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 Amendment
The amendments filed 23 DECEMBER 2025 have been entered. Claims 1, 3 – 7, 11 – 15, 17, and 19 - 23 are pending. Applicant’s amendments to the claims have overcome each and every objection to the specification and claims previously applied in the office action dated 23 SEPTEMBER 2025. Applicant’s amendments have not overcome each and every rejection applied under 35 U.S.C. 112 in the office action dated 23 SEPTEMBER 2025.
Claim Objections
Claim 1 (line 18) is objected to because of the following informalities: “resampled” is missing a hyphen in order to be consistent with the other recitations of “re-sampled.” Appropriate correction is required.
Claims 1, 9, and, 17 are objected to because of the following informalities:
Claim 1 (line 31), Claim 9 (line 34), and Claim 17 (line 32), regarding the term, “whether the correlation between…”: to increase readability and consistency with the amendment previously recited in the claim of “correlation” to “correlation analysis”, it is suggested to revise this term to be “whether the correlation analysis between…” Appropriate correction is required.
Claim 1 (line 21), Claim 9 (line 23), and Claim 17 (line 22), regarding the term “where both waveforms overlap.”: to increase readability and consistency in the claims, it is suggested to revise this term to be “where the scaled re-sampled neural response waveform and the scaled template eCAP waveform overlap”.
Claim 1 (line 24), Claim 9 (line 26 - 27), and Claim 17 (line 25), regarding the term “than a sampling rate used to re-sample”: For readability between the multiple sampling rates, it is suggested to revise the term to “a first sampling rate having a higher resolution than a second sampling rate with a lower resolution used to re-sample”.
Claim 1 (lines 33 and 34), Claim 9 (line 36 and 37), and Claim 17 (line 34 and 35), regarding the term “comprises an eCAP”. For readability and consistency with the preamble, it is suggested to revise the term to “comprises the eCAP.”
Appropriate correction is required.
Claim 4 (line 4), Claim 12 (line 4) and Claim 20 (line 4) is objected to because of the following informalities:
The term “than was used to obtain the neural response waveform” is a change of tense within the claim that is inconsistent within the claim and Claim 1 from which it depends. For readability and consistency, it is suggested to revise the term to be “than is used to obtain the neural response waveform.” Appropriate correction is required.
Claim 6 (line 2 – 3), Claim 14 (line 2 – 3), and Claim 22 (line 2 – 3), is objected to because of the following informalities:
Regarding the term “wherein re-sampling both the scaled re-sampled neural response waveform and the scaled template eCAP waveform the overlapping time period.” There appears to be a missing “at” between “waveform” and “the”, consistent with the limitation’s previous recitation in Claim 1. 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
Claims 1, 3 – 7, 9, 11 – 15, 17, and 19 - 23 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 (line 8 - 11), Claim 9 (line 12 - 15), and Claim 17 (line 11 - 14) each recite the term “determining a mean voltage of the template eCAP waveform and a mean voltage of the re-sampled neural response waveform and subtracting the determined mean voltage in a first time period from the template eCAP waveform and the re-sampled neural response waveform, respectively.” It is unclear which elements of the limitation are the respective elements, whether it is multiple mean voltages or multiple time periods. As recited, the term “the mean voltage” in “subtracting the mean voltage” is indefinite, because it appears to be a singular term, and there are two previously-recited mean voltages (one of the template eCAP waveform and one of the re-sampled neural response waveform). Further, as recited, it is unclear if the subtraction step is what occurs “during a first time period”, or if there are new mean voltages determined in a first time period of each the template eCAP waveform and the re-sampled neural response waveform.
The metes and bounds of this limitation are unclear for ascertaining the scope of the claim. Clarity should be provided for if the limitation is intended to concern multiple time periods and mean voltages. If there is subtraction among 4 mean voltages claimed, a possible suggestion for clarity of language could be “determining a first mean voltage, which is associated with the template eCAP waveform, a second mean voltage, which is associated with a first time period of the template eCAP waveform, a third mean voltage, which is associated with the re-sampled neural response waveform, and a forth mean voltage, which is associated with a first time period of the re-sampled neural waveform; subtracting the first mean voltage and the second mean voltage; subtracting the third mean voltage and the forth mean voltage.” Claims 3 – 7, 11 – 15, and 19 - 23 are similarly rejected due to their dependence on Claims 1, 9, and 17.
In each of claims 1 (lines 22 - 23), 6 (lines 1 – 3), 9 (lines 25 - 26), and 17 (lines 24 – 26), the term “re-sampling both the scaled re-sampled neural response waveform and the scaled template eCAP waveform at an overlapping time period” is indefinite. It is unclear if the overlapping time period recited here is intended a time segment of each waveform, sampling each waveform at a given time (as an example, two wavelengths are sampled at 5:00 pm) concurrently, or that a joined time period section of both waveforms is created and re-sampled as a waveform segment of a given length of time. It is also unclear if the “same time periods” are intended to be the same as the previously-recited “time period” where both waveforms overlap. The metes and bounds of this limitation are unclear for ascertaining scope of the claim. Claims 3 – 7, 11 – 15, and 19 - 23 are similarly rejected due to their dependence on Claims 1, 9, and 17.
Claim 1 (line 22), Claim 9 (line 22), and Claim 17 (line 21 - 22) each recite the term “the scaled re-sampled neural response waveform”. There is no antecedent basis for the term in the claim. As previously-recited, there was ambiguity if the “scaling” modified both the both the template eCAP waveform and re-sampled neural response waveform so that they match at an intermediate scale (altering both waveforms), which would result in a “scaled template eCAP waveform” and a “scaled re-sampled neural response waveform”. Given the amendment specifying that the “scaling” action is taken by “scaling the template eCAP waveform”, it appears that the template eCAP is scaled to match the baseline re-sampled neural response waveform. There is no specifying of particular “scaling” or alternation to the “re-sampled neural response waveform”. It appears that there is no previously-recited instance in which the re-sampled neural response waveform becomes changed into a “scaled re-sampled neural response waveform” in the claim. For the purposes of examination, the term “the scaled re-sampled neural response waveform” is deemed to claim “a scaled re-sampled neural response waveform.” Claims 3 – 7, 11 – 15, and 19 - 23 are similarly rejected due to their dependence on Claims 1, 9, and 17.
Claim 1 (line 25 - 28), Claim 9 (line 27 - 31), and Claim 17 (line 26 - 29) each recite the term “wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs during a time period before the first time period to use a portion of the scaled…in a correlation analysis”. The term is unclear for the following reasons:
There is insufficient antecedent basis for “the portion” in the claim. It is unclear if this is intended to be part of the “any portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform”, or a different “portion”.
For “wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs”: It is unclear if the “portion” is a time section of the re-sampled scaled re-sampled waveforms together, if it is a particular facet of each of the signals individually, or what the intent is. Similarly, it is unclear if the “portion” of the scaled re-sampled neural response waveform and the scaled template eCAP waveform” is a singular section of the waveform data for a given amount of time from one or the other (of scaled re-sampled neural response waveform and scaled template eCAP waveform), multiple sections (one from each), or a singular combination section of the waveform data encompassing data from both. Accounting for this and each of the additional 112(b) rejections for Claim 1, the metes and bounds of this limitation are unclear for ascertaining scope of the claim. cannot be readily determined.
Regarding the term “during a time period before the first time period”: Previously recited in the amended claims, “mean voltages in a first time period from the template eCAP waveform and the re-sampled neural response waveform, respectively.” As recited, it appears that there could be two separate “first time periods”, a “first time period from the template eCAP waveform” and a “first time period from the re-sampled neural response waveform”. Given the possible presence of these two time periods, the later recitation of “a time period before the first time period” is unclear, as it is unknown whether it is the same or different than the first time period associated with the template eCAP waveform or the same or different than the first time period from the re-sampled neural response waveform.
Regarding the term “to use a portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform in a correlation analysis”. It is unclear if this term intends to recite a singular “portion” taken from either one or the other waveform, if this is two “portions” that are taken (one from each waveform), if this is intended to be the same or different than the previously-recited “portion of the scaled re-sample neural response waveform”, or if this is intended to be same or different than the “any portion”. There is a lack of clarity among the recited “portions” in each of Claims 1, 9, and 17 to understand the quantity of portions that are present and thus the metes and bounds of each claim.
Claims 3 – 7, 11 – 15, and 19 - 23 are similarly rejected due to their dependence on Claims 1, 9, and 17.
Claim 6 (line 4 - 7), Claim 14 (line 4 - 7), and Claim 22 (line 3 - 6) each recite the limitation “wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs before the first time period to use the portion of the waveforms in the correlation analysis”. The term is unclear for the following reasons:
Similarly to Claim 1, regarding “wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs”: It is unclear if the “portion” is a time section of the re-sampled scaled re-sampled waveforms together, if it is a particular facet of each of the signals individually, or what the intent is. Similarly, it is unclear if the “portion” of the scaled re-sampled neural response waveform and the scaled template eCAP waveform” is a singular section of the waveform data for a given amount of time from one or the other (of scaled re-sampled neural response waveform and scaled template eCAP waveform), multiple sections (one from each), or a singular combination section of the waveform data encompassing data from both. Accounting for this and each of the additional 112(b) rejections for Claim 1, the metes and bounds of this limitation are unclear for ascertaining scope of the claim.
Regarding the term “before the first time period”: Previously recited in the amended claims, “mean voltages in a first time period from the template eCAP waveform and the re-sampled neural response waveform, respectively.” As recited, it appears that there could be two separate “first time periods”, a “first time period from the template eCAP waveform” and a “first time period from the re-sampled neural response waveform”. Given the possible presence of these two time periods, the later recitation of “before the first time period” is unclear, as it is unknown whether it is the same or different than the first time period associated with the template eCAP waveform or the same or different than the first time period from the re-sampled neural response waveform.
Regarding the term “to use a portion of the waveforms in a correlation analysis”. Based on the similarity of the limitation in Claim 1, it is interpreted that the likely intent is for this limitation to recite “to use the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform in the correlation analysis”. As with Claim 1, It is unclear if this term intends to recite a singular “portion” taken from either one or the other waveform, if this is two “portions” that are taken (one from each waveform), if this is intended to be the same or different than the previously-recited “portion of the scaled re-sample neural response waveform”, or if this is intended to be same or different than the “any portion”. There is a lack of clarity among the recited “portions” in each of Claims 1, 9, and 17 to understand the quantity of portions that are present and thus the metes and bounds of each claim.
Claim 6 (line 6 - 9), Claim 14 (line 6 - 9), and Claim 22 (line 6 - 9) each recite “comprises re-sampling both waveforms with the higher resolution sampling occurring between 0 and 600 µ-sec to place the emphasis on the portion of the waveforms in the correlation analysis.” The term is unclear due to the following:
There is insufficient antecedent basis for “the higher resolution sampling” in the claim relative to the amendment for Claims 1, 9, and 17, from which these claims depend. It is unclear if this is intended to be the same or different than the “the sampling rate having the higher resolution than the sampling rate used to re-sample”. It appears that that previously-recited “resolution” is a higher resolution sampling rate. That higher resolution sampling rate is previously applied to the scaled re-sampled neural response waveform and scaled template eCAP waveform during the “overlapping time period”, and it is “higher” relative to the sampling rate applied to the “sampling rate used to re-sample the neural response waveform”. For the limitation herein, “comprises re-sampling both waveforms with the higher resolution sampling occurring…”, “higher” is a relative term. The term “higher” 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 what other sampling rate this sampling rate is higher than, whether it is intended to be a rate, and it is indefinite how high a sampling rate must be to satisfy the metes and bounds of “higher” condition.
There is insufficient antecedent basis for “the emphasis” in the claim. There is no previously-recited emphasis. Further, it is unclear what the metes and bounds of “emphasis” are. Optionally, it could be to select an area for reporting or analysis, or it could be an ordinal term for which data are analyzed first, but these possible interpretations for the claiming intent are not exhaustive. The metes and bounds of this limitation are unclear for ascertaining scope of the claim regarding “emphasis”.
The term “the portion of the waveforms in the correlation analysis” is indefinite. There are multiple previously-recited “portions”, and it is unclear if this portion is intended to be the same or different than those. As described above, it is unclear how many portions are required for the correlation analysis, therefore the metes and bounds of the claim are unclear.
Should the clarity issues for “re-sampling both waveforms with the higher resolution sampling occurring between 0 and 600 µs” be alleviated, it is suggested that the term “to place the emphasis on the portion of the waveforms in the correlation analysis” be removed. It appears to merely state a reason for why the re-sampling part of the limitation is performed for a field of use, rather than an active additional part of the method.
In claims 5 (line 1 -2), 13 (lines 1 – 2), and 21 (lines 1 – 2), the term “subtracting the determined mean voltages in the first 600 µ-sec” is unclear, as it is indefinite whether the mean voltages originate from the template eCAP waveform, the re-sampled neural response waveform, or both. There is a stacking lack of clarity from claim 1 regarding the “determined mean voltages”, as it is unclear how many mean voltages are determined in the independent claims, either 2 or 4 (including the mean voltages in the first time period(s)). It is also unclear which mean voltages are subtracted from which mean voltages. The metes and bounds of the claim are unclear.
The amendments were not sufficient to overcome the previously-applied 35 U.S.C. 112(b) rejection in the non-final office action dated 23 SEPTEMBER 2025. to Claim 9 for the term “calculate a correlation”. An amendment was applied for the term in Claim 1, but not in its recitation in Claims 9 or 17. For the purposes of examination, the term “calculate a correlation” is deemed to claim “calculate the correlation analysis”. Claims 11 – 15 and 19 – 23 are similarly rejected due to their dependence on Claims 9 and 17.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claims 9 and 17 the claims each recite an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 recites an abstract idea.
Specifically, Independent Claims 1, 9, and 17 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim
A method of determining whether an electrically evoked compound action potential (eCAP) exists in a neural response comprising:
providing a template eCAP waveform;
receiving a recorded neural response waveform obtained from a patient with a cochlear implant;
re-sampling the recorded neural response waveform;
normalizing the re-sampled neural response waveform and the template eCAP waveform by determining a mean voltage of the template eCAP waveform and a mean voltage of the re- sampled neural response waveform and subtracting the determined mean voltages recorded in a first time period from the template eCAP waveform and the re-sampled neural response waveform, respectively;
determining a first negative (N1) peak and a trailing positive peak (P2) in each of the re- sampled neural response waveform and the template eCAP waveform;
scaling the template eCAP waveform in a vertical voltage axis to match an amplitude of the first negative (N1) peak and an amplitude of the trailing positive peak (P2) from the re-sampled neural response waveform and scaling the template eCAP waveform in a horizontal time axis to match latencies in each the resampled neural response waveform N1 and the re-sampled neural response waveform P2;
trimming any portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform to a time period where both waveforms overlap;
re-sampling both the scaled re-sampled neural response waveform and the scaled template eCAP waveform at an overlapping time period with a sampling rate having a higher resolution than a sampling rate used to re-sample the neural response waveform, wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs during a time period before the first time period to use a first part portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform in a correlation analysis;
calculating the correlation analysis between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform; and
determining whether the correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform indicates that the neural response waveform comprises an eCAP; and
if the neural response waveform comprises an eCAP, then using the eCAP to determine an estimated number of surviving neurons in a cochlear nerve of the patient, and using the estimated number of surviving neurons in the cochlear nerve provide the patient with the cochlear implant with a recommended adjustment of the cochlear implant.
Claim 9
A system for determining whether an electrically evoked compound action potential (eCAP) exists in a neural response comprising:
a memory; and
a processor in communication with the memory, wherein the processor executes computer-executable instructions stored in the memory, said instructions causing the processor to:
retrieve a template eCAP waveform from the memory;
receive a recorded neural response waveform obtained from a patient with a cochlear implant;
re-sample the recorded neural response waveform;
normalize the re-sampled neural response waveform and the template eCAP waveform by determining a mean voltage of the template eCAP waveform and a mean voltage of the re-sampled neural response waveform and subtracting the determined mean voltages in a first time period from the template eCAP waveform and the re-sampled neural response waveform, respectively;
determine a first negative (N1) peak and a trailing positive peak (P2) in each of the re-sampled neural response waveform and the template eCAP waveform;
scale the template eCAP waveform in a vertical voltage axis to match the N1 and P2 amplitudes from the re-sampled neural response waveform and scale the template eCAP waveform in a horizontal time axis to match the N1 and P2 latencies from the re-sampled neural response waveform;
trim any portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform to a time period where both waveforms overlap;
re-sample both the scaled re-sampled neural response waveform and the scaled template eCAP waveform at an overlapping time period with a sampling rate having a higher resolution than a sampling rate used to re- sample the neural response waveform, wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs occurring during a time period before the first time period to use a portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform waveforms in a correlation analysis;
calculate a correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform; and
determine whether the correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform indicates that the recorded neural response waveform comprises an eCAP.
if the neural response waveform comprises an eCAP, then using the eCAP to determine an estimated number of surviving neurons in a cochlear nerve of the patient, and using the estimated number of surviving neurons in the cochlear nerve provide the patient with the cochlear implant with a recommended adjustment of the cochlear implant.
Claim 17
A non-transitory computer readable medium comprising computer-executable instructions stored on the non-transitory computer readable medium, said computer-executable instructions for performing a method of determining whether an electrically evoked compound action potential (eCAP) exists in a neural response, said method comprising:
receiving a template eCAP waveform;
receiving a recorded neural response waveform obtained from a patient with a cochlear implant;
re-sampling the recorded neural response waveform;
normalizing the re-sampled neural response waveform and the template eCAP waveform by determining a mean voltage of the template eCAP waveform and a mean voltage of the re- sampled neural response waveform and subtracting the determined mean voltages in a first time period from the template eCAP waveform and the re-sampled neural response waveform, respectively;
determining a first negative (N1) peak and a trailing positive peak (P2) in each of the re- sampled neural response waveform and the template eCAP waveform;
scaling the template eCAP waveform in a vertical voltage axis to match the N1 and P2 _amplitudes from the re-sampled neural response waveform and scaling the template eCAP waveform in a horizontal time axis to match the N1 and P2 latencies from the re-sampled neural response waveform;
trimming any portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform to a time period where both waveforms overlap;
re-sampling both the scaled re-sampled neural response waveform and the scaled template eCAP waveform at an overlapping time period with a sampling rate having a higher resolution than a sampling rate used to re-sample the neural response waveform, wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs during a time period before the first time period to use a portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform in a correlation analysis;
calculating a correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform; and
determining whether the correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform indicates that the recorded neural response waveform comprises an eCAP.
if the neural response waveform comprises an eCAP, then using the eCAP to determine an estimated number of surviving neurons in a cochlear nerve of the patient, and using the estimated number of surviving neurons in the cochlear nerve provide the patient with the cochlear implant with a recommended adjustment of the cochlear implant.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1, 9, and 17, these limitations include:
Evaluating by re-sampling the recorded neural response waveform;
Evaluating by normalizing the re-sampled neural response waveform and the template eCAP waveform by determining a mean voltage of the template eCAP waveform and a mean voltage of the re- sampled neural response waveform and subtracting the determined mean voltages in a first time period from the template eCAP waveform and the re-sampled neural response waveform, respectively;
Observation and judgment to determine a first negative (N1) peak and a trailing positive peak (P2) in each of the re- sampled neural response waveform and the template eCAP waveform;
Observation and judgment to scale the template eCAP waveform in a vertical voltage axis to match the N1 and P2 _amplitudes from the re-sampled neural response waveform
Observation and judgment to scale the template eCAP waveform in a horizontal time axis to match the N1 and P2 latencies from the re-sampled neural response waveform;
Observation and judgement to trim any portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform to a time period where both waveforms overlap;
Evaluating by re-sampling both the scaled re-sampled neural response waveform and the scaled template eCAP waveform at an overlapping time period with a sampling rate having a higher resolution than a sampling rate used to re-sample the neural response waveform, wherein the portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform occurs during a time period before the first time period to use a portion of the scaled re-sampled neural response waveform and the scaled template eCAP waveform in a correlation analysis;
Evaluating a correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform; and
Observation and judgment to determine whether the correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform indicates that the recorded neural response waveform comprises an eCAP.
using the eCAP to observe and judge to determine an estimated number of surviving neurons in a cochlear nerve of the patient if the neural response waveform comprises an eCAP
Observation and judgment of the estimated number of surviving neurons in the cochlear nerve prescribe the patient with the cochlear implant with a recommended adjustment of the cochlear implant.
Similarly, Dependent Claims 3 – 7, 11 – 15, and 19 – 23 include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1, 9 and 17 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
up-sampling the neural response waveform via cubic spline interpolation to create a smooth re-sampled neural response waveform at a higher sampling rate than was used to obtain the neural response waveform.
Evaluating by up-sampling the neural response waveform via cubic spline interpolation to create a smooth re-sampled neural response waveform at a higher sampling rate than was used to obtain the neural response waveform.
subtracting the determined mean voltages in a time period between 0 and 600 µ-sec from the template eCAP waveform and the re-sampled neural response waveform.
Evaluating by subtracting the determined mean voltages in a time period between 0 and 600 µ-sec from the template eCAP waveform and the re-sampled neural response waveform.
re-sampling both waveforms with higher resolution sampling occurring between 0 and 600 µ-sec to place the emphasis on the portion of the waveforms in the correlation analysis.
Evaluating re-sampling both waveforms with higher resolution sampling occurring between 0 and 600 µ-sec to place the emphasis on the portion of the waveforms in the correlation analysis.
calculating a Pearson correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform.
Evaluating a Pearson correlation between the re-sampled scaled re-sampled neural response waveform and the re-sampled scaled template eCAP waveform.
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1, 9 and 17 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1 - 20), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“cochlear implant”
“memory”
“processor”
“non-transitory computer readable medium”
Additional elements recited include a “cochlear implant”, “memory”, “processor”, and “non-transitory computer readable medium” in Independent Claims 1, 9 and 17 (and their respective Dependent Claims). These components are recited at a high level of generality, , i.e., as a processor performing a generic function of processing data (the receiving, sampling, calculating for example); and a memory and non-transitory medium performing a generic function of storing data (the storing). These generic hardware component limitations for “cochlear implant”, “memory”, “processor”, and “non-transitory computer readable medium” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1, 9, and 17 include pre-solution activity limitations, such as:
providing a template eCAP waveform;
receive a neural response waveform obtained from a patient with a cochlear implant;
a processor in communication with the memory, wherein the processor executes computer-executable instructions stored in the memory, said instructions causing the processor to:
retrieve a template eCAP waveform from the memory;
In addition the aforementioned extra-solution activity limitations in Independent Claim 25, additional extra-solution activity limitations recited in Dependent Claims 3 – 7, 11 – 15, and 19 - 23 include:
wherein the neural response waveform is obtained by sending a user-defined stimuli through one electrode of the cochlear implant to stimulate surrounding neurons and recording an electrical response of the surrounding electrons using a neighboring electrode in the cochlear implant.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “cochlear implant”, “memory”, “processor”, and “non-transitory computer readable medium” as recited in Independent Claims 1, 9 and 17 (and their respective Dependent Claims) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1, 9 and 17 (and their respective Dependent Claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1, 9 and 17 (and their respective Dependent Claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1, 9 and 17 (and their respective Dependent Claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “cochlear implant”, “memory”, “processor”, and “non-transitory computer readable medium” as recited in Independent Claims 1, 9 and 17 (and their respective Dependent Claims).
The additional elements of the “cochlear implant”, “memory”, “processor”, and “non-transitory computer readable medium” in Independent Claims 1, 9 and 17 (and their respective Dependent Claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “cochlear implant” is described generically in [0018] “this information can be used to provide patients with a better clinical experience including design, selection and/or specification of the cochlear implant as well as adjustment of the cochlear implant (which can be manual and/or automated),” and [0044] – [0045] “patients receive a cochlear implant with default settings”, “outputs of the disclosed embodiments can be used as feedback to the cochlear implant to dynamically “tune” it. A generic cochlear implant is shown drawn in Fig 1 as “an example of a cochlear implant.”
Per Applicant’s specification, the “memory” is described generically in [0086] as random access memory (RAM) module 1722, a read-only memory (ROM) module 1723, a storage 1724, a database 1725” and “All of the hardware components listed above may not be necessary to practice the methods described herein”. Storage is also generically described in [0088] – [0090]. The “memory” is shown as generic box element “RAM 1722”, “ROM 1723”, or “storage 1724” in Figure 17.
Per Applicant’s specification, the “processor” is described generically in [0087] as “Processor 1721 may include one or more processors”, and [0086] “an exemplary computer”. The processor is presented as generic box element “processor 1721” in Figure 17.
Per Applicant’s specification, the “non-transitory computer readable medium” is described generically in [0085] “…the respective functions can be performed by software, hardware, or a combination of software and hardware,” and [0089] “one or more magnetic and/or optical disk devices, such as hard drives, CD-ROMs, DVD-ROMs, or any other type of mass media device.” The “non-transitory medium” is potentially shown as generic box element “storage 1724” in Figure 17.
Accordingly, in light of Applicant’s specification, the claimed terms “cochlear implant”, “memory”, “processor”, and “non-transitory computer readable medium” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “cochlear implant”, “memory”, “processor”, and “non-transitory computer readable medium”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Independent Claims 1, 9 and 17 (and their respective Dependent Claims) amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and methods of Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1, 9 and 17 (and their respective Dependent Claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23 are not patent eligible and rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 23 DECEMBER 2025 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 112 Analysis:
Applicant argues at [Page 15, “Claim Rejections 35 USC 112” Section” Paragraph 1] – [Page 18, 3rd Full Paragraph] that amendments have been made in regard 35 U.S.C. 112 rejections. The amendments do not overcome the 35 U.S.C. 112 rejections, as described in the 35 U.S.C. 112 rejection analysis above. The argument is not persuasive.
Regarding the 35. U.S.C. 101 Analysis:
Applicant argues at [Page 19, 1st – 2nd Full Paragraph] that the “using the eCAP…” and “Using the estimated number of surviving neurons…to provide the patient with the cochlear implant with a recommended adjustment of the cochlear implant” are not observations, judgments, and opinions, thereby overcoming the 35 U.S.C. 101 rejections. As described in the 35 U.S.C. analysis above, each of these limitations recites an abstract idea. Specifically, broadly “using the eCAP to determine an estimated number of surviving neurons in a cochlear nerve of the patient” describes a human using the eCAP as a data point on which to base a calculated decision regarding the number of surviving neurons of a patient. This could be performed by a doctor or researcher observing a graphical output of an eCAP. Regarding the limitation “using the estimated number of surviving neurons in the cochlear nerve provide the patient with the cochlear implant with a recommended adjustment of the cochlear implant”, this broadly recites a process that can be routinely performed by a medical professional to prescribe a particular cochlear implant with particular settings based on a patient’s nerve condition. The prescription of implant and recommendation of settings is based on cochlear nerve condition information that could be included in a read-out of medical records. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). From MPEP § 2106.04(d)(2): If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration. For example, a step of “prescribing a topical steroid to a patient with eczema” is not a positive limitation because it does not require that the steroid actually be used by or on the patient. The argument is not persuasive.
Conclusion
In light of the current 112(b) rejections, no prior art rejection is currently able to be applied to Claims 1, 3 – 7, 9, 11 - 15, 17, and 19 – 23.
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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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791