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 .
Amendment Entered
This Office action is responsive to the Amendment filed on September 8th, 2025. The examiner acknowledges the amendments to claims 1, 5, 7, 8, 16, 18-21, 23, 28, and 29, as well as the cancellation of claims 4, 6, 17, and 30. Claims 1-3, 5, 7-16, and 18-29 remain pending in the application. New claims 31-34 have been added.
Response to Arguments
Applicant’s amendments, filed September 8th, 2025, with respect to the drawing objections have been fully considered. The drawing objections are withdrawn.
Applicant’s arguments, filed September 8th, 2025, with respect to the rejections under 35 U.S.C. 112(b) have been considered. The rejections under 35 U.S.C. 112(b) are withdrawn.
Applicant’s arguments, filed September 8th, 2025, with respect to the rejections under 35 U.S.C. 101 have been considered but are not persuasive.
At page 10-11, Applicant argues that the claimed audio detection systems and methods of detecting pulsatile tinnitus experience by a subject amount to a practical application related to the detection, identification, diagnosis, and investigation of an abnormal condition of the subject’s ears and that the practical application is also integrated into a particular, non-generic machine. Examiner respectfully disagrees. 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. The claims recite a mouthpiece configured to detect, generate, and transmit a signal which is merely adding insignificant extra-solution activity (data-gathering) to the judicial exception (MPEP 2106.05(g)). The transmitting of the output signal do not provide an improvement to the technological field, the steps/method does not effect a particular treatment or effect a particular change based on the objective diagnosis, nor does the method use a particular machine to perform the Abstract Idea. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed steps/method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more." MPEP 2106.05(b) III. The pending claims utilize a mouthpiece comprising an electronic circuit and vibration sensor for detecting, generating, and transmitting a signal (data gathering steps) and a signal processing module for receiving, generating, and transmitting. The claims do not apply the output signal to a particular machine. Rather, the data is merely output in a post-solution step. The addition of the mouthpiece comprising an electronic circuit and vibration sensor formed on the electronic circuit for detecting, generating, and transmitting does not add a meaningful limitation to the steps/method as it merely adds data-gathering to perform the abstract ideas. With or without the claimed abstract idea, the mouthpiece gathers data the same. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(II) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum. When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. The mouthpiece comprising the electronic circuit and vibration sensor formed on the electronic circuit positioned within the first outer housing and the signal processing module comprising a second outer housing spaced apart from the first out housing of the mouthpiece are generic and well-known in the industry – as evidenced by: The Non-Patent Literature of record; yankodesign.com [online], "These headphones and mouthpiece rely on bone conduction to transmit audio from your bones to your inner ear!," November 27, 5 2021, retrieved on May 7, 2025, retrieved from I URL , 4 pages; digikey.com [online], "BL-21785-000," 2019, retrieved on May 7, 2025, retrieved from URL , 5 pages; Mikio Muramatsu, Junko Kurosawa, Yasuhiro Oikawa, Yoshio Yamasaki; Communication aid utilizing bone-conducted sound via teeth by means of mouthpiece form actuator. Proc. Mtgs. Acoust. 2 June 2013; 19 (1): 050090. https://doi.org/10.1121/1.4800185; Y. Li, W. Lu, Y. He and J. Dang, "Chewing Monitoring With Bone-Conduction Microphone for Body Area Network," in IEEE Access, vol. 7, pp. 99077-99085, 2019, doi: 10.1109/ACCESS.2019.2918988.; Zhizhang Hu, Amirmohammad Radmehr, Yue Zhang, Shijia Pan, and Phuc Nguyen. 2024. IOTeeth: Intra-Oral Teeth Sensing System for Dental Occlusal Diseases Recognition. Proc. ACM Interact. Mob. Wearable Ubiquitous Technol. 8, 1, Article 7 (March 2024), 29 pages. https://doi.org/10.1145/3643516.
At page 11, Applicant argues that the claims provide an improvement in the accurate detection and diagnosis of pulsatile tinnitus. Examiner respectfully disagrees. The improvement cannot be found in the abstract idea itself. “[I]t is important to keep in mind that an improvement in the abstract idea itself ... is not an improvement in technology.” MPEP 2106.05(a) Il. The claims recite steps for generating an output signal and transmitting the output signal for an objective diagnosis. The claims do not integrate the output signal/objective diagnosis into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the signal processing module. “Merely adding generic computer components to perform the method/steps is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology." Id.
Applicant’s arguments, filed September 8th, 2025, with respect to the rejections under 35 U.S.C. 102/103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 101
Claims 1-3, 5, 7-16, 18-29, and 31-34 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 claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of structural elements, including an audio detection system. Thus, the claim is directed to a machine, 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:
Generating an output signal based on the audio input signal as part of an objective characterization of the pulsatile tinnitus;
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to 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. Claim 1 recites a mouthpiece configured to be placed in a subject's mouth and comprising a first outer housing, an electronic circuit positioned within the first outer housing, and a vibration sensor formed on the electronic circuit and positioned within the first outer housing, wherein the mouthpiece is further configured to: detect objective sounds generated by pulsatile tinnitus as vibrations occurring at a subject’s head generate, a signal based on the vibrations, and transmit the signal, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)).
The transmitting the output signal does not provide an improvement to the technological field, the steps/method does not effect a particular treatment or effect a particular change based on the output signal/objective diagnosis, 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 mouthpiece configured to be placed in a subject's mouth and comprising a first outer housing, an electronic circuit positioned within the first outer housing, and a vibration sensor formed on the electronic circuit and positioned within the first outer housing, wherein the mouthpiece is further configured to: detect objective sounds generated by pulsatile tinnitus as vibrations occurring at a subject’s head generate, a signal based on the vibrations, and transmit the signal;
a signal processing module comprising a second outer housing that is spaced apart from the first outer housing of the mouthpiece and located outside of the subject's mouth such that the signal processing module is visible to and accessible by a user while the mouthpiece is disposed within the subject's mouth
receive the signal from the mouthpiece as an audio input signal
transmit the output signal for an objective diagnosis of the pulsatile tinnitus by the user.
The receiving, generating, transmitting steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the detecting, generating, transmitting, and receiving 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.
The same rationale applies to claim 21.
Regarding claim 1, the system recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited mouthpiece are generic sensors configured to perform pre-solutional data gathering activity, and the signal processing module 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; yankodesign.com [online], "These headphones and mouthpiece rely on bone conduction to transmit audio from your bones to your inner ear!," November 27, 5 2021, retrieved on May 7, 2025, retrieved from I URL , 4 pages; digikey.com [online], "BL-21785-000," 2019, retrieved on May 7, 2025, retrieved from URL , 5 pages; Mikio Muramatsu, Junko Kurosawa, Yasuhiro Oikawa, Yoshio Yamasaki; Communication aid utilizing bone-conducted sound via teeth by means of mouthpiece form actuator. Proc. Mtgs. Acoust. 2 June 2013; 19 (1): 050090. https://doi.org/10.1121/1.4800185; Y. Li, W. Lu, Y. He and J. Dang, "Chewing Monitoring With Bone-Conduction Microphone for Body Area Network," in IEEE Access, vol. 7, pp. 99077-99085, 2019, doi: 10.1109/ACCESS.2019.2918988.; Zhizhang Hu, Amirmohammad Radmehr, Yue Zhang, Shijia Pan, and Phuc Nguyen. 2024. IOTeeth: Intra-Oral Teeth Sensing System for Dental Occlusal Diseases Recognition. Proc. ACM Interact. Mob. Wearable Ubiquitous Technol. 8, 1, Article 7 (March 2024), 29 pages. https://doi.org/10.1145/3643516.
The dependent claims also fail to add something more to the abstract independent claims.
Claims 2-3, 5, 7, 22-23, and 31-33 are directed to additional data-gathering that is insignificant pre-solution activity that is well-understood, routine, and previously known in the industry.
Claims 8-12, 18-20, 24, 26, 28-29, and 34 are directed to more abstract ideas. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Claims 13-16, 25, and 27 are directed to additional data outputting that is insignificant extra-solution activity that is well-understood, routine, and previously known in the industry.
The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 112
Claim 33 is 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 term “substantially” in claim 33 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “wherein the first outer housing comprises a substantially flat base and …” is rendered indefinite. The limitation is suggested to recite “a flat base”.
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, 7, 9-13, 18-19, 21-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Shalon (US 20110125063 A1 – previously cited) in view of Song (KR 101666474 B1 English Translation), and further in view of Paré (US 20210044313 A1).
Regarding claim 1, Shalon discloses an audio detection system (“system … acoustic energy”, Abstract, figs. 1a-d) comprising a mouthpiece (sensing unit 12, figs. 1a-2) configured to be placed in a subject’s mouth (“sensor positioned inside the mouth”; “mounted on or in a body region of the subject”, para. [0093, 0098, 0187] (see also “dental appliance”, para. [0236])) and comprising a first outer housing (sensor unit 12, as seen in figs. 1A-B; “separately housed”, para. [0186, 0192]), an electronic circuit positioned within the first outer housing (“circuitry”, para. [0188]), and a vibration sensor positioned within the first outer housing (“microphone”, para. [0062, 0188]), wherein the mouthpiece is further configured to: detect vibrations occurring at a subject's head (“acoustic activity … mechanically-induced vibrations”; “microphone … sense acoustic energy generated within the mouth”, para. [0062, 0188, 0194]), generate a signal based on the vibrations (“analogue electrical output”, para. [0194]) and transmit the signal (“transmitted”, para. [00194]); and a signal processing module (processing unit 14 comprising DSP 30; belt unit 84 comprising DSP 86, para. [0194, 0205, 0235]) comprising a second outer housing that is spaced apart from the first outer housing of the mouthpiece (“separately housed … laptop computer … cell phone”, para. [0186, 0192]) and located outside of the subject’s mouth such that the signal processing module is visible to and accessible by a user while the mouthpiece is disposed within the subject’s mouth (as seen in figs. 1A-B, “pocket … accessed periodically … laptop computer … cell phone”, para. [0186, 0191-0192]), wherein the signal processing module is configured to: receive the signal from the mouthpiece as an audio input signal (“analogue electrical output is transmitted to processing unit 14”; “processes a signal from sensor unit 12”, para. [0194, 0205]), generate an output signal based on the audio input signal (“acoustic features are extracted using a statistical-based pattern recognition system to classify the sounds into specific events … output of the recognizer”; “parameterized”, para. [0206, 0209]), and transmit the output signal (“transmits voice feedback or data to ear unit 82”, para. [0235]).
Shalon does not disclose detecting objective sounds generated by pulsatile tinnitus as vibrations occurring at the subjects head, generating the output signal based on the audio input signal as part of an objective characterization of the pulsatile tinnitus and transmitting the output signal for an objective diagnosis of the pulsatile tinnitus by the user.
However, Song directed to a system and method for diagnosing pulsatile tinnitus discloses comprising audio detection system having an acoustic information obtaining unit 10 and a signal processing module (“computer”; acoustic storage unit 120 & sound information generating unit 130, fig. 1, page 3, 15th paragraph & page 4, 6th para.) discloses wherein the acoustic information obtaining unit is configured to: detect objective sounds generated by pulsatile tinnitus as vibrations occurring at the subject's head (“acoustic information … frequency … audible frequency band (20 to 20,000 HZ)”; “ear canal … obtain acoustic information”, page 3, 3rd and 15th para., figs. 2-5), wherein the signal processing module (“computer”; acoustic storage unit 120 & sound information generating unit 130, fig. 1, page 3, 15th para. & page 4, 6th para.) is configured to: receive the signal from the acoustic information obtaining unit as an audio input signal (“receive … acoustic information”, page 4, 16th-17th para., fig. 1), generate an output signal based on the audio input signal as part of an objective characterization of the pulsatile tinnitus (“objectively diagnose … high frequency or low frequency … location”; “generates sound information to be inspected … frequency of tinnitus perceived by the subject … diagnosis of pulsatile tinnitus … objectively and accurately diagnosed”, page 4, 7th – 13th para. & page 5, 1st-3rd para.) and an objective diagnosis of the pulsatile tinnitus by the user (“objectively diagnose whether the tinnitus perceived by the subject is high frequency or low frequency … location of the causative disease causing the tinnitus of the subject ... diagnosis”, page 4 13th para., page 5 2nd-3rd para.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon such the mouthpiece is further configured for detecting objective sounds generated by pulsatile tinnitus as vibrations occurring at the subjects head and the signal processing module is configured to generate the output signal based on the audio input signal as part of an objective characterization of the pulsatile tinnitus and transmitting the output signal for an objective diagnosis of the pulsatile tinnitus by the user, in view of the teachings of Song, for the obvious advantage of objectively and accurately diagnosing pulsatile tinnitus and informing/providing feedback to the user of the objective diagnosis (page 3 9th paragraph).
Shalon, as modified by Song hereinabove, does not disclose the vibration sensor formed on electronic circuit.
However, Paré directed to a two-way communication system comprising a mouthpiece component 60 having housing 62 including an MEMS type microphone assembly 40 (para. [0038-0039], figs. 3A-3B) discloses a vibration sensor (MEMs microphone 48, fig. 3A) formed on an electronic circuit (PCB 50, fig. 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song hereinabove, such that the vibration sensor is formed on electronic circuit and positioned within the first housing, in view of the teachings of Paré, as such a modification would have been merely a substitution of the microphone of Shalon for the MEMS microphone of Paré in order to detect the vibrations/acoustic energy generated within the mouth.
Regarding claim 2, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 1, wherein the mouthpiece comprises a bite block (“dental appliance … clip or tensile element”, para. [0098, 0236]) that is configured to be held between two or more of the subject's teeth and configured to conduct the vibrations from the two or more of the subject's teeth (“system … dental appliance … clip or tensile element that secures between or around the teeth … bone conduction through the teeth”, para. [0083, 0093, 0098]).
Regarding claim 3, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 1, wherein the mouthpiece comprises a bone conduction device (“bone conduction microphone”, para. [194]).
Regarding claim 5, Shalon, as modified by Song and Paré hereinabove, discloses the system of claim 1, wherein the vibration sensor (“sensor unit 12 … bone conduction microphone”, para. [0193]) is configured to detect the vibrations as an analog signal (“vibrations”; “sense acoustic energy … analogue electrical output”, para. [0062, 0193-0194, 0357]).
Regarding claim 7, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 1, wherein the mouthpiece (sensing unit 12, figs. 1a-d) comprises an electrical cable (“wire”, para. [0186]) that electrically connects the vibration sensor to the signal processing module (communications between 12 and 14 … wired connection”, para. [0186]).
Regarding claim 9, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 1, wherein the signal processing module comprises a benchtop console (“computer”, para. [0192]).
Regarding claim 10, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 1, wherein the signal processing module comprises a handheld console (“PDA … cell phone”, para. [0192]).
Regarding claim 11, Shalon, as modified by Song and Paré hereinabove, discloses the system of claim 5, wherein the output signal comprises a digital output signal (“signal is digitized … digitized signal can be parameterized using short-term analysis frames”; “digitized … spectral analysis or other data manipulation techniques are performed … obtain power in each frequency band … extract features”, para. [0208-0209, 0380]).
Regarding claim 12, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 11, wherein the signal processing module (DSP including on-chip memory, para. [0396]) is configured to store the digital output signal as one or more recorded sounds (“store ... pattern”; memory 32; “sensor signals … module 615 … storage of historical data”, para. [0086, 205-0206, 0433]).
Regarding claim 13, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 11, wherein the signal processing module is configured to transmit the digital output signal (“transmits”, para. [0235]) to a display device for display in graphical form (“visual display of information … graphics”, computer screen, para. [0138, 0178], figs. 10 & 12).
Regarding claim 18, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 1, wherein the signal processing module is configured to generate an indicator associated with the output signal (“visual display of information … vibrate a coded message to the user”; “recorded data was labeled”; “power spectrum of … sounds … measured frequencies”, para. [0138, 0338, 0381], as seen in figs. 10 & 12).
Shalon, as modified by Song and Paré hereinabove, does not disclose wherein the signal processing module is configured to generate an indicator associated with the output signal and corresponding to the pulsatile tinnitus as secondary to an underlying vascular pathology.
However, Song discloses wherein the signal processing module (“computer”; acoustic storage unit 120 & sound information generating unit 130, fig. 1, page 3, 15th paragraph & page 4, 6th para.) is configured to generate an indicator (“spectrogram”, figs. 7-10, page 4) associated with the output signal and corresponding to the pulsatile tinnitus as secondary to an underlying vascular pathology (“time-frequency-magnitude spectrogram … aberrant carotid artery”, page 4, 7th – 11th para., figs. 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the signal processing module is configured to generate an indicator associated with the output signal and corresponding to the pulsatile tinnitus as secondary to an underlying vascular pathology, in view of the teachings of Song, in order to inform/provide feedback to the user of the objective diagnosis.
Regarding claim 19, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 18, wherein the indicator comprises a visual indicator (Shalon “visual display”, para. [0021, 107, 0184] & Song, figs. 7-10).
Regarding claim 21, Shalon discloses a method of detecting a disorder experienced by a subject (“method … monitor … disorders that have unique physiological, sound or motion characteristics ”, para. [0059-0066]), the method comprising: detecting, at a mouthpiece positioned within the subject's mouth (sensing unit 12, figs. 1a-2, “sensor positioned inside the mouth”; “mounted on or in a body region of the subject”, para. [0093, 0098, 0187] (see also “dental appliance”, para. [0236])), sounds generated by the disorder as vibrations occurring within the subject's head (“acoustic activity … mechanically-induced vibrations”; “microphone … sense acoustic energy generated within the mouth”, para. [0062, 0188, 0194]) , wherein the mouthpiece comprises a first outer housing (sensor unit 12, as seen in figs. 1A-B; “separately housed”, para. [0186, 0192]), an electronic circuit positioned within the first outer housing (“circuitry”, para. [0188]), and a vibration sensor positioned within the first outer housing (“microphone”, para. [0062, 0188]); generating a signal based on the vibrations at the mouthpiece (“analogue electrical output”, para. [0194]); transmitting the signal from the mouthpiece (“transmitted”, para. [0194]) to a signal processing module (processing unit 14 comprising DSP 30; belt unit 84 comprising DSP 86, para. [0194, 0205, 0235]), wherein the signal processing module comprises a second outer housing that is spaced apart from the first outer housing of the mouthpiece (“separately housed … laptop computer … cell phone”, para. [0186, 0192]) and located outside of the subject's mouth such that the signal processing module is visible to and accessible by a user while the mouthpiece is disposed within the subject's mouth (as seen in figs. 1A-B, “pocket … accessed periodically … laptop computer … cell phone”, para. [0186, 0191-0192]); receiving the signal as an audio input signal at the signal processing module (“analogue electrical output is transmitted to processing unit 14”; “processes a signal from sensor unit 12”, para. [0194, 0205]); generating an output signal based on the audio input signal at the signal processing module (“acoustic features are extracted using a statistical-based pattern recognition system to classify the sounds into specific events … output of the recognizer”; “parameterized”, para. [0206, 0209]); and transmitting the output signal (“transmits voice feedback or data to ear unit 82”, para. [0235]).
Shalon does not disclose a method of detecting pulsatile tinnitus experienced by a subject, detecting objective sounds generated by the pulsatile tinnitus as vibrations occurring within the subject's head, generating an output signal based on the audio input signal at the signal processing module as part of an objective characterization of the pulsatile tinnitus, and transmitting the output signal for an objective diagnosis of the pulsatile tinnitus by the user.
However, Song directed to a system and method for diagnosing pulsatile tinnitus discloses comprising audio detection system having an acoustic information obtaining unit 10 and a signal processing module (“computer”; acoustic storage unit 120 & sound information generating unit 130, fig. 1, page 3, 15th paragraph & page 4, 6th para.) discloses a method of detecting pulsatile tinnitus experienced by a subject (Abstract), detecting, by the acoustic information obtaining unit 10, objective sounds generated by the pulsatile tinnitus as vibrations occurring within the subject's head (“acoustic information … frequency … audible frequency band (20 to 20,000 HZ)”; “ear canal … obtain acoustic information”, page 3, 3rd and 15th para., figs. 2-5), generating an output signal based on the audio input signal at the signal processing module as part of an objective characterization of the pulsatile tinnitus (“objectively diagnose … high frequency or low frequency … location”; “generates sound information to be inspected … frequency of tinnitus perceived by the subject … diagnosis of pulsatile tinnitus … objectively and accurately diagnosed”, page 4, 7th – 13th para. & page 5, 1st-3rd para.), and an objective diagnosis of the pulsatile tinnitus by the user (“objectively diagnose whether the tinnitus perceived by the subject is high frequency or low frequency … location of the causative disease causing the tinnitus of the subject ... diagnosis”, page 4 13th para., page 5 2nd-3rd para.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon to perform a method of detecting pulsatile tinnitus experienced by a subject, detecting objective sounds generated by the pulsatile tinnitus as vibrations occurring within the subject's head, generating an output signal based on the audio input signal at the signal processing module as part of an objective characterization of the pulsatile tinnitus, and transmitting the output signal for an objective diagnosis of the pulsatile tinnitus by the user, in view of the teachings of Song, for the obvious advantage of objectively and accurately diagnosing pulsatile tinnitus and informing/providing feedback to the user of the objective diagnosis (page 3 9th paragraph).
Shalon, as modified by Song hereinabove, does not disclose the vibration sensor formed on electronic circuit.
However, Paré directed to a two-way communication system comprising a mouthpiece component 60 having housing 62 including an MEMS type microphone assembly 40 (para. [0038-0039], figs. 3A-3B) discloses a vibration sensor (MEMs microphone 48, fig. 3A) formed on an electronic circuit (PCB 50, fig. 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song hereinabove, such that the vibration sensor is formed on electronic circuit and positioned within the first housing, in view of the teachings of Paré, as such a modification would have been merely a substitution of the microphone of Shalon for the MEMS microphone of Paré in order to detect the vibrations/acoustic energy generated within the mouth.
Regarding claim 22 Shalon, as modified by Song and Paré hereinabove, discloses the method of claim 21, wherein the mouthpiece comprises a bite block (“dental appliance … clip or tensile element”, para. [0098, 0236]) that is held between two or more of the subject's teeth and configured to conduct the vibrations from the two or more of the subject's teeth (“system … dental appliance … clip or tensile element that secures between or around the teeth … bone conduction through the teeth”, para. [0083, 0093, 0098]).
Regarding claim 23, Shalon, as modified by Song and Paré hereinabove, discloses the method of claim 21, further comprising detecting the vibrations as an analog signal at the vibration sensor (“vibrations”; “sense acoustic energy … analogue electrical output”, para. [0062, 0194-0194, 0357]).
Regarding claim 24, Shalon, as modified by Song and Paré hereinabove, discloses the method of claim 21, wherein the output signal comprises a digital output signal (“signal is digitized … digitized signal can be parameterized using short-term analysis frames”; “digitized … spectral analysis or other data manipulation techniques are performed … obtain power in each frequency band … extract features”, para. [0208-0209, 0380]).
Regarding claim 25, Shalon, as modified by Song and Paré hereinabove, discloses the method of claim 24, further comprising: storing the digital output signal as one or more recorded sounds (“store ... pattern”; memory 32; DSP including on-chip memory, “sensor signals … module 615 … storage of historical data”, para. [0086, 205-0206, 0396, 0433]); and/or transmitting the digital output signal to a display screen and displaying a representation of the digital output signal on the display screen for observation by a viewer (“broadcast … visual … screen”, para. [0138, 0178, 0380-0381], as seen in figs. 10-12).
Regarding claim 28, Shalon, as modified by Song and Paré hereinabove, discloses the method of claim 21, further comprising outputting an indicator associated with the output signal to a display screen (“visual display of information … vibrate a coded message to the user”; “screen”; “power spectrum of … sounds … measured frequencies”, para. [0138, 0178, 0338, 0381], as seen in figs. 10 & 12). Shalon, as modified by Song and Paré hereinabove, does not disclose wherein the indicator corresponds to the pulsatile tinnitus and a vascular pathology that underlies the pulsatile tinnitus.
However, Song discloses wherein the indicator (“spectrogram”, figs. 7-10, page 4) corresponds to the pulsatile tinnitus and a vascular pathology that underlies the pulsatile tinnitus (“time-frequency-magnitude spectrogram … aberrant carotid artery”, page 4, 7th – 11th para., figs. 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the indicator corresponds to the pulsatile tinnitus and a vascular pathology that underlies the pulsatile tinnitus, in view of the teachings of Song, in order to inform/provide feedback to the user of the objective diagnosis.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shalon, as applied to claims 5 above, and further in view of Saadat (US 20090281433 A1 – previously cited).
Regarding claim 8, Shalon, as modified by Song and Paré hereinabove, discloses the system of claim 5. Shalon further discloses acoustic activity is preferably, non-verbal (i.e. does not result from vocal chord vibrations) acoustic energy at a frequency of 0.001 Hz to 100 kHz, which is generated from mechanically-induced vibrations or motion. Shalon, as modified by Song and Paré hereinabove, does not expressly disclose wherein the output signal has a frequency within a range of 100 Hz to 10,000 Hz.
However, Saadat directed to systems and methods for determining a pulmonary function by mounting one or more sensors intra-orally (Abstract, figs. 1 & 4-5) discloses wherein the output signal has a frequency within a range of 100 Hz to 10,000 Hz (microphone 30/52 … detect auditory signals ranging from … 250 Hertz to 20,000 Hertz, para. [0086, 0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the output signal has a frequency within a range of 100 Hz to 10,000 Hz, in view of the teachings of Saadat, as such a modification would have been merely a substitution of the bone conduction microphone of Shalon for the microphone of Saadat to detect auditory signals/acoustic activity.
Claims 14-16 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Shalon in view of Song and Paré, as applied to claims 11 and 24 above, and further in view of Vega Galvez (US 20250014581 A1 which claims the benefit of U.S. provisional patent application “Silent Intraoral Speech Sensing With Audio Feedback” Ser. No. 63/539,130, filed Sep. 19, 2023 – previously cited).
Regarding claim 14, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 11, wherein the signal processing module is configured to transmit the audio output signal to an output device (“provide … audio feedback … bone conduction speakers”; “belt unit 84 … DSP 86 … transmits voice feedback or data to ear unit 82”, para. [0117-0119, 0234-0235], as seen in fig. 2). Shalon further discloses the processor including A/D and D/A conversion capability (para. [0396]). Shalon, as modified by Song and Paré hereinabove, does not expressly disclose wherein the signal processing module is configured to convert the digital output signal to an analog audio output signal and transmit the analog audio output signal to an output device.
However, Vega Galvez discloses bone conduction microphone to collect audio data within the oral cavity through a mechanical coupling to one or more teeth and a processor (para. [0026, 0032]) wherein the signal processing module (“processor”, para. [0032]) is configured to convert the digital output signal to an analog audio output signal (“transforming … digital output can be converted into analog output”, para. [0032]) and transmit the analog audio output signal to an output device (“output … sent to the bone conduction speaker 162”, para. [0032]). Vega Galvez further discloses providing audio feedback to the user and that the audio feedback comprises non-blocking audio feedback, allows the person to continue to use the mouthpad as the audio feedback is being played by the speaker (para. [0032])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the signal processing module is configured to convert the digital output signal to an analog audio output signal and transmit the analog audio output signal to an output device, in view of the teachings of Vega Galvez, for the obvious advantage of providing non-blocking audio feedback that allows the person to continue to use the system as the audio feedback is being played by the speaker ([0032]).
Regarding claim 15, Shalon, as modified by Song, Paré, and Vega Galvez hereinabove, discloses the audio detection system of claim 14, further comprising the output device (speaker, feedback element 24, ear unit 82, para. [0163-0165, 0241, 0281]).
Regarding claim 16, Shalon, as modified by Song, Paré, and Vega Galvez hereinabove, discloses the audio detection system of claim 15, wherein the output device comprises a headphone or a speaker (“in-the-ear speaker … speaker”, para. [0118, 0196-0197]).
Regarding claim 26, Shalon, as modified by Song and Paré hereinabove, discloses the method of claim 24, further comprising: transmitting the audio output signal to an output device for perception by a (“provide … audio feedback … bone conduction speakers”; “belt unit 84 … DSP 86 … transmits voice feedback or data to ear unit 82”, para. [0117-0119, 0234-0235], as seen in fig. 2). Shalon further discloses the processor including A/D and D/A conversion capability (para. [0396]). Shalon, as modified by Song and Paré hereinabove, does not expressly disclose converting the digital output signal to an analog audio output signal; and transmitting the analog audio output signal to an output device for perception by a listener.
However, Vega Galvez discloses bone conduction microphone to collect audio data within the oral cavity through a mechanical coupling to one or more teeth and a processor (para. [0026, 0032]) and converting the digital output signal to an analog audio output signal (“transforming … digital output can be converted into analog output”, para. [0032]); and transmitting the analog audio output signal to an output device for perception by a listener (“output … sent to the bone conduction speaker 162”, para. [0032]). Vega Galvez further discloses providing audio feedback to the user and that the audio feedback comprises non-blocking audio feedback, allows the person to continue to use the mouthpad as the audio feedback is being played by the speaker (para. [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the method further comprises converting the digital output signal to an analog audio output signal; and transmitting the analog audio output signal to an output device for perception by a listener, in view of the teachings of Vega Galvez, for the obvious advantage of providing non-blocking audio feedback that allows the person to continue to use the system as the audio feedback is being played by the speaker ([0032]).
Regarding claim 27, Shalon, as modified by Song, Paré, and Vega Galvez hereinabove, discloses the method of claim 26, wherein the output device comprises a headphone or a speaker (“speaker, an in-the-ear speaker”, para. [0118, 0196-0197]).
Claims 20, 29 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Shalon in view of Song, and Paré, as applied to claims 18 and 28 above, and further in view of Raz (Raz et al., Emergence of Venous Stenosis as the Dominant Cause of Pulsatile Tinnitus, Stroke: Vascular and Interventional Neurology, Volume 2, Issue 4, 2022, doi: 10.1161/SVIN.121.000154 – previously cited).
Regarding claim 20, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 18. Shalon further discloses that the system can be used for medical monitoring and the system can log cranial sounds for playback to a medical professional for diagnosing medical conditions (para. [0290]). Shalon, as modified by Song and Paré hereinabove, does not disclose wherein the underlying vascular pathology comprises cerebral venous sinus stenosis (CVSS).
However, Raz directed to a review of the cases of PT (page 2, Methods) discloses wherein the underlying vascular pathology comprises cerebral venous sinus stenosis (CVSS) (page 4, Discussion, “Venous stenosis remains, in our opinion, both the most common and the most underrecognized cause of PT”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the underlying vascular pathology comprises cerebral venous sinus stenosis (CVSS), in view of the teachings of Raz, in order to diagnose or treat pulsatile tinnitus caused by venous stenosis.
Regarding claim 29, Shalon, as modified by Song and Paré hereinabove, discloses the method of claim 28, wherein the indicator comprises one or more frequencies of the output signal (Shalon, “visual display of information … vibrate a coded message to the user”; “power spectrum of … sounds … measured frequencies”, para. [0138, 0381] & Song, figs. 7-10). Shalon, as modified by Song and Paré hereinabove, does not disclose wherein the vascular pathology comprises cerebral venous sinus stenosis (CVSS).
However, Raz directed to a review of the cases of PT (page 2, Methods) discloses wherein the underlying vascular pathology comprises cerebral venous sinus stenosis (CVSS) (page 4, Discussion, “Venous stenosis remains, in our opinion, both the most common and the most underrecognized cause of PT”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the underlying vascular pathology comprises cerebral venous sinus stenosis (CVSS), in view of the teachings of Raz, in order to diagnose or treat pulsatile tinnitus caused by venous stenosis.
Regarding claim 34, Shalon, as modified by Song, Paré, and Raz hereinabove, discloses the audio detection system of claim 20 and the underlying vascular pathology as CVSS (Raz, page 4, Discussion, “Venous stenosis remains, in our opinion, both the most common and the most underrecognized cause of PT”). ). Shalon, as modified by Song, Paré, and Raz hereinabove, does not disclose wherein the output signal has a frequency range of 100 Hz to 1,000 Hz such that the audio detection system is configured to facilitate an objective diagnosis of the underlying vascular pathology as CVSS.
However, Song discloses wherein the output signal has a frequency range of 100 Hz to 1,000 Hz (as seen in figs. 9-10) such that the audio detection system is configured to facilitate an objective diagnosis of the underlying vascular pathology (“fig. 10 is a waterfall graph showing a time-frequency-magnitude spectrogram of the acoustic information to be inspected by the subject of the sigmoid sinus diverticulum”; “causative disease causing the tinnitus … frequency of the tinnitus perceived … diagnosis of pulsatile tinnitus can be more objectively and accurately diagnosed”, page 5, 1st-3rd para., figs. 9-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song, Paré, and Raz hereinabove, such that the output signal has a frequency range of 100 Hz to 1,000 Hz such that the audio detection system is configured to facilitate an objective diagnosis of the underlying vascular pathology as CVSS, for the obvious advantage of objectively and accurately diagnosing pulsatile tinnitus based on the causative disease causing the tinnitus and the frequency of the tinnitus perceived by the subject.
Claims 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Shalon in view of Song, and Paré, as applied to claim 2 above, and further in view of Mersky (US 20110251521 A1 – previously cited).
Regarding claim 31, Shalon, as modified by Song and Paré hereinabove, discloses the audio detection system of claim 2. Shalon, as modified by Song and Paré hereinabove, does not disclose wherein the first outer housing of the mouthpiece comprises a rigid molded component.
However, Mersky directed to a tooth-coupling assembly 10 discloses wherein the first outer housing of the mouthpiece comprises a rigid molded component (“customizing dental material … rigid”, para. [0030-0032, 0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song and Paré hereinabove, such that the first outer housing of the mouthpiece comprises a rigid molded component, in view of the teachings of Mersky, as such a modification would have been the result of routine optimization of materials in order to achieve desired mechanical properties, cost, ease-of-use, ease-of-fabrication, retention, repeatability of placement, and sensitivity.
Regarding claim 33, Shalon, as modified by Song, Paré, and Mersky hereinabove, discloses audio detection system of claim 31. Shalon, as modified by Song, Paré, and Mersky hereinabove, does not disclose wherein the first outer housing has an elongate shape, and wherein the first outer housing comprises a substantially flat base and a compartment wall that surrounds the vibration sensor.
However, Mersky discloses wherein the first outer housing has an elongate shape (unlabeled but as seen in fig. 5), and wherein the first outer housing comprises a substantially flat base (unlabeled, but as seen in fig. 5) and a compartment wall that surrounds the vibration sensor (sheath 58, fig. 5, para. [0046-0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song, Paré, and Mersky hereinabove, such that the first outer housing has an elongate shape, and wherein the first outer housing comprises a substantially flat base and a compartment wall that surrounds the vibration sensor, in view of the teachings of Mersky, for the obvious advantage of providing an electric transducer having an impermeable sanitary barrier that can be used to sense vibrations for multiple patients.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Shalon in view of Song, Paré, and Mersky, as applied to claim 31 above, and further in view of Tran (US 10945665 B1).
Regarding claim 32, Shalon, as modified by Song, Paré, and Mersky hereinabove, discloses the audio detection system of claim 31. Shalon, as modified by Song, Paré, and Mersky hereinabove, does not expressly disclose wherein the mouthpiece is configured to maintain a functional integrity while being subjected to a compressive force of 50 N to 200 N from the subject's teeth.
However, Tran directed to an oral data collection device having a microphone (col. 2 lines 31-42) discloses wherein the mouthpiece (100, fig. 1) is configured to maintain a functional integrity while being subjected to a compressive force of 50 N to 200 N from the subject's teeth (“withstanding … biting forces during bruxism … 100 lbs – 200 lbs”, col. 2 lines 19-30 & col. 6 lines 13-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shalon, as modified by Song, Paré, and Mersky hereinabove, such that the mouthpiece is configured to maintain a functional integrity while being subjected to a compressive force of 50 N to 200 N from the subject's teeth, in view of the teachings of Tran, in order to provide a mouthpiece capable of withstanding and measuring during the entire range of a human’s biting force, including the biting forces generated during bruxism.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Anjanappa (US 20040202344 A1) directed to a tooth microphone apparatus worn in a human mouth.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791