DETAILED ACTION
Claims 1-6, 8, 10-12, 15-16, 18, 20-21, 32, 34-35, 39, and 41 are hereby under examination.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statement (IDS) submitted on 10/15/2024 is being considered by the examiner.
Claim Objections
Claims 3, 15, 18, 20, 32, and 35 are objected to because of the following informalities:
Regarding claim 3, line 2 recites “the physiological response signal”, however it appears it should read --the at least one physiological response signal-- (emphasis added).
Regarding claim 4, line 1 recites “the model”, however it appears it should read --the response model-- (emphasis added).
Regarding claim 15, line 3 recites “a control parameter”, however it appears it should read --the control parameter-- (emphasis added).
Regarding claim 18, line 3 recites “the result”, however it appears it should read --a result-- (emphasis added).
Regarding claim 20, lines 1-2 recite “the physiological response signal”, however it appears it should read --the at least one physiological response signal-- (emphasis added).
Regarding claim 20, line 2 recites “fNIRS”, however it appears it should read --functional near-infrared spectroscopy (fNIRS)-- (emphasis added).
Regarding claim 32, line 2 recites “a second”, however it appears it should read --the second-- (emphasis added).
Regarding claim 32, line 3 recites “receiving at least one”, however it appears it should read --receiving the at least one-- (emphasis added).
Regarding claim 35, line 8 recites “a control parameter”, however it appears it should read --the control parameter-- (emphasis added).
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 41: The claim limitation “stimulation delivery member … present … a first aural stimulus to the subject …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “member” coupled with functional language “present … a first aural stimulus to the subject …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “member”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“Stimulation member 145 may be a speaker, earphone, hearing aid, hearing instrument, implantable auditory prosthesis comprising implantable electrodes, transducer, cochlear implant, brain stem implant, auditory midbrain implant, or other component used to provide aural stimulation to a patient …”, or equivalents thereof, as described on pages 10-11 of the disclosure filed on 10/15/2024.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 4, 8, 10, 16, and 34-35 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 4, the claim recites the limitation "the neural response data" in line 2. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the neural response data” is the same as, related to, or different from “the at least one physiological response signal”. For the purposes of examination, “the neural response data” is being interpreted as any data.
Regarding claim 4, the claim recites the limitation "the length of the expected response" in line 3. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the length of the expected response” is the same as, related to, or different from “the at least one physiological response signal”. For the purposes of examination, “the length of the expected response” is being interpreted as length of an expected response from a response model.
Regarding claim 8, the claim recites the limitation "the modelled neural response data" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the modelled neural response data” is the same as, related to, or different from “at least one physiological response signal” and/or “a response model”. For the purposes of examination, “the modelled neural response data” is being interpreted as any data.
Regarding claim 10, the claim recites the limitation "the modelled neural response data" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the modelled neural response data” is the same as, related to, or different from “at least one physiological response signal” and/or “a response model”. For the purposes of examination, “the modelled neural response data” is being interpreted as any data.
Regarding claim 16, the claim recites the limitation "the data" in line 1. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the data” is the same as, related to, or different from “the at least one physiological response signal”. For the purposes of examination, “the data” is being interpreted as any data.
Regarding claim 16, the claim recites the limitation "the models" in line 2. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if claim 16 is attempting to claim mode than one of the at least one physiological response signals are modelled to create multiple response models. For the purposes of examination, “the models” is being interpreted as being related to “a response model” recited in claim 3.
Regarding claim 16, the claim recites the limitation "the response detection decision" in line 3. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the response detection decision” is the same as, related to, or different from, “determining an auditory discrimination response”. For the purposes of examination, “the response detection decision” is being interpreted as any decision.
Regarding claim 34, the claim recites the limitation "the collection of statistical measures" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear what “the collection of statistical measures” is referring to. For the purposes of examination, “the collection of statistical measures” is being interpreted as any collection of statistical measures.
Regarding claim 35, the claim recites the limitation "the received physiological response signals" in line 3. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if claim 35 is attempting to claim more than one physiological response signal is received. For the purposes of examination, “the received physiological response signals” is being interpreted as including two or more of the at least one physiological response signals.
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 1-6, 8, 10-12, 15-16, 18, 20-21, 32, 34-35, 39, and 41 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.
Analysis of independent claims 1 and 41:
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. Claim 41 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 41 recite an abstract idea. In particular, the claims recite the following:
Comparing at least one parameter related to the at least one physiological response signal with a control parameter; and
Determining an auditory discrimination response of the subject based on the outcome of the comparison
These elements recited in claims 1 and 41 are drawn to an abstract idea since (1) 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.
Comparing at least one parameter related to the at least one physiological response signal with a control parameter is directed towards a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can view a parameter related to a physiological response signal on a piece of paper, and mentally compare the parameter with a known control parameter. There is nothing to suggest an undue level of complexity in the comparing step.
Determining an auditory discrimination response of the subject based on the outcome of the comparison is directed towards a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can mentally determine an auditory discrimination response based on the mentally determined comparison utilizing known criteria and/or a look up table. There is nothing to suggest an undue level of complexity in the determining step.
Prong Two: Claims 1 and 41 do 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:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “memory … a processor …” (claim 41)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “presenting a first aural stimulus … presenting a second aural stimulus … receiving at least one physiological response signal …” (claim 1) - with no specific structure recited, “stimulation delivery component … physiological signal sensor … present a first aural stimulus … present a second aural stimulus … receive at least one physiological response signal …” (claim 41)); the post-solution activity of: (e.g. N/A); using generic data-outputting components (e.g. N/A)).
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, “presenting, via the at least one stimulation delivery member, a first aural stimulus …” is well-understood, routine, and conventional, as disclosed by McKay et al. (US 20200205699 A1) - para. [0067], [0079], [0084-0085].
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “receive, from the at least one physiological signal sensor, at least one physiological response signal …” is well-understood, routine, and conventional, as disclosed by McKay et al. (US 20200205699 A1) - para. [0068], [0089].
Further, “a memory storing executable code” and “a processor” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 41 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 necessary pre-solution data gathering steps, 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 provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-6, 8, 10-12, 15-16, 18, 20-21, 32, 34-35, and 39 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 (“modelling the physiological response signal to create a response model” (claim 3), “wherein the model captures unique statistical properties in the neural response data pertaining to its neighbourhood covariance structure relative to aural stimulation onset, spanning the length of the expected response and across one or more responses” (claim 4), “wherein the response model is generated using a stochastic processor” (claim 5), “wherein the response model captures at least two concurrent neural responses in response to one aural stimulus, wherein one response relates to activation of the cortical auditory system and one response relates to activation of the brain arousal system” (claim 6), “using the modelled neural response data to determine a measure corresponding to whether or not the subject discriminated between the first aural stimulus and the second aural stimulus” (claim 8), “using the modelled neural response data to determine a measure corresponding to a difficulty that the subject experienced in discriminating between the first aural stimulus and the second aural stimulus” (claim 10), “wherein the control parameter is determined based on a model of a baseline response signal” (claim 11), “wherein the baseline response signal comprises a physiological response signal measured during any one of: a time not aligned with a time when the second aural stimulus is being delivered to the subject; a time when the first aural stimulus is being delivered to the subject; and a time when no stimulus is being delivered to the subject” (claim 12), “comparing at least one parameter related to the at least one physiological response signal with a control parameter comprises using test statistics to compare whether the response model and the model of the baseline response signal are different” (claim 15), “the data used to generate the models are permuted and create a collection of statistical measures used to generate a confidence level for the response detection decision” (claim 16), “wherein comparing the at least one parameter related to the at least one physiological response signal with a control parameter comprises comparing the combined single physiological response signal with the combined single baseline response signal” (claim 35)),
Further describe the pre-solution activity (or the structure used for such activity) (“the first aural stimulus and the second aural stimulus are presented consecutively without any silence interval between the first aural stimulus and the second aural stimulus” (claim 2), “the first aural stimulus and the second aural stimulus are selected to create a speech contrast, the speech contrast being the result of a difference in one or more speech features between the first aural stimulus and the second aural stimulus for which a discrimination assessment is desired, wherein the first aural stimulus comprises a repeating speech syllable presented as a habituation stimulus, and wherein the second aural stimulus comprises a repeating speech syllable presented as a dishabituation stimulus” (claim 18), “wherein the physiological response signal comprises fNIRS data generated by at least one optode located on a scalp of the subject” (claim 20), “wherein the fNIRS data comprises at least one of: neural response data; and cardiac data” (claim 21), “repeating the steps of presenting the first aural stimulus, presenting a second aural stimulus and receiving at least one physiological response signal until a stopping criterion is met” (claim 32), “wherein the collection of statistical measures is used to calculate a stopping criterion” (claim 34), “combining the received physiological response signals into a combined single physiological response signal, and combining at least two physiological response signals into a combined single baseline response signal” (claim 35)),
Further describe the computer implementation (N/A), and
Further describe the post-solution activity (“communicating the outcome to a user via at least one of: a user interface; and an external computing system” (claim 39)) (recited at a high level of generality).
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 computer/electronic implementation and processing, 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 1-6, 8, 10-12, 15-16, 18, 20-21, 32, 34-35, 39, and 41 are rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8, 10-12, 15-16, 20-21, 32, 34-35, 39, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKay et al. (US 20200205699 A1), hereinafter referred to as McKay.
The claims are generally directed towards a method of assessing the hearing of a subject, the method comprising: presenting a first aural stimulus to the subject; presenting a second aural stimulus to the subject, the second aural stimulus being different to the first aural stimulus; receiving at least one physiological response signal relating to the second aural stimulus received by the subject; comparing at least one parameter related to the at least one physiological response signal with a control parameter; and determining an auditory discrimination response of the subject based on the outcome of the comparison.
Regarding claim 1, McKay discloses a method of assessing the hearing of a subject (Abstract), the method comprising:
presenting a first aural stimulus to the subject (Fig. 1, element 140, element 145, para. [0067], “sound generator causes the stimulation member to produce a range of aural stimulation signals …”, para. [0084-0088], “produce one or more sounds …”, para. [0102]);
presenting a second aural stimulus to the subject, the second aural stimulus being different to the first aural stimulus (Fig. 1, element 140, element 145, para. [0067], “sound generator causes the stimulation member to produce a range of aural stimulation signals …”, para. [0084-0088], “produce one or more sounds … generate sounds with varying levels of intensity or loudness … between approximately 10 and 120 dB …”, para. [0115-0119], “adjust the parameters of the stimulation signal … );
receiving at least one physiological response signal relating to the second aural stimulus received by the subject (Fig. 1, element 166, element 180, para. [0068], “detector optodes are configured to provide output signals via measurement channels …”, para. [0089-0090], “patient hears a sound due to the stimulation provided … neural activity in the patient’s brain in the measured area … changes … patient’s heart rate, heart rate variability, blood pressure and/or breathing rate may also increase or decrease … optodes are used to measure the changes in blood oxygenation …”);
comparing at least one parameter related to the at least one physiological response signal with a control parameter (para. [0091], “automatic processing module … determine whether the aural stimulation provided by stimulation member correlates to a change in activity in the auditory region measured by the source-detector pair of optodes …”, para. [0112-0113]); and
determining an auditory discrimination response of the subject based on the outcome of the comparison (para. [0112], “indicate whether the patient heart the stimulation, or whether the stimulation was of an uncomfortably high level …”, para. [0015], “determine a patient’s hearing range …”).
Regarding claim 2, McKay discloses the method of claim 1, wherein the first aural stimulus and the second aural stimulus are presented consecutively without any silence interval between the first aural stimulus and the second aural stimulus (para. [0085], “alternating time periods may have sounds of different intensity or different type, instead of being periods of sounds and silence …”).
Regarding claim 3, McKay discloses the method of claim 2, further comprising modelling the physiological response signal to create a response model (para. [0090], “pre-processing module may model the response signal …”).
Regarding claim 4, McKay discloses the method of claim 3, wherein the model captures unique statistical properties in the neural response data pertaining to its neighbourhood covariance structure relative to aural stimulation onset, spanning the length of the expected response and across one or more responses (para. [0113], “statistical tests … determine functional connectivity between the brain regions using correlation techniques …”).
Regarding claim 5, McKay discloses the method of claim 3, wherein the response model is generated using a stochastic process (para. [0088], “stimulation levels being applied at random …”, para. [0102], “parameters of the stimulation may be pseudo-randomly determined …”).
Regarding claim 6, McKay discloses the method of claim 3, wherein the response model captures at least two concurrent neural responses in response to one aural stimulus, wherein one response relates to activation of the cortical auditory system and one response relates to activation of the brain arousal system (Fig. 1, element 162, element 165, para. [0070-0071], “arranged to be posited over at least one of the posterior temporal lobe and the anterior temporal lobe/pre-frontal lobe … both hemispheres …”, para. [0073], “channels may be grouped into one or more regions of interest …”, para. [0090], “cardiac monitor may also be used …”, para. [0100]).
Regarding claim 8, McKay discloses the method of claim 6, further comprising using the modelled neural response data to determine a measure corresponding to whether or not the subject discriminated between the first aural stimulus and the second aural stimulus (para. [0117], “find the sound level that corresponds to hearing threshold …”).
Regarding claim 10, McKay discloses the method of claim 6, further comprising using the modelled neural response data to determine a measure corresponding to a difficulty that the subject experienced in discriminating between the first aural stimulus and the second aural stimulus (para. [0117], “find the sound level that corresponds to hearing threshold …”).
Regarding claim 11, McKay discloses the method of claim 3, wherein the control parameter is determined based on a model of a baseline response signal (para. [0094], para. [0119], “peak response magnitude of HbO concentration change relative to baseline …”).
Regarding claim 12, McKay discloses the method of claim 11, wherein the baseline response signal comprises a physiological response signal measured during any one of: a time not aligned with a time when the second aural stimulus is being delivered to the subject; a time when the first aural stimulus is being delivered to the subject; and a time when no stimulus is being delivered to the subject (para. [0162], “percent change in heart rate from the heart rate when there is no stimulation, being a baseline heart rate …”).
Regarding claim 15, McKay discloses the method of claim 11, wherein comparing at least one parameter related to the at least one physiological response signal with a control parameter comprises using test statistics to compare whether the response model and the model of the baseline response signal are different (para. [0120], “statistical methods … process the response signals and determine hearing thresholds …”).
Regarding claim 16, McKay discloses the method of claim 3, where the data used to generate the models are permuted and create a collection of statistical measures used to generate a confidence level for the response detection decision (para. [0117-0118], “statistically significant response …”, para. [0120], “process the response signals … more than one response to determine the signal loudness …”, .
Regarding claim 20, McKay discloses the method of claim 1, wherein the physiological response signal comprises fNIRS data generated by at least one optode located on a scalp of the subject (para. [0068], “detector optodes are configured to provide output signals via measurement channels …”, para. [0089-0090], “patient hears a sound due to the stimulation provided … neural activity in the patient’s brain in the measured area … changes … patient’s heart rate, heart rate variability, blood pressure and/or breathing rate may also increase or decrease … optodes are used to measure the changes in blood oxygenation …”, para. [0094], “source optode and detector optode being used to perform fNIRS on a patient …”).
Regarding claim 21, McKay discloses the method of claim 20, wherein the fNIRS data comprises at least one of: neural response data; and cardiac data (para. [0063-0064], “evaluate neural activity in the brain via changes in blood oxygenation …”, para. [0089], “optodes are used to measure changes in blood oxygenation … result of changes in neural activity, and/or changes in heart rate, heart rate variability, blood pressure and/or breathing …”).
Regarding claim 32, McKay discloses the method of claim 1, further comprising repeating the steps of presenting the first aural stimulus, presenting a second aural stimulus and receiving at least one physiological response signal until a stopping criterion is met (Fig. 6, element 616, para. [0117], “sound may be started at a low intensity and increased in pre-defined steps until a statistically significant response is determined …”).
Regarding claim 34, McKay discloses the method of claim 32, wherein the collection of statistical measures is used to calculate a stopping criterion (Fig. 6, element 616, para. [0117], “sound may be started at a low intensity and increased in pre-defined steps until a statistically significant response is determined …”.
Regarding claim 35, McKay discloses the method of claim 32, further comprising: combining the received physiological response signals into a combined single physiological response signal, and combining at least two physiological response signals into a combined single baseline response signal, wherein comparing the at least one parameter related to the at least one physiological response signal with a control parameter comprises comparing the combined single physiological response signal with the combined single baseline response signal (para. [0071], “overlapping channels may allow for noise to be reduced from the data signals, by averaging the data from two overlapping channels …”).
Regarding claim 39, McKay discloses the method of claim 1, further comprising communicating the outcome to a user via at least one of: a user interface; and an external computing system (para. [0114], “results of the data processing may be displayed on display … results may also be stored in memory and/or communicated to external processing device …”).
Regarding claim 41, McKay discloses a system for assessing the hearing of a subject (Abstract, para. [0001]), the system comprising:
at least one stimulation delivery member (Fig. 1, element 140, element 145, para. [0067], “stimulation member …”);
at least one physiological signal sensor (Fig. 1, element 162, element 165, para. [0089-0090], “patient hears a sound due to the stimulation provided … neural activity in the patient’s brain in the measured area … changes … patient’s heart rate, heart rate variability, blood pressure and/or breathing rate may also increase or decrease … optodes are used to measure the changes in blood oxygenation …”);
memory storing executable code (Fig. 1, element 150, para. [0080]); and
a processor configured to access and execute the code stored in the memory (Fig. 1, element 120, para. [0080]);
wherein, when executing the code, the processor is caused to:
present, via the at least one stimulation delivery member, a first aural stimulus to the subject (para. [0067], “sound generator causes the stimulation member to produce a range of aural stimulation signals …”, para. [0084-0088], “produce one or more sounds …”, para. [0102]);
present, via the at least one stimulation delivery member, a second aural stimulus to the subject, the second aural stimulus being different to the first aural stimulus (Fig. 1, element 140, element 145, para. [0067], “sound generator causes the stimulation member to produce a range of aural stimulation signals …”, para. [0084-0088], “produce one or more sounds … generate sounds with varying levels of intensity or loudness … between approximately 10 and 120 dB …”, para. [0115-0119], “adjust the parameters of the stimulation signal … );
receive, from the at least one physiological signal sensor, at least one physiological response signal relating to the second aural stimulus received by the subject (“detector optodes are configured to provide output signals via measurement channels …”, para. [0089-0090], “patient hears a sound due to the stimulation provided … neural activity in the patient’s brain in the measured area … changes … patient’s heart rate, heart rate variability, blood pressure and/or breathing rate may also increase or decrease … optodes are used to measure the changes in blood oxygenation …”);
compare at least one parameter related to the at least one physiological response signal with a control parameter (para. [0091], “automatic processing module … determine whether the aural stimulation provided by stimulation member correlates to a change in activity in the auditory region measured by the source-detector pair of optodes …”, para. [0112-0113]); and
determine an auditory discrimination response of the subject based on the outcome of the comparison (para. [0112], “indicate whether the patient heart the stimulation, or whether the stimulation was of an uncomfortably high level …”, para. [0015], “determine a patient’s hearing range …”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over McKay et al. (US 20200205699 A1), hereinafter referred to as McKay as applied to claim 1 above, and further in view of Nakano et al. (“Prefrontal Cortical Involvement in Young Infants’ Analysis of Novelty”), hereinafter referred to as Nakano.
Regarding claim 18, McKay discloses the method of claim 1, the first aural stimulus and the second aural stimulus are selected to create a speech contrast, the speech contrast being the result of a difference in one or more speech features between the first aural stimulus and the second aural stimulus for which a discrimination assessment is desired (para. [0117], “stimulation may be adjusted … increasing and decreasing the parameters in turn until the targeted response parameter values are attained, which may be when the patient no longer exhibits a response to the stimulation being provided …”).
However, McKay does not explicitly disclose wherein the first aural stimulus comprises a repeating speech syllable presented as a habituation stimulus, and wherein the second aural stimulus comprises a repeating speech syllable presented as a dishabituation stimulus.
Nakano teaches an analogous method of assessing the hearing of a subject, the method comprising presenting aural stimuli to the subject, receiving at least one physiological response signal related to the aural stimuli, comparing at least one parameter related to the at least one physiological response signal with a control parameter, and determining an auditory discrimination response (Abstract, pg. 456, Stimuli, Experimental Procedures, pg. 461-462, Discussion). Nakano further the stimuli include a repeating speech syllable presented as a habituation stimulus, and a repeating speech syllable presented as a dishabituation stimulus (pg. 456, Stimuli). 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 first and second aural stimuli to explicitly comprise a repeating speech syllable presented as a habituation stimulus, and a repeating speech syllable presented as a dishabituation stimulus, as taught by Nakano. This is because Nakano teaches repeated syllables presented as a habituation stimulus and a dishabituation stimulus allow for an infant’s cognitive ability utilizing stimuli (Discussion, pg. 461-462).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mao et al. (“Speech token detection and discrimination in individual infants using functional near-infrared spectroscopy”)
Paranawithana et al. (“Reducing false discoveries in resting-state functional connectivity using short channel correction: an fNIRS study”)
Zhou et al. (“Comparing fNIRS signal qualities between approaches with and without short channels)
Shoushtarian et al. (“Objective measurement of tinnitus using functional near-infrared spectroscopy and machine learning”)
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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