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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/04/2026 has been entered.
Claims Pending
Applicant’s cancellation of claim 6 and addition of claims 26-28 in the response filed 03/04/2026 and previous cancellation of claims 2, 12, 20, 22-25 is acknowledged.
Claims 1, 3-5, 7-11, 13-19, 21, and 26-28 are the current claims hereby under examination.
Claim Objections
Claims 1, 19, and 28 are objected to because of the following informalities:
Claim 1 limitation, “wherein the at least one compound action potential basis function comprises a function matched to a noiseless ECAP morphology” (lines 5-6) should read -wherein the at least one compound action potential basis function comprises a function matched to a noiseless evoked compound action potential (ECAP) morphology- (Examiner's Note: This is the first time “ECAP” is presented in the claim, and as such should be written out. Additionally, with this change, the later statement of “the neural recording comprising an evoked compound action potential (ECAP)” (lines 10-11) within claim 1 does not need “evoked compound action potential” to be fully written out.)
Claim 19 limitation, “wherein the at least one compound action potential basis function comprises a function matched to a noiseless ECAP morphology” (lines 6-7), should read -wherein the at least one compound action potential basis function comprises a function matched to a noiseless evoked compound action potential (ECAP) morphology- (Examiner's Note: This is the first time “ECAP” is presented in the claim, and as such should be written out. However, with this change, the later statement of “the neural recording comprising an evoked compound action potential (ECAP)” (lines 9-10) within claim 19 does not need “evoked compound action potential” to be fully written out.)
Claim 28 limitation “wherein the joint decomposition the neural recording” (line 1), should read -wherein the joint decomposition of the neural recording-
Appropriate correction is required.
Claim Interpretation – Previously Withdrawn
Applicant’s amendments, filed 11/15/2024 have been fully considered, and the previous interpretation withdrawn.
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 1, 3-5, 7-11, 13-19, 21, and 26-28 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 1 recites the limitation “decompose the neural recording jointly into the ECAP and the artefact, using regression on the stored set of basis functions, wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the manner in which the signal is decomposed. For example, is the regression only meant to be performed on the stored basis functions and not include any connection to the neural recording? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the neural recording also being involved with the regression.
Claim 1 recites the limitation “output the ECAP to the feedback controller”, which fails to effectively define the metes and bounds of the claim as it is unclear as to which “ECAP” is being referred to. Is this the ECAP from the joint decomposition step? Is this the noiseless ECAP? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the ECAP from the decomposition step.
Claim 1 recites the limitation “wherein the feedback controller is configured to control the application of a subsequent electrical stimulus to the neural tissue via one or more stimulus electrodes of the electrode array based on the ECAP”, which fails to effectively define the metes and bounds of the claim as it is unclear as to which “ECAP” is being referred to. Is this the ECAP from the joint decomposition step? Is this the noiseless ECAP? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the ECAP from the decomposition step.
Claim 26 recites the limitation “wherein the feedback controller is configured to decompose the neural recording jointly into the ECAP and the artefact by estimating coefficients of a linear expansion of the neural recording in terms of the stored set of basis functions”, which fails to effectively define the metes and bounds of the claim as it is unclear as to which “ECAP” is being referred to. Is this the ECAP from the joint decomposition step? Is this the noiseless ECAP? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the ECAP from the decomposition step.
Claim 26 recites the limitation “wherein the feedback controller is configured to decompose the neural recording jointly into the ECAP and the artefact by estimating coefficients of a linear expansion of the neural recording in terms of the stored set of basis functions”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what structure is performing the decomposition functions. For example, claim 1 recites “a processor configured to: decompose the neural recording jointly into the ECAP and the artefact, using regression on the stored set of basis functions, wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording” (Claim 1), where the decomposition step is performed by the processor, and claim 1 also states “wherein the feedback controller is configured to control the application of a subsequent electrical stimulus to the neural tissue via one or more stimulus electrodes of the electrode array based on the ECAP”, where the feedback controller controls the application of a stimulus. As such, it is unclear as to which structure is decomposing the neural recording. Is it the feedback controller? Is it the processor? Are both configured for the indicated function? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the processor performing the indicated function (Par. 13 of applicant’s spec.). (Examiner's Note: There is no direct indication within the applicant’s specification as to a feedback controller performing the decomposition step, and as such, this will be interpreted as the processor).
Claim 27 is dependent on claim 26, and as such is also rejected.
The term “best” in claim 28 is a relative term which renders the claim indefinite. The term “best” 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. It is unclear as to how much representation corresponds to “a balance of ECAP and artefact contributions that best represents the neural recording in a least squares sense”. As such the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any level of representation.
Claims 1, 3-5, 7-11, 13-18, 21, and 26-28 are dependent on claim 1, and as such are also rejected.
Claim 19 recites the limitation “decomposing the neural recording jointly into the ECAP and the artefact, using regression on the stored set of basis functions, wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the manner in which the signal is decomposed. For example, is the regression only meant to be performed on the stored basis functions and not include any connection to the neural recording? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the neural recording also being involved with the regression.
Claim 19 recites the limitation “outputting the ECAP to the feedback controller”, which fails to effectively define the metes and bounds of the claim as it is unclear as to which “ECAP” is being referred to. Is this the ECAP from the joint decomposition step? Is this the noiseless ECAP? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the ECAP from the decomposition step.
Claim 19 recites the limitation “applying a subsequent electrical stimulus to the neural tissue based on the ECAP”, which fails to effectively define the metes and bounds of the claim as it is unclear as to which “ECAP” is being referred to. Is this the ECAP from the joint decomposition step? Is this the noiseless ECAP? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the ECAP from the decomposition step.
Claim Rejections - 35 USC § 101 – Previously Withdrawn
Applicant’s amendments, filed 11/15/2024 have been fully considered, and the previous rejection withdrawn as a result of the added limitations regarding the application of an electrical stimulus.
Claim Rejections - 35 USC § 102 – Previously Withdrawn
Applicant’s amendments, filed 11/15/2024 have been fully considered, and the previous rejection withdrawn as a result of the added limitations regarding the feedback controller.
Claim Rejections - 35 USC § 103 - Withdrawn
Applicant’s amendment’s, filed 03/04/2026, have been fully considered, and the previous rejection withdrawn.
Allowable Subject Matter
Claims 1, 3-5, 7-11, 13-19, 21, and 26-28 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record includes Strahl (US Pat. No. 9044155) hereinafter Strahl, and further in view of Litvak (US Pub. No. 20060276722) hereinafter Litvak, Parker (US Pat. No. 9386934) hereinafter Parker, Sabes (US Pub. No. 20200129766) hereinafter Sabes, Prakash (US Pub. No. 20100292606) hereinafter Prakash, and Krishnaswamy (US Pub. No. 20160038091) hereinafter Krishnaswamy.
Strahl discloses A system (Col. 4, lines 9-17) for separating a compound action potential and an artefact from a neural recording comprising the compound action potential, the artefact (Col. 2, lines 49-59) (Col. 3, lines 30-47), the system comprising:
a memory (Col. 4, lines 26-30) storing a set of basis functions (Col. 2, lines 49-59) comprising at least one compound action potential basis function (Col. 2, lines 49-59) (Col. 3, lines 30-50) and at least one artefact basis function (Col. 2, lines 49-59)(Col. 3, lines 42-50);
an input for receiving a neural recording of electrical activity in neural tissue (Claim 1, “measuring the electrical stimulation response measurement waveform signal at the target tissue”), the neural recording captured subsequent to application of an electrical stimulus to the neural tissue (Claim 1, “applying the derived electrical stimulation signal to target neural tissue; measuring the electrical stimulation response measurement waveform signal at the target tissue”), the neural recording comprising an evoked compound action potential (ECAP) evoked by the electrical stimulus, the artefact (Col. 2, lines 49-59) (Col. 3, lines 30-47); and
a processor (Claim 1, “using at least one pre-programmed hardware element for processing an electrical stimulation response measurement waveform signal”) configured to:
decompose the neural recording jointly into the ECAP and the artefact (Claim 1, “processing the measured electrical stimulation response measurement waveform signal using a source separation algorithm to remove the stimulus artifact component”) (Col. 3, lines 30-47) (Col. 2, lines 49-59) (Col. 3, lines 47-55 (derivation of waveforms)) (Col. 3, lines 61-64 (processing performed in real time)), wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording (Col. 3, lines 30-47) (Claim 1, “processing the measured electrical stimulation response measurement waveform signal using a source separation algorithm to remove the stimulus artifact component”, (the use of the algorithm results in an output that represents the neural recording)) (Col. 2, lines 49-59 (further inclusion of matched filter to maximize signal to noise ratio)),
output (Col. 3, lines 47-55 (derivation of waveforms)) the ECAP (Col. 3, lines 30-47) (Claim 1, “processing the measured electrical stimulation response measurement waveform signal using a source separation algorithm to remove the stimulus artifact component”, (the use of the algorithm results in an output)).
Strahl highly suggests but fails to explicitly disclose the neural recording comprising background neuronal activity.
Strahl does disclose neural recordings with a compound action potential and artifact (Col. 2, lines 49-59) (Col. 3, lines 30-47), a signal mixture (Col. 1, lines 16-22) (Col. 2, lines 49-59), low signal to noise situations (Col. 2, lines 49-59), and the use of a matched filter to maximize a signal to noise ratio (Col. 2, lines 49-59) (Examiner's Note: It is highly suggested that there is also noise present in the signal of Strahl, where the noise is considered to be the claimed background neuronal activity).
However, Litvak teaches the neural recording comprising background neuronal activity (Par. 6, “As will be explained in more detail below, a neural recording signal may include any combination of a neural response signal, noise, and/or stimulus artifact. Neural recording signals are sometimes referred to as evoked potential recording”) (Par. 7, “As mentioned, a neural recording signal may include noise. Noise refers to any signal that is not correlated with the stimulus that is applied to the neural tissue by the neural stimulator. Noise is generally unpredictable.”(the noise is considered to be the background neuronal activity)) (Par. 10 (noise present in the signal that filtering may not remove)).
Strahl fails to explicitly disclose wherein the at least one compound action potential basis function comprises a function matched to an expected noiseless ECAP morphology
However, Litvak teaches wherein the at least one compound action potential basis function comprises a function matched to an expected noiseless ECAP morphology (Par. 97, “On the other hand, suppose that the incoming neural recording is noiseless. Therefore, when the incoming neural recording signal is correlated with the single basis function, the resulting weight number is high, indicating that the incoming neural recording signal correlates with the basis function…” (matching to the single basis function)) (Par. 91, “FIG. 12 is a graph showing seven basis functions or components. As shown in FIG. 12, the top basis function (basis function number 7…”) (Par. 84-85 (noise removed from signals)) (Par. 87-92).
Modified Strahl fails to explicitly disclose an electrode array; application of an electrical stimulus to the neural tissue via one or more stimulus electrodes of the electrode array; a feedback controller coupled to the electrode array.
However, Parker teaches an electrode array (Col. 9, lines 9-25, “The stimulus electrodes 204 and sense electrode 202 are in the same electrode array of a single implanted device.”); application of an electrical stimulus to the neural tissue via one or more stimulus electrodes of the electrode array (Fig. 2C, Col. 9, lines 9-25, lines 41-45) (Abstract (neural tissue)) (Fig. 4, Col. 10, lines 22-39 (neural response)); a feedback controller coupled to the electrode array (Claim 23, “feedback control of a neural stimulus using an implanted control unit, wherein the implanted control unit uses the obtained CAP measurement to control the delivery of subsequent neural stimuli by the implant.”) (Col. 4, lines 4-35 (control unit and electrodes)) (Col. 5, lines 33-40 (control unit connected to the array)).
Modified Strahl fails to explicitly disclose decompose the neural recording jointly into the ECAP and the artefact, using regression on the stored set of basis functions, wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording.
However, Strahl does disclose decompose the neural recording jointly into the ECAP and the artefact (Claim 1, “processing the measured electrical stimulation response measurement waveform signal using a source separation algorithm to remove the stimulus artifact component” (artifact is separated)) (Col. 3, lines 30-47) (Col. 2, lines 49-59) (Col. 3, lines 47-55 (derivation of waveforms)) (Col. 3, lines 61-64 (processing performed in real time)), wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording (Col. 3, lines 30-47) (Claim 1, “processing the measured electrical stimulation response measurement waveform signal using a source separation algorithm to remove the stimulus artifact component”, (the use of the algorithm results in an output that represents the neural recording)) (Col. 2, lines 49-59 (further inclusion of matched filter to maximize signal to noise ratio)).
Litvak further teaches decompose the neural recording into the ECAP and the artefact (Par. 77, (evoked response signal)) (Fig. 8,9) (Par. 85 (evoked neural recording signals)) (Par. 89-91 (basis functions derived and weights modified)) (Par. 81, (principal component analysis)) (Par. 102-104 (artifact model)) (Par. 104, “Once the artifact model has been fitted to the neural recording signal (step 216), the fitted artifact model signal is denoised (step 217). The fitted artifact model is denoised to eliminate or reduce distortions or uncertainties in the model due to the noise that is present in the neural recording signal. The fitted artifact model signal may be denoised using principal component analysis, as described above, or by using any other suitable denoising technique”), wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording (Par. 85 (evoked neural recording signals)) (Par. 89-92 (basis functions derived and weights modified)) (Par. 81, (principal component analysis)) (Par. 103, (neural recording signal m(t) with artifact and neural response)).
Litvak fails to teach using regression on the stored set of basis functions.
Sabes teaches using predictive functions for signal measurements (Par. 46, “With respect to any selected recording electrode of the array, the mathematical relationship may comprise any predictive function based on signals measured on the other recording electrodes of the array. For example, the mathematical relationship may be derived by multiple linear regression…”).
Prakash teaches decompose the neural recording (Fig. 5, step – 520-550) (Par. 51 (measure of similarity yields scalar quantities)), wherein the joint decomposition results in a of contributions that represents the neural recording (Par. 51 (measure of similarity yields scalar quantities)) (Fig. 5).
Krishnaswamy teaches using a regression model to define a cost function (Claim 1, “process the electrophysiologic data as a time-series signal; b) apply a regression model that defines an interference signal caused by periodic artifacts in the time-series signal using a harmonic representation to define a cost function; c) perform an iterative optimization process to estimate regression parameters that minimize the cost function;”).
Modified Strahl fails to explicitly disclose output the ECAP to the feedback controller; wherein the feedback controller is configured to control the application of a subsequent electrical stimulus to the neural tissue via one or more stimulus electrodes of the electrode array based on the ECAP.
However, Parker further teaches output the ECAP to the feedback controller (Claim 23, “feedback control of a neural stimulus using an implanted control unit, wherein the implanted control unit uses the obtained CAP measurement to control the delivery of subsequent neural stimuli by the implant.”) (Col. 4, lines 4-35 (control unit and electrodes)) (Col. 5, lines 33-40 (control unit connected to the array));
wherein the feedback controller is configured to control the application of a subsequent electrical stimulus to the neural tissue via one or more stimulus electrodes of the electrode array based on the estimate of the compound action potential (Fig. 2C, Col. 9, lines 9-25, lines 41-45) (Fig. 4, Col. 10, lines 22-39 (neural response)) (Claim 23, “feedback control of a neural stimulus using an implanted control unit, wherein the implanted control unit uses the obtained CAP measurement to control the delivery of subsequent neural stimuli by the implant.”) (Col. 4, lines 4-35 (control unit and electrodes)) (Col. 5, lines 33-40 (control unit connected to the array)).
Additionally, the combination of the above references would not reasonably disclose, teach, or suggest decompose the neural recording jointly into the ECAP and the artefact, using regression on the stored set of basis functions, wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording.
These prior art references do not reasonably disclose, teach, or suggest decompose the neural recording jointly into the ECAP and the artefact, using regression on the stored set of basis functions, wherein the joint decomposition results in a balance of ECAP and artefact contributions that represents the neural recording.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Parker (US Pub. No. 20160287126) hereinafter Parker 2, Fridman (US Pub. No. 20070244410) hereinafter Fridman, Karunasiri (US Pat. No. 6195585) hereinafter Karunasiri, Single (US Pub. No. 20160287182) hereinafter Single, and Schmoock (US Pat. No. 6522112) hereinafter Schmoock.
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791