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 .
Status of Claims
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set
forth in 37 CFR 1.136(a).
Claims 81, 94, and 101 have been amended.
Claims 87 and 100 have been cancelled. Claim 102 is newly added.
Claims 81-86, 88-99, 101, and 102 are pending.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 94, 97-99, and 102 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024).
With respect to claim 94, ROUSSO discloses a system comprising at least one implantable device adapted to be implanted adjacent to at least one vessel or tissue containing flowing blood. “A method and/or system are provided for improving kidney function and/or increasing Glomerular Filtration Rate (GFR) of the renal system, by applying acoustic and/or ultrasonic energy to one or more of the kidneys… which could also be implemented invasively and/or by implantable device.” (Abstract; see also [0285]: “…some or all parts of the device can be implanted inside the body of the subject, making the device an implantable device.”). The at least one implantable device comprising at least one ultrasonic transducer configured to emit ultrasonic energy toward the at least one vessel or tissue, so as to cause a physiologic effect in the at least one vessel or tissue. “There is provided a method of modifying kidney activity, comprising: irradiating at least a portion of a kidney by applying to the kidney ultrasonic energy at a frequency, repetition rate and amplitude suitable to affect kidney function; repeating said irradiating until said affect kidney function is achieved.” ([0008]; see also Figures 1 and 2 illustrating a transducer array 16). The system also includes at least one on-skin remote controller configured to be positioned externally to the patient and configured to control the ultrasonic energy. “In some embodiments, the device is controllable wirelessly from a cellphone, smartphone, tablet and/or a dedicated device… In some embodiments, the transducer and waveform generator (and possibly associated circuitry, e.g. power circuitry and/or communication circuitry and/or control circuitry) are implanted inside the body of the subject, with the signal and/or power transmitted to it wirelessly from the external components, either by RF, wireless technology or by coupled coils, or by acoustic energy transmission.” (emphasis added) ([0285]). NOTE: The term “on-skin” recites a functional limitation and/or intended use or result. It does not limit the claim structurally. (MPEP 2173.05(g)). The “external components” and “cellphone, smartphone, tablet, and/or dedicated device” described in ROUSSO are capable of being an on-skin remote controller. The system also includes at least one sensor configured to monitor at least one physiological state of the patient. “In some embodiments, the systems include one or more sensors for or is configured to receive a sensor signal indicative of a physiological measure, for example, one or more of blood pressure, its cycles, or the heart rate, either mechanically or by ECG or by imaging, or by ultrasound or by sound, or by light emission or reflection, or similarly.” ([0222]; see also [0254]). The at least one implantable device is configured to be in communication with the at least one on-skin remote controller and with the at least one sensor. (see [0254] regarding communication with remote controller and [0244] regarding communication with at least one sensor).
ROUSSO also discloses wherein one or more of the at least one implantable device and one or more of the at least one on-skin remote controller comprise at least one coil configured to form an inductive link between the at least one implantable device and the at least one on-skin remote controller. “In some embodiments, the device is controllable wirelessly from a cellphone, smartphone, tablet and/or a dedicated device…In some embodiments, the transducer and waveform generator (and possibly associated circuitry, e.g. power circuitry and/or communication circuitry and/or control circuitry) are implanted inside the body of the subject, with the signal and/or power transmitted to it wirelessly from the external components, either by RF, wireless technology or by coupled coils.” (emphasis added) ([0285]).
With respect to claim 97, ROUSSO discloses wherein the at least one on-skin remote controller is configured to control at least one parameter of the ultrasonic energy, the at least one parameter being one or more of: phase, frequency, power, intensity, amplitude, timing, duration, and any combination thereof. “In some embodiments, the device is controllable wirelessly from a cellphone, smartphone, tablet and/or a dedicated device…In some embodiments, the transducer and waveform generator (and possibly associated circuitry, e.g. power circuitry and/or communication circuitry and/or control circuitry) are implanted inside the body of the subject, with the signal and/or power transmitted to it wirelessly from the external components, either by RF, wireless technology or by coupled coils, or by acoustic energy transmission.” ([0285]). See [0258] regarding parameters that can be controlled: “…the digital controller drives the waveform generator, and is in charge of determining the various parameters of the sonication. In some embodiments, such parameters include, for example, the sonication times and durations, waveform parameters and shape, amplitude or area of sonication.”
With respect to claim 98, ROUSSO discloses wherein the at least one sensor is configured to be one or more of: implanted in the patient, integrated within the implantable device, worn by the patient, integrated within the at least one on-skin remote controller, and any combination thereof. “In some embodiments, the sensors are implanted sensors in the body of the subject.” ([0225]; see also [0251] in which the transducer array and various sensors are housed within the same chamber).
With respect to claim 99, ROUSSO discloses wherein the at least one sensor comprises one or more of: an accelerometer, a temperature sensor, a pulse wave sensor and an electrocardiogram (ECG) sensor. “In some embodiments, the set of sensors 10 include, but are not limited to, a cavitation detector, a blood pressure meter, heart rate meter, temperature sensor, vital signs monitor, ECG….” ([0254]).
With respect to claim 102, ROUSSO teaches that at least one sensor configured to sense one or more acoustic waves generated by the at least one vessel or tissue and wherein at least one parameter of the ultrasonic energy emitted toward the at least one vessel or tissue is configured to be automatically adjusted in response to the sensing of the one or more acoustic waves generated by the at least one vessel or tissue. “In some embodiments, the systems include one or more sensors for or is configured to receive a sensor signal indicative of a physiological measure, for example, one or more of blood pressure, its cycles, or the heart rate, either mechanically or by ECG or by imaging, or by ultrasound or by sound, or by light emission or reflection, or similarly. In some embodiments, the system times the delivery of the acoustic signals to the systolic phase and/or to the diastolic phase and/or to an intermediate phase of the cardiac cycle or of the arterial blood pressure cycle, to achieve efficiency or to avoid capillary damage. In some embodiments, the system delivers the signals not synchronized to the cardiac cycle or to the arterial blood pressure cycle. In some embodiments, the system delivers the signals in an anti-synchronized manner to the cardiac cycle or to the arterial blood pressure cycle.” (emphasis added) ([0222]). NOTE: Examiner is interpreting “times the delivery” as satisfying the “automatically adjusted” limitation. (see, e.g., Applicant’s disclosure at [0049] or [0095]).
RESPONSE TO APPLICANT’S ARGUMENTS
With respect to claims 94-99 and 102, Applicant argues that ROUSSO fails to show certain features of the invention. However, the features upon which applicant relies (i.e., an inductive link that enables the on-skin controller to directly drive the transducer) are not recited in the rejected claims. While these features are recited in claims 81-83, 85, 89-93, and 101, the features are not recited in claims 94-99 and 102.
With respect to claim 102, Applicant argues that ROUSSO’s use of reflected ultrasonic waves is “limited to imaging or general purposes” and that ROUSSO does not teach “using sensed acoustic waves from the vessel or tissue itself nor automatically adjusting therapy parameters (energy level, frequency, duty cycle, etc.) based on such sensing.” Examiner respectfully disagrees. As explained above, ROUSSO teaches “one or more sensors” that can “receive a sensor signal indicative of…blood pressure, its cycles, or the heart rate…by ultrasound or sound….” ([0222]). ROUSSO teaches that the system “times the delivery” of therapy to “the diastolic phase and/or to an intermediate phase of the cardiac cycle or of the arterial blood pressure cycle.” ([0222]). Applicant’s disclosure describes “timing” as being one of the parameters of the ultrasonic energy that can be controlled. (see, e.g., Applicant’s disclosure at [0049] or [0095]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 81-83, 85, and 89-93 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024) and U.S. Patent Appl. Publ. No. 2009/0198307 A1 (hereinafter “BIN MI”).
With respect to claim 81, ROUSSO discloses a device adapted to be implanted adjacent to at least one vessel or tissue containing flowing blood. “A method and/or system are provided for improving kidney function and/or increasing Glomerular Filtration Rate (GFR) of the renal system, by applying acoustic and/or ultrasonic energy to one or more of the kidneys… which could also be implemented invasively and/or by implantable device.” (Abstract). The device includes at least one ultrasonic transducer configured to emit ultrasonic energy toward the at least one vessel or tissue, so as to cause a physiologic effect in the at least one vessel or tissue. “There is provided a method of modifying kidney activity, comprising: irradiating at least a portion of a kidney by applying to the kidney ultrasonic energy at a frequency, repetition rate and amplitude suitable to affect kidney function; repeating said irradiating until said affect kidney function is achieved.” ([0008]). The device is configured to be in communication with at least one on-skin remote controller positioned externally to the patient and configured to control the ultrasonic energy. “In some embodiments, the device is controllable wirelessly from a cellphone, smartphone, tablet and/or a dedicated device… In some embodiments, the transducer and waveform generator (and possibly associated circuitry, e.g. power circuitry and/or communication circuitry and/or control circuitry) are implanted inside the body of the subject, with the signal and/or power transmitted to it wirelessly from the external components, either by RF, wireless technology or by coupled coils, or by acoustic energy transmission.” (emphasis added) ([0285]). NOTE: The term “on-skin” recites a functional limitation and/or intended use or result. It does not limit the claim structurally. (MPEP 2173.05(g)). The “external components” and “cellphone, smartphone, tablet, and/or dedicated device” described in ROUSSO are capable of being an on-skin remote controller. The device is also configured to be in communication with at least one sensor configured to monitor at least one physiological state of the patient. “In some embodiments, the systems include one or more sensors for or is configured to receive a sensor signal indicative of a physiological measure, for example, one or more of blood pressure, its cycles, or the heart rate, either mechanically or by ECG or by imaging, or by ultrasound or by sound, or by light emission or reflection, or similarly.” ([0222]; see also [0254]).
However, ROUSSO does not teach the device further comprising at least one coil configured to form an inductive link between the device and the at least one on-skin remote controller to directly drive the at least one ultrasonic transducer.
BIN MI teaches systems and methods for communicating with or powering implantable medical devices using a direct inductive/acoustic telemetry link. (Abstract). “[A]n implantable medical device including an energy translator circuit [is] adapted to convert inductive or RF signals received from the interrogator device into an acoustic signal for driving an acoustic transducer.” (Abstract). BIN MI is particularly concerned with implantable medical devices (IMD's), such as pacemakers and implantable cardioverter defibrillators. ([0003]). BIN MI notes that “[i]n some techniques, telemetric communication between the external programming device and the implanted device can be accomplished using an acoustical link provided by an ultrasonic transducer.” ([0004]).
BIN MI describes a problem with conventional implanted designs: “Due to their size, conventional IMD's are typically implanted in remote regions within the body away from the source of the signal or the target of the therapy…In some cases, it may be desirable to sense physiological parameters or therapeutic functions at a location within the body having a limited space or volume, requiring the packaging, battery, and associated electronics to be made small to reduce device size.” ([0005]).
Figure 3 of BIN MI is shown here. “[T]he translator circuit 60 comprises a single LC circuit loop formed by an inductor coil 64 inductively coupled to an externally powered coil 66, and the ultrasonic transducer 44, which for a piezoelectric ultrasonic transducer, functions within the circuit 60 as a capacitor in series with the inductor coil 64.” Notably, the transducer can be directly controlled through this configuration. The inductive or RF signal is directly converted into an electrical signal for driving the transducer. (see claim 18). The benefits of the design include reduced complexity ([0032]) and reduced size ([0004]), and possibly efficiency gains ([0034], [0036]).
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It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ROUSSO device to include at least one coil configured to form an inductive link between the device and the at least one on-skin remote controller to directly drive the ultrasonic transducer. One would be motivated to incorporate this feature in order to reduce the complexity and size of the device. There would have been a reasonable expectation of success as BIN MI teaches that transducer can be directly driven through an inductive link.
With respect to claim 82, ROUSSO discloses that the at least one ultrasonic transducer comprises an array of ultrasonic transducers. “FIG. 2 is a schematic representation of an example of an embodiment of a transducer array.” ([0166]; see also [0246]-[0248] describing a transducer array).
With respect to claim 83 (depending from claim 82), ROUSSO discloses that the array of ultrasonic transducers is configured to facilitate alignment of the ultrasonic energy relative to the at least one vessel or tissue. “In some embodiments, the transducer array is a phased array, comprising multiple element probes, by which the beam can be focused and swept electronically without moving the probes.” ([0247]). “In some embodiments, the energy is delivered in a focused manner, or to a wide area of the kidney, or by scanning multiple regions, or by parallel applying to multiple focused locations, or combinations thereof.” ([0216]).
With respect to claim 85, ROUSSO discloses that the emitting of the ultrasonic energy is synchronized to a pulse wave signal. “…said irradiation is synchronized to an arrival of a pulse wave to a part of said kidney.” ([0053]).
With respect to claim 89, ROUSSO discloses that the monitored physiological state comprises one or more of: position of the patient, physical activity of the patient, nitric oxide levels in the at least one vessel or tissue, tissue perfusion, medical treatment provided to the patient, and any combination thereof. “… the sensor controller receives measurements from a set of sensors, based on which it sends commands to the digital controller…In some embodiments, these measurements may be used to estimate the treatment efficiency, efficacy, provide warning of patient stress or discomfort, and to adjust or stop the treatment in response.” ([0254]).
With respect to claim 90, ROUSSO discloses that the physiologic effect comprises one or more of: vasodilation, increase in local ATP, enhanced ATP release, increase in local nitric oxide, prolonged local nitric oxide effects, enhanced nitric oxide release from vascular endothelium, enhanced nitric oxide release from red blood cells, alteration in erythrocytes function, modification in oxygen release from hemoglobin, increase in blood temperature, modification in pH of blood, modulation in immune response of blood leucocytes, modulation of coagulation and/or thrombocyte function, modification in function of heme catalyst enzymes in the blood, improved bioavailability of medication, improved efficiency of a hemodialysis session, artery dilation, increased blood perfusion, and any combination thereof. “In some exemplary embodiments, the system is integrated with a dialysis system. In some exemplary embodiments, the system implements similar ultrasonic energy to enhance the ex-vivo filtration processes implemented as part of the dialysis system.” ([0234]: see also [0006] regarding nitric oxide and [0321]: “the system is used for treating a patient with known risk of developing kidney disorder due to a procedure that might impair normal cardiac output and/or blood pressure and/or blood flow and/or perfusion to kidney.”).
With respect to claim 91, ROUSSO discloses that wherein upon change of the at least one physiological state one or more of the following is performed: (a) the device is activated and ultrasonic energy is emitted, such that an on-demand treatment is provided; (b) at least one parameter of the ultrasonic energy is amended, such that an as-needed treatment is provided; (c) a notification is generated. “In some embodiments, the digital controller dynamically changes different parameters of its output signals, according to pre-defined programs or in response to inputs from the sensor controller. In some embodiments, some of the parameters that are changed dynamically are: activation times and durations, transmission amplitude (power), shut-down in response to safety alerts (such as sudden patient movement)….” ([0260]).
With respect to claim 92, ROUSSO discloses that the device is configured to be automatically activated upon change of the at least one physiological state. “In some embodiments, the digital controller dynamically changes different parameters of its output signals, according to pre-defined programs or in response to inputs from the sensor controller.” ([0260]).
With respect to claim 93, ROUSSO discloses that the device comprises one or more of the at least one sensor. “In some embodiments, apart from the transducer array, the chamber may house also other parts of the system, such as the waveform generator, the digital controller, the sensor controller, various sensors, or an energy source such as a battery.” ([0251]).
Claim 101 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024) and U.S. Patent Appl. Publ. No. 2009/0198307 A1 (hereinafter “BIN MI”) and U.S. Patent Appl. Publ. No. 2003/0225331 A1 to Diederich et al. (hereinafter “DIEDERICH”).
With respect to claim 101, ROUSSO discloses a method of treating a patient using an implantable device adapted to be implanted adjacent to at least one vessel or tissue containing flowing blood. “A method and/or system are provided for improving kidney function and/or increasing Glomerular Filtration Rate (GFR) of the renal system, by applying acoustic and/or ultrasonic energy to one or more of the kidneys… which could also be implemented invasively and/or by implantable device.” (Abstract; see also [0285]: “…some or all parts of the device can be implanted inside the body of the subject, making the device an implantable device.”). The method comprises using at least one ultrasonic transducer of the implantable device, emitting ultrasonic energy toward the at least one vessel or tissue, so as to cause a physiologic effect in the at least one vessel or tissue. “There is provided a method of modifying kidney activity, comprising: irradiating at least a portion of a kidney by applying to the kidney ultrasonic energy at a frequency, repetition rate and amplitude suitable to affect kidney function; repeating said irradiating until said affect kidney function is achieved.” ([0008]). The method also includes using at least one sensor, monitoring at least one physiological state of the patient. “In some embodiments, the systems include one or more sensors for or is configured to receive a sensor signal indicative of a physiological measure, for example, one or more of blood pressure, its cycles, or the heart rate, either mechanically or by ECG or by imaging, or by ultrasound or by sound, or by light emission or reflection, or similarly.” ([0222]; see also [0254]). The method also includes using at least one remote controller, controlling at least one of an operation of the implantable device and one or more parameters of the emitted ultrasonic energy, based on data collected by the at least one sensor. “In some embodiments, the device is controllable wirelessly from a cellphone, smartphone, tablet and/or a dedicated device… In some embodiments, the transducer and waveform generator (and possibly associated circuitry, e.g. power circuitry and/or communication circuitry and/or control circuitry) are implanted inside the body of the subject, with the signal and/or power transmitted to it wirelessly from the external components, either by RF, wireless technology or by coupled coils, or by acoustic energy transmission.” (emphasis added) ([0285]).
Regarding parameters that can be controlled: “…the digital controller drives the waveform generator, and is in charge of determining the various parameters of the sonication. In some embodiments, such parameters include, for example, the sonication times and durations, waveform parameters and shape, amplitude or area of sonication.” ([0258]). Regarding data collected by the at least one sensor, see [0260]: “In some embodiments, the digital controller dynamically changes different parameters of its output signals,…in response to inputs from the sensor controller.….” and [0254]: “…the sensor controller receives measurements from a set of sensors, based on which it sends commands to the digital controller.”
While ROUSSO teaches using a remote controller, ROUSSO does not explicitly teach using at least one on-skin remote controller. NOTE: Unlike claims 81 and 94, claim 101 is a method claim. The term “on-skin remote controller” is being interpreted as the remote controller contacting the skin while controlling the implantable device.
DIEDERICH teaches a “long-term implantable ultrasound therapy system and method is provided that provides directional, focused ultrasound to localized regions of tissue within body joints.” (Abstract). While DIEDERICH’s embodiments are primarily directed to skeletal and spinal applications, DIEDERICH notes that therapeutic ultrasound can be useful for treating many conditions, such as “chronic intractable pain, hemodynamic insufficiency resulting in angina, peripheral vascular disease, cerebral vascular disease, various movement disorders, and bowel and bladder control” among others. ([0051).
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Figure 66 of DIEDERICH is shown here and illustrates a long-term implantable ultrasound therapy system 400 and includes a long-term implantable ultrasound treatment assembly 420. ([0407]) (see also [0110] teaching that a system may “operate the ultrasound treatment assembly according to a set of ultrasound operating parameters…”). “A coupling assembly 430 connects treatment assembly 420 with a control unit 440 that is shown in this embodiment to also be implanted as a long-term implant within the body 402 of the patient…Further to the illustrative embodiment, control unit 440 is adapted to communicate with an external assembly 460 via a transmitter 448 and a receiver 450 of control unit 440 and reciprocal transmitter 468 and receiver 470 for external assembly 460.” (Id). DIEDERICH explains that “[s]uch cooperation may be for example in order to provide telemetry to receive and process data monitored by control unit 440 regarding the treatment with ultrasound assembly 420, such as monitored parameters including for example temperature, thermal dose, number of treatments, duration of treatment, power levels.” (emphasis added) (Id).
Accordingly, DIEDERICH teaches using an on-skin remote controller (i.e., the external assembly 460).
It would have been obvious to one having ordinary skill in the art to incorporate ROUSSO’s system with DIEDERICH’s long-term implantable ultrasound therapy system that includes an on-skin remote controller. One would have been motivated to incorporate DIEDERICH’s on-skin remote controller as it enables wireless monitoring and control while also permitting the ultrasound treatment assembly to be placed closer to the targeted region. There would have been a reasonable expectation of success because DIEDERICH demonstrates such long-term implantable ultrasound therapy system and remote controllers can be used.
However, ROUSSO and DIEDERICH do not teach the device further comprising at least one coil configured to form an inductive link between the device and the at least one on-skin remote controller to directly drive the at least one ultrasonic transducer.
BIN MI teaches systems and methods for communicating with or powering implantable medical devices using a direct inductive/acoustic telemetry link. (Abstract). “[A]n implantable medical device including an energy translator circuit [is] adapted to convert inductive or RF signals received from the interrogator device into an acoustic signal for driving an acoustic transducer.” (Abstract). BIN MI is particularly concerned with implantable medical devices (IMD's), such as pacemakers and implantable cardioverter defibrillators. ([0003]). BIN MI notes that “[i]n some techniques, telemetric communication between the external programming device and the implanted device can be accomplished using an acoustical link provided by an ultrasonic transducer.” ([0004]).
BIN MI describes a problem with conventional implanted designs: “Due to their size, conventional IMD's are typically implanted in remote regions within the body away from the source of the signal or the target of the therapy…In some cases, it may be desirable to sense physiological parameters or therapeutic functions at a location within the body having a limited space or volume, requiring the packaging, battery, and associated electronics to be made small to reduce device size.” ([0005]).
Figure 3 of BIN MI is shown here. “[T]he translator circuit 60 comprises a single LC circuit loop formed by an inductor coil 64 inductively coupled to an externally powered coil 66, and the ultrasonic transducer 44, which for a piezoelectric ultrasonic transducer, functions within the circuit 60 as a capacitor in series with the inductor coil 64.” Notably, the transducer can be directly controlled through this configuration. The inductive or RF signal is directly converted into an electrical signal for driving the transducer. (see claim 18). The benefits of the design include reduced complexity ([0032]) and reduced size ([0004]), and possibly efficiency gains ([0034], [0036]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ROUSSO device to include at least one coil configured to form an inductive link between the device and the at least one on-skin remote controller to directly drive the ultrasonic transducer. One would be motivated to incorporate this feature in order to reduce the complexity and size of the device. There would have been a reasonable expectation of success as BIN MI teaches that transducer can be directly driven through an inductive link.
Claim 88 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024) and U.S. Patent Appl. Publ. No. 2009/0198307 A1 (hereinafter “BIN MI”) as applied to claim 81 above, and further in view of 2003/0225331 A1 to Diederich et al. (hereinafter “DIEDERICH”).
ROUSSO also teaches at least one implant comprising the at least one coil. “In some embodiments, the transducer and waveform generator (and possibly associated circuitry, e.g. power circuitry and/or communication circuitry and/or control circuitry) are implanted inside the body of the subject, with the signal and/or power transmitted to it wirelessly from the external components, either by RF, wireless technology or by coupled coils, or by acoustic energy transmission.” (emphasis added) ([0285]).
However, ROUSSO does not explicitly teach at least one pig tail comprising the at least one ultrasonic transducer and wherein the at least one pig tail is configured to be wired or wirelessly connected to the at least one implant. NOTE: Applicant does not explicitly define “pig tail.” Examiner is interpreting this term as an elongated cable-like or catheter-like device that may be positioned adjacent to targeted tissue. (see, e.g., Figure 2 of Applicant’s disclosure showing “sealed electric wiring 201” and [0341], which refers to the electric wiring as a “pig tail cable 201”). (see MPEP 2111: “During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”).
DIEDERICH teaches a “long-term implantable ultrasound therapy system and method is provided that provides directional, focused ultrasound to localized regions of tissue within body joints.” (Abstract). While DIEDERICH’s embodiments are primarily directed to skeletal and spinal applications, DIEDERICH notes that therapeutic ultrasound can be useful for treating many conditions, such as “chronic intractable pain, hemodynamic insufficiency resulting in angina, peripheral vascular disease, cerebral vascular disease, various movement disorders, and bowel and bladder control” among others. ([0051). DIEDERICH teaches “an ultrasound applicator 11…[having] a cylindrical support member such as a tube, conduit or catheter 12 which may be compatible for adjunctive radiation therapy.” ([0265], see Figures 3A-4). “Catheter 12 is coaxially disposed through a plurality of tubular piezoceramic transducers 16 which are spaced apart and electrically isolated as shown, thus forming a segmented array of tubular ultrasound transducers which radiate acoustical energy in the radial dimension.” ([0266]). “Device 11 along the array of treatment transducers 16 is sufficiently flexible to track over guidewire 60 in order to be positioned for treatment along the desired treatment region.” ([0275]).
Figure 66 of DIEDERICH is shown here and illustrates a long-term implantable ultrasound therapy system 400 that includes a long-term implantable ultrasound treatment assembly 420. ([0407]). “A coupling assembly 430 connects treatment assembly 420 with a control unit 440 that is shown in this embodiment to also be implanted as a long-term implant within the body 402 of the patient. Control unit 440 includes for example a power source 442 that cooperates with a controller 444. Further to the illustrative embodiment, control unit 440 is adapted to communicate with an external assembly 460 via a transmitter 448 and a receiver 450 of control unit 440 and reciprocal transmitter 468 and receiver 470 for external assembly 460.” DIEDERICH explains that “[s]uch cooperation may be for example in order to provide telemetry to receive and process data monitored by control unit 440 regarding the treatment with ultrasound assembly 420, such as monitored parameters including for example temperature, thermal dose, number of treatments, duration of treatment, power levels. Or, such cooperation between internally implanted control unit 440 and external assembly 460 may be for the purpose of downloading new software such as operation protocols to the drive unit tailored to advance therapy to account for new therapeutic information or to advance or otherwise modify an overall therapy protocol to a different stage.”
Accordingly, DIEDERICH teaches at least one pig tail comprising the at least one ultrasonic transducer (see, e.g., flexible applicator 11 having transducers 16 in Figures 3A-4; see also Figures 7A-13 for various configurations) and wherein the at least one pig tail is configured to be wired or wirelessly connected to the at least one implant (see Figure 66 showing wired connection through coupling assembly 430).
It would have been obvious to one having ordinary skill in the art to incorporate ROUSSO’s system with DIEDERICH’s long-term implantable ultrasound therapy system. ROUSSO teaches that the parts of the system may be implanted within the patient and that the system may be wirelessly charged/controlled through coupled coils. (([0285] of ROUSSO). Likewise, DIEDERICH teaches a similar system in which the transducers are incorporated into a catheter-like device for placing near the targeted region and are controlled by an implanted device. One would have been motivated to incorporate a design similar to DIEDERICH’s as it enables wireless control and/or charging while also permitting the ultrasound transducers to be placed closer to the targeted region. There would have been a reasonable expectation of success because DIEDERICH demonstrates such long-term implantable ultrasound therapy system can be used.
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024) as applied to claim 94 above, and further in view of 2003/0225331 A1 to Diederich et al. (hereinafter “DIEDERICH”).
With respect to claim 95, ROUSSO teaches the limitations of claim 94 as discussed above from which claim 95 depends.
However, ROUSSO does not explicitly teach wherein the at least one on-skin remote controller is configured to collect data from the at least one sensor and perform at least one of: monitor the data, adjust a treatment provided to the patient, maintain the treatment provided to the patient as is, and any combination thereof.
NOTE: As discussed above with respect to claim 94, the term “on-skin” recites a functional limitation and/or intended use or result. It does not limit the claim structurally. (MPEP 2173.05(g)).
DIEDERICH teaches a “long-term implantable ultrasound therapy system and method is provided that provides directional, focused ultrasound to localized regions of tissue within body joints.” (Abstract). While DIEDERICH’s embodiments are primarily directed to skeletal and spinal applications, DIEDERICH notes that therapeutic ultrasound can be useful for treating many conditions, such as “chronic intractable pain, hemodynamic insufficiency resulting in angina, peripheral vascular disease, cerebral vascular disease, various movement disorders, and bowel and bladder control” among others. ([0051).
Figure 66 of DIEDERICH is shown here and illustrates a long-term implantable ultrasound therapy system 400 and includes a long-term implantable ultrasound treatment assembly 420. ([0407]) (see also [0110] teaching that a system may “operate the ultrasound treatment assembly according to a set of ultrasound operating parameters…”). “A coupling assembly 430 connects treatment assembly 420 with a control unit 440 that is shown in this embodiment to also be implanted as a long-term implant within the body 402 of the patient…Further to the illustrative embodiment, control unit 440 is adapted to communicate with an external assembly 460 via a transmitter 448 and a receiver 450 of control unit 440 and reciprocal transmitter 468 and receiver 470 for external assembly 460.” (Id). DIEDERICH explains that “[s]uch cooperation may be for example in order to provide telemetry to receive and process data monitored by control unit 440 regarding the treatment with ultrasound assembly 420, such as monitored parameters including for example temperature, thermal dose, number of treatments, duration of treatment, power levels.” (emphasis added) (Id).
It would have been obvious to one having ordinary skill in the art to incorporate ROUSSO’s system with DIEDERICH’s long-term implantable ultrasound therapy system. ROUSSO teaches that the parts of the system may be implanted within the patient and that the system may be wirelessly charged/controlled through coupled coils. (([0285] of ROUSSO). Likewise, DIEDERICH teaches a similar system in which an on-skin remote controller may receive and monitor data from an implanted control unit. One would have been motivated to incorporate a design similar to DIEDERICH’s as it enables wireless monitoring and control while also permitting the ultrasound treatment assembly to be placed closer to the targeted region. There would have been a reasonable expectation of success because DIEDERICH demonstrates such long-term implantable ultrasound therapy system and remote controllers can be used.
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024) and U.S. Patent Appl. Publ. No. 2009/0198307 A1 (hereinafter “BIN MI”) as applied to claim 81 above, and further in view of Liu, Hao-Li, and Chao-Ming Hsieh. “Single-transducer dual-frequency ultrasound generation to enhance acoustic cavitation.” Ultrasonics sonochemistry 16.3 (2009): 431-438 (hereinafter “LIU”).
With respect to claim 84, ROUSSO teaches the limitations of claim 81 from which claim 84 depends as set forth above.
ROUSSO does not explicitly teach that the ultrasonic energy is provided in at least two different frequencies of a carrier signal.
LIU teaches that “ultrasound can enhance bubble activity or the so-called acoustic cavitation.” (p.431, Introduction, left column, first paragraph). “Bubble activity enhanced by acoustic cavitation may have practical benefits and potential applications Figure 2 of LIU illustrates that the carrier signal includes two different frequencies.” (Id). LIU teaches that “[d]ual- or multiple-frequency ultrasound stimulation is capable of effectively enhancing the acoustic cavitation effect over single-frequency ultrasound.” (Abstract). LIU notes that “dual- and multiple-frequency ultrasound excitation methods proposed in the literature use separate piezoelectric transducers to individually generate single-frequency ultrasonic waves that interfere spatially.” (p.432, left column, first full paragraph). “However, it can be easily found that most of the piezoelectric crystals show more than one resonant frequency. It is hypothesized that dual- or multiple-frequency ultrasonic wave irradiations are possible to be generated from a single crystal once the driving frequency matches the characteristic frequency of the transducer.” LIU’s design combines “the irradiations of dual-frequency mode excitation from a single piezoelectric crystal can significantly increase the yield of cavitation activity during sonication as compared with single-frequency excitation.” (p.436, right column, Discussion). The tested frequencies include 83 kHz, 241 kHz, and 271 kHz. (p.434, Results, left column). LIU tests different combinations of these frequencies. (Id and Figure 5). Figure 2 of LIU shows that the carrier wave includes two different frequencies. (p.433).
It would have been obvious to one having ordinary skill in the art to incorporate LIU single element transducer design into ROUSSO’s system. One would have been motivated to make this modification because “the irradiations of dual-frequency mode excitation from a single piezoelectric crystal can significantly increase the yield of cavitation activity during sonication as compared with single-frequency excitation” as taught in LIU. (p.436, right column, Discussion). A single piezoelectric crystal would permit cheaper and less complex designs. There would have been a reasonable expectation of success because LIU teaches that such transducers can utilize a single piezoelectric crystal while effectively providing cavitation activity.
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024) and U.S. Patent Appl. Publ. No. 2009/0198307 A1 (hereinafter “BIN MI”) as applied to claim 81 above, and further in view of U.S. Patent Appl. Publ. No. 2022/0022844 A1 to Garza et al. (hereinafter “GARZA”).
With respect to claim 86, ROUSSO teaches the limitations of claim 81 from which claim 86 depends.
However, ROUSSO does not explicitly teach that the at least one ultrasonic transducer is configured to function as an acoustic sensor and sense one or more acoustic waves generated by the at least one vessel or tissue. However, ROUSSO does teach that “…the transducer array 16 may also act as a receiving element (connected and processed to/by the sensor controller 8), picking up reflected ultrasonic waves and using them to form an image or other types of information.” ([0248]). “In some embodiments, this information includes…Doppler effect flow velocities within the sonicated space, organ edge detection, automatic organ classification…renal artery blood flow imager or tracker….” (Id). ROUSSO also teaches detecting the heart rate by sound. ([0222]: “In some embodiments, the systems include one or more sensors for or is configured to receive a sensor signal indicative of a physiological measure, for example, one or more of blood pressure, its cycles, or the heart rate, either mechanically or by ECG or by imaging, or by ultrasound or by sound, or by light emission or reflection, or similarly. In some embodiments, the system times the delivery of the acoustic signals to the systolic phase and/or to the diastolic phase and/or to an intermediate phase of the cardiac cycle or of the arterial blood pressure cycle, to achieve efficiency or to avoid capillary damage.”)
NOTE: Applicant does not explicitly distinguish acoustic waves and ultrasonic/ultrasound waves. Examiner is interpreting “acoustic sensor” as a sensor that can detect a pulse wave from a vessel wall. For example, [0055] of Applicant’s disclosure describes a device that contains “at least one pulse wave sensor, adapted to sense at least one acoustic wave generated by said at least one vessel or tissue containing flowing blood and thereby monitor at least one physiological state of the patient.”
In the same field of endeavor, GARZA teaches an implantable sensor system using sensor implants that comprise ultrasonic transducers. (Abstract). The sensor implants may continuously measure physiological hemodynamic signals such as diastolic and systolic blood pressure. (Id). The sensor implants may be “positioned at a known distance from the outer wall of the blood vessel (BV) to be interrogated. Optimum placement distance from the blood vessel may be set by persons of ordinary skill based on the teachings of the present disclosure taking into account parameters such as a sensor array configuration, tuning of the US signal using system electronics and selection of an acoustic lens.” ([0046]).
It would have been obvious to one having ordinary skill in the art to modify ROUSSO’s system to enable the ultrasonic transducer to detect acoustic waves. ROUSSO suggests using the transducer array as a receiving element to generate other useful information. One would have been motivated to make this modification because GARZA teaches that physiological hemodynamic signals can be detected using ultrasonic transducers. There would have been a reasonable expectation of success because GARZA teaches that ultrasonic transducers can be used sensors that detect acoustic waves generated by blood vessel walls.
Claim 96 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0188696 A1 to Rousso et al. (hereinafter “ROUSSO”) (cited in Information Disclosure Statement dated 29 May 2024) and U.S. Patent Appl. Publ. No. 2009/0198307 A1 (hereinafter “BIN MI”) and U.S. Patent Appl. Publ. No. 2003/0225331 A1 to Diederich et al. (hereinafter “DIEDERICH”) as applied to claim 95 above and further in view of U.S. Patent Appl. Publ. No. 2022/0022844 A1 to Garza et al. (hereinafter “GARZA”).
With respect to claim 96, ROUSSO and DIEDERICH teach the limitations of claim 95 from which claim 96 depends.
However, neither ROUSSO nor DIEDERICH explicitly teach that the data comprises one or more of: shape of a pulse wave signal, velocity of a pulse wave signal and a time delay between an ECG signal and the pulse wave signal. ROUSSO does teach that one or more of the sensors may detect “a physiological measure, for example, one or more of blood pressure, its cycles, or the heart rate, either mechanically or by ECG or by imaging, or by ultrasound or by sound, or by light emission or reflection, or similarly.” ([0222] of ROUSSO).
In the same field of endeavor, GARZA teaches an implantable sensor system using one or more sensor implants comprised of micro-electrical mechanical system (MEMS) sensors for the accurate and continuous measurement of physiological hemodynamic signals such as diastolic and systolic blood pressure. (Abstract). The sensor implants may be ultrasonic transducers and are configured to be placed adjacent to a blood vessel. (Id). The sensor implant is capable of calculating the pulse wave velocity and communicating that data to an external device. (see, e.g., [0051]: “While in some embodiments pulse wave velocity and patient blood pressure may be calculated within sensor implant 102….” and [0066] and [0067] teaching that “pulse wave velocity” may be determined within the sensor implant).
It would have been obvious to one having ordinary skill in the art to incorporate the implantable sensing system of GARZA with the ROUSSO-DIEDERICH’s long-term implantable ultrasound therapy system. One would have been motivated to make this modification because ROUSSO teaches that it is desirable to use sensors to obtain and monitor data in order to determine how to adjust the therapy being provided and GARZA teaches one such sensor that can provide “accurate and continuous measurement of physiological hemodynamic signals.” There would have been a reasonable expectation of success because ROUSSO teaches communicating with implanted sensors and GARZA teaches an implantable sensor.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant’s arguments with respect to claims 81-86, 88-93, and 101 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797