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 .
Applicant’s preliminary amendments filed on 09/04/2024 are acknowledged.
Claims 1-12 and 14-21 are pending for examination. Claim 13 is cancelled.
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are directed to signal per se, which does not fall into the categories of “process”, “machine”, “manufacture” and “composition of matter”. Referring to claim 15, claim 15 recites the limitation, “A computer readable medium”, which directs the claim to “computer readable medium having computer readable code”. The broadest reasonable interpretation of this phrase includes non-transitory embodiments, such as memory elements (ROM, RAM) and memory media (CDs) as well as transitory embodiments, such as carrier waves encoded with the software steps. However, transitory forms of signals are not statutory (In re Nuijten, 84 USPQ2d 1495). A claim that covers both statutory and non-statutory embodiments embraces subject matter that is improperly directed to non-statutory subject matter. Applicant can amend the limitation to "A non-transitory computer readable medium” to overcome the rejection.
Claims 1-12 and 14-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-12 and 14-21 recite methods, which fall within one of statutory categories (i.e. process) (Step 1: YES).
Step 2A Prong One analysis: Claim 1 recites “processing the response signals to obtain a peri-stimulus time response of the auditory nerve, the peri-stimulus time response comprising a peak corresponding to a first amplitude value and a plateau corresponding to a second amplitude value, calculating the ratio between the first amplitude value and the second amplitude value, to obtain a peak-to-plateau ratio, and deducing a parameter of the response of the auditory nerve based on the peak-to-plateau ratio”; and claim 21 recites “determining at least one parameter of the response of an auditory nerve of a subject wearing the hearing aid or the cochlear implant to be adjusted . The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations and/or mental process, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claim 1 does not recite any element. Claim 14 recites “a suitable computing device”. Claim 21 recites “a hearing aid or a cochlear implant” in the preamble. This judicial exception is not integrated into a practical application because claim 1 does not recite any specific element and the hearing aid or the cochlear recited in claim 21 is/are considered as intended use without any specific step(s) for adjusting the function(s) of the elements. Thus, there is no improvement or change in the function of the device (see at least MPEP 2106.05(a), (f) and (g)). And the “receiving cochlea response signals, each response signal being the electrical response of a subject's cochlea to a respective excitation, to obtain received response signals”, are considered as data gathering steps to be insignificant extra-solution activity. And/ or the abstract idea (mental process) is directed as being performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept (see MPEP 2106.04(a)(2).III.C). And/ or the abstract idea (mental process) is directed as “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea” (see MPEP 2106.04(a)(2).III.B). (Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element(s), when considered separately and in combination, are insignificant extra-solution activity (see MPEP 2106.05(g)) and mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) and do not improve the functioning of a computer, e.g. an improvement in the application of the mathematical relationship in determining the parameter(s), which is, itself, an abstract idea (see MPEP 2106.05(a)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). Dependent claims 2-12 and 14-20 further limit the judicial exception and/or are reciting elements that are well understood, routine, and conventional. Therefore claims 1-12 and 14-21 are not patent eligible under 35 USC 101.
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 2-12 and 14-20 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. Claims that depend directly or indirectly from claims 2 is/are also rejected due to said dependency.
In regard to claim 2, the claim recites “a predefined number of consecutive received signals, preferably two”. The term “preferably” is not considered as positive claim language. It is unclear whether “the predefined number” should be interpreted as two or other numbers. Clarification is requested by amendments.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 7 and 8 recite the broad recitations “200 Hz and 700 Hz” and “1000 Hz and 1500 Hz”, and the claims also recite “preferably between 200 Hz and 400 Hz” and “preferably between 1100 Hz and 1300 Hz”. which is the narrower statement of the ranges/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In regard to claim 14, the claim recites “a suitable computer device”. It is unclear what type(s) of computer device(s) is/are considered as “suitable”, since the term does not provide any structural limited effect(s) to the “computer device”. Clarification is requested by amendments. It is suggested that the term “suitable” should be deleted.
In regard to claim 16, “the determined parameters” lacks of sufficient antecedent basis. It is unclear whether the limitation refers to “at least one parameter” or “a parameter” recited to claim 1 or additional parameters. Clarification is requested by amendments.
In regard to claim 17, “the determined parameters” lacks of sufficient antecedent basis. It is unclear whether the limitation refers to “at least one parameter” or “a parameter” recited to claim 1 or additional parameters. Clarification is requested by amendments.
In regard to claim 18, “the first subject” recited in line 4, “the second subject” recited in line 8, and “the comparison” recited in line 12 lack of sufficient antecedent bases. In addition, it is unclear whether “a therapeutic target” recited in the selecting step is the same or different therapeutic target(s) as recited in the preamble. Clarification is requested by amendments.
In regard to claim 19, “the treatment” recited in line 3 and “the comparison” recited in line 14 lack of sufficient antecedent bases. In addition, it is unclear whether “a biomarker” recited in the selecting step is the same or different biomarker(s) as recited in the preamble. Clarification is requested by amendments.
In regard to claim 20, “the comparison” recited in line 15 lacks of sufficient antecedent bases. In addition, it is unclear whether “a compound” recited in the selecting step is the same or different compound(s) as recited in the preamble. Clarification is requested by amendments.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12, 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Huet et al: "Probing adaptation and spontaneous firing in human auditory-nerve fibers with far-field peri-stimulus time response", BIORXIV, 2021-03-08 – applicant cited). In regard to claim 1, Huet discloses method for determining at least one parameter of the response of an auditory nerve of a subject (abstract; Figs. 1-8 and associated descriptions), the method being computer-implemented and comprising the following steps: receiving cochlea response signals, each response signal being the electrical response of a subject's cochlea to a respective excitation, to obtain received response signals (Fig. 1 and associated descriptions), processing the response signals to obtain a peri-stimulus time response of the auditory nerve, the peri-stimulus time response comprising a peak corresponding to a first amplitude value and a plateau corresponding to a second amplitude value (Fig. 1e and associated descriptions), calculating the ratio between the first amplitude value and the second amplitude value, to obtain a peak-to-plateau ratio (Figs. 2h, 3g, 5d and 8d and associated descriptions), and deducing a parameter of the response of the auditory nerve based on the peak-to-plateau ratio (Fig. 8d and associated descriptions; prediction of SR (spontaneous discharge rate) based on PSTR peak-to-plateau ratio).
In regard to claims 2-10, Huet discloses “the received signals are shared into sets of received signals comprising a predefined number of consecutive received signals, preferably two, the processing step comprising: applying processing operations on each set of received signals, to obtain a set of processed received signals, and applying an average operation on the set of processed received signals to obtain the peri-stimulus time response of the auditory nerve.”; “the received signals are shared into sets of received signals comprising a predefined number of consecutive received signals, preferably two, the processing step comprising: applying processing operations on each set of received signals, to obtain a set of processed received signals, and applying an average operation on the set of processed received signals to obtain the peri-stimulus time response of the auditory nerve.”; “the neurophonic isolation comprises an averaging sub-operation followed by a filtering sub-operation”; “the averaging sub-operation comprises applying a weighted sum”; “the filtering sub-operation comprises applying a band-pass filter”; “a lower frequency is defined for the band-pass filter, the lower frequency being comprised between 200 Hz and 700 Hz, preferably between 200 Hz and 400 Hz.”; “an upper frequency is defined for the band-pass filter, the upper frequency being comprised between 1000 Hz and 1500 Hz, preferably between 1100 Hz and 1300 Hz.”; “the extracting operation comprises applying a rectification sub-operation followed by a smoothing sub-operation”; and “each excitation is a bandpass-filtered noise.” (round-window recordings/ results and associated descriptions in pages 4-14; Figs. 1-8 and associated descriptions).
In regard to claim 11, Huet discloses fitting the peri-stimulus time response by two decaying exponential functions to determine the first amplitude value and the second amplitude value (Fig. 1 and associated descriptions).
In regard to claim 12, Huet discloses a parameter determined at the determining step is the spontaneous rate of the fibers of the auditory nerve (spontaneous rate of fibers, abstract/ Fig. 8d and associated descriptions; Spontaneous activity of auditory nerve fibers section and associated descriptions, pages 15-16).
In regard to claims 14-15, Huet discloses a computer program product comprising instructions for carrying out the steps of a method according to claim 1 when said computer program product is executed on a suitable computer device and a computer readable medium having encoded thereon a computer program according to claim 14 (inherent properties of using Matlab in a computer device; Matlab, data fitting section and associated descriptions; page 6; Figs. 1-8 and associated descriptions).
In regard to claim 16, Huet discloses method for predicting that a subject is at risk of suffering from an auditory disorder, the method for predicting at least comprising the step of: carrying out the steps of a method determining at least one parameter of the response of an auditory nerve of the subject, to obtain at least one determined parameter, the method for determining being according to claim 1 (referring to claim 1 above), and predicting that the subject is at risk of suffering from the auditory disorder based on the determined parameters (neuropathies, tinnitus, and hyperacusis. pages 2-3 and 17).
In regard to claim 17, Huet discloses method for diagnosing an auditory disorder, the method for diagnosing at least comprising the step of: carrying out the steps of a method determining at least one parameter of the response of an auditory nerve of the subject, to obtain at least one determined parameter, the method for determining being according to claim 1 (referring to claim 1 above), and diagnosing the auditory disorder based on the determined parameters (neuropathies, tinnitus, and hyperacusis. pages 2-3 and 17).
Claim 21 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Verhulst et al. (USPGPUB 2023/0051834). In regard to claim 21, Verhulst discloses method for adjusting a hearing aid or a cochlear implant (Figs. 1-15 and associated descriptions; cochlear implants or hearing aids, [0273]; [0287]; [0361]), the method comprising carrying the steps of a method for determining at least one parameter of the response of an auditory nerve of a subject wearing the hearing aid or the cochlear implant to be adjusted (EEG/ MEG and integrity of auditory nerve synapses (ANS), auditory nerve fibers (ANF) and/or inner-hair cells (IHC) in a subject, [0088-0103]; auditory EEG responses, sound perception, cochlear, ANF and brainstem processing, 400) can be used to determine the subject specific ANF and OHC damage auditory profile, [0362].
Conclusion
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/CHU CHUAN LIU/ Primary Examiner, Art Unit 3791
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