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 Amendment
This Office Action is responsive to the amendment filed on 12 Feb 2025. As directed by the amendment: claims 1, 8-9, 12, and 15 have been amended, claims 2-7 have been canceled, and claims 18-31 have been added. Thus, claims 1 and 8-31 are presently pending in this application.
Response to Arguments
Objection to the Drawings
Applicant’s arguments, see Remarks, filed 12 Feb 2025, with respect to objections to the drawings have been fully considered and are persuasive in light of the newly filed replacement drawings. The objections of the drawings have been withdrawn.
Objection to the Claims
Although not mentioned in Applicant’s Remarks, Applicant’s amendment to claim 15 obviates the objection made in the previous Non-Final Office Action, and thus the objection to claim 15 is withdrawn.
However, new objections are made below as necessitated by the claim amendments.
Rejection of the Claims Under 35 U.S.C. §112
Applicant’s arguments, see Remarks, filed 12 Feb 2025, with respect to rejections to claims 1-17 under 35 U.S.C. 112 have been fully considered. The rejections of claims 1-14 and 16-17 under 35 U.S.C. 112 have been withdrawn.
However, the rejection of claim 15 regarding the limitation “the AC input” is maintained, as the claim was not amended to obviate this rejection.
Furthermore, new rejections under 35 U.S.C. 112 are made below as necessitated by the claim amendments.
Rejection of the Claims Under 35 U.S.C. §103
Applicant’s arguments, see Remarks, filed 12 Feb 2025, with respect to the rejections of claims 1 and 8-17 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Griffith (US Patent No. 6073050 A), as explained in further detail below.
Claim Objections
Claims 1, 24, and 28-29 are objected to because of the following informalities:
Claim 1: a semicolon should be added after “notch” in line 14
Claim 24: “wherein” should be added before CSTOR in line 1
Claim 28: A period should replace the comma at the end of the claim
Claim 29: “an Rx antenna a radio frequency (RF) signal” in line 2 should read “an Rx antenna configured to receive a radio frequency (RF) signal”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15, 18-20, 22, and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the AC input" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, "the AC input" will be interpreted as "an AC input".
The term “substantially the same” in claims 18-20 is a relative term which renders the claim indefinite. The term “substantially the same” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In claim 18, it is unclear as to how similar the duration of the energy release and the duration of the notch are required to be. In claim 19, it is unclear as to how similar the duration of the pulse signal and the duration of the notch are required to be. In claim 20, it is unclear as to how similar the amplitude of the pulse signal and VDD are required to be. For the purposes of examination, “substantially the same as” will be interpreted as “equal to”.
Claim 22 recites “a Tx antenna”, which is unclear as to whether it is referring to the Tx antenna established in claim 1, or a new Tx antenna. For the purposes of examination, “a Tx antenna” will be interpreted as “the Tx antenna” of claim 1.
Claim 22 further recites “a Tx antenna … applies amplitude modulation on the same RF signal to produce notches on the IPG”. It is unclear as to how notches are applied on the IPG. For the purposes of examination, “produce notches on the IPG” will be interpreted as “produce notches on the RF signal”.
Claim 28 recites the limitations "the pulse signal" in lines 1-2, and “the tissue” in line 2. There is insufficient antecedent basis for these limitations in the claim. For the purposes of examination, “the pulse signal” will be interpreted as “a pulse signal”, and “the tissue” will be interpreted as “tissue”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 11, 13, and 18-31 are rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A).
Regarding claim 1, Pivonka discloses a wirelessly powered stimulator (Fig. 2, paragraph [0114], implantable device 200, "Functional element 260 can comprise one or more implantable sensors or transducers, such as an electrode configured to deliver electrical energy to tissue"), comprising:
an implantable pulse generator (IPG) (Fig. 2, paragraph [0111], implantable device 200), comprising:
an Rx antenna (Fig. 2, paragraph [0111], implantable antenna 240) that receives a radio frequency (RF) signal from an external Tx antenna (Fig. 3, external antenna 540; paragraph [0114], "Antenna 240 receives power and/or data from an external antenna, such as external antenna 540");
a rectifier (Fig. 12, paragraph [0134], rectifier 232);
an energy storage capacitor CSTOR (Fig. 2, paragraph [0114], energy storage assembly 270, "Energy storage assembly 270 can comprise one or more components selected from the group consisting of: battery; rechargeable battery; capacitor; and combinations of one or more of these."), wherein the RF signal coupled to the Rx antenna is rectified by the rectifier to generate VDD and charges the CSTOR (paragraph [0134], "implantable device 200 comprises a boost converter that boosts a first rectifier stage output voltage (e.g. V.sub.driver of FIG. 12) to a higher voltage (e.g. V.sub.store of FIG. 12) to store energy in energy storage assembly 270, which can be configured to at least store stimulation energy for modulation of varies types of tissue, such as nerves, muscles, and/or organ tissue");
a demodulator (paragraph [0134], demodulator 231a);
an output voltage regulator that generates a stable voltage to activate the demodulator (paragraph [0135], "a regulator configured to provide a stable voltage for active circuits in implantable device 200"); and
a Tx antenna (Fig. 3, paragraph [0115], external antenna 540) that generates the RF signal that wirelessly powers the IPG (paragraph [0115], "Data and power can be transferred by external device 500 to multiple implantable devices 200"; paragraph [0118], "each implantable device 200 implantable antenna 240 (e.g. comprising one or more antennas) can be configured to wirelessly receive power and/or data from one or more external devices 500 via its external antenna 540 (e.g. comprising one or more antennas)") and that controls timing of output stimulations of the IPG (paragraph [0138], "Controller 250 can receive data asynchronously from antenna 240, and store the received data into memory registers of integrated circuit 220. The data can be used to configure the functionality of implantable device 200, including configuring the functionality of pulse generator 280"; paragraph [0111], "The pulse generator can be configured to control amplitude; timing and frequency; pulse duration; duty cycle and/or polarity of one or more stimulation waveforms delivered by implantable device 200 to tissue."), wherein amplitude modulation is applied to the RF signal to control the timing of the output stimulations (paragraph [0014], "The external system can transmit data to the implantable system using ASK modulation"; paragraph [0151], "amplitude shift-keying can be used with data encoded in the pulse-width (ASK-PW)").
Although Pivonka discloses releasing the energy stored in the CSTOR on an electrode (paragraph [0134], "Alternative configurations can use a boost converter at the output of any of the other stages of the rectifier or rely on a rectifier to provide sufficient output voltage for temporary energy storage (e.g. in energy storage assembly 270) or direct use (e.g. directly supplied to one or more functional elements 260 such as one or more electrodes configured to deliver electrical energy to tissue to modulate the tissue)"), Pivonka does not disclose that the demodulator is configured to detect notches based on amplitude modulation in the RF signal, and responsive to each detected notch, to release the energy stored in the CSTOR for a duration based on the duration of the notch.
However, Griffith teaches an efficient RF telemetry transmitter system (Abstract) that uses amplitude modulation with a varying pulse width to transmit control signals to the implanted device, wherein detected notches in the amplitude modulation (pulse-by-pulse variations in amplitude modulation) indicate bits of information (column 10, lines 5-18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka with the teachings of Griffith so that the demodulator is configured to detect notches based on amplitude modulation in the RF signal, and responsive to each detected notch, to release the energy stored in the CSTOR for a duration based on the duration of the notch, because doing so allows the desired transmit power level to be obtained, and allows an extra bit of information to be transmitted, thus increasing the information transfer rate to the implanted device (Griffith, column 10, lines 5-18).
Regarding claim 11, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the IPG is used for deep brain stimulation (paragraph [0008]).
Regarding claim 13, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the amplitude modulation is applied to the RF signal to control duration of the output stimulation in a digital manner (paragraph [0105]), but does not explicitly disclose that the amplitude modulation is applied to the RF signal to control at least one of a repetition rate and a duration of the output stimulation in an analog manner.
However, Borkan teaches an electronic tissue stimulator system (Abstract) wherein the amplitude modulation is applied to the RF signal to control a repetition rate (column 5, lines 10-15, frequency) and a duration (column 5, lines 10-15, width) of the output stimulation in an analog manner.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka and Griffith with the teachings of Borkan so that amplitude modulation is applied to the RF signal to control at least one of a repetition rate and a duration of the output stimulation in an analog manner, because doing so allows stimulation to be achieved by transmitting stimulation pulses without reprogramming the stimulator (Borkan, column 6, lines 4-6).
Regarding claim 18, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith explicitly discloses that the duration of energy release is substantially the same as the duration of the notch.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the duration of energy release the same as the duration of the notch, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 19, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith explicitly discloses that the release of energy from the CSTOR for the duration produces a pulse signal with a duration that is substantially the same as the duration of the notch.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the duration of the pulse signal the same as the duration of the notch, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 20, the wirelessly powered stimulator of claim 19 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith explicitly discloses that the amplitude of the pulse signal is substantially the same as VDD.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the amplitude of the pulse signal the same as VDD, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 21, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses one or more electrodes coupled to the CSTOR (paragraph [0134], " Alternative configurations can use a boost converter at the output of any of the other stages of the rectifier or rely on a rectifier to provide sufficient output voltage for temporary energy storage (e.g. in energy storage assembly 270) or direct use (e.g. directly supplied to one or more functional elements 260 such as one or more electrodes configured to deliver electrical energy to tissue to modulate the tissue).") and configured to be placed adjacent to tissue to thereby deliver the pulse signal to the tissue (paragraph [0128]).
Regarding claim 22, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the Tx antenna generates the RF signal that wirelessly powers the IPG (paragraph [0115], "Data and power can be transferred by external device 500 to multiple implantable devices 200"; paragraph [0118], "each implantable device 200 implantable antenna 240 (e.g. comprising one or more antennas) can be configured to wirelessly receive power and/or data from one or more external devices 500 via its external antenna 540 (e.g. comprising one or more antennas)") and applies amplitude modulation on the same RF signal (paragraph [0014], "The external system can transmit data to the implantable system using ASK modulation"; paragraph [0151], "amplitude shift-keying can be used with data encoded in the pulse-width (ASK-PW)").
Regarding claim 23, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the frequency of the RF signal is between 100 kHz and 500 MHz (paragraph [0121], the disclosed ranges of 0.3 GHz-3 GHz and 0.434 GHz-0.915 GHz overlap with the claimed range of 100 kHz-500 MHz (equal to 1e-4 GHz-0.5 GHz).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use an RF signal between 100 kHz and 500 MHz, for the purpose of optimizing the size and shape of the transmitter and optimizing power usage, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 24, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith explicitly discloses that CSTOR is between 10 nF and 1 mF.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a CSTOR between 10 nF and 1 mF, for the purpose of providing safe and effective stimulation, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 25, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith explicitly discloses that the repetition rate of notches is between 1 Hz and 10 kHz.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a repetition rate of notches between 1 Hz and 10 kHz, for the purpose of optimizing energy and signal transmission, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 26, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith explicitly discloses that the duration of the notch is more than two times the period of the RF frequency.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a notch with a duration more than two times the period of the RF frequency, for the purpose of optimizing energy and signal transmission, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the VDD is between 100 mV and 30 V (paragraph [0133], "This first stage can be configured to output an unregulated voltage of approximately 300 mV-800 mV (e.g. at node V.sub.driver of FIG. 11)").
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a VDD between 100 mV and 30 V, for the purpose of safely and effectively charging CSTOR, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 28, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the pulse signal applied to the tissue is used to stimulate nerves for therapeutic applications (paragraphs [0013], [0108], [0134], [0139]).
Regarding claim 29, Pivonka discloses an implantable pulse generator (IPG) (Fig. 2, paragraph [0114], implantable device 200, "Functional element 260 can comprise one or more implantable sensors or transducers, such as an electrode configured to deliver electrical energy to tissue"), comprising:
an Rx antenna (Fig. 2, paragraph [0111], implantable antenna 240) that receives a radio frequency (RF) signal from an external Tx antenna (Fig. 3, external antenna 540; paragraph [0114], "Antenna 240 receives power and/or data from an external antenna, such as external antenna 540");
a rectifier coupled to the Rx antenna and configured to rectify the RF signal to generate VDD (Fig. 12, paragraph [0134], rectifier 232);
an energy storage capacitor CSTOR (Fig. 2, paragraph [0114], energy storage assembly 270, "Energy storage assembly 270 can comprise one or more components selected from the group consisting of: battery; rechargeable battery; capacitor; and combinations of one or more of these."), wherein the RF signal coupled to the Rx antenna is rectified by the rectifier to generate VDD and charges the CSTOR (paragraph [0134], "implantable device 200 comprises a boost converter that boosts a first rectifier stage output voltage (e.g. V.sub.driver of FIG. 12) to a higher voltage (e.g. V.sub.store of FIG. 12) to store energy in energy storage assembly 270, which can be configured to at least store stimulation energy for modulation of varies types of tissue, such as nerves, muscles, and/or organ tissue");
a demodulator (paragraph [0134], demodulator 231a); and
an output voltage regulator that generates a stable voltage to activate the demodulator (paragraph [0135], "a regulator configured to provide a stable voltage for active circuits in implantable device 200").
Although Pivonka discloses releasing the energy stored in the CSTOR on an electrode (paragraph [0134], "Alternative configurations can use a boost converter at the output of any of the other stages of the rectifier or rely on a rectifier to provide sufficient output voltage for temporary energy storage (e.g. in energy storage assembly 270) or direct use (e.g. directly supplied to one or more functional elements 260 such as one or more electrodes configured to deliver electrical energy to tissue to modulate the tissue)"), Pivonka does not disclose that the demodulator is configured to detect notches based on amplitude modulation in the RF signal, and responsive to each detected notch, to release the energy stored in the CSTOR for a duration based on the duration of the notch.
However, Griffith teaches an efficient RF telemetry transmitter system (Abstract) that uses amplitude modulation with a varying pulse width to transmit control signals to the implanted device, wherein detected notches in the amplitude modulation (pulse-by-pulse variations in amplitude modulation) indicate bits of information (column 10, lines 5-18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka with the teachings of Griffith so that the demodulator is configured to detect notches based on amplitude modulation in the RF signal, and responsive to each detected notch, to release the energy stored in the CSTOR for a duration based on the duration of the notch, because doing so allows the desired transmit power level to be obtained, and allows an extra bit of information to be transmitted, thus increasing the information transfer rate to the implanted device (Griffith, column 10, lines 5-18).
Regarding claim 30, Pivonka discloses a method of delivering stimulation therapy (paragraph [0114], "Functional element 260 can comprise one or more implantable sensors or transducers, such as an electrode configured to deliver electrical energy to tissue"), comprising:
receiving, at an implantable pulse generator (IPG) (Fig. 2, paragraph [0111], implantable device 200), a radio frequency signal (paragraphs [0098], [0138]);
applying, through one or more electrodes coupled to the IPG, the pulse signal to a target site (Fig. 2, paragraph [0139], "Pulse generator 280 can be configured to generate and deliver one or more electric pulses to tissue, via one or more functional elements 260 (e.g. electrodes), such as to stimulate tissue").
Although Pivonka discloses releasing the energy stored in the CSTOR on an electrode (paragraph [0134], "Alternative configurations can use a boost converter at the output of any of the other stages of the rectifier or rely on a rectifier to provide sufficient output voltage for temporary energy storage (e.g. in energy storage assembly 270) or direct use (e.g. directly supplied to one or more functional elements 260 such as one or more electrodes configured to deliver electrical energy to tissue to modulate the tissue)"), Pivonka does not disclose that the demodulator is configured to detect notches based on amplitude modulation in the RF signal, and responsive to each detected notch, to release the energy stored in the CSTOR for a duration based on the duration of the notch.
However, Griffith teaches an efficient RF telemetry transmitter system (Abstract) that uses amplitude modulation with a varying pulse width to transmit control signals to the implanted device, wherein detected notches in the amplitude modulation (pulse-by-pulse variations in amplitude modulation) indicate bits of information (column 10, lines 5-18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka with the teachings of Griffith so that the demodulator is configured to detect notches based on amplitude modulation in the RF signal, and responsive to each detected notch, to release the energy stored in the CSTOR for a duration based on the duration of the notch, because doing so allows the desired transmit power level to be obtained, and allows an extra bit of information to be transmitted, thus increasing the information transfer rate to the implanted device (Griffith, column 10, lines 5-18).
Regarding claim 31, the method of claim 30 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the target site comprises neural tissue (paragraphs [0013], [0116], [0134], [0158]), or a brain (paragraphs [0013], [0158]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A), and further in view of Smith (US Publication No. 20150088115 A1, previously cited).
Regarding claim 8, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith explicitly discloses that amplitude modulation comprises detecting at least a threshold percentage reduction in power of the RF signal from the Tx antenna.
However, Smith teaches a portable surgical instrument with wireless power and data transfer capabilities (Abstract), wherein amplitude modulation comprises detecting at least a threshold percentage reduction in power of the RF signal from the Tx antenna (paragraphs [0063], [0070], [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka and Griffith with the teachings of Smith so that amplitude modulation comprises detecting at least a threshold percentage reduction in power of the RF signal from the Tx antenna, because doing so enables efficient bi-directional wireless data transfer and power transfer between devices (Smith, paragraph [0038], [0062]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A), and further in view of Feldman et al. (US Publication No. 20180140831 A1, previously cited), hereinafter Feldman.
Regarding claim 9, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith discloses a DC-block capacitor, CBCK, that delivers the output stimulations for charge-neutralization.
However, Feldman teaches an implantable pulse generator (Fig. 1, paragraph [0004], IPG 10) comprising a DC-block capacitor (Fig. 2B, paragraph [0009], DC-blocking capacitor 55) that delivers the output stimulations for charge-neutralization (paragraph 0046], “Because the capacitors may be charged to different values (e.g., VC1=VC2=3V, while other capacitors are charged to 0V), a discharge current, I.sub.D, will flow through the patient's tissue, Rt, as the equivalent circuit 95 seeks to equilibrate the amount of charge across each of the DC-blocking capacitors 55”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka and Griffith with the teachings of Feldman to include a DC-block capacitor, CBCK, that delivers the output stimulations for charge-neutralization, because doing so ensures that DC current is not inadvertently injected into the patient's tissue, thus improving the safety of the stimulator (Feldman, paragraph [0009]).
Regarding claim 10, the wirelessly powered stimulator of claim 9 is obvious over Pivonka, Griffith, and Feldman, as explained above. Neither Pivonka nor Borkan discloses a discharge resistor, RDIS, that nulls the accumulated charge on the CBCK.
However, Feldman further teaches a discharge resistor (Fig. 3B, paragraph [0023], passive recovery resistor 97) that nulls the accumulated charge on the CBCK (paragraph [0023], “The passive recovery resistors 97 set the rate at which remaining charge on the DC-blocking capacitors 55 are discharged during the passive charge recovery phases 98.”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka and Griffith with the teachings of Feldman to include a discharge resistor that nulls the accumulated charge on the CBCK, because doing so ensures that DC current is not inadvertently injected into the patient's tissue, thus improving the safety of the stimulator (Feldman, paragraph [0009]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A), and further in view of Borkan (US Patent No. 4459989 A, previously cited) and Genov et al. (WO 2017059540 A1, previously cited), hereinafter Genov.
Regarding claim 12, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Pivonka further discloses that the output voltage regulator limits an amplitude of output stimulations within a specific range (paragraph [0141], “In the case of current amplitude control, the current can be sensed in a variety of ways, such as by sensing voltage across a known series resistance and regulating the current driver strength in order to bring that sensed voltage to a desired value, and thus setting the current to the desired value. In some embodiments of amplitude control loop, an analog error amplifier or a comparator can be used to compare the above mentioned sensed voltage to a set reference value, which can be set by a controller based on the desired amplitude, and in turn can regulate the current driver strength directly, based on the difference between the sensed and desired quantities”).
Pivonka does not disclose that the output voltage regulator enables the demodulator when a supply voltage exceeds a lower tier, and does not disclose that when the supply voltage exceeds a higher tier, enables a discharge path to rapidly discharge excess incident charge.
However, Borkan teaches an electronic tissue stimulator system (Abstract) wherein, when a supply voltage (Vm) exceeds a lower tier, the demodulator is disabled (column 7, line 66-column 8, line 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka and Griffith with the teachings of Borkan to disable the demodulator when a supply voltage exceeds a lower tier, because doing so allows for continued system operation during those brief periods when the receiver might lose the transmitted signal due to dislocation of the antenna during routine activities of daily living (Borkan, column 5, lines 63-67).
Neither Pivonka, nor Griffith, nor Borkan discloses that when the supply voltage exceeds a higher tier, the output voltage regulator enables a discharge path to rapidly discharge excess incident charge.
However, Genov teaches an electronic device for continuous and simultaneous powering and data transfer (Abstract) wherein, when the supply voltage exceeds a higher tier, a discharge path is enabled to rapidly discharge excess incident charge (paragraph [0055], "The limiter discharges the excess charge on the capacitor Cs to prevent the Cs voltage from rising beyond a threshold set by the forward voltages of the 2 series diodes.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka, Griffith, and Borkan with the teachings of Genov to include a plurality of reverse bias diodes that release energy from the CSTOR when the energy stored reaches an upper threshold level because doing so protects the electronic components from breaking down (Genov, paragraph [0055]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A), and further in view of Borkan (US Patent No. 4459989 A, previously cited).
Regarding claim 14, the wirelessly powered stimulator of claim 1 is obvious over Pivonka and Griffith, as explained above. Neither Pivonka nor Griffith discloses that the demodulator replicates a timing of the amplitude modulation applied to the RF signal. However, Borkan teaches an electronic tissue stimulator system (Abstract) wherein the demodulator replicates a timing of the amplitude modulation applied to the RF signal (column 5, lines 38-40).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka and Griffith with the teachings of Borkan so that the demodulator replicates a timing of the amplitude modulation applied to the RF signal, because doing so allows stimulation to be achieved by transmitting stimulation pulses without reprogramming the stimulator (Borkan, column 6, lines 4-6).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A), and further in view of Borkan (US Patent No. 4459989 A, previously cited) and Schulman et al. (US Patent No. 4220156 A, previously cited), hereinafter Schulman.
Regarding claim 15, the wirelessly powered stimulator of claim 14 is obvious over Pivonka, Griffith, and Borkan, as explained above. Neither Pivonka, nor Griffith, nor Borkan explicitly discloses that the demodulator comprises three source follower replicas with a high end VH, low end VL, and transient envelope VENV of the RF signal and the VENV detection branch uses a small capacitor Csm and VH and VL are extracted on large capacitors with and without the AC input respectively.
However, Schulman teaches an implantable AM receiver (Abstract) comprising a VENV detection branch (Fig. 3, column 5, lines 1-3, AM detector 45) with a capacitor (column 3, lines 1-3, capacitor C1), a high end (Fig. 3, column 5, lines 7-9, peak detector 46) with a capacitor (column 5, lines 10-11, capacitor C3), and low end (column 5, lines 24-29, predetermined minimum level 20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka, Griffith, and Borkan with the teachings of Schulman to include a high end, low end, and transient envelope detection branch with capacitors because doing so allows the stimulator to distinguish between received signals and noise (Schulman, column 1, lines 58-61).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A), and further in view of Borkan (US Patent No. 4459989 A, previously cited), Schulman et al. (US Patent No. 4220156 A, previously cited), hereinafter Schulman, and Adams (US Patent No. 3945387 A, previously cited).
Regarding claim 16, the wirelessly powered stimulator of claim 15 is obvious over Pivonka, Griffith, Borkan, and Schulman, as explained above. Pivonka, Griffith, Borkan, and Schulman do not disclose that an average of VH and VL, VM, is obtained using a resistive divider and compared with VENV to reconstruct the timing of the amplitude modulation.
However, Adams teaches an implantable cardiac pacer (Abstract) comprising a resistive divider for controlling the timing of stimulation pulses (Fig. 1, column 3, lines 31-46, resistors 34 and 35).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain an average of VH and VL, VM, using a resistive divider and compare with VENV to reconstruct the timing of the amplitude modulation, because doing so optimizes stimulus rate and conserves battery (Adams, column 1, lines 40-43).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pivonka et al. (US Publication No. 20170001003 A1, previously cited), hereinafter Pivonka, in view of Griffith (US Patent No. 6073050 A), and further in view of Borkan (US Patent No. 4459989 A, previously cited), Schulman et al. (US Patent No. 4220156 A, previously cited), hereinafter Schulman, and Hajimiri et al. (US Publication No. 20150130293 A1, previously cited), hereinafter Hajimiri.
Regarding claim 17, the wirelessly powered stimulator of claim 15 is obvious over Pivonka, Griffith, Borkan, and Schulman, as explained above. Pivonka, Griffith, Borkan, and Schulman do not disclose that a recovered timing signal is sharpened by a buffer.
However, Hajimiri teaches an RF signal generator wirelessly transferring power to a wireless device (Abstract) wherein a timing signal is sharpened by a buffer (paragraphs [0060]-[0061]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pivonka, Griffith, Borkan, and Schulman with the teachings of Hajimiri so that a recovered timing signal is sharpened by a buffer, because doing so enables generating an RF signal whose amplitude and/or delay is controlled independently (Hajimiri, paragraph [0061]).
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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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796