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 07/02/2025 have been fully considered but they are not persuasive. The applicant argues that the prior art references either alone or in combination do not teach different overhead consumption rates for 1) periods of electrical stimulation and for 2) time periods between electrical stimulation. However as admitted by the applicant, Cooke teaches energy consumption estimates for a first, second, and third energy demand action ([0051]). The applicant claims that by defining ED (energy demand) actions, the actions are specified compared to the unspecified actions of the claimed invention. However, the distinction between specified and unspecified actions is unclear and the other actions described by references such as operations performed by device operation circuitry including wireless communication reads on the “unspecified” actions as these are not directly involved in stimulation. Additionally, the actions being unspecified does not improve the patentability of the application because abstracting an already defined action is obvious. The applicant also argues that the prior art doesn’t address estimating energy consumption between pulses however, the prior art does address wirelessly communicating with a separate device and that typically happens outside of the stimulation pulses.
The applicant did not address the 35 USC 112(f) interpretation of claim 1, so it is assumed that the interpretation is accepted as is.
The applicant’s request for rejoinder of claims 11-20 is acknowledged, however since the base claims are still not in condition for allowance, the request for rejoinder is not granted.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1,4, 6-10, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crook et al (US 20210098124 A1); hereinafter Crook in view of Davis et al (US 10204706); hereinafter Davis.
Regarding claim 1, Crook teaches an electrical stimulation system ([0035] neurostimulator devices), comprising:
an implantable control module ([0079] microprocessor or equivalent control circuitry) coupled, or couplable, to the lead ([0080] pulse generator controlled by microcontroller via control signal, pulse generator couples to electrodes) and configured for implantation in a patient ([0079] LIMD includes programmable microcontroller), the implantable control module comprising a power source (battery 12), and
a processor coupled to the power source and configured for directing electrical stimulation through the electrodes of the lead using the power source ([0079] microcontroller controls various operations including stimulation therapy) and for calculating an estimate of a capacity or energy of the power source that has been used based, at least in part, on the directed electrical stimulation ([0006] energy consumption estimate),
Wherein the estimate of the capacity or energy of the power source that has been used comprises
1) an estimate of the charge or power delivered by each of the electrodes during each of a plurality of electrical stimulation instances ([0006] energy consumption estimate)
2) an estimate of the charge or power used for performing unspecified operations of the electrical stimulation system during each of the electrical stimulation instances ([0008] energy consumption estimate may estimate the power demand) calculated using a first overhead consumption rate and a collective time for the electrical stimulation instances ([0006] energy consumption estimate), and
3) an estimate of the charge or power used for performing the unspecified operations of the electrical stimulation system for time periods outside of the electrical stimulation instances using a second overhead consumption rate, different from the first overhead consumption rate, and a collective time for the time periods outside of the electrical stimulation instances ([0008] energy demand action to be performed by device operation circuitry …wirelessly communicating with a separate device - communication usually happens outside of the stimulation pulses).
Crook fails to teach that the device has leads as it focuses on leadless devices. Davis teaches a lead (implantable medical lead 10) comprising a plurality of electrodes disposed along a distal portion of the lead (electrodes 11, fig 1 shows electrodes being on distal portion). It would have been obvious to modify Crook with Davis because it constitutes a simple substitution to use a system with leads rather than a leadless system as they achieve the same basic purpose of providing electrical stimulation to the targeted areas of the body.
Regarding claim 4, the combination of Crook and Davis teaches the electrical stimulation system of claim 1. Davis teaches the estimate of the power used during a one of the electrical stimulation instances ([column 2 line 8] energy consumption estimate) comprises a summation of, for each of the electrodes used for delivery of the electrical stimulation during the electrical stimulation instance ([column 23 lines 36-55] discusses how the values can be added up in a stimulation zone), a) a product of a compliance voltage, stimulation amplitude, pulse width, pulse frequency, and duration of the electrical stimulation instance for the electrode or b) a product of the compliance voltage, stimulation amplitude, pulse width, and pulse frequency integrated over the duration of the electrical stimulation instance for the electrode.
Regarding claim 6, the combination of Crook and Davis teaches the estimate of the capacity or energy of the power source further comprises 4) an estimate of charge or power used for one or more specified operations of the implantable pulse generator ([0008] energy demand action to be performed by device operation circuitry …wirelessly communicating with a separate device).
Regarding claim 7, the combination of Crook and Davis teaches the electrical stimulation system of claim 6, wherein the estimate of the charge or power used for the one or more specified operations of the implantable pulse generator comprises at least one calculation or estimation of the charge or power used for at least one instance of at least one of the one or more other operations ([0029] discussion of how energy demand is calculated for the data transfer process).
Regarding claim 8, the combination of Crook and Davis teaches the electrical stimulation system of claim 6, wherein the estimate of the charge or power used for the one or more specified operations of the implantable pulse generator uses at least one specific consumption value accounting for the one or more specified operations ([0051] energy consumption estimate may be a preprogrammed value).
Regarding claim 9, the combination of Crook and Davis teaches the electrical stimulation system of claim 6, wherein the estimate of the charge or power used for the one or more specified operations of the implantable pulse generator uses an average charge consumption over a predefined period of time for at least one of the one or more specified operations ([0051]).
Regarding claim 10, the combination of Crook and Davis teaches the electrical stimulation system of claim 6, wherein the one or more specified operations of the implantable pulse generator comprise at least one of the following: operation of communications components of the implantable pulse generator ([0008] wirelessly communicating with separate device).
Regarding claim 21, the combination of Crook and Davis teaches the electrical stimulation system of claim 8. Crook further teaches the at least one specific consumption value comprises a first specific consumption value for the one or more specified operations during each of the electrical stimulation instances ([0006] energy consumption estimate for an amount of energy to be consumed by the device operational circuitry in connection with performing the ED action) and a second specific consumption, different from the first specific consumption value, for the one or more specified operations outside of the electrical stimulation instances ([0008] energy demand action to be performed by device operation circuitry …wirelessly communicating with a separate device - communication usually happens outside of the stimulation pulses).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crook, Davis, and Tahmasian et al (US 20210236830 A1); hereinafter Tahmasian.
The combination of Crook and Davis teaches the electrical stimulation system of claim 1. Davis teaches the estimate of the charge ([column 16 lines 10-13] Coulomb counter 55) used during a one of the electrical stimulation instances comprises a summation of, for each of the electrodes used for delivery of the electrical stimulation during one of the electrical stimulation instances ([column 23 lines 36-55] discusses how the values can be added up in a stimulation zone). The combination of Crook and Davis fails to teach the exact method of calculation. Tahmasian teaches a product of a stimulation amplitude, pulse width, pulse frequency, and duration of the electrical stimulation instance for the electrode ([0063] charge for each therapeutic pulse issued by IPG comprises intensity times pulse width then multiply by number of pulses (frequency times duration)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Crook and Davis with Tahmasian because there is some teaching, suggestion, or motivation to do so. Tahmasian teaches that “because the discharge curves of primary batteries (i.e.,Vbat) are non-linear and thus may be difficult to curve fit, the MDA 170 may employ other means to estimate primary battery end of life that considers the stimulation parameters in the primary battery history file 522” ([0063]). Therefore, it would have been obvious to use a method that calculates the energy capacity of the battery based on the stimulation parameters.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Crook and Davis in view of Shi et al (US 20150066108 A1); hereinafter Shi.
The combination of Brook and Davis teaches the system of claim 4. The combination fails to teach compliance voltage. Shi teaches the compliance voltage is determined using an estimate or measurement of tissue impedance and the stimulation amplitude ([0016] discusses adjustments to the compliance voltage in response to tissue impedance and programmed amplitude indicated that the parameters are needed to calculate compliance voltage).
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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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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