DETAILED ACTION
This Office action is responsive to communications filed on 01/22/2026. Claims 1-4, 8-12, 14-17, &21-22 have been amended. Claims 5-7, 13, 18-20, & 23 are canceled. Presently, Claims 1-4, 8-12, 14-17, & 21-22 remain pending and are hereinafter examined on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Previous interpretations under 35 USC § 112(f) are withdrawn in view of the amendments filed on 01/22/2026.
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 01/22/2026.
Previous claim objections are withdrawn in view of the amendments filed on 01/22/2026.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely Bharat et al (US 2019/0380679 A1, herein Bharat) alone applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The new grounds of rejection now relies on the following prior arts:
Claims 1-4, 8-10 are rejected under 35 U.S.C. 103 is being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Shiina et al (US 20090275837 A1).
Claims 11-12, and 15-16 are rejected under 35 U.S.C. 103 is being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Lazebnik (US 2011/0125022 A1) in view of Shiina et al (US 20090275837 A1).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Lazebnik (US 2011/0125022 A1) in view of Shiina et al (US 20090275837 A1), as applied to claim 11, in further view of Govari (US 2002/0107445 A1).
Claims 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Shiina et al (US 20090275837 A1), as applied to claim 1, in further view of Wodlinger et al (US 2020/0022681 A1, herein Wodlinger).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Lazebnik (US 2011/0125022 A1) in view of Shiina et al (US 20090275837 A1), as applied to claim 11, in further view of Wodlinger et al (US 2020/0022681 A1, herein Wodlinger).
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 4:
line 2, “acquiring a scout scan of the subject prior to the acquiring the real time image data[[;]].”
Claim 11:
line 11, “acquiring real time image data”.
line 14, “acquire the real time image data”.
line 26, “acquire the real time image data”.
Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 8-12, 14-17, & 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 1: “the need” & “at the same time”. There is insufficient antecedent basis for these limitations in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes “a need” & “simultaneously”. Accordingly, proper antecedent basis is required.
The above rejections to claim 1 apply to claim 11 for substantially identical claim limitations recited in the claim. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 8-10 are rejected under 35 U.S.C. 103 is being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Shiina et al (US 20090275837 A1).
Claim 1: Bharat discloses, A method of imaging a subject, comprising: (¶Abstract, ‘An ultrasound imaging system according to the present disclosure may include an ultrasound transducer assembly comprising a plurality of apertures that are configured to transmit signals toward and receive signals from a region of interest (ROI) of a subject [...]’)
providing a plurality of ultrasound transducers relative to the subject;
-Bharat explicitly discloses an ultrasound imaging system that includes an ultrasound transducer assembly comprising a plurality of apertures, FIG. 2A, ¶Abstract, ¶0007, Claim 1. These apertures are configured to transmit and receive signals from a region of interest (ROI) of a subject, FIG. 2A, ¶Abstract, ¶0007, Claim 1. The apertures can be implemented as a plurality of ultrasound probes, ¶0009, ¶0047, Claim 13. The apertures are arranged in relation to the subject such that each aperture includes at least a portion of the vessel within its field of view, ¶0029.
determining a field of view of each of the plurality of ultrasound transducers;
-The system of Bharat relies on the concept of field-of-view (FOV) of each individual aperture, ¶0009, ¶0029, Claim 9. The FOV of the combined assembly may be 10 cm or greater, but the FOV of a typical aperture (e.g., probe footprint) is much smaller (e.g., 3-5 cm), Claim 10-11, ¶0046, ¶0059. The transducers are positioned such that the field of view of each of the plurality of independently controllable apertures includes a portion of the vessel, Claim 9. The system of Bharat determines when a tracking sensor approaches the boundary of or exists the FOV of the currently active aperture, ¶0036, ¶0039, ¶0045, Claim 5-6.
mapping a device relative to each field of view of each of the plurality of ultrasound transducers to determine a pose of the device relative to at least one of the subject or the plurality of ultrasound transducers;
-Bharat discloses that the system is configured to identify a position of the tracking sensor using tracking data, ¶Abstract, Claim 1. The tracking allows the system of Bharat to determine whether the tracking sensor is within the field of view of the active aperture, ¶0035, ¶0037, ¶0039. In ultrasound tracking, the location (i.e., position) of the receiver (i.e., sensor) is determined based on one-way delays to ascertain the distance and thus relative location of the receiver to the transmitter (i.e., aperture), ¶0034. Furthermore, since the relative position of the apertures in the array is known, the location of the tracking sensor relative to the reference aperture allows the system to compute the distance traveled by the tool in relation to a reference location, providing guidance information, ¶0051, ¶Abstract, Claim 1, thereby Bharat meets the claimed requirements.
determining a pose of at least one ultrasound transducer of the plurality of ultrasound transducers by tracking the at least one ultrasound transducer of the plurality of ultrasound transducers;
-Bharat discloses utilizing an electromagnetic (EM) tracking system, the system is operable to localize each of the apertures and the tracking sensor, in relation to a single reference frame. The EM tracking system is configured to determine the location (e.g., a position and/or orientation) of each tracked object including the apertures within the tracked field, ¶0037.
determining which of the at least one ultrasound transducer of the plurality of ultrasound transducers should be activated to acquire real time image data of the subject and the device based at least on both (1) the determined pose of the device relative to the field of view of each ultrasound transducer of the plurality of ultrasound transducers and (2) the determined pose of each ultrasound transducer of the plurality of ultrasound transducers relative to at least one of the subject or the plurality of ultrasound transducers;
-The core function of Bharat system is to automatically select and activate apertures based on the interventional tool’s position, ¶Abstract, ¶0011, ¶0027, Claim 16. The system includes at least one processor to identify a position of the tracking sensor, which is positioned on a tool, using tracking data, ¶Abstract, ¶0026, Claim 1. Based on the identified position, the processor or a multiplexer controlled by it is configured to activate another aperture to generate a subsequent image, ¶Abstract, ¶0027, Claim 16, Claim 1. The multiplexer is configured to selectively control the aperture based on the identified position of the tracking sensor, Claim 3. This control involves communicatively coupling one or more apertures to the ultrasound imaging apparatus based on tracking information, ¶0010-0011, Claim 20, Claim 25. As stated above, the system is specifically designed to determine when a sensor approaches the boundary of or exist the FOV of the currently active aperture, triggering the activation of the next aperture, ¶0008, ¶0035-0036, Claim 5-6.
-For condition (1) the decision to activate a specific aperture is linked to the device’s position within the active FOV. The tracking system determines, based on tracking information (e.g., location of the tracking sensor relative to an active aperture and/or signal intensity), whether the tracking sensor is within the FOV of the active aperture, ¶0035. Further note, the 3D position of the tracking sensor can be estimated in real-time, provided it is present within the FOV of the imaging probe, ¶0050. The relative location information (i.e., tracking sensor position relative to the active aperture’s FOV) is used to generate commands for activating and/or deactivating other apertures, ¶0035, ¶0039.
-For condition (2) the system of Bharat relies on knowing the position or pose of the apertures, both relative to the subject and relative to each other, to manage aperture switching and locate the tool in the overall imaging field. The EM tracking system specifically is operable to localize each of the apertures and the tracking sensor in relation to a single reference frame, ¶0037. The EM tracking system determines the location (e.g., a position and/or orientation) of each tracked object, including apertures, within the tracked field. Based on this, the tracking system can determine when the tracking sensor enters or exists the FOV of a given aperture, ¶0037. Because the relative position of each aperture is known (via tracking or position sensors), the relative position of objects in the images acquired with each probe can be determined, ¶0051. Also note, the system of Bharat teaches adjusting the position of individual apertures relative to the subject such that the FOV of each aperture includes a portion of the vessel, Claim 16, ¶0012, ¶0030, ¶0043-0044, ¶0060.
-Therefore, the activation decision (i.e., determining which aperture should be activated) is driven by the tool’s pose relative to the FOV, (i.e., condition 1), and this determination is calculated because the system tracks and knows the pose of the aperture relative to the subject and other apertures (i.e., condition 2), ensuring the correct adjacent aperture along the path travel is selected, ¶0039, ¶0063.
multiplexing the plurality of ultrasound transducers to selectively acquire the real time image data of the subject
-Bharat discloses multiplexing the plurality of ultrasound transducers (apertures) to selectively acquire real-time image data based on the determination of which transducer should be active. The system of Bharat utilizes a multiplexer to manage the activation and deactivation of the individual apertures (i.e., transducers) in the assembly. The ultrasound imaging includes this multiplexer that is in communication with at least one processor, ¶0008, Claim 3. The multiplexer is configured to selectively control the apertures based on the identified position of the tracking sensor, ¶0008, Claim 3. The multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system, ¶0010-0011, Claim 25. This coupling process is selective, for instance, the multiplexer may be configured to communicatively couple only a single aperture to the imaging apparats at any given time, ¶0008, ¶0040, Claim 5-6. In addition, the multiplexer performs this selective coupling automatically in response to tracking data, ¶0033, ¶0041, with selection criteria tied to the determined transducer, specifically, the multiplexer “receiv[es] the tracking information [...] and communicatively coupling the another one of the plurality of independently controllable apertures to the at least one processor based on the tracking information”-¶0012.
that is longer in at least one of length or span than any single ultrasound transducer of the plurality of ultrasound transducers eliminating the need to move any single ultrasound transducer of the plurality of ultrasound transducers;
-As previously, discussed Bharat discloses that the ultrasound imaging system utilizes a multiplexer to selectively acquire one or more independently controllable apertures to the image imaging apparats to acquire real-time image data, ¶0010, ¶0038. By electronically switching between the apertures, the system provides a combined extended FOV that is longer than what a single ultrasound transducer can capture, ¶0009, ¶0041. Bharat teaches that standard US transducers provide an imaging width of 3-5cm, ¶0005, the multiplexed transducer assembly of Bharat can achieve a combined FOV length of 10 cm or greater, 30 cm or greater, ¶0009, ¶0059. See ¶0041, ¶0059, because the multiple automatically tracks the interventional tool and electronically shifts the active imaging aperture along the length of the assembly, it completely obviates the need for a sonographer to physically move, maneuver, or manipulate the transducer probe to capture the extended region during the procedure.
selectively automating a current switch between the plurality of ultrasound transducers, the current switch configured to regulate the number of ultrasound transducers of the plurality of ultrasound transducers operating at the same time; and
-Bharat teaches, see ¶¶0037-0045, the multiplexer is configured with a switching circuitry to automatically control and regulate how many ultrasound transducers are active at any given time.
acquiring the real time image data with the determined at least one ultrasound transducer of the plurality of ultrasound transducers.
-Regarding the real-time image data, the activated aperture is then used by the ultrasound imaging system to acquire and generate the real-time image data. Specifically, the process involves transmitting ultrasound with at least one of the plurality of independently controllable apertures and receiving echoes with the same at least one of the plurality of independently controllable apertures, ¶0011, Claim 16. The processor is configured to generate a first image of a first portion of the ROI from the signals received from the at least one activated aperture, ¶Abstract. Upon selection and activation of a new aperture based on the tracking information, the processor is configured to generate a second image of a second potion of the ROI from signals received from at least one other aperture activated based on the identified position, ¶Abstract. Hence, the overall method includes generating and displaying, responsive to echoes, an ultrasound image of the ROI including the vessel, ¶0010-0011, Claim 16. This image generation occurs as the tool advances, constituting the acquisition of real-time image data, ¶0040.
Bharat fails to teach: thereby reducing crosstalk and interference between the plurality of ultrasound transducers while activated;
However, Shiina in the context of preventing interference or the light when multiple probes receive ultrasonic waves, discloses, thereby reducing crosstalk and interference between the plurality of ultrasound transducers while activated;
-Shiina teaches switching between different probes in an alternating manner to reduce crosstalk and interface between the plurality of ultrasound transducers while activated, ¶0064, FIG. 10. Specially, to avoid interface that occurs when individual probes FOV overlap, Siinna switches between the transmitting timings of the probes. The principle of avoiding/preventing interference or the like in this alternating manner to prevent overlapping signals of activated transducers from disrupting each other amounts to avoiding/preventing cross-talk too.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the activation of Bharat selectively automated current switch in view of the teachings of Shinna regarding alternating the transmission between different probes to reduce crosstalk and interference while activated. The motivation to do this yield predictable results such as avoid interference when ultrasonic wave transmitting areas of individual probes overlap, ¶0064 as explicitly suggested by Shinna.
Claim 2: Modified Bharat discloses all the elements above in claim 1, Bharat discloses, further comprising: providing each of the plurality of ultrasound transduces moveable relative to each of the plurality of ultrasound transducers. (FIG. 2A, -the provided plurality of ultrasound transducers are relative to the subject; [0030], ‘By enabling the apertures to move in relation to one another, the transducer assembly may more effectively be able to follow the path of the vessel even when the vessel curves or changes direction along its length’)
Claim 3: Modified Bharat discloses all the elements above in claim 2, Bharat discloses, further comprising: providing the plurality of ultrasound transducers such that each ultrasound transducer of the plurality of ultrasound transducers is fixed relative to another ultrasound transducer of the plurality of transducers. (FIG. 2A, -the plurality of ultrasound transducers are fixed relative to each other via the multiplexer., [0010], ‘multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus’; [0030], ‘By providing pivotal connection between adjacent apertures, the transducer assembly may more effectively be able to follow a contour of the surface of the subject upon which the large array is placed for imaging.’)
Claim 4: Modified Bharat discloses all the elements above in claim 1, Bharat discloses,
acquiring a scout scan of the subject prior to the acquiring the real time image data;
-Bharat discloses, an ultrasound imaging system including a processor configured to generate a first image of a first portion of the ROI (Region of Interest) from the signals received from at least one activated aperture, [Abstract], ¶0006-0007, & ¶0025. The “first portion” of the ROI is different from a “second portion” that is imaged later based on the tracking sensor’s position, ¶0027. Specifically, the method includes imaging prior to intervention imaging the vessel prior to advancing the interventional tool through the vessel to determine a target position for each of the apertures, such that each respective aperture includes a portion of the vessel, FIG. 5, ¶0012, ‘apertures may include activating an aperture adjacent to one side of one or more currently active apertures and deactivating an aperture adjacent to the opposite side of the one or more currently active apertures. In some embodiments, the method may include imaging the vessel prior to advancing the interventional tool through the vessel to determine a target position for each of the apertures in which the respective apertures includes a portion of the vessel, and the target position may be maintained during the advancing of the interventional tool through the vessel.’ & ¶0060. Furthermore, the probes can be manually or electronically positioned prior to the invasive procedure to ensure that the FOV of each probe’s array includes at least a portion of the vessel. This initial positioning can also involve adjusting the probes to an optimal orientation where the imaging plane intersects most or all of the length of the vessel portion within the FOV. In some instances, the optimal orientation may also be determined based on signal strength from the tracking sensor, by adjusting probes until the strongest signal is detected when the tracking sensor is within the FOV of a given probe, ¶0043, ‘using a gantry or frame 214. The frame 214 may include a corresponding number of holding components 216, which may be adjustable to enable each probe 212 to be independently positioned in relation to other probes in the assembly 210. For example, the frame may enable each aperture to be moved laterally (e.g., perpendicular to the vessel) and pivoted (i.e., to change the angle of the nominal imaging plane of each aperture) for optimal orientation of an aperture in relation to the vessel.’ & ¶0044. (and thus the plurality of ultrasound transducers are configured to acquire a scout scan of the subject prior to intervention (i.e., a multiplexed image data acquisition) with the one ultrasound transducer of the plurality of ultrasound transducers.)
Claim 8: Modified Bharat discloses all the elements above in claim 1, Bharat discloses, wherein the multiplexing comprises: ([0038], ‘The multiplexer 130 may be configured to selectively communicatively couple any one (or more) of the apertures 112 to the imaging apparatus 120 based on tracking information from the sensor 142 positioned on the interventional tool 106.’)
tracking the device to determine the pose of the device; determining that a selected portion of the device is within a selected proximity of the determined at least one ultrasound transducer of the plurality of ultrasound transducers; and ([Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’; [0008], ‘the ultrasound imaging system may further include a multiplexer that is in communication with the at least one processor and the ultrasound transducer assembly and the multiplexer may be configured to selectively control the apertures based on the identified position of the tracking sensor.’; [0010], ‘an ultrasound imaging apparatus coupled to each of the plurality of independently controllable apertures and configured to generate ultrasound images based on the received signals, a tracking sensor operatively associated with a tracking system and configured to be positioned on an interventional tool during an intervention procedure, and a multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system’; [0035], ‘the tracking system 140 determines that the sensor is aligned with the perimeter scan lines of the active aperture (as determined based on the known location of the transmit beams), the system (e.g., multiplexer 130) may activate the next probe ahead of the currently active aperture. In some examples, the perimeter scan lines may correspond from about 1 mm to about 3 mm, in some cases about 2 mm, of a FOV of about 4 cm in length, which may be achieved by a probe, for example, with about 320 transmit beams or a different number of beams. Additionally or alternatively, when the sensor is determined to be aligned with the perimeter scan lines and the sensor signal decreases at each frame, the multiplexer may activate the next probe in the array. Additionally or alternatively, the multiplexer may activate the next probe in the array once the signal fall off completely, which may correspond to the sensor leaving the FOV of the active aperture.’)
operating the determined at least one ultrasound transducer of the plurality of ultrasound transducers to acquire the real time image data. ([Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’)
Claim 9: Modified Bharat discloses all the elements above in claim 1, Bharat discloses, wherein the multiplexing comprises: ([0038], ‘The multiplexer 130 may be configured to selectively communicatively couple any one (or more) of the apertures 112 to the imaging apparatus 120 based on tracking information from the sensor 142 positioned on the interventional tool 106.’)
generating an initial scan of the subject with the plurality of ultrasound transducers; determining the field of view of each of the ultrasound transducers of the plurality of ultrasound transducers; tracking the device to determine the pose of the device; determining the determined field of view that a selected portion of the device is within or within a selected proximity of the determined field of view; and ([0038], ‘The multiplexer 130 may be configured to selectively communicatively couple any one (or more) of the apertures 112 to the imaging apparatus 120 based on tracking information from the sensor 142 positioned on the interventional tool 106.’; [Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’; [0008], ‘the ultrasound imaging system may further include a multiplexer that is in communication with the at least one processor and the ultrasound transducer assembly and the multiplexer may be configured to selectively control the apertures based on the identified position of the tracking sensor.’; [0010], ‘an ultrasound imaging apparatus coupled to each of the plurality of independently controllable apertures and configured to generate ultrasound images based on the received signals, a tracking sensor operatively associated with a tracking system and configured to be positioned on an interventional tool during an intervention procedure, and a multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system’; [0035], ‘the tracking system 140 determines that the sensor is aligned with the perimeter scan lines of the active aperture (as determined based on the known location of the transmit beams), the system (e.g., multiplexer 130) may activate the next probe ahead of the currently active aperture. In some examples, the perimeter scan lines may correspond from about 1 mm to about 3 mm, in some cases about 2 mm, of a FOV of about 4 cm in length, which may be achieved by a probe, for example, with about 320 transmit beams or a different number of beams. Additionally or alternatively, when the sensor is determined to be aligned with the perimeter scan lines and the sensor signal decreases at each frame, the multiplexer may activate the next probe in the array. Additionally or alternatively, the multiplexer may activate the next probe in the array once the signal fall off completely, which may correspond to the sensor leaving the FOV of the active aperture.’)
independently operating the determined at least one ultrasound transducer of the plurality of ultrasound transducers having the determined field of view in order acquire real time image data. ([Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’)
-Bharat discloses multiplexing the plurality of ultrasound transducers (apertures) to selectively acquire real-time image data based on the determination of which transducer should be active. The system of Bharat utilizes a multiplexer to manage the activation and deactivation of the individual apertures (i.e., transducers) in the assembly. The ultrasound imaging includes this multiplexer that is in communication with at least one processor, ¶0008, Claim 3. The multiplexer is configured to selectively control the apertures based on the identified position of the tracking sensor, ¶0008, Claim 3. The multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system, ¶0010-0011, Claim 25. This coupling process is selective, for instance, the multiplexer may be configured to communicatively couple only a single aperture to the imaging apparats at any given time, ¶0008, ¶0040, Claim 5-6. In addition, the multiplexer performs this selective coupling automatically in response to tracking data, ¶0033, ¶0041, with selection criteria tied to the determined transducer, specifically, the multiplexer “receiv[es] the tracking information [...] and communicatively coupling the another one of the plurality of independently controllable apertures to the at least one processor based on the tracking information”-¶0012.
-Regarding the real-time image data, the activated aperture is then used by the ultrasound imaging system to acquire and generate the real-time image data. Specifically, the process involves transmitting ultrasound with at least one of the plurality of independently controllable apertures and receiving echoes with the same at least one of the plurality of independently controllable apertures, ¶0011, Claim 16. The processor is configured to generate a first image of a first portion of the ROI from the signals received from the at least one activated aperture, ¶Abstract. Upon selection and activation of a new aperture based on the tracking information, the processor is configured to generate a second image of a second potion of the ROI from signals received from at least one other aperture activated based on the identified position, ¶Abstract. Hence, the overall method includes generating and displaying, responsive to echoes, an ultrasound image of the ROI including the vessel, ¶0010-0011, Claim 16. This image generation occurs as the tool advances, constituting the acquisition of real-time image data, ¶0040.
Claim 10: Modified Bharat discloses all the elements above in claim 1, Bharat discloses, wherein the multiplexing comprises: sensing a proximity of the device relative to the determined at least one ultrasound transducer of the plurality of ultrasound transducers; and operating the determined at least one ultrasound transducer of the plurality of ultrasound transducers to acquire real time image data. ([0038], ‘The multiplexer 130 may be configured to selectively communicatively couple any one (or more) of the apertures 112 to the imaging apparatus 120 based on tracking information from the sensor 142 positioned on the interventional tool 106.’; [Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’; [0008], ‘the ultrasound imaging system may further include a multiplexer that is in communication with the at least one processor and the ultrasound transducer assembly and the multiplexer may be configured to selectively control the apertures based on the identified position of the tracking sensor.’; [0010], ‘an ultrasound imaging apparatus coupled to each of the plurality of independently controllable apertures and configured to generate ultrasound images based on the received signals, a tracking sensor operatively associated with a tracking system and configured to be positioned on an interventional tool during an intervention procedure, and a multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system’; [0035], ‘the tracking system 140 determines that the sensor is aligned with the perimeter scan lines of the active aperture (as determined based on the known location of the transmit beams), the system (e.g., multiplexer 130) may activate the next probe ahead of the currently active aperture. In some examples, the perimeter scan lines may correspond from about 1 mm to about 3 mm, in some cases about 2 mm, of a FOV of about 4 cm in length, which may be achieved by a probe, for example, with about 320 transmit beams or a different number of beams. Additionally or alternatively, when the sensor is determined to be aligned with the perimeter scan lines and the sensor signal decreases at each frame, the multiplexer may activate the next probe in the array. Additionally or alternatively, the multiplexer may activate the next probe in the array once the signal fall off completely, which may correspond to the sensor leaving the FOV of the active aperture.’)
Claims 11-12, and 15-16 are rejected under 35 U.S.C. 103 is being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Lazebnik (US 2011/0125022 A1) in view of Shiina et al (US 20090275837 A1).
Claim 11: Bharat discloses, A system configured to image a subject, comprising: ([Abstract], ‘An ultrasound imaging system according to the present disclosure may include an ultrasound transducer assembly comprising a plurality of apertures that are configured to transmit signals toward and receive signals from a region of interest (ROI) of a subject, a tracking sensor disposed within the subject and configured to move within the ROI, the sensor being responsive to signals transmitted by the apertures, and at least one processor in communication with the ultrasound transducer assembly and the tracking sensor. The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures,’)
a plurality of ultrasound transducers configured to be positioned relative to the subject; (FIG. 2A); ([0007], ‘An ultrasound imaging system according to the present disclosure may include an ultrasound transducer assembly comprising a plurality of apertures that are configured to transmit signals toward and receive signals from a region of interest (ROI) of a subject,’; [0031], ‘an ultrasound imaging apparatus 120 coupled to the plurality of apertures 112. The ultrasound imaging apparatus 120 may be configured to control the sub-arrays of the ultrasound transducer assembly 110 to transmit ultrasound waves and receive echoes for generating ultrasound images based on the echoes.’; [0043], ‘FIG. 2A, the ultrasound transducer assembly 210 is implemented using a plurality of ultrasound probes 212, and the array of each individual probe may correspond to one of the independently controllable apertures of the large area array.’; [0043], ‘FIG. 2A, the probes 212 may be held in place (e.g., maintained in a desired position with respect to one another and/or the subject) using a gantry or frame 214.’)
a device (interventional tool) configured to be positioned relative to at least one of the subject or the plurality of ultrasound transducers; ([0010], ‘an ultrasound imaging apparatus coupled to each of the plurality of independently controllable apertures and configured to generate ultrasound images based on the received signals, a tracking sensor operatively associated with a tracking system and configured to be positioned on an interventional tool during an intervention procedure, and a multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system’; [0024], ‘a tracking sensor configured to be disposed within the subject and movable within the ROI. For example, the tracking sensor may be attached to an interventional tool (e.g., a needle, guidewire, cannula, catheter, or the like).’)
a device tracker coupled to the device; (FIG. 2A, tracking sensor 142/224) (¶0033, ‘the tracking sensors 142 may be operatively associated with a tracking system 140. As shown, the sensor 142 may be positioned on an intervention tool 106 (e.g., a needle, guidewire or catheter) during an intervention procedure and the tracking system 140’; ¶0037, ‘ the tracking system may be configured to determine the location (e.g., a position and/or orientation) of each tracked object within the tracked field’)
track a pose of the at least one ultrasound transducer;
-Bharat discloses utilizing an electromagnetic (EM) tracking system, the system is operable to localize each of the apertures and the tracking sensor, in relation to a single reference frame. The EM tracking system is configured to determine the location (e.g., a position and/or orientation) of each tracked object including the apertures within the tracked field, ¶0037.
a processor (processor 121) configured to determine a relative pose of the device relative to each ultrasound transducer of the plurality of ultrasound transducers; and
-Bharat discloses that the system is configured to identify a position of the tracking sensor using tracking data, ¶Abstract, Claim 1. The tracking allows the system of Bharat to determine whether the tracking sensor is within the field of view of the active aperture, ¶0035, ¶0037, ¶0039. In ultrasound tracking, the location (i.e., position) of the receiver (i.e., sensor) is determined based on one-way delays to ascertain the distance and thus relative location of the receiver to the transmitter (i.e., aperture), ¶0034. Furthermore, since the relative position of the apertures in the array is known, the location of the tracking sensor relative to the reference aperture allows the system to compute the distance traveled by the tool in relation to a reference location, providing guidance information, ¶0051, ¶Abstract, Claim 1, thereby Bharat meets the claimed requirements.
a multiplexer configured to operate the at least one ultrasound transducer of the plurality of ultrasound transducers for acquiring image data of the subject based at least on a determined pose of the device relative to at least one of the subject or the plurality of ultrasound transducers;
-The core function of Bharat system is to automatically select and activate apertures based on the interventional tool’s position, ¶Abstract, ¶0011, ¶0027, Claim 16. The system includes at least one processor to identify a position of the tracking sensor, which is positioned on a tool, using tracking data, ¶Abstract, ¶0026, Claim 1. Based on the identified position, the processor or a multiplexer controlled by it is configured to activate another aperture to generate a subsequent image, ¶Abstract, ¶0027, Claim 16, Claim 1. The multiplexer is configured to selectively control the aperture based on the identified position of the tracking sensor, Claim 3. This control involves communicatively coupling one or more apertures to the ultrasound imaging apparatus based on tracking information, ¶0010-0011, Claim 20, Claim 25. As stated above, the system is specifically designed to determine when a sensor approaches the boundary of or exist the FOV of the currently active aperture, triggering the activation of the next aperture, ¶0008, ¶0035-0036, Claim 5-6.
-For condition (1) the decision to activate a specific aperture is linked to the device’s position within the active FOV. The tracking system determines, based on tracking information (e.g., location of the tracking sensor relative to an active aperture and/or signal intensity), whether the tracking sensor is within the FOV of the active aperture, ¶0035. Further note, the 3D position of the tracking sensor can be estimated in real-time, provided it is present within the FOV of the imaging probe, ¶0050. The relative location information (i.e., tracking sensor position relative to the active aperture’s FOV) is used to generate commands for activating and/or deactivating other apertures, ¶0035, ¶0039.
-For condition (2) the system of Bharat relies on knowing the position or pose of the apertures, both relative to the subject and relative to each other, to manage aperture switching and locate the tool in the overall imaging field. The EM tracking system specifically is operable to localize each of the apertures and the tracking sensor in relation to a single reference frame, ¶0037. The EM tracking system determines the location (e.g., a position and/or orientation) of each tracked object, including apertures, within the tracked field. Based on this, the tracking system can determine when the tracking sensor enters or exists the FOV of a given aperture, ¶0037. Because the relative position of each aperture is known (via tracking or position sensors), the relative position of objects in the images acquired with each probe can be determined, ¶0051. Also note, the system of Bharat teaches adjusting the position of individual apertures relative to the subject such that the FOV of each aperture includes a portion of the vessel, Claim 16, ¶0012, ¶0030, ¶0043-0044, ¶0060.
-Therefore, the activation decision (i.e., determining which aperture should be activated) is driven by the tool’s pose relative to the FOV, (i.e., condition 1), and this determination is calculated because the system tracks and knows the pose of the aperture relative to the subject and other apertures (i.e., condition 2), ensuring the correct adjacent aperture along the path travel is selected, ¶0039, ¶0063.
wherein the multiplexer is configured to operate the at least one ultrasound transducer of the plurality of ultrasound transducers to acquire real time image data, the multiplexer configured to:
-Bharat discloses multiplexing the plurality of ultrasound transducers (apertures) to selectively acquire real-time image data based on the determination of which transducer should be active. The system of Bharat utilizes a multiplexer to manage the activation and deactivation of the individual apertures (i.e., transducers) in the assembly. The ultrasound imaging includes this multiplexer that is in communication with at least one processor, ¶0008, Claim 3. The multiplexer is configured to selectively control the apertures based on the identified position of the tracking sensor, ¶0008, Claim 3. The multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system, ¶0010-0011, Claim 25. This coupling process is selective, for instance, the multiplexer may be configured to communicatively couple only a single aperture to the imaging apparats at any given time, ¶0008, ¶0040, Claim 5-6. In addition, the multiplexer performs this selective coupling automatically in response to tracking data, ¶0033, ¶0041, with selection criteria tied to the determined transducer, specifically, the multiplexer “receiv[es] the tracking information [...] and communicatively coupling the another one of the plurality of independently controllable apertures to the at least one processor based on the tracking information”-¶0012.
generate an initial scan of the subject with the plurality of ultrasound transducers determine a field of view of each of the ultrasound transducers of the plurality of ultrasound transducers;
-The system of Bharat utilities a processor configured to generate a first image of a first portion of the ROI from signals received from at least one active aperture, ¶Abstract, ¶0007, ¶0025, Claim 1. The apertures are the individual transducers within the plurality of ultrasound transducers, ¶0023, ¶0028, ¶0052. The method of Bharat includes transmitting ultrasound with at least one of the plurality of independently controllable apertures and receiving echoes with that aperture, and then generating and displaying, responsive to the echoes, an ultrasound image of the ROI, Claim 16.
track the device to determine the pose of the device;
-The system of Bharat actively tracks the sensor located on the tool to determines is pose. The system includes a tracking sensor disposed within the subject and configured to move within the ROI, ¶Abstract, ¶0007, Claim 1. The sensor is positioned on the tool during the intervention procedure, ¶0010, ¶0033, Claim 1. The processor is configured to identify a pose of the tracking sensor using tracking data, ¶0007-0011, Claim 1. The tracking data may be generated based on the location of the sensor with a tracked field, ¶0033.
assess the determined field of view that a selected portion of the device is within or within a selected proximity of the determined field of view;
-The system of Bharat core function relies on the known or determined FOV of each aperture. The transducers are positioned such that the FOV of each of the plurality of independently controllable apertures includes a portion of the vessel, ¶0009, ¶0029, Claim 9. The system of Bharat continuously assess the relation ship between the tool’s position and the FOV of the active transducer to determine when a switch is necessary. The tracking system determines, based on tracking information (e.g., location of the tracking sensor relative to an active aperture and/or signal intensity), whether the tracking sensor is within the FOV of the active aperture, ¶0035.
independently activate the at least one ultrasound transducer of the plurality of ultrasound transducers having the determined field of view in order to acquire the real time image data.
-Bharat discloses automatically activates the required next transducer based on the aforementioned assessment, allowing for continuous, real time imaging of the tool. Specifically, the process involves transmitting ultrasound with at least one of the plurality of independently controllable apertures and receiving echoes with the same at least one of the plurality of independently controllable apertures, ¶0011, Claim 16. The processor is configured to generate a first image of a first portion of the ROI from the signals received from the at least one activated aperture, ¶Abstract. Upon selection and activation of a new aperture based on the tracking information, the processor is configured to generate a second image of a second potion of the ROI from signals received from at least one other aperture activated based on the identified position, ¶Abstract. Hence, the overall method includes generating and displaying, responsive to echoes, an ultrasound image of the ROI including the vessel, ¶0010-0011, Claim 16. This image generation occurs as the tool advances, constituting the acquisition of real-time image data, ¶0040.
wherein the multiplexer is configured to selectively acquire real time image data of the subject
-Bharat discloses multiplexing the plurality of ultrasound transducers (apertures) to selectively acquire real-time image data based on the determination of which transducer should be active. The system of Bharat utilizes a multiplexer to manage the activation and deactivation of the individual apertures (i.e., transducers) in the assembly. The ultrasound imaging includes this multiplexer that is in communication with at least one processor, ¶0008, Claim 3. The multiplexer is configured to selectively control the apertures based on the identified position of the tracking sensor, ¶0008, Claim 3. The multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system, ¶0010-0011, Claim 25. This coupling process is selective, for instance, the multiplexer may be configured to communicatively couple only a single aperture to the imaging apparats at any given time, ¶0008, ¶0040, Claim 5-6. In addition, the multiplexer performs this selective coupling automatically in response to tracking data, ¶0033, ¶0041, with selection criteria tied to the determined transducer, specifically, the multiplexer “receiv[es] the tracking information [...] and communicatively coupling the another one of the plurality of independently controllable apertures to the at least one processor based on the tracking information”-¶0012.
that is longer in at least one of length or span than any single ultrasound transducer of the plurality of ultrasound transducers eliminating the need to move any single ultrasound transducer of the plurality of ultrasound transducers to acquire real time image data: and
-As previously, discussed Bharat discloses that the ultrasound imaging system utilizes a multiplexer to selectively acquire one or more independently controllable apertures to the image imaging apparats to acquire real-time image data, ¶0010, ¶0038. By electronically switching between the apertures, the system provides a combined extended FOV that is longer than what a single ultrasound transducer can capture, ¶0009, ¶0041. Bharat teaches that standard US transducers provide an imaging width of 3-5cm, ¶0005, the multiplexed transducer assembly of Bharat can achieve a combined FOV length of 10 cm or greater, 30 cm or greater, ¶0009, ¶0059. See ¶0041, ¶0059, because the multiple automatically tracks the interventional tool and electronically shifts the active imaging aperture along the length of the assembly, it completely obviates the need for a sonographer to physically move, maneuver, or manipulate the transducer probe to capture the extended region during the procedure.
a current switch operably associated with the multiplexer and configured to regulate the number of ultrasound transducers of the plurality of ultrasound transducers operating at the same time.
-Bharat teaches, see ¶¶0037-0045, the multiplexer is configured with a switching circuitry to automatically control and regulate how many ultrasound transducers are active at any given time.
Bharat fails to disclose: at least one ultrasound tracker attached to at least one ultrasound transducer of the plurality of ultrasound transducers to track a pose of the at least one ultrasound transducer;
However, Lazebnik in the context of multi-directional ultrasound scanning discloses: at least one ultrasound tracker attached to at least one ultrasound transducer of the plurality of ultrasound transducers to track a pose of the at least one ultrasound transducer;
-Lazebnik discloses, location device 14 is included in or on the ultrasound transducer (12, 16), ¶0027-0028. The location device 14 may be mounted on, placed within, or formed as part of the housing of the transducer. ¶0027-0028. The function of the location device 14 is determined the spatial location and/or orientation of each transducer (12, 16), ¶0038. This is necessary because high quality registration of subvolumes may be difficul without accurate spatial information regarding each transducer’s location and orientation, ¶0017. The location device 14 determines the location of the probe or transducer such as relative to room space or other transducers, and indicates the relative positions of scanned voles or places acquired with different transducers, ¶0029-0030. The sensors may also include optical sensors, ¶0031. The usage of such positional information from the location device 14 is used for aligning (registering) the scan volumes, respectfully, indicating the positions of the transducers during their respective scans, ¶0045-0046. In addition, initial position estimates can be provided by the location device 14 associated with each transducer, ¶0049.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the at least on ultrasound transducer of the plurality of ultrasound transducers of Bharat to include a sensor (i.e., the tracker attached to probes) in view of the teachings of Lazebnik. The motivation to do this yields predictable results such as improving spatial information regarding each transducers location, ¶0017, during their respective scans, ¶0045-0046, as suggested by Lazebnik.
Bharat fails to teach: thereby reducing crosstalk and interference between the plurality of ultrasound transducers while activated;
However, Shiina in the context of preventing interference or the light when multiple probes receive ultrasonic waves, discloses, thereby reducing crosstalk and interference between the plurality of ultrasound transducers while activated;
-Shiina teaches switching between different probes in an alternating manner to reduce crosstalk and interface between the plurality of ultrasound transducers while activated, ¶0064, FIG. 10. Specially, to avoid interface that occurs when individual probes FOV overlap, Siinna switches between the transmitting timings of the probes. The principle of avoiding/preventing interference or the like in this alternating manner to prevent overlapping signals of activated transducers from disrupting each other amounts to avoiding/preventing cross-talk too.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the activation of Bharat selectively automated current switch in view of the teachings of Shinna regarding alternating the transmission between different probes to reduce crosstalk and interference while activated. The motivation to do this yield predictable results such as avoid interference when ultrasonic wave transmitting areas of individual probes overlap, ¶0064 as explicitly suggested by Shinna.
Claim 12: Modified Bharat discloses all the elements above in claim 11, Bharat discloses, further comprising:
a tracking system (tracking system 140) including the device tracker (tracking sensor 144) ([Abstract], ‘a tracking sensor disposed within the subject and configured to move within the ROI, the sensor being responsive to signals transmitted by the apertures, and at least one processor in communication with the ultrasound transducer assembly and the tracking sensor.’; [0010], ‘multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system.’; [0025], ‘at least one processor (e.g., the receipt and processing of tracking data) may be performed by a processor separate from the medical diagnostic system, such as a processor of a tracking system which is communicatively coupled to the medical diagnostic system.’), the processor; ¶0027, ‘the processor may track the position of the sensor and controls the large area array to activate an aperture which includes the tracking sensor within its field of view. The active aperture may be any group of elements (e.g., a group of contiguous elements of a single large area array), which are selected electronically based on the position of the tracking sensor and thus based on the location of the interventional tool within the vessel.’), and the multiplexer (Multiplexer 230);
wherein the tracking system is configured to determine the pose of the device relative to the at least one ultrasound transducer of the plurality of ultrasound transducers. ([0032], ‘a position of the tracking sensor from data generated responsive to signals transmitted by at least one aperture, and generate another image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position of the tracking sensor. These functions can be performed by one or more processors of the ultrasound imaging apparatus 120 (e.g., processor 121), one or more processors of a tracking system 140 (e.g., circuitry 144), or combinations thereof.’; [0033], ‘the tracking sensors 142 may be operatively associated with a tracking system 140. As shown, the sensor 142 may be positioned on an intervention tool 106 (e.g., a needle, guidewire or catheter) during an intervention procedure and the tracking system 140 may generate tracking information based on the location of the sensor 142 within a tracked field. The tracking sensor may include an ultrasound sensor, pressure sensor, or any other sensor responsive to ultrasound pulses emitted from the assembly 110. The tracking information may be transmitted to the multiplexer and/or the imaging apparatus 120 for selectively activating (e.g., via automatic electronic control) an appropriate aperture of the large array transducer. In this manner the system 100 may be configured to selectively activate one or more apertures 112 of the large area array based on the tracking information.’)
Bharat fails to disclose that the tracking system includes the at least one ultrasound transducer tracker; wherein the tracking system is configured to determine the pose of the at least one ultrasound transducer of the plurality of ultrasound transducers with the at least one ultrasound transducer tracker.
However, Lazebnik discloses: the at least one ultrasound transducer tracker; wherein the tracking system is configured to determine the pose of the at least one ultrasound transducer of the plurality of ultrasound transducers with the at least one ultrasound transducer tracker.
-Lazebnik discloses, location device 14 is included in or on the ultrasound transducer (12, 16), ¶0027-0028. The location device 14 may be mounted on, placed within, or formed as part of the housing of the transducer. ¶0027-0028. The function of the location device 14 is determined the spatial location and/or orientation of each transducer (12, 16), ¶0038. This is necessary because high quality registration of subvolumes may be difficul without accurate spatial information regarding each transducer’s location and orientation, ¶0017. The location device 14 determines the location of the probe or transducer such as relative to room space or other transducers, and indicates the relative positions of scanned voles or places acquired with different transducers, ¶0029-0030. The sensors may also include optical sensors, ¶0031. The usage of such positional information from the location device 14 is used for aligning (registering) the scan volumes, respectfully, indicating the positions of the transducers during their respective scans, ¶0045-0046. In addition, initial position estimates can be provided by the location device 14 associated with each transducer, ¶0049.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the at least on ultrasound transducer of the plurality of ultrasound transducers of modified Bharat to include a sensor (i.e., the tracker attached to probes) in view of the teachings of Lazebnik. The motivation to do this yields predictable results such as improving spatial information regarding each transducers location, ¶0017, during their respective scans, ¶0045-0046, as suggested by Lazebnik.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the tracking system of modified to include the teachings of Lazebnik. The motivation to do this yields predictable results such as improving spatial information regarding each transducers location, ¶0017, during their respective scans, ¶0045-0046, as suggested by Lazebnik. The modified combination would disclose wherein the tracking system is configured to determine the pose of the device and the at least one ultrasound transducer of the plurality of ultrasound transducers with the device tracker and the at least one ultrasound transducer tracker, respectively.
Claim 15: Modified Bharat as modified discloses all the elements above in claim 12, Bharat discloses, the processor (121) is configured to execute instructions to: ([0025], ‘The ultrasound imaging system may further include at least one processor in communication with the ultrasound transducer assembly and the tracking sensor.’; ¶0027, ‘the processor may track the position of the sensor and controls the large area array to activate an aperture which includes the tracking sensor within its field of view. The active aperture may be any group of elements (e.g., a group of contiguous elements of a single large area array), which are selected electronically based on the position of the tracking sensor and thus based on the location of the interventional tool within the vessel.’)
determine the pose of the device based at least on tracking the device tracker; and ([0024], ‘a tracking sensor configured to be disposed within the subject and movable within the ROI. For example, the tracking sensor may be attached to an interventional tool (e.g., a needle, guidewire, cannula, catheter, or the like).’; [0008], ‘the ultrasound imaging system may further include a multiplexer that is in communication with the at least one processor and the ultrasound transducer assembly and the multiplexer may be configured to selectively control the apertures based on the identified position of the tracking sensor.’)
wherein the multiplexer is configured to execute instructions to: ([0038], ‘The multiplexer 130 may be configured to selectively communicatively couple any one (or more) of the apertures 112 to the imaging apparatus 120 based on tracking information from the sensor 142 positioned on the interventional tool 106.’)
determine that a selected portion of the device is within a selected proximity of the at least one of the ultrasound transducers of the plurality of ultrasound transducers; and (([Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’; [0008], ‘the ultrasound imaging system may further include a multiplexer that is in communication with the at least one processor and the ultrasound transducer assembly and the multiplexer may be configured to selectively control the apertures based on the identified position of the tracking sensor.’; [0010], ‘an ultrasound imaging apparatus coupled to each of the plurality of independently controllable apertures and configured to generate ultrasound images based on the received signals, a tracking sensor operatively associated with a tracking system and configured to be positioned on an interventional tool during an intervention procedure, and a multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system’; [0035], ‘the tracking system 140 determines that the sensor is aligned with the perimeter scan lines of the active aperture (as determined based on the known location of the transmit beams), the system (e.g., multiplexer 130) may activate the next probe ahead of the currently active aperture. In some examples, the perimeter scan lines may correspond from about 1 mm to about 3 mm, in some cases about 2 mm, of a FOV of about 4 cm in length, which may be achieved by a probe, for example, with about 320 transmit beams or a different number of beams. Additionally or alternatively, when the sensor is determined to be aligned with the perimeter scan lines and the sensor signal decreases at each frame, the multiplexer may activate the next probe in the array. Additionally or alternatively, the multiplexer may activate the next probe in the array once the signal fall off completely, which may correspond to the sensor leaving the FOV of the active aperture.’)
activate the at least one ultrasound transducer of the plurality of ultrasound transducers to acquire real time image data. ([Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’)
Claim 16: Modified Bharat as modified discloses all the elements above in claim 12, Bharat discloses, the processor is configured to execute instructions to: ([0025], ‘The ultrasound imaging system may further include at least one processor in communication with the ultrasound transducer assembly and the tracking sensor.’; ¶0027, ‘the processor may track the position of the sensor and controls the large area array to activate an aperture which includes the tracking sensor within its field of view. The active aperture may be any group of elements (e.g., a group of contiguous elements of a single large area array), which are selected electronically based on the position of the tracking sensor and thus based on the location of the interventional tool within the vessel.’)
evaluate an initial scan of the subject with the plurality of ultrasound transducers to determine a field of view of each ultrasound transducers of the plurality of ultrasound transducers; and determine the determined field of view that a selected portion of the device is within or within a proximity of the determined field of view based at least on the determined pose of the device; wherein the multiplexer is configured to execute instructions to activate the at least one ultrasound transducer of the plurality of ultrasound transducers having the determined field of view to acquire the real time image data. ([0038], ‘The multiplexer 130 may be configured to selectively communicatively couple any one (or more) of the apertures 112 to the imaging apparatus 120 based on tracking information from the sensor 142 positioned on the interventional tool 106.’; [Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’; [0008], ‘the ultrasound imaging system may further include a multiplexer that is in communication with the at least one processor and the ultrasound transducer assembly and the multiplexer may be configured to selectively control the apertures based on the identified position of the tracking sensor.’; [0010], ‘an ultrasound imaging apparatus coupled to each of the plurality of independently controllable apertures and configured to generate ultrasound images based on the received signals, a tracking sensor operatively associated with a tracking system and configured to be positioned on an interventional tool during an intervention procedure, and a multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system’; [0035], ‘the tracking system 140 determines that the sensor is aligned with the perimeter scan lines of the active aperture (as determined based on the known location of the transmit beams), the system (e.g., multiplexer 130) may activate the next probe ahead of the currently active aperture. In some examples, the perimeter scan lines may correspond from about 1 mm to about 3 mm, in some cases about 2 mm, of a FOV of about 4 cm in length, which may be achieved by a probe, for example, with about 320 transmit beams or a different number of beams. Additionally or alternatively, when the sensor is determined to be aligned with the perimeter scan lines and the sensor signal decreases at each frame, the multiplexer may activate the next probe in the array. Additionally or alternatively, the multiplexer may activate the next probe in the array once the signal fall off completely, which may correspond to the sensor leaving the FOV of the active aperture.’)
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Lazebnik (US 2011/0125022 A1) in view of Shiina et al (US 20090275837 A1), as applied to claim 11, in further view of Govari (US 2002/0107445 A1).
Claim 17: Modified Bharat discloses all the elements above in claim 11, Bharat discloses, further comprising: wherein the multiplexer is configured to execute instructions to operate the at least one ultrasound transducer to acquire the real time image data. ([0038], ‘The multiplexer 130 may be configured to selectively communicatively couple any one (or more) of the apertures 112 to the imaging apparatus 120 based on tracking information from the sensor 142 positioned on the interventional tool 106.’; ([Abstract], ‘The at least one processor may be configured to generate a first image of a first portion of the ROI from signals received from at least one activated aperture, identify a position of the tracking sensor using signal data from the tracking sensor that corresponds to at least one signal transmitted by the apertures, and generate a second image of a second portion of the ROI from signals received from at least one other aperture activated based on the identified position, wherein the second portion of the ROI is different from the first portion of the ROI.’; [0008], ‘the ultrasound imaging system may further include a multiplexer that is in communication with the at least one processor and the ultrasound transducer assembly and the multiplexer may be configured to selectively control the apertures based on the identified position of the tracking sensor.’; [0010], ‘an ultrasound imaging apparatus coupled to each of the plurality of independently controllable apertures and configured to generate ultrasound images based on the received signals, a tracking sensor operatively associated with a tracking system and configured to be positioned on an interventional tool during an intervention procedure, and a multiplexer connecting each of the independently controllable apertures to the ultrasound imaging apparatus, wherein the multiplexer is configured to communicatively couple one or more of the plurality of independently controllable apertures to the ultrasound imaging apparatus based on tracking information received from the tracking system’; [0035], ‘the tracking system 140 determines that the sensor is aligned with the perimeter scan lines of the active aperture (as determined based on the known location of the transmit beams), the system (e.g., multiplexer 130) may activate the next probe ahead of the currently active aperture. In some examples, the perimeter scan lines may correspond from about 1 mm to about 3 mm, in some cases about 2 mm, of a FOV of about 4 cm in length, which may be achieved by a probe, for example, with about 320 transmit beams or a different number of beams. Additionally or alternatively, when the sensor is determined to be aligned with the perimeter scan lines and the sensor signal decreases at each frame, the multiplexer may activate the next probe in the array. Additionally or alternatively, the multiplexer may activate the next probe in the array once the signal fall off completely, which may correspond to the sensor leaving the FOV of the active aperture.’)
Bharat fails to disclose:
a proximity sensor included with the at least one of the ultrasound transducers of the plurality of ultrasound transducers; a sense portion included with the device;
wherein the proximity sensor is configured to sense the sense portion to determine a proximity of the device relative to at least one of the ultrasound transducers of the plurality of ultrasound transducers; and
However, Govari in the context of passive tags in a ultrasound field of endeavor discloses: a proximity sensor (detectors 34, 36 and 38) included with at least one of the ultrasound transducers of the plurality of ultrasound transducers (FIG. 1); ([0078], ‘The position and/or orientation of the distal end of the catheter is obtained by determining the position and/or orientation of tag 12. Different possible implementations of tag 12 are shown below in FIGS. 2, 3, 4 and 5A/5B and are described in detail with reference thereto. In some embodiments, tag 12 emits ultrasonic radiation when subjected to ultrasonic irradiation by acoustic generators 11, 13 and 15. The ultrasonic emission of the tag is sensed by acoustic detectors 34, 36 and 38.’; [0092], ‘These ultrasound waves are sensed by acoustic detectors 34, 36 and 38, and the resultant signals are analyzed by signal processor 30 to determine the location of the tag by triangulation.’)
a sense portion included with the device; ([0077], ‘Catheter 22 comprises a body 14, a wireless locating tag 12, and an active portion 10 at the distal end of the catheter.’)
wherein the proximity sensor is configured to sense the sense portion to determine a proximity of the device relative to at least one of the ultrasound transducers of the plurality of ultrasound transducers; and (FIG. 1; [0078], ‘The position and/or orientation of the distal end of the catheter is obtained by determining the position and/or orientation of tag 12. Different possible implementations of tag 12 are shown below in FIGS. 2, 3, 4 and 5A/5B and are described in detail with reference thereto. In some embodiments, tag 12 emits ultrasonic radiation when subjected to ultrasonic irradiation by acoustic generators 11, 13 and 15. The ultrasonic emission of the tag is sensed by acoustic detectors 34, 36 and 38.’; [0081], ‘The position measurement is preferably based on a triangulation algorithm, as is known in the art. The detectors may be arranged in any convenient position and orientation, but it is preferable that (a) they are fixed in respect to some reference frame;’; [0085], ‘The power of the signal emitted by the tag at frequency f2 is preferably measured by detectors 34, 36, 38 at three or more sites outside the patient's body, in order to allow the determination of the target's location by triangulation.’; [0092], ‘These ultrasound waves are sensed by acoustic detectors 34, 36 and 38, and the resultant signals are analyzed by signal processor 30 to determine the location of the tag by triangulation.’; [0098], ‘Triangulation of the power of the electromagnetic wave emitted by the circuit yields the location of the tag. Typically, three or more RF detectors at respective sites are used for this purpose. The angular position of the tag can also be determined, at least in part, based on the angular position of the inductor in the resonant circuit’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ultrasound transducers and device of Bharat such that it includes a proximity sensor and sense portion respectively as taught by Govari for the advantage of improving guidance with such an apparatus being able to [0014], ‘provide improved wireless tags, which are fixed to devices that are inserted into or implanted in the body of a patient for use in determining coordinates of the device inside the body.’, as suggested by Govari.
Claims 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Shiina et al (US 20090275837 A1), as applied to claim 1, in further view of Wodlinger et al (US 2020/0022681 A1, herein Wodlinger).
Claim 21: Bharat as modified discloses all the elements above in claim 1, Bharat discloses, wherein the multiplexing includes at least operating a switch to turn on and off at least one ultrasound transducer of the plurality of ultrasound transducers. ([0037], 'Based on this relative localizing of tracked objects within the tracked field, the tracking system 140 may determine when the tracking sensor enters and exits the field of view, and correspondingly, is within the FOV, of a given aperture. This information can be used to provide activation commands (e.g., generate a select signal for operating the switching circuitry of the multiplexer) to selectively couple and decouple signal lines of one or more apertures of the large area array 110.'; [0039], 'the multiplexer may include a plurality of switches 132, each of which is coupled to one of the apertures 112. The multiplexer 130 may also include a selector circuit 130 which is configured to generate the select signals for operating the switches 132. For example, the selector circuit 130 may receive data, generated by the tracking system 140 based on tracking information from sensor 142, which may be indicative of whether the tracking sensor 142 is within the field of view of a current active aperture (i.e., an aperture communicatively coupled to transmit and receive signals from the imaging apparatus 120). Based on the data, the selector circuit 130 may generate one or more select signals 135. The select signal(s) may be configured to close a switch associated with the next aperture if the data indicates that the tracking sensor is outside of the FOV of the currently active aperture. In some examples, the select signal(s) may be further configured, responsive to an indication that the tracking sensor is outside of the FOV of the currently active aperture, to open a switch associated with currently active aperture or an aperture preceding the currently active aperture to deactivate the currently active aperture or an aperture preceding the currently active aperture. The terms next and preceding (or equivalently ahead of and behind) are generally used herein in imply relative location of apertures with relation to the travel path of the interventional tool (e.g., next being the aperture forward of the currently active aperture along the path of travel of the interventional tool and preceding being the aperture before the currently active aperture along the path of travel of the interventional tool) and are not meant to be limiting in any other way.'; [0041], 'the multiplexer may automatically switch between apertures responsive to commands from the processor 460. In this manner, the multiplexer may be configured to selectively communicatively couple one or more of the plurality of independently controllable apertures to the imaging apparatus based on tracking information received from the tracking system. By automatically (e.g., electronically) moving the aperture along the length of the array and thus along the length of the vessel, the system obviates the need for physically moving a probe during the guidance procedure as was needed with conventional system, which may not only simplify the clinical workflow, but may also reduce artifacts in the images (e.g., in panoramic views obtained from and while physically moving a probe).'; [0045], 'select signals may be applied to switching circuitry of the multiplexer to communicatively couple the second probe to the imaging apparatus 220. Additionally and optionally (e.g., in the case where the imaging apparatus 220 is operable to receive echo information from only one aperture at a time), the multiplexer 230 may generate a command for deactivating the first probe. Responsively, select signals may be applied to switching circuitry of the multiplexer to communicatively decouple the first probe from the imaging apparatus 220. This process of automatic electronic movement of the aperture along the length of the array 210 may continue during the intervention procedure to track the movement and thus continue to image the interventional tool as it advances along the length of the vessel 204. While only four probes are shown in FIG. 2A, for illustration only, it will be understood that any (e.g., fewer or more than four) number of probes may be used in some examples.')
Bharat discusses, switching between ultrasound apertures and transducers by providing examples involving automatic or electronic control based on information or commands. However, Bharat fails to disclose the feature of manually operating the switch, such that wherein the multiplexing includes at least manually operating a switch to turn on and turn off at least one ultrasound transducer of the plurality of ultrasound transducers.
However, Wodlinger in the context of signal processing pathway for ultrasonic imaging device discloses, least manually operating a switch to turn on and turn off at least one ultrasound transducer of the plurality of ultrasound transducers. ([0114], ‘the transducer switch 400 may be a manual switch whereby a user can manually select which ultrasonic transducer array 103 to use.’; [0115], ‘the transducer switch 400 may be a part of a hot-swap mechanism that allows users to plug and unplug ultrasonic transducer arrays 103 as required. This allows for different ultrasonic transducer arrays 103 to be used in the same signal processing pathway 100.”)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the operation switching of transducers of modified Bharat such that it is a manual operation of switching as taught by Wodlinger. The motivation to do this yields predictable results such as allowing different ultrasound transducers to be used in the same signal processing pathway as suggested by Wodlinger, [0115].
Claim 14: Bharat as modified discloses all the elements above in claim 22, Bharat fails to disclose, wherein the manual switch includes an electronic switch that is manually selected by a user.
However, Wodlinger is relied upon above discloses, wherein the manual switch includes an electronic switch that is manually selected by a user. ([0114], ‘the transducer switch 400 may be a manual switch whereby a user can manually select which ultrasonic transducer array 103 to use.’; [0115], ‘the transducer switch 400 may be a part of a hot-swap mechanism that allows users to plug and unplug ultrasonic transducer arrays 103 as required. This allows for different ultrasonic transducer arrays 103 to be used in the same signal processing pathway 100.”)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the manual switch of modified Bharat such that includes an electronic switch that is manually selected by a user as taught by Wodlinger. The motivation to do this yields predictable results such as allowing different ultrasound transducers to be used in the same signal processing pathway as suggested by Wodlinger, [0115].
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al (US 2019/0380679 A1, herein Bharat) in view of Lazebnik (US 2011/0125022 A1) in view of Shiina et al (US 20090275837 A1), as applied to claim 11, in further view of Wodlinger et al (US 2020/0022681 A1, herein Wodlinger).
Claim 22: Bharat as modified discloses all the elements above in claim 11, Bharat discloses, wherein the multiplexing includes a switch configured to allow turning off and turning on at least one ultrasound transducer of the plurality of ultrasound transducers. ([0037], 'Based on this relative localizing of tracked objects within the tracked field, the tracking system 140 may determine when the tracking sensor enters and exits the field of view, and correspondingly, is within the FOV, of a given aperture. This information can be used to provide activation commands (e.g., generate a select signal for operating the switching circuitry of the multiplexer) to selectively couple and decouple signal lines of one or more apertures of the large area array 110.'; [0039], 'the multiplexer may include a plurality of switches 132, each of which is coupled to one of the apertures 112. The multiplexer 130 may also include a selector circuit 130 which is configured to generate the select signals for operating the switches 132. For example, the selector circuit 130 may receive data, generated by the tracking system 140 based on tracking information from sensor 142, which may be indicative of whether the tracking sensor 142 is within the field of view of a current active aperture (i.e., an aperture communicatively coupled to transmit and receive signals from the imaging apparatus 120). Based on the data, the selector circuit 130 may generate one or more select signals 135. The select signal(s) may be configured to close a switch associated with the next aperture if the data indicates that the tracking sensor is outside of the FOV of the currently active aperture. In some examples, the select signal(s) may be further configured, responsive to an indication that the tracking sensor is outside of the FOV of the currently active aperture, to open a switch associated with currently active aperture or an aperture preceding the currently active aperture to deactivate the currently active aperture or an aperture preceding the currently active aperture. The terms next and preceding (or equivalently ahead of and behind) are generally used herein in imply relative location of apertures with relation to the travel path of the interventional tool (e.g., next being the aperture forward of the currently active aperture along the path of travel of the interventional tool and preceding being the aperture before the currently active aperture along the path of travel of the interventional tool) and are not meant to be limiting in any other way.'; [0041], 'the multiplexer may automatically switch between apertures responsive to commands from the processor 460. In this manner, the multiplexer may be configured to selectively communicatively couple one or more of the plurality of independently controllable apertures to the imaging apparatus based on tracking information received from the tracking system. By automatically (e.g., electronically) moving the aperture along the length of the array and thus along the length of the vessel, the system obviates the need for physically moving a probe during the guidance procedure as was needed with conventional system, which may not only simplify the clinical workflow, but may also reduce artifacts in the images (e.g., in panoramic views obtained from and while physically moving a probe).'; [0045], 'select signals may be applied to switching circuitry of the multiplexer to communicatively couple the second probe to the imaging apparatus 220. Additionally and optionally (e.g., in the case where the imaging apparatus 220 is operable to receive echo information from only one aperture at a time), the multiplexer 230 may generate a command for deactivating the first probe. Responsively, select signals may be applied to switching circuitry of the multiplexer to communicatively decouple the first probe from the imaging apparatus 220. This process of automatic electronic movement of the aperture along the length of the array 210 may continue during the intervention procedure to track the movement and thus continue to image the interventional tool as it advances along the length of the vessel 204. While only four probes are shown in FIG. 2A, for illustration only, it will be understood that any (e.g., fewer or more than four) number of probes may be used in some examples.')
Bharat discusses, switching between ultrasound apertures and transducers by providing examples involving automatic or electronic control based on information or commands. However, Bharat fails to disclose the feature of a manual switch, such that wherein the multiplexer includes a manual switch configured to allow manually turning on and turning off at least one ultrasound transducer of the plurality of ultrasound transducers.
However, Wodlinger in the context of signal processing pathway for ultrasonic imaging device discloses, a manual switch configured to allow turning on and turning off at least one ultrasound transducer of the plurality of ultrasound transducers. ([0114], ‘the transducer switch 400 may be a manual switch whereby a user can manually select which ultrasonic transducer array 103 to use.’; [0115], ‘the transducer switch 400 may be a part of a hot-swap mechanism that allows users to plug and unplug ultrasonic transducer arrays 103 as required. This allows for different ultrasonic transducer arrays 103 to be used in the same signal processing pathway 100.”)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the apparatus of modified Bharat such that it includes the manual switch configured to allow turning on an off at least one ultrasound transducer of the plurality of ultrasound transducers as taught by Wodlinger. The motivation to do this yields predictable results such as allowing different ultrasound transducers to be used in the same signal processing pathway as suggested by Wodlinger, [0115].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bharat et al (US 2020/0022680 A1) discloses: multiplexing a plurality of ultrasound transducers to generate a composite image of ultrasound sensors disposed within a subject.
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.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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