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 .
Claim Status
Claims 21-42 are currently pending.
Claims 1-20 are cancelled (01/17/2024).
Claims 21-42 under examination herein.
Claims 21-42 are rejected.
Priority
Domestic Priority data as claimed by applicant is acknowledged. This application is a 371 of PCT/US2021/062073, filed 12/06/2021, which claims benefit of 63/122,083, filed 12/07/2020.
In this action, all claims 21-42 are examined for an effective filing date of 12/07/2020. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
Information Disclosure Statement, filed 09/17/2023, has been considered. Signed copies of the IDS are included with this Office Action.
Drawings
The Drawings submitted 06/06/2023 are accepted. The drawings as filed are suitable to the Examiner. Applicant is encouraged to review the submission in PAIR to ensure all details, especially figure labels, are legible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 26-31 and 37-42 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.
The metes and bounds of claims 26 and 37 are unclear. Claims 26 and 37 recite “applying at least one statistical method to do at least one of measuring and comparing trends for hearing loss metrics…” The claim fails to particularly point out any statistical method to do, at least one of which method, and applied how, to hearing loss metric trends. This is not a particular direction to make a certain calculation. Applicant can claim the invention’s statistical methods or equivalents, as rooted in the specification [FIG 2-5, 0130-143, 164-165: e.g. (a) Shewhart chart; (b) cumulative sum (“cusum”) control chart; (c) Wald-Wolfowitz test; (d) Wallis-Moore test; (e) Sen's slope estimator; (f) pooled Kendall's tau-beta].
The metes and bounds of claims 29 and 40 are unclear. Claims 29 and 40 recite “wherein the trends … are applied to evaluate the effectiveness of a hearing conservation program…” (HCP) is entirely unclear [p41-44: Aggregate Analytics (HCP Effectiveness), Tables 10-16]. The claim fails to particularly point out how the audiometric data is applied to achieve the claimed goals. Merely stating that trend audiometric data “are applied” is not a specific, clearly defined step (how said trends are applied to what HCP programs/parameters). There are no steps or limitations which define “effectiveness” (what criteria/thresholds for effectiveness). This applies equally to claims 30-31 and 41-42. Whether to evaluate/to measure the effectiveness, or to identify risk, there are no particular steps or limitations for one of ordinary skill in the art to be reasonably apprised of applying said trends, as required [0175-0179].
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 21-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture, or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): yes, the claims 21-42 are directed to a method and system for detection of early noise-induced hearing loss from audiometric patterns, the answer is "yes".
With respect to step (2A)(1), the claims recite abstract ideas and natural correlations. To determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon, MPEP at 2106.03 teaches abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships, and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (see MPEP 2106.04(a)(2)). In the instant application, the claims recite the following limitations that equate to abstract ideas and natural correlations.
Abstract ideas include mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information) (MPEP 2106.04(a)(2). Laws of nature or natural phenomena include naturally occurring principles/ relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature (MPEP2106(b)).
The claims directed to judicial exceptions are as follows:
Mental processes:
Claims 26 and 37: having a plurality of subjects assigned to at least one of a defined population and a defined sub-population, in which each subject has a plurality of audiograms that includes the baseline audiogram which is administered to the subject upon entering the population, and at least the subsequent audiogram;
Mathematical concepts:
Claims 21 and 32: providing an expected hearing response function (fi) for the hearing loss condition calculated from a plurality of sound frequencies (I) tested in the audiogram of the ear, wherein a scalar, which includes a unitless proportional value, is assigned for the hearing level; generating a weighted hearing level, W, from a measured hearing level associated with the subject for each ear from the audiogram and the expected hearing response function (fi) for the hearing loss condition according to a first equation:
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wherein W includes a metric that summarizes the degree of conformity between the measured audiogram and the hearing loss condition in the ear, reported as a numerical value in decibel (dB)-equivalent units termed 'dBw';
i includes the sound frequency at which at least one of the measured hearing level and the expected hearing response is recorded in the ear in the audiogram;
Li includes the measured hearing level for each sound frequency (i) in the ear in the audiogram associated with the subject, measured in dB;
L includes a first arithmetic mean of the measured hearing levels Li, calculated in dB;
fi includes the expected hearing response function at each recorded sound frequency (i);
f includes a second arithmetic mean of the fi values;
& includes a summation of the (i) values; and
fm includes a maximum value in the set of fi values…
calculating W for a baseline audiogram and calculating W for a subsequent audiogram for each ear of the subject, using the same expected hearing response function (fi);
calculating a DW for each ear of the subject by subtracting the W value calculated for the baseline audiogram from the W value calculated for the subsequent audiogram, wherein a positive increase in the value of W corresponds to a decline in hearing for the hearing loss condition;
generating a weighted correlation coefficient, rw, from the measured hearing level (Li) and the expected hearing response function (fi) for each ear from the baseline audiogram and the subsequent audiogram of the subject, according to a second equation
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116
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wherein rw includes a statistical correlation metric measuring the extent of a linear relationship between a change in hearing toward the hearing loss condition from the baseline audiogram to the subsequent audiogram in the ear of the subject based on the expected hearing response function (fi);
0 includes a first subscript that denotes the baseline audiogram;
t includes a second subscript that denotes the subsequent audiogram conducted at a date and time ('f) that occurs later than the baseline audiogram ('0'); and the remainder of the symbols are the same as those defined in the first equation;
determining if the DW value and the corresponding rw value for each ear in the subject indicates that the hearing loss condition has resulted in at least one of a worsened state, an improved state, and an unchanged state at the time interval between the baseline audiogram and the subsequent audiogram;…calculating a DW per unit time in each ear of the subject between the baseline audiogram and the subsequent audiogram, which is expressed as at least one of an absolute rate of change in DW per year, a DW/year, and a proportional rate of change in W per year.
Claims 23 and 34: selected from a template library consisting of:0.5 kHz given 0.0 weight, 1 kHz given 0.0 weight, 2 kHz given 0.0 weight, 3 kHz given a weight of 1.0, 4 kHz given a weight of 2.0, 6 kHz given a weight of 1.0 and 8 kHz given a weight of 0.5; 0.5 kHz given 0.0 weight, 1 kHz given 0.0 weight, 2 kHz given 0.0 weight, 3 kHz given a weight of 0.5, 4 kHz given a weight of 2.0, 6 kHz given a weight of 1.0 and 8 kHz given a weight of 0.5; and 0.5 kHz given 0.0 weight, 1 kHz given 0.0 weight, 2 kHz given 0.0 weight, 3 kHz given a weight of 1.0, 4 kHz given a weight of 2.0, 6 kHz given a weight of 0.5 and 8 kHz given a weight of 0.5.
Claims 25 and 36: utilizing the measured hearing level data for the subject from the baseline audiogram and a plurality of the subsequent audiograms conducted over a plurality of time intervals.
Claims 26 37: calculating the W value for the baseline audiogram and calculating the W value for each of the subsequent audiograms for each ear of the subject using the expected hearing response function (fi)…calculating the DW value for each ear of the subject for each subsequent audiogram by subtracting the W value calculated for the baseline audiogram from the W value calculated for the subsequent audiogram…generating the weighted correlation coefficient, rw, from the measured hearing level (Li) and the expected hearing response function (f;) for each ear from the baseline audiogram and the subsequent audiogram of the subject…calculating the DW /year trend value and the proportional rate of change in W per year in each ear of the subject between the baseline audiogram and the subsequent audiogram for each of the subsequent audiograms;… applying a rw cutoff criterion value to each corresponding DW value for each ear in each audiogram among the subjects in the population to exclude the subsequent audiogram with the DW value that does not positively correlate with the hearing loss condition from the measurements of the aggregated population changes over time; calculating at least one of an arithmetic mean and a median of the DW /year trend for each ear, including the baseline audiogram and the subsequent audiograms, for each subject in the population over a period of time; calculating at least one of an arithmetic mean and a median of the DW /year trend values for each subject for each ear, for a population DW/year trend value; calculating at least one of an arithmetic mean and a median of the population DW trend value for each subject for each ear in the population…
Claims 28 and 39: selected from a template library consisting of:0.5 kHz given 0.0 weight, 1 kHz given 0.0 weight, 2 kHz given 0.0 weight, 3 kHz given a weight of 1.0, 4 kHz given a weight of 2.0, 6 kHz given a weight of 1.0 and 8 kHz given a weight of 0.5; 0.5 kHz given 0.0 weight, 1 kHz given 0.0 weight, 2 kHz given 0.0 weight, 3 kHz given a weight of 0.5, 4 kHz given a weight of 2.0, 6 kHz given a weight of 1.0 and 8 kHz given a weight of 0.5; and 0.5 kHz given 0.0 weight, 1 kHz given 0.0 weight, 2 kHz given 0.0 weight, 3 kHz given a weight of 1.0, 4 kHz given a weight of 2.0, 6 kHz given a weight of 0.5 and 8 kHz given a weight of 0.5.
Natural phenomenon:
Claims 21 and 32: identifying the hearing loss condition measured in at least one pure-tone audiogram…estimating a trend in hearing toward the hearing loss condition
Claims 22 and 33: wherein the hearing loss condition is an early audiometric phase of noise-induced hearing loss (NIHL).
Claims 23 and 34: wherein the fi weightings comprise a template of the expected hearing response in the ear for early NIHL…
Claims 24 and 35: wherein having the DW value greater than or equal to 10.0 dBw and the rw value greater than 0.00 indicates a shift toward early NIHL in the ear of the subject.
Claims 26 and 37: transforming the measured hearing level data from the plurality of pure-tone audiograms associated with the subject and the expected hearing response function (f;) for the hearing loss condition into the weighted hearing level associated with the subject for each ear, to detect and measure at least one of an aggregated change over time for at least one of a population and a sub-population… wherein a positive increase in the value of W corresponds to a decline in hearing for the hearing loss condition…estimating the trend in hearing toward the hearing loss condition…applying at least one statistical method to do at least one of measuring and comparing trends for hearing loss metrics that relate to the hearing loss condition for at least one of the population and the sub-population.
Claims 27 and 38: wherein the hearing loss condition is early NIHL.
Claims 28 and 39: wherein the fi weightings comprise a template of the expected hearing response in the ear for early NIHL.
Claims 29 and 40: wherein the trends for hearing loss that relate to the hearing loss condition for at least one of the population and the sub-population are applied to evaluate the effectiveness of a hearing conservation program for preventing NIHL in at least one of the population, the populations, and the sub-populations.
Claims 30 and 41: wherein the trends for hearing loss that relate to the hearing loss condition for at least one of the population and the sub-population are applied to identify at least one of the subjects, the sub- populations, the population, and the populations at increased risk for development of NIHL.
Claims 31 and 42: wherein the trends for hearing loss that relate to the hearing loss condition for at least one of the population and the sub-population are applied to measure the effectiveness of a preventive method for noise exposure control within at least one of the population, the populations, and the sub-populations.
Hence, the claims explicitly recite elements that, individually and in combination, constitute abstract ideas and natural phenomenon.
With respect to step 2A(2): The claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements considered for practical application:
Claims 21 and 32: pure-tone audiogram
Claim 32: system, processor, non-transitory computer-readable medium
Claims 21 and 32 do not utilize the audiometric data in any real world or practical application, only to characterize the data (A method for transforming data from a plurality of pure- tone audiograms associated with a subject into a numerical metric …estimating a trend in hearing).
Claims 21-42 recite conventional testing steps of obtaining data that was measured in at least one pure-tone audiogram by a characteristic pattern …. (Liao et al (10/27/2020) [PTO 892 cited]; Bongers S et al. (2017) [PTO 892 cited]). Claims 21 and 32 recite additional elements that are not an abstract idea but are data gathering steps which are extra-solution activity, as they collect the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Claims 21 and 32 also recite the additional non-abstract elements: pure-tone audiogram, system, processor, and non-transitory computer-readable medium. The claims do not describe any specific laboratory steps by which the audiogram, system, processor, and non-transitory computer-readable medium perform or carry out the abstract idea, nor do they provide any details of how specific structures of the system, processor, computer- readable medium are used to implement these functions. The claims require nothing more than a minimally described, generic audiogram device, system, processor, and CRM [0144: … data collection, organization, calculations and statistical analyses are typically conducted using computerized systems and software designed for this purpose… any sophisticated data management platform can be used to perform the calculations and analyses described herein]. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not recite integrate that abstract idea into a practical application. (see MPEP 2106.05(f)).
Claims 21-42 recite no additional element/limitation related to the natural law and so do not provide a particular limitation which would integrate the natural law into a practical application. To integrate a judicial exception into a practical application, the additional limitation must be specifically identified, and not merely instructions to apply the judicial exception. The additional limitation must have more than a nominal or insignificant relationship to the identified judicial exception. (MPEP 2106.04(d)(2))
Remaining dependent claims have been analyzed. These further limitations are sample materials that provide data, are field of use limitations (employing a pure-tone audiogram), or intended use limitations in claims 21 and 32 (estimating a trend in hearing toward the hearing loss condition by calculating a DW per unit time in each ear of the subject between the baseline audiogram and the subsequent audiogram …)
None of these dependent claims recite additional elements which would integrate a judicial exception into a practical application.
Finally, the (2B) analysis. Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims lack a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering, instructions, and field of use limitations described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rest in whether or not the additional elements (or combination of elements) represent well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant recitations, the claims recite the following additional elements considered for inventive concept:
Claims 21 and 32: pure-tone audiogram
Claim 32: system, processor, non-transitory computer-readable medium
Said steps that are “in addition” to the recited judicial exception in the instant claims represent those of mere data handling instructions (a method for transforming data from a plurality of pure- tone audiograms associated with a subject into a numerical metric …estimating a trend in hearing), or field of use and intended use limitations (measured in at least one pure-tone audiogram by a characteristic pattern …) to implement in the recited judicial exception and do not impart meaning to said recited judicial exception, such that is applied in a practical manner. Further with respect to the additional elements in the instant claims, these steps direct to mere data gathering and handling of audiometric data to carry out the abstract idea without imposing any meaningful limitation on the abstract idea and is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
Claims 21-42 recite conventional testing steps of obtaining data that was measured in at least one pure-tone audiogram by a characteristic pattern …. (Liao et al (10/27/2020) [PTO 892 cited]; Bongers S et al. (2017) [PTO 892 cited]). Claims 21 and 32 recite additional elements that are not an abstract idea but are data gathering steps which are extra-solution activity, as they collect the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g)). Activities such as routine hearing testing steps to produce audiogram data, followed by data gathering, do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not effect a transformation of matter, nor do they provide a non-conventional or unconventional step. Data gathering steps constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
Claims 21 and 32 also recite the additional non-abstract elements: pure-tone audiogram, system, processor, and non-transitory computer-readable medium. The claims do not describe any specific laboratory steps by which the audiogram, system, processor, and non-transitory computer-readable medium perform or carry out the abstract idea, nor do they provide any details of how specific structures of the system, processor, computer- readable medium are used to implement these functions. The claims require nothing more than a minimally described, generic audiogram device, system, processor, and CRM [0144: … data collection, organization, calculations and statistical analyses are typically conducted using computerized systems and software designed for this purpose… any sophisticated data management platform can be used to perform the calculations and analyses described herein]. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not recite integrate that abstract idea into a practical application. (see MPEP 2106.05(f)). Therefore, these tangible components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
Claims 21-42 recite no additional element/limitation related to the natural law and so does not claim a particular limitation which would provide the natural law into an inventive concept. To integrate a judicial exception into a practical application, the additional limitation must be specifically identified, and not merely instructions to apply the judicial exception. The additional limitation must have more than a nominal or insignificant relationship to the identified judicial exception. (MPEP 2106.04(d)(2))
Remaining dependent claims have been analyzed. These further limitations are sample materials that provide data, are field of use limitations (employing a pure-tone audiogram), or intended use limitations in claims 21 and 32 (estimating a trend in hearing toward the hearing loss condition by calculating a DW per unit time in each ear of the subject between the baseline audiogram and the subsequent audiogram …) None of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter (Step 2B: No). As such, claims 21-42 are not patent eligible.
Remarks on Prior Art
Claims 21 and 32 appear free from the prior art as the prior art does not teach nor fairly suggest the specific functions recited in claims 21 and 32 along with the particular variables.
The closest prior art is Bertrand et al. (2017) US 20170300631 [PTO 892 cited] teaches a method for calculating, using a prediction formula and a reference audiogram, projected audiogram patterns that correlate noise exposure levels with observed evolution of hearing acuity (i.e. noise-induced HL). However, this formula function and variables are different from those set forth in the claimed invention. In addition, other prior art documents that are related to also do not teach nor fairly suggest the particular claimed functions.
The prior art made of record but not relied upon is considered pertinent to applicant's disclosure, as follows:
Liao et al. (10/27/2020) US20220125342A1 [PTO 892 cited] provides method and system for diagnosing hearing loss with Hearing Scale Test (HST) based on consecutive hearing screening procedures. It is used to estimate the current hearing status of each ear and compares the difference between the hearing scales to a threshold for hearing loss diagnosis, outcomes monitoring, and patient surveillance [Abstract].
Bongers S et al. (2017) [PTO 892 cited] provides for evaluation of MRI-related acoustic noise hearing loss based on serial audiometry. Linear regression models and regression coefficient assessed the association between change in hearing threshold levels per year (ΔdB/y), with further subpopulation analysis to assess impact of Hearing Prevention Devices (e.g. earmuff/earplugs), and rule out confounders [Abstract, p777, 779-781].
Conclusion
No claims are allowed.
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/VR/
Examiner
Art Unit 1685
/MARY K ZEMAN/Primary Examiner, Art Unit 1686
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