DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive.
Applicant argues that the amended claims limitation of “charging the energy provider from the implantable energy source with the energy received wirelessly at the implantable charger” and “providing the energy consuming part with a burst of energy from the energy provider at least during startup of the energy consuming part” is not taught by the prior art. The examiner respectfully disagrees as Crook teaches providing supplement energy from the charge bank to the device operation for performing the ED (energy demand) action. The abstract of Crook teaches device operational circuitry obtains an energy consumption estimate for an amount of energy to be consumed by the device operational circuitry in connection with performing the ED action (energy consuming part) and dispatches a charge instruction to charge the charge bank from the battery with supplemental energy. Paragraph [0088] discloses based on energy estimation, a charge instruction to charge the charge bank 639 from the battery 672 with supplemental energy. The energy management module 636 supplies the supplemental energy, from the charge bank 639, to the device operational circuitry for performing the ED action. Additionally claim 3 of Crook discloses adding the supplemental power from the charge bank when the battery cannot supply the energy without experiencing a battery voltage dip below a battery voltage threshold.
Crooks therefore teaches the use of a battery (implantable energy source) which provides power to the charging bank (energy provider) which in combination with the battery supplies energy demanding/ high energy activities (energy consuming part). Crooks is modified by the teachings of Almendinger et al to use an external power source to supply energy to the internal coil of the IMD to recharge the internal battery 151 (e.g. Paragraph [0102]) which makes the implantable device of Crooks more versatile and improves device life by enabling the device to receive power from external sources without subjecting the patient to replacement battery surgery.
Claim Objections
Claim 55 is objected to because of the following informalities: “providing a burst of energy” is not referring back to a previous established step, but is identifying the delivery of energy and therefore should be changed to “providing the burst of energy”. 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.
Claim 49 is 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 49 requires the energy comprises a capacitor; this is unclear because energy is the ability to perform work and cannot be a capacitor; it is unclear if this is meant to state the energy provided comprises a capacitor or if another structure is supposed to be a capacitor.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 43-46, 48-50, 52-53, and 58-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crook et al (US Publication 2021/0098124) in view of Almendinger et al (US Publication 2013/0238048).
Referring to Claim 43, Crook et al teaches a method of powering an implant for a human patient , an implantable energy source for storing energy received by the implantable charger and for providing energy to the implant (e.g. Figure 1,battery 12), and an energy provider connected to the implantable energy source (e.g. Figure 1, charge bank 19) and connected to an energy consuming part of the implant (e.g. Paragraph [0088] and claim 3), the method comprising: charging the energy provide form the implantable energy source, with the energy received wirelessly at the implantable charger (Paragraph [0088] and claim 3), and providing the energy consuming part with a burst of energy from the energy provided at least during the startup of the energy consuming part (Paragraph [0088] and claims 3 and 4 and Paragraph [0030] disclose delivery of high energy shocks which are an ED action). However, Crook et al does not explicitly disclose the implant comprises an implantable charger configured for receiving wirelessly transmitted energy and the method of receiving, at the implantable charger, energy transmitted wirelessly which is stored in the battery. Almendinger et al teaches that it is known to use an external power source to supply energy to the internal coil of the IMD to recharge the internal battery 151 as set forth in Figure 1, 4 and Paragraphs [0102]-[0103] to provide improved versatility and improves device life by enabling the device to receive power from external sources without subjecting the patient to replacement battery surgery. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Crook et al, with the implant comprises an implantable charger configured for receiving wirelessly transmitted energy and the method of receiving, at the implantable charger, energy transmitted wirelessly which is stored in the battery as taught by Almendinger et al, since such a modification would provide the predictable results of improved versatility and improves device life by enabling the device to receive power from external sources without subjecting the patient to replacement battery surgery.
Referring to Claim 44, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein the step of providing the burst of energy comprises providing a burst of energy corresponding to a difference between a required energy consumption and a maximum energy capable of being delivered by the implantable energy source (e.g. Paragraph [0031] charge bank to render sufficient energy and avoid an undue dip in battery voltage during the energy demand action and claim 3).
Referring to Claim 45, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein discharging of energy from the implantable energy source during startup of the energy consuming part is slower than an energy needed for startup of the energy consuming part (e.g. Paragraphs [0031] and [0088]).
Referring to Claim 46, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein a maximum energy consumption of the energy consuming part is higher than the maximum energy capable of being delivered by the implantable energy source without causing damage to the implantable energy source, and wherein the step of providing the energy consuming part with a burst of energy comprises providing an energy provider is adapted to deliver an energy burst corresponding to a difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy source (e.g. Paragraphs [0031] and [0088]).
Referring to Claim 48, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein the implantable energy source is connected to the energy consuming part and wherein the method further comprises the step of providing energy form the energy source to the energy consuming part to power the energy consuming part, after the energy consuming part has been started using the energy provider (e.g. Figure 1 and Paragraph [0088]).
Referring to Claim 49, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein the energy [provider] comprises a capacitor (e.g. Figure 1, capacitor 21).
Referring to Claim 50, Crook et al in view of Almendinger et al teaches the method according to claim 49, wherein the energy provide comprises one of: a start capacitor, a run capacitor, a dual run capacitor, or a supercapacitor (e.g. Figure 1, capacitor 21).
Referring to Claim 52, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein the step of providing the energy consuming part with a burst of energy from the energy provider comprises providing a burst of energy to at least one of: a motor for operating a device or function of the implant, motor for powering a hydraulic pump, a control unit for controlling at least a part of the implant, a device for providing electrical stimulation to a tissue portion of the body of the patient, a CPU for encrypting information, a transmitting and/or receiving unit for communication with an external unit, a measurement unit or a sensor, a data collection unit, a solenoid, a piezo-electrical element, a memory metal unit (e.g. Paragraph [0088] discloses energy demand resulting from monitoring, treating or wireless communication).
Referring to Claim 53, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein the step of providing the energy consuming part with a burst of energy form the energy provider comprises providing a burst of energy to feedback unit (e.g. Paragraph [0088] monitoring or Paragraphs [0046] and [0066] discloses feedback loop based on condition of the battery).
Referring to Claim 58, Crooks et al in view of Almendinger et al teaches the method according to claim 57, except wherein the step of storing in the implantable energy source, energy received wirelessly at the implantable charger comprises controlling the charging of the implantable energy source by controlling receipt of electrical power from the external energy source at the implantable charger.
Almendinger et al teaches that it is known to use an external power source to supply energy to the internal coil of the IMD to recharge the internal battery 151, the external charger 101 controls when the internal battery 151 of the implanted device 104 is recharged as set forth in Figure 1, 4 and Paragraphs [0102]-[0103] to provide improved versatility and improves device life by enabling the device to receive power from external sources without subjecting the patient to replacement battery surgery. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Crook et al, with the step of storing in the implantable energy source, energy received wirelessly at the implantable charger comprises controlling the charging of the implantable energy source by controlling receipt of electrical power from the external energy source at the implantable charger as taught by Almendinger et al, since such a modification would provide the predictable results of improved versatility and improves device life by enabling the device to receive power from external sources without subjecting the patient to replacement battery surgery.
Referring to Claim 59, Crook et al in view of Almendinger et al teaches the method according to claim 43, except wherein the step of storing in the implantable energy source, energy received wirelessly at the implantable charger comprises controlling the charging of the implantable energy source by controlling a transmission of electrical power from the external energy source to the implantable charger.
Almendinger et al teaches that it is known to use an external power source to supply energy to the internal coil of the IMD to recharge the internal battery 151, the external charger 101 controls when the internal battery 151 of the implanted device 104 is recharged as set forth in Figure 1, 4 and Paragraphs [0102]-[0103] to provide improved versatility and improves device life by enabling the device to receive power from external sources without subjecting the patient to replacement battery surgery. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Crook et al, with the step of storing in the implantable energy source, energy received wirelessly at the implantable charger comprises controlling the charging of the implantable energy source by controlling a transmission of electrical power from the external energy source to the implantable charger as taught by Almendinger et al, since such a modification would provide the predictable results of improved versatility and improves device life by enabling the device to receive power from external sources without subjecting the patient to replacement battery surgery.
Referring to Claim 60, Crook et al in view of Almendinger et al teaches the method according to claim 43, further comprising indicating, using an energy source indicator, a functional status of the implantable energy source (e.g. Figure 2, Element 216 and Paragraph [0088]).
Referring to Claim 61, Crook et al in view of Almendinger et al teaches the method according to claim 60, wherein the functional status indicates at least one of charge level and temperature of the implantable energy source (e.g. Paragraphs [0056]-[0057] and [0066] discloses when the battery exhibits strong battery charge level the therapy is implemented without initiating the supplemental energy of the charge bank 19).
Referring to Claim 62, Crook et al in view of Almendinger et al teaches the method according to claim 60, except further comprising transmitting the functional status in a signal transmitted to the outside of the body. Almendinger et al teaches that it is known to use an the implantable device to include a signal communicating to the external charger a functional status when the battery charge level is below a predetermined threshold as set forth in Paragraphs [0151] to provide reducing the risk of overcharging/damaging the implant and/or wasting energy trying to recharge the device when charging is not required. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Crook et al, with wherein the controller is further configured to include the functional status in a signal transmitted to the outside of the body as taught by Almendinger et al, since such a modification would provide the predictable results of reducing the risk of overcharging/damaging the implant and/or wasting energy trying to recharge the device when charging is not required.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crook et al (US Publication 2021/0098124) in view of Almendinger et al (US Publication 2013/0238048), as applied above, and further in view of Meadows et al (US Patent 6,516,227).
Referring to Claim 50, Crook et al in view of Almendinger et al teaches the method according to claim 49, except wherein the energy provider comprises is a supercapacitor.
Meadows et al teaches that it is known to use a power source with that includes a rechargeable battery and a supercapacitor as set forth in Column 17 lines 24-29 to provide higher power density which enables greater versatility in providing high power needs. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Crook et al, with wherein the energy provider is a supercapacitor as taught by Meadows et al, since such a modification would provide the predictable results of higher power density which enables greater versatility in providing high power needs.
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crook et al (US Publication 2021/0098124) in view of Almendinger et al (US Publication 2013/0238048), as applied above, and further in view of Keimel et al (US Publication 2007/0255334).
Referring to Claim 54, Crook et al in view of Almendinger et al teaches the method according to claim 53, except wherein the feedback unit is a vibrator. Keimel et al teaches that it is known to use the feedback unit is a vibrator as set forth in Figure 2, Element 50 and Paragraph [0007] to provide notification to the patient when measured signals indicate unfavorable conditions. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Crook et al, with the feedback unit is a vibrator as taught by Keimel et al, since such a modification would provide the predictable results of notification to the patient when measured signals indicate unfavorable conditions.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crook et al (US Publication 2021/0098124) in view of Almendinger et al (US Publication 2013/0238048), as applied above, and further in view of Whitehurst et al (US Publication 2004/0082908).
Referring to Claim 55, Crook et al in view of Almendinger et al teaches the method according to claim 43, except wherein the step of providing the energy consuming part with a burst of energy from the energy provider comprises providing a burst of energy to a valve comprised in the implant.
Whitehurst et al teaches that it is known to use a controller to control valves which control the delivery of drugs as set forth in Figure 6, Element 32 and Paragraphs [0033]-[0034] to provide improved treatment by including drugs that help with reducing infection after implantation or with treating the patient’s condition. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Crook et al, with the step of providing the energy consuming part with a burst of energy from the energy provider comprises providing a burst of energy to a valve comprised in the implant as taught by Whitehurst et al , since such a modification would provide the predictable results of improved treatment by including drugs that help with reducing infection after implantation or with treating the patient’s condition.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crook et al (US Publication 2021/0098124) in view of Almendinger et al (US Publication 2013/0238048), as applied above, and further in view of Alt (US Patent 6,157,859).
Referring to Claim 56, Crook et al in view of Almendinger et al teaches the method according to claim 43, wherein the implant further comprises a control unit for controlling at least a part of the implant, and wherein the control unit has a sleep mode and an operational mode, and wherein the step of providing the energy consuming part with a burst of energy from the energy provider comprises providing a burst of energy to the control unit for transitioning from the sleep mode to the operational mode. Alt teaches that it is known to use a sleep mode when no immediate demand for therapy is being imposed and is awaken to fully operation when a therapy requirement is sensed as set forth in Column 6 lines 60-Column 7 line 3 and to provide reducing power requirements of the implant when there is no immediate demand for therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Crook et al, with a control unit for controlling at least a part of the implant, and wherein the control unit has a sleep mode and an operational mode, and wherein the step of providing the energy consuming part with a burst of energy from the energy provider comprises providing a burst of energy to the control unit for transitioning from the sleep mode to the operational mode as taught by Alt, since such a modification would provide the predictable results of reducing power requirements of the implant when there is no immediate demand for therapy.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796