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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 6, 2025 has been entered.
Response to Arguments
This Office Action is in response to the amendment filed on November 6, 2025. As directed by the amendment, Claims 1, 5-9, 11-15, 19, and 20 have been amended. Claims 1, 5-9, 11-15, 19, and 20 are pending in the instant application.
Regarding the Office Action mailed July 21, 2025:
The claims still invoke 35 USC 112(f). Therefore, the invocations are maintained.
Applicant’s arguments regarding the 35 USC 103 rejections 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. Examiner has applied additional prior art to address the claims. See 35 USC 103 rejections below for more details.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A hyperbaric oxygen therapy unit in Claim 1. The corresponding structure is merely a hyperbaric chamber capable of supplying pressurized oxygen as known by one of ordinary skill in the art (paragraph 0040).
A light therapy unit in Claim 1. The corresponding structure is a visible light or infrared light fixture capable of providing light at visible or infrared wavelengths and is adjustable (paragraph 0042).
A temperature regulation unit in Claim 1. The corresponding structure is a ventilation system capable of having cooling and heating features (paragraph 0043).
A remote mind-body synergy system in Claim 1. The corresponding structure is an algorithm working in conjunction with sensors and two-way communication components (paragraphs 0045, 0048, and 0049).
A light intensity management system in Claim 5. The corresponding structure is an algorithm for adjusting the lighting based on time of day (paragraph 0042).
A capturing unit in Claim 6. The corresponding structure is a high-definition camera (paragraph 0049).
One or more carbon dioxide discharge devices in Claim 7. The corresponding structure is an exhaust or vent or similar structure for removal of CO2 (paragraph 0050).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 states “processor is configured to receive data from one or more sensors, which continuously monitor the real-time physiological and psychological parameters of the user” (Lines 3-5). This statement fails to comply with the written description requirement because there is no support regarding only one sensor being capable of monitoring multiple parameters. (Note how the claim recites “one or more sensors” which only requires a minimum of one sensor.) In Claim 13, which is dependent on Claim 14, the claim describes the analysis of multiple physiological and psychological data and lists out a bunch of different types of parameters (Lines 9-13). The use of the claim limitation “including” positively claims all of the listed types of parameters. Claim 14 further defines the processor being capable of receiving all of the listed parameters with one sensor, which is not possible due to the complexity of multiple parameters in a single sensor. The instant disclosure describes these different types of parameters but lists them as merely examples by utilizing “such as” (paragraph 0023). There is nothing in the disclosure that describes one sensor being capable of monitoring all of the listed types of parameters. Therefore, there is sufficient doubt that Applicant was in possession of the claimed invention. Similar rejections are applied to Claim 20 (Lines 2-3).
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 14 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 states “data” and “the real-time physiological and psychological parameters” (Lines 3-4). This statement is indefinite because it is unclear if this is the same data mentioned earlier in Claim 13. It appears the applicant was trying to say they’re the same. However, it is possible the sensors are monitoring completely different data and parameters. Therefore, the number of data and parameters cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same as the ones mentioned in Claim 13. Similar rejections are applied to Claim 20 (Lines 2-3).
Claim 14 states “processor is configured to receive data from one or more sensors, which continuously monitor the real-time physiological and psychological parameters of the user” (Lines 3-5). This statement is indefinite because it is unclear how one sensor would be capable of monitoring all of the different types of parameters or data involved. It appears the applicant was trying to say there are multiple sensors for monitoring all of the parameters or data. However, the use of “one or more sensors” creates confusion regarding the number of sensors involved in monitoring all of the different types of parameters or data. Therefore, the number of sensors involved cannot be determined. For examination purposes, the claim limitation will be interpreted as there are multiple sensors that are involved that monitor all of the different types of parameters or data. Similar rejections are applied to Claim 20 (Lines 2-3).
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 13-15, 19, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an Abstract Idea without significantly more.
Claim 13 is directed to a machine and is within one of the four statutory categories [STEP 1]. The claim directed to an Abstract Idea and is a form of mental process as all the claim limitations are tied with collecting and processing information [STEP 2A, Prong One]. The judicial exception is not integrated into a practical application because the claim merely recites a computing device with a processor and memory that performs collection and analysis of data and then generates a treatment plan through the use of AI models. All of these steps being done by the computing device are intangible and are not put into a practical application since there are no additional structural components that are affected or modified by these processes. All of the steps involved can be performed as mental processes [STEP 2A, Prong Two]. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim merely recites a computing device and is silent about any additional structural elements. Even though the claim states a “remote mind-body synergy system integrated into a multifunctional hyperbaric oxygen device”, there are no additional structural components that further detail what the system and the device are. The collection and analysis of data and the optimization of treatment are all well-understood, routine, conventional activity in the evaluation and treatment of a patient. See MPEP 2106.05(d). Additionally, due to the lack of structural claim limitations regarding the device and system, the claim is not directed to a particular machine and the processes involved can be applied by a general purpose, conventional computer [STEP 2B]. See MPEP 2106.05(b).
Claim 14 does claim that the processor is configured to receive data from one or more sensors, but the sensors themselves are not positively claimed. Similar to Claim 13, the claim does not implement the steps into a practical application since the sensors are merely a form of collecting data. There are no additional elements that amount to significantly more than the judicial exception since the sensors are not positively claimed. Even if the sensors were positively claimed, they would be considered insignificant extra-solution activity that are merely a nominal or tangential addition to the claim. See MPEP 2106.05(g).
Claim 15 does claim a control system that is configured to adjust therapy settings within the device based on the feedback. However, similar to Claim 13, the claim does not implement the steps into a practical application because there are no structural details regarding the control system or the therapy settings. The control system could merely be performing another processing step of changing values in therapy settings. There are no additional elements that amount to significantly more than the judicial exception since there are no structural details regarding the control system or the therapy settings. The adjustment of therapy settings would be considered insignificant extra-solution activity that are merely a nominal or tangential addition to the claim. See MPEP 2106.05(g). There are no details into what the therapy settings are and what is structurally being adjusted.
Claim 19 is directed to a process and is within one of the four statutory categories [STEP 1]. Similar to Claim 13, the claim directed to an Abstract Idea and is a form of mental process as all the claim limitations are tied with collecting and processing information [STEP 2A, Prong One]. The judicial exception is not integrated into a practical application because the claim merely recites a processor that performs collection and analysis of data and then generates a treatment plan through the use of AI models. All of these steps being done by the processor are intangible and are not put into a practical application since there are no additional structural components that are affected or modified by these processes. All of the steps involved can be performed as mental processes [STEP 2A, Prong Two]. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim merely recites a processor and is silent about any additional structural elements. Even though the claim states a “remote mind-body synergy system integrated into a multi-functional hyperbaric oxygen device”, there are no additional structural components that further detail what the system and the device are. The collection and analysis of data and the optimization of treatment are all well-understood, routine, conventional activity in the evaluation and treatment of a patient. See MPEP 2106.05(d). Additionally, due to the lack of structural claim limitations regarding the device and system, the claim is not directed to a particular machine and the processes involved can be applied by a general purpose, conventional computer [STEP 2B]. See MPEP 2106.05(b).
Similar to Claim 14, Claim 20 does claim that the processor is configured to receive data from one or more sensors, but the sensors themselves are not positively claimed. The claim does not implement the steps into a practical application since the sensors are merely a form of collecting data. There are no additional elements that amount to significantly more than the judicial exception since the sensors are not positively claimed. Even if the sensors were positively claimed, they would be considered insignificant extra-solution activity that are merely a nominal or tangential addition to the claim. See MPEP 2106.05(g).
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.
Claims 13-15, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Preminger et al. (US 2022/0395216 A1) in view of Assouad (US 2021/0244365 A1).
Regarding Claim 13, Preminger discloses a remote mind-body synergy system integrated into a multifunctional hyperbaric oxygen device (apparatus of Fig 1; system includes hyperbaric chamber 102, paragraph 0068), comprising: a computing device (112, Fig 1) having a processor and a memory to store one or more instructions executable by said processor (control system 112 can provide and operate the cognitive training assignments for each subject, as well as collect data from the subject and, at times, also analyze the data received from the subject in order to tailor the cognitive training task to be carried out by the subject, paragraph 0069; operating cognitive training assignments and collecting data implies the presence of a memory), wherein said processor is configured to collect and analyze real-time physiological data of a user in the multi-functional hyperbaric oxygen device (system may comprise at least one monitoring unit for monitoring at least one physical parameter of the subject, paragraph 0058), including heart rate, blood oxygen levels (heart rate, oxygen saturation level, paragraph 0058); assess and analyze psychological data of the user, including cognitive performance (each station 104 associated with at least one means of cognitive training 106, permitting subject to carry out at least one cognitive training, paragraph 0069); transmit the collected physiological and psychological data for analysis (monitored physical parameters may, by some embodiments, be used to determine (at least partially) the conditions in one or more subsequent treatment cycles, paragraph 0058; control system 112 can provide and operate the cognitive training assignments for each subject, as well as collect data from the subject and, at times, also analyze the data received from the subject in order to tailor the cognitive training task to be carried out by the subject, paragraph 0069), receive feedback and generate a personalized treatment plan for the user (control system 112 can provide and operate the cognitive training assignments for each subject, as well as collect data from the subject and, at times, also analyze the data received from the subject in order to tailor the cognitive training task to be carried out by the subject, paragraph 0069). Preminger also discloses one or more communication means within the chamber, allowing the treated subject and an operator residing outside the chamber to communicate with one another during the treatment session (paragraph 0060).
Preminger fails to disclose wherein said computing device is in communication with a server via a network; physiological data including respiration rate and body temperature; psychological data including stress levels and emotional state; transmit the collected physiological and psychological data to the server for analysis by a healthcare specialist; thereby enabling the healthcare specialist to provide feedback; using one or more artificial intelligence (Al)-based models to optimize therapeutic outcomes.
However, Assouad, of the same field of endeavor and reasonably pertinent to the problem of collecting and analyzing healthcare data, teaches a health monitoring system (Abstract) applicable to hyperbaric therapy (paragraph 0137) including a computing device is in communication with a server via a network (optional tracking and feedback may be provided by a remote server system, paragraph 0127); physiological data including respiration rate and body temperature (health-related profile comprises a combination of at least two of a designated body temperature threshold, a respiration rate or variation profile, paragraph 0035; sensor amenable to suitable body temperature, monitor critical health-related parameters such as body temperature, spectroscopic respiratory system monitoring including respiratory rate, paragraph 0095); psychological data including stress levels and emotional state (monitoring systems and methods described herein may further be used to derive a cognition level or index of the user at different levels of blood oxygenation, cognition level may include characterizations of user fatigue, stress, confusion, paragraph 0110; system 1100 may be used for stress detection and assessment, stress in a user or patient impacts physiological parameters such as pulse, respiration, and blood flow rate, paragraph 0217); transmit the collected physiological and psychological data to the server for analysis by a healthcare specialist (optional tracking and feedback may be provided by a remote server system, paragraph 0127; an integrated instrumented forehead skin patch with a wirelessly enabled mobile or portable device for local health tracking and/or data transmission to a remote health-monitoring server, database, center or clinic, for example, data can be wirelessly, or less conveniently so, via wired connection, relayed to a local or remote user and/or monitoring interface for monitoring, historical tracking, trend tracking, population modelling and/or forecasting, medical intervention and/or planning (e.g. at the local, regional, provincial, state, federal, national, international and/or global level), alerting, and/or further processing, paragraph 0098); thereby enabling the healthcare specialist to provide feedback (optionally use this data to update, refine or optimize benchmark profiles (218) can be relayed to/exchanged with the user's local device/system, and also serve to globally track health risks, conditions, improvements, etc. (220) and ultimately serve to update treatment/therapeutic protocols (222), paragraph 0127; Risk or condition escalation may also be used to locally induce or recommend adjustment of a treatment or therapeutic protocol (222), as the case may be, so to dynamically monitor an impact thereof on the user's condition/wellbeing, paragraph 0125); using one or more artificial intelligence (Al)-based models to optimize therapeutic outcomes (artificial-intelligence-based system to provide an improved monitoring capabilities of the user's oxygen levels and related risks, paragraph 0124; Data acquired from steps 1003 to 1007 is sent to a central processing unit (i.e. digital processing unit 106 for example) to be analyzed and compared to preset benchmark profiles at step 1008, step 1008 may be performed using machine-learning techniques such as deep learning techniques or similar, paragraph 0164) since servers are a known way to communicate data, since the various parameters are critical in monitoring the patient’s health and well-being (paragraph 0095), since it is known to allow feedback to a patient via a healthcare provider to monitor and modify treatment (paragraph 0127) and since the use of artificial intelligence or machine learning is a known technique to improve analysis and therapeutic outcomes (paragraph 0164).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to relay the data to servers, monitor the additional parameters on the patient, provide the data to a healthcare provider and receive feedback, and utilize AI or machine learning, as taught by Assouad, since servers are a known way to communicate data, since the various parameters are critical in monitoring the patient’s health and well-being (Assouad: paragraph 0095), since it is known to allow feedback to a patient via a healthcare provider to monitor and modify treatment (Assouad: paragraph 0127) and since the use of artificial intelligence or machine learning is a known technique to improve analysis and therapeutic outcomes (Assouad: paragraph 0164). These modifications are obvious as the modifications would merely be improving the communication processes, the number of parameters monitored, and the way the data is analyzed. It is noted that Applicant has not provided any additional structural features in the claim besides the computing device and has not positively claimed the multifunctional hyperbaric oxygen device.
Regarding Claim 14, Preminger-Assouad combination teaches said processor is configured to receive data from one or more sensors, which continuously monitor the real-time physiological and psychological parameters of the user, thereby enabling the remote mind-body synergy system to analyze and generate health reports (Preminger: system may comprise at least one monitoring unit for monitoring at least one physical parameter of the subject, paragraph 0058; Assouad: an integrated sensor that can be operated from skin contact on or near the patient or user's head (e.g. on the skin of the forehead), or in other body skin locations amenable to suitable body temperature and spectroscopic probing, paragraph 0095; additional sensors may also be used in parallel or integrated with the epidermal patch 104, paragraph 0117).
Regarding Claim 15, Preminger-Assouad combination teaches said processor of the remote mind-body synergy system is in communication with a control system, which is configured to adjust therapy settings within the multi-functional hyperbaric oxygen device based on the feedback provided by the healthcare specialist, thereby optimizing therapeutic experience for chronic disease recovery, psychological health improvement, and overall health management of the user (Preminger: 108, Fig 1; controllable oxygen source 108, thus permitting control of the oxygen level, duration of exposure, oxygen exposure profile/regimen, etc. for each of the stations 104, either collectively or independently of one another, paragraph 0068; Assouad: risk or condition escalation may also be used to locally induce or recommend adjustment of a treatment or therapeutic protocol (222), as the case may be, so to dynamically monitor an impact thereof on the user's condition/wellbeing, paragraph 0125).
Regarding Claim 19, Preminger discloses a method of operating a remote mind-body synergy system integrated into a multi-functional hyperbaric oxygen device (apparatus of Fig 1; system includes hyperbaric chamber 102, paragraph 0068), comprising: collecting and analyzing, by a processor (112, Fig 1; control system 112 can provide and operate the cognitive training assignments for each subject, as well as collect data from the subject and, at times, also analyze the data received from the subject in order to tailor the cognitive training task to be carried out by the subject, paragraph 0069) of the remote mind-body synergy system, real-time physiological data of a user in the multi-functional hyperbaric oxygen device (system may comprise at least one monitoring unit for monitoring at least one physical parameter of the subject, paragraph 0058), including heart rate, blood oxygen levels, (heart rate, oxygen saturation level, paragraph 0058); assessing and analyzing, by the processor, psychological data of the user, including cognitive performance (each station 104 associated with at least one means of cognitive training 106, permitting subject to carry out at least one cognitive training, paragraph 0069); transmitting, by the processor, the collected physiological and psychological data (monitored physical parameters may, by some embodiments, be used to determine (at least partially) the conditions in one or more subsequent treatment cycles, paragraph 0058; control system 112 can provide and operate the cognitive training assignments for each subject, as well as collect data from the subject and, at times, also analyze the data received from the subject in order to tailor the cognitive training task to be carried out by the subject, paragraph 0069); and receiving, by the processor, feedback and generating a personalized treatment plan for the user (control system 112 can provide and operate the cognitive training assignments for each subject, as well as collect data from the subject and, at times, also analyze the data received from the subject in order to tailor the cognitive training task to be carried out by the subject, paragraph 0069).
Preminger fails to disclose physiological data including respiration rate, and body temperature; psychological data including stress levels and emotional state; transmitting, by the processor, the collected physiological and psychological data to a healthcare specialist for feedback; using one or more artificial intelligence (Al)-based models to optimize therapeutic outcomes.
However, Assouad, of the same field of endeavor and reasonably pertinent to the problem of collecting and analyzing healthcare data, teaches a health monitoring system (Abstract) applicable to hyperbaric therapy (paragraph 0137) including physiological data including respiration rate, and body temperature (health-related profile comprises a combination of at least two of a designated body temperature threshold, a respiration rate or variation profile, paragraph 0035; sensor amenable to suitable body temperature, monitor critical health-related parameters such as body temperature, spectroscopic respiratory system monitoring including respiratory rate, paragraph 0095); psychological data including stress levels and emotional state (monitoring systems and methods described herein may further be used to derive a cognition level or index of the user at different levels of blood oxygenation, cognition level may include characterizations of user fatigue, stress, confusion, paragraph 0110; system 1100 may be used for stress detection and assessment, stress in a user or patient impacts physiological parameters such as pulse, respiration, and blood flow rate, paragraph 0217); transmitting, by the processor, the collected physiological and psychological data to a healthcare specialist for feedback (optional tracking and feedback may be provided by a remote server system, paragraph 0127; an integrated instrumented forehead skin patch with a wirelessly enabled mobile or portable device for local health tracking and/or data transmission to a remote health-monitoring server, database, center or clinic, for example, data can be wirelessly, or less conveniently so, via wired connection, relayed to a local or remote user and/or monitoring interface for monitoring, historical tracking, trend tracking, population modelling and/or forecasting, medical intervention and/or planning (e.g. at the local, regional, provincial, state, federal, national, international and/or global level), alerting, and/or further processing, paragraph 0098); thereby enabling the healthcare specialist to provide feedback (optionally use this data to update, refine or optimize benchmark profiles (218) can be relayed to/exchanged with the user's local device/system, and also serve to globally track health risks, conditions, improvements, etc. (220) and ultimately serve to update treatment/therapeutic protocols (222), paragraph 0127; Risk or condition escalation may also be used to locally induce or recommend adjustment of a treatment or therapeutic protocol (222), as the case may be, so to dynamically monitor an impact thereof on the user's condition/wellbeing, paragraph 0125); using one or more artificial intelligence (Al)-based models to optimize therapeutic outcomes (artificial-intelligence-based system to provide an improved monitoring capabilities of the user's oxygen levels and related risks, paragraph 0124; Data acquired from steps 1003 to 1007 is sent to a central processing unit (i.e. digital processing unit 106 for example) to be analyzed and compared to preset benchmark profiles at step 1008, step 1008 may be performed using machine-learning techniques such as deep learning techniques or similar, paragraph 0164) since the various parameters are critical in monitoring the patient’s health and well-being (paragraph 0095), since it is known to allow feedback to a patient via a healthcare provider to monitor and modify treatment (paragraph 0127) and since the use of artificial intelligence or machine learning is a known technique to improve analysis and therapeutic outcomes (paragraph 0164).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor the additional parameters on the patient, provide the data to a healthcare provider and receive feedback, and utilize AI or machine learning, as taught by Assouad, since the various parameters are critical in monitoring the patient’s health and well-being (Assouad: paragraph 0095), since it is known to allow feedback to a patient via a healthcare provider to monitor and modify treatment (Assouad: paragraph 0127) and since the use of artificial intelligence or machine learning is a known technique to improve analysis and therapeutic outcomes (Assouad: paragraph 0164). These modifications are obvious as the modifications would merely be improving the communication processes, the number of parameters monitored, and the way the data is analyzed. It is noted that Applicant has not provided any additional structural features regarding the multi-functional hyperbaric oxygen device.
Regarding Claim 20, Preminger-Assouad combination teaches the processor is configured to receive data from one or more sensors, which continuously monitor the real-time physiological and psychological parameters of the user, thereby enabling the remote mind-body synergy system to analyze and generate health reports (Preminger: system may comprise at least one monitoring unit for monitoring at least one physical parameter of the subject, paragraph 0058; Assouad: an integrated sensor that can be operated from skin contact on or near the patient or user's head (e.g. on the skin of the forehead), or in other body skin locations amenable to suitable body temperature and spectroscopic probing, paragraph 0095; additional sensors may also be used in parallel or integrated with the epidermal patch 104, paragraph 0117).
Allowable Subject Matter
Claims 1, 5-9, 11, and 12 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 discusses a multi-functional hyperbaric oxygen device that has multiple components, including a hyperbaric oxygen therapy unit positioned within a treatment chamber, an oxygen management system that dynamically adjust oxygen levels and switches to low-concentration modes after predefined durations, an air circulation mode for emergency situations, a light therapy unit that emits lights at predetermined wavelengths and synchronizes with the circadian cycle, a temperature regulation unit, and a remote mind-body synergy system that has sensors for monitoring physiological and psychological parameters of the user.
Preminger et al. (US 2022/0395216 A1) discusses a system and method for improving cognitive performance under hyperbaric conditions. Regarding Claim 1, Preminger does measure both physiological and psychological parameters of the user but does not have all of the claimed features involved in the instant invention. The instant invention has various oxygen and air circulation modes as well as light and temperature features that are not ordinarily found in a hyperbaric chamber. All of these features are found integrated or situated within the treatment chamber of the instant invention. Preminger merely discusses a simpler hyperbaric chamber with the capability to test cognitive performance. Adding these additional features and modes would require drastic modifications to Preminger and drastic structural integration into the device. Therefore, Preminger does not disclose Claim 1.
Claims 5-9, 11, and 12 contain allowable subject matter due to their dependency on Claim 1.
Conclusion
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/BRIAN T KHONG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785