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 .
Claim Objections
Claim 2 is objected to because of the following informalities: “wherein” should be added so the claim reads: “The method of claim 1, wherein the sequence is delivered…” (line 1).
Claim 17 is objected to because of the following informalities: “medium” should be added so the claim reads: “The non-transitory machine-readable medium of claim 16…” (line 1).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 1-2, 4-9, 11-12, and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esteller et al. (US Pre-Grant Publication 2022/0347479), hereinafter ‘Esteller’.
Regarding claim 1, Esteller teaches a method, comprising:
generating, using a tonic waveform generator (IPG 10, Fig. 1), a train of tonic pulses having a uniform pulse-to-pulse interval ([0063], tonic stimulation, top plot of Fig. 7A);
applying, using a neurostimulation modifier, a neurostimulation-effect modulation to modify the train of tonic pulses ([0072], modulate tonic stimulation pulses); and
delivering a sequence of electrical pulses ([0042], produce stimulation at electrode) to a neural target ([0015], provide stimulation to patient's tissue) using an electrode set that includes at least one electrode (electrodes 16, Fig. 1), wherein the modified train of tonic pulses and a neurostimulator output are used to deliver the sequence (Fig. 7A, modified pulses),
wherein the applied neurostimulation-effect modulation changes at least one stimulation parameter for at least a portion of the train of tonic pulses (step 188, Fig. 11, [0092], adjust modulation function by changing modulation parameters) to enhance or reduce a neurostimulation effect ([0064], assess ECAP features) for one or more pulses within the sequence of electrical pulses.
Regarding claim 16, see rejection of similarly worded claim 1. Esteller further teaches a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method ([0026], computer readable media).
Regarding claim 18, see rejection of similarly worded claim 1. Esteller further teaches a system comprising a neurostimulator (Fig. 1, [0002], neurostimulator).
Regarding claim 2, Esteller teaches the method of claim 1, further comprising:
the sequence is delivered using a driver to drive the sequence to the neural target (stimulation circuitry 28, Fig. 3, [0008], current sources 40).
Regarding claim 4, Esteller teaches the method of claim 2, further comprising:
wherein the neurostimulation-effect modulation is applied using hardware circuits configured to modulate the train of tonic pulses ([0026], programmed external device and control circuitry).
Regarding claim 5, Esteller teaches the method of claim 2, further comprising:
wherein the tonic waveform generator and the neurostimulation modifier are implemented using software ([0026], computer readable media), and both the train of tonic pulses and the modified train of pulses are digital ([0042], digital control signals).
Regarding claim 6, Esteller teaches the method of claim 1, further comprising:
wherein the neurostimulation-effect modulation is a charge modulation function ([0013], charge balanced when pulse width and amplitude of phases are the same, Fig. 7A, modulation functions 150a, 150b, 150c).
Regarding claim 7, Esteller teaches the method of claim 6, further comprising:
wherein the charge modulation function is applied by modulating more than one stimulation parameter for at least the portion of the train of tonic pulses ([0070], more than one stimulation parameter can be modulated).
Regarding claim 8, Esteller teaches the method of claim 7, further comprising:
wherein the charge modulation function is applied by modulating at least two stimulation parameters from: amplitude, pulse width, pulse frequency, a charge balance configuration, burst duration, burst frequency or burst ON/OFF duty cycle ([0070], more than one stimulation parameter can be modulated including amplitude, pulse width, frequency.
Regarding claims 9 and 19, Esteller teaches the method/system of claims 1/18, respectively, further comprising:
receiving a user input to program the neurostimulation-effect modulation (Fig. 7B, GUI 160, [0071], user defines modulation function).
Regarding claims 11 and 17, Esteller teaches the method/non-transitory machine-readable medium of claims 1/16, respectively, further comprising:
wherein the sequence of electrical pulses includes a section of monophasic pulses and a recharge balance section for balancing delivered net charge (Fig. 3, [0068], monophasic pulses with passive charge recovery, [0013], charge balancing).
Regarding claim 12, Esteller teaches the method of claim 1, further comprising:
wherein the sequence of electrical pulses includes two or more phases (Fig. 2A, [0013], biphasic pulses).
Regarding claim 14, Esteller teaches the method of claim 1, further comprising:
wherein the neurostimulation-effect modulation is applied to provide some pulses within the sequence of electrical pulses that engage neural tissue and to provide other pulses within the sequence of electrical pulses that do not engage neural tissue ([0079], sub-perception therapy, paresthesia threshold).
Regarding claim 15, Esteller teaches the method of claim 1, further comprising:
wherein the neurostimulation-effect modulation is applied to provide some pulses within the sequence of electrical pulses that are supra-threshold stimulation and to provide other pulses within the sequence of electrical pulses that are sub- threshold stimulation ([0079], sub-perception therapy, paresthesia threshold).
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.
Claims 3, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Esteller et al. (US Pre-Grant Publication 2022/0347479) in view of Cholette et al. (US Pre-Grant Publication 2018/0369573), hereinafter ‘Cholette’.
Regarding claim 3, Esteller teaches the method of claim 2, further comprising:
wherein the driver includes energy sources (IPG battery 14, Fig. 1).
Esteller does not specifically teach that the neurostimulation-effect modulation is applied using firmware.
Cholette teaches a spinal cord stimulator (see Fig. 1, [0012], abstract), further comprising:
wherein the neurostimulation-effect modulation is applied using firmware to adjust energy sources ([0127], IssuePulse function called by pulse generator firmware).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Esteller to incorporate the teachings of Cholette to include that the neurostimulation-effect modulation is applied using firmware. Doing so would allow for the control of stimulation, as recognized by Cholette [0127].
Regarding claims 10 and 20, Esteller teaches the method/system of claims 1/18, respectively, but does not specifically teach that the neurostimulation-effect modulation is a predetermined function.
Cholette teaches a spinal cord stimulator (see Fig. 1, [0012], abstract), further comprising:
wherein the neurostimulation-effect modulation is a predetermined function that is not user-programmable ([0099], change waveform automatically).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Esteller to incorporate the teachings of Cholette to include that the neurostimulation-effect modulation is a predetermined function. Doing so would allow for the use of certain waveforms in certain conditions depending on the physiological context, as recognized by Cholette [0099].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Esteller et al. (US Pre-Grant Publication 2022/0347479) in view of Mishra et al. (US Pre-Grant Publication 2019/0001139), hereinafter ‘Mishra’.
Regarding claim 13, Esteller teaches the method of claim 12, further comprising arbitrary modulation shapes (see Fig. 7A, [0065]) and that modulation of multiple parameters can occur on different time scales (see [0070]), but does not specifically teach providing a first parameter value in a first phase independent of a second parameter value in a second phase.
Mishra teaches an apparatus for delivering stimulation to a patient (see abstract, [0008]), further comprising:
wherein the neurostimulation-effect modulation is applied by providing a first value (period 1 length, Fig. 32) for at least one parameter in a first phase independent of a second value (period 2 length, Fig. 32) for the at least one parameter in a second phase ([0428], randomly varying inter-pulse gaps, frequencies, other stimulation parameter). See annotated Fig. 32 below.
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It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Esteller to incorporate the teachings of Mishra to include providing a first parameter value in a first phase independent of a second parameter value in a second phase. Doing so would reduce undesired patient conditions, as recognized by Mishra [0430].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/E.L.O./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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