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 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “determining, by a processor of the computing device, one or more health characteristics of the inner ear of the user based at least in part on the recorded otoacoustic emissions” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“emitting, by a signal generator, a stimulus tone that is to be received by a user, wherein the stimulus tone comprises a swept level stimuli;”
“recording, in a memory of a computing device, otoacoustic emissions generated by an inner ear of the user, wherein the otoacoustic emissions are in response to the stimulus tone;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, signal generators are general fields of use and memories and processors are generic computer elements used to perform generic computer functions don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of evaluating otoacoustic emissions generated by an inner ear to determine health characteristics of the inner ear of the user and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 2-10 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 11, the claim(s) recites “determines one or more health characteristics of the inner ear of the user based at least in part on the otoacoustic emissions” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a signal generator that emits a stimulus tone that is to be received by a user, wherein the stimulus tone comprises a swept level stimuli;”
a computing device operatively coupled to the signal generator, wherein the computing device includes:
a memory that stores otoacoustic emissions generated by an inner ear of the user, wherein the otoacoustic emissions are in response to the stimulus tone;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, signal generators are general fields of use and memories and processors are generic computer elements used to perform generic computer functions don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of evaluating otoacoustic emissions generated by an inner ear to determine health characteristics of the inner ear of the user and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 12-20 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
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.
Claim(s) 1-8 and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable Abdala et al (“Characterizing the Relationship Between Reflection and Distortion Otoacoustic Emissions in Normal‑Hearing Adults”) (“Abdala”) in view of Housley et al (US 2021/0015405) (“Housley”).
Regarding Claim 1, while Abdala teaches a method of conducting an otoacoustic emission test (Abstract), the method comprising:
emitting, by a signal generator, a stimulus tone that is to be received by a user, wherein the stimulus comprises a swept level stimuli (p648, Instrumentation and Calibration “BabyFace Pro USB High Speed Audio Interface (RME Audio, Germany) and ER-10X probe system (Etymōtic Research, Elk Grove Village, IL) controlled by custom software written in MATLAB (MathWorks, Natick, MA) were used to generate stimulus waveforms and record the ear-canal pressures." Signal generator, p649, OAE Stimulus Parameters and Data Collection, “For both OAEs, pure tone frequencies were exponentially swept at 1 octave per second upward (for DPOAEs) or downward (for SFOAEs) across a 5-octave range (0.5–16 kHz). These sweep rates and directions were established from past work in our labs (Kalluri and Shera 2013; Abdala et al. 2015; Shera and Abdala 2016). For normal hearers, the SFOAE probe was presented in 5 dB steps at levels between 20 and 65 dB FPL, and the DPOAE L2 was presented between 25 and 75 dB FPL.”, Fig. 6, swept level stimuli reflect in measured X-axis),
recording otoacoustic emissions generated by an inner ear of the user, wherein the otoacoustic emissions are in response to the stimulus tone (p649-650, OAE Stimulus Parameters and Data Collection, measured DPOAEs); and
determining one or more health characteristics of the inner ear of the user based at least in part on the recorded otoacoustic emissions (p657-659, Hearing-Impaired and Joint-OAE Profile, recognized distinctions in health characteristics between normal hearing and hearing-impaired patients, p661-662, Distinguishing Among Hearing Losses),
where the method is guided by software (p648, Instrumentation and Calibration, software written in Matlab).
Abdala fails to teach
wherein the stimulus tone comprises a swept level stimuli;
recording, in a memory of a computing device, otoacoustic emissions; and
determining, by a processor of the computing device, one or more health characteristics.
However Housley teaches a method for testing hearing by otoacoustic emission testing (Abstract) comprising
recording, in a memory of a computing device, otoacoustic emissions ([0023], [0062]); and
determining, by a processor of the computing device, one or more health characteristics ([0023]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the computing elements of a memory and computer as taught by Housley to perform the software processing of acoustic data of Abdala as a way to provide necessary context on how the steps in Abdala could be performed.
Regarding Claim 2, Abdala and Housley teach the method of claim 1, wherein the swept level stimuli simultaneously includes a plurality of distinct frequencies (See Claim 1 Rejection).
Regarding Claim 3, Abdala and Housley teach the method of claim 1, and Abdala further teaches wherein the stimulus tone comprises a pair of stimulus tones that have a fixed frequency ratio (p649, OAE Stimulus Parameters and Data Collection, “2 f1−f2 DPOAEs were evoked with swept tones separated in frequency by a fixed f2/f1 ratio of 1.22 using the so-called “scissors” formula to determine primary tone level separation: 0.4 L2 + 39 dB FPL (Kummer et al. 1998).”).
Regarding Claim 4, Abdala and Housley teach the method of claim 3, wherein the fixed frequency ratio is in a range between 1.1 and 1.3 (See Claim 3 Rejection).
Regarding Claim 5, Abdala and Housley teach the method of claim 1, and Abdala further teaches further comprising calibrating the stimulus tone using a forward pressure level (FPL) technique (p649, Instrumentation and Calibration, “Forward-pressure-level (FPL) stimulus calibration was applied to correct for the effects of ear-canal standing waves on stimulus level by controlling the amplitude of the forward-traveling stimulus wave rather than the total pressure.”).
Regarding Claim 6, Abdala and Housley teach the method of claim 1, and Abdala further teaches wherein determining the one or more health characteristics includes determining an amount of cochlear aging in the user (p661, Distinguishing Among Hearing Losses, “While both SFOAEs and DPOAEs drop in level with aging, the decline is greater for distortion emissions. That is, OAEs in elderly adults are more reduced along the DPOAE level dimension (y-axis) than the SFOAE level dimension (x-axis). A different cochlear pathology—for example, one producing equal reduction in both SFOAE and DPOAE levels—could possibly be distinguished from this pattern.”).
Regarding Claim 7, Abdala and Housley teach the method of claim 1, and Abdala further teaches wherein determining the one or more health characteristics includes determining a growth function for the inner ear of the user (p655, Fig. 6, multiple growth functions shown).
Regarding Claim 8, Abdala and Housley teach the method of claim 7, wherein the growth function comprises a pattern of distortion product otoacoustic emission growth with increasing stimulus level at a given frequency (See Claim 7 Rejection).
Regarding Claim 11, while Abdala teaches a system for conducting an otoacoustic emission test (Abstract), the system comprising:
a signal generator that emits a stimulus tone that is to be received by a user, wherein the stimulus tone comprises a swept level stimuli (p648, Instrumentation and Calibration “BabyFace Pro USB High Speed Audio Interface (RME Audio, Germany) and ER-10X probe system (Etymōtic Research, Elk Grove Village, IL) controlled by custom software written in MATLAB (MathWorks, Natick, MA) were used to generate stimulus waveforms and record the ear-canal pressures." Signal generator, p649, OAE Stimulus Parameters and Data Collection, “For both OAEs, pure tone frequencies were exponentially swept at 1 octave per second upward (for DPOAEs) or downward (for SFOAEs) across a 5-octave range (0.5–16 kHz). These sweep rates and directions were established from past work in our labs (Kalluri and Shera 2013; Abdala et al. 2015; Shera and Abdala 2016). For normal hearers, the SFOAE probe was presented in 5 dB steps at levels between 20 and 65 dB FPL, and the DPOAE L2 was presented between 25 and 75 dB FPL.”, Fig. 6, swept level stimuli reflect in measured X-axis); and
software coupled to the signal generator (p648, Instrumentation and Calibration, software written in Matlab), wherein the software includes steps of:
storing otoacoustic emissions generated by an inner ear of the user, wherein the otoacoustic emissions are in response to the stimulus tone (p649-650, OAE Stimulus Parameters and Data Collection, measured DPOAEs); and
determining one or more health characteristics of the inner ear of the user based at least in part on the otoacoustic emissions (p657-659, Hearing-Impaired and Joint-OAE Profile, recognized distinctions in health characteristics between normal hearing and hearing-impaired patients, p661-662, Distinguishing Among Hearing Losses),
Abdala fails to teach a computing device operatively coupled to the signal generator, wherein the computing device includes the software;
a memory that performs the storage of otoacoustic emissions; and
a processor operatively coupled to the memory, wherein the processor performs the determining.
However Housley teaches a method for testing hearing by otoacoustic emission testing (Abstract) comprising
recording, in a memory of a computing device, otoacoustic emissions ([0023], [0062]); and
determining, by a processor of the computing device, one or more health characteristics ([0023]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the computing elements of a memory and computer as taught by Housley to perform the software processing of acoustic data of Abdala as a way to provide necessary context on how the steps in Abdala could be performed.
Regarding Claim 12, Abdala and Housley teach the system of claim 11, wherein the swept level stimuli simultaneously includes a plurality of distinct frequencies (See Claim 11 Rejection).
Regarding Claim 13, Abdala and Housley teach the system of claim 11, and Abdala further teaches wherein the stimulus tone comprises a pair of stimulus tones that have a fixed frequency ratio (p649, OAE Stimulus Parameters and Data Collection, “2 f1−f2 DPOAEs were evoked with swept tones separated in frequency by a fixed f2/f1 ratio of 1.22 using the so-called “scissors” formula to determine primary tone level separation: 0.4 L2 + 39 dB FPL (Kummer et al. 1998).”).
Regarding Claim 14, Abdala and Housley teach the system of claim 11, wherein the fixed frequency ratio is in a range between 1.1 and 1.3 (See Claim 13 Rejection).
Regarding Claim 15, Abdala and Housley teach the system of claim 11, and Abdala further teaches wherein the processor is further configured to calibrate the stimulus tone using a forward pressure level (FPL) technique (p649, Instrumentation and Calibration, “Forward-pressure-level (FPL) stimulus calibration was applied to correct for the effects of ear-canal standing waves on stimulus level by controlling the amplitude of the forward-traveling stimulus wave rather than the total pressure.”).
Regarding Claim 16, Abdala and Housley teach the system of claim 11, further comprising a measurement probe configured to record the otoacoustic emissions generated by the inner ear of the user (See Claim 11 Rejection, uses a microphone as a measurement probe).
Regarding Claim 17, Abdala and Housley teach the system of claim 11, and Abdala further teaches wherein the one or more health characteristics include an amount of cochlear aging in the user (p661, Distinguishing Among Hearing Losses, “While both SFOAEs and DPOAEs drop in level with aging, the decline is greater for distortion emissions. That is, OAEs in elderly adults are more reduced along the DPOAE level dimension (y-axis) than the SFOAE level dimension (x-axis). A different cochlear pathology—for example, one producing equal reduction in both SFOAE and DPOAE levels—could possibly be distinguished from this pattern.”).
Regarding Claim 18, Abdala and Housley teach the system of claim 11, and Abdala further teaches wherein the one or more health characteristics include a growth function for the inner ear of the user (p655, Fig. 6, multiple growth functions shown).
Regarding Claim 19, Abdala and Housley teach the system of claim 18, wherein the growth function comprises a pattern of distortion product otoacoustic emission growth with increasing stimulus level at a given frequency (See Claim 18 Rejection).
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable Abdala in view of Housley as evidenced by Kraus et al (US 2012/0197153) (“Kraus”) and further in view of Zoth et al (US 2007/0156063) (“Zoth”).
Regarding Claim 9, while Abdala and Housley teach the method of claim 1, and Abdala further teaches wherein the determining includes analyzing the recorded otoacoustic emissions using time analysis windows with a least- squares fitting procedure (p650-651, Least Squares Fit and Signal Processing¸ where the time windows analyzed in succession of Abdala would be known as a sliding window analysis as evidenced by Kraus [0254]), their combined efforts fail to teach analyzing the recorded otoacoustic emissions using a weighted least- squares fitting (WLSF) procedure.
However Zoth teaches a distortion product otoacoustic emission analysis (Abstract) where weighted least square regression analysis is used to find DPOAE parameters (Fig. 1B, [0010]-[0011], [0046]-[0049], [0050]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the least square fitting of Abdala to a weighted least square regression as Zoth teaches that this improves the hearing threshold extrapolation from the growth function ([0010], Fig. 1B).
Regarding Claim 20, while Abdala and Housley teach the system of claim 11, and Abdala further teaches wherein the processor analyzes the otoacoustic emissions using sliding time analysis windows with a least-squares fitting procedure to determine the one or more health characteristics (p650-651, Least Squares Fit and Signal Processing¸ where the time windows analyzed in succession of Abdala would be known as a sliding window analysis as evidenced by Kraus [0254]), their combined efforts fail to teach analyzing the recorded otoacoustic emissions using a weighted least- squares fitting (WLSF) procedure.
However Zoth teaches a distortion product otoacoustic emission analysis (Abstract) where weighted least square regression analysis is used to find DPOAE parameters (Fig. 1B, [0010]-[0011], [0046]-[0049], [0050]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the least square fitting of Abdala to a weighted least square regression as Zoth teaches that this improves the hearing threshold extrapolation from the growth function ([0010], Fig. 1B).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable Abdala in view of Housley as evidenced by Kraus and further in view of Zoth and further in view of Long et al (“Measuring distortion product otoacoustic emissions using continuously sweeping primaries”) (“Long”).
Regarding Claim 10, Abdala, Housley, Kraus, and Zoth teach the method of claim 9, wherein there is an overlap between sliding time analysis windows (See Claim 9 Rejection), their combined efforts fail to teach the sliding time analysis windows are between 100-300 milliseconds in length.
However Long teaches an otoacoustic emission testing (Abstract) where a least squares fitting is used to find parameters of distortion product otoacoustic emission tests, with the least squares fitting analysis comprising overlapping windows of 500 milliseconds in length (p1615, 4. Analysis, “In this experiment, the analysis window was ½ s (22 050 points), which gives a bandwidth of 2 Hz (sampling rate/analysis window).” And further identifies that the size of the analysis window may be reduced).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the window of Abdala at a current length as taught by Long as a way to standardize the steps of the method and increase consistency across applications of the invention. Furthermore, it would be obvious that one of ordinary skill in the art could arrive at overlapping window size of 100-300 milliseconds in length from Long’s teaching of 500 milliseconds or lower as a routine optimization in view of prior art conditions [ “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)].
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791