter referred to as Zhang) in view of Shochat (US20170071672A1).
Regarding Claim 1, Zhang discloses a method for guiding movement of a probe, so as to perform ultrasound imaging (“A display method and system for ultrasound-guided intervention.” [Abstract]), comprising:
using the probe to acquire a real-time ultrasound image related to a tissue to be imaged (“In step S10, data may be obtained. The data may at least include real-time ultrasound data and real-time spatial orientation information of the probe. The real-time ultrasound data may be two-dimensional or three-dimensional ultrasound data obtained by scanning the tissue by the probe, or other suitable real-time data representing the tissue.” [0035]);
determining a current intervention starting point, and determining a target intervention region and a non-intervention region in the ultrasound image (“In step S12, a planning image of ultrasound-guided intervention may be generated based on the obtained data and displayed. The planning image may include a probe marker for planning, an ultrasound image and an area of tissue to be ablated. The planning image may at least represent the relative spatial position relationship between the probe marker for planning, the ultrasound image and the area of tissue to be ablated.” [0036], “in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0059], “the needle insertion path may be shown by a solid line, a dashed line or a line with an arrow, etc. in a certain color. By the needle insertion path on the planning image, the user can clearly observe the organs and tissues to be punctured by the ablation needle when the ablation needle is inserted along the needle insertion path. Therefore, the accidental injury to important organs and blood vessels and the influence of ribs to the needle insertion path can be avoided during the planning of the needle insertion path. The predicted ablation area may simulate the predicted ablation range under the set needle insertion path and the set ablation parameter.” [0051]);
and determining a target intervention path based on the target intervention region and the non-intervention region (“the needle insertion path may be shown by a solid line, a dashed line or a line with an arrow, etc. in a certain color. By the needle insertion path on the planning image, the user can clearly observe the organs and tissues to be punctured by the ablation needle when the ablation needle is inserted along the needle insertion path. Therefore, the accidental injury to important organs and blood vessels and the influence of ribs to the needle insertion path can be avoided during the planning of the needle insertion path. The predicted ablation area may simulate the predicted ablation range under the set needle insertion path and the set ablation parameter.” [0051]);
and based on the current position and the target intervention path, generating and displaying movement guidance related to the probe, the movement guidance being configured to guide the probe to move such that the current position and the target intervention path coincide (“in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0059], “, in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0065]).
Zhang does not specifically disclose determining a current intervention path based on the target intervention region and the current intervention starting point.
However, in a similar field of endeavor, Shochat teaches a method of planning an image-guided interventional procedure to be performed on a patient [Abstract].
Shochat also teaches determining a current intervention path based on the target intervention region and the current intervention starting point (“the described method implementations are not limited to the use of CT scans, and they can be implemented using images generated by other imaging systems, such as an X-ray fluoroscopic system, an ultrasonic system, or an MRI system.” [0012], “One exemplary implementation involves a method of planning an image-guided interventional procedure in a region of interest of a subject, comprising: (a) obtaining a plurality of time-separated images of the region of interest, (b) defining on a first image of the plurality of images, an entry point, a target point and one or more regions into which entry by the interventional procedure is forbidden, (c) calculating a trajectory for the interventional procedure between the entry point and the target point, which avoids entry into any of the one or more forbidden regions, (d) selecting a second image of the plurality of images generated at a time different from that at which the first of the plurality of images was generated, (e) determining changes in the position of the entry point, target point and any regions into which entry by the interventional procedure is forbidden in the second image of the plurality of images, and (f) repeating step (c) on the second image of the plurality of images based on the changes in position determined in step (e).” [0013])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with a current intervention path based on the target intervention region and the current intervention starting point as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 3, Zhang discloses the current intervention starting point moves in real time with the movement of the probe, and during said movement, the relative positions of the current intervention starting point and the probe remain unchanged (“During the user moving the probe 21 to make the probe marker for guiding to coincide with the probe marker for planning, the spatial position of the probe marker for guiding will change due to the movement of the probe 21. Therefore, the probe marker for guiding and the probe marker for planning can be distinguished.“ [0074]).
Regarding Claim 4, Zhang discloses further comprising: displaying the target intervention path in real time during the movement of the probe (“During the user moving the probe 21 to make the probe marker for guiding to coincide with the probe marker for planning, the spatial position of the probe marker for guiding will change due to the movement of the probe 21. Therefore, the probe marker for guiding and the probe marker for planning can be distinguished.“ [0074]).
Zhang does not specifically disclose displaying the current intervention path in real time.
However, in a similar field of endeavor, Shochat teaches displaying the current intervention path in real time (“The system may include at least one processor 61 for determining changes in the positions of the entry point, target point and any obstacles therebetween, using object tracking methods of image processing. The at least one processor 61 may be further adapted to calculate needle trajectories, and in some implementations, to analyze the calculated trajectories and compare them to one another... The system may further include a display/screen 63 for displaying, inter alia, the obtained images and the calculated trajectories.” [0070])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with displaying the current intervention path in real time as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 5, Zhang discloses all limitations noted above except that the current intervention path is a line connecting a point in the target intervention region to the current intervention starting point.
However, in a similar field of endeavor, Shochat teaches the current intervention path is a line connecting a point in the target intervention region to the current intervention starting point (“the doctor may use the CT image shown in FIG. 1A in order to mark the obstacle 12 and the target 13 and choose an entry point 11, which enables a substantially linear trajectory 100 from the entry point 11 to the target 13, while avoiding the obstacle 12.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with the current intervention path is a line connecting a point in the target intervention region to the current intervention starting point as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 6, Zhang discloses all limitations noted above except that the target intervention path passes through a point of the target intervention region and does not pass through the non-intervention region.
However, in a similar field of endeavor, Shochat teaches the target intervention path passes through a point of the target intervention region and does not pass through the non-intervention region (“the doctor may use the CT image shown in FIG. 1A in order to mark the obstacle 12 and the target 13 and choose an entry point 11, which enables a substantially linear trajectory 100 from the entry point 11 to the target 13, while avoiding the obstacle 12.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with the target intervention path passes through a point of the target intervention region and does not pass through the non-intervention region as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 7, Zhang discloses further comprising: simultaneously displaying a target intervention starting point and the current intervention starting point in real time during the movement of the probe (“During the user moving the probe 21 to make the probe marker for guiding to coincide with the probe marker for planning, the spatial position of the probe marker for guiding will change due to the movement of the probe 21. Therefore, the probe marker for guiding and the probe marker for planning can be distinguished.“ [0074]);
Zhang does not specifically disclose the target intervention starting point is an intersection point of the target intervention path and the upper edge of the ultrasound image; and/or simultaneously displaying the current intervention path and the target intervention path in real time during the movement of the prob.
However, in a similar field of endeavor, Shochat teaches the target intervention starting point is an intersection point of the target intervention path and the upper edge of the ultrasound image; and/or simultaneously displaying the current intervention path and the target intervention path in real time during the movement of the prob (“The system may include at least one processor 61 for determining changes in the positions of the entry point, target point and any obstacles therebetween, using object tracking methods of image processing. The at least one processor 61 may be further adapted to calculate needle trajectories, and in some implementations, to analyze the calculated trajectories and compare them to one another... The system may further include a display/screen 63 for displaying, inter alia, the obtained images and the calculated trajectories.” [0070])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with the target intervention starting point is an intersection point of the target intervention path and the upper edge of the ultrasound image; and/or simultaneously displaying the current intervention path and the target intervention path in real time during the movement of the prob as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 13, Zhang discloses An ultrasound imaging system(“A display method and system for ultrasound-guided intervention.” [Abstract]), comprising:
a probe, the probe transmitting an ultrasound beam to tissue to be imaged, and receiving an echo signal (“a display method for ultrasound-guided intervention is provided, which may include: obtaining a data, where the data includes at least a real-time ultrasound data and a real-time spatial orientation information of a probe” [0009]);
a processor configured to: acquire a real-time ultrasound image related to a tissue to be imaged (“In step S10, data may be obtained. The data may at least include real-time ultrasound data and real-time spatial orientation information of the probe. The real-time ultrasound data may be two-dimensional or three-dimensional ultrasound data obtained by scanning the tissue by the probe, or other suitable real-time data representing the tissue.” [0035]);
determining a current intervention starting point, and determining a target intervention region and a non-intervention region in the ultrasound image (“In step S12, a planning image of ultrasound-guided intervention may be generated based on the obtained data and displayed. The planning image may include a probe marker for planning, an ultrasound image and an area of tissue to be ablated. The planning image may at least represent the relative spatial position relationship between the probe marker for planning, the ultrasound image and the area of tissue to be ablated.” [0036], “in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0059], “the needle insertion path may be shown by a solid line, a dashed line or a line with an arrow, etc. in a certain color. By the needle insertion path on the planning image, the user can clearly observe the organs and tissues to be punctured by the ablation needle when the ablation needle is inserted along the needle insertion path. Therefore, the accidental injury to important organs and blood vessels and the influence of ribs to the needle insertion path can be avoided during the planning of the needle insertion path. The predicted ablation area may simulate the predicted ablation range under the set needle insertion path and the set ablation parameter.” [0051]);
and determining a target intervention path that intersects the target intervention region and that does not intersect the non-intervention region (“the needle insertion path may be shown by a solid line, a dashed line or a line with an arrow, etc. in a certain color. By the needle insertion path on the planning image, the user can clearly observe the organs and tissues to be punctured by the ablation needle when the ablation needle is inserted along the needle insertion path. Therefore, the accidental injury to important organs and blood vessels and the influence of ribs to the needle insertion path can be avoided during the planning of the needle insertion path. The predicted ablation area may simulate the predicted ablation range under the set needle insertion path and the set ablation parameter.” [0051]);
and based on the current position and the target intervention path, generating and display movement guidance for moving the probe, the movement guidance being configured to guide the probe to move such that the current position and the target intervention path coincide (“in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0059], “, in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0065]).
Zhang does not specifically disclose determining a current intervention path that intersects the target intervention region and the current intervention starting point.
However, in a similar field of endeavor, Shochat teaches a method of planning an image-guided interventional procedure to be performed on a patient [Abstract].
Shochat also teaches determining a current intervention path that intersects the target intervention region and the current intervention starting point (“the described method implementations are not limited to the use of CT scans, and they can be implemented using images generated by other imaging systems, such as an X-ray fluoroscopic system, an ultrasonic system, or an MRI system.” [0012], “One exemplary implementation involves a method of planning an image-guided interventional procedure in a region of interest of a subject, comprising: (a) obtaining a plurality of time-separated images of the region of interest, (b) defining on a first image of the plurality of images, an entry point, a target point and one or more regions into which entry by the interventional procedure is forbidden, (c) calculating a trajectory for the interventional procedure between the entry point and the target point, which avoids entry into any of the one or more forbidden regions, (d) selecting a second image of the plurality of images generated at a time different from that at which the first of the plurality of images was generated, (e) determining changes in the position of the entry point, target point and any regions into which entry by the interventional procedure is forbidden in the second image of the plurality of images, and (f) repeating step (c) on the second image of the plurality of images based on the changes in position determined in step (e).” [0013])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with determining a current intervention path that intersects the target intervention region and the current intervention starting point as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 14, Zhang discloses a non-transitory computer-readable medium, the non-transitory computer-readable medium having a computer program stored therein, the computer program having at least one code segment, and the at least one code segment being executable by a machine, to cause the machine to execute the steps of: (“A display method and system for ultrasound-guided intervention.” [Abstract], “Those skilled in the art can understand that all or part of the functions of the various methods in the embodiments described above may be implemented by hardware, or by a computer program.” [0078]):
a probe, the probe transmitting an ultrasound beam to tissue to be imaged, and receiving an echo signal (“a display method for ultrasound-guided intervention is provided, which may include: obtaining a data, where the data includes at least a real-time ultrasound data and a real-time spatial orientation information of a probe” [0009]);
a processor configured to: acquire a real-time ultrasound image related to a tissue to be imaged (“In step S10, data may be obtained. The data may at least include real-time ultrasound data and real-time spatial orientation information of the probe. The real-time ultrasound data may be two-dimensional or three-dimensional ultrasound data obtained by scanning the tissue by the probe, or other suitable real-time data representing the tissue.” [0035]);
determining a current intervention starting point, and determining a target intervention region and a non-intervention region in the ultrasound image (“In step S12, a planning image of ultrasound-guided intervention may be generated based on the obtained data and displayed. The planning image may include a probe marker for planning, an ultrasound image and an area of tissue to be ablated. The planning image may at least represent the relative spatial position relationship between the probe marker for planning, the ultrasound image and the area of tissue to be ablated.” [0036], “in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0059], “the needle insertion path may be shown by a solid line, a dashed line or a line with an arrow, etc. in a certain color. By the needle insertion path on the planning image, the user can clearly observe the organs and tissues to be punctured by the ablation needle when the ablation needle is inserted along the needle insertion path. Therefore, the accidental injury to important organs and blood vessels and the influence of ribs to the needle insertion path can be avoided during the planning of the needle insertion path. The predicted ablation area may simulate the predicted ablation range under the set needle insertion path and the set ablation parameter.” [0051]);
and determining a target intervention path based on the target intervention region and the non-intervention region (“the needle insertion path may be shown by a solid line, a dashed line or a line with an arrow, etc. in a certain color. By the needle insertion path on the planning image, the user can clearly observe the organs and tissues to be punctured by the ablation needle when the ablation needle is inserted along the needle insertion path. Therefore, the accidental injury to important organs and blood vessels and the influence of ribs to the needle insertion path can be avoided during the planning of the needle insertion path. The predicted ablation area may simulate the predicted ablation range under the set needle insertion path and the set ablation parameter.” [0051]);
and based on the current position and the target intervention path, generating and displaying movement guidance related to the probe, the movement guidance being configured to guide the probe to move such that the current position and the target intervention path coincide (“in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0059], “, in order to make it easier for the user to move the probe to make the probe marker for guiding to be coincided with the probe marker for planning, the probe marker (including the probe marker for guiding and the probe marker for planning) in the guiding image may be generated and displayed in a form that can indicate one or more sides of the probe such that the orientation of the probe marker for guiding determined and updated according to the real-time spatial orientation information of the probe represents the orientation of the probe, so as to assist the user to coincide the probe marker for guiding with the probe marker for planning by moving the probe to cause the orientation of the probe marker for guiding to be same with the orientation of the probe marker for planning.” [0065]).
Zhang does not specifically disclose determining a current intervention path based on the target intervention region and the current intervention starting point.
However, in a similar field of endeavor, Shochat teaches a method of planning an image-guided interventional procedure to be performed on a patient [Abstract].
Shochat also teaches determining a current intervention path based on the target intervention region and the current intervention starting point (“the described method implementations are not limited to the use of CT scans, and they can be implemented using images generated by other imaging systems, such as an X-ray fluoroscopic system, an ultrasonic system, or an MRI system.” [0012], “One exemplary implementation involves a method of planning an image-guided interventional procedure in a region of interest of a subject, comprising: (a) obtaining a plurality of time-separated images of the region of interest, (b) defining on a first image of the plurality of images, an entry point, a target point and one or more regions into which entry by the interventional procedure is forbidden, (c) calculating a trajectory for the interventional procedure between the entry point and the target point, which avoids entry into any of the one or more forbidden regions, (d) selecting a second image of the plurality of images generated at a time different from that at which the first of the plurality of images was generated, (e) determining changes in the position of the entry point, target point and any regions into which entry by the interventional procedure is forbidden in the second image of the plurality of images, and (f) repeating step (c) on the second image of the plurality of images based on the changes in position determined in step (e).” [0013])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with a current intervention path based on the target intervention region and the current intervention starting point as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 16, Zhang discloses the current intervention starting point moves in real time with the movement of the probe, and during said movement, the relative positions of the current intervention starting point and the probe remain unchanged (“During the user moving the probe 21 to make the probe marker for guiding to coincide with the probe marker for planning, the spatial position of the probe marker for guiding will change due to the movement of the probe 21. Therefore, the probe marker for guiding and the probe marker for planning can be distinguished.“ [0074]).
Regarding Claim 17, Zhang discloses further comprising: displaying the target intervention path in real time during the movement of the probe (“During the user moving the probe 21 to make the probe marker for guiding to coincide with the probe marker for planning, the spatial position of the probe marker for guiding will change due to the movement of the probe 21. Therefore, the probe marker for guiding and the probe marker for planning can be distinguished.“ [0074]).
Zhang does not specifically disclose displaying the current intervention path in real time.
However, in a similar field of endeavor, Shochat teaches displaying the current intervention path in real time (“The system may include at least one processor 61 for determining changes in the positions of the entry point, target point and any obstacles therebetween, using object tracking methods of image processing. The at least one processor 61 may be further adapted to calculate needle trajectories, and in some implementations, to analyze the calculated trajectories and compare them to one another... The system may further include a display/screen 63 for displaying, inter alia, the obtained images and the calculated trajectories.” [0070])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with displaying the current intervention path in real time as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 18, Zhang discloses all limitations noted above except that the current intervention path is a line connecting a point in the target intervention region to the current intervention starting point.
However, in a similar field of endeavor, Shochat teaches the current intervention path is a line connecting a point in the target intervention region to the current intervention starting point (“the doctor may use the CT image shown in FIG. 1A in order to mark the obstacle 12 and the target 13 and choose an entry point 11, which enables a substantially linear trajectory 100 from the entry point 11 to the target 13, while avoiding the obstacle 12.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with the current intervention path is a line connecting a point in the target intervention region to the current intervention starting point as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 19, Zhang discloses all limitations noted above except that the target intervention path passes through a point of the target intervention region and does not pass through the non-intervention region.
However, in a similar field of endeavor, Shochat teaches the target intervention path passes through a point of the target intervention region and does not pass through the non-intervention region (“the doctor may use the CT image shown in FIG. 1A in order to mark the obstacle 12 and the target 13 and choose an entry point 11, which enables a substantially linear trajectory 100 from the entry point 11 to the target 13, while avoiding the obstacle 12.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with the target intervention path passes through a point of the target intervention region and does not pass through the non-intervention region as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Regarding Claim 20, Zhang discloses further comprising: simultaneously displaying a target intervention starting point and the current intervention starting point in real time during the movement of the probe (“During the user moving the probe 21 to make the probe marker for guiding to coincide with the probe marker for planning, the spatial position of the probe marker for guiding will change due to the movement of the probe 21. Therefore, the probe marker for guiding and the probe marker for planning can be distinguished.“ [0074]);
Zhang does not specifically disclose the target intervention starting point is an intersection point of the target intervention path and the upper edge of the ultrasound image; and/or simultaneously displaying the current intervention path and the target intervention path in real time during the movement of the prob.
However, in a similar field of endeavor, Shochat teaches the target intervention starting point is an intersection point of the target intervention path and the upper edge of the ultrasound image; and/or simultaneously displaying the current intervention path and the target intervention path in real time during the movement of the prob (“The system may include at least one processor 61 for determining changes in the positions of the entry point, target point and any obstacles therebetween, using object tracking methods of image processing. The at least one processor 61 may be further adapted to calculate needle trajectories, and in some implementations, to analyze the calculated trajectories and compare them to one another... The system may further include a display/screen 63 for displaying, inter alia, the obtained images and the calculated trajectories.” [0070])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang as outlined above with the target intervention starting point is an intersection point of the target intervention path and the upper edge of the ultrasound image; and/or simultaneously displaying the current intervention path and the target intervention path in real time during the movement of the prob as taught by Shochat, because it prevents withdrawing the needle and restarting the insertion procedure or even the trajectory planning process [0041].
Claims 2 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Shochat as applied to Claim 1 above, and further in view of Sauer et al (US20030120155A1; hereinafter referred to as Sauer)
Regarding Claim 2, Zhang in view of Shochat discloses all limitations noted above except that the current intervention starting point is configured to be close to a side edge of the probe and located at an upper edge of the ultrasound image.
However, in a similar field of endeavor, Sauer teaches a method for video assistance for ultrasound guided needle biopsy of a patient [Abstract].
Sauer also teaches that the current intervention starting point is configured to be close to a side edge of the probe and located at an upper edge of the ultrasound image (“the procedure is performed “in-plane”, that is, the ultrasound imaging is performed in a plane. In accordance with known procedures, with the ultrasound transducer being in a position where the target is visible in the image, the insertion point of the needle is chosen on the intersection of the ultrasound plane and the patient's skin surface. The needle is oriented so that it lies in this plane and points towards the target. When the needle is now inserted, it will appear in the ultrasound image, and the progress along its path towards the target can be monitored.” [0014], “The camera provides the user with an image of a “bird's eye view” of the transducer head and the region on the patient where the needle will be inserted. Graphical markers in the image tell the user the location of the ultrasound transducer plane. Accordingly, the user can easily choose a needle entry point that lies in the ultrasound imaging plane and can further align the whole needle to lic in this plane, by aligning the needle as seen in the video image with the markers overlaid onto the video image. During needle insertion, the correct “in-plane” needle alignment can be monitored on the video image.” [0025])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang in view of Shochat as outlined above with the current intervention starting point is configured to be close to a side edge of the probe and located at an upper edge of the ultrasound image as taught by Sauer, because it allows for the correct needle alignment to be monitored on the video image [0025].
Regarding Claim 15, Zhang in view of Shochat discloses all limitations noted above except that the current intervention starting point is configured to be close to a side edge of the probe and located at an upper edge of the ultrasound image.
However, in a similar field of endeavor, Sauer teaches a method for video assistance for ultrasound guided needle biopsy of a patient [Abstract].
Sauer also teaches that the current intervention starting point is configured to be close to a side edge of the probe and located at an upper edge of the ultrasound image (“the procedure is performed “in-plane”, that is, the ultrasound imaging is performed in a plane. In accordance with known procedures, with the ultrasound transducer being in a position where the target is visible in the image, the insertion point of the needle is chosen on the intersection of the ultrasound plane and the patient's skin surface. The needle is oriented so that it lies in this plane and points towards the target. When the needle is now inserted, it will appear in the ultrasound image, and the progress along its path towards the target can be monitored.” [0014], “The camera provides the user with an image of a “bird's eye view” of the transducer head and the region on the patient where the needle will be inserted. Graphical markers in the image tell the user the location of the ultrasound transducer plane. Accordingly, the user can easily choose a needle entry point that lies in the ultrasound imaging plane and can further align the whole needle to lic in this plane, by aligning the needle as seen in the video image with the markers overlaid onto the video image. During needle insertion, the correct “in-plane” needle alignment can be monitored on the video image.” [0025])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang in view of Shochat as outlined above with the current intervention starting point is configured to be close to a side edge of the probe and located at an upper edge of the ultrasound image as taught by Sauer, because it allows for the correct needle alignment to be monitored on the video image [0025].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Shochat as applied to Claim 1 above, and further in view of Pelissier et al (US20160199023A1; hereinafter referred to as Pelissier)
Regarding Claim 8, Zhang in view of Shochat discloses all limitations noted above except that further comprising: controlling an ultrasound beam transmitted by the probe, causing the ultrasound beam to deflect in a direction perpendicular to the target intervention path.
However, in a similar field of endeavor, Pelissier teaches an ultrasound imaging apparatus that includes a transducer array that transmits an ultrasound beam into an examination field of view [0001].
Pelissier also teaches that further comprising: controlling an ultrasound beam transmitted by the probe, causing the ultrasound beam to deflect in a direction perpendicular to the target intervention path (“A beam angle determiner 144 determines a beam steering angle for the transmitted beam based on the mode. For example, when operating in the E mode 128, the beam steering angle is set to zero, with respect the axis 304, which is perpendicular to transducer array 118, or other, non-zero, beam steering angle determined based on the subject or object 110. However, when operating in the BS mode 130, the beam steering angle is determined based on the predicted location and orientation of the needle 106 with respect to the transducer array 118.” [0040], “For example, in the latter instance, the beam steering angle can be set so that the beam is perpendicular or approximately perpendicular to the long axis 114 of the needle 106 and hence the needle shaft 103. Generally, the needle 106 reflects an ultrasound beam traversing at an angle closer to 90 degrees to the shaft in a manner in which the needle 106 is clearer in the generated image relative to angle less than 90 degrees. However, angles of less than 90 degrees, but around 90 degrees, are contemplated herein and may facilitate mitigating reverberation noise.” [0041])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang in view of Shochat as outlined above with the current intervention starting point is configured to be close to a side edge of the probe and located at an upper edge of the ultrasound image as taught by Pelissier, because it may facilitate mitigating reverberation noise [0041].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Shochat as applied to Claim 1 above, and further in view of St. Pierre et al (US20210100626A1; hereinafter referred to as St. Pierre)
Regarding Claim 9, Zhang in view of Shochat discloses all limitations noted above except that further comprising: identifying an interventional object in the ultrasound image; generating and displaying an intervention process guide based on a positional relationship between the identified interventional object and the target intervention region.
However, in a similar field of endeavor, St. Pierre teaches methods and systems providing guidance for operation of a biopsy needle based on ultrasonic imaging [Abstract].
St. Pierre also teaches further comprising: identifying an interventional object in the ultrasound image; generating and displaying an intervention process guide based on a positional relationship between the identified interventional object and the target intervention region (“Accordingly, based on the distinguishing shape and material of the biopsy needle 224, image analysis techniques may more easily identify the biopsy needle within the ultrasound image 201. The image analysis techniques may also be based on machine learning techniques, such as neural networks, deep learning algorithms, statistical analysis techniques, enhanced contrast techniques, or other pattern recognition or matching techniques that are trained based on the shape of the biopsy needle.” [0046],” The biopsy needle prediction indicators include a trajectory indicator 202, a tip indicator 204, a deflection probability indicator 206, aperture indicators 208, and a maximum needle depth indicator 210. The trajectory indicator 202 indicates the trajectory of the biopsy needle 224. For instance, if the biopsy needle 224 was fired in its current position in the ultrasound image 201, the throw portion of the biopsy needle 224 is predicted to follow the line of the trajectory indicator 202.” [0050])
It would have been obvious to an ordinary skilled person in the art before the effective filing date of the claimed invention to modify the system of Zhang in view of Shochat as outlined above with further comprising: identifying an interventional object in the ultrasound image; generating and displaying an intervention process guide based on a positional relationship between the identified interventional object and the target intervention region as taught by St. Pierre, because it may facilitate mitigating reverberation noise [0041].
Claims 10 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Shochat and further in view of St. Pierre as applied to Claim 9, and further in view of Mewes et al (A. Mewes, F. Heinrich, B. Hensen, F. Wacker, K. Lawonn, and C. Hansen, “Concepts for augmented reality visualisation to support needle guidance inside the MRI,” Healthcare Technology Letters, vol. 5, no. 5, pp. 172–176, Oct. 2018; hereinafter referred to as Mewes)
Regarding Claim 10, Zhang in view of Shochat and further in view of St. Pierre discloses all limitations noted above except that information displayed in the intervention process guide comprises: an endpoint of the interventional object, and a minimum distance and a maximum distance from the target intervention region to the current intervention starting point; and the intervention process guide is displayed independently of the ultrasound image.
However, in a similar field of endeavor, Mewes teaches visualization concepts for needle navigation aids [Abstract].
Mewes also teaches information displayed in the intervention process guide comprises: an endpoint of the interventional object, and a minimum distance and a maximum distance from the target intervention region to the current intervention starting point; and the intervention process guide is displayed independently of the ultrasound image (“Supporting needle guidance during image-guided interventions is a widely discussed topic. Separating the needle insertion task into three subtasks (tip positioning, needle alignment, needle insertion) and applying a cross-hair visualisation for needle positioning/alignment as well as a progress bar indicating the needle depth has been proposed [11, 12] and is nowadays implemented in many commercial navigation systems. [Introduction], “Visualisation of 2D explicit navigation aids. The visualisation contains the needle-surface intersection (red dot), the planned insertion point (orange/green circle with white borders), an arrow for needle alignment (red/yellow arrow) and a depth progress bar (red bar with white borders). After rendering, the visualisation is projected on the patient. Left: Needle is positioned next to the planned insertion point. Middle: Needle is positioned as planned (insertion point got smaller and green) and almost correctly aligned ( <1∘; arrow turned yellow). Right: Needle is positioned and aligned as planned (arrow turned into a green sphere) and has already been inserted into the body” [Fig. 3]).
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It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang in view of Shochat and further in view of St. Pierre as outlined above with information displayed in the intervention process guide comprises: an endpoint of the interventional object, and a minimum distance and a maximum distance from the target intervention region to the current intervention starting point; and the intervention process guide is displayed independently of the ultrasound image as taught by Mewes, because it allows for appropriate instrument guidance which is essential to simplify and shorten the intervention [Introduction].
Regarding Claim 12, Zhang in view of Shochat and further in view of St. Pierre discloses all limitations noted above except that the endpoint of the interventional object, the minimum distance, and the maximum distance are displayed in a same linear direction.
However, in a similar field of endeavor, Mewes the endpoint of the interventional object, the minimum distance, and the maximum distance are displayed in a same linear direction (“Supporting needle guidance during image-guided interventions is a widely discussed topic. Separating the needle insertion task into three subtasks (tip positioning, needle alignment, needle insertion) and applying a cross-hair visualisation for needle positioning/alignment as well as a progress bar indicating the needle depth has been proposed [11, 12] and is nowadays implemented in many commercial navigation systems. [Introduction], “Visualisation of 2D explicit navigation aids. The visualisation contains the needle-surface intersection (red dot), the planned insertion point (orange/green circle with white borders), an arrow for needle alignment (red/yellow arrow) and a depth progress bar (red bar with white borders). After rendering, the visualisation is projected on the patient. Left: Needle is positioned next to the planned insertion point. Middle: Needle is positioned as planned (insertion point got smaller and green) and almost correctly aligned ( <1∘; arrow turned yellow). Right: Needle is positioned and aligned as planned (arrow turned into a green sphere) and has already been inserted into the body” [Fig. 3]).
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It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Zhang in view of Shochat and further in view of St. Pierre as outlined above with the endpoint of the interventional object, the minimum distance, and the maximum distance are displayed in a same linear direction as taught by Mewes, because it allows for appropriate instrument guidance which is essential to simplify and shorten the intervention [Introduction].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure (US 20240350208 A1; US 20240050061 A1; US 20210161612 A1; US 20220061803 A1).
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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