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 .
Priority
Claims 1-20 are deemed to have an effective filing date of December 12, 2022.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 506 (Fig. 5) and 1072 (Fig. 10).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The above-identified claims recite that “multiple implantable devices communicatively coupled to each other to increase a maximum frequency for the VHF stimulation waveform”; but, the originally-filed specification (OFS) does not explain how the presence of multiple implantable devices communicatively coupled to each other would achieve the function of increasing a maximum frequency for the VHF stimulation waveform. The description in the OFS restates the language of claims 7 and 19 in paragraphs [0028], [00122], and [00152]. The Examiner notes that paragraph [0067] of the OFS describes that a patient can increase the amplitude of neurostimulation pulses or change the time that a preprogrammed stimulation pulse train is applied (i.e., delay the pulse train); and Fig. 11 shows multiple implanted IMDs, but does not mention increasing the frequency of the VHF stimulation waveform in paragraph [0093] of the OFS. Instead, paragraph [0093] states that the multiple stimulation units multiply pulses to be delivered through a lead or lead system, or provide coordinated pulse delivery, such as implantable stimulation units 1105 A-N can each generate and deliver neurostimulation pulses in fast succession, at VHF, in response to a pulse generated from implantable stimulator 1104.
Thus, the written description of the originally-filed specification discloses that additional IMDs can multiple the number of neurostimulation pulses generated by the stimulation unit. Consequently, one of ordinary skill in the art would not have recognized that the inventors, at the time of filing, had possession of multiple implantable devices communicatively coupled to each other to increase a maximum frequency for the VHF stimulation waveform.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 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 1 recites the limitation "the power management circuit" in line 16. There is insufficient antecedent basis for this limitation in the claim. Thus, the scope of the claim is indefinite.
Claims 2-10 are rejected because they depend from an indefinite claim.
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 1-3, 8-15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2020/0179697 to Schepis et al. (EFD: at least 11/6/2019 and hereinafter referred to as “Schepis”)
Referring to claim 1, Schepis discloses a system for delivering neurostimulation to one or more regions of tissue in a patient (e.g., abstract), the system comprising: one or more sensors configured to be placed in the patient to sense a measure of tissue heating caused by the delivery of the neurostimulation (e.g., paragraphs [0068], [0189]: temperature sensor 210 measures the temperature of the patient’s tissue adjacent the electrode; and [0198]-[0199]: temperature sensor measures tissue temperature; and Fig. 3G, 210); a stimulation output circuit configured to deliver the neurostimulation (e.g., paragraph [0240]: signal generator 140 delivers an electrical stimulation signal to the target nervous structure); and a stimulation control circuit configured to control the delivery of the neurostimulation using stimulation parameters (e.g., paragraph [0240]: controller 130 directs operation of the signal generator using feedback that enables tuning of treatment parameters), the stimulation control circuit including: temperature sensing circuitry configured to receive the measure of tissue heating and to determine a temperature parameter representing a temperature or a temperature change using the received measure of tissue heating (e.g., paragraphs [0240]-[0241]: controller enables feedback data collection to understand the waveform delivered via the electrode and parameters of the cooling mechanism and the thermal and electrical state of the tissue); and stimulation parameter circuitry configured to adjust the stimulation parameters using the temperature parameter (e.g., paragraph [0241]: temperature sensors are coupled to the controller 130 and the controller adjusts a parameter of the electrical stimulation in response to the feedback information) and to adjust the stimulation parameters to limit a dosage based on an operational capability of the stimulation output circuit and the power management circuit and a safety limit related to tissue heating (e.g., paragraphs [0068]: controller adjusts at least one parameter of the electrical stimulation in response to the thermal feedback information to maintain the temperature of the patient’s tissue below a destructive tissue temperature where the power management circuit is part of the controller that controls the power/energy sent to the stimulation device; and [0243]: controller is configured to vary the duty cycle and/or stimulation duration of the electrical stimulation in real-time during treatment to maximize the voltage delivered to the treatment site while not exceeding a target tissue temperature at the treatment site, i.e., a destructive tissue temperature … controlling current … to more easily control for tissue temperature and safety), the dosage including an amount of at least one of an electrical energy or electrical charge injected in to the tissue by the delivery of the neurostimulation over a specified duration (e.g., paragraph [0243]).
Regarding claims 11 and 20, Schepis discloses a method (or non-transitory computer-readable storage medium) for delivering neurostimulation to one or more regions of tissue in a patient (e.g., abstract and paragraphs [0093] and [0285]: controller may include a computer-readable medium), the method comprising: delivering the neurostimulation from a stimulation output circuit from a stimulation device (e.g., paragraph [0240]: signal generator 140 delivers an electrical stimulation signal to the target nervous structure); sensing a measure of tissue heating caused by the delivery of the neurostimulation using one or more sensors (e.g., paragraphs [0068], [0092]: measuring, at a temperature sensor, a temperature of at least one of a contact surface of the stimulation device and the patient’s tissue adjacent the contact surface during delivery of the electrical stimulation; [0189] and [0198]-[0199]: temperature sensor measures tissue temperature; and Fig. 3G, 210); determining a temperature parameter representing a temperature or a temperature change using the received measure of tissue heating (e.g., paragraphs [0068]: controller varies at least one parameter of the electrical stimulation in response to the thermal feedback information received from the temperature sensor; [0240]: controller 130 directs operation of the signal generator using thermal and electrical state of the tissue feedback that enables tuning of treatment parameters); adjusting the stimulation parameters using the temperature parameter (e.g., paragraphs [0240]: controller enables feedback data collection to understand the waveform delivered via the electrode and parameters of the cooling mechanism and the thermal and electrical state of the tissue to tune/adjust stimulation parameters; [0241]: [0241]: temperature sensors are coupled to the controller 130 and the controller adjusts a parameter of the electrical stimulation in response to the feedback information); and adjusting the stimulation parameters to limit a dosage based on an operational capability of the implantable neurostimulator and a safety limit related to tissue heating, the dosage including an amount of at least one of an electrical energy or electrical charge injected in to the tissue by the delivery of the neurostimulation over a specified duration (e.g., paragraphs [0068]: controller adjusts at least one parameter of the electrical stimulation in response to the thermal feedback information to maintain the temperature of the patient’s tissue below a destructive tissue temperature; and [0243]: controller is configured to vary the duty cycle and/or stimulation duration of the electrical stimulation in real-time during treatment to maximize the voltage delivered to the treatment site while not exceeding a target tissue temperature at the treatment site, i.e., a destructive tissue temperature … controlling current … to more easily control for tissue temperature and safety).
With respect to claims 2 and 12, Schepis discloses the system of claim 1 and the method of claim 11, wherein the stimulation output circuit is configured to deliver the neurostimulation using a very-high-frequency (VHF) stimulation waveform to the patient, the VHF stimulation waveform having a frequency of at least 100 kHz (e.g., paragraph [0024]: controller is adjustable to deliver electrical stimulation having a frequency of 100kHz- about 1 MHz).
As to claim 13, Schepis discloses the method of claim 12, wherein delivering the neurostimulation comprises delivering the neurostimulation using an implantable neurostimulator (e.g., paragraphs [0012]: electrodes of a neural tissue electrical stimulator may be positioned adjacent a peripheral nerve, a cranial nerve, a spinal cord; [0034]: the electrical stimulation device is configured to be implanted within the patient at a location adjacent the treatment site (e.g., implanted)).
With respect to claims 3 and 14, Schepis discloses the system of claim 2 and the method of claim 12, comprising an implantable neurostimulator (e.g., paragraph [0034]) including at least the stimulation output circuit (e.g., Fig. 2A, output of signal generator 140) , the power management circuit (e.g., part of controller 130), and the stimulation control circuit (part of controller 130), and further comprising: one or more heat dissipators (e.g., paragraph [0189]: cooling mechanism creates a cooling effect that prevents damage to patient’s tissue); a thermal management device configured to be coupled to the one or more heat dissipators (e.g., paragraph [0189]: temperature sensor 210 is electrically coupled to controller 130 and in response to the temperature feedback information, operation of the cooling mechanism and/or parameters of the electrical stimulation can be adjusted to control the temperature at the contact surface of the electrode thereby reducing temperature of adjacent patient tissue); and a thermal conductive lead having a proximal end configured to be coupled to the thermal management device and a distal end configured to be placed in or about a region of the one or more regions of tissue (e.g., paragraph [0191]: cooling mechanism includes a heat transfer material or heat sink provided in contact with the tissue of the treatment site and/or electrode where the heat transfer material can be disposed within leads (L) or on an introducer), wherein the thermal management device is configured to provide a thermal conductive path for a portion of a thermal energy causing the tissue heating to be dissipated through at least the one or more heat dissipators (e.g., paragraph [0191]: heat transfer material acts as a heat sink removing heat from the electrode, the tissue of the treatment site and the neighboring tissue and can include a material with high thermal conductivity and/or one or more Peltier circuits).
As to claim 8, Schepis discloses the system of claim 1, wherein the one or more sensors comprise at least one physiological sensor configured to sense a physiological signal indicative of a temperature or a change of the temperature (e.g., paragraph [0016]: controller is adjustable to vary the electrical stimulation (parameter of electrical stimulation based on measured feedback selected from measured temperature (e.g., at the treatment site, etc.), and/or a patient physiological response (e.g., blood flow, skin conductance, heart rate, muscle activity).
With respect to claims 9-10, Schepis discloses the system of claim 1, wherein the stimulation parameter circuitry is configured to adjust the stimulation parameters using the temperature parameter to prevent the temperature or the temperature change from exceeding a specified threshold, or to maintain the temperature or the temperature change within a specified range (e.g., paragraph [0068]: controller is adjustable to vary at least one parameter of the electrical stimulation in response to the thermal feedback information received from the temperature sensor to maintain the temperature of the patient’s tissue below a destructive tissue temperature – prevent the temperature from exceeding a specified threshold, or to maintain the temperature in a specified range – below a destructive tissue temperature).
As to claim 15, Schepis discloses the method of claim 14, wherein providing the one or more heat dissipators comprises providing at least one implantable heat dissipator configured to be coupled to the implantable neurostimulator (e.g., Fig. 2A and the lead of Fig. 4A and corresponding paragraphs [0146]: stimulation device 100, in its entirety, can be sized and configured for implantation within the patient; and [0212]: implanted lead has an electrode that acts as a heat sink and/or shaft of the electrode may be selected to maximize thermal conductivity and/or thermal mass).
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schepis as applied to claim 3 above, and further in view of US Patent Application Publication NO. 2011/0190849 to Faltys et al. (hereinafter referred to as “Faltys”).
Schepis discloses the system of claim 3, wherein the implantable neurostimulator further comprises the thermal management device (e.g., paragraph [0068]: software re: thermal feedback), and the one or more heat dissipators comprise at least one of an implantable heat dissipator configured to be coupled to the implantable neurostimulator (e.g., paragraphs [0188]-[0189]: the delivered electrical stimulation waveforms from the implanted stimulator can result in heating of tissue adjacent the delivery electrode; and cooling mechanism creates a cooling effect that prevents damage to patient’s tissue) or a portion of the case (not required), but does not expressly disclose a case housing at least the stimulation output circuit, the power management circuit, the stimulation control circuit, and the thermal management device. However, Faltys, in a related art: neural stimulation devices, teaches a case housing of a microstimulator (e.g., paragraphs [0150]: microstimulators described herein are configured for implantation and stimulation oof the vagus nerve; and [0154] and Fig. 7 of Faltys) having disposed within a stimulation output circuit (e.g., Fig. 1D of Faltys, stimulator with connections to electrodes), a power management circuit (e.g., Fig. 1D of Faltys: box labeled “power management”), a stimulation control circuit (e.g., Fig. 1D of Faltys: box labeled MCU) and a thermal management device (e.g., paragraphs [0192]-[0193] of Faltys: the microstimulator may include thermal protection to ensure that the microstimulator does not overheat or saturate the telemetry communications by adding a thermistor at the base of the coil that receives energy from the charger). Accordingly, one of ordinary skill in the art would have recognized the benefits of a casing enclosing the circuits of a neurostimulator in view of the teachings of Faltys. Consequently, one of ordinary skill in the art would have modified the system of Schepis so that a case encloses the circuitry of its implantable neurostimulator in view of the teachings of Faltys that such was a well-known engineering expedient, and because the combination would have yielded a predictable result.
Claims 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Schepis as applied to claims 3 and 14 above, and further in view of US Patent Application Publication No. 2016/0199639 to Stem.
Schepis discloses the system of claim 3 and the method of claim 14, further comprising: one or more implantable leads each including a proximal end configured to be coupled to the implantable neurostimulator (e.g., paragraph [146]: stimulation device 100, in its entirety, can be sized and configured for implantation within the patient at a location adjacent the targeted nervous structure as shown in Fig. 2A, implanted leads (L) coupled to the implantable neurostimulator 130, 140), a distal and configured to be placed in or about a region of the one or more regions of tissue (e.g., paragraph [0146] and Fig. 2A where the distal end is at electrodes 120), and a plurality of electrodes at the distal end (e.g., paragraph [0146] and Fig. 2A, electrodes 120), and the stimulation output circuit is configured to deliver the neurostimulation to the one or more regions of tissue using one or more electrodes selected from the plurality of electrodes at the distal end of each lead of the one or more implantable leads (e.g., paragraphs [0068] and [0240]-[0243]), wherein: at least one of the one or more implantable leads is configured to be the thermal conductive lead (e.g., paragraphs [0068]: temperature sensor coupled to the stimulation device for measuring temperature of a contact surface of the stimulation device and/or the patient’s tissue adjacent the contact surface or electrode; [0191]: cooling mechanism includes a heat transfer material or heat sink provided in contact with the tissue of the treatment site and/or electrode where the heat transfer material can be disposed within leads (L) or on an introducer); but does not expressly disclose that the one or more sensors are each incorporated into the distal end of a lead of the one or more implantable leads. However, Stem, in a related art: implantable medical leads used to monitor and limit temperature changes in proximity to electrodes, teaches that at least one of the implantable leads is configured to be a thermal conductive lead as a temperature sensor is included within a lead in proximity to the distal electrodes and that actions can be taken when the temperature exceeds a threshold due to heating from induced current (e.g., Abstract, paragraphs [0056]-[0057] and Fig. 17, lead 1706; temperature sensor 1738; electrodes 1730 and unnumbered electrodes where the electrical conductors end). Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized the benefits of an implantable neurostimulator having at least one thermal conductive lead, one or more sensors incorporated into the distal end of the lead, and a stimulation output circuit that delivers neurostimulation to tissue using one or more electrodes selected from the plurality of electrodes at the distal end of the implantable lead in view of the teachings of Stem. Consequently, one of ordinary skill in the art would have modified the system and method of Schepis so that its implantable neurostimulator has one or more implantable leads where at least one is configured to be a thermal conductive lead and at least one sensor is incorporated into the distal end of a lead in view of the teachings of Stem that such was a well-known engineering expedient to determine the temperature of the patient’s tissue at the electrode to tissue interface, and because the combination would have yielded a predictable result.
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schepis as applied to claims 3 and 14 above, and further in view of US Patent Application Publication No. 2022/0226149 to Springer et al. (EFD: 01/19/2022 and hereinafter referred to as “Springer”).
Schepis discloses the system of claim 3 and the method of claim 14, but does not expressly disclose a coolant circulation path formed in the one or more heat dissipators, the thermal management device, and the thermal conductive lead, and wherein the thermal management device comprises: a coolant reservoir coupled to the coolant circulation path and configured to store a coolant; and a coolant pump coupled to the coolant circulation path and configured to control movement of the coolant in the coolant circulation path. However, Springer, in a related art: treatment systems employing cooling, teaches that it was known in the medical arts to provide a thermal management device with a coolant reservoir 2004 coupled to the coolant circulation path (shown in Fig. 20, 2000) and configured to store a coolant; and a coolant pump (Fig. 20, 220) coupled to the coolant circulation path and configured to control movement of the coolant in the circulation path (e.g., paragraphs [0159] and [0161]-[0162] of Springer where the coolant can be a heat sink as disclosed by Schepis). Accordingly, one of ordinary skill in the art would have recognized the benefits of a thermal management unit including a coolant reservoir coupled to a coolant circulation path and a coolant pump coupled to the coolant circulation path and to control movement of the coolant in view of the teachings of Springer. Consequently, one of ordinary skill in the art would have modified the thermal management device of Schepis to include a coolant reservoir and a coolant pump in view of the teachings of Springer that such were well-known engineering expedients in the medical arts, and because the combination would have yielded a predictable result.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Schepis as applied to claims 3 and 13 above, and further in view of US Patent Application Publication No. 2018/0021583 to Ciciarelli et al. (hereinafter referred to as “Ciciarelli”).
Schepis discloses the system of claim 3 and the method of claim 13, but does not expressly disclose that the implantable neurostimulator comprises multiple implantable devices communicatively coupled to each other, as best understood. However, Ciciarelli, in a related art: methods and system for managing synchronous conducted communications for an implantable medical device, teaches that establishing and maintaining conducted communication between an IMD and another IMD where one IMD is a neurostimulation device and other IMDs are located in particular parts of the patient body is important and that multiple IMDs may be used to perform operations of Fig. 5 (e.g., paragraph [0065] of Ciciarelli). Accordingly, one of ordinary skill in the art would have recognized the benefits of multiple implantable devices communicatively coupled to each other in view of the teachings of Ciciarelli. Consequently, one of ordinary skill in the art would have modified the system and method of Schepis so that multiple implantable devices are communicatively coupled to each other and thus, would be capable of increasing a maximum frequency for the VHF stimulation waveform in view of the teachings of Ciciarelli that it was well-known in the medical arts to employ multiple IMDs communicatively coupled to each other to perform operations of the IMD, and because the combination would have yielded a predictable result.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schepis as applied to claim 14 above, and further in view of US Patent Application Publication No. 2013/0197608 to Eiger.
Schepis discloses the method of claim 14, but does not expressly disclose that providing the one or more heat dissipators comprises using a portion of the implantable neurostimulator as a heat dissipator of the one or more heat dissipators. However, Eiger, in a related art: heat dispersion for implantable medical devices, teaches that heat management systems in implants are focused on recharging system for limiting heating and thermally conductive materials to maximize the use of the heat sink, which is the exterior wall of the implant or the implant housing (e.g., paragraph [0045] of Eiger). Accordingly, one of ordinary skill in the art would have recognized the benefits of providing a heat dissipator as a portion of the implantable stimulator in view of the teachings of Eiger. Consequently, one of ordinary skill in the art would have modified a portion of the implantable neurostimulator so that it provides a heat dissipator in order to disperse heat throughout the housing to allow the use of stronger inductive power fields when charging the IMD as taught by Eiger (e.g., paragraphs [0005] and [0045] of Eiger), and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2011/0046700 to McDonald et al. is directed to an implantable lead with a safety element, where the safety element is a heat sink and a pump or Peltier cooler is used to remove the heat (e.g., abstract and paragraphs [0054]-[0055]).
US Patent Application Publication No. 2020/0179698 to Schepis et al. is directed to a device and method to selectively modulate a nervous system structure that is similar to the applied Schepis reference.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792