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 .
DETAILED ACTION
Claim Objections
Claim 51 is objected to because of the following informalities: linear is misspelled as “liner”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 51, 53, 55, 61-65 and 68-71 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al. (US 2022/0008112 (provided in the IDS)), in view of Peters et al. (US 2023/0149746) and further in view of Papadacci et al. (US 2024/0180524).
Addressing claims 51 and 71, discloses a system for generating an ultrasound focus at a target region, the system comprising:
an ultrasound transducer array comprising a plurality of transducer elements movably positioned on a conformal scaffold (see Fig. 1 and [0105]; flexible applicator is a conformal scaffold; enabling moving one element with respect to its adjacent element is transducer elements movably positioned on a conformal scaffold);
one or more unique, transducer-specific visible fiducial elements respectively disposed over and identifying a position of one or more corresponding transducer elements of the plurality of transducer elements and visible with the conformal scaffold positioned on a patient (see [0165-0166]; position sensor is a marker; the controller determines the position of the ultrasound applicator 102 and/or a position of one or more ultrasound transducers 104 based on signals received from the optic sensor 111; marker/transducer-specific visible fiducial element visualize by sensor 111 and identifying position of one or more corresponding transducer elements of the plurality of transducer elements and visible with the conformal scaffold positioned on a patient based on signals received from optical sensor 111);
a controller, operably coupled to the ultrasound transducer array, configured to:
acquire first images of the conformal scaffold from a plurality of sensors and the one or more fiducial elements (see [0163], [0166], [0169] and Fig. 1, at least one optical sensor 111; the system could have plurality of sensors; In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a “web” which lies in the joint, and a plurality of “ribs” projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced));
computationally establish, based on the first images, positions and orientations of the one or more fiducial elements with respect to the target region in a spatial coordinate system (see [0165-0166]; determine position/orientation of applicator and marker 113 on the patient);
identify, based on the computed positions of the one or more fiducial elements, the position of the one or more corresponding transducer elements with respect to the target region in the spatial coordinate system (see [0165-0167]; position sensor is a marker; the controller determines the position of the ultrasound applicator 102 and/or a position of one or more ultrasound transducers 104 based on signals received from the optic sensor 111; marker/transducer-specific visible fiducial element visualize by sensor 111 and identifying position of one or more corresponding transducer elements of the plurality of transducer elements and visible with the conformal scaffold positioned on a patient based on signals received from optical sensor 111; base on optical signal of marker/fiducial determine the transducer position relative to the target);
determine, based in part on the identified positions of the one or more corresponding transducer elements, one or more transducer parameters for operating at least some of the plurality of transducer elements, for each of the at least some of the plurality of transducer elements, from the identified position of that transducer element (see [0133] and [0165]; [0165] discloses determine transducer positions; [0133] discloses determine each transducer distance/location from the blood vessel and/or nerves and provide specific parameter for the transducer according to each transducer distance/location from the blood vessel and/or nerve; the transducer distance from the target is one of transducer position information so the system does select transducer parameters base on identify transducer position distance from the target);
operate, based on the determined parameter, at least some of the plurality of transducer elements to collectively transmit an ultrasound beam to the target region (see [0040], [0133] and [0165-0170]; determine position of applicator/transducer, generate map and select parameters to perform ultrasound treatment in desire position/region).
Sverdlik does not explicitly disclose the one or more transducer parameters including per-transducer phase and/or amplitude values selected such that acoustic waves emitted by the at least some of the plurality of transducer elements constructively interfere at the target region to generate an ultrasound focus. Sverdlik discloses determine each transducer distance and position from target and select treatment parameters for each transducer to transmit focus ultrasound at the target (see [0133], [0151] and [0165]). He does not disclose the parameters are phase and/or amplitude to have constructively interfere at the target region to generate an ultrasound focus. Sverdlik discloses select treatment parameters transmit focus ultrasound at the target therefore it would have been obvious to one of ordinary skill in the art that Sverdlik select phase and/or amplitude to generate constructive interference because constructive interference produces focus ultrasound. Examiner only relies on Peters to explicitly discloses an obvious limitation that the one or more transducer parameters including per-transducer phase and/or amplitude values selected such that acoustic waves emitted by the at least some of the plurality of transducer elements constructively interfere at the target region to generate an ultrasound focus (see [0207]; Peters applied/select phase changes to have constructive interference wavefront to focus ultrasound at the target site; Peters determine the location of array ultrasound transducer on patient body then applied phase changes to have constructive interference wavefront to focus ultrasound at the target site (see [0108], [0180], [0207] and [0261]); Peters select phase and/or amplitude for each transducer element; Peters take the position of the transducer array as the position of each transducer element; Sverdlik explicitly determine each transducer element location/distance from the target). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sverdlik to select phase and/or amplitude to have constructive interference as taught by Peters because this help focus and/or steer the ultrasound waves (see [0207]).
Sverdlik does not explicitly disclose each of the plurality of transducer elements having a maximum linear dimension no greater than 5λ. Papadacci discloses each of the plurality of transducer elements having a maximum linear dimension no greater than 5λ (see Figs. 4a-b, [0110-0111], [0115], [0117] and [0150-0151]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sverdlik to have each of the plurality of transducer elements having a maximum linear dimension no greater than 5λ as taught by Papadacci because this is conventional dimension (see [0110-0111] and [0151]; 0.5λ x 0.5λ is conventional dimension; using bigger dimension provide a stronger directivity for each transducer).
Addressing claims 53, 55 and 61-64, Sverdlik discloses:
addressing claim 53, wherein the controller is configured to represent the one or more fiducial elements and the target region in a common spatial reference frame (see [0165-0167]; the marker to identify applicator/transducer register with marker 113 on the patient/target so they are in the same/common spatial reference frame).
addressing claim 55, wherein each of the plurality of transducer elements has a corresponding fiducial element (see [0165-0167]; each transducer corresponds to the marker).
addressing claim 64, wherein the plurality of body-specific visible fiducial elements includes a unique anatomical body feature of the patient (see [0165-0166]; marker place on body includes a unique anatomical body feature of the patient; examiner interprets the claim limitation according to the specification as place marker on the patient body; the placement of the marker on the patient anatomical feature includes a unique anatomical body feature of the patient).
addressing claim 61, wherein the controller is further configured to: obtain surface 3D data of the target region relative to a plurality of body-specific visible fiducial elements positioned on a surface of the patient from the plurality of sensors; acquire second images of the body-specific visible fiducial elements from an imager; and register one or more of the plurality body-specific fiducial elements to the target region by comparing the second images to the surface 3D data; and determine a distance of each of the plurality of transducer elements relative to the target region using the registration of the acquired second images to the surface 3D data (see [0165-0169]; Sverdlik’s optic sensor/camera captures images/video of marker on the applicator and on the body and register to determine position/distance/orientation of the transducer to the target region; 3D model of the subject obtain from external camera and compare 3D model with the images from optic sensors 111; Sverdlik does not clearly disclose if marker is one or plurality; however, using plurality of markers/fiducial elements only require routine skill in the art; In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a “web” which lies in the joint, and a plurality of “ribs” projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced)).
addressing claim 62, wherein the controller is configured to register the second images to the surface 3D data by: matching the plurality of body-specific visible fiducial elements in the surface 3D data to the plurality of body-specific visible fiducial elements in the second images (see [0165-0169]).
addressing claim 63, wherein the controller is configured to determine the distance of each of the plurality of transducer elements relative to the target region by: calculating a distance between the plurality of body-specific visible fiducial elements and the target region using the registration of the second images to the surface 3D data; and/or calculating a distance between the plurality of body-specific visible fiducial elements and the one or more fiducial elements using the second images (see [0165-0169]; determine position/distance of ultrasound transducer from the target region).
Addressing claims 65 and 68-70, the system in claims 51 and 61-63 perform the method in claims 65 and 68-70 therefore claims 65 and 68-70 are being rejected for the same reason as claims 51 and 61-63.
Claims 52, 54, 56 and 66-67 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al. (US 2022/0008112 (provided in the IDS)), in view of Peters et al. (US 2023/0149746), further in view of Papadacci et al. (US 2024/0180524) and Guenther et al. (US 2011/0190629).
Addressing claims 52, 54, 56 and 66-67, Sverdlik discloses wherein the plurality of transducer elements are configured for mobility along the conformable scaffold and transducer elements has corresponding fiducial element. However, Sverdlik does not disclose wherein the plurality of transducer elements and their corresponding fiducial elements are configured for mobility along the conformable scaffold; wherein each of at least some of the fiducial elements is uniquely identifiable by the controller based on relative position, in the first images, with respect to (i) the conformal scaffold and/or (ii) at least one other fiducial element; wherein the plurality of transducer elements include at least some transducer elements with corresponding fiducial elements and at least some transducer elements without corresponding fiducial elements, and the controller is configured to determine positions of the at least some of the transducer elements without corresponding fiducial elements from positions of the at least some of the transducer elements with corresponding fiducial elements. Guenther discloses wherein the plurality of transducer elements and their corresponding fiducial elements are configured for mobility along the conformable scaffold (see Figs. 1-2, [0035-0036] and [0053]; transducers 101a-c and markers 201a-c; Guenther explicitly disclose plurality of markers; the markers attach to transducers and move along the conformable scafford/body encapsulating the object of interest 104); wherein each of at least some of the fiducial elements is uniquely identifiable by the controller based on relative position, in the first images, with respect to (i) the conformal scaffold and/or (ii) at least one other fiducial element (see Figs. 1-2 and [0053]; Guenther explicitly disclose plurality of markers/fiducial elements; Sverdlik discloses fiducial element is uniquely identifiable by the controller based on relative position, in the first images, with respect to (i) the conformal scaffold and/or (ii) at least one other fiducial element; Sverdlik does not clearly disclose if there are plurality of markers/fiducial elements); wherein the plurality of transducer elements include at least some transducer elements with corresponding fiducial elements and at least some transducer elements without corresponding fiducial elements, and the controller is configured to determine positions of the at least some of the transducer elements without corresponding fiducial elements from positions of the at least some of the transducer elements with corresponding fiducial elements (see Fig. 4 and [0092-0093]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sverdlik to have wherein the plurality of transducer elements and their corresponding fiducial elements are configured for mobility along the conformable scaffold; wherein each of at least some of the fiducial elements is uniquely identifiable by the controller based on relative position, in the first images, with respect to (i) the conformal scaffold and/or (ii) at least one other fiducial element; wherein the plurality of transducer elements include at least some transducer elements with corresponding fiducial elements and at least some transducer elements without corresponding fiducial elements, and the controller is configured to determine positions of the at least some of the transducer elements without corresponding fiducial elements from positions of the at least some of the transducer elements with corresponding fiducial elements as taught by Guenther because this allow the system to track each transducer or track each transducer in relation to the other transducer (see [0092-0093] and [0096]). Sverdlik track transducers in relation to scaffold/applicator because the sensor is in the scaffold/applicator and the transducers are in the scaffold/applicator. Sverdlik track applicator with transducers as one unit/device.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al. (US 2022/0008112 (provided in the IDS)), in view of Peters et al. (US 2023/0149746), further in view of Papadacci et al. (US 2024/0180524) and Liu et al. (US 2019/03288462 (provided in the IDS)).
Addressing claim 57, Sverdlik does not disclose wherein the one or more fiducial elements are 2D barcodes. Liu discloses wherein the one or more fiducial elements are 2D barcodes (see [0021]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sverdlik to have wherein the one or more fiducial elements are 2D barcodes as taught by Liu because this help easily recognized the marker (see [0021]).
Claims 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al. (US 2022/0008112 (provided in the IDS)), in view of Peters et al. (US 2023/0149746), further in view of Papadacci et al. (US 2024/0180524) and Friedman et al. (WO 02/43805 (provided in the IDS)).
Addressing claims 58-60, Sverdlik does not disclose wherein the conformal scaffold includes a plurality of movable frame elements, at least some of the frame elements carrying at least some of the plurality of transducer elements; wherein the controller is further configured to cause movement of the at least some of the plurality of transducer elements relative to the conformal scaffold to improve an ultrasound focus at the target region; wherein each of the plurality of transducer elements comprises an emission element and a flexible container for a coupling liquid. Friedman discloses wherein the conformal scaffold includes a plurality of movable frame elements, at least some of the frame elements carrying at least some of the plurality of transducer elements (see page 9, line 8 - page 10, line 11); wherein the controller is further configured to cause movement of the at least some of the plurality of transducer elements relative to the conformal scaffold to improve an ultrasound focus at the target region (see page 7, lines 20-24; steer/pivot sub-array)wherein each of the plurality of transducer elements comprises an emission element and a flexible container for a coupling liquid (see page 15, lines 9-11; casing 40 include fluid fill chamber 42). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sverdlik to have wherein the conformal scaffold includes a plurality of movable frame elements, at least some of the frame elements carrying at least some of the plurality of transducer elements; wherein each of the plurality of transducer elements comprises an emission element and a flexible container for a coupling liquid as taught by Friedman because this allow each sub-array to move with respect to each other to allow adjustment of the orientation of the acoustic emission surface (see page 10, lines 1-5) and coupling liquid help improve transmission.
Response to Arguments
Applicant’s arguments with respect to claim(s) 51- 71 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2019/0054324 (see [0022] and [0049]; adjust phase base on position information to focus); US 2009/0326420 (see [0079] and [0091]; determine position of transducers in MRI images; adjusting phase to have constructive interference to focus ultrasound) and US 2012/0143063 (see [0028]; transducer dimension less than 5λ).
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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793
Prosecution Insights