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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 31st, 2026 and April 14th, 2026 has been entered.
Examiner acknowledges the amendments to claims 1, 2, 21, 22, 25, 28, and 33, as well as the cancellation of claims 4, 6, 8, 17, 18, 20, 29, 30, 32, and 34. New claims 35-40 have been added.
Claims 1-3, 5, 7, 9-16, 19, 21-28, 31, 33, and 35-40 are pending in the application.
Response to Arguments
Applicant's arguments filed, March 31st, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
At pages 10-11, Applicant argues that the generation of the claimed output signal is not directed to a mental process because it is rooted in an objective characterization that deals with factors or conditions as perceived without distortion by personal feelings, prejudices or interpretation and teaches away from a subjective characterization. Examiner respectfully disagrees. A mental process is a concept performed in the human mind or by a human using a pen and paper (including an observation, evaluation, judgment, opinion). Claims that recite mental processes include: a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). The step of generating an output signal based on the audio input signals as part of objective characterization of the pulsatile tinnitus and generating an indicator associated with the output signal are recited at a high level of generality that the step could be performed in the human mind or by a human using a pen and paper. Furthermore, the human mind is capable of performed objective analysis and there is no level of complexity in the step of generating the output signal that would prevent the step from being capable of being performed in the human mind.
At pages 11-12, Applicant argues that the claims recite additional elements that integrate the judicial exception into a practical application because the mouthpiece is not incidental, nominal, or tangential to the claim, rather the mouthpiece and its associated limitations comprise significant non-trivial aspects of the claimed system and that the claims require specific, non-conventional constraints. Examiner respectfully disagrees. The mouthpiece is configured for detecting, generating, and transmitting which are directed to insignificant pre-solution activity i.e. data-gathering steps necessary to perform the abstract idea. Furthermore, the mouthpiece 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 first outer housing of the mouthpiece is configured to withstand a compressive force of 50 N to 200 N applied by one or more upper teeth of the patient and one or more lower teeth of the patient for a period of 30 s to 90 s to allow sufficient detection of the objective sounds and the 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 patient's mouth is a generic processor configured to perform the Abstract Idea, are generic and well-known in the industry – as evidenced by the non-patent literature of record and Dossey, C., Abasolo, E., & Starr, I. (2023). Bruxism Biofeedback Device. General Engineering. https://digitalcommons.calpoly.edu/genengsp/14/; Kim et al., "Development of Bite Guard for Wireless Monitoring of Bruxism Using Pressure-Sensitive Polymer," 2010 International Conference on Body Sensor Networks, Singapore, 2010, pp. 109-116, doi: 10.1109/BSN.2010.62. 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. The addition of the mouthpiece does not add a meaningful limitation to the 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. Therefore, it is unclear how there can be an improvement to the technology.
At pages 13-14, Applicant argues that the claims clearly reflect an improvement to the field of diagnosing a subject with an abnormal condition that is secondary to a vascular technology. 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 an analysis of data. The claims do not integrate the analysis into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the processor. “Merely adding generic computer components to perform the method 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, March 31st, 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered and are persuasive. The rejections under 35 U.S.C. 103 are withdrawn.
Claim Objections
Claims 1 and 38 are objected to because of the following informalities:
Claim 1 line 12 “30s to 90 s” should recite “30 seconds to 90 seconds”.
Claim 38 line 8 “30s to 90 s” should recite “30 seconds to 90 seconds”.
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 1-3, 5, 7, 9-16, 19, 21-28, 31, 33, and 35-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “sufficient” in claim 1 line 12 and claim 21 line 11 (claims 2-3, 5, 7, 9-16, 19, 21-28, 31, 33, and 35-37 by virtue of dependency) is a relative term which renders the claim indefinite. The term “sufficient” 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 is configured to withstand a compressive force of 50 N to 200 N applied by one or more upper teeth of the subject and one or more lower teeth of the patient for a period of 30 seconds to 90 seconds to allow sufficient detection of the objective sounds” is rendered indefinite.
Claim 2 line 4 (claim 31 by virtue of dependency) and Claim 22 line 4 recites the limitation “the patient’s bones”. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “conduct the vibrations from the one or more upper teeth and the one or more lower teeth”.
Claim Rejections - 35 USC § 101
Claims 1-3, 5, 7, 9-16, 19, 21-28, 31, and 37 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 21 follows.
STEP 1
Regarding claims 1 and 21, the claim recites a series of structural elements and/or a series of steps or acts, including a device. Thus, the claim is directed to a machine and/or 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:
generate an output signal based on the audio input signal as part of an objective characterization of the pulsatile tinnitus
generate an indicator associated with the output signal and corresponding to the pulsatile tinnitus as secondary to an underlying vascular pathology, wherein the indicator corresponds to a frequency within a range of 100 Hz to 1,000 Hz of the output signal, such that the audio detection system is configured to facilitate an objective diagnosis of the underlying vascular pathology as cerebral venous sinus stenosis (CVSS) based on the frequency within the range of 100 Hz to 1,000 Hz
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. Claims 1 and 21 recite a mouthpiece 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; detect, at the vibration sensor, objective sounds generated by pulsatile tinnitus as vibrations occurring at the subject's patient's head without subjecting the patient to an invasive procedure, wherein the first outer housing of the mouthpiece is configured to withstand a compressive force of 50 N to 200 N applied by one or more upper teeth of the patient and one or more lower teeth of the patient for a period of 30 s to 90 s to allow sufficient detection of the objective sounds; 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 patient's mouth; receive the signal from the mouthpiece as an audio input signal, and transmit the output signal and the indicator for an objective diagnosis of the pulsatile tinnitus by the user, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The detecting, generating a signal, transmitting receiving, and transmitting steps do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the presented intrinsic frequency, nor does the method use a particular machine to perform the Abstract Idea.
Regarding claims 1 and 21, the audio detection system mouthpiece and signal processing module recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited mouthpiece is a generic sensor configured to perform pre-solutional data gathering activity, the signal processing module is configured to perform insignificant extra-solution 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.
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 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
detect, at the vibration sensor, objective sounds generated by pulsatile tinnitus as vibrations occurring at the subject's patient's head without subjecting the patient to an invasive procedure,
wherein the first outer housing of the mouthpiece is configured to withstand a compressive force of 50 N to 200 N applied by one or more upper teeth of the patient and one or more lower teeth of the patient for a period of 30 s to 90 s to allow sufficient detection of the objective sounds,
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 patient's mouth,
receive the signal from the mouthpiece as an audio input signal,
transmit the output signal and the indicator for an objective diagnosis of the pulsatile tinnitus by the user
The detecting, generating the signal, transmitting the signal, receiving, and transmitting steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the detecting, generating the signal, transmitting the signal, receiving, and transmitting steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity and insignificant extra-solution activity, e.g., mere data gathering and data outputting steps 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 claims 1 and 21, the audio detection system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The mouthpiece and signal processing module are generic and well-known in the industry – as evidenced by the non-patent literature of record and Dossey, C., Abasolo, E., & Starr, I. (2023). Bruxism Biofeedback Device. General Engineering. https://digitalcommons.calpoly.edu/genengsp/14/; Kim et al., "Development of Bite Guard for Wireless Monitoring of Bruxism Using Pressure-Sensitive Polymer," 2010 International Conference on Body Sensor Networks, Singapore, 2010, pp. 109-116, doi: 10.1109/BSN.2010.62. The recited mouthpiece 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 first outer housing of the mouthpiece is configured to withstand a compressive force of 50 N to 200 N applied by one or more upper teeth of the patient and one or more lower teeth of the patient for a period of 30 s to 90 s to allow sufficient detection of the objective sounds is a generic sensor configured to perform pre-solutional data gathering activity, the interface is configured to perform insignificant extra-solution activity, and the 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 patient's mouth is a generic processor 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.
The dependent claims also fail to add something more to the abstract independent claims.
Claims 2-3, 5, 7, 22-23, and 31 are directed to additional data-gathering that is insignificant pre-solution activity that is well-understood, routine, and previously known in the industry.
Claims 9-12, 19, 24, 26, 28, and 37 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.
Allowable Subject Matter
Claims 33 and 35-36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and 35 U.S.C. 101 set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 38-40 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record:
Shalon (US 20110125063) discloses a system comprising a sensing unit 12/dental appliance having a microphone positioned on circuitry in the sensor unit, the sensor unit positioned in the subjects mouth and separately housed (para. [0093, 0098, 0186-0188, 0192, 0236]) from a processing unit that processes a signal from the sensing unit (para. [0186, 0194, 0205, 0235]). Shalon does not disclose the bone conduction device comprising an elongate housing comprising a flat base, comprising a circumferential compartment wall positioned on top of the flat base, having a total length of 3 cm to 10 cm, having a total height of 1 cm to 2 cm, made of an epoxy-based resin, and configured to withstand a compressive force of 50 N to 200 N applied by the patient's one or more upper teeth and one or more lower teeth for a period of 30 s to 90 s, a vibration sensor formed on the electronic circuit and contained within the circumferential compartment wall of the elongate housing, detecting objective sounds as vibrations occurring at the patient’s head a result of pulsatile tinnitus and having a frequency in the range of 100 Hz to 1,000 Hz in association with the pulsatile tinnitus, and an objective diagnosis of cerebral venous sinus stenosis (CVSS) as an underlying cause of the pulsatile tinnitus based on the frequency within the range of 100 HHzjjjjjjjkdjfldslkflflsdjffdfdddfddHz to 1,000 Hz.
Song (KR 101666474 English Translation) is directed to a system and method for diagnosing pulsatile tinnitus that objectively and accurately diagnoses pulsatile tinnitus along with the location and causative disease (pages 4-5). Song does not disclose a bone conduction device and transmitting the signal for an objective diagnosis of cerebral venous sinus stenosis (CVSS) as an underlying cause of the pulsatile tinnitus based on the frequency within the range of 100 Hz to 1,000 Hz.
Paré (US 20210044313) directed to a two-way communication system discloses a mouthpiece component having an MEMS type microphone assembly 40 with a microphone 48 positioned on PCB 50 (fig. 3A). Paré does not disclose the bone conduction device comprising an elongate housing comprising a flat base, comprising a circumferential compartment wall positioned on top of the flat base, having a total length of 3 cm to 10 cm, having a total height of 1 cm to 2 cm, made of an epoxy-based resin, and configured to withstand a compressive force of 50 N to 200 N applied by the patient's one or more upper teeth and one or more lower teeth for a period of 30 s to 90 s, a vibration sensor formed on the electronic circuit and contained within the circumferential compartment wall of the elongate housing, detecting objective sounds as vibrations occurring at the patient’s head a result of pulsatile tinnitus and having a frequency in the range of 100 Hz to 1,000 Hz in association with the pulsatile tinnitus, and an objective diagnosis of cerebral venous sinus stenosis (CVSS) as an underlying cause of the pulsatile tinnitus based on the frequency within the range of 100 HHzjjjjjjjkdjfldslkflflsdjffdfdddfddHz to 1,000 Hz.
The prior art of record either taken singularly or in a combination fails to anticipate or fairly suggest the combination of features of independent claim 38 which includes: “the bone conduction device comprising: an elongate housing comprising a flat base, comprising a circumferential compartment wall positioned on top of the flat base, having a total length of 3 cm to 10 cm, having a total height of 1 cm to 2 cm, made of an epoxy-based resin, and configured to withstand a compressive force of 50 N to 200 N applied by the patient's one or more upper teeth and one or more lower teeth for a period of 30 s to 90 s”; “a vibration sensor formed on the electronic circuit and contained within the circumferential compartment wall of the elongate housing” “transmit the signal for an objective diagnosis of cerebral venous sinus stenosis (CVSS) as an underlying cause of the pulsatile tinnitus based on the frequency within the range of 100 Hz to 1,000 Hz”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Ding (CN211187262 (U) English Translation) directed to a medical device for tinnitus detection; Tran (US 10945665 B1) directed to an oral data collection device (fig. 1); Husain (US 10959670 B2) directed to systems and methods for determining or quantifying tinnitus conditions within a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/
Primary Examiner, Art Unit 3791
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