DETAILED ACTION
This office action is in response to the communication received on 07/24/2024 concerning application no. 18/832,708 filed on 07/24/2024.
Claims 1-20 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 .
Drawings
The drawings are objected to because:
The drawings (Figs. 2A-2P and 3A-3D) are objected to because, according to MPEP 608.02 and 67 CFR 1.84, "India ink, or its equivalent that secures solid black lines, must be used for drawings". Drawings should be presented as India ink drawings unless the illustration is not capable of being accurately or adequately depicted by India ink drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7, and 11-14 are rejected under 35 U.S.C. 102(a)(1) 102(a)(2) as being anticipated by Qian et al. (PGPUB No. US 2008/0167555).
Regarding claim 1, Qian teaches an ultrasound treatment head, comprising:
a therapy transducer array configured to deliver ultrasound pulses to a focal location (Paragraph 0062 teaches a combined head for the high intensity ultrasonic treatment of tissue. Paragraph 0108 teaches the therapeutic system and its components. See Fig. 1. Paragraph 0041 teaches using a therapeutic transducer, such as HIFU transducer shaped, or adapted with a lens, to direct the sound, the ultrasound beam may be concentrated on a focal region, resulting in maximum acoustical pressure concentrated in this region. A therapeutic transducer may also include a plurality of transducers elements all focused on the focal point, producing HIFU);
a bore located within the therapy transducer array (Paragraph 0120 teaches that the transducer is passed through a hole in the therapeutic transducer. See Figs. 1-3);
a coupling assembly sized and configured for axial and rotational movement within the bore of the therapy transducer array (Paragraphs 0120-22 teach that the coupling that is used with the imaging transducer. The actuator and the rotator are mounted and facilitate the rotational and linear movement. See Figs. 1-3);
an ultrasound imaging probe coupled to the coupling assembly (Paragraphs 0120-22 teach that the coupling that is used with the imaging transducer. The actuator and the rotator are mounted and facilitate the rotational and linear movement. See Figs. 1-3); and
at least one user input device configured to control axial movement and/or rotation of the ultrasound imaging probe relative to the therapy transducer array (Paragraph 0115 teaches that the controller is connected to the apparatus and allows for the operation of the transducers and the movement of the device that controls the transducers’ location. Paragraphs 0136-37 teach that each scan produces and image. The target tissue is then treated via the device based on the images. See Fig. 1).
Regarding claim 7, Qian teaches the ultrasound treatment head in claim 1, as discussed above.
Qian further teaches an ultrasound treatment head, wherein the at least on user input device further comprises:
a rotational sleeve disposed around the coupling assembly, the rotational sleeve being keyed to the coupling assembly, wherein rotation of the rotational sleeve results in a corresponding rotational movement of the ultrasound imaging probe (Paragraph 0136 teaches scan of the target tissue produces an image, which is then assessed by the system with the assistance of a human operator to outline the target tissue on the image. Each outline is referred to as a capture of the target tissue. Paragraphs 0120-22 teach that the coupling that is used with the imaging transducer. The actuator and the rotator are mounted and facilitate the rotational and linear movement. The rotator comprises a stepper motor directly coupled through a coupling to the imaging transducer. Paragraph 0115 teaches that the controller controls the rotator and the stepper motor to manipulate the transducer. See Figs. 1-3).
Regarding claim 11, Qian teaches the ultrasound treatment head in claim 1, as discussed above.
Qian further teaches an ultrasound treatment head, further comprising a position sensor configured to determine when the ultrasound imaging probe is in a retracted position (Paragraph 0123 teaches a safety switch, which prevents the activation of the therapeutic transducer if the imaging transducer is mispositioned or overextended).
Regarding claim 12, Qian teaches the ultrasound treatment head in claim 11, as discussed above.
Qian further teaches an ultrasound treatment head, further comprising one or more processors in electrical communication with the position sensor configured to prevent initiation of therapy with the therapy transducer array if the position sensor determines that the ultrasound imaging probe is not in a specified position with respect to the therapy transducer array (Paragraph 0115 teaches that the controller is connected to the apparatus and allows for the operation of the transducers and the movement of the device that controls the transducers’ location. Paragraph 0123 teaches a safety switch, which prevents the activation of the therapeutic transducer if the imaging transducer is mispositioned or overextended).
Regarding claim 13, Qian teaches the ultrasound treatment head in claim 12, as discussed above.
Qian further teaches an ultrasound treatment head, wherein the specified position comprises fully retracted within the ultrasound treatment head (Paragraph 0115 teaches that the controller is connected to the apparatus and allows for the operation of the transducers and the movement of the device that controls the transducers’ location. Paragraph 0123 teaches a safety switch, which prevents the activation of the therapeutic transducer if the imaging transducer is mispositioned or overextended. Paragraph 0114 teaches that the linear motion that would include a state in which the probe is not extend).
Regarding claim 14, Qian teaches the ultrasound treatment head in claim 12, as discussed above.
Qian further teaches an ultrasound treatment head, wherein the specified position comprises positioned so as to not obstruct or substantially obstruct the therapy transducer array wherein the specified position comprises positioned so as to not obstruct or substantially obstruct the therapy transducer array (Paragraph 0123 teaches a safety switch, which prevents the activation of the therapeutic transducer if the imaging transducer is mispositioned or overextended).
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 2-6, 8-9, 15-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (PGPUB No. US 2008/0167555) in view of Weng et al. (PGPUB No. US 2001/0031922).
Regarding claim 2, Qian teaches the ultrasound treatment head in claim 1, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, further comprising at least one encoder configured to track an axial and/or rotational position of the ultrasound imaging probe.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, further comprising at least one encoder configured to track an axial and/or rotational position of the ultrasound imaging probe (Paragraph 0065 teaches a rotational encoder that monitors the rotation of the threaded shaft).
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 Qian with Weng’s teaching of an encoder. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 3, modified Qian teaches the ultrasound treatment head in claim 2, as discussed above.
Qian further teaches an ultrasound treatment head, further comprising one or more processors configured to register the axial and/or rotational position of the ultrasound imaging probe with a digital treatment plan (Paragraphs 0137-40 teach the creation of a treatment plan that dictates the movement of the transducers for the treatment. Paragraph 0136 teaches scan of the target tissue produces an image, which is then assessed by the system with the assistance of a human operator to outline the target tissue on the image. Each outline is referred to as a capture of the target tissue. Paragraphs 0120-22 teach that the coupling that is used with the imaging transducer. The actuator and the rotator are mounted and facilitate the rotational and linear movement. The rotator comprises a stepper motor directly coupled through a coupling to the imaging transducer. Paragraph 0115 teaches that the controller controls the rotator and the stepper motor to manipulate the transducer. See Figs. 1-3).
Regarding claim 4, modified Qian teaches the ultrasound treatment head in claim 2, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, wherein the at least one encoder is in electrical communication with one or more remote processors configured to register the axial and/or rotational position of the ultrasound imaging probe with a digital treatment plan.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, wherein the at least one encoder is in electrical communication with one or more remote processors configured to register the axial and/or rotational position of the ultrasound imaging probe with a digital treatment plan (Paragraph 0065 teaches a rotational encoder that monitors the rotation of the threaded shaft. Paragraphs 0063-67 teaches the user controls the implementation of the array and the device is able to rotated to the desired form for treatment).
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 Qian with Weng’s teaching of rotational encoding in accordance with a plan. The encoder’s tracking of the rotational position can be integrated to the planning of treatment as discussed by Qian. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 5, modified Qian teaches the ultrasound treatment head in claim 4, as discussed above.
Qian further teaches an ultrasound treatment head, wherein the digital treatment plan further comprises at least one of a target contour and a margin contour (Paragraphs 0137-40 teach the creation of a treatment plan that dictates the movement of the transducers for the treatment. Paragraph 0136 teaches scan of the target tissue produces an image, which is then assessed by the system with the assistance of a human operator to outline the target tissue on the image. Each outline is referred to as a capture of the target tissue. Paragraphs 0120-22 teach that the coupling that is used with the imaging transducer. The actuator and the rotator are mounted and facilitate the rotational and linear movement. The rotator comprises a stepper motor directly coupled through a coupling to the imaging transducer. Paragraph 0115 teaches that the controller controls the rotator and the stepper motor to manipulate the transducer. See Figs. 1-3).
Regarding claim 6, modified Qian teaches the ultrasound treatment head in claim 1, as discussed above.
Qian further teaches an ultrasound treatment head, wherein the at least one user input device further comprises:
an image probe control (Paragraph 0115 teaches that the controller controls the rotator and the stepper motor to manipulate the transducer. See Figs. 1-3);
a second shaft coupled to the second gear (Paragraph 0122 teaches the user of a gear system for the control of the linear movement of the imaging transducer that effects the shaft. See Fig. 3);
a shuttle assembly coupled to the coupling assembly and configured to move axially along the second shaft when the second shaft is rotated (Paragraph 0120 teaches that the transducer is passed through a hole in the therapeutic transducer. Paragraphs 0120-22 teach that the coupling that is used with the imaging transducer. The actuator and the rotator are mounted and facilitate the rotational and linear movement. See Figs. 1-3);
wherein manipulation of the image probe control results in a corresponding axial movement of the ultrasound imaging probe along a length of the second shaft (Paragraph 0120 teaches that the transducer is passed through a hole in the therapeutic transducer. Paragraphs 0120-22 teach that the coupling that is used with the imaging transducer. The actuator and the rotator are mounted and facilitate the rotational and linear movement. See Figs. 1-3).
However, Qian is silent regarding an ultrasound treatment head, comprising:
a first shaft coupled to the image probe control;
a first gear coupled to the first shaft;
a second gear coupled to the first gear.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, comprising:
a first shaft coupled to the image probe control (Paragraph 0081 teaches that the gears work in conjunction with one another to control the transducer array and facilitate the rotation of the shaft that then rotates the transducer element);
a first gear coupled to the first shaft (Paragraph 0081 teaches that the gears work in conjunction with one another to control the transducer array and facilitate the rotation of the shaft that then rotates the transducer element);
a second gear coupled to the first gear (Paragraph 0081 teaches that the gears work in conjunction with one another to control the transducer array and facilitate the rotation of the shaft that then rotates the transducer element).
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 Qian with Weng’s teaching of use of gears and shafts to control transducer rotation. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 8, modified Qian teaches the ultrasound treatment head in claim 7, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, further comprising one or more detents positioned at specified rotational angles against the rotational sleeve to provide tactile feedback to a user.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, further comprising one or more detents positioned at specified rotational angles against the rotational sleeve to provide tactile feedback to a user (Paragraph 0075 teaches the use of stop pins that move longitudinally to position heads and ridges of a key inserted into a slot in the transducer housing and can act on the inner ends of the stops to set the desired position of the heads. The key and transducer housing will be provided with predefined registration markings to enable the user to identify the selected shape. See Fig. 16).
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 Qian with Weng’s teaching of use of detents to control tactile feedback. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 9, modified Qian teaches the ultrasound treatment head in claim 7, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, wherein the rotational sleeve further includes one or more tabs which align with an axial position of the ultrasound imaging probe.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, wherein the rotational sleeve further includes one or more tabs which align with an axial position of the ultrasound imaging probe (Paragraph 0064 teaches that the threaded shaft includes a rotatable end captively and rotatably coupled to a sliding block, further connected to flexible transducer assembly. When the threaded shaft is rotated, it causes sliding blocks to slide within the longitudinally extended grooved slides. See Fig. 13).
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 Qian with Weng’s teaching of for the rotational sleeve to have more tabs. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 15, Qian teaches the ultrasound treatment head in claim 1, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, further comprising a keyed plate configured to rotate with rotation of the ultrasound imaging probe.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, further comprising a keyed plate configured to rotate with rotation of the ultrasound imaging probe (Paragraph 0066 teaches the flexible cable is retracted or extended relative to a fixed sheath as knob is rotated about a central hub. Flexible cable extends inside housing and is coupled to a moving movable member. As knob is rotated, flexible cable is either wound onto central hub, or is unwound from the hub. See Figs. 13 and 16).
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 Qian with Weng’s teaching of a keyed plate to facilitate rotation. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 16, modified Qian teaches the ultrasound treatment head in claim 15, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, further comprising a rotational encoder coupled to the keyed plate, wherein a rotor of the rotational encoder rotates with rotation of the keyed plate and a stator of the rotational encoder remains static during rotation of the keyed plate.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, further comprising a rotational encoder coupled to the keyed plate, wherein a rotor of the rotational encoder rotates with rotation of the keyed plate and a stator of the rotational encoder remains static during rotation of the keyed plate (Paragraph 0066 teaches the flexible cable is retracted or extended relative to a fixed sheath as knob is rotated about a central hub. Flexible cable extends inside housing and is coupled to a moving movable member. As knob is rotated, flexible cable is either wound onto central hub, or is unwound from the hub. See Figs. 13 and 16. The longitudinal movement of flexible cable pushes or pulls movable member. The flexible transducer assembly is supported between rods, one of which is connected to the movable member).
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 Qian with Weng’s teaching of the user of a rotational encoder with the keyed plate that allows rotation. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 17, modified Qian teaches the ultrasound treatment head in claim 16, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, further comprising a grip base disposed over the keyed plate and configured to couple to the therapy transducer array.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, further comprising a grip base disposed over the keyed plate and configured to couple to the therapy transducer array (Paragraph 0066 teaches a flexible cable that is retracted or extended relative to a fixed sheath, that pushes or pulls movable members and changes the curvature of flexible transducer assemblies. See Fig. 13).
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 Qian with Weng’s teaching of the grip base that is over the keyed plate and couples to the transducer. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Regarding claim 20, modified Qian teaches the ultrasound treatment head in claim 16, as discussed above.
Qian further teaches an ultrasound treatment head, further comprising one or more handles, wherein at least one handle is hollow (Fig. 5 shows hollow handles on the sides of the motional apparatus and connected to the therapy bed).
However, Qian is silent regarding an ultrasound treatment head, allow for routing of a wire from the rotational encoder to a processor.
In an analogous imaging field of endeavor, regarding focused ultrasound delivery, Weng teaches an ultrasound treatment head, further comprising one or more handles, wherein at least one handle is hollow to allow for routing of a wire from the rotational encoder to a processor (Paragraph 0066-67 teaches that the rotational encoder monitors the rotational position of the shaft and producing an output signal over the lead that conveys signals between the transducer and the controller).
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 Qian with Weng’s teaching of allow for the routing of the wire from the encoder to the processor. This modified apparatus would allow the user to improve the image quality of the overall array (Paragraph 0080 of Weng). Furthermore, the modification ensures precise and proper focusing of the ultrasound beam (Paragraph 0072 of Weng).
Claims 10 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (PGPUB No. US 2008/0167555) in view of Kwoh et al. (US Patent No. 5,078,140).
Regarding claim 10, Qian teaches the ultrasound treatment head in claim 1, as discussed above.
Qian further teaches an ultrasound treatment head, further comprising to align an outer diameter of the coupling assembly with an inner diameter of the bore (Paragraph 0120 teaches that the center of the therapeutic transducer has the imaging transducer pass through its hole and is placed in the housing. The imaging transducer is aligned with the therapeutic transducer so that the focal point of the therapeutic transducer lies within the field of view of the imaging transducer).
However, Qian is silent regarding an ultrasound treatment head, one or more bushings.
In an analogous imaging field of endeavor, regarding ultrasound guidance, Kwoh teaches an ultrasound treatment head, one or more bushings (Col. 5, lines 23-40 teach the use of sleeve and brushing means for the probe holder).
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 Qian with Kwoh’s teaching of brushings. This modified apparatus would allow the user to accurate probe guidance and targeting (Cols. 1, lines 31-52 of Kwoh). Furthermore, the modification allows for greater precision and control (Abstract of Kwoh).
Regarding claim 18, Qian teaches the ultrasound treatment head in claim 1, as discussed above.
Qian further teaches an ultrasound treatment head, further comprising to couple a robotic positioning arm to the ultrasound treatment head (Paragraph 0113 teaches that the combined head is mounted to a multidirectional apparatus that permits the movement of the combined head in three dimensions and permits the orientation to be towards the target tissue. See Fig. 1).
However, Qian is silent regarding an ultrasound treatment head, a quick-release connector.
In an analogous imaging field of endeavor, regarding ultrasound guidance, Kwoh teaches an ultrasound treatment head, a quick-release connector (Col. 5, lines 23-40 teach the use of a quick release means for affixing the probe holder to the robotic arm).
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 Qian with Kwoh’s teaching of a quick release connector. This modified apparatus would allow the user to accurate probe guidance and targeting (Cols. 1, lines 31-52 of Kwoh). Furthermore, the modification allows for greater precision and control (Abstract of Kwoh).
Regarding claim 19, modified Qian teaches the ultrasound treatment head in claim 18, as discussed above.
However, Qian is silent regarding an ultrasound treatment head, wherein the quick-release connector includes mating features configured to interface with corresponding mating features on the robotic positioning arm.
In an analogous imaging field of endeavor, regarding ultrasound guidance, Kwoh teaches an ultrasound treatment head, wherein the quick-release connector includes mating features configured to interface with corresponding mating features on the robotic positioning arm (Col. 5, lines 23-40 teach the use of a probe holder that is included in a point of attachment for affixing the probe holder to the join of the robotic arm and the hinge means and the quick release means).
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 Qian with Kwoh’s teaching of the quick release connector with the mating features to interface with the robotic system. This modified apparatus would allow the user to accurate probe guidance and targeting (Cols. 1, lines 31-52 of Kwoh). Furthermore, the modification allows for greater precision and control (Abstract of Kwoh).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pernot et al. (PGPUB No. US 2019/0126317): Teaches a combined imaging and treatment array system with a bore that accommodates the transducer.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798