DETAILED ACTION
This office action is in response to the communication received on 06/30/2025 concerning application no. 19/255,666 filed on 06/30/2025.
Claims 1-12 are pending.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 are eligible under 35 U.S.C. 101. Independent claim 1 is using collected ultrasound information from a 3D field of view to assess the position of a position indicator within the 3D field of view according to a maximum intensity beam from a plurality of beams and controlling the beamforming ultrasound imaging probe to then transmit and receive at only a localized field of view where the position indicator is located. This second subsequent ultrasound emission at the localized field of view is the basis on which the ultrasound image is generated. Such a localization of the field of view based on the determinations quick and “alleviates the need for a user to manually adjust the positioning of the ultrasound imaging probe in order to find the position indicator” as noted in paragraph 0014 of the specification. Paragraph 0014 continues with “Moreover, by dividing the entire field of view into such sub-volumes and scanning the sub-volumes sequentially, the need to search the entire three-dimensional field of view in order to provide the localized field of view is typically avoided, and thus the localized field of view is provided quickly.” Therefore, claims 1-12 are deemed to be patent eligible.
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 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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vaidya et al. (WO2018/108638) in view of Van Rens et al. (WO2017076758).
Regarding claim 1, Vaidya teaches an apparatus, comprising:
one or more processors configured for communication with the beamforming ultrasound imaging probe (Paragraph 0022 teaches the use of a processor), wherein the one or more processor is configured to:
control the beamforming ultrasound imaging probe to transmit and receive first ultrasound signals within the 3D field of view (Paragraphs 0024-26 teach the use of beamforming that transmits and receives reflected ultrasound);
identify, based on the first ultrasound signals, a maximum intensity beam from among the plurality of ultrasound beams, wherein the maximum intensity beam is representative of a position indicator disposed on an interventional device (Paragraph 0054 teaches that the sensor is an ultrasonic sensor. Paragraphs 0054-55 teach that the sensor receives the ultrasound signal and emits it to the transceiver that is tracking the sensor. Paragraph 0059 teaches that the localization and synchronization is according to the sensor relative to the scanned image);
control the beamforming ultrasound imaging probe to transmit and receive second ultrasound signals within only a localized field of view in which the position indicator is located, wherein the localized field of view is smaller than the 3D field of view, wherein the localized field of view is defined by the maximum intensity beam and a subset of the plurality of ultrasound beams proximate to the maximum intensity beam in the first dimension and the second dimension (Paragraph 0065 teaches that that the location is performed according to the time at the clock where the maximum signal is received. The clock is synchronized using the frame and line triggers that are wirelessly received. Paragraph 0067 teaches that the signal of the sensor may be clipped only the relevant parts that are in and around the maximum signal intensity location. Paragraph 0078 teaches that the location of the sensor can be repeatedly sent and can be superposed on the particular frame in real time); and
cause a display to display an ultrasound image based on the second ultrasound signals (Paragraphs 0036-38 teaches the display of the images. Paragraph 0078 teaches that the location of the sensor can be repeatedly sent and can be superposed on the particular frame in real time).
However, Vaidya is silent regarding an apparatus,
a beamforming ultrasound imaging probe configured to provide a three-dimensional (3D) field of view defined by a plurality of ultrasound beams arranged in a first dimension and in a second dimension perpendicular to the first dimension.
In an analogous imaging field of endeavor, regarding beamforming, Van Rens teaches an apparatus, a beamforming ultrasound imaging probe configured to provide a three-dimensional (3D) field of view defined by a plurality of ultrasound beams arranged in a first dimension and in a second dimension perpendicular to the first dimension (Page 20 teaches acquisition of 3D field of view. Pages 6-7 teach that the OFK plane of imaging is perpendicular to the probe surface and parallel to the elevation direction. The OEF other plane is perpendicular to both and is parallel to the azimuth direction. The azimuth steering angle of the beam is an angle between the steered beam and the plane being perpendicular to the array and parallel to the elevation direction such as OKF plane. An elevation steering angle (alpha) of the beam is defined as an angle between the steered beam and the plane being perpendicular to the array and parallel to the azimuth direction such as OEF plane. See Figs. 2-5).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Vaidya with Van Rens’s teaching of 3D field of view imaging with perpendicular beams. This modified apparatus would allow the user to improve image contrast and have optimal acquisition (Page 10 of Van Rens). Furthermore, the modification provides optimal beam steering (Page 4 of Van Rens).
Regarding claim 2, modified Vaidya teaches the apparatus in claim 1, as discussed above.
Vaidya further teaches an apparatus, wherein the subset of the plurality of ultrasound beams comprises a predetermined selection of the plurality of ultrasound beams (Paragraph 0074 teaches that the beamformer can transmit only a predetermined subset of the triggers. Paragraph 0024 teaches that the beam is emitted according to the trigger).
Regarding claim 3, modified Vaidya teaches the apparatus in claim 2, as discussed above.
Vaidya further teaches an apparatus, wherein the localized field of view is centered on the maximum intensity beam (Paragraph 0065 teaches that that the location is performed according to the time at the clock where the maximum signal is received. The clock is synchronized using the frame and line triggers that are wirelessly received. Paragraph 0067 teaches that the signal of the sensor may be clipped only the relevant parts that are in and around the maximum signal intensity location. Paragraph 0078 teaches that the location of the sensor can be repeatedly sent and can be superposed on the particular frame in real time).
Regarding claim 4, modified Vaidya teaches the apparatus in claim 3, as discussed above.
Vaidya further teaches an apparatus, wherein the subset of the plurality of ultrasound beams comprises ultrasound beams surrounding the maximum intensity beam (Paragraph 0074 teaches that the beamformer can transmit only a predetermined subset of the triggers. Paragraph 0024 teaches that the beam is emitted according to the trigger. Paragraph 0065 teaches that that the location is performed according to the time at the clock where the maximum signal is received. The clock is synchronized using the frame and line triggers that are wirelessly received. Paragraph 0067 teaches that the signal of the sensor may be clipped only the relevant parts that are in and around the maximum signal intensity location. Paragraph 0078 teaches that the location of the sensor can be repeatedly sent and can be superposed on the particular frame in real time).
Regarding claim 5, modified Vaidya teaches the apparatus in claim 1, as discussed above.
Vaidya further teaches an apparatus, wherein the subset of the plurality of ultrasound beams comprises ultrasound beams adjacent to the maximum intensity beam in at least one of the first dimension or the second dimension (Paragraph 0059 teaches that the timing is according to the location of the sensor. Fig. 4 shows the beams that are adjacent to the beam associated with the reflector).
Regarding claim 6, modified Vaidya teaches the apparatus in claim 1, as discussed above.
However, Vaidya is silent regarding an apparatus, wherein the plurality of ultrasound beams define a 2D grid, wherein the maximum intensity beam comprises a location along the first dimension and a location along the second dimension in the 2D grid.
In an analogous imaging field of endeavor, regarding beamforming, Van Rens teaches an apparatus, wherein the plurality of ultrasound beams define a 2D grid, wherein the maximum intensity beam comprises a location along the first dimension and a location along the second dimension in the 2D grid (Page 20 teaches acquisition of 3D field of view. Pages 6-7 teach that the OFK plane of imaging is perpendicular to the probe surface and parallel to the elevation direction. The OEF other plane is perpendicular to both and is parallel to the azimuth direction. The azimuth steering angle of the beam is an angle between the steered beam and the plane being perpendicular to the array and parallel to the elevation direction such as OKF plane. An elevation steering angle (alpha) of the beam is defined as an angle between the steered beam and the plane being perpendicular to the array and parallel to the azimuth direction such as OEF plane. See Figs. 2-5).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Vaidya with Van Rens’s teaching of a grid shaped steering. This modified apparatus would allow the user to improve image contrast and have optimal acquisition (Page 10 of Van Rens). Furthermore, the modification provides optimal beam steering (Page 4 of Van Rens).
Regarding claim 7, modified Vaidya teaches the apparatus in claim 1, as discussed above.
Vaidya further teaches an apparatus, wherein the position indicator comprises an ultrasound sensor distinct from the beamforming ultrasound imaging probe (Paragraph 0054 teaches use of an ultrasonic sensor).
Regarding claim 8, modified Vaidya teaches the apparatus in claim 7, as discussed above.
Vaidya further teaches an apparatus, wherein the ultrasound sensor is configured to generate electrical signals in response to the first ultrasound signals transmitted by the beamforming ultrasound imaging probe, wherein the electrical signals comprise intensities representative of a closeness of the plurality of ultrasound beams to the ultrasound sensor (Paragraph 0065 teaches that that the location is performed according to the time at the clock where the maximum signal is received. The clock is synchronized using the frame and line triggers that are wirelessly received. Paragraph 0067 teaches that the signal of the sensor may be clipped only the relevant parts that are in and around the maximum signal intensity location. Paragraph 0078 teaches that the location of the sensor can be repeatedly sent and can be superposed on the particular frame in real time. See Fig. 4).
Regarding claim 9, modified Vaidya teaches the apparatus in claim 8, as discussed above.
Vaidya further teaches an apparatus, wherein, to determine the maximum intensity beam, the one or more processors is configured to:
receive synchronization signals from the beamforming ultrasound imaging probe, wherein the synchronization signals are representative of times at which the first ultrasound signals are transmitted by the beamforming ultrasound imaging probe (Paragraph 0059 teaches that the clock of the medical device and the control unit of the probe are synchronized. Fig. 4 shows the association of the sensor signal and the delta t with respect to the trigger); and
receive the electrical signals generated by the ultrasound sensor (Paragraph 0054 teaches that the ultrasound signal is converted to an electric signal); and
determine the maximum intensity beam based on the synchronization signals and intensities of the electrical signals generated by the ultrasound sensor (Paragraphs 0063-65 teach that the position of the sensor can be located in each of the frames and the time that is clocked. Paragraph 0020 teaches that the imaging can be in 3D).
Regarding claim 10, modified Vaidya teaches the apparatus in claim 1, as discussed above.
Vaidya further teaches an apparatus, wherein the one or more processors are further configured to control the beamforming ultrasound imaging probe to track movement of the position indicator without manual adjustment of the beamforming ultrasound imaging probe (Paragraphs 0024-26 teach the beamforming is transmitted automatically and will track the instrument for purpose of targeting and perform dynamic receive beamforming. Paragraph 0079 teaches identify and track the medical device using ultrasound-guided procedures by attaching a miniaturized ultrasound sensor to the medical device, and analyzing the ultrasound data received by the sensor as the imaging probe insonifies the medium).
Regarding claim 11, modified Vaidya teaches the apparatus in claim 10, as discussed above.
Vaidya further teaches an apparatus, wherein, to control the beamforming ultrasound imaging probe to track the position indicator, the one or more processors are configured to automatically change the localized field of view in response to the movement of the position indicator (Paragraphs 0024-26 teach the beamforming is transmitted automatically and will track the instrument for purpose of targeting and perform dynamic receive beamforming. Paragraph 0079 teaches identify and track the medical device using ultrasound-guided procedures by attaching a miniaturized ultrasound sensor to the medical device, and analyzing the ultrasound data received by the sensor as the imaging probe insonifies the medium).
Regarding claim 12, modified Vaidya teaches the apparatus in claim 1, as discussed above.
However, Vaidya is silent regarding an apparatus, wherein the beamforming ultrasound probe comprises at least one of a transthoracic echocardiography (TTE) probe, an intravascular ultrasound (IVUS) probe, or an intracardiac echocardiography (ICE) probe.
In an analogous imaging field of endeavor, regarding beamforming, Van Rens teaches an apparatus, wherein the beamforming ultrasound probe comprises at least one of a transthoracic echocardiography (TTE) probe, an intravascular ultrasound (IVUS) probe, or an intracardiac echocardiography (ICE) probe (Page 15 teaches use of ICE and IVUS).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Vaidya with Van Rens’s teaching of use of beamforming in ICE and IVUS. This modified apparatus would allow the user to improve image contrast and have optimal acquisition (Page 10 of Van Rens). Furthermore, the modification provides optimal beam steering (Page 4 of Van Rens).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,343,203 in view of Vaidya et al. (WO2018/108638) in view of Van Rens et al. (WO2017076758).
Regarding claim 1, U.S. Patent No. 12,343,203 teaches an apparatus,
one or more processors configured for communication with the beamforming ultrasound imaging probe, wherein the one or more processor is configured to: control the beamforming ultrasound imaging probe to transmit and receive first ultrasound signals within the 3D field of view; identify, based on the first ultrasound signals, a maximum intensity beam from among the plurality of ultrasound beams, wherein the maximum intensity beam is representative of a position indicator disposed on an interventional device; control the beamforming ultrasound imaging probe to transmit and receive second ultrasound signals within only a localized field of view in which the position indicator is located, wherein the localized field of view is smaller than the 3D field of view, wherein the localized field of view is defined by the maximum intensity beam and a subset of the plurality of ultrasound beams proximate to the maximum intensity beam in the first dimension and the second dimension (Claim 1 recites: A system for localizing a three-dimensional field of view, the system comprising: a beamforming ultrasound imaging probe is configured to transmit and receive ultrasound signals within the three-dimensional field of view comprising a plurality of predetermined sub-volumes, each sub-volume of the plurality of predetermined sub-volumes defined by a two-dimensional array of beams; a controller in communication with the beamforming ultrasound imaging probe, the controller comprising a first processor and is configured to cause the beamforming ultrasound imaging probe to scan the plurality of predetermined sub-volumes sequentially by transmitting and receiving ultrasound signals corresponding to each beam; a tracking system in communication with the beamforming ultrasound imaging probe and the controller, the tracking system comprising a second processor configured to: determine a position of a position indicator disposed within the three-dimensional field of view, and determine a sub-volume of the plurality of predetermined sub-volumes in which the position indicator is located based on the scan of the plurality of predetermined sub-volumes; and the first processor of the controller further configured to: cause the beamforming ultrasound imaging probe to scan the plurality of predetermined sub-volumes by transmitting and receiving ultrasound signals corresponding to each beam of the two-dimensional array of beams, and cause the beamforming ultrasound imaging probe to provide a localized field of view including the position of the position indicator by constraining the transmitting and receiving of ultrasound signals by the beamforming ultrasound imaging probe to a portion of the determined sub-volume in which the position indicator is located. Claim 2 recites: The system according to claim 1, wherein the position indicator is an ultrasound sensor; wherein the first processor of the controller is further configured to localize the three-dimensional field of view of the beamforming ultrasound imaging probe based on ultrasound signals detected by the ultrasound sensor; wherein the tracking system is an ultrasound tracking system; and wherein the second processor of the ultrasound tracking system is further configured to: receive synchronization signals from the beamforming ultrasound imaging probe, the synchronization signals corresponding to a time of emission of transmitted ultrasound signals for each beam of the two-dimensional array of beams, and receive electrical signals generated by the ultrasound sensor in response to ultrasound signals transmitted by the beamforming ultrasound imaging probe, determine the position of the position indicator within the three-dimensional field of view based on the received synchronization signals from the beamforming ultrasound imaging probe and the received electrical signals generated by the ultrasound sensor, and determine the sub-volume in which the ultrasound sensor is located, based on the received synchronization signals and a first scanned sub-volume of the plurality of predetermined sub-volumes having a maximum intensity beam for which an intensity of the generated electrical signals exceeds a predetermined threshold and is maximum for the respective sub-volume; and wherein the first processor of the controller is further configured to cause the beamforming ultrasound imaging probe to provide the localized field of view comprising the maximum intensity beam by constraining transmitting and receiving of ultrasound signals to the portion of the sub-volume in which the ultrasound sensor is located).
However, the claims of U.S. Patent No. 12,343,203 is silent regarding an apparatus, a beamforming ultrasound imaging probe configured to provide a three-dimensional (3D) field of view defined by a plurality of ultrasound beams arranged in a first dimension and in a second dimension perpendicular to the first dimension; and
cause a display to display an ultrasound image based on the second ultrasound signals.
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Vaidya teaches an apparatus, cause a display to display an ultrasound image based on the second ultrasound signals (Paragraphs 0036-38 teaches the display of the images. Paragraph 0078 teaches that the location of the sensor can be repeatedly sent and can be superposed on the particular frame in real time).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Vaidya’s teaching of a display for the image. This modified apparatus would allow the user to overcome the shortage of complicated workstations and improve marketplace acceptance (Paragraphs 0003-04 of Vaidya). Furthermore, the modification allows for in-situ tracking of medical devices with minimal invasion (Paragraph 0001 of Vaidya).
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Van Rens teaches an apparatus, beamforming ultrasound imaging probe configured to provide a three-dimensional (3D) field of view defined by a plurality of ultrasound beams arranged in a first dimension and in a second dimension perpendicular to the first dimension (Page 20 teaches acquisition of 3D field of view. Pages 6-7 teach that the OFK plane of imaging is perpendicular to the probe surface and parallel to the elevation direction. The OEF other plane is perpendicular to both and is parallel to the azimuth direction. The azimuth steering angle of the beam is an angle between the steered beam and the plane being perpendicular to the array and parallel to the elevation direction such as OKF plane. An elevation steering angle (alpha) of the beam is defined as an angle between the steered beam and the plane being perpendicular to the array and parallel to the azimuth direction such as OEF plane. See Figs. 2-5).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Van Rens’s teaching of perpendicular beamforming. This modified apparatus would allow the user to improve image contrast and have optimal acquisition (Page 10 of Van Rens). Furthermore, the modification provides optimal beam steering (Page 4 of Van Rens).
Regarding claim 2, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 1, as discussed above.
Claim 7 of U.S. Patent No. 12,343,203 further teaches an apparatus, wherein the subset of the plurality of ultrasound beams comprises a predetermined selection of the plurality of ultrasound beams (Claim 6 recites: The system according to claim 2, wherein the portion of the sub-volume comprises a predetermined selection of beams surrounding the maximum intensity beam. Claim 7 recites: The system according to claim 6, wherein the predetermined selection of beams is centered on the maximum intensity beam.).
Regarding claim 3, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 2, as discussed above.
Claim 7 of U.S. Patent No. 12,343,203 further teaches an apparatus, wherein the localized field of view is centered on the maximum intensity beam (Claim 6 recites: The system according to claim 2, wherein the portion of the sub-volume comprises a predetermined selection of beams surrounding the maximum intensity beam. Claim 7 recites: The system according to claim 6, wherein the predetermined selection of beams is centered on the maximum intensity beam.).
Regarding claim 4, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 3, as discussed above.
Claim 7 of U.S. Patent No. 12,343,203 further teaches an apparatus, wherein the subset of the plurality of ultrasound beams comprises ultrasound beams surrounding the maximum intensity beam (Claim 6 recites: The system according to claim 2, wherein the portion of the sub-volume comprises a predetermined selection of beams surrounding the maximum intensity beam. Claim 7 recites: The system according to claim 6, wherein the predetermined selection of beams is centered on the maximum intensity beam.).
Regarding claim 5, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 1, as discussed above.
However, the claims of U.S. Patent No. 12,343,203 is silent regarding an apparatus, wherein the subset of the plurality of ultrasound beams comprises ultrasound beams adjacent to the maximum intensity beam in at least one of the first dimension or the second dimension.
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Vaidya teaches an apparatus, wherein the subset of the plurality of ultrasound beams comprises ultrasound beams adjacent to the maximum intensity beam in at least one of the first dimension or the second dimension (Paragraph 0059 teaches that the timing is according to the location of the sensor. Fig. 4 shows the beams that are adjacent to the beam associated with the reflector).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Vaidya’s teaching of beams adjacent to the maximum intensity beam. This modified apparatus would allow the user to overcome the shortage of complicated workstations and improve marketplace acceptance (Paragraphs 0003-04 of Vaidya). Furthermore, the modification allows for in-situ tracking of medical devices with minimal invasion (Paragraph 0001 of Vaidya).
Regarding claim 6, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 1, as discussed above.
However, the claims of U.S. Patent No. 12,343,203 is silent regarding an apparatus, wherein the plurality of ultrasound beams define a 2D grid, wherein the maximum intensity beam comprises a location along the first dimension and a location along the second dimension in the 2D grid.
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Van Rens teaches an apparatus, wherein the plurality of ultrasound beams define a 2D grid, wherein the maximum intensity beam comprises a location along the first dimension and a location along the second dimension in the 2D grid (Page 20 teaches acquisition of 3D field of view. Pages 6-7 teach that the OFK plane of imaging is perpendicular to the probe surface and parallel to the elevation direction. The OEF other plane is perpendicular to both and is parallel to the azimuth direction. The azimuth steering angle of the beam is an angle between the steered beam and the plane being perpendicular to the array and parallel to the elevation direction such as OKF plane. An elevation steering angle (alpha) of the beam is defined as an angle between the steered beam and the plane being perpendicular to the array and parallel to the azimuth direction such as OEF plane. See Figs. 2-5).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Van Rens’s teaching of grid shaped steering. This modified apparatus would allow the user to improve image contrast and have optimal acquisition (Page 10 of Van Rens). Furthermore, the modification provides optimal beam steering (Page 4 of Van Rens).
Regarding claim 7, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 1, as discussed above.
Claim 2 of U.S. Patent No. 12,343,203 further teaches an apparatus, wherein the position indicator comprises an ultrasound sensor distinct from the beamforming ultrasound imaging probe (Claim 2 recites: The system according to claim 1, wherein the position indicator is an ultrasound sensor; wherein the first processor of the controller is further configured to localize the three-dimensional field of view of the beamforming ultrasound imaging probe based on ultrasound signals detected by the ultrasound sensor; wherein the tracking system is an ultrasound tracking system; and wherein the second processor of the ultrasound tracking system is further configured to: receive synchronization signals from the beamforming ultrasound imaging probe, the synchronization signals corresponding to a time of emission of transmitted ultrasound signals for each beam of the two-dimensional array of beams, and receive electrical signals generated by the ultrasound sensor in response to ultrasound signals transmitted by the beamforming ultrasound imaging probe, determine the position of the position indicator within the three-dimensional field of view based on the received synchronization signals from the beamforming ultrasound imaging probe and the received electrical signals generated by the ultrasound sensor, and determine the sub-volume in which the ultrasound sensor is located, based on the received synchronization signals and a first scanned sub-volume of the plurality of predetermined sub-volumes having a maximum intensity beam for which an intensity of the generated electrical signals exceeds a predetermined threshold and is maximum for the respective sub-volume; and wherein the first processor of the controller is further configured to cause the beamforming ultrasound imaging probe to provide the localized field of view comprising the maximum intensity beam by constraining transmitting and receiving of ultrasound signals to the portion of the sub-volume in which the ultrasound sensor is located.).
Regarding claim 8, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 7, as discussed above.
However, the claims of U.S. Patent No. 12,343,203 is silent regarding an apparatus, wherein the ultrasound sensor is configured to generate electrical signals in response to the first ultrasound signals transmitted by the beamforming ultrasound imaging probe, wherein the electrical signals comprise intensities representative of a closeness of the plurality of ultrasound beams to the ultrasound sensor.
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Vaidya teaches an apparatus, wherein the ultrasound sensor is configured to generate electrical signals in response to the first ultrasound signals transmitted by the beamforming ultrasound imaging probe, wherein the electrical signals comprise intensities representative of a closeness of the plurality of ultrasound beams to the ultrasound sensor (Paragraph 0065 teaches that that the location is performed according to the time at the clock where the maximum signal is received. The clock is synchronized using the frame and line triggers that are wirelessly received. Paragraph 0067 teaches that the signal of the sensor may be clipped only the relevant parts that are in and around the maximum signal intensity location. Paragraph 0078 teaches that the location of the sensor can be repeatedly sent and can be superposed on the particular frame in real time. See Fig. 4).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Vaidya’s teaching of generation of electrical signals according to intensity. This modified apparatus would allow the user to overcome the shortage of complicated workstations and improve marketplace acceptance (Paragraphs 0003-04 of Vaidya). Furthermore, the modification allows for in-situ tracking of medical devices with minimal invasion (Paragraph 0001 of Vaidya).
Regarding claim 9, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 8, as discussed above.
Claim 2 of U.S. Patent No. 12,343,203 further teaches an apparatus, wherein, to determine the maximum intensity beam, the one or more processors is configured to: receive synchronization signals from the beamforming ultrasound imaging probe, wherein the synchronization signals are representative of times at which the first ultrasound signals are transmitted by the beamforming ultrasound imaging probe; receive the electrical signals generated by the ultrasound sensor; and determine the maximum intensity beam based on the synchronization signals and intensities of the electrical signals generated by the ultrasound sensor (Claim 1 recites: A system for localizing a three-dimensional field of view, the system comprising: a beamforming ultrasound imaging probe is configured to transmit and receive ultrasound signals within the three-dimensional field of view comprising a plurality of predetermined sub-volumes, each sub-volume of the plurality of predetermined sub-volumes defined by a two-dimensional array of beams; a controller in communication with the beamforming ultrasound imaging probe, the controller comprising a first processor and is configured to cause the beamforming ultrasound imaging probe to scan the plurality of predetermined sub-volumes sequentially by transmitting and receiving ultrasound signals corresponding to each beam; a tracking system in communication with the beamforming ultrasound imaging probe and the controller, the tracking system comprising a second processor configured to: determine a position of a position indicator disposed within the three-dimensional field of view, and determine a sub-volume of the plurality of predetermined sub-volumes in which the position indicator is located based on the scan of the plurality of predetermined sub-volumes; and the first processor of the controller further configured to: cause the beamforming ultrasound imaging probe to scan the plurality of predetermined sub-volumes by transmitting and receiving ultrasound signals corresponding to each beam of the two-dimensional array of beams, and cause the beamforming ultrasound imaging probe to provide a localized field of view including the position of the position indicator by constraining the transmitting and receiving of ultrasound signals by the beamforming ultrasound imaging probe to a portion of the determined sub-volume in which the position indicator is located. Claim 2 recites: The system according to claim 1, wherein the position indicator is an ultrasound sensor; wherein the first processor of the controller is further configured to localize the three-dimensional field of view of the beamforming ultrasound imaging probe based on ultrasound signals detected by the ultrasound sensor; wherein the tracking system is an ultrasound tracking system; and wherein the second processor of the ultrasound tracking system is further configured to: receive synchronization signals from the beamforming ultrasound imaging probe, the synchronization signals corresponding to a time of emission of transmitted ultrasound signals for each beam of the two-dimensional array of beams, and receive electrical signals generated by the ultrasound sensor in response to ultrasound signals transmitted by the beamforming ultrasound imaging probe, determine the position of the position indicator within the three-dimensional field of view based on the received synchronization signals from the beamforming ultrasound imaging probe and the received electrical signals generated by the ultrasound sensor, and determine the sub-volume in which the ultrasound sensor is located, based on the received synchronization signals and a first scanned sub-volume of the plurality of predetermined sub-volumes having a maximum intensity beam for which an intensity of the generated electrical signals exceeds a predetermined threshold and is maximum for the respective sub-volume; and wherein the first processor of the controller is further configured to cause the beamforming ultrasound imaging probe to provide the localized field of view comprising the maximum intensity beam by constraining transmitting and receiving of ultrasound signals to the portion of the sub-volume in which the ultrasound sensor is located).
Regarding claim 10, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 1, as discussed above.
However, the claims of U.S. Patent No. 12,343,203 is silent regarding an apparatus, wherein the one or more processors are further configured to control the beamforming ultrasound imaging probe to track movement of the position indicator without manual adjustment of the beamforming ultrasound imaging probe.
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Vaidya teaches an apparatus, wherein the one or more processors are further configured to control the beamforming ultrasound imaging probe to track movement of the position indicator without manual adjustment of the beamforming ultrasound imaging probe (Paragraphs 0024-26 teach the beamforming is transmitted automatically and will track the instrument for purpose of targeting and perform dynamic receive beamforming. Paragraph 0079 teaches identify and track the medical device using ultrasound-guided procedures by attaching a miniaturized ultrasound sensor to the medical device, and analyzing the ultrasound data received by the sensor as the imaging probe insonifies the medium).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Vaidya’s teaching of automated adjustment of the beamforming. This modified apparatus would allow the user to overcome the shortage of complicated workstations and improve marketplace acceptance (Paragraphs 0003-04 of Vaidya). Furthermore, the modification allows for in-situ tracking of medical devices with minimal invasion (Paragraph 0001 of Vaidya).
Regarding claim 11, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 10, as discussed above.
However, the claims of U.S. Patent No. 12,343,203 is silent regarding an apparatus, wherein, to control the beamforming ultrasound imaging probe to track the position indicator, the one or more processors are configured to automatically change the localized field of view in response to the movement of the position indicator.
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Vaidya teaches an apparatus, wherein, to control the beamforming ultrasound imaging probe to track the position indicator, the one or more processors are configured to automatically change the localized field of view in response to the movement of the position indicator (Paragraphs 0024-26 teach the beamforming is transmitted automatically and will track the instrument for purpose of targeting and perform dynamic receive beamforming. Paragraph 0079 teaches identify and track the medical device using ultrasound-guided procedures by attaching a miniaturized ultrasound sensor to the medical device, and analyzing the ultrasound data received by the sensor as the imaging probe insonifies the medium).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Vaidya’s teaching of automated adjustment of the field of view. This modified apparatus would allow the user to overcome the shortage of complicated workstations and improve marketplace acceptance (Paragraphs 0003-04 of Vaidya). Furthermore, the modification allows for in-situ tracking of medical devices with minimal invasion (Paragraph 0001 of Vaidya).
Regarding claim 12, modified U.S. Patent No. 12,343,203 teaches the apparatus in claim 1, as discussed above.
However, the claims of U.S. Patent No. 12,343,203 is silent regarding an apparatus, wherein the beamforming ultrasound probe comprises at least one of a transthoracic echocardiography (TTE) probe, an intravascular ultrasound (IVUS) probe, or an intracardiac echocardiography (ICE) probe.
In an analogous imaging field of endeavor, regarding beamforming ultrasound, Van Rens teaches an apparatus, wherein the beamforming ultrasound probe comprises at least one of a transthoracic echocardiography (TTE) probe, an intravascular ultrasound (IVUS) probe, or an intracardiac echocardiography (ICE) probe (Page 15 teaches use of ICE and IVUS).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify U.S. Patent No. 12,343,203 with Van Rens’s teaching of use of beamforming in ICE and IVUS. This modified apparatus would allow the user to improve image contrast and have optimal acquisition (Page 10 of Van Rens). Furthermore, the modification provides optimal beam steering (Page 4 of Van Rens).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Scampini et al. (PGPUB No. US 2004/0193042): Teaches localizing a field of view of an ultrasound imaging.
Kadokura et al. (PGPUB No. US 20100217125): Teaches maximum intensity reflection assessment.
Ramamurthy et al. (PGPUB No. US 20110125017): Teaches maximum intensity reflection assessment.
Vignon et al. (PGPUB No. US 20160324501): Teaches maximum intensity reflection assessment.
Shigeta (PGPUB No. US 20170258333): Teaches maximum intensity reflection assessment.
Jain et al. (US Patent No. 10,660,710): Teaches maximum intensity reflection assessment.
Megens et al. (EP 3632333): Teaches localizing a field of view of an ultrasound imaging.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
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