DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 14-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/06/2026.
Applicant's election with traverse of the method in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that “Accordingly, the elected system and the method claims are not directed to independent or distinct inventions. The method claims are directed to use of the same system architecture recited in the system claims, and do not require a materially different apparatus or a materially different field of search. Examination of the amended system claim necessarily involves examination of the corresponding method of using the same transducer arrangement, controllers, communication link, target-location information, and electronic beamforming operation. Applicant therefore respectfully submits that there is now clearly no serious search or examination burden, especially since the Applicant also submits there was no serious burden before”. This is found persuasive
The applicant also argues the election of species is traversed because
“As for the required election of supposed "species", all of the system claims other than 12, 13 (not withdrawn) are totally generic to the relative placement of the imaging transducer. The alleged species are alternative placements of the same imaging transducer within the same integrated therapy/imaging architecture. They are not separate inventions. The specification expressly describes these placements as design alternatives within a common inventive concept. It explains that the imaging array may be placed at the center, inner edge, outer edge, or corner depending on designer preference, and that software alignment compensation can maintain coincident therapeutic and imaging volumes. Thus, the centered and off-centered arrangements are not mutually exclusive inventions requiring materially different search or examination”. This is found persuasive.
The requirements have been removed and the claims rejoined.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites “and calculating three-dimensional coordinates defining the position, shape, and size of the target tissue. focusing the therapeutic ultrasound energy comprises automatically adjusting a beamforming delay profile for the therapy transducer based on the three-dimensional coordinates.” should be semi-colons instead of periods.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-15, & 17-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 14 recite the limitation "the communication link being configured to transfer target location information from the imaging controller " in lines 13-14 of claim 1 and “target location” in line 13 of claim 14. There is insufficient antecedent basis for this limitation in the claims, the target location information in claim 1 and target location in claim 14 were never described as being acquired.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 9-15, 18 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Raju et al (US20100069754A1; hereinafter referred to as Raju) in view of Shoudy et al (US20230414972A1; hereinafter referred to as Shoudy).
Regarding Claim 1, Raju discloses an ultrasound therapy system (“An apparatus for application of three-dimensional ultrasound imaging and therapy comprising a two-dimensional ultrasound imaging array of transducer elements “ [Abstract]) comprising:
a therapy transducer comprising an array of piezoelectric elements configured to transmit therapeutic ultrasound energy toward a target tissue (“The controller that controls and co-registers the ultrasound therapy delivery with 3D images provided by the ultrasound image transmitter and receiver can include one or more computers or processors. The beam forming and steering electronics controlled by the controller are conventional and can be operated according to computer programs known to one skilled in the art. The therapy system consists of an array of piezo-electric, piezo-composite, crystal, or ceramic elements capable of generating either a high, low duty cycle or a lower, longer duty cycle pressure field.“ [0041]);
a therapy controller operatively coupled to the therapy transducer and configured to independently energize the piezoelectric elements to cause the therapy transducer to focus the therapeutic ultrasound energy at a selectable focal position within a three-dimensional treatment region (“one or more two-dimensional ultrasound therapy arrays of transducer elements, each array having a therapy signal transmitter that forms, steers and selectively focuses and delivers ultrasound therapy to the volume; wherein the location of the array of imaging and therapy transducer elements are known relative to one another” [0015], “a controller that controls the image transmitter and receiver to provide three-dimensional images of the volume and simultaneously independently controls each of the one or more therapy transmitters to deliver therapy to the volume” [0016], “Another object of the invention is to provide an apparatus further comprising each of the imaging and therapy transducer arrays having a plurality of ultrasound elements that are individually controllable in amplitude, phase and frequency of operation.” [0017]);
an imaging transducer configured to acquire ultrasound imaging data of the target tissue over a three-dimensional volume (“a two-dimensional ultrasound imaging array of transducer elements having an image signal transmitter and receiver that forms, steers and selectively focuses ultrasound beams to a three-dimensional moving or stationary spatial volume;” [0014]);
an imaging controller operatively coupled to the imaging transducer and configured to generate a three-dimensional ultrasound image of the target tissue from the imaging data (“a controller that controls the image transmitter and receiver to provide three-dimensional images of the volume and simultaneously independently controls each of the one or more therapy transmitters to deliver therapy to the volume.” [0016]);
the communication link being configured to transfer target location information from the imaging controller to the therapy controller (“ further comprising the controller correlating the imaged volume with the therapy transducer array so that the therapy is delivered to the volume.” [0018],
wherein the therapy controller is configured to adjust the focal position of the therapeutic ultrasound energy within the three-dimensional treatment region based on the target location information (“The imaging array can image in real time this motion, then the therapy array can be programmed to deliver the therapeutic ultrasound with temporal gating and/or spatial steering so that the treatment zone coincides with the target volume.” [0036])
Raju does not specifically disclose that the controller is configured to cause display of a representation of the imaging data for viewing by a user; and a communication link between the imaging controller and the therapy controlled and by electronically controlling timing and phasing of transmissions from elements of the therapy transducer without mechanical movement of the therapy transducer.
However, in a similar field of endeavor, Shoudy teaches structures and devices to facilitate application of an ultrasound therapy beam to a target anatomic region [Abstract].
Shoudy also teaches that the imaging controller is configured to cause display of a representation of the imaging data for viewing by a user (“The method 120 for alignment may be used in combination with an application that may help the user guide alignment via a user interface of the application. With that in mind, FIG. 4 is an illustration of a user interface 150 for alignment control of the probe of the neuromodulation delivery system of FIG. 1 , in accordance with embodiments of the present disclosure. The user may be guided by an application that includes a user interface 150 during alignment control of the energy application device. The user interface 150 may display the ultrasound images generated by the imaging transducer 22 of the probe module 14. The user interface 150 may also display an alignment score visualization 152 that includes a current alignment score for the probe module 14, and also includes a target alignment score metric 154 and a best alignment score metric 156” [0071]);
a communication link between the imaging controller and the therapy controlled (“While depicted as separate modules for the purpose of illustration and explanation, in practice the probe module 14 and therapy module 12 may actually be one and the same (i.e., an integral structure or device configured to perform the functions of both the therapy module and probe module as discussed herein). With this in mind, though discussed separately herein, in practice the hardware controllers 86 and 98 may be implemented as a single hardware controller. In the depicted example the MCU 88 is depicted as being in communication with the master controller 80 and its components and modules. The FPGA 90 communicates with and/or controls other components of the therapy module 12, such as therapy pulser-receivers 92 (depicted as being in communication with the therapy transducers 24 of the probe module 14), safety circuitry 94, and/or power management circuitry 96. In practice, the master controller 80 in conjunction with the hardware controllers 86, 98 may control operation of the therapy module 12 and probe module 14, such as to perform application of therapy in accordance with processes and structures described herein” [0042])
and adjusting the focal position by electronically controlling timing and phasing of transmissions from elements of the therapy transducer without mechanical movement of the therapy transducer (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with the controller is configured to cause display of a representation of the imaging data for viewing by a user; and a communication link between the imaging controller and the therapy controlled and by electronically controlling timing and phasing of transmissions from elements of the therapy transducer without mechanical movement of the therapy transducer as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Regarding Claim 2, Raju discloses the therapy transducer and the imaging transducer are integrated within a common housing (“FIG. 1 depicts an embodiment of the apparatus having a combined 2D therapy and 2D imaging array or probe.” [0035]).
Regarding Claim 3, Raju discloses the therapy transducer and the imaging transducer have piezoelectric elements disposed in a common plane but are energized and controlled by the separate respective controllers (“the apparatus contains two separate 2D ultrasound array transducers, one for providing 3D images, and the other for providing therapy beam that is electronically steerable in three dimensions; the individual elements of both arrays are distributed along two dimensions, and are individually controllable in amplitude, phase, and frequency of operation. “ [0037]).
Regarding Claim 4, Raju discloses the imaging transducer comprises a two- dimensional matrix array of piezoelectric elements and the imaging controller is configured to electronically steer an imaging focal position within the three-dimensional volume (“a two-dimensional ultrasound imaging array of transducer elements having an image signal transmitter and receiver that forms, steers and selectively focuses ultrasound beams to a three-dimensional moving or stationary spatial volume;” [0014], “the apparatus contains two separate 2D ultrasound array transducers, one for providing 3D images, and the other for providing therapy beam that is electronically steerable in three dimensions; the individual elements of both arrays are distributed along two dimensions, and are individually controllable in amplitude, phase, and frequency of operation. “ [0037]).
Regarding Claim 9, Raju discloses all limitations noted above except that the therapy controller is configured to dynamically change the focal position of the therapeutic ultrasound energy within the three- dimensional treatment region without mechanical movement of the therapy transducer.
However, in a similar field of endeavor, Shoudy teaches the therapy controller is configured to dynamically change the focal position of the therapeutic ultrasound energy within the three- dimensional treatment region without mechanical movement of the therapy transducer (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with the therapy controller is configured to dynamically change the focal position of the therapeutic ultrasound energy within the three- dimensional treatment region without mechanical movement of the therapy transducer as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Regarding Claim 10, Raju discloses all limitations noted above except that the imaging controller and therapy controller are further configured to operate in real time such that the therapy focal position is updated based on changes in the target tissue location detected in the three-dimensional ultrasound image.
However, in a similar field of endeavor, Shoudy teaches the imaging controller and therapy controller are further configured to operate in real time such that the therapy focal position is updated based on changes in the target tissue location detected in the three-dimensional ultrasound image (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with the imaging controller and therapy controller are further configured to operate in real time such that the therapy focal position is updated based on changes in the target tissue location detected in the three-dimensional ultrasound image as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Regarding Claim 11, Raju discloses all limitations noted above except that the system is further configured to halt transmission of therapeutic ultrasound energy upon detecting movement of the target tissue outside a predetermined range.
However, in a similar field of endeavor, Shoudy teaches the system is further configured to halt transmission of therapeutic ultrasound energy upon detecting movement of the target tissue outside a predetermined range (“The alignment controller 30, at block 172, sends a control signal to disable therapy in response to the therapy dose alignment being misaligned. The alignment controller 30, at decision block 174, determines if the alignment score satisfies one or more realignment criteria. The realignment criteria may include a numerical threshold for the alignment score, a threshold percent on-target alignment of the alignment score over time, or any other suitable numerical and/or time dependent alignment criteria. For example, if the alignment score is 20% less than the predetermined alignment score threshold, the realignment criteria may be met, and the alignment controller 30 may send a signal to trigger realignment. In another example, if the alignment score is determined to be less than the predetermined threshold range for greater than 5 consecutive seconds, the alignment controller 30 may send a signal to trigger realignment.” [0077])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with the system is further configured to halt transmission of therapeutic ultrasound energy upon detecting movement of the target tissue outside a predetermined range as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Regarding Claim 12, Raju discloses the imaging transducer is located at a central position within the therapy transducer (“In one embodiment, the therapy array consists of a 2D spherical annulus. The hole in the annulus provides space for the imaging array. The elements of the therapy array are circular in shape and randomly distributed throughout the array. FIG. 1 shows the therapeutic array with the imaging array at the center.” [0038]).
Regarding Claim 13, Raju discloses the imaging transducer is located at an off- center position of the therapy transducer (“In another embodiment, the 2D imaging array is attached to the side of the therapy array and fixed with respect to it. The two arrays are rigidly fixed with respect to each other and hence the registration information is known a priori.” [0039]).
Regarding Claim 14, Raju discloses A method for performing ultrasound therapy guided by three-dimensional ultrasound images (“An apparatus for application of three-dimensional ultrasound imaging and therapy comprising a two-dimensional ultrasound imaging array of transducer elements “ [Abstract]) comprising:
positioning a therapy transducer and an imaging transducer in proximity to a target tissue within a patient (“The controller that controls and co-registers the ultrasound therapy delivery with 3D images provided by the ultrasound image transmitter and receiver can include one or more computers or processors. The beam forming and steering electronics controlled by the controller are conventional and can be operated according to computer programs known to one skilled in the art. The therapy system consists of an array of piezo-electric, piezo-composite, crystal, or ceramic elements capable of generating either a high, low duty cycle or a lower, longer duty cycle pressure field.“ [0041]);
acquiring ultrasound imaging data from the imaging transducer over a three- dimensional volume (“a two-dimensional ultrasound imaging array of transducer elements having an image signal transmitter and receiver that forms, steers and selectively focuses ultrasound beams to a three-dimensional moving or stationary spatial volume;” [0014]);
generating, by an imaging controller, a three-dimensional ultrasound image of the target tissue from the imaging data (“a controller that controls the image transmitter and receiver to provide three-dimensional images of the volume and simultaneously independently controls each of the one or more therapy transmitters to deliver therapy to the volume.” [0016]);
identifying a location of the target tissue within the three-dimensional ultrasound image; transmitting the target location from the imaging controller to a therapy controller; and focusing therapeutic ultrasound energy as a beam from the therapy transducer onto the target tissue based on the target location (“one or more two-dimensional ultrasound therapy arrays of transducer elements, each array having a therapy signal transmitter that forms, steers and selectively focuses and delivers ultrasound therapy to the volume; wherein the location of the array of imaging and therapy transducer elements are known relative to one another” [0015], “a controller that controls the image transmitter and receiver to provide three-dimensional images of the volume and simultaneously independently controls each of the one or more therapy transmitters to deliver therapy to the volume” [0016], “Another object of the invention is to provide an apparatus further comprising each of the imaging and therapy transducer arrays having a plurality of ultrasound elements that are individually controllable in amplitude, phase and frequency of operation.” [0017]), “The imaging array can image in real time this motion, then the therapy array can be programmed to deliver the therapeutic ultrasound with temporal gating and/or spatial steering so that the treatment zone coincides with the target volume.” [0036])
Raju does not specifically disclose displaying a representation of the imaging data for viewing by a user; and the focusing is performed by electronically controlling timing and phasing of transmissions from elements of the therapy transducer without mechanical movement of the therapy transducer.
However, in a similar field of endeavor, Shoudy teaches structures and devices to facilitate application of an ultrasound therapy beam to a target anatomic region [Abstract].
Shoudy also teaches displaying a representation of the imaging data for viewing by a user (“The method 120 for alignment may be used in combination with an application that may help the user guide alignment via a user interface of the application. With that in mind, FIG. 4 is an illustration of a user interface 150 for alignment control of the probe of the neuromodulation delivery system of FIG. 1 , in accordance with embodiments of the present disclosure. The user may be guided by an application that includes a user interface 150 during alignment control of the energy application device. The user interface 150 may display the ultrasound images generated by the imaging transducer 22 of the probe module 14. The user interface 150 may also display an alignment score visualization 152 that includes a current alignment score for the probe module 14, and also includes a target alignment score metric 154 and a best alignment score metric 156” [0071]);
and the focusing is performed by electronically controlling timing and phasing of transmissions from elements of the therapy transducer without mechanical movement of the therapy transducer (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with displaying a representation of the imaging data for viewing by a user; and the focusing is performed by electronically controlling timing and phasing of transmissions from elements of the therapy transducer without mechanical movement of the therapy transducer as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Regarding Claim 15, Raju discloses all limitations noted above except further comprising dynamically adjusting the focus of the therapeutic ultrasound energy within the three-dimensional volume in response to changes in the detected target tissue location.
However, in a similar field of endeavor, Shoudy teaches further comprising dynamically adjusting the focus of the therapeutic ultrasound energy within the three-dimensional volume in response to changes in the detected target tissue location (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with further comprising dynamically adjusting the focus of the therapeutic ultrasound energy within the three-dimensional volume in response to changes in the detected target tissue location as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Regarding Claim 18, Raju discloses all limitations noted above except further comprising automatically halting the transmission of therapeutic ultrasound energy upon detecting that the target tissue has moved outside a predetermined positional range.
However, in a similar field of endeavor, Shoudy teaches further comprising automatically halting the transmission of therapeutic ultrasound energy upon detecting that the target tissue has moved outside a predetermined positional range (“The alignment controller 30, at block 172, sends a control signal to disable therapy in response to the therapy dose alignment being misaligned. The alignment controller 30, at decision block 174, determines if the alignment score satisfies one or more realignment criteria. The realignment criteria may include a numerical threshold for the alignment score, a threshold percent on-target alignment of the alignment score over time, or any other suitable numerical and/or time dependent alignment criteria. For example, if the alignment score is 20% less than the predetermined alignment score threshold, the realignment criteria may be met, and the alignment controller 30 may send a signal to trigger realignment. In another example, if the alignment score is determined to be less than the predetermined threshold range for greater than 5 consecutive seconds, the alignment controller 30 may send a signal to trigger realignment.” [0077])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with further comprising automatically halting the transmission of therapeutic ultrasound energy upon detecting that the target tissue has moved outside a predetermined positional range as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Regarding Claim 20, Raju discloses further comprising including the therapy and imaging transducers in a common housing (“FIG. 1 depicts an embodiment of the apparatus having a combined 2D therapy and 2D imaging array or probe.” [0035]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Shoudy as applied to Claim 1 above, and further in view of Weese et al (US20240252150A1; hereinafter referred to as Weese).
Regarding Claim 6, Raju discloses all limitation noted above except the imaging controller is configured to identify a boundary of the target tissue in the three-dimensional ultrasound image and determine three-dimensional coordinates of the target tissue, and the therapy controller is configured to automatically focus the therapeutic ultrasound energy based on the three-dimensional coordinates.
However, in a similar field of endeavor, Shoudy teaches the therapy controller is configured to automatically focus the therapeutic ultrasound energy based on the three-dimensional coordinates (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with the therapy controller is configured to automatically focus the therapeutic ultrasound energy based on the three-dimensional coordinates as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Raju in view of Shoudy does not specifically teach the imaging controller is configured to identify a boundary of the target tissue in the three-dimensional ultrasound image and determine three-dimensional coordinates of the target tissue.
However, in a similar field of endeavor, Weese teaches an ultrasound imaging system having an image processor configured to receive at volume data resulting from a three-dimensional ultrasound scan of a body.
Weese also teaches the imaging controller is configured to identify a boundary of the target tissue in the three-dimensional ultrasound image and determine three-dimensional coordinates of the target tissue (“The anatomy detector (AD) 38 identifies the orientation and position of the anatomical object of interest within the acquired 3D volume data.” [0075], “Said model may be a multi-compartment mesh model. This initial model will be deformed by a transformation. This transformation is decomposed into two transformations of different kinds: A global transformation that can translate, rotate or rescale the initial shape of the geometrical model, if needed, and a local deformation that will actually deform the geometrical model so that it matches more precisely to the anatomical object of interest. This is usually done by defining the normal vectors of the surface of the geometrical model to match the image gradient; that is to say, the segmentation will look in the received ultrasonic image for bright-to-dark edges (or dark-to-bright), which usually represent the tissue borders in ultrasound images, i.e. the boundaries of the anatomical object of interest.” [0076]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju in view of Shoudy as outlined above with the imaging controller is configured to identify a boundary of the target tissue in the three-dimensional ultrasound image and determine three-dimensional coordinates of the target tissue as taught by Weese, because it is less operator-dependent and allows a more reliable diagnosis [0006].
Claim 7 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Shoudy as applied to Claim 1 and 14 above, and further in view of Cannata et al (US20240350153A1; hereinafter referred to as Cannata).
Regarding Claim 7, Raju in view of Shoudy discloses all limitations noted above except that the therapy controller is configured to supply current focal position coordinates to the imaging controller for display in relation to the three- dimensional ultrasound image.
However, in a similar field of endeavor, Cannata teaches a system and method, including an ultrasound imaging transducer, an ultrasound therapy transducer [Abstract].
Cannata also teaches that the therapy controller is configured to supply current focal position coordinates to the imaging controller for display in relation to the three- dimensional ultrasound image (“the user interface displays an indication of which focal locations in the planned treatment volume is currently receiving histotripsy pulses.” [0043], “At step 816, following selection of the focus button 704 in FIG. 37 , the focal point 726, depicted as crosshairs can be adjusted by moving across 734 up or down the focal axis 735 using one of the knobs 28 as and shown by indicator 730, depicted in FIG. 37 . Focal steering is adjusted using one of the knobs 28, as depicted in indicator 730 at step 816 in order to reach the required depth. As shown in FIG. 34 , the default focal point 726 is placed at the furthest point in the −Z direction (deepest within the body of the patient or furthest from the patient's skin) relative to the target contour 728 and the margin contour 732. Adjustment of the focal point 726 may be required if the planned treatment volume cannot encompass the distal edge of the target tumor. The planned treatment volume may not be able to encompass the distal edge of the target tumor if moving the treatment head further would impinge on the patient's abdomen. Following adjustment of the focus, steps to adjust the location and size target contour 728 and margin contour 732 may be repeated. In some embodiments, the user may opt to change treatment heads in order to obtain a different focal depth. A treatment head having more transducer elements may provide therapy deeper within the patient. In the alternative, if the targeted lesion or tumor is located in a shallow or less deep portion of the body, the user may select to down-size to a treatment head with less transducer elements to reduce energy application to the tissue.” [0210])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju in view of Shoudy as outlined above with the imaging controller is configured to identify a boundary of the target tissue in the three-dimensional ultrasound image and determine three-dimensional coordinates of the target tissue as taught by Cannata, because cavitation appears bright on ultrasound imaging thereby confirming correct targeting and localization of treatment [0005].
Regarding Claim 19, Raju discloses all limitations noted above except identifying the location of the target tissue comprises user marking of the target in the three-dimensional image, followed by automated tracking of the target tissue.
However, in a similar field of endeavor, Shoudy teaches automated tracking of the target tissue (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with focusing the therapeutic ultrasound energy comprises automatically adjusting a beamforming delay profile for the therapy transducer based on the three-dimensional coordinates, computing a focal position of the therapeutic ultrasound beam as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Raju in view of Shoudy discloses all limitations noted above except identifying the location of the target tissue comprises user marking of the target in the three-dimensional image.
However, in a similar field of endeavor, Cannata teaches identifying the location of the target tissue comprises user marking of the target in the three-dimensional image (“the user interface displays an indication of which focal locations in the planned treatment volume is currently receiving histotripsy pulses.” [0043], “At step 816, following selection of the focus button 704 in FIG. 37 , the focal point 726, depicted as crosshairs can be adjusted by moving across 734 up or down the focal axis 735 using one of the knobs 28 as and shown by indicator 730, depicted in FIG. 37 . Focal steering is adjusted using one of the knobs 28, as depicted in indicator 730 at step 816 in order to reach the required depth. As shown in FIG. 34 , the default focal point 726 is placed at the furthest point in the −Z direction (deepest within the body of the patient or furthest from the patient's skin) relative to the target contour 728 and the margin contour 732. Adjustment of the focal point 726 may be required if the planned treatment volume cannot encompass the distal edge of the target tumor. The planned treatment volume may not be able to encompass the distal edge of the target tumor if moving the treatment head further would impinge on the patient's abdomen. Following adjustment of the focus, steps to adjust the location and size target contour 728 and margin contour 732 may be repeated. In some embodiments, the user may opt to change treatment heads in order to obtain a different focal depth. A treatment head having more transducer elements may provide therapy deeper within the patient. In the alternative, if the targeted lesion or tumor is located in a shallow or less deep portion of the body, the user may select to down-size to a treatment head with less transducer elements to reduce energy application to the tissue.” [0210])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju in view of Shoudy as outlined above with identifying the location of the target tissue comprises user marking of the target in the three-dimensional image as taught by Cannata, because cavitation appears bright on ultrasound imaging thereby confirming correct targeting and localization of treatment [0005].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Shoudy as applied to Claim 1 above, and further in view of Hand et al (US6488630B1; hereinafter referred to as Hand).
Regarding Claim 8, Raju in view of Shoudy discloses all limitations noted above except that element pitch of the therapy transducer is less than 1.5 times the wavelength of the transmitted ultrasound at a center frequency.
However, in a similar field of endeavor, Hand teaches an ultrasound transducer array suitable for medical uses such as tissue ablation and short duration high intensity hyperthermia [Abstract].
Hand also element pitch of the therapy transducer is less than 1.5 times the wavelength of the transmitted ultrasound at a center frequency (“The practical realization of such an array involves several competing factors. To increase the distance over which the focus may be steered and the volume of tissue treated, it is necessary to decrease the size of the elements to make them less directive. To eliminate grating lobes in a regular array the centre to centre spacing between elements should be less than half the wavelength. On the other hand, to satisfy the required power handling capability, the minimum active area of the array should be approximately 50 cm2 or greater corresponding to an intensity at the elements of approximately 6-8 W/cm2.” [Pg. 12 Col. 8 Lines 8-15])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju in view of Shoudy as outlined above with the imaging controller is configured to identify a boundary of the target tissue in the three-dimensional ultrasound image and determine three-dimensional coordinates of the target tissue as taught by Hand, because it increases the distance over which the focus may be Steered and the Volume of tissue treated [Pg. 12 Col. 8 Lines 9-10].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Shoudy as applied to Claim 14 above, further in view of Weese and further in view of Cannata
Regarding Claim 17, Raju discloses all limitation noted above except detecting a boundary of the target tissue within the three-dimensional ultrasound image; and calculating three-dimensional coordinates defining the position, shape, and size of the target tissue; focusing the therapeutic ultrasound energy comprises automatically adjusting a beamforming delay profile for the therapy transducer based on the three-dimensional coordinates; computing a focal position of the therapeutic ultrasound beam transmitting focal position coordinates from the therapy controller to the imaging controller; and displaying, within the three-dimensional ultrasound image, a representation of the focal position for user guidance prior to therapy activation.
However, in a similar field of endeavor, Shoudy teaches focusing the therapeutic ultrasound energy comprises automatically adjusting a beamforming delay profile for the therapy transducer based on the three-dimensional coordinates, computing a focal position of the therapeutic ultrasound beam (“In further examples, certain implementations discussed herein utilize an alignment controller of the system to enable a user to position the energy application device so as to direct the energy application device toward a region in which an anatomic target (e.g., clinician predetermined anatomic target) of the human subject is located… Additionally, the alignment may be automatic such that the alignment controller may send signals to electronically steer and/or focus the energy application device to the desired position and/or orientation.” [0031]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju as outlined above with focusing the therapeutic ultrasound energy comprises automatically adjusting a beamforming delay profile for the therapy transducer based on the three-dimensional coordinates, computing a focal position of the therapeutic ultrasound beam as taught by Shoudy, because this may enable the therapy dose to be delivered accurately during the subject's body surface movement and internal movement caused by the respiration cycle of the subject [0031].
Raju in view of Shoudy does not specifically teach detecting a boundary of the target tissue within the three-dimensional ultrasound image; and calculating three-dimensional coordinates defining the position, shape, and size of the target tissue; transmitting focal position coordinates from the therapy controller to the imaging controller; and displaying, within the three-dimensional ultrasound image, a representation of the focal position for user guidance prior to therapy activation.
However, in a similar field of endeavor, Weese teaches detecting a boundary of the target tissue within the three-dimensional ultrasound image; and calculating three-dimensional coordinates defining the position, shape, and size of the target tissue (“The anatomy detector (AD) 38 identifies the orientation and position of the anatomical object of interest within the acquired 3D volume data.” [0075], “Said model may be a multi-compartment mesh model. This initial model will be deformed by a transformation. This transformation is decomposed into two transformations of different kinds: A global transformation that can translate, rotate or rescale the initial shape of the geometrical model, if needed, and a local deformation that will actually deform the geometrical model so that it matches more precisely to the anatomical object of interest. This is usually done by defining the normal vectors of the surface of the geometrical model to match the image gradient; that is to say, the segmentation will look in the received ultrasonic image for bright-to-dark edges (or dark-to-bright), which usually represent the tissue borders in ultrasound images, i.e. the boundaries of the anatomical object of interest.” [0076]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju in view of Shoudy as outlined above with detecting a boundary of the target tissue within the three-dimensional ultrasound image; and calculating three-dimensional coordinates defining the position, shape, and size of the target tissue as taught by Weese, because it is less operator-dependent and allows a more reliable diagnosis [0006].
Raju in view of Shoudy and further in view of Weese does not specifically teach transmitting focal position coordinates from the therapy controller to the imaging controller; and displaying, within the three-dimensional ultrasound image, a representation of the focal position for user guidance prior to therapy activation.
However, in a similar field of endeavor, Cannata teaches transmitting focal position coordinates from the therapy controller to the imaging controller; and displaying, within the three-dimensional ultrasound image, a representation of the focal position for user guidance prior to therapy activation (“the user interface displays an indication of which focal locations in the planned treatment volume is currently receiving histotripsy pulses.” [0043], “At step 816, following selection of the focus button 704 in FIG. 37 , the focal point 726, depicted as crosshairs can be adjusted by moving across 734 up or down the focal axis 735 using one of the knobs 28 as and shown by indicator 730, depicted in FIG. 37 . Focal steering is adjusted using one of the knobs 28, as depicted in indicator 730 at step 816 in order to reach the required depth. As shown in FIG. 34 , the default focal point 726 is placed at the furthest point in the −Z direction (deepest within the body of the patient or furthest from the patient's skin) relative to the target contour 728 and the margin contour 732. Adjustment of the focal point 726 may be required if the planned treatment volume cannot encompass the distal edge of the target tumor. The planned treatment volume may not be able to encompass the distal edge of the target tumor if moving the treatment head further would impinge on the patient's abdomen. Following adjustment of the focus, steps to adjust the location and size target contour 728 and margin contour 732 may be repeated. In some embodiments, the user may opt to change treatment heads in order to obtain a different focal depth. A treatment head having more transducer elements may provide therapy deeper within the patient. In the alternative, if the targeted lesion or tumor is located in a shallow or less deep portion of the body, the user may select to down-size to a treatment head with less transducer elements to reduce energy application to the tissue.” [0210])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raju in view of Shoudy and further in view of Weese as outlined above with transmitting focal position coordinates from the therapy controller to the imaging controller; and displaying, within the three-dimensional ultrasound image, a representation of the focal position for user guidance prior to therapy activation as taught by Cannata, because cavitation appears bright on ultrasound imaging thereby confirming correct targeting and localization of treatment [0005].
Conclusion
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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