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 .
Election/Restriction - Maintained
The restriction requirement between Group I (claims 1, 3, and 5-9), Group II (claims 15, 17-18, 20, 22-23, and 25), and Group III (claims 27-30 and 32-33) was made Final in the Non-Final Rejection mailed on 07/16/2024. The following is substantially reiterated from the Non-Final Rejection mailed on 02/18/2026 in regards to Applicants arguments filed on 05/18/2026.
Groups I, II, and III do not fall within one of the combination of categories as provided in 37 CFR 1.475 (b). Groups I, II, and III are drawn to three distinct products, which is not one of the combinations of categories outlined. That is, because all groupings of the claims are not drawn to only one of the combination of categories, the claims will not be considered to have unity of invention. Further, no technical feature is shared across all inventions. Therefore, unity of invention is lacking a priori between Groups I, II, and III. See MPEP 1850 regarding Unity of Invention.
Status of Claims
Applicant's arguments, filed 05/18/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 05/18/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 40, 43, 46, and 50.
Applicants have left claims 3, 5-9, 38-39, 41, 44-45, 47-49, 51-56, and 58 as originally filed/previously presented.
Applicants have introduced new claims 59-66.
Applicants have canceled/previously canceled claims 2, 4, 10-14, 16-17, 19-29, 31-37, 42, and 57.
Claims 15, 18, and 30 remain withdrawn from further consideration as being drawn to nonelected inventions.
Claims 1, 3, 5-9, 38-41, 43-56, and 58-66 are the current claims hereby under examination.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 12 of Remarks, filed 05/18/2026, with respect to claims 43, 46, and 50 have been fully considered and are persuasive. Applicants have amended the claims rendering the objections moot. The objection of claims 43, 46, and 50 have been withdrawn.
Claim Rejections - 35 USC § 112 - Newly Applied Necessitated by Applicant’s Amendments
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 3, 41, 60-62, and 66 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.
Regarding claim 3, line 2 recites “the recipient is a person”. However, claim 1 has been amended to recite “applying electrical stimulation to a recipient with a sensory implant implanted in a person …”. In light of the specification, it is currently unclear if the recitation of “the recipient is a person” is the same as, related to, or different from the recitations of “a person” in amended claim 1. Claim 1 and the instant specification suggest but do not make clear that “a recipient” and “a person” are the same. For the purposes of examination, recitations of “a recipient” and “a person” are being interpreted as being the same. It is recommended to the Applicant to amend the claims to maintain consistent claim language.
Regarding claim 41, the claim recites “an implant” and “the implant”. However, claim 1 has been amended to recite “a sensory implant …”. In light of the specification, it is currently unclear if the recitations of “an implant” and “the implant” in claim 41 are the same as, related to, or different from “a sensory implant”, recited in claim 1. For the purposes of examination, the recitations of “an implant” and “the implant” are being interpreted as being the same as “a sensory implant”. It is recommended to the Applicant to amend the claims to maintain consistent claim language.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 60, the claim recites “an implant”. However, claim 1 has been amended to recite “a sensory implant …”, and claim 41 recites “an implant”. In light of the specification, it is currently unclear if the recitation of “an implant” in claim 60 is the same as, related to, or different from “a sensory implant”, recited in claim 1, and/or “an implant” recited in claim 41. For the purposes of examination, the recitations of “an implant” and “the implant” are being interpreted as being the same as “a sensory implant”. It is recommended to the Applicant to amend the claims to maintain consistent claim language.
Regarding claim 62, the claim recites “the implant” and “the sensory implant”. However, claim 1 has been amended to recite “a sensory implant …”, and claim 41 recites “an implant”. In light of the specification, it is currently unclear if the recitation of “the implant” and “the sensor implant” in claim 60 is the same as, related to, or different from “a sensory implant”, recited in claim 1, and/or “an implant” recited in claim 41. For the purposes of examination, the recitations of “an implant” and “the implant” are being interpreted as being the same as “a sensory implant”. It is recommended to the Applicant to amend the claims to maintain consistent claim language.
Regarding claim 66, the claim recites the limitation "the sensor prosthesis" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 has been amended to recite “a sensory implant”. However, in light of the specification, it is currently unclear if “the sensor prosthesis” is the same as, related to, or different from, “a sensor implant. For the purposes of examination, “the sensor prosthesis” is being interpreted as being the same as “a sensory implant”. It is recommended to the Applicant to amend the claims to maintain consistent claim language.
Claim Rejections - 35 USC § 101 - Modified Necessitated by Applicant’s Amendments
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, 5-9, 38-41, 43-56, and 58-66 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.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
Obtaining an artefact model based at least in part on the read data; and
Obtaining neural response data of the person relating to the person’s sensory system by comparing the read data to the artefact model.
The elements of claim 1 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
“Obtaining an artefact model based at least in part on the read data” is drawn to a mental process that can practically be performed in the human mind, with the aid of pen and paper. A person with ordinary skill in the art could reasonably obtain, or construct, an artefact model based on obtained read data on a piece of paper. There is nothing to suggest an undue level of complexity in the obtaining an artefact model step. Further, “obtaining an artefact model based at least in part on the read data” is a mathematical concept of manipulating mathematical formulas and equations. Obtaining the artefact model involves adjusting a mathematical formula in view of the obtained read data.
“Obtaining neural response data of the person relating to the person’s sensory system by comparing the read data to the artefact model” is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. A person of ordinary skill in the art could reasonably obtain a neural response by comparing a set of data and an artefact model on a piece of paper. There is nothing to suggest an undue level of complexity in the “comparing” step. Further, “obtaining neural response data by comparing the read data to the artefact model” is a mathematical concept in the form of mathematical formulas or equations. “Comparing the read data to the artefact model” involves subtracting an artefact model from the read data (para. [0110] of the instant disclosure filed 06/21/2021). A mathematical concept need not be expressed in mathematical symbols to be considered a mathematical concept (see MPEP 2106.04(a)(2), I).
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “applying electrical stimulation to a recipient with a sensory implant implanted in a person with a sensor system having a sensor deficiency”, “obtaining from read electrodes of the sensory implant while implanted in the person read data resulting from the applied stimulation”).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, “applying electrical stimulation to a recipient with a sensory implant implanted in a person with a sensor system having a sensor deficiency” and “obtaining from read electrodes of the sensory implant while implanted in the person read data” is well-understood, routine and convention, as disclosed by Stefan Strahl (US 20100069996 A1) - para. [0009-0010], and Long et al. (US 20150258337 A1) - para. [0002], [0030-0032], [0041].
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution activities of necessary data gathering, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely are directed towards pre-solution activities to be used by the abstract idea, where the result of the abstract idea remains within a “black box”.
Analysis of the dependent claims:
Claims 3, 5-9, 38-41, 43-56, and 58-66 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the artefact model is based on a constant phase model” (claim 5), “the artefact model is based on a true constant phase model” (claim 6), “the artefact model does not rely on the results of a double exponential” (claim 7), “the action of obtaining neural response data is executed by subtracting the artefact model from the read data” (claim 8), “accounting for, at least in part, noise that influenced the results of the obtained artefact model” (claim 9), “accounting for, at least in part, noise that influenced data that formed a basis for the obtained artefact model” (claim 38), “the obtained artefact model is based on the certain parameters and based on the read data” (claim 39), “the action of obtaining neural response data includes developing the neural response data without introducing additional thermal and/or quantization noise” (claim 40), “the artefact model is based on one or more of: stimulation parameters of an implant used for the applying action and the obtaining from read electrode actions; configuration of the implant used for the applying action and the obtaining from read electrode actions; behavioral characteristics of the implant used for the applying action and the obtaining from read electrode actions; or electrode interface properties” (claim 41), “the action of obtaining the artefact model is executed by repeatedly developing embryonic models, at least some of which are based on respective separate data sets of the read data” (claim 43), “the artefact model is a model that was developed by using predetermined constants and by using data from in-situ electrodes relative to the recipient” (claim 45), “the action of obtaining the artefact model includes: obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient; developing various iterations of embryonic models, all of which are intended to be different from the temporally and/or frequency based dataset(s); and using one of the iterations as a basis for the obtained artefact model” (claim 46), “the action of obtaining the artefact model includes: developing various iterations of embryonic models based on the dataset(s);comparing at least some of the respective various iterations of the embryonic models to the dataset(s) in an iterative manner, while making adjustments to the respective iteration to further drive the next embryonic model towards the dataset(s); selecting an iteration of the embryonic model from a subset of one or more of the iterations of the embryonic models where further adjustments of the subset will result in a statistically insignificant difference between the embryonic model and the dataset” (claim 47), “developing the artefact model at least in part based thereon” (claim 48), “using one or more of the iterations individually and/or collectively as the model to compare to the temporally and/or frequency based dataset(s) to determine neural response based on the comparison (claim 50), “the comparison to the temporally and/or frequency based dataset(s) yields a difference between the temporally and/or frequency based dataset(s) and the artefact model, the difference being the neural response” (claim 51), “the artefact model excludes neural response data” (claim 54), “the neural response data is based on a phenomenon that decays faster than decay of a phenomenon upon which the artefact model is based” (claim 55), “the obtained neural response data is data corresponding to the neural response in the recipient” (claim 56), “the action of obtaining the neural response data includes removing the non-neural response data from the neural response data” (claim 57), “the action of obtaining the artefact model includes constructing the artefact model based on the non-neural response data” (claim 58), “the action of obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient includes obtaining one or more frequency based dataset(s) from sensors attached to the recipient and the action of developing various iterations of embryonic models, includes developing various iterations of embryonic models, all of which are intended to be different from the frequency based dataset(s)” (claim 59), “the artefact model is based on at least: stimulation parameters of an implant used for the applying action and the obtaining from read electrode action” (claim 60), “the artefact model is based on at least data pertaining to a configuration of the implant used for the applying action and the obtaining from read electrode actions” (claim 61), “the artefact model is based on at least behavioral characteristics of the implant used for the applying action and the obtaining from read electrode actions and at least electrode interface properties of electrode(s) of the sensory implant implanted in the person” (claim 62), “the action of obtaining the artefact model includes developing at least three (3) iterations of embryonic artefact models and determining respective errors between the respective developed embryonic artefact models of the various iterations and the read data, and selecting at least one of the embryonic artefact models as the obtained model based on a determination that error between the selected artefact model and the read data is lower than a threshold” (claim 63), “obtaining the artefact model includes developing the artefact model in part based on a model of an electo-tissue interface” (claim 64)),
Further describe the pre-solution activity (or the structure used for such activity) (“the application of electrical stimulation and the obtaining of the read data occurs at a cochlea of a person” (claim 3), “the electrical stimulation is applied internally to the recipient” (claim 38), “the stimulation applied to the recipient meets certain parameters” (claim 39), “the action of obtaining from read electrodes read data is executed in a plurality of temporally spaced obtaining actions” (claim 43), “the read electrodes are platinum electrodes” (claim 44), “obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient” (claim 47), “obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient” (claim 48), “the one or more temporally and/or frequency based dataset(s) is/are dataset(s) where the obtained neural response is overwhelmed by an artefact”, (claim 49), “the obtained read data includes residual artefacts of the electrical stimulation which are at least 0.1 orders of magnitude larger than a signal of interest in the read data, wherein the signal of interest in the read data corresponds to data resulting from a neural response created by the action of applying the electrical stimulation to the recipient” (claim 53), “the electrical stimulation evokes a neural response in the recipient” (claim 56), “the obtained read data includes neural response data and non-neural response data” (claim 58), “the obtained read data includes an eCAP response component and a residual artefact from the applied electrical stimulation component that is at least 0.3 orders of magnitude larger than the eCAP response component” (claim 65)); and
Further describe the post-solution activity (“adjusting a medical device based on the obtained neural response data so that the medical device operates differently” (claim 52), “adjusting the sensory prosthesis based on the obtained neural response data” (claim 66) (recited at a high level of generality)).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, “platinum electrodes” are well-understood, routine, and conventional as disclosed by Patrick et al. (US 20140350640 A1) - para. [0103-0104].
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide means for collecting data to be used by the abstract idea, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1, 3, 5-9, 38-41, 43-56, and 58-66 are rejected.
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 12-15 of Remarks, filed 05/18/2026, that “where is Art Unit 3791’s implementation of the updated required evaluation of Step 2A, Prong Two? … In this context, we have the additional element that applies or uses a judicial exception …”.
The Examiner respectfully disagrees. As recited above, in the 101 analysis above, specifically the Step 2A, Prong two analysis, the claims recite additional elements “applying electrical stimulation to a recipient with a sensory implant implanted in a person with a sensor system having a sensor deficiency” and “obtaining from read electrodes of the sensor implant while implanted in the person read data from the applied stimulation”. However, the additional elements do not integrate the exception into a practical application. Specifically, the elements add insignificant extra-solution activities of necessary data gathering to be used by the judicial exceptions (see MPEP 2106.04(d) and 2106.05(g)), and the additional elements are well-understood, routine, and conventional. Further, Applicants have not shown persuasive arguments supporting how the additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field (see MPEP 2106.05(a)), the claims do not affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition (see MPEP 2106.04(d)(2)), the additional element(s) is merely utilized for an extra-solution activity (see MPEP 2106.05(b), III), the claims do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)), and the additional elements do not add meaningful limitations beyond data gathering and linking the use of the judicial exception to the field of sensor deficiency. Further, in regards to Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016) and Ex parte Desjardins, the current claims do not recite specifics regarding an improvement to the functioning of the computer itself or the technical field, and an improvement is not readily self-evident from the instant specification. As recited above, persuasive arguments supported by necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology have not been provided (see MPEP 2106.05(a)).
Applicants have argued on pages 15-17 of Remarks, filed 05/18/2026, that “despite our claims not falling within one of the above three (3) groups … our claim 1 squarely fits the above” and on page 21 of Remarks, filed 05/18/2026, that “what is the abstract idea?”.
The Examiner respectfully disagrees. As outlined above, the claims recite abstract ideas, specifically, mathematical concepts and mental processes. Further, the response to arguments regarding integrating an exception into a practical application as recited above is reiterated.
Applicants have argued on pages 19-20 of Remarks, filed 05/18/2026, that “How can an artefact model be performed in the human mind? … We are told that is nothing to suggest an undue level of complexity in the obtaining an artefact model step … Why is the action of obtaining neural response data by comparing the read data to the artefact model something that is drawn to a mental process … An artefact model is complex …”.
The Examiner respectfully disagrees. Applicants arguments regarding “an artefact model is complex” is not commensurate in scope with the claimed invention. Currently, the claims do not recite specifics regarding the artefact model. As recited above, an artefact model can include a simple mathematical equation, which can be obtained and manipulated in the human mind and/or is a mathematical concept. Further, the claims do not recite specifics regarding what “comparing” includes in the obtaining neural response data step. As recited above, “comparing” includes subtracting the artefact model from the read data which can be done in the human mind and/or is a mathematical concept. The claims currently do not recite specifics regarding the quantity, size, or complexity of the data.
Claim Rejections - 35 USC § 102 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see page 21 of Remarks, filed 05/18/2026, with respect to the rejection(s) of claim(s) 1, 3, 7-9, 38-39, 41-42, 45, 48, 52, and 54-58 under 35 USC 101 have been fully considered and are persuasive. Specifically, Applicants have amended independent claim 1, rendering the previous rejection moot. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Long et al. (US 20150258337 A1). Further, see the response to arguments section below.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 7-9, 38, 39, 41, 43, 45-56, 58, 60, 61, 63, 65, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Stefan Strahl (US 20100069996 A1) (previously cited), hereinafter referred to as Strahl, in view of Long et al. (US 20150258337 A1) (previously cited), hereinafter referred to as Long.
The claims are generally directed towards a method, comprising: applying electrical stimulation to a recipient with a sensory implant implanted in a person with a sensory system having a sensor deficiency; obtaining from read electrodes of the sensory implant while implanted in the person read data resulting from the applied stimulation; obtaining an artefact model based at least in part on the read data; and obtaining neural response data of the person relating to the person’s sensor system by comparing the read data to the artefact model.
Regarding claim 1, Strahl discloses a method (Abstract, “method … for processing a waveform signal containing a stimulus artifact …”), comprising:
applying electrical stimulation to a recipient with a sensory implant (para. [0009-0010], “cochlear implant … applying the electrical stimulation signal to target neural tissue”);
obtaining from read electrodes read data resulting from the applied stimulation (Fig. 2, “recorded data”, para. [0009-0010], “neuronal action potentials may be an electrically evoked compound action potential, for example, as determined for a cochlear implant … measuring the waveform signal at the target tissue …”, para. [0013], - the cochlear implant inherently includes electrodes in order to obtain and measure the recorded data);
obtaining an artefact model based at least in part on the read data (para. [0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …”); and
obtaining neural response data by comparing the read data to the artefact model (para. [0010], “removing the stimulus artifact from the waveform signal using a source separation algorithm that leaves the neuronal action potential signal remaining”, para. [0018], “stimulus artifact waveform can be changed to be optimized for the actual measurement waveform signal …”).
However, Strahl does not explicitly disclose the sensory implant is implanted in a person with a sensor system having a sensor deficiency, the read data is obtained from read electrodes of the sensory implant while implanted in the person, and the obtained neural response data is neural response data of the person relating to the person’s sensor system.
Long teaches an analogous method, specifically for reducing a stimulation artefact of an implantable stimulator (Abstract, para. [0006]). Long further applying electrical stimulation to a recipient specifically with a sensor implant implanted in a person with a sensor system having a sensory deficiency (Fig. 1, para. [0002], para. [0029-0033], para. [0087], para. [0117-0119]), obtaining from read electrodes of the sensory implant while implanted in the person read data resulting from an applied stimulation (para. [0041], para. [0059-0060], para. [0117-0119]), and obtaining neural response data of the person relating to the person’s sensory system (para. [0101-0103]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Strahl to additionally apply the electrical stimulation with a sensory implant implanted in a person with a sensory system having a sensory deficiency, obtaining read data from read electrodes of the sensory implant while implanted in the person, and obtaining neural response data of the person relating to the person’s sensory system, as taught by Long. This is because Long teaches utilizing a cochlear implant with stimulating and recording electrodes to obtain neural response data relating to the person’s sensory system allows for adjustment of the cochlear implant due to recorded stimulation artefacts, thereby reducing the stimulation artefacts (para. [0002], para. [0006]).
Regarding claim 3, modified Strahl discloses the method of claim 1, wherein: the application of the electrical stimulation and the obtaining of the read data occurs at a cochlea of the recipient, wherein the recipient is a person (para. [0009-0010], “neuronal action potentials may be an electrically evoked compound action potential, for example, as determined for a cochlear implant …”, para. [0013], further, see the rejection of claim 1).
Regarding claim 7, modified Strahl discloses the method of claim 1, wherein the artefact model does not rely on results of a double exponential (para. [0017-0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …”).
Regarding claim 8, modified Strahl discloses the method of claim 1, wherein the action of obtaining the neural response data is executed by subtracting the artefact model from the read data (Fig. 2, para. [0010], “removing the stimulus artifact from the waveform signal using a source separation algorithm that leaves the neuronal action potential signal remaining”, para. [0018], “stimulus artifact waveform can be change to be optimized for the actual measurement waveform signal …”).
Regarding claim 9, modified Strahl discloses the method of claim 1, further comprising accounting for, at least in part, noise that influenced the results of the obtained artefact model (para. [0010], “removing the stimulus artifact from the waveform signal using a source separation algorithm that leaves the neuronal action potential signal remaining” - noise being the stimulus artifact that is accounted for and removed).
Regarding claim 38, modified Strahl discloses the method of claim 1, further comprising accounting for, at least in part, noise that influenced data that formed a basis for the obtained artefact mode (para. [0010], “removing the stimulus artifact from the waveform signal using a source separation algorithm that leaves the neuronal action potential signal remaining” - noise being the stimulus artifact that is accounted for and removed)l, wherein the electrical stimulation is applied internally to the recipient (para. [0009], “cochlear implant”, para. [0013]).
Regarding claim 39, modified Strahl discloses the method of claim 1, wherein: the stimulation applied to the recipient meets certain parameters (Fig. 2, para. [0009], “cochlear implant”, para. [0013] - the stimulation meets certain parameters to evoke a neuronal action potential); and the obtained artefact model is based on the certain parameters and based on the read data (para. [0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …”).
Regarding claim 41, modified Strahl discloses the method of claim 1, wherein the artefact model is based on one or more of: stimulation parameters of an implant used for the applying action and the obtaining from read electrode actions; configuration of the implant used for the applying action and the obtaining from read electrode actions (para. [0009-0010], para. [0013], “processing electrically evoked compound action potentials (ECAPs) signals in neuroprosethtic devices such as cochlear implants, which contain a stimulus artifact component …”); behavioral characteristics of the implant used for the applying action and the obtaining from read electrode actions (para. [0009-0010], para. [0013], “processing electrically evoked compound action potentials (ECAPs) signals in neuroprosethtic devices such as cochlear implants, which contain a stimulus artifact component …”); or electrode interface properties.
Regarding claim 43, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein: the action of obtaining from read electrodes read data is executed in a plurality of temporally spaced obtaining actions; and the action of obtaining the artefact model is executed by repeatedly developing embryonic models, at least some of which are based on respective separate data sets of the read data.
Long further teaches the action of obtaining from read electrodes read data is executed in a plurality of temporally spaced obtaining actions (para. [0059]), and the action of obtaining an artefact model is executed by repeatedly developing embryonic models, at least some of which are based on respective separate data sets of the read data (para. [0049-0051], para. [0085-0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally obtain from read electrodes read data in a plurality of temporally spaced obtaining actions; and obtain the artefact model by repeatedly developing embryonic models, at least some of which are based on respective separate data sets of the read data, as taught by Long. This is because Long teaches a plurality of temporally spaced data allows for artefacts at different locations to be mitigated (para. [0049]), and developing embryonic models, which are based on separate data sets, allows for the artefact model to be repeatedly adjusted until the model reaches an acceptable level (para. [0085]).
Regarding claim 45, modified Strahl discloses the method of claim 1, wherein: the artefact model is a model that was developed by using predetermined constants and by using data from in-situ electrodes relative to the recipient (para. [0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …”).
Regarding claim 46, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein the action of obtaining the artefact model includes: obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient; developing various iterations of embryonic models, all of which are intended to be different from the temporally and/or frequency based dataset(s); and using one of the iterations as a basis for the obtained artefact model.
Long further teaches wherein the action of obtaining the artefact model includes: obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient (para. [0058-0059]); developing various iterations of embryonic models, all of which are intended to be different from the temporally and/or frequency based dataset(s) (para. [0049-0051], para. [0085-0087]); and using one of the iterations as a basis for the obtained artefact model (para. [0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally include obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient; developing various iterations of embryonic models, all of which are intended to be different from the temporally and/or frequency based dataset(s); and using one of the iterations as a basis for the obtained artefact model, as taught by Long. This is because Long teaches obtaining temporally based data sets, developing various iterations of embryonic models that are different, and using one of the iterations as a basis for the obtain artefact model, allows for the artefact model to be repeatedly adjusted until the model reaches an acceptable level (para. [0085]).
Regarding claim 47, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein the action of obtaining the artefact model includes: obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient; developing various iterations of embryonic models based on the dataset(s); comparing at least some of the respective various iterations of the embryonic models to the dataset(s) in an iterative manner, while making adjustments to the respective iteration to further drive the next embryonic model towards the dataset(s); selecting an iteration of the embryonic model from a subset of one or more of the iterations of the embryonic models where further adjustments of the subset will result in a statistically insignificant difference between the embryonic model and the dataset.
Long further teaches wherein the action of obtaining the model includes: obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient (para. [0058-0059]); developing various iterations of embryonic models based on the dataset(s) (para. [0049-0051], para. [0085-0087]); comparing at least some of the respective various iterations of the embryonic models to the dataset(s) in an iterative manner, while making adjustments to the respective iteration to further drive the next embryonic model towards the dataset(s) (para. [0085-0087]); selecting an iteration of the embryonic model from a subset of one or more of the iterations of the embryonic models where further adjustments of the subset will result in a statistically insignificant difference between the embryonic model and the dataset (para. [0085-0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally include obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient; developing various iterations of embryonic models based on the dataset(s); comparing at least some of the respective various iterations of the embryonic models to the dataset(s) in an iterative manner, while making adjustments to the respective iteration to further drive the next embryonic model towards the dataset(s); selecting an iteration of the embryonic model from a subset of one or more of the iterations of the embryonic models where further adjustments of the subset will result in a statistically insignificant difference between the embryonic model and the dataset, as taught by Long. This is because Long teaches obtaining temporally based data sets, developing various iterations of embryonic models, comparing at least some of the respective various iterations to the datasets, and selecting an iteration that results in a statistically insignificant difference, allows for the artefact model to be repeatedly adjusted until the model reaches an acceptable level (para. [0085]).
Regarding claim 48, modified Strahl discloses the method of claim 1, wherein: the action of obtaining the artefact model includes obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient and developing the artefact model at least in part based thereon (Fig. 2, “recorded data”, para. [0009-0010], “neuronal action potentials may be an electrically evoked compound action potential, for example, as determined for a cochlear implant … measuring the waveform signal at the target tissue …”, para. [0013], para. [0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …”).
Regarding claim 49, modified Strahl discloses the method of claim 47.
However, modified Strahl does not explicitly disclose the one or more temporally and/or frequency based dataset(s) is/are dataset(s) where the obtained neural response is overwhelmed by an artefact.
Long further teaches the one or more temporally and/or frequency based dataset(s) is/are dataset(s) where the obtained neural response is overwhelmed by an artefact (para. [0038-0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the datasets taught by modified Strahl to explicitly be overwhelmed by an artefact, as taught by Long. This is because Long teaches in an ECAP measurement, artefacts overwhelm the actual ECAP response (para. [0039]), and datasets that include the artefacts allow for the model to more accurately obtained to obtain the neural response data, as taught by Long.
Regarding claim 50, modified Strahl discloses the method of claim 46, further comprising: using one or more of the iterations individually and/or collectively as the model to compare to the temporally and/or frequency based dataset(s) to determine neural response based on the comparison (para. [0010], “removing the stimulus artifact from the waveform signal using a source separation algorithm that leaves the neuronal action potential signal remaining”).
Regarding claim 51, modified Strahl discloses the method of claim 50, wherein: the comparison to the temporally and/or frequency based dataset(s) yields a difference between the temporally and/or frequency based dataset(s) and the artefact model, the difference being the neural response (Fig. 2, para. [0010], “removing the stimulus artifact from the waveform signal using a source separation algorithm that leaves the neuronal action potential signal remaining”).
Regarding claim 52, modified Strahl discloses the method of claim 1, further comprising: adjusting a medical device based on the obtained neural response data so that the medical device operates differently (para. [0013], “cochlear implants … electrical stimulation signal is derived based on satisfying a cost function … improved removal of the stimulus artifact …”).
Regarding claim 53, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein: the obtained read data includes residual artefacts of the electrical stimulation which are at least 0.1 orders of magnitude larger than a signal of interest in the read data, wherein the signal of interest in the read data corresponds to data resulting from a neural response created by the action of applying the electrical stimulation to the recipient.
Long further teaches wherein: the obtained read data includes residual artefacts of the electrical stimulation which are at least 0.1 orders of magnitude larger than a signal of interest in the read data, wherein the signal of interest in the read data corresponds to data resulting from a neural response created by the action of applying electrical stimulation to the recipient (para. [0038-0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally include obtained read data with residual artefacts of the electrical stimulation which are at least 0.1 orders of magnitude larger than a signal of interest in the read data, wherein the signal of interest in the read data corresponds to data resulting from a neural response created by the action of applying electrical stimulation to the recipient, as taught by Long. This is because Long teaches ECAP measurement methods allow for information pertaining to the response of the nerves to electrical stimulus to be measured (para. [0038-0041]), and allow for stimulus artifacts to be removed to accurately obtain the neural response data.
Regarding claim 54, modified Strahl discloses the method of claim 1, wherein: the artefact model excludes neural response data (Fig. 2, “stimulus artifact”, para. [0010], “removing the stimulus artifact from the waveform signal …”, para. [0018], “stimulus artifact waveform …” - the stimulus artifact waveform excludes the neural response data, the NAP).
Regarding claim 55, modified Strahl discloses the method of claim 1, wherein: the neural response data is based on a phenomenon that decays faster than decay of a phenomenon upon which the artefact model is based (Fig. 2, the NAP decays faster than the stimulus artifact, para. [0013], para. [0015]; Further, para. [0068] of the instant specification recites the decay response is due to ECAP).
Regarding claim 56, modified Strahl discloses the method of claim 1, wherein: the electrical stimulation evokes a neural response in the recipient (Fig. 2, para. [0009-0010], “cochlear implant … applying the electrical stimulation signal to target neural tissue”, para. [0013], “processing electrically evoked compound action potentials (ECAP) … which contain … a neuronal action potential (NAPs) component”); and the obtained neural response data is data corresponding to the neural response in the recipient (para. [0010], “removing the stimulus artifact from the waveform signal using a source separation algorithm that leaves the neuronal action potential signal remaining”).
Regarding claim 58, modified Strahl discloses the method of claim 1, wherein: the obtained read data includes neural response data and non-neural response data (Fig. 2, para. [0009-0010], “cochlear implant … applying the electrical stimulation signal to target neural tissue”, para. [0013], “processing electrically evoked compound action potentials (ECAP) … which contain a stimulus artifact component and a neuronal action potential (NAPs) component”; and the action of obtaining the artefact model includes constructing the artefact model based on the non-neural response data (para. [0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …”).
Regarding claim 60, modified Strahl discloses the method of claim 41, wherein the artefact model is based on at least: stimulation parameters of an implant used for the applying action and the obtaining from read electrode action (para. [0003], “signal mixture containing two major components: (1) the desired NAPs, and (2) the applied electrical stimulus”, para. [0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …” - the artefact model is “based on” the applied electrical stimulus of the implant because the artifact is known within the model so the separation of the two components can be achieved).
Regarding claim 61, modified Strahl discloses the method of claim 41, wherein the artefact model is based on at least data pertaining to a configuration of the implant used for the applying action and the obtaining from read electrode actions (para. [0003], “signal mixture containing two major components: (1) the desired NAPs, and (2) the applied electrical stimulus”, para. [0018], “patient dependent waveform is derived dynamically … measurement starts with the a priori derived waveform … standard optimization algorithms, the stimulus artifact waveform can be changed to be optimized for the actual measure waveform …” - the configuration of the implant being the known applied electrical stimulus).
Regarding claim 63, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein the action of obtaining the artefact model includes developing at least three (3) iterations of embryonic artefact models and determining respective errors between the respective developed embryonic artefact models of the various iterations and the read data, and selecting at least one of the embryonic artefact models as the obtained model based on a determination that error between the selected artefact model and the read data is lower than a threshold.
Long further teaches wherein the action of obtaining the model includes developing various iterations of embryonic artefact models (para. [0049-0051], para. [0085-0087]); determining respective errors between the respective developed embryonic artefact models of the various iterations and the read data (para. [0085-0087]); and selecting at least one of the embryonic artefact models as the obtained model based on a determination that error between the selected artefact model and the read data is lower than a threshold (para. [0085-0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally develop iterations of embryonic artefact models and determine respective errors between the respective developed embryonic artefact models of the various iterations and the read data, and select at least one of the embryonic artefact models as the obtained model based on a determination that error between the selected artefact model and the read data is lower than a threshold, as taught by Long. This is because Long teaches developing various iterations of embryonic models, comparing at least some of the respective various iterations to the datasets, and selecting an iteration that results in a statistically insignificant difference, allows for the artefact model to be repeatedly adjusted until the model reaches an acceptable level (para. [0085]).
Further, in regards to at least three (3) iterations, Long explicitly teaches multiple iterations can be repeated until a value is acceptable (para. [0086]). As such, it would have been obvious to try utilizing at least three (3) iterations to determine the iteration that provides the most acceptable value. One of ordinary skill in the art would have recognized that multiple iterations provides for more optimization of the model.
Regarding claim 65, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein: the obtained read data includes an eCAP response component and a residual artefact from the applied electrical stimulation component that is at least 0.3 orders of magnitude larger than the eCAP response component.
Long further teaches the obtained read data includes an eCAP response component and a residual artefact from the applied electrical stimulation component that is at least 0.3 orders of magnitude larger than the eCAP response component (para. [0037-0041], para. [0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify to explicitly obtain an eCAP response component and a residual artefact from the applied electrical stimulation component that is at least 0.3 orders of magnitude larger than the eCAP response component, as taught by Long. This is because Long teaches ECAP measurement methods allow for information pertaining to the response of the nerves to electrical stimulus to be measured (para. [0038-0041]), and allow for stimulus artifacts to be removed to accurately obtain the neural response data.
Regarding claim 66, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose the method further comprises: adjusting the sensory prosthesis based on the obtained neural response data.
Long further teaches adjusting the sensory prosthesis based on the obtained neural response data (para. [0085-0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally adjust the sensory prosthesis based on the obtained neural response data, as taught by Long. This is because Long teaches adjusting the sensory prosthesis based on the obtained neural response data allows for a reduction of a stimulation artefact (para. [0006]).
Claims 5, 6, 62, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Stefan Strahl (US 20100069996 A1) (previously cited), hereinafter referred to as Strahl, in view of Long et al. (US 20150258337 A1) (previously cited), hereinafter referred to as Long as applied to claim 1 and 41 above, and further in view of Peter Single (US 20170049345 A1) (previously cited), hereinafter referred to as Single.
Regarding claim 5 and claim 6, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein the artefact model is based on a constant phase model (claim 5), or wherein the artefact model is based on a true constant phase model (claim 6).
Single teaches of an analogous method (Abstract), specifically of measuring a neural response to a stimulus (para. [0010]). Single teaches applying an electrical stimulus to a patient (para. [0011]) and obtaining a neural response data by comparing read data with an artefact model (para. [0069-0070]). Single further teaches the artefact model is based on a constant phase or a true constant phase (para. [0019], para. [0045-0047], para. [0053], para. [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the artefact model taught by modified Strahl to explicitly be a constant phase model or a true constant phase model, as taught by Single. This is because Single teaches by using a constant phase model or a true constant phase model it allows for sources of artefacts to be reduced, specifically from the electrode-electrolyte interface capacitance and tissue capacitance (para. [0019], para. [0070]).
Regarding claim 62, modified Strahl discloses the method of claim 41, wherein the artefact model is based on at least behavioral characteristics of the implant used for the applying action and the obtaining from read electrode actions (para. [0009-0010], para. [0013], “processing electrically evoked compound action potentials (ECAPs) signals in neuroprosethtic devices such as cochlear implants, which contain a stimulus artifact component …”).
However, modified Strahl does not explicitly disclose the artefact model is based on at least electrode interface properties of electrode(s) of the sensory implant implanted in the person.
Single teaches of an analogous method (Abstract), specifically of measuring a neural response to a stimulus (para. [0010]). Single teaches applying an electrical stimulus to a patient (para. [0011]) and obtaining a neural response data by comparing read data with an artefact model (para. [0069-0070]). Single further teaches the artefact model is based on at least electrode interface properties of electrode(s) of the sensory implant implanted in the person (para. [0019], para. [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally have the artefact model based on at least electrode interface properties of electrode(s) of the sensory implant implanted in the person, as taught by Single. This is because Single teaches accounting for electrode interface properties allows for more accurate artifact reduction (para. [0005], para. [0019]).
Regarding claim 64, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein: obtaining the artefact model includes developing the artefact model in part based on a model of an electo-tissue interface.
Single teaches of an analogous method (Abstract), specifically of measuring a neural response to a stimulus (para. [0010]). Single teaches applying an electrical stimulus to a patient (para. [0011]) and obtaining a neural response data by comparing read data with an artefact model (para. [0069-0070]). Single further teaches wherein: obtaining the artefact model includes developing the artefact model in part based on a model of an electo-tissue interface (para. [0019], para. [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally developing the artefact model in part based on a model of an electo-tissue interface, as taught by Single. This is because Single teaches accounting for electo-tissue interface properties allows for more accurate artifact reduction (para. [0005], para. [0019]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Stefan Strahl (US 20100069996 A1) (previously cited), hereinafter referred to as Strahl, in view of Long et al. (US 20150258337 A1) (previously cited), hereinafter referred to as Long as applied to claim 1 above, and further in view of Paul Holmberg (US 20130114835 A1) (previously cited), hereinafter referred to as Holmberg.
Regarding claim 40, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein the action of obtaining the neural response data includes developing the neural response data without introducing additional thermal and/or quantization noise.
Holmberg teaches of an analogous method (Abstract, Fig. 4, para. [0006]). Holmberg further teaches obtaining the neural response data includes developing the neural response data without introducing additional thermal noise (Fig. 4, para. [0032], para. [0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to additionally develop the neural response data without introducing additional thermal and/or quantization noise, as taught by Holmberg. This is because Holmberg teaches the presence of thermal noise may make hearing difficult or unpleasant for a user of a hearing prosthesis, and eliminating thermal noise improves the experience for the user (para. [0005]).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Stefan Strahl (US 20100069996 A1) (previously cited), hereinafter referred to as Strahl, in view of Long et al. (US 20150258337 A1) (previously cited), hereinafter referred to as Long as applied to claim 1 above, and further in view of Patrick et al. (US 20140350640 A1) (previously cited), hereinafter referred to as Patrick.
Regarding claim 44, modified Strahl discloses the method of claim 1.
However, modified Strahl does not explicitly disclose wherein: the read electrodes are platinum electrodes.
Patrick teaches an analogous method, comprising obtaining from read electrodes read data (Abstract, para. [0008], para. [0103-0104]). Patrick further teaches the read electrodes are platinum electrodes (para. [0103-0104]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the read electrodes taught by modified Strahl to explicitly be platinum electrodes, as taught by Patrick. This is because Patrick teaches platinum is a suitable conductive material for electrodes, specifically for cochlear implants (para. [0103-0104]).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Stefan Strahl (US 20100069996 A1) (previously cited), hereinafter referred to as Strahl, in view of Long et al. (US 20150258337 A1) (previously cited), hereinafter referred to as Long as applied to claim 46 above, and further in view of Bastiaan van Dijk (US 20120191161 A1), hereinafter referred to as van Dijk.
Regarding claim 59, modified Strahl discloses the method of claim 46.
However, modified Strahl does not explicitly disclose wherein the action of obtaining one or more temporally and/or frequency based dataset(s) from sensors attached to the recipient includes obtaining one or more frequency based dataset(s) from sensors attached to the recipient and the action of developing various iterations of embryonic models, includes developing various iterations of embryonic models, all of which are intended to be different from the frequency based dataset(s).
van Dijk teaches an analogous method for obtaining neural response data by removing artifacts (para. [0091]). van Dijk further teaches explicitly utilizing frequency based dataset(s) for analysis (para. [0089-0090], para. [0099]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Strahl to explicitly utilize frequency based dataset(s) as taught by van Dijk. This is because van Dijk teaches temporal and frequency based dataset(s) are known and reliable alternatives for analyzing and obtaining neural response data (para. [0089-0090]).
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
First, Applicants amendments have necessitated new grounds of rejections.
Applicants have argued on pages 21-23 of Remarks, filed 05/18/2026, that “there is no electrode disclosed on those paragraphs. You say it is inherent. But there is no support for such.”.
The Examiner respectfully disagrees. As reiterated and expanded on from above, Strahl discloses the use of a cochlear implant for applying electrical stimulations (para. [0009-0010]) and recording neuronal action potentials evoked by the electrical stimulation (para. [0009-0010], para. [0013]). Strahl discloses a graph of the recorded data (Fig. 1, Fig. 2). Strahl explicitly recites measuring the waveform signal at the target tissue (para. [0010]). It is inherent from Strahl that an electrode is utilized to measure the waveform signal to then remove the stimulus artifact. It is further noted that Applicants amendments necessitated a new rejection in view of Long.
Applicants have argued on pages 23-24 of Remarks, filed 05/18/2026, that “That is not our claim”, in regards to “obtaining from read electrodes read data resulting from the applied stimulation”.
The Examiner respectfully disagrees. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As reiterated above, Strahl explicitly recites “an artefact model” is obtained based on measurements. The claims do not recite specifics regarding “an artefact model”. It is further noted that Applicants amendments necessitated a new rejection in view of Long.
Applicants have argued on page 24 of Remarks, filed 05/18/2026, that “Why is ‘neuronatal action potential signal’ our ‘neural response data’”.
The broadest reasonable interpretation, in light of the instant specification, of “neural response data”, includes “neuronatal action potential signals”, which are evoked signals as a result of applied electrical stimulation.
Applicants have argued on page 25 of Remarks, filed 05/18/2026, “you are doing that rewriting of our claim again”, in regards to claim 7.
The Examiner respectfully disagrees. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As reiterated above, modified Strahl discloses the artefact model does not rely on results of a double exponential (see para. [0017-0018]). The claims do not recite further specifics regarding the artefact model.
Applicants have argued on page 25 of Remarks, filed 05/18/2026, that “why is the BRI of subtract mere “removing”?”
The broadest reasonable interpretation of “subtract” includes “removing” as the two are known synonyms. Further, according to Merriam-Webster, the definition of “subtract” is “to take away by or as if by deducting” and as reiterated above, modified Strahl explicitly discloses “removing” or taking away or as if by deducting the stimulus that leaves the neural action potential signal remaining (see Fig. 1, Fig. 2, para. [0010] of Strahl).
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Applicants have argued on pages 25-27 of Remarks, filed 05/18/2026, that “This is translating the English language into … the English language …”, in regards to claim 9, “There is more of that English language translation into English language”, in regards to claim 38, and similar arguments to claim 39.
The Examiner respectfully disagrees. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As reiterated above, modified Strahl teaches claims 9, 38, and 39.
Applicants have argued on pages 27-28 of Remarks, filed 05/18/2026, that “How is the artefact model based on the configuration of the implant from what is in paragraphs 0009, 0010, 0013?” and “And why is it based on “behavioral characteristics of the implant used for the applying action and the obtaining from read electrode actions”.
As reiterated above, modified Strahl discloses the artefact model is based on a configuration of the implant used for the applying action and the obtaining from read electrode actions, specifically a configuration of the implant being a cochlear implant for specifically applying and obtaining signals relating to neuronal action potentials as recited in cited paragraphs [0009-0010] and [0013], and the behavioral characteristics of the implant being the addition of the stimulus artifact component as recited in cited paragraphs [0009-0010] and [0013]). The claims do not recite specifics regarding what a “configuration of the implant” and/or “behavioral characteristics” includes.
Applicants have argued on pages 29-30 of Remarks, filed 05/18/2026, that “The above is a bit different from the other rejections is it not?”, in regards to claim 42, “The trend continues”, in regards to claim 45, and “The rejection of claim 48 has the same practice of rewriting our claim”.
The Examiner respectfully disagrees. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. As reiterated above, modified Strahl teaches claims 42, 45, and 48.
Further, Applicants arguments did not directly address the previous 35 USC 103 rejections, therefore the Examiner cannot find a reason to withdraw the rejections.
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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/K.W.K./Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791
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