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 .
Specification
The disclosure is objected to because of the following informalities:
Page 6 line 21 should recite “anechoic ear canal were the tympanic membrane an ideal flow source”.
Appropriate correction is required.
Claim Objections
Claims 2-7 and 9-11 are objected to because of the following informalities:
For dependent claims 2-7 and 9-11: The dependent claims should begin/start with “The device” or “The method”
Claim 4 line 2 “a Norton-equivalent circuit” should recite “the Norton-equivalent circuit”
Claim 6 line 3 “anechoic ear canal were the tympanic membrane is an ideal flow source” should recite “anechoic ear canal where the tympanic membrane an ideal flow source”.
Claim 10 line 6 should recite “measuring”.
Appropriate correction is required.
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 1-12 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.
Claim 1 line 10 & claim 8 line 10 (claims 2-7 & 9-12 by virtue of dependency) recites the limitation "the middle ear". There is insufficient antecedent basis for this limitation in the claims. The limitation is suggested to recite “a middle ear”.
Claim 2 recites “the effect of the middle ear of the test subject” in lines 2-3. There is insufficient antecedent basis for this limitation in the claims. The limitation is suggested to recite “an effect of the middle ear of the test subject”.
Claim 4 recites “the term” in line 1. There is insufficient antecedent basis for this limitation in the claims. The “term” is not recited claim 1 and it is unclear what the “term” is referring to and what the “term” is for. The limitation is suggested to recite “a term”.
Claim 4 recites “a compensated pressure level” in lines 2-3. It is unclear if this is referring to the compensated pressure level (Pnpl) as recited in claim 1 or a different compensated pressure level. The limitation is suggested to recite “determining the compensated pressure level (Pnpl)”.
Claim 6 recites “the sound pressure” and “the tympanic membrane” in lines 2 & 3, respectively. There is insufficient antecedent basis for these limitations in the claims. The limitations are suggested to recite “a sound pressure” and “a tympanic membrane”.
Claims 7 & 11 recites “the equation”. There is insufficient antecedent basis for this limitation in the claims. The limitation is suggested to recite “an equation”.
Claims 7 & 11 recites “Rec”, “Rs”, and “T”. It is unclear what “Rec”, “Rs”, and “T” are referring to and what “Rec”, “Rs”, and “T” are for. Claims 7 and 11 are suggested to be depend from claims 3 and 9, respectively, so that “Rec”, “Rs”, and “T” are defined; or claims 7 and 11 are suggested to define “Rec”, “Rs”, and “T” in the claims similar to the recitations in claims 3 and 9.
Claim 10 recites “determining the reflectance” in lines 1-2, “the one-way propagation coefficient” in line 2. There is insufficient antecedent basis for these limitations in the claims. The limitation are suggested to recite “determining a reflectance” and “a one-way propagation coefficient” or claim 10 is suggested to depend from claim 9 for proper antecedence. The claim will be interpreted as reciting “determining a reflectance” and “a one-way propagation coefficient” for examination purposes.
Claim 12 recites “the program” in line 1. There is insufficient antecedent basis for this limitation in the claims. The limitation is suggested to recite “the computer program” or “the instructions”.
Claim Rejections - 35 USC § 101
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1 and 8 follows.
STEP 1
Regarding claims 1 and 8, the claims recite a series of structural elements and a series of steps or acts, including a device and a method. Thus, the claims are directed to a machine and a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
determine a compensated pressure level (Pnpl) of said measured acoustic emission (Pspl), where the middle ear of the test subject is characterized as a Norton-equivalent circuit in the determination of the compensated pressure level (Pnpl).
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) and a mathematical concept. Thus, the claim is drawn to a Mathematical process and/or a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1 and 8 recites a stimulus generator configured to generate at least one acoustic stimulus, an ear probe comprising an output unit for emitting said at least one acoustic stimulus into an ear canal and an input unit for measuring an acoustic emission, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The generating at least one acoustic stimulus, measuring an acoustic emission, and determined compensated pressure does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determined compensated pressure, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a stimulus generator configured to generate at least one acoustic stimulus;
an ear probe comprising an output unit for emitting said at least one acoustic stimulus into an ear canal and an input unit for measuring an acoustic emission from the ear …;
analysis unit connected to the ear probe.
The generating, emitting, and measuring steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the generating, emitting, and measuring steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited stimulus generator and ear probe are generic stimulators and sensors configured to perform pre-solutional data gathering activity and the analysis unit is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. See the non-patent literature of record.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-7 and 9-12 are directed to more abstract ideas relating to the determining of the compensated pressure, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "computer program” is not a process, machine, manufacture, or composition of matter. "Computer program" is not tangible, as it is not tied to a structural element and could be transitory in nature. To overcome this 35 U.S.C. 101 rejection, Examiner suggests rewording the claim to recite that the computer program product is embodied on a “non-transitory product”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-6, 8, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Charaziak (US 20190159702 A1) in view of Hiipakka (Hiipakka, "Estimating pressure and volume velocity in the ear canal for insert headphones," 2011 IEEE International Conference on Acoustics, Speech and Signal Processing (ICASSP), Prague, Czech Republic, 2011, pp. 289-292, doi: 10.1109/ICASSP.2011.5946397).
Regarding claim 1, Charaziak discloses a device for measuring otoacoustic emissions (OAE) of a test subject (“OAE probe measurement system”, Abstract), the device comprising:
[Symbol font/0x2D] a stimulus generator (“RME Babyface® Audio Interface”, para. [0066]) configured to generate at least one acoustic stimulus (“stimulus waveform”, para. [0066]),
[Symbol font/0x2D] an ear probe (“OAE probe”, para. [0012, 0058]) connected to said stimulus generator (para. [0012, 0058, 0066]), where the ear probe comprises an output unit (“sound transducer”, para. [0012, 0058]) for emitting said at least one acoustic stimulus into an ear canal of the test subject (“stimulus is delivered to the ear canal using a sound source transducer … OAE probe”, para. [0012, 0058], process 108 in fig. 3), and an input unit (“OAE probe microphone”, para. [0012, 0062]) for measuring an acoustic emission (Pspl) from the ear of the test subject (“OAE response is acquired with the OAE probe microphone”, para. [0062], process 110 in fig. 3), and
[Symbol font/0x2D] an analysis unit (“software written in MATLAB® “, para. [0066]) connected to the ear probe (“RME Babyface® Audio Interface … probe system … MATLAB® … used to control the hardware and analyze the data”, para. [0066]),
where the analysis unit (“software written in MATLAB® “, para. [0066]) is configured to receive said measured acoustic emission (Pspl) (“custom written software written in MATLAB® … analyze the data”, para. [0066]), and to determine a compensated pressure level (Pnpl) of said measured acoustic emission (Pspl) (“calculating a load-independent Thévenin-equivalent complex OAE source pressure at the eardrum”, para. [0019], processes 112-114 in fig. 3).
Charaziak does not disclose where the middle ear of the test subject is characterized as a Norton-equivalent circuit in the determination of the compensated pressure level (Pnpl).
However, Hiipakka discloses where the middle ear of the test subject is characterized as a Norton-equivalent circuit in the determination of the compensated pressure level (Pnpl) (page 290, 2.2 Ear canal modeling and estimation of pressure at eardrum & 2.3. Thevenin and Norton models of the earphone, “A direct transform from the original Thevenin equivalent source to a Norton equivalent source model was made … more accurate Norton equivalent source was obtained …” & page 291, 3.1. Modeled and measured frequency responses of the ear canal simulator, “new Norton model was needed for accurate modeling of volume velocity frequency responses at different points in the ear canal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Charaziak such that the middle ear of the test subject is characterized as a Norton-equivalent circuit in the determination of the compensated pressure level (Pnpl), in view of the teachings of Hiipakka, as this would aid in providing a more accurate model for modeled pressure and velocity responses.
Regarding claim 2, Charaziak, as modified by Hiipakka hereinabove, discloses the device according to claim 1, wherein determination of the compensated pressure level (Pnpl) is based on compensating for the test subject’s ear canal acoustics, the effect of the middle ear of the test subject, and/or for the ear probe insertion position on the acoustic emission (Pspl) (“diminish the sensitivity … PTPL is completely independent of the acoustic load (both related to the ear canal and probe source) … compensating for the effects of ear-canal acoustics”, para.[0013, 0048, 0076, 0083-0084]).
Regarding claim 3, Charaziak, as modified by Hiipakka hereinabove, discloses the device according to claim 1, wherein determination of the compensated pressure level (Pnpl) is based on said measured acoustic emission (Pspl) (“OAE measured at the microphone (PSPL)”, para. [0063]), a reflectance of the ear canal (Rec) (“REC is the ear-canal reflectance”, para. [0063]), a source reflectance of the ear probe (Rs) (“RS is the OAE probe reflectance”, para. [0063]), and a one-way propagation coefficient (T) of the ear canal (“t is equal to e2πfτ, with τ corresponding to one-way ear canal delay”, para. [0063]).
Regarding claim 5, Device according to claim 3, wherein the device is further configured to determine said reflectance of the ear canal (Rec) and/or said one-way propagation coefficient (T) of the ear canal (“calculating ear-canal reflectance … one-way ear canal delay”, para. [0057]) by:
[Symbol font/0x2D] emitting at least one calibration stimulus, generated by the stimulus generator, into the ear canal of the test subject, via said output unit (processes 104-106, fig. 3, “sound source is used to generate a calibration stimulus”, para. [0012, 0057]),
[Symbol font/0x2D] measuring an acoustic calibration response from the ear canal, via the input unit (processes 104-106, fig. 3, “measuring the pressure generated in the ear canal in response to a calibration stimulus”, para. [0012, 0057]), and
[Symbol font/0x2D] determining said reflectance of the ear canal (Rec) and/or said one-way propagation coefficient (T) of the ear canal, based on said measured acoustic calibration response, by the analysis unit (process 106, fig. 3, “calculating ear-canal reflectance … one-way ear canal delay”, para. [0012, 0057]).
Regarding claim 6, Charaziak, as modified by Hiipakka hereinabove, discloses the device according to claim 1, wherein the compensated pressure level (Pnpl) of said measured acoustic emission represents the sound pressure that would be emitted into an anechoic ear canal were the tympanic membrane is an ideal flow source (“eardrum, equivalent … complex OAE pressure measured in an anechoic ear canal”, para. [0010, 0018, 0051]).
Regarding claim 8 , Charaziak discloses a method of measuring otoacoustic emissions (OAE) of a test subject (Abstract, fig. 3), the method comprising:
[Symbol font/0x2D] generating at least one acoustic stimulus, by a stimulus generator (“stimulus waveform … RME Babyface® Audio Interface”, para. [0066]),
[Symbol font/0x2D] emitting the at least one acoustic stimulus into the ear canal of the test subject, by an output unit of an ear probe (“stimulus is delivered to the ear canal using a sound source transducer … OAE probe”, para. [0012, 0058], process 108 in fig. 3),
[Symbol font/0x2D] measuring an acoustic emission (Pspl) from the ear of the test subject, by an input unit of the ear probe (“OAE response is acquired with the OAE probe microphone”, para. [0062], process 110 in fig. 3),
[Symbol font/0x2D] receiving said measured acoustic emission (Pspl), by an analysis unit (“custom written software written in MATLAB® … analyze the data”, para. [0066]), and
[Symbol font/0x2D] determining a compensated pressure level (Pnpl) of said measured acoustic emission (Pspl) (“calculating a load-independent Thévenin-equivalent complex OAE source pressure at the eardrum”, para. [0019], processes 112-114 in fig. 3), by the analysis unit (para. [0066]),
Charaziak does not disclose where the middle ear of the test subject is characterized as a Norton-equivalent circuit in the determination of the compensated pressure level (Pnpl).
However, Hiipakka discloses where the middle ear of the test subject is characterized as a Norton-equivalent circuit in the determination of the compensated pressure level (Pnpl) (page 290, 2.2 Ear canal modeling and estimation of pressure at eardrum & 2.3. Thevenin and Norton models of the earphone, “A direct transform from the original Thevenin equivalent source to a Norton equivalent source model was made … more accurate Norton equivalent source was obtained …” & page 291, 3.1. Modeled and measured frequency responses of the ear canal simulator, “new Norton model was needed for accurate modeling of volume velocity frequency responses at different points in the ear canal”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Charaziak such that the middle ear of the test subject is characterized as a Norton-equivalent circuit in the determination of the compensated pressure level (Pnpl), in view of the teachings of Hiipakka, as this would aid in providing a more accurate model for modeled pressure and velocity responses.
Regarding claim 10, Charaziak, as modified by Hiipakka hereinabove, discloses the method according to claim 8, wherein the method further comprises determining the reflectance of the ear canal (Rec) and/or the one-way propagation coefficient (T) of the ear canal (“calculating ear-canal reflectance … one-way ear canal delay”, para. [0057]) by:
[Symbol font/0x2D] emitting at least one calibration stimulus, generated by the stimulus generator, into the ear canal of the test subject, via said output unit (processes 104-106, fig. 3, “sound source is used to generate a calibration stimulus”, para. [0012, 0057]),
[Symbol font/0x2D] measuring an acoustic calibration response from the ear canal, via the input unit (processes 104-106, fig. 3, “measuring the pressure generated in the ear canal in response to a calibration stimulus”, para. [0012, 0057]), and
[Symbol font/0x2D] determining said reflectance of the ear canal (Rec) and/or said one-way propagation coefficient (T) of the ear canal, based on said measured acoustic calibration response, by the analysis unit (process 106, fig. 3, “calculating ear-canal reflectance … one-way ear canal delay”, para. [0012, 0057]).
Regarding claim 12, Charaziak, as modified by Hiipakka hereinabove, discloses a computer program comprising instructions which, when the program is executed by a device, cause the device to carry out the steps of the method according to claim 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Slama et al., Middle ear function and cochlear input impedance in chinchilla. J. Acoust. Soc. Am. 1 March 2010; 127 (3): 1397–1410. https://doi.org/10.1121/1.3279830
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791