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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 05, 2025 and September 19, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on August 05, 2025 are accepted.
Claim Objections
Claims 1, 6-9, 14 and 21-25 are objected to because of the following informalities:
Claims 1 and 16, first line: the term “hearing” should be corrected to –hearing function--.
Claims 1 and 16, second to the last line, claims 6-9 and 21-24: the term “hearing function” should be corrected to –the hearing function--.
Claims 1 and 16, second to the last line, claims 6-9, 14, 21-24, and claim 25 except for line 1: the term “intracranial pressure” should be corrected to –the intracranial pressure--.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-15 are directed to an “apparatus” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Claims 16-25 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1 and 16 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “analyze the auditory response to estimate at least one of hearing function or intracranial pressure of the subject”.
Claim 25 recites (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “calibrating a model for noninvasive assessment of intracranial pressure based on the paired intracranial pressures and auditory responses”.
In claims 1 and 16, the above recited step can be practically performed in the human mind, with the aid of a pen and paper. If a person were to examine, i.e., perform an observation or evaluation, either in a printout or an electronic format of the auditory response, or in an audio format, he/she would be able to identify, either based on his/her experience or by comparing to a reference, a baseline or a look up table, whether there is any abnormality and further based on the identification estimate at least one of the hearing function or the intracranial pressure associated with the subject. For example, if there is no auditory response, it may be reasonably estimate that the subject either has an impaired hearing function, or a high intracranial pressure such that the subject does not have sufficient consciousness to make a reasonable auditory response. There is nothing recited in the claim to suggest an undue level of complexity in how the hearing function or the intracranial pressure of the subject is estimated, or more specifically, how the auditory response is analyzed and used to estimate the hearing function or the intracranial pressure of the subject. Therefore, a person would be able to perform the analysis and the estimation mentally.
In claim 25, the above recited step can be practically performed in the human mind, with the aid of a pen and paper. First of all, there is no recitation in regard to what the model is like. Hence, under the broadest interpretation, a model may be as simple as a function that generates an output based on an input. Hence, to calibrate a model may be as simple as rescaling, normalizing, thresholding or setting a boundary, for any of which may be performed mentally or with a pen and paper. There is nothing recited in the claim to suggest an undue level of complexity in what the model is and how it is calibrated. Therefore, a person would be able to perform the calibration mentally.
Prong Two: Claims 1, 16 and 25 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, claims 1, 16 and 25 recite additional steps of (1) an ultrasound transducer, and transmitting an ultrasound wave pattern using the ultrasound transducer; a microphone, and measuring an auditory response using the microphone; and (2) a controller operatively coupled to the ultrasound transducer and the microphone and configured to perform the above steps in (1) and also perform the analysis.
Claim 25 recites further (3) a pressure transducer, and measuring an intracranial pressure using the pressure transducer; (4) a controller operatively coupled to the ultrasound transducer, the pressure transducer and the microphone.
The steps in (1)-(4) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
Further in regard to the steps (2) and (4), a claim that requires computer may still recite a mental process. MPEP 2106.04(a)(2).III.C.: “Performing a mental process on a generic computer, in a computer environment, or using a computer as a tool to perform the steps are considered a mental process”.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the outcome of the analysis is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 16 and 25 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, claims 1, 16 and 25 recite additional steps of (1) an ultrasound transducer, and transmitting an ultrasound wave pattern using the ultrasound transducer; a microphone, and measuring an auditory response using the microphone; and (2) a controller operatively coupled to the ultrasound transducer and the microphone and configured to perform the above steps in (1) and also perform the analysis. Claim 25 recites further (3) a pressure transducer, and measuring an intracranial pressure using the pressure transducer; (4) a controller operatively coupled to the ultrasound transducer, the pressure transducer and the microphone.
These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. Any conventional ultrasound transducer functions to transmit ultrasound waves. Any conventional microphone functions to measure an auditory response. For similar reasons set forth in Step 2A, Prong Two above, the additional elements do not provide an inventive concept under Step 2B.
Accordingly, these additional steps amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The dependent claims incorporate all the limitations of their respective independent claims. The following analysis focus on the limitations recited in the dependent claims to determine whether they merely recite further abstract idea, or whether or not they recite additional elements that may either amount to significantly more than the abstract idea in their respective independent claims, or may integrate the abstract idea in their respective independent claims to a practical application.
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons as stated in the analysis for their respective independent claims, hence are patent ineligible:
assessing the hearing function or the intracranial pressure further based on a model (claims 6-9, 21) – with a similar consideration for claim 25, since there is no recitation in regard to what the model is like. Under the broadest interpretation, a model may be as simple as a function that generates an output based on an input, and to access a model or to perform a step based on a model is considered a step that may be reasonably performed mentally or with a pen and paper.
analyzing the auditory response by comparing the auditory response to a database (claim 20) – performing a comparison may be reasonably done as a mental step or with a pen and paper.
assessing the hearing function or the intracranial pressure further based on additional parameters of the neural response and the one or more optical images (claims 7-9, 22, 23, 24) – since there is no recitation in regard to how the neural response and the one or more optical images are used for the assessment, these steps are considered being able to be performed reasonably as a mental step via an observation or evaluation.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons as stated in the analysis for their respective independent claims, hence are patent ineligible:
describing a further component of a sound generator and its function of producing a sound signal, and how the sound signal is introduced (claims 2, 17-19)
describing a further component of one or more electrodes and its function of acquiring neural response (claims 3, 23, 24)
describing a further component of an optical imaging device and its function of acquiring one or more optical images (claims 4, 5, 22, 24
describing further the auditory response (claim 12);
describing further components of a pressure transducer or a pressure modulator (claim 14)
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Based on the above consideration and analysis, claims 1-9, 12, 14 and 16-25 are patent ineligible, i.e., rejected under 35 U.S.C. 101.
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 1-25 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 pre-AIA the applicant regards as the invention.
Claims 1 line 4 and claim 16 line 5 recite “a microphone configured to measure an auditory response” and three lines down “transmit an ultrasound wave pattern using the ultrasound transducer, and measure an auditory response using the microphone. It is unclear whether the auditory response is from the subject to whose head or body the ultrasound transducer is configured to contact and whether the ultrasound wave pattern is transmitted to the subject. For examination purpose, it is interpreted such that the ultrasound wave pattern is transmitted to the subject, and the auditory response is of the same subject.
Claims 1 and 16 recite “a controller…configured to: transmit an ultrasound wave using the ultrasound transducer; and measure an auditory response using the microphone” that renders the scope of the claim indefinite. It is unclear whether the transmission and the measuring is performed by the transducer and the microphone, or by the controller. As the controller is merely a circuitry and has no functionality of transmitting the ultrasound wave pattern, it is interpreted such that the controller is configured to cause the ultrasound transducer to transmit the ultrasound wave pattern, and to cause the microphone to measure the auditory response.
Claim 9 in line 3 recites “the neural response” that lacks proper antecedent basis.
Claim 25 recites in the second line to the last “a model for noninvasive assessment…”. It is unclear whether it refers to the same as the identical term recited in line 1 of the claim. For examination purpose, they are interpreted to be the same.
Claim 25 recites “the paired intracranial pressures and auditory responses” that lacks proper antecedent basis. Note that the claim only recites singular auditory response and intracranial pressure being measured. Further it is unclear what auditory response and intracranial pressure are considered a paired.
Claim 25 is directed to a method for generating a model. Claim 25 recites limitations of using the apparatus to measure some parameters. Yet there is no recitation in regard to how the model is generated, but it goes ahead to calibrate the model. The scope of the claim hence is unclear.
Claim 25 lines 5-6 recite “a microphone configured to measure an auditory response, and a pressure transducer configured to measure intracranial pressure”. It is unclear whether the auditory response and the intracranial pressure is of the subject to whose head or body the ultrasound transducer is configured to contact. For examination purpose, it is interpreted such that the auditory response and the intracranial pressure is of the same subject.
Claim 25 recites in line 4 that an ultrasound transducer is configured to contact a head or a body of a subject, a microphone is configured to measure an auditory response [of the subject], and a pressure transducer is configured to measure intracranial pressure [of the subject] (see above for the underlined interpretation). It then recites in line 9 “transmitting, using the ultrasound transducer, an ultrasound wave pattern to a plurality of subjects; measuring, using the microphone, an auditory response from the plurality of subjects; and measuring, using the pressure transducer, an intracranial pressure from the plurality of subject, the intracranial pressure being paired to the auditory response”. These recitations render the scope of the claim indefinite. It is unclear if there are a plurality of subjects each wears an apparatus for each ultrasound transducer transmitting the ultrasound wave pattern to each subject, and each subject is measured with the auditory response and the intracranial pressure, which would be considered “paired” as they are from the same subject. For examination purpose, this claim is interpreted such that the ultrasound wave pattern is transmitted to the subject, and the auditory response and the intracranial pressure are measured for the same subject.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 14, 16-19 and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lyon et al., US 2020/0077906 A1, hereinafter Lyon.
Claims 1 and 16. Lyon teaches an apparatus for noninvasive assessment of at least one of hearing or intracranial pressure (Title: Method and system for monitoring brain function and intracranial pressure; 300, 100, 224; [0030]: brain monitoring device 100; FIG.1; [0043]: a system 300 incorporating device 100; FIG.3; [0049]: an intracranial pressure ((CP) monitor 224; FIG.6), comprising:
an ultrasound transducer configured to contact a head or a body of a subject ([0050]: monitor 224 may include a patient unit 602 and a base unit 604. Patient unit 602 may include a two-dimensional matrix array of ultrasound transducers 606 that are placed in contact with an eye 608 of a patient; and [0030]: FIG.1, brain monitoring device 100 may include a wearable platform – the goggles);
a microphone configured to measure an auditory response ([0030]: FIG.1, brain monitoring device 100 may include a wearable platform – the goggles – including, for example,…patient microphone 104); and
a controller operatively coupled to the ultrasound transducer and the microphone ([0043]: system 300 may include brain monitoring device 100…and operator interface 310…Operator interface 310 may include operator display 102, as well as other input and/or output components that may provide the capability for operator control of brain monitoring device 100; FIG.6: control circuitry 614 is coupled to the ultrasound transducer 606; and FIG.2: the subsystems of the brain monitoring device 100: 104 patient microphone and 224 ICP are coupled) and configured to:
transmit an ultrasound wave pattern using the ultrasound transducer ([0050]: each transducer in array 606 may be connected to interface circuitry 610, which may provide electrical signals to cause each transducer to emit an ultrasonic signal into eye 608, and may receive electrical signals from each transducer corresponding to the return or echo ultrasonic signal from eye 608),
measure an auditory response using the microphone ([0031]: responses may be measured by tracking eye movements with patient camera 108 or by the patient responding verbally to provocative stimuli (read the sentence on the screen aloud) as picked up by microphone 104), and
analyze the auditory response to estimate at least one of hearing function or intracranial pressure of the subject ([0053]: base unit 604 may include communication circuitry 616, which may communicate with communication circuitry 612 in patient unit 602, and processing circuitry 618, which may process the signal from patient unit 602 to compute an ICP result and other associated data).
Claims 2 and 17. Lyon further teaches
a sound generator, and wherein the controller is operatively coupled to the sound generator and configured to produce a sound signal using the sound generator ([0030]: patients are able to interact with the stimuli provided visually by patient screen 110 or auditory by speaker 106; and [0043]: operator interface 310 may include operator display 102, as well as other input and/or output components that may provide the capability for operator control of brain monitoring device 100) – the speaker is the sound generator as claimed.
Claims 3 and 23. Lyon further teaches
one or more electrodes operatively coupled to the controller and configured to be placed on the head of the subject to measure a neural response (FIG.2, electroencephalograph monitor (EEG) 222; and [0041]: EEG monitor 222 measures brain waves. While traditional EEG utilizes many electrodes for precisely evaluating brain waves for diagnosis of multiple conditions, the EEG monitor utilized in embodiments of the present systems and methods may be simplified, using fewer electrodes, to achieve the goal of detecting subclinical seizure activity) – in an EEG procedure for detecting seizures, the electrodes are placed on the scalp as a standard protocol, wherein
the controller is further configured to obtain a signal from the one or more electrodes indicative of the neural response of the subject ([0043]: operator interface 310 may include operator display 102, as well as other input and/or output components that may provide the capability for operator control of brain monitoring device 100).
Claims 4 and 22. Lyon further teaches
an optical imaging device (108 Patient camera) operatively coupled to the controller ([0030]: FIG.1, brain monitoring device 100 may include a wearable platform – the goggles – including, for example,…patient microphone 104, in-ear speaker 106, eye camera 108; and [0043]: system 300 may include brain monitoring device 100…and operator interface 310…Operator interface 310 may include operator display 102, as well as other input and/or output components that may provide the capability for operator control of brain monitoring device 100) and configured to
acquire one or more images of at least one of a first eardrum of the subject, a second eardrum of the subject, a first eyeball of the subject, or a second eyeball of the subject ([0031]: responses may be measured by tracking eye movements with patient camera 108…Patient camera 108 can detect pupillary constriction and dilation, helping to determine if the patient is able to focus on a displayed image on screen 110).
Claim 14. Lyon further teaches at least one of:
a pressure transducer configured to measure an intracranial pressure in the subject, or a pressure modulator configured to modulate an intracranial pressure in the subject ([0042]: ultrasound (US) (ICP) monitor 224 may be used to noninvasively measure the optic nerve sheath parameters in multiple planes; and [0050]: monitor 224 may include a patient unit 602 and a base unit 604. Patient unit 602 may include a two-dimensional matrix array of ultrasound transducers 606 that are placed in contact with an eye 608 of a patient).
Claim 18. Lyon further teaches that the sound signal introduces
acoustic stimulation to the subject ([0030]: at the highest levels of consciousness, patients are able to interact with the stimuli provided visually by patient screen or auditory by speaker 106) and
the ultrasound wave pattern introduces ultrasound stimulation to the subject ([0050]: each transducer in array 606 may be connected to interface circuitry 610, which may provide electrical signals to cause each transducer to emit an ultrasonic signal into eye 608).
Claim 19. Lyon further teaches that
the acoustic and ultrasound stimulation are introduced simultaneously to the subject ([0025]: embodiments of the present systems and method may provide the capability for cognitive monitoring during transport…Embodiments may provide broad monitoring functions…and may provide multi-modal sensors with telemedicine transmission of data…Components may include…an in-ear speaker to provide auditory commands…automatic lower cognitive function monitoring using one or more of a TCD ultrasound…and ICP measurements) – as all these sensing and monitoring are performed during transportation, they are considered being introduced simultaneously to the subject.
Claim 24. Lyon further teaches
one or more electrodes operatively coupled to the controller (FIG.2, electroencephalograph monitor (EEG) 222; and [0041]: EEG monitor 222 measures brain waves. While traditional EEG utilizes many electrodes for precisely evaluating brain waves for diagnosis of multiple conditions, the EEG monitor utilized in embodiments of the present systems and methods may be simplified, using fewer electrodes, to achieve the goal of detecting subclinical seizure activity) and
an optical imaging device operatively coupled to the controller ([0030]: FIG.1, brain monitoring device 100 may include a wearable platform – the goggles – including, for example,…patient microphone 104, in-ear speaker 106, eye camera 108; and [0043]: system 300 may include brain monitoring device 100…and operator interface 310…Operator interface 310 may include operator display 102, as well as other input and/or output components that may provide the capability for operator control of brain monitoring device 100), and wherein the method further comprises:
recording a neural response using the one or more electrode (FIG.2, electroencephalograph monitor (EEG) 222; and [0041]: EEG monitor 222 measures brain waves. While traditional EEG utilizes many electrodes for precisely evaluating brain waves for diagnosis of multiple conditions, the EEG monitor utilized in embodiments of the present systems and methods may be simplified, using fewer electrodes, to achieve the goal of detecting subclinical seizure activity);
recording one or more optical images of at least one of a first eardrum of the subject, a second eardrum of the subject, a first eyeball of the subject, or a second eyeball of the subject ([0031]: responses may be measured by tracking eye movements with patient camera 108…Patient camera 108 can detect pupillary constriction and dilation, helping to determine if the patient is able to focus on a displayed image on screen 110); and
analyzing at least one of the auditory response, the neural response, or the one or more optical images to estimate at least one of hearing function or intracranial pressure of the subject ([0053]: base unit 604 may include communication circuitry 616, which may communicate with communication circuitry 612 in patient unit 602, and processing circuitry 618, which may process the signal from patient unit 602 to compute an ICP result and other associated data; and Claim 16. The transcranial Doppler device, electroencephalograph monitor device, and optic nerve sheath diameter measurement device are only activated after the subject has been determined to be unconscious).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 6-9, 21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lyon in view of Firouzi et al., US 2021/0000358 A1, hereinafter Firouzi.
Claim 6. As applied to claim 1, Lyon teaches that the controller is configured to assess at least one of hearing function or intracranial pressure based on the auditory response ([0031], [0053]).
Lyon does not teach that the assessment is based on the auditory response and a model that relates at least one of hearing function or intracranial pressure to the auditory response.
However, in an analogous intracranial pressure monitoring field of endeavor, Firouzi teaches
assessing intracranial pressure based on auditory response and a model that relates at least one of hearing function or intracranial pressure to the auditory response ([0138]: The intracranial pressure is determined from the acquired data, e.g., as shown in FIG.10. For example, determining the intracranial pressure may include assessing changes in amplitude, bandwidth, and/or frequency of the standing waves. Additionally, or alternatively, the acquired data may be transmitted to an external device with a processor to determine the intracranial pressure. For example, the intracranial pressure may be determined at the external device using a statistical model (e.g., as described with respect to FIGS. 15-16 or another suitable statistical model; and [0160]:…These inputs are fed into a physical acoustics model…Both A and B are fed into a statistical model or a machine learning model).
When Lyon and Firouzi are combined, since Lyon teaches that the acquired data represent the intracranial pressure to the auditory response, the statistical model or the machine learning model of Firouzi that are taught to be built based on the acquired data would be “a model that relates intracranial pressure to the auditory response” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Lyon employ such a feature of “assessing intracranial pressure based on auditory response and a model that relates intracranial pressure to the auditory response” as taught in Firouzi for the well-acknowledged advantage of analyzing acquired signal data with a model for a more accurate prediction and a more effective assessment, in this case, of intracranial pressure assessment.
Claim 7. As applied to claim 1, Lyon teaches that the controller is configured to assess at least one of hearing function or intracranial pressure based on the auditory response ([0031], [0053]).
Lyon further teaches that the assessment is based on the neural response ([0042]: US ICP monitor 224 may be used to noninvasively measure the optical nerve sheath parameters in multiple planes. For example, the optical nerve sheath diameter (ONSd) increases with increasing intracranial pressure and is an outstanding noninvasive measure in the unconscious patient who has suffered a brain injury).
Lyon does not teach that the assessment is further based on a model that relates intracranial pressure to the auditory response and the neural response.
However, in an analogous intracranial pressure monitoring field of endeavor, Firouzi teaches
assessing intracranial pressure based on a model that relates acquired data ([0138]: The intracranial pressure is determined from the acquired data, e.g., as shown in FIG.10. For example, determining the intracranial pressure may include assessing changes in amplitude, bandwidth, and/or frequency of the standing waves. Additionally, or alternatively, the acquired data may be transmitted to an external device with a processor to determine the intracranial pressure. For example, the intracranial pressure may be determined at the external device using a statistical model (e.g., as described with respect to FIGS. 15-16 or another suitable statistical model); and [0160]:…These inputs are fed into a physical acoustics model…Both A and B are fed into a statistical model or a machine learning model).
When Lyon and Firouzi are combined, since Lyon teaches that the acquired data represent the intracranial pressure to the auditory response and the neural response, the statistical model or the machine learning model of Firouzi that are taught to be built based on the acquired data would be “a model that relates intracranial pressure to the auditory response and the neural response” as claimed; and the intracranial pressure is assessed based on “the auditory response, the neural response, and the model that relates intracranial pressure to the auditory response and the neural response” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Lyon employ such a feature of “assessing intracranial pressure based on a model that relates acquired data” as taught in Firouzi for the well-acknowledged advantage of analyzing acquired signal data with a model for a more accurate prediction and a more effective assessment, in this case, of intracranial pressure assessment.
Claim 8. As applied to claim 1, Lyon teaches that the controller is configured to assess at least one of hearing function or intracranial pressure based on the auditory response and the one or more images ([0031], [0053]).
Lyon further teaches that the assessment is further based on the one or more images ([0031]: responses may be measured by tracking eye movements with patient camera 108…Patient camera 108 can detect pupillary constriction and dilation, helping to determine if the patient is able to focus on a displayed image on screen 110; and Claim 16. The transcranial Doppler device, electroencephalograph monitor device, and optic nerve sheath diameter measurement device are only activated after the subject has been determined to be unconscious).
Lyon does not teach that the assessment is based on a model that relates intracranial pressure to the auditory response and the one or more images.
However, in an analogous intracranial pressure monitoring field of endeavor, Firouzi teaches
assessing intracranial pressure based on a model that relates acquired data ([0138]: The intracranial pressure is determined from the acquired data, e.g., as shown in FIG.10. For example, determining the intracranial pressure may include assessing changes in amplitude, bandwidth, and/or frequency of the standing waves. Additionally, or alternatively, the acquired data may be transmitted to an external device with a processor to determine the intracranial pressure. For example, the intracranial pressure may be determined at the external device using a statistical model (e.g., as described with respect to FIGS. 15-16 or another suitable statistical model; and [0160]:…These inputs are fed into a physical acoustics model…Both A and B are fed into a statistical model or a machine learning model).
When Lyon and Firouzi are combined, since Lyon teaches that the acquired data represent the intracranial pressure to the auditory response and one or more images, the statistical model or the machine learning model of Firouzi that are taught to be built based on the acquired data would be “a model that relates intracranial pressure to the auditory response and the one or more images” as claimed; and the intracranial pressure is assessed based on “the auditory response, the one or more images, and the model that relates intracranial pressure to the auditory response and the one or more images” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Lyon employ such a feature of “assessing intracranial pressure based on a model that relates acquired data” as taught in Firouzi for the well-acknowledged advantage of analyzing acquired signal data with a model for a more accurate prediction and a more effective assessment, in this case, of intracranial pressure assessment.
Claim 9. As applied to claim 1, Lyon teaches that the controller is configured to assess at least one of hearing function or intracranial pressure based on the auditory response ([0031], [0053]).
Lyon further teaches that the assessment is based on the neural response ([0042]: US ICP monitor 224 may be used to noninvasively measure the optical nerve sheath parameters in multiple planes. For example, the optical nerve sheath diameter (ONSd) increases with increasing intracranial pressure and is an outstanding noninvasive measure in the unconscious patient who has suffered a brain injury).
Lyon further teaches that the assessment is further based on the one or more images ([0031]: responses may be measured by tracking eye movements with patient camera 108…Patient camera 108 can detect pupillary constriction and dilation, helping to determine if the patient is able to focus on a displayed image on screen 110; and Claim 16. The transcranial Doppler device, electroencephalograph monitor device, and optic nerve sheath diameter measurement device are only activated after the subject has been determined to be unconscious).
Lyon does not teach that the assessment is based on assessing intracranial pressure based on a model that relates acquired data.
However, in an analogous intracranial pressure monitoring field of endeavor, Firouzi teaches
assessing intracranial pressure based on a model that relates acquired data ([0138]: The intracranial pressure is determined from the acquired data, e.g., as shown in FIG.10. For example, determining the intracranial pressure may include assessing changes in amplitude, bandwidth, and/or frequency of the standing waves. Additionally, or alternatively, the acquired data may be transmitted to an external device with a processor to determine the intracranial pressure. For example, the intracranial pressure may be determined at the external device using a statistical model (e.g., as described with respect to FIGS. 15-16 or another suitable statistical model; and [0160]:…These inputs are fed into a physical acoustics model…Both A and B are fed into a statistical model or a machine learning model).
When Lyon and Firouzi are combined, since Lyon teaches that the acquired data represent the intracranial pressure to the auditory response, the neural response, and one or more images, the statistical model or the machine learning model of Firouzi that are taught to be built based on the acquired data would be “a model that relates intracranial pressure to the auditory response, the neural response and the one or more images” as claimed; and the intracranial pressure is assessed based on “the auditory response, the neural response, the one or more images, and the model that relates intracranial pressure to the auditory response, the neural response, and the one or more images” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Lyon employ such a feature of “assessing intracranial pressure based on a model that relates acquired data” as taught in Firouzi for the well-acknowledged advantage of analyzing acquired signal data with a model for a more accurate prediction and a more effective assessment, in this case, of intracranial pressure assessment.
Claim 21. Lyon teaches all the limitation of claim 16.
Lyon does not teach the claimed features associated with the model.
However, in an analogous intracranial pressure monitoring field of endeavor, Firouzi teaches
accessing a model trained on at least one of paired intracranial pressure data and auditory response data or paired hearing function data and auditory response data ([0169]: FIG.13 shows an illustrative flow diagram 1300 for a process for ICP estimation…At step 1302, raw data is received from acoustic resonances in the skull at a selection of one or more frequencies…At step 1304, this training data is preprocessed for input into a statistical model…Using a model-based machine learning algorithm, these changes can be distinguished and quantified…At step 1306, the statistical model is trained on the preprocessed training data to predict intracranial pressure), and wherein
analyzing the auditory response to estimate at least one of hearing function or intracranial pressure of the subject comprises analyzing the auditory response based on the model ([0138]: The intracranial pressure is determined from the acquired data, e.g., as shown in FIG.10. For example, determining the intracranial pressure may include assessing changes in amplitude, bandwidth, and/or frequency of the standing waves. Additionally, or alternatively, the acquired data may be transmitted to an external device with a processor to determine the intracranial pressure. For example, the intracranial pressure may be determined at the external device using a statistical model (e.g., as described with respect to FIGS. 15-16 or another suitable statistical model); [0160]: FIG. 8 shows an overview of an illustrative algorithm 800 for determining the intracranial pressure across the brain, its distribution, presence of seizure, location of seizure site, or other indicators of brain functions or conditions…Nodes A and B represent the outputs of the physical model and the acquired data, which could be in several forms, including but not limited to the frequency response, impulse/transient response, or distribution of acoustic modes. Both A and B are fed into a statistical model or a machine learning model. The final output can be the intracranial pressure across the brain, its distribution, presence of seizure, location of seizure site, or other indicators of brain functions or conditions…FIG.9, including data acquisition, data preprocessing, building a model, training the model, evaluating the model, testing, and adjusting model parameters).
When Lyon and Firouzi are combined, since Lyon teaches that the acquired data represent the intracranial pressure data and the auditory response data, the statistical model or the machine learning model of Firouzi that are taught to be built based on the acquired data would be “a model that relates the paired intracranial pressure data and the auditory response data as claimed”.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Lyon employ such a feature of “accessing a model trained on at least one of paired intracranial pressure data and auditory response data, and wherein analyzing the auditory response to estimate at least one of hearing function or intracranial pressure of the subject comprises analyzing the auditory response based on the model” as taught in Firouzi for the well-acknowledged advantage of analyzing acquired signal data with a model for a more accurate prediction and a more effective assessment, in this case, of intracranial pressure assessment.
Claim 25. Lyon teaches a method for generating a model for noninvasive assessment of intracranial pressure (Title: Method and system for monitoring brain function and intracranial pressure), comprising:
providing an apparatus (300, 100, 224; [0030]: brain monitoring device 100; FIG.1; [0043]: a system 300 incorporating device 100; FIG.3; [0049]: an intracranial pressure ((CP) monitor 224; FIG.6)comprising:
an ultrasound transducer configured to contact a head or a body of a subject ([0050]: monitor 224 may include a patient unit 602 and a base unit 604. Patient unit 602 may include a two-dimensional matrix array of ultrasound transducers 606 that are placed in contact with an eye 608 of a patient; and [0030]: FIG.1, brain monitoring device 100 may include a wearable platform – the goggles),
a microphone configured to measure an auditory response ([0030]: FIG.1, brain monitoring device 100 may include a wearable platform – the goggles – including, for example,…patient microphone 104),
a controller operatively coupled to the ultrasound transducer, and the microphone ([0043]: system 300 may include brain monitoring device 100…and operator interface 310…Operator interface 310 may include operator display 102, as well as other input and/or output components that may provide the capability for operator control of brain monitoring device 100; FIG.6: control circuitry 614 is coupled to the ultrasound transducer 606; and FIG.2: the subsystems of the brain monitoring device 100: 104 patient microphone and 224 ICP are coupled);
transmitting, using the ultrasound transducer, an ultrasound wave pattern to a plurality of subjects ([0050]: each transducer in array 606 may be connected to interface circuitry 610, which may provide electrical signals to cause each transducer to emit an ultrasonic signal into eye 608, and may receive electrical signals from each transducer corresponding to the return or echo ultrasonic signal from eye 608);
measuring, using the microphone, an auditory response from the plurality of subjects ([0031]: responses may be measured by tracking eye movements with patient camera 108 or by the patient responding verbally to provocative stimuli (read the sentence on the screen aloud) as picked up by microphone 104), and
the intracranial pressure being paired to the auditory response ([0053]: base unit 604 may include communication circuitry 616, which may communicate with communication circuitry 612 in patient unit 602, and processing circuitry 618, which may process the signal from patient unit 602 to compute an ICP result and other associated data).
Lyon does not teach a pressure transducer configured to measure intracranial pressure, a controller operatively coupled to the pressure transducer; measuring, using the pressure transducer, an intracranial pressure from the plurality of subject; and calibrating a model for noninvasive assessment of intracranial pressure based on the paired intracranial pressures and auditory responses measured for the plurality of subject.
However, in an analogous intracranial pressure monitoring field of endeavor, Firouzi teaches
a pressure transducer configured to measure intracranial pressure, a controller operatively coupled to the pressure transducer; and measuring, using the pressure transducer, an intracranial pressure from the plurality of subject, the intracranial pressure being paired to the auditory response ([0137]: a device for a brain acoustic resonance intracranial pressure monitor transmits acoustic signals to the brain using one or more transducers. The transducers receives data acquired from the brain; and [0138]: the transcranial pressure is determined from the acquired data…Additionally or alternatively, the acquired data may be transmitted to an external device with a processor to determine the intracranial pressure).
Firouzi further teaches that the intracranial pressure is assessed based on a model ([0169]: FIG.13 shows an illustrative flow diagram 1300 for a process for ICP estimation…At step 1302, raw data is received from acoustic resonances in the skull at a selection of one or more frequencies…At step 1304, this training data is preprocessed for input into a statistical model…Using a model-based machine learning algorithm, these changes can be distinguished and quantified…At step 1306, the statistical model is trained on the preprocessed training data to predict intracranial pressure), and
the model is calibrated for noninvasive assessment of intracranial pressure based on the paired intracranial pressures and auditory responses measured for the plurality of subject (FIG.9: steps 900 often undertaken to construct and deploy such algorithms including data acquisition, data preprocessing, building a model, training the model, evaluating the model, testing and adjusting model parameters) – to adjust model parameters is to “calibrate the model” as claimed.
When Lyon and Firouzi are combined, since Lyon teaches that the acquired data represent the intracranial pressure data and the auditory response data, the statistical model or the machine learning model of Firouzi that are taught to be calibrated would be based on the acquired data that is “the paired intracranial pressure data and the auditory response data” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Lyon employ such a feature of “a pressure transducer configured to measure intracranial pressure, a controller operatively coupled to the pressure transducer; measuring, using the pressure transducer, an intracranial pressure from the plurality of subject; and calibrating a model for noninvasive assessment of intracranial pressure based on the acquired data” as taught in Firouzi for the well-acknowledged advantage of analyzing acquired signal data with a model for a more accurate prediction and a more effective assessment, in this case, of intracranial pressure assessment.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lyon in view of Meyerson et al., US 2001/0027335 A1, hereinafter Meyerson.
Claim 12. Lyon teaches all the limitations of claim 1.
Lyon does not teach that the auditory response comprises otoacoustic emissions, and wherein the otoacoustic emissions comprise distortion production otoacoustic emissions.
However, in an analogous intracranial pressure monitoring field of endeavor, Meyerson teaches that
the auditory response comprises otoacoustic emissions, and wherein the otoacoustic emissions comprise distortion production otoacoustic emissions ([0042]: it is an object of this invention to provide a continuous intracranial pressure monitoring system that is non-invasive and easily administered…by stimulating and interpreting predictable changes measured in the otoacoustic emission (OAE) signal (transient, or cubic distortion) of the patient).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the auditory response of Lyon employ such a feature of “comprising otoacoustic emissions, and wherein the otoacoustic emissions comprise distortion production otoacoustic emissions” as taught in Meyerson for the advantage of providing as one of the suitable measurements in a continuous monitoring of the ICP level that may be used individually or in conjunction with one another, as suggested in Meyerson, [0042].
Examiner’s Notes
Claims 5 and 20 are not rejected under prior arts.
The limitations recited in claim 5 in regard to the features of “assess the one or more images to characterize a vibration of at least one of the first eardrum of the subject, the second eardrum of the subject, the first eyeball of the subject, or the second eyeball of the subject", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
The limitations recited in claim 20 in regard to the features of “comparing the auditory response to a database that comprises previously measured auditory responses that correspond with directly measured intracranial pressure values obtained in a plurality of subjects", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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