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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 is rejected as those of ordinary skill in the art would not understand the processing steps of the algorithm necessary to implement the claimed invention using the claimed controller. In particular, no equations, flowcharts, or phraseology is present in the disclosure that describes the algorithm necessary for the controller to be configured to generate an image of the target location using an imaging algorithm.
As explained in MPEP 2161.01(I), simply specifying a desired outcome without sufficiently describing how the functions necessary to achieve the outcome are performed or how the result is achieved, is insufficient to fulfill the written description requirement; the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. MPEP 2161.01(I) further states that:
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015).
Applicant’s specification has not disclosed the necessary algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the claimed invention, including how to program a computer to generate an image of the target location using an imaging algorithm.
There is insufficient written description of the particular algorithm implemented by the invention of claim 15.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Vortman et al. (US 2010/0030076, hereinafter "Vortman" ) in view of Zhang (WO 2014164363 A1), and Vortman et al. (US 20040122323 A1, hereinafter "Vortman '323")
Regarding claim 1, Vortman teaches a pressure wave system comprising a transmitter array (the transducer array includes a plurality of grouped transducer elements [0010]), the transmitter array comprising:
a plurality of pressure wave transducer elements (a system for delivering acoustic energy … includes a transducer array comprising multiple transducers[0009]; multiple independent transducer arrays may be mechanically connected to form the ultrasound transducer array” [0014]), the transducer elements all being arranged to transmit therapeutic pressure waves at the same transmission frequency (wherein [e]ach group of transducer elements may be independently controllable [0011]; Embodiments using hardware circuitry may be implemented on, for example, one or more FPGA, CPLD or ASIC processors for controlling the phase, frequency and amplitude of the respective elements; the PZT rods typically have rectangular (or square) profiles, with an aspect ratio (i.e., ratio of height to width) of greater than or equal to one, and are preferably uniform in size to produce the same frequency response [0025]);
a controller (610 [0040]; a controller coupled to the processor and the transducer elements [0009]) arranged to:
determine a received phase offset (The element groupings and the phase-shift values are determined based on one or more targeting criteria by the processor 605 [0041]; one of ordinary skill in the art would recognize phase shift and phase offset are analogous as both are the difference in time or space between multiple waveforms) for the… pressure waves as received at each of the transducer elements (In particular, the processor may receive information related to the arrangement of the transducer elements within the array, the elements' geometry, elements frequency response, the number and locations of the target areas (with respect to the array, each other, other anatomical structures, or some combination thereof) [0041]).
Vortman, however, does not teach:
(1) a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to transmit test pressure waves; and
(2)[determine a received phase offset for the] test [pressure waves as received at each of the transducer elements]
(3) reverse the phase offsets to determine a transmission phase offset for each of the transducer elements
(4) control the transducer elements to transmit the therapeutic pressure waves at the transmission frequency with the transmission phase offsets such that the therapeutic pressure waves from the transducer elements arrive at the target location in phase with each other.
With regards of (1), Zhang is considered analogous to the instant application as it discloses systems and methods for delivery of focused ultrasound, which shares a technical field with the instant application. Zhang teaches a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to transmit test pressure waves ([f]or example, an ultrasound transducer may be positioned in the distal tip of the needle…physician would insert the needle or trocar into the patient's body, and maneuver the distal tip of the needle or trocar to the target region…the distal tip of the needle or trocar can then emit a tracking/honing signal and allow the ultrasound therapy system to locate the treatment region” ([500]; tracking/honing signals are the test pressure signals as claimed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined invention of Vortman to include a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to transmit test pressure waves, as taught by Zhang, because “ATOF signals are monitored to confirm proper targeting of the tissue to be treated” ([346]). Additionally, “[w]hen the beacon senses the focused ultrasound, it can be used to send feedback to the processor and power supply to alter the output, creating a closed loop system to apply power to the region of the blood vessels or tissue” ([515]), which provides more useful control of the ultrasound transducer array elements than the information provided from just imaging alone.
The combined invention still does not teach (2)-(4). Vortman ‘323 is considered analogous to the instant application as a ultrasound system is disclosed (abstract). Vortman teaches a controller arranged to (a controller coupled to the processor and the transducer array [0018]):
(2) determine a received phase offset for the test pressure waves as received at each of the transducer elements (the treatment parameters may be adjusted, e.g., by providing further amplitude and/or phase correction factors, to modify the energy delivered to the tissue region and reflect events as they unfold [0065]; controller can be used/arranged such that the pressure wave/acoustic energy is received/determined)
(3) reverse the phase offsets (the phases may be adjusted to compensate for acoustic energy from respective transducer elements 16 passing through different tissue types and/or encountering one or more tissue boundaries [0063]; phase offsets and phase shifts are analogous as both are used to find differences between phase waveforms) to determine a transmission phase offset for each of the transducer elements (the excitation correction factors may include phase shift factors [0025]; a controller coupled to the processor and the transducer array that
may be configured for receiving the correction factors from the processor and providing excitation signals to the transducer elements based upon the correction factors [0018])
(4) control the transducer elements (At step 72, the focused ultrasound system may use the correction factors to control a beam former or signal adjuster [0063]; fig. 2) to transmit the therapeutic pressure waves at the transmission frequency with the transmission phase offsets (At step 74, the amplified and phase-adjusted excitation signals may be delivered to the transducer 14 to drive the respective transducer elements 16 [0064]; fig. 2) such that the therapeutic pressure waves from the transducer elements arrive at the target location in phase with each other (At step 74, the amplified and phase-adjusted excitation signals may be delivered to the transducer 14 to drive the respective transducer elements 16 [0064]; fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined invention of Vortman to include determine a received phase offset for the test pressure waves as received at each of the transducer elements, reverse the phase offsets to determine a transmission phase offset for each of the transducer elements, and control the transducer elements to transmit the therapeutic pressure waves at the transmission frequency with the transmission phase offsets such that the therapeutic pressure waves from the transducer elements arrive at the target location in phase with each other, as taught by Vortman ‘323, in order to minimizing damaging tissue outside the focal zone.
Regarding claim 2, modified Vortman teaches the system of claim 1, as discussed above. Vortman further teaches a plurality of modules (a system for delivering acoustic energy … includes a transducer array comprising multiple transducers[0009]; multiple independent transducer arrays may be mechanically connected to form the ultrasound transducer array” [0014]).
Regarding claim 3, modified Vortman teaches the system of claim 2, as discussed above. Vortman further teaches wherein each module comprises a plurality of the pressure wave transducer elements (the transducer array includes a plurality of grouped transducer elements [0010]),
Regarding claim 4, modified Vortman teaches the system of claim 3, as discussed above. Vortman, however, does not teach wherein the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same; each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length.
Zhang, however, teaches wherein the transducer elements on each of the modules are arranged in a curved array (example of curved array designs in Figs. 63-66 that comprise “six lobes 362” [0472], the curved array of each of the modules having a shape (curved array shape shown in figs. 63-66 shown below), the shape of the curved array of all of the modules being the same (the modules 362 all have the same shape, as shown below); each of the curved arrays has a length and two ends (length and two ends annotated in fig. below); each of the curved arrays has a radius of curvature which is constant along its length (example of concave array designs in Figs. 63-66 that comprise “six lobes 362” [0472] this design results in an array with a radius of curvature along both its length and width
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Figs. 63-77 of Zhang reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the individual transducer array 205 of Vortman with the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same, each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length, as taught in Zhang, as an alternative design choice in the shape of the individual elements of the array, in the absence of showing any criticality of unexpected results (See MPEP 2144.04 IV. B. Changes in Shape).
Regarding claim 5, modified Vortman teaches the system of claim 4, as discussed above. Vortman further teaches at least one connector operable to connect the modules together (Fig. 7 of Vortman illustrates adjacent transducer arrays 205 connecting to one another by both their sides and ends via connector 705).
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Fig. 7 Vortman reproduced above
Regarding claim 6, modified Vortman teaches the system of claim 5, as discussed above. Vortman further teaches wherein the at least one connector is configured such that any two of the modules can be connected end-to-end (Fig. 7 of Vortman illustrates adjacent transducer arrays 205 connecting to one another by both their sides and ends via connector 705) such that the curved arrays of said two of the modules have a common centre of curvature ([0035] discloses the arrays having a curved surface area, and they have a common center of curvature as shown in fig. 5).
Regarding claim 7, modified Vortman teaches the system of claim 6, as discussed above. Vortman, further teaches wherein the at least one connector operable to connect the modules together is operable to connect the modules together in each of a plurality of different configurations Referring to Fig. 7, multiple independent arrays 205 may be joined together to form a single array using various connectors 705.. the arrays may be joined using a flexible material (e.g., a fabric strap) to allow the arrays to move about each other. Such implementations permit the array to “fit” over a non-planar surface (e.g., a skull, abdomen or breast), in an orifice, or about a rounded appendage [0044]; the transducer element groups are mechanically connected and/or flexibly connected to allow for contortion of the array about a patient [0011]; as the arrays to move about each other according to the application, i.e. the “non-planar surface”, implies that the modules can have a plurality of configurations) of the modules whereby the modules can form a reconfigurable transmitter array having a plurality of different shapes each associated with one of the configurations (some embodiments may utilize rigid connectors (e.g., rods or bars made of hard plastic or metal) to ensure the arrays 205 enforce a constant spacing and geometric arrangement. In other embodiments, the arrays may be joined using a flexible material (e.g., a fabric strap) to allow the arrays to move about each other. Such implementations permit the array to “fit” over a non-planar surface (e.g., a skull, abdomen or breast), in an orifice, or about a rounded appendage” [0044]; this evidence suggests multiple different configurations based on the treatment target and relevant body part).
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Fig. 7 Vortman reproduced above
Regarding claim 8, Vortman teaches a pressure wave system comprising a transmitter array (a system for delivering acoustic energy … includes a transducer array comprising multiple transducers[0009]; multiple independent transducer arrays may be mechanically connected to form the ultrasound transducer array” [0014]), the transmitter array comprising a plurality of pressure wave transducer elements (the transducer array includes a plurality of grouped transducer elements [0010]), the transducer elements all being arranged to transmit therapeutic pressure waves at the same transmission frequency (wherein [e]ach group of transducer elements may be independently controllable [0011]; Embodiments using hardware circuitry may be implemented on, for example, one or more FPGA, CPLD or ASIC processors for controlling the phase, frequency and amplitude of the respective elements; the PZT rods typically have rectangular (or square) profiles, with an aspect ratio (i.e., ratio of height to width) of greater than or equal to one, and are preferably uniform in size to produce the same frequency response [0025]).
Vortman, however, does not teach:
(1) a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to receive the pressure waves from each of the transducer elements; and
(2) a controller arranged to: determine a transmission time for the pressure waves from each of the transducer elements to the further pressure wave transducer; determine from the transmission time for the pressure waves from each of the transducer elements a respective phase offset; and
(3) control the transducer elements to transmit ultrasound at the transmission frequency and with respective phase offsets such that the pressure waves from the transducer elements arrive at the target location in phase with each other.
With regards of (1), Zhang is considered analogous to the instant application as it discloses systems and methods for delivery of focused ultrasound, which shares a technical field with the instant application. Zhang teaches a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to receive the pressure waves from each of the transducer elements ([f]or example, an ultrasound transducer may be positioned in the distal tip of the needle…physician would insert the needle or trocar into the patient's body, and maneuver the distal tip of the needle or trocar to the target region…the distal tip of the needle or trocar can then emit a tracking/honing signal and allow the ultrasound therapy system to locate the treatment region” [500]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Vortman to include a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to receive the pressure waves from each of the transducer elements, as taught by Zhang, because “ATOF signals are monitored to confirm proper targeting of the tissue to be treated” ([346]). Additionally, “[w]hen the beacon senses the focused ultrasound, it can be used to send feedback to the processor and power supply to alter the output, creating a closed loop system to apply power to the region of the blood vessels or tissue” ([515]), which provides more useful control of the ultrasound transducer array elements than the information provided from just imaging alone.
The combined invention still does not teach (2)-(4)
Vortman ‘323 is considered analogous to the instant application as a ultrasound system is disclosed (abstract). Vortman discloses:
a controller (a controller coupled to the processor and the transducer array [0018]) arranged to:
determine a transmission time for the pressure waves from each of the transducer elements to the further pressure wave transducer (the actual trajectory and derived propagation time of acoustic energy from respective transducer elements may be determined [0086]; the acoustic energy time is can be determined across all of the transducer elements);
determine from the transmission time for the pressure waves from each of the transducer elements (the actual trajectory and derived propagation time of acoustic energy from respective transducer elements may be determined [0086]; the acoustic energy time is can be determined across all of the transducer elements) a respective phase offset (At step 74, the amplified and phase-adjusted excitation signals may be delivered to the transducer 14 to drive the respective transducer elements 16 [0064]; fig. 2); and
control the transducer elements to transmit ultrasound at the transmission frequency (specific frequency [0039]) and with respective phase offsets (At step 74, the amplified and phase-adjusted excitation signals may be delivered to the transducer 14 to drive the respective transducer elements 16 [0064]; fig. 2; The element groupings and the phase-shift values are determined based on one or more targeting criteria by the processor 605. In particular, the processor may receive information related to the arrangement of the transducer elements within the array, the elements' geometry, elements frequency response, the number and locations of the target areas (with respect to the array [0041]) such that the pressure waves from the transducer elements arrive at the target location in phase with each other (the transducer elements 16 convert the excitation signals into acoustic energy that is transmitted from the respective transducer elements 16 of the transducer 14 into the imaged tissue region of the patient 30, i.e., through any intervening tissue to a target site within the tissue region, e.g [0064]; If necessary, the treatment parameters may be adjusted, e.g., by providing further amplitude and/or phase correction factors, to modify the energy delivered to the tissue region and reflect events as they unfold [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined invention of Vortman to include a controller arranged to: determine a transmission time for the pressure waves from each of the transducer elements to the further pressure wave transducer; determine from the transmission time for the pressure waves from each of the transducer elements a respective phase offset; and control the transducer elements to transmit ultrasound at the transmission frequency and with respective phase offsets such that the pressure waves from the transducer elements arrive at the target location in phase with each other, as taught by Vortman ‘323, in order to minimizing damaging tissue outside the focal zone.
Regarding claim 9, modified Vortman teaches the system of claim 8, as discussed above. Vortman further teaches a plurality of modules (a system for delivering acoustic energy … includes a transducer array comprising multiple transducers[0009]; multiple independent transducer arrays may be mechanically connected to form the ultrasound transducer array” [0014]).
Regarding claim 10, modified Vortman teaches the system of claim 9, as discussed above. Vortman further teaches wherein each module comprises a plurality of the pressure wave transducer elements (the transducer array includes a plurality of grouped transducer elements [0010]),
Regarding claim 11, modified Vortman teaches the system of claim 10. Vortman, however, does not teach wherein the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same; each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length.
Zhang, however, teaches wherein the transducer elements on each of the modules are arranged in a curved array (example of curved array designs in Figs. 63-66 that comprise “six lobes 362” [0472], the curved array of each of the modules having a shape (curved array shape shown in figs. 63-66 shown below), the shape of the curved array of all of the modules being the same (the modules 362 all have the same shape, as shown below); each of the curved arrays has a length and two ends (length and two ends annotated in fig. below); each of the curved arrays has a radius of curvature which is constant along its length (example of concave array designs in Figs. 63-66 that comprise “six lobes 362” [0472] this design results in an array with a radius of curvature along both its length and width
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Figs. 63-77 of Zhang reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the individual transducer array 205 of Vortman with the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same, each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length, as taught in Zhang, as an alternative design choice in the shape of the individual elements of the array, in the absence of showing any criticality of unexpected results (See MPEP 2144.04 IV. B. Changes in Shape).
Regarding claim 12, modified Vortman teaches the system of claim 11, as discussed above. Vortman further teaches at least one connector operable to connect the modules together (Fig. 7 of Vortman illustrates adjacent transducer arrays 205 connecting to one another by both their sides and ends via connector 705).
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Fig. 7 Vortman reproduced above
Regarding claim 13, modified Vortman teaches the system of claim 12, as discussed above. Vortman further teaches wherein the at least one connector is configured such that any two of the modules can be connected end-to-end (Fig. 7 of Vortman illustrates adjacent transducer arrays 205 connecting to one another by both their sides and ends via connector 705) such that the curved arrays of said two of the modules have a common centre of curvature ([0035] discloses the arrays having a curved surface area, and they have a common center of curvature as shown in fig. 5)
Regarding claim 14, modified Vortman teaches the system of claim 13, as discussed above. Vortman, further teaches wherein the at least one connector operable to connect the modules together is operable to connect the modules together in each of a plurality of different configurations Referring to Fig. 7, multiple independent arrays 205 may be joined together to form a single array using various connectors 705.. the arrays may be joined using a flexible material (e.g., a fabric strap) to allow the arrays to move about each other. Such implementations permit the array to “fit” over a non-planar surface (e.g., a skull, abdomen or breast), in an orifice, or about a rounded appendage [0044]; the transducer element groups are mechanically connected and/or flexibly connected to allow for contortion of the array about a patient [0011]; as the arrays to move about each other according to the application, i.e. the “non-planar surface”, implies that the modules can have a plurality of configurations) of the modules whereby the modules can form a reconfigurable transmitter array having a plurality of different shapes each associated with one of the configurations (some embodiments may utilize rigid connectors (e.g., rods or bars made of hard plastic or metal) to ensure the arrays 205 enforce a constant spacing and geometric arrangement. In other embodiments, the arrays may be joined using a flexible material (e.g., a fabric strap) to allow the arrays to move about each other. Such implementations permit the array to “fit” over a non-planar surface (e.g., a skull, abdomen or breast), in an orifice, or about a rounded appendage” [0044]; this evidence suggests multiple different configurations based on the treatment target and relevant body part).
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Fig. 7 Vortman reproduced above
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vortman et al. (US 2010/0030076, hereinafter "Vortman" ) in view of Zhang (WO 2014164363).
Regarding claim 15, Vortman teaches a pressure wave system comprising:
a transducer array, the transducer array comprising a plurality of pressure wave transducer elements (the transducer array includes a plurality of grouped transducer elements [0010]) each arranged to receive pressure waves and output a signal in response thereto (wherein [e]ach group of transducer elements may be independently controllable [0011]; Embodiments using hardware circuitry may be implemented on, for example, one or more FPGA, CPLD or ASIC processors for controlling the phase, frequency and amplitude of the respective elements; each of the previously independent arrays may receive its own drive signal. In such cases, each of the arrays may be connected to a common processor and controller to permit coordination of signals across the multiple arrays [0039]).
Vortman, however, does not teach:
(1) a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location;
(2) and a controller arranged to:
analyse a transmission time of a pressure wave test signal transmitted between each of the array of pressure wave transducer elements and the further ultrasound transducer; and
(3) process the signals from the array of transducer elements to generate an image of the target location using an imaging algorithm, wherein the imaging algorithm is adjusted based on the transmission times.
Zhang teaches a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to transmit test pressure waves ([f]or example, an ultrasound transducer may be positioned in the distal tip of the needle…physician would insert the needle or trocar into the patient's body, and maneuver the distal tip of the needle or trocar to the target region…the distal tip of the needle or trocar can then emit a tracking/honing signal and allow the ultrasound therapy system to locate the treatment region” ([500]; tracking/honing signals are the test pressure signals as claimed).
a controller arranged to: analyse a transmission time of a pressure wave test signal transmitted between each of the array of pressure wave transducer elements and the further ultrasound transducer (Based on the Acoustic Time of Flight (ATOF) signal transmission from the ultrasound beacon to the various receivers, the position of the beacon, relative to the receivers, can be calculated [0304]);
process the signals from the array of transducer elements to generate an image of the target location using an imaging algorithm, wherein the imaging algorithm is adjusted based on the transmission times (detecting a position of a beacon based on acoustic time of flight calculation [22]; the ultrasound therapeutic systems disclosed herein are implemented with ultrasound imaging capability for locating and/or tracking the target tissue to be treated [526]; ATOF receivers may be used to locate the position of the beacon. …the step may be achieved with the use of an image transducer array that allows the user to identify the target tissue and mark the target tissue for tracking [380]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined invention of Vortman to include a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and a controller arranged to: analyse a transmission time of a pressure wave test signal transmitted between each of the array of pressure wave transducer elements and the further ultrasound transducer, and process the signals from the array of transducer elements to generate an image of the target location using an imaging algorithm, wherein the imaging algorithm is adjusted based on the transmission times, as taught by Zhang, because “ATOF signals are monitored to confirm proper targeting of the tissue to be treated” ([346]). Additionally, “[w]hen the beacon senses the focused ultrasound, it can be used to send feedback to the processor and power supply to alter the output, creating a closed loop system to apply power to the region of the blood vessels or tissue” ([515]), which provides more useful control of the ultrasound transducer array elements than the information provided from just imaging alone.
Regarding claim 16, modified Vortman teaches the system of claim 15, as discussed above. Vortman further teaches a plurality of modules (a system for delivering acoustic energy … includes a transducer array comprising multiple transducers[0009]; multiple independent transducer arrays may be mechanically connected to form the ultrasound transducer array” [0014]).
Regarding claim 17, modified Vortman teaches the system of claim 16, as discussed above. Vortman further teaches wherein each module comprises a plurality of the pressure wave transducer elements (the transducer array includes a plurality of grouped transducer elements [0010]),
Regarding claim 18 , modified Vortman teaches the system of claim 3, as discussed above. Vortman, however, does not teach wherein the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same; each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length.
Zhang, however, teaches wherein the transducer elements on each of the modules are arranged in a curved array (example of curved array designs in Figs. 63-66 that comprise “six lobes 362” [0472], the curved array of each of the modules having a shape (curved array shape shown in figs. 63-66 shown below), the shape of the curved array of all of the modules being the same (the modules 362 all have the same shape, as shown below); each of the curved arrays has a length and two ends (length and two ends annotated in fig. below); each of the curved arrays has a radius of curvature which is constant along its length (example of concave array designs in Figs. 63-66 that comprise “six lobes 362” [0472] this design results in an array with a radius of curvature along both its length and width
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Figs. 63-77 of Zhang reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the individual transducer array 205 of Vortman with the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same, each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length, as taught in Zhang, as an alternative design choice in the shape of the individual elements of the array, in the absence of showing any criticality of unexpected results (See MPEP 2144.04 IV. B. Changes in Shape).
Regarding claim 19, modified Vortman teaches the system of claim 18, as discussed above. Vortman further teaches at least one connector operable to connect the modules together (Fig. 7 of Vortman illustrates adjacent transducer arrays 205 connecting to one another by both their sides and ends via connector 705).
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Fig. 7 Vortman reproduced above
Regarding claim 20, modified Vortman teaches the system of claim 18, as discussed above. Vortman further teaches wherein the at least one connector is configured such that any two of the modules can be connected end-to-end (Fig. 7 of Vortman illustrates adjacent transducer arrays 205 connecting to one another by both their sides and ends via connector 705) such that the curved arrays of said two of the modules have a common centre of curvature ([0035] discloses the arrays having a curved surface area, and they have a common center of curvature as shown in fig. 5).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 and 11 of U.S. Patent No. US 12285289 B2. Although the claims at issue are not identical, they are not patentably distinct from each other, see comparison chart below.
Instant Application (18/924,638 )
Reference patent (US 12285289 B2)
1. A pressure wave system comprising a transmitter array, the transmitter array comprising a plurality of pressure wave transducer elements, the transducer elements all being arranged to transmit therapeutic pressure waves at the same transmission frequency;
a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to transmit test pressure waves; and
a controller arranged to: determine a received phase offset for the test pressure waves as received at each of the transducer elements; reverse the phase offsets to determine a transmission phase offset for each of the transducer elements; and
control the transducer elements to transmit the therapeutic pressure waves at the transmission frequency with the transmission phase offsets such that the therapeutic pressure waves from the transducer elements arrive at the target location in phase with each other.
1. A pressure wave system comprising: a plurality of modules, each module comprising a plurality of pressure wave transducer elements, the transducer elements all being arranged to transmit therapeutic pressure waves at the same transmission frequency;
…
a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to transmit test pressure waves;
a controller arranged to: determine a received phase offset for the test pressure waves as received at each of the transducer elements; reverse the phase offsets to determine a transmission phase offset for each of the transducer elements; and
control the transducer elements to transmit the therapeutic pressure waves at the transmission frequency with the transmission phase offsets such that the therapeutic pressure waves from the transducer elements arrive at the target location in phase with each other:…
2. The system of claim 1, further comprising a plurality of modules.
1. A pressure wave system comprising: a plurality of modules,…
3. The system of claim 2, wherein each module comprises a plurality of the pressure wave transducer elements.
1. A pressure wave system comprising: a plurality of modules, each module comprising a plurality of pressure wave transducer elements
4. The system of claim 3, wherein the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same; each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length.
1. A pressure wave system comprising: …wherein the transducer elements on each of the modules are arranged in a curved array, the curved array of each of the modules having a shape, the shape of the curved array of all of the modules being the same; each of the curved arrays has a length and two ends; each of the curved arrays has a radius of curvature which is constant along its length
5. The system of claim 4, further comprising at least one connector operable to connect the modules together.
1. A pressure wave system comprising: …at least one connector operable to connect the modules together in each of a plurality of different configurations of the modules whereby the modules can form a reconfigurable transmitter array having a plurality of different shapes each associated with one of the configurations;
…
6. The system of claim 5, wherein the at least one connector is configured such that any two of the modules can be connected end-to-end such that the curved arrays of said two of the modules have a common centre of curvature.
1. A pressure wave system comprising:… and the at least one connector is configured such that any two of the modules can be connected end-to-end such that the curved arrays of said two of the modules have a common centre of curvature.
7. The system of claim 6, wherein the at least one connector operable to connect the modules together is operable to connect the modules together in each of a plurality of different configurations of the modules whereby the modules can form a reconfigurable transmitter array having a plurality of different shapes each associated with one of the configurations.
1. A pressure wave system comprising: …
at least one connector operable to connect the modules together in each of a plurality of different configurations of the modules whereby the modules can form a reconfigurable transmitter array having a plurality of different shapes each associated with one of the configurations
8. A pressure wave system comprising a transmitter array, the transmitter array comprising a plurality of pressure wave transducer elements, the transducer elements all being arranged to transmit pressure waves at the same transmission frequency;
a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to receive the pressure waves from each of the transducer elements; and
a controller arranged to: determine a transmission time for the pressure waves from each of the transducer elements to the further pressure wave transducer; determine from the transmission time for the pressure waves from each of the transducer elements a respective phase offset; and control the transducer elements to transmit ultrasound at the transmission frequency and with respective phase offsets such that the pressure waves from the transducer elements arrive at the target location in phase with each other.
10. A pressure wave system comprising: a plurality of modules, each module comprising a plurality of pressure wave transducer elements, the transducer elements all being arranged to transmit pressure waves at the same transmission frequency;
…
a further pressure wave transducer supported on a needle arranged for insertion into a patient at a target location and arranged to receive the pressure waves from each of the transducer elements;
a controller arranged to: determine a transmission time for the pressure waves from each of the transducer elements to the further pressure wave transducer; determine from the transmission time for the pressure waves from each of the transducer elements a respective phase offset; and control the transducer elements to transmit ultrasound at the transmission frequency and with the respective phase offsets such that the pressure waves from the transducer elements arrive at the target location in phase with each other; and
…
9. The system of claim 8, further comprising a plurality of modules.
10. A pressure wave system comprising: a plurality of modules…
10. The system of claim 9, wherein each module comprises a plurality of the pressure wave transducer elements.
10. A pressure wave system comprising: a plurality of modules, each module comprising a plurality of pressure wave transducer elements,
11. The system of claim 10, wherein the transducer elements on each of the modules are arranged in a cu