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 .
Response to Arguments
Applicant’s arguments in Applicant’s responses filed 05/26/2026 with respect to the rejection of claims 1 and 19 under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, newly found prior art Maharbiz, et al., US 20190022427 A1 teaches implantable devices that generate physiological data and transmit the data as modulated backscattered signal to an ultrasound imaging interrogator, and hence teaching generating and transmitting data…using a modulation of the one or more ultrasound signals (abstract) as required by claims 1 and 19, as argued for on pages 12-14 of Applicant’s remarks. Maharbiz, et al., US 20190022427 A1 further discloses simultaneous communications between the interrogator and multiple implanted device with respective signatures [0273], as it pertains to claims 36-37.
Applicant further remarks on page 14 that, regarding claim 13, Shepard does not teach wherein the at least one implantable device has a monolithically-integrated piezoelectric transducer. However, Examiner notes that [0007] discloses that each individual tag can include a customized IC chip with a piezoelectric transducer integrated on the top surface of the chip. Such integration of the transducer into the IC chip comprises a monolithically-integrated structure. Further, as can be seen in reproduced fig. 1 below, the IC chip 102 and the piezoelectric transducer 101 are depicted as a single unit and NOT modularly. Hence, Shepard teaches wherein the at least one implantable device has a monolithically-integrated piezoelectric transducer
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Therefore, the claims stand rejected.
Withdrawn Claim Objections
Pursuant of Applicant’s amendments filed 05/26/2026, the objection made to claim 12 has been withdrawn.
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.
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 1-3, 6-8, 12-14, 16-20, 23, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Shepard, et al., US 20180193000 A1 in view of Maharbiz, et al., US 20190022427 A1, hereinafter referred to as “’427”.
Regarding claim 1, Shepard teaches an apparatus for use with ultrasound imaging (“Apparatus and methods for powering micron-scale implantable and injectable integrated circuit (IC) chips for in-vivo sensing and acquisition of various physiological signals are provided. The disclosed subject matter includes the integration of piezoelectric transducers, such as polyvinylidene fluoride (PVDF) or lead zirconate titanate (PZT), onto implantable and injectable IC chips for power transfer and data transmission using ultrasound waves generated from commercial ultrasound imaging equipment” (abstract)), comprising:
at least one implantable device (“The presently disclosed subject matter provides micron-scale implantable and injectable USID sensing tags, where certain IC chips are integrated with piezoelectric transducers” [0021]) which is configured to:
communicate with an ultrasound imaging system (“The scanhead 130 of commercial ultrasound imaging equipment, such as for example, the Verasonics Vantage 256 system, transmits ultrasound waves 131 to the USID sensing tag 100 through the material of interest 120”, [0022]),
be located by the ultrasound imaging system using one or more ultrasound signals generated thereby to generate a location of the at least one implantable device(“When excited emitted energy, such as from, commercial ultrasound imaging equipment, an implanted or injected USID sensing tag can reflect part of the received ultrasound waves as echoes back to the equipment, which can form a brightness-mode (B-mode) ultrasound image showing the shape, location, and even movement of the tag”, [0009]), and
transmit data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system (“These implantable and injectable devices can be wirelessly powered by ultrasound waves and can wirelessly transmit data also through ultrasound, therefore referred to as ultrasound identification (USID) sensing tags” [0005]). (“When excited emitted energy, such as from, commercial ultrasound imaging equipment, an implanted or injected USID sensing tag can reflect part of the received ultrasound waves as echoes back to the equipment…”, [0009]) using a modulation of the one or more ultrasound signals (“The modulator 340 of exemplary FIG. 3 is thereby implementing a standard amplitude-shift keying (ASK) scheme to alter the echo reflected from the piezoelectric transducer 310 during excitation. For example and without limitation, the size of the MOSFET can be 2 μm/450 nm (length/width) so that the impedance at the ultrasonic input 311 can be decreased by a factor of approximately three when the oscillator output changes from the low state to the high state, thereby modulating the reflected ultrasound waves back to the ultrasound imaging equipment”, [0031]).
Shepard teaches generate and transmit data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system.
However, within the same field of endeavor, ‘427 teaches an implantable device having a sensor configured to detect an amount of an analyte, a pH, a temperature, strain, or a pressure; and an ultrasonic transducer with a length of about 5 mm or less in the longest dimension, configured to receive current modulated based on the analyte amount, the pH, the temperature, or the pressure detected by the sensor, and emit an ultrasonic backscatter based on the received current (see abstract) and more specifically, a medical system wherein pulse signature is used by the system to determine an identity of the implantable device that produced an ultrasound reflection [0273]. ‘427 further teaches generate and transmit data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system ([0094] discloses that the implantable device and the interrogator wirelessly communicate with each other using ultrasonic waves. The implantable device receives ultrasonic waves from the interrogator through a miniaturized ultrasonic transducer on the implantable device. Vibrations of the miniaturized ultrasonic transducer on the implantable device generate a voltage across the electric terminals of the transducer and a current flows through the device, including the sensor and/or, if present, the ASIC. Depending on the physiological condition detected by the sensor, information relating to the physiological condition can alter the current, which in turns modulates the backscatter from the miniaturized ultrasonic transducer. The sensor system (optionally including an ASIC) presents electrical impedance to the electric terminals on the transducer. If this impedance changes, the mechanical impedance of the transducer (as seen from outside the device) changes, resulting in changes in backscatter. Thus, the sensor system modulates the electrical impedance presented to the transducer to effect backscatter communication. The backscatter is then received by an external ultrasonic transceiver (which may be the same or different from the external ultrasonic transceiver that transmitted the initial ultrasonic waves). The information from the sensor can thus be encoded by changes in amplitude, frequency, or phase of the backscattered ultrasound waves. FIG. 4 illustrates an interrogator in communication with an implantable device. The external ultrasonic transceiver emits ultrasonic waves (“carrier waves”), which can pass through tissue. The carrier waves cause mechanical vibrations on the miniaturized ultrasonic transducer (e.g., a miniaturized bulk piezoelectric transducer, a PMUT, or a CMUT). A voltage across the miniaturized ultrasonic transducer is generated, which imparts a current flowing through a sensor on the implantable device. In some embodiments, the implantable device includes an ASIC, and current flows from the miniaturized ultrasonic transducer, through the ASIC, to the radiation detector, back to the ASIC, and returns to the miniaturized ultrasonic transducer. The current flowing through the miniaturized ultrasonic transducer causes the transducer on the implantable device to emit backscatter ultrasonic waves. The current flowing through the miniaturized ultrasonic transducer changes the amplitude, frequency, and/or phase of the backscatter ultrasonic wave emitted or reflected from the ultrasonic transducer. Since the physiological condition affects the current returning to the ASIC and/or the miniaturized ultrasonic transducer, the backscatter waves encode information relating to the physiological condition. The backscatter waves can be detected by the interrogator, and can be deciphered to determine the physiological condition or a change in the physiological condition).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Shepard to generate and transmit data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system, as taught by ‘427, to provide a more accurate measure of the physiological conditions in a subject [0143] for improved health outcomes [0005], with a reasonable expectation of success as Shepard also strives to improve health outcomes by improving the performance of implantable and injectable devices for health monitoring [0003]-[0004].
Regarding claim 2, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches, wherein the at least one implantable device is further
configured to receive further data from the ultrasound imaging system ([0022] states “The scanhead 130…transmits ultrasound waves 131 to the USID sensing tag 100 through the material of interest 120….The mechanical energy of the ultrasound waves 131 of exemplary FIG. 1 can be converted to electrical energy by the piezoelectric transducer 101 integrated onto the IC chip 102 of the USID sensing tag 100. The electrical energy converted from ultrasound waves 131 can power the IC chip 102 for sensing and data transmission”).
Regarding claim 3, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the at least one implantable device is further configured to be powered by the ultrasound imaging system (“The presently disclosed subject matter provides micron-scale implantable and injectable USID sensing tags, where certain IC chips are integrated with piezoelectric transducers. The USID sensing tags can be wirelessly powered and detected/imaged by ultrasound waves at 1-50 MHz from certain commercial ultrasound imaging equipment”, [0021]).
Regarding claim 6, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the at least one implantable device is further configured to be implanted into a body through an injection (“the fabricated USID sensing tag 100 can be implanted or injected into a material of interest 120, such as an organ, a cell, soft tissue, or water”, [0022]).
Regarding claim 7, Shepard in view of ‘427 teaches all the limitations of claim 6 above.
Shepard further teaches wherein the at least one implantable device is sized and configured to be injected into the body using a syringe (“Such fully fabricated USID sensing tags 100 can be either dried or can be implanted/injected into a sample of interest using a syringe”, [0027]).
Regarding claim 8, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the at least one implantable device is further configured to receive ultrasound signals from the ultrasound imaging system so that the ultrasound imaging system ascertains the location of the at least one implantable device (“When excited emitted energy, such as from, commercial ultrasound imaging equipment, an implanted or injected USID sensing tag can reflect part of the received ultrasound waves as echoes back to the equipment, which can form a brightness-mode (B-mode) ultrasound image showing the shape, location, and even movement of the tag”, [0009]).
Regarding claim 12, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the at least one implantable device is a complementary metal oxide semiconductor (CMOS) device (“the IC chip herein disclosed and illustrated in exemplary FIG. 3 can be implemented in a 180-nm CMOS technology provided by Taiwan Semiconductor Manufacturing Company (TSMC)”, [0028]).
Regarding claim 13, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the at least one implantable device has a monolithically-integrated piezoelectric transducer (“Each individual tag can include a customized IC chip with a piezoelectric transducer integrated on the top surface of the chip”, [0007]).
Regarding claim 14, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the at least one implantable device is a plurality of implantable devices (reproduced fig. 1 below depicts a distribution of sensing tags 100 at different locations within a region of interest, with [0012] stating that “FIG. 1 depicts the operation of multiple USID sensing tags in the organ/cell of interest in accordance with an exemplary embodiment of the disclosed subject matter”).
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Regarding claim 16, Shepard in view of ‘427 teaches all the limitations of claim 14 above.
Shepard further teaches wherein each of the plurality of the implantable devices is configured to be implanted at different locations within a body (reproduced fig. 1 above depicting a distribution of sensing tags 100 at different locations within a region of interest, with [0012] stating that “FIG. 1 depicts the operation of multiple USID sensing tags in the organ/cell of interest in accordance with an exemplary embodiment of the disclosed subject matter”).
Regarding claim 17, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the transmission of the data from the at least one implantable device to the ultrasound imaging system (“These implantable and injectable devices can be wirelessly powered by ultrasound waves and can wirelessly transmit data also through ultrasound”, [0005], and “an implanted or injected USID sensing tag can reflect part of the received ultrasound waves as echoes back to the equipment” [0009]) is performed using a backscattered acoustic energy (“circuitry can be added and configured for sensing functionality with transduced voltages analog-to-digital-converted with a voltage-controlled oscillator, such that, for example and without limitation, changes in voltage can produce discernible changes in oscillation frequency of the backscattered ultrasound energy”, [0011]).
Regarding claim 18, Shepard in view of ‘427 teaches all the limitations of claim 1 above.
Shepard further teaches wherein the data transmitted to the ultrasound imaging system includes information regarding at least one area of a body on which the at least one implantable devices is provided (“the USID sensing tags can potentially incorporate sensors for in-vivo acquisition of various physiological signals. Therefore, the USID sensing tags of the presently disclosed subject matter can be implanted or injected into various organs in several kinds of small animals and excited/imaged by the commercial ultrasound imaging equipment for numerous applications and studies. With different kinds of embedded sensors, applications of these tags include, but not limited to, monitoring electrophysiology in the brain through the vasculature, probing intracellular activities by examining concentrations of certain molecules, and detecting biogenic amine levels in the gastrointestinal tract to study communication between the microbiota and the brain”, [0033]).
Regarding claim 19, Shepard teaches method for performing ultrasound imaging (“Apparatus and methods for powering micron-scale implantable and injectable integrated circuit (IC) chips for in-vivo sensing and acquisition of various physiological signals are provided. The disclosed subject matter includes the integration of piezoelectric transducers, such as polyvinylidene fluoride (PVDF) or lead zirconate titanate (PZT), onto implantable and injectable IC chips for power transfer and data transmission using ultrasound waves generated from commercial ultrasound imaging equipment” (abstract)), comprising:
implanting, into a structure, at least one device which is configured to be responsive to one or more ultrasound signals generated by the ultrasound imaging system(“the fabricated USID sensing tag 100 can be implanted or injected into a material of interest 120, such as an organ, a cell, soft tissue, or water”, [0022]);
locating the at least one device within the structure by the ultrasound imaging system using the one or more ultrasound signals to generate a location of the at least one device within the structure (“When excited emitted energy, such as from, commercial ultrasound imaging equipment, an implanted or injected USID sensing tag can reflect part of the received ultrasound waves as echoes back to the equipment, which can form a brightness-mode (B-mode) ultrasound image showing the shape, location, and even movement of the tag”, [0009]); and
transmitting data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system (“These implantable and injectable devices can be wirelessly powered by ultrasound waves and can wirelessly transmit data also through ultrasound, therefore referred to as ultrasound identification (USID) sensing tags” [0005], and “When excited emitted energy, such as from, commercial ultrasound imaging equipment, an implanted or injected USID sensing tag can reflect part of the received ultrasound waves as echoes back to the equipment, which can form a brightness-mode (B-mode) ultrasound image showing the shape, location, and even movement of the tag”, [0009]) using a modulation of the one or more ultrasound signals (“The modulator 340 of exemplary FIG. 3 is thereby implementing a standard amplitude-shift keying (ASK) scheme to alter the echo reflected from the piezoelectric transducer 310 during excitation. For example and without limitation, the size of the MOSFET can be 2 μm/450 nm (length/width) so that the impedance at the ultrasonic input 311 can be decreased by a factor of approximately three when the oscillator output changes from the low state to the high state, thereby modulating the reflected ultrasound waves back to the ultrasound imaging equipment”, [0031]).
Shepard teaches generating and transmitting data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system.
However, within the same field of endeavor, ‘427 teaches an implantable device having a sensor configured to detect an amount of an analyte, a pH, a temperature, strain, or a pressure; and an ultrasonic transducer with a length of about 5 mm or less in the longest dimension, configured to receive current modulated based on the analyte amount, the pH, the temperature, or the pressure detected by the sensor, and emit an ultrasonic backscatter based on the received current (see abstract) and more specifically, a medical system wherein pulse signature is used by the system to determine an identity of the implantable device that produced an ultrasound reflection [0273]. ‘427 further teaches generating and transmitting data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system ([0094] discloses that the implantable device and the interrogator wirelessly communicate with each other using ultrasonic waves. The implantable device receives ultrasonic waves from the interrogator through a miniaturized ultrasonic transducer on the implantable device. Vibrations of the miniaturized ultrasonic transducer on the implantable device generate a voltage across the electric terminals of the transducer and a current flows through the device, including the sensor and/or, if present, the ASIC. Depending on the physiological condition detected by the sensor, information relating to the physiological condition can alter the current, which in turns modulates the backscatter from the miniaturized ultrasonic transducer. The sensor system (optionally including an ASIC) presents electrical impedance to the electric terminals on the transducer. If this impedance changes, the mechanical impedance of the transducer (as seen from outside the device) changes, resulting in changes in backscatter. Thus, the sensor system modulates the electrical impedance presented to the transducer to effect backscatter communication. The backscatter is then received by an external ultrasonic transceiver (which may be the same or different from the external ultrasonic transceiver that transmitted the initial ultrasonic waves). The information from the sensor can thus be encoded by changes in amplitude, frequency, or phase of the backscattered ultrasound waves. FIG. 4 illustrates an interrogator in communication with an implantable device. The external ultrasonic transceiver emits ultrasonic waves (“carrier waves”), which can pass through tissue. The carrier waves cause mechanical vibrations on the miniaturized ultrasonic transducer (e.g., a miniaturized bulk piezoelectric transducer, a PMUT, or a CMUT). A voltage across the miniaturized ultrasonic transducer is generated, which imparts a current flowing through a sensor on the implantable device. In some embodiments, the implantable device includes an ASIC, and current flows from the miniaturized ultrasonic transducer, through the ASIC, to the radiation detector, back to the ASIC, and returns to the miniaturized ultrasonic transducer. The current flowing through the miniaturized ultrasonic transducer causes the transducer on the implantable device to emit backscatter ultrasonic waves. The current flowing through the miniaturized ultrasonic transducer changes the amplitude, frequency, and/or phase of the backscatter ultrasonic wave emitted or reflected from the ultrasonic transducer. Since the physiological condition affects the current returning to the ASIC and/or the miniaturized ultrasonic transducer, the backscatter waves encode information relating to the physiological condition. The backscatter waves can be detected by the interrogator, and can be deciphered to determine the physiological condition or a change in the physiological condition).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Shepard for generating and transmitting data to the ultrasound imaging system from the location of the at least one implantable device that was located by the ultrasound imaging system, as taught by ‘427, to provide a more accurate measure of the physiological conditions in a subject [0143] for improved health outcomes [0005], with a reasonable expectation of success as Shepard also strives to improve health outcomes by improving the performance of implantable and injectable devices for health monitoring [0003]-[0004].
Regarding claim 20, Shepard in view of ‘427 teaches all the limitations of claim 19 above.
Shepard further teaches comprising powering the at least one device by the ultrasound imaging system (“The presently disclosed subject matter provides micron-scale implantable and injectable USID sensing tags, where certain IC chips are integrated with piezoelectric transducers. The USID sensing tags can be wirelessly powered and detected/imaged by ultrasound waves at 1-50 MHz from certain commercial ultrasound imaging equipment”, [0021]).
Regarding claim 23, Shepard in view of ‘427 teaches all the limitations of claim 19 above.
Shepard further teaches wherein the at least one implantable device is further configured to be implanted into the structure through an injection using a syringe(“Such fully fabricated USID sensing tags 100 can be either dried or can be implanted/injected into a sample of interest using a syringe”, [0027]).
Regarding claim 36, Shepard in view of ‘427 teaches all the limitations of claim 14 above.
Shepard fails to teach wherein a first one of the plurality of the implantable devices is configured to generate a first digital signature which is different from a second digital signature degenerated by a second one of the plurality of the implantable devices, and wherein the ultrasound imaging system is configured to differentiate between the first and second ones of the plurality of the implantable devices based on the receipt and analysis of the first and second digital signatures.
However, ‘427 further teaches wherein a first one of the plurality of the implantable devices is configured to generate a first digital signature which is different from a second digital signature degenerated by a second one of the plurality of the implantable devices, and wherein the ultrasound imaging system is configured to differentiate between the first and second ones of the plurality of the implantable devices based on the receipt and analysis of the first and second digital signatures ([0021] indicates that in some embodiments, the interrogator is configured to simultaneously receive ultrasonic backscatter from at least two implantable devices. One of such embodiments comprising embodiment 104 of [0273] which is disclosed as the medical system of embodiment 103, wherein the pulse signature is used by the system to determine an identity of the implantable device that produced an ultrasound reflection, the embodiment of 103 disclosed as The medical system of embodiment 102, wherein the system comprises a plurality of the implantable devices with different configurations of the responsive and non-responsive regions, to produce a different pulse signatures [0272], with embodiment 102 disclosed as medical system comprising: an ultrasound transceiver configured to generate ultrasound interrogation pulses and receive ultrasound backscatter produced by transmitted ultrasound interrogation pulses; and an implantable device comprising leads to sense a biological condition, at least one responsive region responsive to a sensed biological condition sensed by the leads, and at least one non-responsive region that is not responsive to the sensed biological condition, the implantable device reflects received ultrasound interrogation pulses producing a particular pulse signature with at least one portion of the signature corresponding to the at least one responsive region at least one other portion of the signature corresponding to the at least one non-responsive region [0271]. Examiner notes that the rejection relies on the embodiment 104 which includes subject matter of both embodiments 102 and 103).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Shepard, , as taught by the
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Shepard wherein a first one of the plurality of the implantable devices is configured to generate a first digital signature which is different from a second digital signature degenerated by a second one of the plurality of the implantable devices, and wherein the ultrasound imaging system is configured to differentiate between the first and second ones of the plurality of the implantable devices based on the receipt and analysis of the first and second digital signatures, as taught by ‘427, to provide a more accurate measure of the physiological conditions in a subject [0143] for improved health outcomes [0005], with a reasonable expectation of success as Shepard also strives to improve health outcomes by improving the performance of implantable and injectable devices for health monitoring [0003]-[0004].
Regarding claim 37, Shepard in view of ‘427 teaches all the limitations of claim 19 above.
Shepard fails to teach wherein the at least one implantable device is a plurality of implantable devices., and further comprising: generating a first digital signature by a first one of the plurality of the implantable devices, and a second digital signature by a second one of the plurality of the implantable devices, wherein the first and second digital signatures are different from one another, wherein the ultrasound imaging system is configured to differentiate between the first and second ones of the plurality of the implantable devices based on the receipt and analysis of the first and second digital signatures.
However, ‘427 further teaches wherein the at least one implantable device is a plurality of implantable devices., and further comprising: generating a first digital signature by a first one of the plurality of the implantable devices, and a second digital signature by a second one of the plurality of the implantable devices, wherein the first and second digital signatures are different from one another, wherein the ultrasound imaging system is configured to differentiate between the first and second ones of the plurality of the implantable devices based on the receipt and analysis of the first and second digital signatures ([0021] indicates that in some embodiments, the interrogator is configured to simultaneously receive ultrasonic backscatter from at least two implantable devices. One of such embodiments comprising embodiment 104 of [0273] which is disclosed as the medical system of embodiment 103, wherein the pulse signature is used by the system to determine an identity of the implantable device that produced an ultrasound reflection, the embodiment of 103 disclosed as The medical system of embodiment 102, wherein the system comprises a plurality of the implantable devices with different configurations of the responsive and non-responsive regions, to produce a different pulse signatures [0272], with embodiment 102 disclosed as medical system comprising: an ultrasound transceiver configured to generate ultrasound interrogation pulses and receive ultrasound backscatter produced by transmitted ultrasound interrogation pulses; and an implantable device comprising leads to sense a biological condition, at least one responsive region responsive to a sensed biological condition sensed by the leads, and at least one non-responsive region that is not responsive to the sensed biological condition, the implantable device reflects received ultrasound interrogation pulses producing a particular pulse signature with at least one portion of the signature corresponding to the at least one responsive region at least one other portion of the signature corresponding to the at least one non-responsive region [0271]. Examiner notes that the rejection relies on the embodiment 104 which includes subject matter of both embodiments 102 and 103).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Shepard wherein the at least one implantable device is a plurality of implantable devices., and further comprising: generating a first digital signature by a first one of the plurality of the implantable devices, and a second digital signature by a second one of the plurality of the implantable devices, wherein the first and second digital signatures are different from one another, wherein the ultrasound imaging system is configured to differentiate between the first and second ones of the plurality of the implantable devices based on the receipt and analysis of the first and second digital signatures, as taught by ‘427, to provide a more accurate measure of the physiological conditions in a subject [0143] for improved health outcomes [0005], with a reasonable expectation of success as Shepard also strives to improve health outcomes by improving the performance of implantable and injectable devices for health monitoring [0003]-[0004].
Claims 4, 9-10, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Shepard in view of ‘427, as applied to claim 3 above, and further in view of Maharbiz, et al., US 20220143414 A1, hereinafter referred to as “414”.
Regarding claim 4, Shepard in view of ‘427 teaches all the limitations of claim 3 above.
Shepard in view of ‘427 fails to teach wherein the at least one implantable device is further configured to be continuously powered by the ultrasound imaging system when the at least one implantable device is located within a field of view of the ultrasound imaging system.
However, within the same field of endeavor, ‘414 teaches “systems and methods for operating a device implantable within a subject using ultrasonic waves” according to [0042], FIG. 7 ([0157]) illustrating a diagram 700 showing example operating logic of an implantable device (e.g., implantable device 104), wherein the at least one implantable device is further configured to be continuously powered by the ultrasound imaging system when the at least one implantable device is located within a field of view of the ultrasound imaging system ([0169] states that “In operating state 702J, a charge detector of the implantable device can be configured to determine whether a stimulation capacitor is sufficiently charged to be used to stimulate a nerve. If the charge detector indicates sufficient charge (i.e., Charge Indication=1), the implantable device transitions to operating state 702L, otherwise the implantable device remains in operating state 702K in which the stimulation capacitor continues to be charged based on ultrasonic waves received from the interrogator”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Shepard, as modified by ‘427, wherein the at least one implantable device is further configured to be continuously powered by the ultrasound imaging system when the at least one implantable device is located within a field of view of the ultrasound imaging system, as taught by ‘414, as such a modification would allow implementation of miniaturized implants with more efficient powering techniques [0006] while also providing access to deeper tissues with reduced negative impact on surrounding tissues [0007], with a reasonable expectation of success, since Shepard is also endeavored with improvements in powering micron-scale implantable and injectable devices (abstract, [0006]).
Regarding claim 9, Shepard in view of ‘427 teaches all the limitations of claim 8 above.
Shepard in view of ‘427 fails to teach wherein the transmission of the data to the ultrasound imaging system and the receipt of the ultrasound signals are synchronized.
However, ‘414 further teaches wherein the transmission of the data to the ultrasound imaging system and the receipt of the one or more ultrasound signals are synchronized ([0158] states that “the implantable device can be configured to compare information corresponding to the operating mode command to one or more patterns from a plurality of predetermined patterns to set the operating mode and associated operating state in the FSM. For example, as shown in diagram 700, the operating mode command can be associated with an ultrasound pulse duration (e.g., T.sub.us) that can match an uplink pattern (e.g., a time period of T.sub.sync_up) or a downlink pattern (e.g., a time period of T.sub.sync_down). The uplink pattern may be associated with transitioning the implantable device to an operating state for uploading data and the downlink pattern may be associated with transitioning the implantable device to an operating state for downloading data”. Meaning that the transmission of data from the implantable device (signified by the time period T.sub.sync.up) is synchronized with the reception/downloading of data (signified by the time period T.sub.sync.down)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Shepard, as modified by ‘427, wherein the transmission of the data to the ultrasound imaging system and the receipt of the ultrasound signals are synchronized, as taught by ‘414, as such a modification would allow implementation of miniaturized implants with more efficient powering techniques [0006] while also providing access to deeper tissues with reduced negative impact on surrounding tissues [0007], with a reasonable expectation of success, since Shepard is also endeavored with improvements in powering micron-scale implantable and injectable devices (abstract, [0006]).
Regarding claim 10, Shepard in view of ‘427 and ‘414 teaches all the limitations of claim 9 above.
Shepard further teaches wherein the receipt of the one or more ultrasound signals by the at least one implantable device from the ultrasound imaging system (“These implantable and injectable devices can be wirelessly powered by ultrasound waves and can wirelessly transmit data also through ultrasound”, [0005], and “an implanted or injected USID sensing tag can reflect part of the received ultrasound waves as echoes back to the equipment” [0009]) is performed through the modulation of the one or more ultrasound signals (“The modulator 340 of exemplary FIG. 3 is thereby implementing a standard amplitude-shift keying (ASK) scheme to alter the echo reflected from the piezoelectric transducer 310 during excitation. For example and without limitation, the size of the MOSFET can be 2 μm/450 nm (length/width) so that the impedance at the ultrasonic input 311 can be decreased by a factor of approximately three when the oscillator output changes from the low state to the high state, thereby modulating the reflected ultrasound waves back to the ultrasound imaging equipment”, [0031]).
Regarding claim 21, Shepard in view of ‘427 teaches all the limitations of claim 20 above.
Shepard in view of ‘427 fails to teach wherein the at least one device is continuously powered by the ultrasound imaging system when the at least one device is located within a field of view of the ultrasound imaging system.
However, ‘414 further teaches wherein the at least one device is continuously powered by the ultrasound imaging system when the at least one device is located within a field of view of the ultrasound imaging system ([0169] states that “In operating state 702J, a charge detector of the implantable device can be configured to determine whether a stimulation capacitor is sufficiently charged to be used to stimulate a nerve. If the charge detector indicates sufficient charge (i.e., Charge Indication=1), the implantable device transitions to operating state 702L, otherwise the implantable device remains in operating state 702K in which the stimulation capacitor continues to be charged based on ultrasonic waves received from the interrogator”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Shepard, as modified by ‘427, wherein the at least one device is continuously powered by the ultrasound imaging system when the at least one device is located within a field of view of the ultrasound imaging system, as taught by ‘414, as such a modification would allow implementation of miniaturized implants with more efficient powering techniques [0006] while also providing access to deeper tissues with reduced negative impact on surrounding tissues [0007], with a reasonable expectation of success, since Shepard is also endeavored with improvements in powering micron-scale implantable and injectable devices (abstract, [0006]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shepard in view of ‘427 and ‘414, as applied to claim 10 above, and further in view of Porter, et al., US 20220101992 A1.
Regarding claim 11, Shepard in view of ‘427 and ‘414 teaches all the limitations of claim 10 above.
Shepard in view of ‘427 and ‘414 fails to teach wherein a further modulation of the received ultrasound signals is performed using at least one amplitude shift key, and wherein the modulation of the transmission of the data is performed using at least one load shift key back.
However, within the same field of endeavor, Porter teaches an apparatus, such as a sensor package, includes a sensor, an antenna, and a power circuit. The package is configured for attachment to an object or a subject, for example a patient in need of clinical monitoring (abstract). According to [0099], Porter discloses that the apparatus includes a communication circuit 106 configured to receive source information and transfer sensor-patch information from a sensor patch 100 to the source. [0099] states that “the source is configured to generate the source signal by amplitude, frequency, or phase modulating a sinusoidal carrier signal with a source information signal that represents the source information; further in example, the source is configured to generate the source signal by amplitude-shift-key (ASK) modulating a sinusoidal carrier signal with a source information signal that represents the source information”. Further, a “modulator circuit 122 is configured to send sensor-patch information, such as a sensor-measurement value (e.g., temperature), sensor-patch status, or other sensor-patch data, to the source by modulating the source signal with the sensor-patch information….the modulator circuit 122 is configured to amplitude-load-modulate (ALM) the carrier signal generated by the source with the sensor-patch information signal”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Shepard, wherein the further modulation of the received ultrasound signals is performed using at least one amplitude shift key, and wherein the modulation of the transmission of the data is performed using at least one load shift key back, as taught by Porter, as such modification would improve the miniaturization of the system ([0003]), while also improving the power consumption of the system ([0011]), with a reasonable expectation of success, since Shepard is also endeavored with improvements in powering micron-scale implantable and injectable devices (abstract, [0006]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shepard in view of ‘427, as applied to claim 14 above, and further in view of Palti, et al., US 20190240495 A1.
Regarding claim 15, Shepard in view of ‘427 teaches all the limitations of claim 14 above.
Shepard further teaches wherein each of the plurality of the implantable devices is deployable within a field of view of the ultrasound imaging system (see reproduced fig. 1 above and [0022] for the directing of the ultrasound waves 131 toward the plurality of sensing tags 100, meaning the sensing tags 100 are provided within the field of view of the scanhead 130).
Shepard in view of ‘427 fails to teach providing a non-interfering parallel operation.
However, within the same field of endeavor, Palti teaches medical devices that have been implanted into human bodies (as well as other devices that have been implanted into other objects) and are controllable via RF commands are subject to intentional tampering and unintentional interference (abstract). [0073] states that “two or more implantable devices may be implanted into a single object (e.g., into a single human body). In these situations, it may be desirable to communicate with only a desired one of the implants… In case of a body containing a few implants, one can wake-up the desired implant alone by using a second transducer that outputs an ultrasound beam, for example one having a beam with a diameter of a few mm, beaming or aiming the ultrasound energy to the specific area where the selected first transducer is located. In these embodiments, the distance between the implants should be such that the distance between them will enable safe operation without crosstalk”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Shepard for providing a non-interfering parallel operation, as taught by Palti, to “provide a safe way to control from the outside or from another implanted device, the activity of the implanted devices, for example to alter the heart rate, cardiac stimulation timing, timing of sensor (pressure, etc.), reporting etc. from the outside. Specifically, the system does not allow any interference with the implant function by an unauthorized agent”, [0070], with a reasonable expectation of success, as Shepard directs to the use of multiple tags for parallel operation [0012] for different applications [0033].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
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