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 Amendment
The proposed reply filed on 06/15/2026 has been entered. Claims 1 and 3-21 remain pending in the current application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 3-5, 16-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al. (US 2024/0341891) in the view of Lazebnik et al. (US 2011/0125022) and Smith et al. (US 2010/0262013).
Regarding claim 1, Helm teaches an ultrasound system comprising (fig. 7, para. 0110):
one or more ultrasound scanners configured to generate ultrasound data based on received reflections of ultrasound signals transmitted by the one or more ultrasound scanners at a patient anatomy during a first ultrasound scan (fig. 7, element 400, paras. 0111-0112; the ultrasound probe 400 may be used to collect image data of the subject 30, such as with the ultrasound waves. The ultrasound probe 400, therefore, may be moved relative to the subject 32 to acquire image data of the subject 30. Briefly, again, the ultrasound probe 400 may include a transducer, a transmitter, and/or a receiver.);
one or more robotic manipulators configured to couple to the one or more ultrasound scanners, the one or more robotic manipulators configured to control positioning, movement, and operation of the one or more ultrasound scanners in accordance with a coordinate system (fig. 7, element 20, paras. 0111-0112 and 0131-0132; The ultrasound probe 400 may further include other portions, such as a portion to connect to the end effector 44 and/or to connect to the robotic system 20. Generally, the robotic system 20 may be moved or operated by the user 72 and/or by executing selected instructions, such as with a processor assembly including the processor assembly 102 and/or robotic processor assembly 410. A memory portion may also be provided with the robotic assembly 20 from which instructions may be recalled and/or allowing for communication with other systems. As discussed above, the ultrasound probe 400 may be used to collect image data of the subject 30, such as with the ultrasound waves. The ultrasound probe 400, therefore, may be moved relative to the subject 32 to acquire image data of the subject 30. The robotic assembly 20 may move the ultrasound probe 400 based upon input instructions from the user 72, substantially automatically based upon a predetermined imaging path and/or based upon a determination of a portion to be imaged of the subject, and/or combinations thereof. In addition to the robotic arm 20 physically moving the US probe 400 and/or the contact surface 404, various beam shaping or steering techniques may be used to move the area being imaged with the US probe 400. In beam forming or beam steering, various ultrasound transducer arrays may be used to generate selected beam portions, such as beam shapes or beam parameters. Selected portions of the array may be energized separately or simultaneously to generate different beam configurations and/or angles relative to a fixed position of the ultrasound probe 400. The examiner notes that in addition to the robotic arm controlling the movement and the position of the ultrasound probe, it can perform beam forming and beam steering by generating different beam parameters, therefore controlling the operation of the ultrasound probe.);
a processor system configured to (para. 0112):
receive the ultrasound data from the one or more ultrasound scanners (para. 0125; The process 430 may then acquire image data in a first position in Block 438. The image data may be acquired relative to the subject in any appropriate position. The ultrasound probe 400 may be moved by the robotic system 20 to a selected location, positioned manually by the user 72, or in another appropriate manner including combinations thereof. The image data may be acquired of the subject 30 in any appropriate manner. After acquiring image data, or at any appropriate time, a recall or selection of an image to be generated may be made in Block 442.);
generate registration data based on the ultrasound data (para. 0116; Therefore, the position of the ultrasound probe 400, and the image data collected there with, may be known or determined relative to the subject 30. This allows the image data to be registered relative to the subject 30. The examiner notes that image data is registered relative to the subject.); and
generate, based on the ultrasound data, scan instructions to configure the one or more ultrasound scanners for an imaging mode for a second ultrasound scan (paras. 0129-1032; The system may determine further portions that required additional image data and may move the robotic system 20 accordingly to move the US probe 400 to acquire additional image data. In addition to the robotic arm 20 physically moving the US probe 400 and/or the contact surface 404, various beam shaping or steering techniques may be used to move the area being imaged with the US probe 400. In beam forming or beam steering, various ultrasound transducer arrays may be used to generate selected beam portions, such as beam shapes or beam parameters. Selected portions of the array may be energized separately or simultaneously to generate different beam configurations and/or angles relative to a fixed position of the ultrasound probe 400. The examiner notes that after receiving the first image data, the processor determines if additional images are required. If additional images are required, the robotic system controls the movement and the operation of the ultrasound probe to acquire additional image); and
a position controller configured to generate movement instructions for the one or more robotic manipulators based on the registration data, the movement instructions configured to cause the one or more robotic manipulators to move to one or more locations in the coordinate system to enable the one or more ultrasound scanners to perform the second ultrasound scan at the one or more locations in accordance with the imaging mode to generate additional ultrasound data (paras.0129-0130; The system may determine further portions that required additional image data and may move the robotic system 20 accordingly to move the US probe 400 to acquire additional image data. For example, if a heart is selected to be imaged a first image may be segmented and a portion of the heart (e.g., an inferior portion of a right atrium) may be identified. The robotic system 20 may then move the US probe 400 in a manner based on known anatomy (e.g., an atlas of the heart) to acquire image data of additional portions of the heart (e.g., a superior portion of the right atrium).).
However, Helm fails to explicitly teach one or more ultrasound scanners including a multi-array transducer having at least a first array adjacent to a second array; and generate, based on the ultrasound data, scan instructions to configure the multi-array transducer for an imaging mode of a plurality of imaging modes for a second ultrasound scan, the scan instructions configuring the imaging mode to operate the multi-array transducer as a separated aperture with second ultrasound signals transmitted by the first array and reflections of the second ultrasound signals received by the second array.
Lazebnik, in the same field of endeavor, teaches the one or more ultrasound scanners include a multi-array transducer having a first array and a second array (paras. 0021-0022; system 10 for synchronizing multi-directional ultrasound scanning. The system 10 includes two or more transducers 12, 16, location devices 14, an ultrasound imaging system 18, a processor 20, a memory 22, and a display 24. The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements.); and generate, based on the ultrasound data, scan instructions to configure the multi-array transducer for an imaging mode of a plurality of imaging modes for a second ultrasound scan (paras. 0021-0022 and 0075; system 10 for synchronizing multi-directional ultrasound scanning. The system 10 includes two or more transducers 12, 16, location devices 14, an ultrasound imaging system 18, a processor 20, a memory 22, and a display 24. The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements. The transducers may be configured to scan an identical or different sized FOV. Each transducer's imaging parameters (frequency, depth, and others) may also be identical or different from other transducers. The scanning may be for B-mode, color flow mode, tissue harmonic mode, contrast agent mode or other now known or later developed ultrasound imaging modes. Combinations of modes may be used, such as scanning for B-mode and Doppler mode data. Any ultrasound scan format may be used, such as a linear, sector, or Vector.RTM.. Using beamforming or other processes, data representing the scanned region is acquired. The examiner notes that each array of the multi array scanner can be controlled to operate in different mode to acquire images.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner. This modification will help in improving contrast and spatial resolution by imaging multiple subregions using multiple arrays. Additionally, using multiple arrays will reduce shadow artifacts when a given transducer may not adequately visualize a subvolume within the transducer's field of view, another transducer at a different orientation may visualize the same structure more effectively as disclosed within Lazebnik in paras. 0015-0016.
However, Helm in the view of Lazebnik fail to explicitly teach scan instructions configuring the imaging mode to operate the multi-array transducer as a separated aperture with second ultrasound signals transmitted by the first array and reflections of the second ultrasound signals received by the second array.
Smith, in the same field of endeavor, teaches scan instructions configuring the imaging mode to operate the multi-array transducer as a separated aperture with second ultrasound signals transmitted by the first array and reflections of the second ultrasound signals received by the second array (paras. 0083-0085; the Multiple Aperture Ultrasound Imaging System (MAUI Electronics) 640 used with the probe is a stand-alone system with its own on-board transmitter (i.e., no host ultrasound system is used). This system may use any element on any transducer 610, 620, or 630 for transmit or receive. The angulation of the outboard arrays 610 and 630 is illustrated as angle .DELTA. 660. This angle can be varied to achieve optimum beamforming for different depths or fields of view. FIG. 6b shows elements on the left array 610 transmitting, and elements on the right array 620 receiving. Using one transducer for transmit only has advantages with regard to a lack of distortion due to variation in fat layer. In a standalone system, transmit and/or receive elements can be mixed in both or all three apertures. The examiner notes that the controller (MAUI electronics) controls the multi-array probe to configure one array as a transmit array and the other as a receive array. For example, fig. 6b, array 620 is controlled to operate as a transmit probe and array 610 is controlled to receive the reflected data.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm in the view of Lazebnik to incorporate the transmit/receive control arrangement teachings of Smith. This modification will improve image quality and resolution as it helps to get more energy to the targets closer to each aperture while still enjoying the full benefit of the wide aperture and also facilitating imaging around anatomical structures that may otherwise degrade or obstruct ultrasound imaging as disclosed within Smith in paras. 0031-0033 and 0088.
Regarding claim 3, Helm teaches the ultrasound system of claim 1, wherein: the movement instructions are configured to cause the one or more robotic manipulators to move to the one or more locations in the coordinate system (paras. 0129-0130; The movement of the US probe 400 with the robotic system may be substantially automatic. For example, the robotic system 20 may be tracked relative to the subject to allow a pose of the US probe 400 to be known based on tracking the subject 30 and the robotic system 20. The US probe 400 may be automatically moved to the pose.); and the scan instructions configure the ultrasound scanner for the imaging mode (paras. 0131-0132; In addition to the robotic arm 20 physically moving the US probe 400 and/or the contact surface 404, various beam shaping or steering techniques may be used to move the area being imaged with the US probe 400. In beam forming or beam steering, various ultrasound transducer arrays may be used to generate selected beam portions, such as beam shapes or beam parameters.).
However, Helm fails to explicitly teach a multiarray scanner comprising a first array and a second array and scan instructions for configuring the second array for the imaging mode.
Lazebnik, in the same field of endeavor, teaches the one or more ultrasound scanners include a multi-array ultrasound scanner having a first array and a second array and scan instructions for configuring the second array for the imaging mode (paras. 0021-0022; system 10 for synchronizing multi-directional ultrasound scanning. The system 10 includes two or more transducers 12, 16, location devices 14, an ultrasound imaging system 18, a processor 20, a memory 22, and a display 24. The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements. The transducers may be configured to scan an identical or different sized FOV. Each transducer's imaging parameters (frequency, depth, and others) may also be identical or different from other transducers).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner. This modification will help in improving contrast and spatial resolution by imaging multiple subregions using multiple arrays. Additionally, using multiple arrays will reduce shadow artifacts when a given transducer may not adequately visualize a subvolume within the transducer's field of view, another transducer at a different orientation may visualize the same structure more effectively as disclosed within Lazebnik in paras. 0015-0016.
Regarding claim 4, Helm teaches the ultrasound system of claim 1, further comprising a motion-compensation system configured to compensate for motion of the patient anatomy to enable the one or more robotic manipulators to dynamically adjust for the motion, the motion determined based on (para. 0156; The process 500 may continue with an estimation of a movement of the selected portion, such as based upon the subject motion, instrument motion relative to the portion, or other features. For example, the image data may illustrate that the selected portion is being acted upon via an instrument, such as for resection, implantation, or the like. A possible or average motion may be used to estimate a movement of the portion. Further the system may recall predetermined or known motion relative to a portion of the subject, such as due to a beating of the heart, to estimate a motion of the selected portion. Therefore, the system in the process 500 may estimate a movement of the portion in Block 606):
positional differences of the patient anatomy over a set of ultrasound images generated from the ultrasound data using the ultrasound scanner over a duration of time (paras. 0155-0156; Therefore, as discussed above, the ultrasound probe 400 may collect image data substantially in real time and continuously. Therefore, the image 108b may be the image that is last collected with the ultrasound probe 400. For example, the ultrasound probe 400 may collect image data at about 30 frames per second. Therefore, the image 108b is the last image frame collected with the ultrasound probe 400. Again, following the display of the image of Block 614, the process 500 may continue to the estimate movement of the portion in Block 606. The examiner notes that the movement of the anatomical portion of the patient is estimated using image data generated over a duration of time and using a prediction of the next movement of the anatomical portion);
a prediction of a next position of the patient anatomy relative to a current position of the patient anatomy, wherein the prediction is generated based on the positional differences of the patient anatomy determined from the set of ultrasound images (para. 0156; The process 500 may continue with an estimation of a movement of the selected portion, such as based upon the subject motion, instrument motion relative to the portion, or other features. For example, the image data may illustrate that the selected portion is being acted upon via an instrument, such as for resection, implantation, or the like. A possible or average motion may be used to estimate a movement of the portion. Further the system may recall predetermined or known motion relative to a portion of the subject, such as due to a beating of the heart, to estimate a motion of the selected portion. Therefore, the system in the process 500 may estimate a movement of the portion in Block 606.); and
an offset representing the prediction, wherein the offset is included in the registration data to enable the movement instructions generated from the registration data to cause the one or more robotic manipulators to dynamically adjust for the motion when operating the one or more scanners to generate the additional ultrasound data using the ultrasound scanner (paras. 0154-0158 and 0167; Following the estimated movement of the portion, an unlock command received determination may be made in Block 610. If an unlock command is received, a YES path may be followed in Block 615. If the imaging system, including the ultrasound probe 400, is commanded to not lock onto any particular image portion and may be moved and/or maintain a selected position. The command to move the imager may include moving the imager in any appropriate manner and to move the imager, including the US probe 400, to maintain the selected image based upon the estimated movement of the portion from block 606. The move command may include a movement of the robotic system 20 in a selected three-dimensional space location and/or three-dimensional orientation for movement of the imaging system 400. The movement command may include a selected movement in any appropriate axis and/or orientation to position the imaging system, including the ultrasound probe 400, relative to the subject 30 to maintain the imaging of the selected portion. After the move command is made, the imaging system may be moved and an acquisition of image data at a subsequent position may be made in Block 552. The movement in block 552 may include beam steering and/or forming as discussed above. Therefore, the process 500 may loop or iterate to maintain acquisition of image data of a selected portion of the subject, such as the locked on feature in the subject 30. It is understood, however, that the coordinate system of the robotic system 20 that holds the ultrasound probe 400 may be registered or coordinated with any other appropriate coordinate space to allow the command to move the robotic system 20 to move the ultrasound probe 400 to any appropriate pose. The examiner notes based on estimated movement of the anatomical portion a command to move the robotic arm to adjust the position of the movement is initiated to compensate for the motion of the patient anatomy.).
However, Helm fails to explicitly teach the one or more ultrasound scanners include a multi-array transducer having a first array and a second array.
Lazebnik, in the same field of endeavor, teaches the one or more ultrasound scanners include a multi-array transducer having a first array and a second array (paras. 0021-0022; system 10 for synchronizing multi-directional ultrasound scanning. The system 10 includes two or more transducers 12, 16, location devices 14, an ultrasound imaging system 18, a processor 20, a memory 22, and a display 24. The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements. The transducers may be configured to scan an identical or different sized FOV. Each transducer's imaging parameters (frequency, depth, and others) may also be identical or different from other transducers).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner. This modification will help in improving contrast and spatial resolution by imaging multiple subregions using multiple arrays. Additionally, using multiple arrays will reduce shadow artifacts when a given transducer may not adequately visualize a subvolume within the transducer's field of view, another transducer at a different orientation may visualize the same structure more effectively as disclosed within Lazebnik in paras. 0015-0016.
Regarding claim 5, Helm teaches the ultrasound system of claim 1, wherein the position controller is configured to receive pre-tune data usable to generate initial movement instructions for the one or more robotic manipulators, the initial movement instructions configured to cause the one or more robotic manipulators to begin an ultrasound scan without explicit positional instructions provided by a clinician or derived from a current use of the ultrasound system (paras. 0112 and 0143-0144; The robotic assembly 20 may move the ultrasound probe 400 based upon input instructions from the user 72, substantially automatically based upon a predetermined imaging path and/or based upon a determination of a portion to be imaged of the subject, and/or combinations thereof. The image controller 96 may include a processor and may process image data from any appropriate imaging system, such as the imaging system 80, or the imaging system including the ultrasound probe 400. Accordingly, acquisition of image data at a first position may be made in Block 514. The ultrasound probe 400 may be positioned at a first position and orientation relative to the subject 30. For example, the subject 30 may extend along a long axis 516. The ultrasound probe 400 may be positioned by the robotic system 20 along an axis 520. The examiner notes that the robotic arm moves the probe to a first position to acquire images based on pre-acquired images or predefined path.).
Regarding claim 16, Helm teaches a method for repeatable ultrasound using ultrasound scanners, the method comprising (para. 0124):
generating first ultrasound data based on first received reflections of first ultrasound signals transmitted by the ultrasound scanner at a patient anatomy (para. 0125; The process 430 may then acquire image data in a first position in Block 438. The image data may be acquired relative to the subject in any appropriate position. The ultrasound probe 400 may be moved by the robotic system 20 to a selected location, positioned manually by the user 72, or in another appropriate manner including combinations thereof. The image data may be acquired of the subject 30 in any appropriate manner.);
generating registration data based on the first ultrasound data (paras. 0116 and 0126; Therefore, the position of the ultrasound probe 400, and the image data collected there with, may be known or determined relative to the subject 30. This allows the image data to be registered relative to the subject 30.);
generating movement instructions for a robotic manipulator coupled to the ultrasound scanner based on the registration data, the movement instructions configured to cause the robotic manipulator to move to one or more locations in a coordinate system (paras. 0126 and 0128; After segmenting the image, a structure may be identified. The structure in the image data may be identified as the portion or a portion of the subject to be imaged. The structure identified may be used to identify where to move the ultrasound probe 402 to acquire image data to generate image data to generate the selected image of the subject. Based upon the acquisition of the image in Block 438 and the identification of the structure in Block 448 and based upon the recalled portion of the subject for which an image is to be generated in block 442, the robotic system 20 may move the ultrasound probe 400 to a subsequent or second position to acquire subsequent or second image data at block 452.); and
generating second ultrasound data based on second received reflections of second ultrasound signals transmitted by the ultrasound scanner at the patient anatomy in accordance with the one or more locations (paras. 0126 and 0128; After segmenting the image, a structure may be identified. The structure in the image data may be identified as the portion or a portion of the subject to be imaged. The structure identified may be used to identify where to move the ultrasound probe 402 to acquire image data to generate image data to generate the selected image of the subject. Based upon the acquisition of the image in Block 438 and the identification of the structure in Block 448 and based upon the recalled portion of the subject for which an image is to be generated in block 442, the robotic system 20 may move the ultrasound probe 400 to a subsequent or second position to acquire subsequent or second image data at block 452.).
However, Helm fails to explicitly teach multi-array scanners comprising a first and second arrays and generating second ultrasound data by operating the multi-array ultrasound scanner as a separated aperture, the second ultrasound data being based on second received reflections received by a second array of the multi-array ultrasound scanner, the second received reflections corresponding to second ultrasound signals transmitted by the first array of the multi-array ultrasound scanner at the patient anatomy.
Lazebnik, in the same field of endeavor, teaches the one or more ultrasound scanners include a multi-array ultrasound scanner having a first array and a second array (paras. 0021-0022; system 10 for synchronizing multi-directional ultrasound scanning. The system 10 includes two or more transducers 12, 16, location devices 14, an ultrasound imaging system 18, a processor 20, a memory 22, and a display 24. The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements.); the ultrasound data is generated using the first array (paras. 0024 and 0044; Each transducer 12, 16 converts between electrical signals and acoustic energy for scanning a region of the patient body. The region of the body scanned is a function of the type of transducer array and position of the transducer 12 relative to the patient. The imaging system 18 generates an image from the scan data. Beamformation, detection, scan conversion, and/or rendering are used to generate each image. Separate images may be generated for the data from separate transducers 12, 16. The examiner notes that each transducer performs a scan independently of the other and generates a separate ultrasound data); and the additional ultrasound data is generated using the second array (paras. 0024 and 0044; Each transducer 12, 16 converts between electrical signals and acoustic energy for scanning a region of the patient body. The region of the body scanned is a function of the type of transducer array and position of the transducer 12 relative to the patient. The imaging system 18 generates an image from the scan data. Beamformation, detection, scan conversion, and/or rendering are used to generate each image. Separate images may be generated for the data from separate transducers 12, 16. The examiner notes that each transducer performs a scan independently of the other and generates a separate ultrasound data).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner. This modification will help in improving contrast and spatial resolution by imaging multiple subregions using multiple arrays. Additionally, using multiple arrays will reduce shadow artifacts when a given transducer may not adequately visualize a subvolume within the transducer's field of view, another transducer at a different orientation may visualize the same structure more effectively as disclosed within Lazebnik in paras. 0015-0016.
However, Helm in the view of Lazebnik fail to explicitly teach operating the multi-array ultrasound scanner as a separated aperture, the ultrasound data being based on received reflections received by a second array of the multi-array ultrasound scanner, the received reflections corresponding to ultrasound signals transmitted by the first array of the multi-array ultrasound scanner at the patient anatomy.
Smith, in the same field of endeavor, teaches operating the multi-array ultrasound scanner as a separated aperture, the ultrasound data being based on received reflections received by a second array of the multi-array ultrasound scanner, the received reflections corresponding to ultrasound signals transmitted by the first array of the multi-array ultrasound scanner at the patient anatomy (paras. 0083-0085; the Multiple Aperture Ultrasound Imaging System (MAUI Electronics) 640 used with the probe is a stand-alone system with its own on-board transmitter (i.e., no host ultrasound system is used). This system may use any element on any transducer 610, 620, or 630 for transmit or receive. The angulation of the outboard arrays 610 and 630 is illustrated as angle .DELTA. 660. This angle can be varied to achieve optimum beamforming for different depths or fields of view. FIG. 6b shows elements on the left array 610 transmitting, and elements on the right array 620 receiving. Using one transducer for transmit only has advantages with regard to a lack of distortion due to variation in fat layer. In a standalone system, transmit and/or receive elements can be mixed in both or all three apertures. The examiner notes that the controller (MAUI electronics) controls the multi-array probe to configure one array as a transmit array and the other as a receive array. For example, fig. 6b, array 620 is controlled to operate as a transmit probe and array 610 is controlled to receive the reflected data.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm in the view of Lazebnik to incorporate the transmit/receive control arrangement teachings of Smith. This modification will improve image quality and resolution as it helps to get more energy to the targets closer to each aperture while still enjoying the full benefit of the wide aperture and also facilitating imaging around anatomical structures that may otherwise degrade or obstruct ultrasound imaging as disclosed within Smith in paras. 0031-0033 and 0088.
Regarding claim 17, Helm teaches the method of claim 16, further comprising: generating an ultrasound image based on the first ultrasound data, the second ultrasound data, or both the first ultrasound data and the second ultrasound data; and displaying the ultrasound image via a display device (para. 0135; After generating the image in block 464, the image may be output in block 466. Outputting the image in block 466 may include various selected or optional portions, such as saving the image in block 468 and/or or displaying the generated image in block 470.).
Regarding claim 18, Helm teaches the method of claim 16, however, fails to explicitly teach the first ultrasound data and the second ultrasound data are generated at different imaging planes from one another; and the method further comprises generating a three-dimensional image of the patient anatomy based on the first ultrasound data from the first array and the second ultrasound data from the second array.
Lazebnik, in the same field of endeavor, teaches the first ultrasound data and the second ultrasound data are generated at different imaging planes from one another (paras. 0024-0025; Each transducer 12, 16 converts between electrical signals and acoustic energy for scanning a region of the patient body. The planes are spaced apart due to movement of the array. The planes represent a volume of the patient. Different planes may be scanned by moving the array, such as by rotation, rocking, and/or translation.); and the method further comprises generating a three-dimensional image of the patient anatomy based on the first ultrasound data from the first array and the second ultrasound data from the second array (paras. 0044-0045; the image is generated as a rendering of data representing a three-dimensional region. A data set is formed by combining data from two or more transducers. Once volume data is independently acquired by all participating transducers 12, 16, a composite volume is assembled.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner for acquiring images in different planes and generating a three dimensional composite image. This modification will provide an expanded field of view and improve contrast and resolution of the data as disclosed within Lazebnik in paras. 0014-0015.
Regarding claim 19, Helm teaches the method of claim 16, further comprising: generating ultrasound images based on the first ultrasound data (para. 0125; The process 430 may start in start Block 434. The process 430 may then acquire image data in a first position in Block 438. The image data may be acquired relative to the subject in any appropriate position. The ultrasound probe 400 may be moved by the robotic system 20 to a selected location, positioned manually by the user 72, or in another appropriate manner including combinations thereof. The image data may be acquired of the subject 30 in any appropriate manner. After acquiring image data, or at any appropriate time, a recall or selection of an image to be generated may be made in Block 442.); receiving perspective data from a machine-learned model, the perspective data representing a perspective for each of the ultrasound images and including an amount of movement of the perspective from one of the ultrasound images to another one of the ultrasound images (paras. 0147-0158; the examiner notes that the images received are evaluated and segmented using machine learning system. Using the segmented images the system can determine the amount of movement of the segmented portion.); and adjusting the registration data based on the perspective data to compensate for motion of the patient anatomy, the motion of the patient anatomy represented by the amount of movement in the perspective data (paras. 0156-0158; The process 500 may continue with an estimation of a movement of the selected portion, such as based upon the subject motion, instrument motion relative to the portion, or other features. For example, the image data may illustrate that the selected portion is being acted upon via an instrument, such as for resection, implantation, or the like. A possible or average motion may be used to estimate a movement of the portion. Further the system may recall predetermined or known motion relative to a portion of the subject, such as due to a beating of the heart, to estimate a motion of the selected portion. Therefore, the system in the process 500 may estimate a movement of the portion in Block 606. Following the estimated movement of the portion, an unlock command received determination may be made in Block 610. If an unlock command is received, a YES path may be followed in Block 615. If the imaging system, including the ultrasound probe 400, is commanded to not lock onto any particular image portion and may be moved and/or maintain a selected position. Therefore, if the unlocked command is received, the YES path 615 may be followed to end the process in Block 620. The end of the process 500 will be discussed further below. The examiner notes that the movement of the probe is based on registered data, thus, after estimating the movement of the portion, the registration data is updated to control the movement of the probe relative to the new position of the portion.).
Regarding claim 21, Helm teaches the ultrasound system of claim 1, however, fails to explicitly teach wherein: each imaging mode of the plurality of imaging modes includes a different transducer-array configuration of the first and second arrays with respect to one or more of frequency, transmission, reception, and harmonic imaging.
Lazebnik, in the same field of endeavor, teaches each imaging mode of the plurality of imaging modes includes a different transducer-array configuration of the first and second arrays with respect to one or more of frequency, transmission, reception, and harmonic imaging (paras. 0022, 0042, and 0075; The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements. The elements are piezoelectric or capacitive materials or structures. The transducer 12 is adapted for use external to the patient, such as including a hand held housing or a housing for mounting to an external structure. Two transducers 12, 16 are shown, but three, four, or more transducers 12, 16 may be provided. Different ones of the transducers 12, 16 may have the same or different structure, such as one transducer being a linear array and another being a curved linear array. The transducers may be configured to scan an identical or different sized FOV. Each transducer's imaging parameters (frequency, depth, and others) may also be identical or different from other transducers. The scanning may be for B-mode, color flow mode, tissue harmonic mode, contrast agent mode or other now known or later developed ultrasound imaging modes. Combinations of modes may be used, such as scanning for B-mode and Doppler mode data. Any ultrasound scan format may be used, such as a linear, sector, or Vector.RTM.. Using beamforming or other processes, data representing the scanned region is acquired.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner. This modification will help in improving contrast and spatial resolution by imaging multiple subregions using multiple arrays. Additionally, using multiple arrays will reduce shadow artifacts when a given transducer may not adequately visualize a subvolume within the transducer's field of view, another transducer at a different orientation may visualize the same structure more effectively as disclosed within Lazebnik in paras. 0015-0016.
Claim(s) 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al. (US 2024/0341891) in the view of Lazebnik et al. (US 2011/0125022) and Smith et al. (US 2010/0262013) and further view of Boctor et al. (US 2015/0297177).
Regarding claim 7, Helm teaches the ultrasound system of claim 1, wherein: the one or more robotic manipulators include a first robotic manipulator and a second robotic manipulator (para. 0110; Thus, the robotic system 20 may move the ultrasound probe 33 and/or alternatively move the instrument 68′. Additionally or alternatively, an additional robotic assembly 20′ may be provided to move the instrument 68′.);
the one or more ultrasound scanners include a first ultrasound scanner (para. 0111; The ultrasound probe 400 may further include other portions, such as a portion to connect to the end effector 44 and/or to connect to the robotic system 20.);
the robotic manipulator is configured to couple to and control first positioning, first movement, and first operation of the ultrasound scanner (paras. 0111-0112 and 0131; Generally, the robotic system 20 may be moved or operated by the user 72 and/or by executing selected instructions, such as with a processor assembly including the processor assembly 102 and/or robotic processor assembly 410. The robotic assembly 20 may move the ultrasound probe 400 based upon input instructions from the user 72, substantially automatically based upon a predetermined imaging path and/or based upon a determination of a portion to be imaged of the subject, and/or combinations thereof. In addition to the robotic arm 20 physically moving the US probe 400 and/or the contact surface 404, various beam shaping or steering techniques may be used to move the area being imaged with the US probe 400.);
the first ultrasound scanner is configured to generate the ultrasound data during the first ultrasound scan and the additional ultrasound data during the second ultrasound scan (paras. 0129-1032; The system may determine further portions that required additional image data and may move the robotic system 20 accordingly to move the US probe 400 to acquire additional image data. In addition to the robotic arm 20 physically moving the US probe 400 and/or the contact surface 404, various beam shaping or steering techniques may be used to move the area being imaged with the US probe 400. In beam forming or beam steering, various ultrasound transducer arrays may be used to generate selected beam portions, such as beam shapes or beam parameters. Selected portions of the array may be energized separately or simultaneously to generate different beam configurations and/or angles relative to a fixed position of the ultrasound probe 400. The examiner notes that after receiving the first image data, the processor determines if additional images are required. If additional images are required, the robotic system controls the movement and the operation of the ultrasound probe to acquire additional image)
although Helm teaches using two robotic manipulator and an ultrasound scanner for acquiring an ultrasound data and additional ultrasound data, however, fails to explicitly teach that the one or more ultrasound scanners include a first ultrasound scanner and a second ultrasound scanner; the first ultrasound scanner includes the multi-array transducer and the second ultrasound scanner includes a second multi-array transducer; the second robotic manipulator is configured to couple to and control second positioning, second movement, and second operation of the second ultrasound scanner; and the second ultrasound scanner is configured to generate additional ultrasound data during the ultrasound scan.
Lazebnik, in the same field of endeavor, teaches the one or more ultrasound scanners include a multi-array ultrasound scanner having a first array and a second array (paras. 0021-0022; system 10 for synchronizing multi-directional ultrasound scanning. The system 10 includes two or more transducers 12, 16, location devices 14, an ultrasound imaging system 18, a processor 20, a memory 22, and a display 24. The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements.); the ultrasound data is generated using the first array (paras. 0024 and 0044; Each transducer 12, 16 converts between electrical signals and acoustic energy for scanning a region of the patient body. The region of the body scanned is a function of the type of transducer array and position of the transducer 12 relative to the patient. The imaging system 18 generates an image from the scan data. Beamformation, detection, scan conversion, and/or rendering are used to generate each image. Separate images may be generated for the data from separate transducers 12, 16. The examiner notes that each transducer performs a scan independently of the other and generates a separate ultrasound data); and the additional ultrasound data is generated using the second array (paras. 0024 and 0044; Each transducer 12, 16 converts between electrical signals and acoustic energy for scanning a region of the patient body. The region of the body scanned is a function of the type of transducer array and position of the transducer 12 relative to the patient. The imaging system 18 generates an image from the scan data. Beamformation, detection, scan conversion, and/or rendering are used to generate each image. Separate images may be generated for the data from separate transducers 12, 16. The examiner notes that each transducer performs a scan independently of the other and generates a separate ultrasound data).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the ultrasound scanner of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner. This modification will help in improving contrast and spatial resolution by imaging multiple subregions using multiple arrays. Additionally, using multiple arrays will reduce shadow artifacts when a given transducer may not adequately visualize a subvolume within the transducer's field of view, another transducer at a different orientation may visualize the same structure more effectively as disclosed within Lazebnik in paras. 0015-0016.
However, Helm in the view of Lazebnik and Smith fail to explicitly teach the one or more robotic manipulators include a first robotic manipulator and a second robotic manipulator; the one or more ultrasound scanners include a first ultrasound scanner and a second ultrasound scanner; the ultrasound system is configured to implement a calibration routine to determine positional and orientation data to align respective imaging planes of the first and second ultrasound scanners.
Boctor, in the same field of endeavor, teaches the one or more robotic manipulators include a first robotic manipulator and a second robotic manipulator (paras. 0124 and 0257, 0261; according to some embodiments of the invention, the robot-assisted ultrasound system includes two manipulation arms, with an ultrasound probe attached to the end of each arm.); the one or more ultrasound scanners include a first ultrasound scanner and a second ultrasound scanner (paras. 0124 and 0262; Two identical 60 mm 128 array linear Ultrasonix US probes, together with the Sonix Touch US machine (Analogic Ultrasound, Richmont, BC, Canada) are used. We have designed and manufactured US probe holders that enable the attachment of the US probe to the robot tooltip.); the ultrasound system is configured to implement a calibration routine to determine positional and orientation data to align respective imaging planes of the first and second ultrasound scanners (paras. 0263-0266; FIG. 49 illustrates transformations involved in calculating the desired second arm pose such that the two US probes are aligned. B.sub.2′=X.sub.3.sup.−1B.sub.1X.sub.1DX.sub.2.sup.−1 where B.sub.2′ is the desired pose for the second arm, B.sub.1 is the first arm's pose, and D is the desired transformation from first US probe image frame to the second. ] B.sub.1 and B.sub.2 can be read from robot encoders; however, X.sub.1, X.sub.2, and X.sub.3 should be determined through calibrations. X.sub.1 and X.sub.2 are the transformation matrices from robot tooltips to US images and hence are called US calibrations. X.sub.3 is the transformation between the two robotic arm bases. To find X.sub.1 and X.sub.2, we used an active echo US calibration[13] (the active echo circuitry is shown in FIG. 48A). It is a point based calibration in which the active echo is imaged by the US probe from various poses. The active echo is an active miniaturized US element that listens to US signals. It sends back an US signal when it receives one. When the US probe's trigger signals are connected to the active echo circuitry, the probe can measure the delay between the time the US signal was transmitted by the US probe and the time it was received by the active echo element. In addition, the probe's element with minimum delay can be determined. These two parameters can be used to localize the active echo element in the US image coordinate frame. The examiner notes that the system uses calibration to align the two probes ).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Helm in the view of Lazebnik and Smith to incorporate a second ultrasound scanner coupled to a second robotic arm and using a calibration routine to align planes of the ultrasound probes of Boctor. This modification will provide higher imaging depth and enable ultrasound tomography imaging. Additionally, it facilitates precise and automatic alignment of the ultrasound probes, thereby, reducing the difficulty associated with manual alignment of multiple probes and enabling the probes to maintain the know relative pose needed for multi-probe tomographic imaging as disclosed within Boctor in para. 0103.
Regarding claim 8, Helm teaches the ultrasound system of claim 7, wherein: the movement instructions are further configured to cause the robotic manipulator to move to the one or more locations in the coordinate system (para. 0112; Generally, the robotic system 20 may be moved or operated by the user 72 and/or by executing selected instructions, such as with a processor assembly including the processor assembly 102 and/or robotic processor assembly 410. The robotic assembly 20 may move the ultrasound probe 400 based upon input instructions from the user 72, substantially automatically based upon a predetermined imaging path and/or based upon a determination of a portion to be imaged of the subject, and/or combinations thereof.); and the scan instructions further configure the ultrasound scanner for one of the plurality of imaging modes (paras. 0131-0132; In addition to the robotic arm 20 physically moving the US probe 400 and/or the contact surface 404, various beam shaping or steering techniques may be used to move the area being imaged with the US probe 400. In beam forming or beam steering, various ultrasound transducer arrays may be used to generate selected beam portions, such as beam shapes or beam parameters.).
However, Helm in the view of Lazebnik and Smith fail to explicitly teach that the ultrasound scanner comprising a first and second scanners controlled by separate robotic manipulators.
Boctor, in the same field of endeavor, teaches ultrasound scanner comprising a first and second scanners controlled by separate robotic manipulators (paras. 0124 and 0257; according to some embodiments of the invention, the robot-assisted ultrasound system includes two manipulation arms, with an ultrasound probe attached to the end of each arm.);
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Helm in the view of Lazebnik and Smith to incorporate a second ultrasound scanner coupled to a second robotic arm of Boctor. This modification will provide higher imaging depth and enable ultrasound tomography imaging. Additionally, it facilitates scanning multiple anatomical regions at the same time as disclosed within Boctor in paras. 0103 and 0191.
Regarding claim 9, modified Helm teaches the ultrasound system of claim 7, however, fails to explicitly teach wherein the first robotic manipulator and the second robotic manipulator are coupled to a same robot.
Boctor, in the same field of endeavor, teaches wherein the first robotic manipulator and the second robotic manipulator are coupled to a same robot (fig. 48A, para. 0262; UR5 is an 18.4 kg lightweight robotic arm. We have designed and manufactured a portable dual arm cart, as shown in FIG. 48A, where the two robotic arms can be installed. There is a space on the lower part of the cart to put the robot controllers.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Helm in the view of Lazebnik and Smith to incorporate a first robotic manipulator and second robotic manipulator coupled to a dual arm cart of Boctor. This modification will provide a common support platform for the two robotic manipulators and their respective controllers while enabling manipulators to cooperatively position and maintain alignment of the respective ultrasound probes.
Regarding claim 10, Helm teaches the ultrasound system of claim 7, wherein the first robotic manipulator and the second robotic manipulator are separate robots (fig. 12, elements 20 and 20’; para. 0161; Robotic system 20′ may be substantially similar to the robotic system 20).
Claim(s) 11-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al. (US 2024/0341891) in the view of Lazebnik et al. (US 2011/0125022).
Regarding claim 11, Helm teaches an ultrasound system comprising (fig. 12):
an ultrasound scanner configured to generate ultrasound data based on received reflections of ultrasound signals transmitted by the ultrasound scanner at a patient anatomy during a first ultrasound scan, the ultrasound data including first ultrasound data and second ultrasound data (paras. 0160-0161; The ultrasound probe 400 may acquire image data of various portions of the subject, as discussed above. Various images may be displayed on the display device 84′ and/or any appropriate display device, based upon the acquired image data. The ultrasound probe 400 may acquire image data of various portions of the subject, as discussed above. Various images may be displayed on the display device 84′ and/or any appropriate display device, based upon the acquired image data.);
a first robotic manipulator configured to couple to the ultrasound scanner, the first robotic manipulator configured to control first positioning, first movement, and first operation of the ultrasound scanner in accordance with a coordinate system (paras. 0131-0132 and 0161; the robotic system 20 may hold and or position (e.g., move) the US probe 400 separate from and/or while the robotic system 20′ may hold and position (e.g., move) the instrument 68′. In addition to or alternatively to the robotic arm 20 physically moving the US probe 400 and/or the contact surface 404, various beam shaping or steering techniques may be used to move the area being imaged with the US probe 400. In beam forming or beam steering, various ultrasound transducer arrays may be used to generate selected beam portions, such as beam shapes or beam parameters.);
a second robotic manipulator configured to couple to an interventional instrument, the second robotic manipulator configured to control second positioning, second movement, and second operation of the interventional instrument in accordance with the coordinate system figs. 12-14, para. 0161; The system 20′ may include an end effector 44′ that engages the instrument 68′. Therefore the instrument 68′ may be moved with the robotic system 20′ to various positions relative to the subject 30. the robotic system 20 may hold and or position (e.g., move) the US probe 400 separate from and/or while the robotic system 20′ may hold and position (e.g., move) the instrument 68′. The examiner notes that the robotic manipulator 20’ connects to interventional instrument and is configured to control its insertion, position, and movement as illustrated in figures 12-14);
a processor system configured to: receive the ultrasound data from the ultrasound scanner (paras. 0161-0162; The ultrasound probe 400 may be moved to acquire image data at various positions relative to the subject 30 to allow for a generation or reconstruction of the images 1108);
generate registration data based on the ultrasound data (para. 0048; According to various embodiments, therefore, the patient defines a patient space in which an instrument can be tracked and navigated. The image space defined by the image data can be registered to the patient space defined by the patient); and
generate operating instructions for the second robotic manipulator to operate the interventional instrument based on the ultrasound data (figs. 12-14; paras. 0161-0162; the ultrasound probe 400 may be moved to acquire image data at various positions relative to the subject 30 to allow for a generation or reconstruction of the images 1108. An instrument 68′ may be moved relative to the subject 30. The instrument 68′ may be substantially similar to the instrument 68, discussed above. According to various embodiments, the instrument 68′ may be held and/or moved with a robotic system 20′. Robotic system 20′ may be substantially similar to the robotic system 20. The system 20′ may include an end effector 44′ that engages the instrument 68′. Therefore the instrument 68′ may be moved with the robotic system 20′ to various positions relative to the subject 30. Briefly, as illustrated FIG. 12, the ultrasound probe 400 may capture or acquire image data from a region 700 of the subject 30. The region 700 may not include a portion of the instrument 68′, such as a distal tip 704 of the instrument 68′. Turning reference to FIG. 13, the ultrasound probe 400 and/or the instrument 68′, may be moved to image a region 700 of the US probe 400 and/or encompasses at least the distal tip 704 of the instrument 68′. Therefore, the image 1108a-c may include an icon or graphical representation of the instrument 68′ as the graphical representation 68i′. As discussed further herein, according to various processes or methods, the ultrasound probe 400 may move to a second position or different position relative to the subject and/or the instrument 68′ may move relative to the subject such that the image area 700 of the ultrasound probe 400 continues to ensure that at least the distal tip 704 of the instrument 68′ is within the volume being imaged 700 and included in the image 1108c. The examiner notes that the robotic system 20 moves the ultrasound scanner to capture image data of the patient, using the acquired image data, the robotic system 20’ moves the instrument relative to the imaged region (fig. 13) and continues to control the movement of the instrument relative to the images region (figs. 13-14).); and
a position controller configured to generate movement instructions for the second robotic manipulator based on the registration data, the movement instructions configured to cause the second robotic manipulator to move to one or more locations and orientations in the coordinate system to enable the operation of the interventional instrument at the one or more locations and orientations in accordance with the operating instructions (figs. 12-14; paras. 0161-0162; the ultrasound probe 400 may be moved to acquire image data at various positions relative to the subject 30 to allow for a generation or reconstruction of the images 1108. An instrument 68′ may be moved relative to the subject 30. The instrument 68′ may be substantially similar to the instrument 68, discussed above. According to various embodiments, the instrument 68′ may be held and/or moved with a robotic system 20′. Robotic system 20′ may be substantially similar to the robotic system 20. The system 20′ may include an end effector 44′ that engages the instrument 68′. Therefore the instrument 68′ may be moved with the robotic system 20′ to various positions relative to the subject 30. Briefly, as illustrated FIG. 12, the ultrasound probe 400 may capture or acquire image data from a region 700 of the subject 30. The region 700 may not include a portion of the instrument 68′, such as a distal tip 704 of the instrument 68′. Turning reference to FIG. 13, the ultrasound probe 400 and/or the instrument 68′, may be moved to image a region 700 of the US probe 400 and/or encompasses at least the distal tip 704 of the instrument 68′. Therefore, the image 1108a-c may include an icon or graphical representation of the instrument 68′ as the graphical representation 68i′. As discussed further herein, according to various processes or methods, the ultrasound probe 400 may move to a second position or different position relative to the subject and/or the instrument 68′ may move relative to the subject such that the image area 700 of the ultrasound probe 400 continues to ensure that at least the distal tip 704 of the instrument 68′ is within the volume being imaged 700 and included in the image 1108c. The examiner notes that the robotic system 20 moves the ultrasound scanner to capture image data of the patient, using the acquired image data, the robotic system 20’ moves the instrument relative to the imaged region (fig. 13) and continues to control the movement of the instrument relative to the images region (figs. 13-14).).
However, Helm fails to explicitly teach a multi-array ultrasound scanner having at least a first array and a second array configured to acquire ultrasound data, the ultrasound data including first ultrasound data generated using the first array and second ultrasound data generated using the second array; generate scan instructions for the first ultrasound scan, the scan instructions configuring the multi-array ultrasound scanner to: concurrently operate the first array in a linear scanning format and the second array in a phased scanning format; or concurrently operate the first array in the phased scanning format and the second array in the linear scanning format; receive, from the multi-array ultrasound scanner, the ultrasound data generated in accordance with the scan instructions.
Lazebnik, in the same field of endeavor, teaches a multi-array ultrasound scanner having at least a first array and a second array, the multi-array ultrasound scanner configured to generate ultrasound data based on received reflections of ultrasound signals transmitted by the multi-array ultrasound scanner at a patient anatomy during a first ultrasound scan (paras. 0021-0022; The system 10 includes two or more transducers 12, 16. The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements.); the ultrasound data including first ultrasound data generated using the first array and second ultrasound data generated using the second array (para. 0044; The imaging system 18 generates an image from the scan data. Beamformation, detection, scan conversion, and/or rendering are used to generate each image. Separate images may be generated for the data from separate transducers 12, 16.); generate scan instructions for the first ultrasound scan, the scan instructions configuring the multi-array ultrasound scanner to (paras. 0040 and 0042; the ultrasound imaging system 18 is a medical diagnostic ultrasound system. For example, the ultrasound imaging system 18 includes a transmit beamformer, a receive beamformer, a detector (e.g., B-mode and/or Doppler), a scan converter, and the display 24 or a different display. The ultrasound imaging system 18 connects with the transducers 12, 16, such as through one or more releasable connectors. Transmit signals are generated and provided to a selected transducer 12, 16. A multiplexer or connector receptacle selection selects the transducer 12, 16 to be used for scanning at any given time. Responsive electrical signals are received from the selected transducer 12, 16 and processed by the ultrasound imaging system 18. The ultrasound imaging system 18 causes a scan of an internal region of a patient with the transducer 12, 16 and generates data representing the region as a function of the scanning. Using a multiplexer or other structure and programming, the imaging system 18 is configured to sequentially scan an internal region of the patient with the different transducers 12, 16. Signals are transmitted to and received from one of the transducers 12, 16 at a given time. For example, one transducer 12 is used to scan a volume. Another transducer 16 is then used to scan another volume. The transmit and receive signals are beamformed as appropriate for scanning with the type of transducer 12, 16. Alternatively, more than one transducer 12, 16 may be selected and scan at a same time. The examiner notes that the ultrasound system generates scan instruction by transmitting signals to each array to control the operation of such array.): concurrently operate the first array in a linear scanning format and the second array in a phased scanning format (paras. 0022, 0042-0043, 0057, and 0085; The transducers 12, 16 are single element transducers, linear arrays, curved linear arrays, phased arrays, 1.5 dimensional arrays, two-dimensional arrays, radial arrays, annular arrays, multidimensional arrays, or other now known or later developed arrays of elements. The elements are piezoelectric or capacitive materials or structures. Different ones of the transducers 12, 16 may have the same or different structure, such as one transducer being a linear array and another being a curved linear array. The transducers may be configured to scan an identical or different sized FOV. Each transducer's imaging parameters (frequency, depth, and others) may also be identical or different from other transducers. Using a multiplexer or other structure and programming, the imaging system 18 is configured to sequentially scan an internal region of the patient with the different transducers 12, 16. Signals are transmitted to and received from one of the transducers 12, 16 at a given time. For example, one transducer 12 is used to scan a volume. Another transducer 16 is then used to scan another volume. The transmit and receive signals are beamformed as appropriate for scanning with the type of transducer 12, 16. Alternatively, more than one transducer 12, 16 may be selected and scan at a same time. These sequential scans have overlapping fields of view. The transducers 12, 16 are positioned and the scan format selected to cause the field of view of the transducers 12, 16 to at least partially overlap. Alternatively, non-overlapping fields of view and/or simultaneous scanning are used. The scanning may be for B-mode, color flow mode, tissue harmonic mode, contrast agent mode or other now known or later developed ultrasound imaging modes. Combinations of modes may be used, such as scanning for B-mode and Doppler mode data. Any ultrasound scan format may be used, such as a linear, sector, or Vector.RTM.. Using beamforming or other processes, data representing the scanned region is acquired. The examiner notes that the multi-array scanner can comprise different type of arrays such as one being a linear array and the second being a phased array, where each array is controlled and operated based on its type and the scan format desired such as linear and sector. The examiner further notes that the first and second arrays cam be operated at the same time or simultaneously); receive, from the multi-array ultrasound scanner, the ultrasound data generated in accordance with the scan instructions (paras. 0075 and 0087; In act 52, data from different scans is combined. Data for the field of views from the different arrays is combined into a data set representing an extended field of view.).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Helm to incorporate the teachings of Lazebnik to provide a multiarray ultrasound scanner. This modification will help in improving contrast and spatial resolution by imaging multiple subregions using multiple arrays. Additionally, using multiple arrays will reduce shadow artifacts when a given transducer may not adequately visualize a subvolume within the transducer's field of view, another transducer at a different orientation may visualize the same structure more effectively as disclosed within Lazebnik in paras. 0015-0016.
Regarding claim 12, Helm teaches the ultrasound system of claim 11, wherein: the operating instructions include instructions for inserting the interventional instrument into the patient anatomy and injecting or extracting fluid or tissue via the interventional instrument (figs. 12-14, paras. 0050 and 0161-0162; the robotic system 20′ may hold and position (e.g., move) the instrument 68′. Briefly, as illustrated FIG. 12, the ultrasound probe 400 may capture or acquire image data from a region 700 of the subject 30. The region 700 may not include a portion of the instrument 68′, such as a distal tip 704 of the instrument 68′. Turning reference to FIG. 13, the ultrasound probe 400 and/or the instrument 68′, may be moved to image a region 700 of the US probe 400 and/or encompasses at least the distal tip 704 of the instrument 68′. Therefore, the image 1108a-c may include an icon or graphical representation of the instrument 68′ as the graphical representation 68i′. As discussed further herein, according to various processes or methods, the ultrasound probe 400 may move to a second position or different position relative to the subject and/or the instrument 68′ may move relative to the subject such that the image area 700 of the ultrasound probe 400 continues to ensure that at least the distal tip 704 of the instrument 68′ is within the volume being imaged 700 and included in the image 1108c. Therefore, the image 1108c may include the graphical representation 68i′ of the instrument 68′, including the distal and 704 thereof. A tool or moveable member 68 may be any appropriate tool such as a drill, forceps, or other tool operated by a user 72. The tool 68 may also include an implant, such as a spinal implant or orthopedic implant. It should further be noted that the navigation system 26 may be used to navigate any type of instrument, implant, or delivery system, including: guide wires, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulation (DBS) probes, etc. Moreover, the instruments may be used to navigate or map any region of the body. The navigation system 26 and the various instruments may be used in any appropriate procedure, such as one that is generally minimally invasive or an open procedure. The examiner notes that the robotic system controls the insertion and the movement of the instrument and the instrument can be a delivery instrument which is used to deliver fluids, implants, guide wires, etc.).
Regarding claim 14, Helm teaches the ultrasound system of claim 11, wherein the processor system is configured to: receive perspective data from a machine-learned model, the perspective data representing a perspective for an ultrasound image generated from the ultrasound data (para. 0126; Also, various machine learning systems may be trained to identify segmented features. The examiner notes that the segmented image is generated using machine learning system); receive secondary data corresponding to the patient anatomy (paras. 0137-0138; the Segmented image may be registered to preoperative multiphase (4D) cardiac CT or other appropriate images.); and
generate the registration data based on a combination of the ultrasound data, the perspective data, and the secondary data (paras. 0137-0138; The acquired 4D image data and/or image may also be segmented and may be registered to the subject and/or preacquired images such as for identification of selected structures, or verification of a predetermined outcome, etc. The examiner notes that the ultrasound data is registered to the segmented image and the preacquired images.).
Regarding claim 15, Helm teaches the ultrasound system of claim 14, wherein the secondary data includes one or more of physiological data, previous scan data or images of the patient anatomy, inertial measurement unit data, protocol data, and clinician instructions (paras. 0137-0138; preoperative multiphase (4D) cardiac CT or other appropriate images).
Claim 6 and 20 rejected under 35 U.S.C. 103 as being unpatentable over as being unpatentable over Helm et al. (US 2024/0341891) in the view of Lazebnik et al. (US 2011/0125022) and Smith et al. (US 2010/0262013) and in further view of Mine et al. (US 2017/0252002).
Regarding claim 6, Helm teaches the ultrasound system of claim 1, wherein: the processor system is further configured to: receive examination instructions from a user for performing an ultrasound examination on a first patient having the patient anatomy (para. 0112-0113; Generally, the robotic system 20 may be moved or operated by the user 72 and/or by executing selected instructions, such as with a processor assembly including the processor assembly 102 and/or robotic processor assembly 410. A memory portion may also be provided with the robotic assembly 20 from which instructions may be recalled and/or allowing for communication with other systems. As discussed above, the ultrasound probe 400 may be used to collect image data of the subject 30, such as with the ultrasound waves. The ultrasound probe 400, therefore, may be moved relative to the subject 32 to acquire image data of the subject 30. The robotic assembly 20 may move the ultrasound probe 400 based upon input instructions from the user 72), the ultrasound examination including the first ultrasound scan and the second ultrasound scan (paras. 0126 and 0128; The structure in the image data may be identified as the portion or a portion of the subject to be imaged. The structure identified may be used to identify where to move the ultrasound probe 402 to acquire image data to generate image data to generate the selected image of the subject. For example, a heart wall or edge of a structure may be segmented and an identification of the structure may be made. The identification of the structure may be automatic, such as with the processor assembly 102, manually by the user 72, or in any appropriate manner. Based upon the acquisition of the image in Block 438 and the identification of the structure in Block 448 and based upon the recalled portion of the subject for which an image is to be generated in block 442, the robotic system 20 may move the ultrasound probe 400 to a subsequent or second position to acquire subsequent or second image data at block 452.).
However, Helm in the view of Lazebnik and Smith fails to explicitly teach determine automatically and without further instructions from the user to repeat the ultrasound examination on one or more additional patients.
Mine, in the same field of endeavor, teaches determine automatically and without further instructions from the user to repeat the ultrasound examination on one or more additional patients (paras. 0119-0122; An examination of the same organ (e.g., a liver) is performed on each of plural patients in some cases, and the same examination is performed on each of plural patients in e.g., a medical checkup in some cases. In the case of repeating the same examination as described above, the object (i.e., the first patient) from which the reference trace information has been acquired is different from the next object (i.e., the second patient) on which an automatic scan using the trace instruction information is to be performed. The examiner notes that the examination instruction is repeated on a second patient automatically).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Helm in the view of Lazebnik and Smith to incorporate the teachings of Mine to provide a process of automatically repeating examination on a different patient. This modification will shorten examination time and increase accuracy of the results. Using automatic initiation of the same scan on different patient reduce the need for an operator to input examination instruction and modify examination plan.
Regarding claim 20, Helm teaches the method of claim 16, wherein: generating the first ultrasound data, generating the registration data, generating the movement instructions, and generating the second ultrasound data are operations included in an ultrasound examination; and the method further comprises: receiving examination instructions from a user for performing the ultrasound examination on a first patient having the patient anatomy (para. 0112-0113; Generally, the robotic system 20 may be moved or operated by the user 72 and/or by executing selected instructions, such as with a processor assembly including the processor assembly 102 and/or robotic processor assembly 410. A memory portion may also be provided with the robotic assembly 20 from which instructions may be recalled and/or allowing for communication with other systems. As discussed above, the ultrasound probe 400 may be used to collect image data of the subject 30, such as with the ultrasound waves. The ultrasound probe 400, therefore, may be moved relative to the subject 32 to acquire image data of the subject 30. The robotic assembly 20 may move the ultrasound probe 400 based upon input instructions from the user 72.).
However, Helm in the view of Lazebnik and Smith fails to explicitly teach determining automatically and without further instructions from the user to repeat the ultrasound examination on one or more additional patients.
Mine, in the same field of endeavor, teaches determining automatically and without further instructions from the user to repeat the ultrasound examination on one or more additional patients (paras. 0119-0122; An examination of the same organ (e.g., a liver) is performed on each of plural patients in some cases, and the same examination is performed on each of plural patients in e.g., a medical checkup in some cases. In the case of repeating the same examination as described above, the object (i.e., the first patient) from which the reference trace information has been acquired is different from the next object (i.e., the second patient) on which an automatic scan using the trace instruction information is to be performed. The examiner notes that the examination instruction is repeated on a second patient automatically).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Helm in the view of Lazebnik and Smith to incorporate the teachings of Mine to provide a process of automatically repeating examination on a different patient. This modification will shorten examination time and increase accuracy of the results. Using automatic initiation of the same scan on different patient reduce the need for an operator to input examination instruction and modify examination plan.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Helm et al. (US 2024/0341891) in the view of Lazebnik et al. (US 2011/0125022) and in further view of Moskovich et al (WO 2023/067587).
Regarding claim 13, Helm teaches the ultrasound system of claim 11, further comprising a motion-compensation system configured to: generate, based on a set of ultrasound images generated from the ultrasound data, a prediction of a next position of the patient anatomy relative to a current position of the patient anatomy (paras. 0155-0156; the ultrasound probe 400 may collect image data at about 30 frames per second. Therefore, the image 108b is the last image frame collected with the ultrasound probe 400. Again, following the display of the image of Block 614, the process 500 may continue to the estimate movement of the portion in Block 606. The process 500 may continue with an estimation of a movement of the selected portion, such as based upon the subject motion, instrument motion relative to the portion, or other features. For example, the image data may illustrate that the selected portion is being acted upon via an instrument, such as for resection, implantation, or the like. A possible or average motion may be used to estimate a movement of the portion. Further the system may recall predetermined or known motion relative to a portion of the subject, such as due to a beating of the heart, to estimate a motion of the selected portion. Therefore, the system in the process 500 may estimate a movement of the portion in Block 606.) and determine, based on the prediction, an offset to include in the registration data to adjust the movement instructions generated for the robotic manipulator to dynamically compensate for motion of the patient anatomy (paras. 0157-0158; Following the estimated movement of the portion, an unlock command received determination may be made in Block 610. If an unlock command is received, a YES path may be followed in Block 615. If the imaging system, including the ultrasound probe 400, is commanded to not lock onto any particular image portion and may be moved and/or maintain a selected position. The command to move the imager may include moving the imager in any appropriate manner and to move the imager, including the US probe 400, to maintain the selected image based upon the estimated movement of the portion from block 606. Therefore, based upon the maintaining of the lock command, a move command may be made. The move command may include a movement of the robotic system 20 in a selected three-dimensional space location and/or three-dimensional orientation for movement of the imaging system 400. The movement command may include a selected movement in any appropriate axis and/or orientation to position the imaging system, including the ultrasound probe 400, relative to the subject 30 to maintain the imaging of the selected portion.).
However, Helm in the view of Lazebnik fails to explicitly teach adjusting the movement instructions generated for the robotic manipulator connected to the instrument to dynamically compensate for motion of the patient anatomy.
Moskovich, in the same field of endeavor, teaches adjusting the movement instructions generated for the robotic manipulator connected to the instrument to dynamically compensate for motion of the patient anatomy (page 17, line 8 to page 18, line 2; the planned trajectory may be updated in real-time based on the real-time position of the medical instrument (for example, the distal tip thereof) and/or the real-time position of the target and/or the real-time positions of obstacle/s, or based on tissue and target movement predictions generated by one or more machine learning models. The initial target location may be obtained manually (i.e., marked by the user) or automatically (i.e., determined by the processor). medical instrument 174 being inserted into the subject’s body, along the planned trajectory 160. As shown in FIG. 4B, the target has moved from its initial position to new (updated) position 162’ as a result of for example but not limited to the advancement of the medical instrument within the tissue, respiration cycle behavior, patient movements, as detailed herein. the trajectory may be updated based on the determined real-time position of the target. In some embodiments, the subsequent movement of the target is predicted, for example using a target movement model, and the trajectory may then be updated based on the predicted location (e.g., the end-point location) of the target. In some embodiments, the updating of the trajectory based on the predicted location of the target may be performed automatically, by utilizing one or more of the Al models, including the respiration behavior model, tissue movement model, target movement model, trajectory model and any suitable sub-model (or individual model). The examiner notes that the movement of the robotic arm manipulating the instrument is based on a planned trajectory which updates in real time based on motion of the anatomy for motion compensation).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of in the view of Lazebnik in the view of to incorporate the teachings of Moskovich to provide an updated planned trajectory for the second robotic manipulator to compensate for motion of the anatomy. This modification will allow accurate navigation of the instrument to the desired region and reduce the risk of navigating the instrument to a different region due to the movement of the anatomy during the procedure.
Response to Arguments
Applicant’s arguments with respect to claim 1, 35 USC 102 rejection have been considered but are moot in view of the amendment because the new ground of rejection does not rely on Helm alone as disclosing the amended limitation. Rather, the claim as amended is rejected based on the combination of references set above.
Applicant's arguments filed 06/15/2026 have been fully considered but they are not persuasive. The applicant argues that cited references do not describe features of amended claim 11. The examiner disagrees. As discussed in the rejection above, Lazebnik teaches an ultrasound imaging scanner comprising multiple transducer arrays, 12 and 16, and expressly teach that the arrays may comprise different types of arrays, including a linear array and a phased array. Lazebnik further teaches that the region scanned is a function of the type of the array and that the ultrasound system drives and controls the multiple arrays for scanning based on their types and scanning format. Lazebnik additionally teaches simultaneous operation, including that multiple arrays may be addressed simultaneously and that multiple arrays may be driven simultaneously by the ultrasound system. Thus, Lazebnik teaches controlling multiple arrays according to their respective array types and operating multiple arrays simultaneously, including expressly contemplated linear and phased arrays. Accordingly, when applied to the ultrasound scanner of Helm as set forth in the rejection, the combination teaches or suggests configuring multi-array scanner to concurrently operate arrays according to their respective scanning configuration.
Applicant’s arguments with respect to claim 16, 35 USC 103 rejection have been considered but are moot in view of the amendment because the new ground of rejection does not rely on Helm and Lazebnik alone as disclosing the amended limitation. Rather, the claim as amended is rejected based on the combination of references set above.
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them. For example, merely asserting that the dependent claims 3-10, 12-15, and 17-20 include their own recited features, which the applied references have not been shown to teach or disclose, alone or in combination, without identifying the particular limitations at issue and explaining why those limitation distinguish over the cited references, does not practically address the rejection.
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).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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