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 .
Response to Arguments
Rejection Under 112
Applicant's arguments filed 06/09/2026 have been fully considered. Applicant argues that the amendments resolves the issue and the rejection should be withdrawn. In response to the amendments, the rejection is withdrawn.
Rejection Under 101
Applicant's arguments filed 06/09/2026 have been fully considered.
Applicant argues that the rejection oversimplifies the claims and fails to consider the claimed invention as a whole.
In response to Applicant’s argument, the entire claim is reproduced in the rejection and therefore cannot be oversimplified. The underlined limitations are understood to be the abstract idea when the entire claim was analyzed as a whole during the Step 2A Prong One analysis. See below for further clarification.
Applicant argues that the claims address a technological problem arising from the operation and coordination of PBM treatment systems and provide a solution implemented through specialized device interaction and distributed computing infrastructure.
In response to Applicant’s argument, as discussed in the rejection below the additional elements (bolded below) amount to nothing more than merely instructions to apply an exception and adding insignificant extra-solution activity to the abstract idea. For example, the computer components (i.e., server, processor, wellness database, etc.,) are recited at a high level of generality and are used for their intended purposes. Thus, the claims do not recite a technical solution.
Applicant argues that the claims are characterized at a level of abstraction that is disconnected from the actual claim language and disclosure. The claims don’t just recite treatment recommendations but also recite PBM devices, software clients, servers, databases, distributed treatment management infrastructure. The specification repeatedly describes a technical ecosystem with these recited limitations that are integral parts of the system. The claims therefore integrate the abstract idea into a practical application.
In response to Applicant’s argument, the entire claim is reproduced in the rejection and therefore cannot be disconnected from the claim language and disclosure. The computer components are considered additional elements, which are recited at a high level of generality. Although claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 26 USPQ2d 1057 (CA FC 1993). The additional elements amount to nothing more than merely instructions to apply an exception and adding insignificant extra-solution activity to the abstract idea. Therefore, the claims do not integrate the abstract idea into a practical application.
Applicant argues that the claims do not recite a generic computer used as a tool. Rather, it recites a specific arrangement of components that cooperate to perform functions not traditionally performed by generic computing systems. The claim recites PBM devices configured to collect wellness information, software clients, server-side processing, wellness databases, distributed ledger functionality.
In response to Applicant’s argument, as discussed in the rejection below the additional elements (bolded below) amount to nothing more than merely instructions to apply an exception and adding insignificant extra-solution activity to the abstract idea. For example, the computer components (i.e., server, processor, wellness database, etc.,) are recited at a high level of generality and are used for their intended purposes.
Applicant argues that the invention and the abstract characterization is distinct and illustrated by the references relied upon in elsewhere in the rejection. Based on the distinctions with Wright, the invention therefore improves technological operation of PBM treatment systems rather than merely generating information for review. Based on the distinctions with Williams, the claims describe a specific technological implementation that improves operations. Therefore, the claims recite a non-conventional arrangement of components operating together to achieve results. The specification addresses the technical problem and further recognizes details about the variables recited in the claims.
In response to Applicant’s argument, the additional elements recite merely instructions to apply an exception and adding insignificant extra-solution activity to the abstract idea. Although claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 26 USPQ2d 1057 (CA FC 1993). For example, the computer components (i.e., server, processor, wellness database, etc.,) are recited at a high level of generality and are used for their intended purposes. Any recited improvement would be to the abstract idea.
Applicant argues that analogous to Enfish and McRo, the claims recite a technological improvement to the functioning of the PBM treatment system.
In response to Applicant’s argument, the claims are directed to a personalized treatment recommendation and merely using generically recited PBM devices that are already existing does not amount to an improvement. The devices are merely used to carry out the abstract idea, since they are a known tool and are being used for the intended purpose. Any recited improvement is to the abstract idea.
Applicant argues that the claims now recite administering treatment to a plurality of users and no longer recites merely generating recommendations for human review. The claims are directed to technological improvement.
In response to Applicant’s argument, the claims do not actively recite administering treatment but rather storing treatment outcome information associated with treatments administered. There are no other actively recited steps directed to administering treatment. Additionally, the specificity needed to be considered a particular treatment appears to be lacking. See MPEP 2106.04(d)(2).
Rejection Under 103
Applicant's arguments filed 06/09/2026 have been fully considered.
Applicant argues that the rejection uses impermissible hindsight reconstruction to reject the claims.
In response to applicant’s argument, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Support for each modification is provided below. For example, see page 14 for one such explanation to support the modification of the references.
Applicant argues that the cited references fail to teach or suggest the amended claim 1. Examiner does not identify where the newly added claim limitations are taught or suggested.
In response to applicant’s argument, the argument appears to be directed to the amendment and is therefore moot. See the updated rejection for further clarification.
Applicant argues that newly added claim 20 further distinguishes the invention from the prior art and the cited references fails to teach or suggest the functionality recited.
In response to applicant’s argument, the argument appears to be directed to the amendment and is therefore moot. See the updated rejection for further clarification.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1-20 are drawn to a system, which is within the four statutory categories (i.e. apparatus).
Step 2A of the Alice/Mayo Test - Prong One
The independent claim recites an abstract idea. For example, claim 1 recites:
A cloud-based wellness system, comprising:
a wellness database;
a plurality of photobiomodulation (PBM) devices, each device associated with one of a plurality of users and adapted for communication with other PBM devices;
a distributed ledger system containing records of wellness data and treatment regimens, where each record is cryptographically secured, and wherein any modification is time-stamped and appended to the ledger;
a server, equipped with a software client to facilitate communication between PBM devices and to record wellness data and treatment regimens to the distributed ledger system; and
at least one processor that operates on the wellness database to generate personalized treatment recommendations for each of the plurality of users, wherein said recommendations are recorded onto the distributed ledger system;
wherein the wellness database further stores treatment outcome information associated with photobiomodulation treatments administered to a plurality of users;
wherein the artificial intelligence engine is configured to analyze the treatment outcome information to identify correlations between treatment parameters and treatment outcomes;
wherein the artificial intelligence engine is configured to generate a personalized photobiomodulation treatment recommendation for a user based at least in part upon treatment outcome information associated with one or more other users; and
wherein the personalized photobiomodulation treatment recommendation comprises one or more photobiomodulation treatment parameters selected from the group consisting of wavelength, intensity, treatment duration, treatment frequency, pulse frequency, duty cycle, and treatment location.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the personal behavior or interactions, but for the recitation of generic computer components. For example, but for the cloud-based system, PBM devices, distributed ledger system, server, software client, processor, wellness database, artificial intelligence engine, the limitations in the context of this claim encompass provide a personalized treatment recommendation for users. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-20 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 1 recites:
A cloud-based wellness system, comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a wellness database; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a plurality of photobiomodulation (PBM) devices, each device associated with one of a plurality of users and adapted for communication with other PBM devices; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a distributed ledger system containing records of wellness data and treatment regimens, where each record is cryptographically secured, and wherein any modification is time-stamped and appended to the ledger; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a server, equipped with a software client to facilitate communication between PBM devices and to record wellness data and treatment regimens to the distributed ledger system; and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
at least one processor that operates on the wellness database (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) to generate personalized treatment recommendations for each of the plurality of users, wherein said recommendations are recorded onto the distributed ledger system; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
wherein the wellness database further stores treatment outcome information associated with photobiomodulation treatments administered to a plurality of users; (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g)) and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
wherein the artificial intelligence engine is configured to (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) analyze the treatment outcome information to identify correlations between treatment parameters and treatment outcomes;
wherein the artificial intelligence engine is configured to (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) generate a personalized photobiomodulation treatment recommendation for a user based at least in part upon treatment outcome information associated with one or more other users; and
wherein the personalized photobiomodulation treatment recommendation comprises one or more photobiomodulation treatment parameters selected from the group consisting of wavelength, intensity, treatment duration, treatment frequency, pulse frequency, duty cycle, and treatment location.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the cloud-based system, PBM devices, distributed ledger system, server, software client, processor, wellness database, artificial intelligence engine, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0029], [0045], [0047], [0050], [0052], [00244]-[00247], [0266], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of storing treatment outcome information amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-20 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 2-20 recite additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the cloud-based system, PBM devices, distributed ledger system, server, software client, processor, wellness database, artificial intelligence engine, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0029], [0045], [0047], [0050], [0052], [00244]-[00247], [0266], see also Steingold et al. (WO 2022/197937) and Zhang (US 2019/0083809) which describes PBM devices); using the cloud-based system, distributed ledger system, server, software client, processor, wellness database, artificial intelligence engine, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. The following represent examples that courts have identified as insignificant extrasolution activities (e.g. see MPEP 2106.05(g)): storing treatment outcome information, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
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 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.
Claim 1-10, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Steingold et al. (WO 2022/197937) in view of Wright et al. (US 2020/0273579), Tran et al. (US 2019/0361917), and Zhang (US 2019/0083809).
Regarding claim 1, Steingold discloses a cloud-based wellness system, comprising:
a plurality of photobiomodulation (PBM) devices, each device associated with one of a plurality of users and adapted for communication with other PBM devices; ([0008] Transcranial photobiomodulation (“tPBM”) of the brain with near infrared and red light has been shown to be beneficial for treating various psychiatric and neurological conditions such as anxiety, stroke and traumatic brain injury. [0012] Preferred embodiments provide devices and methods in which a head wearable device is configured to be worn by a subject that is operated to deliver illuminating wavelengths of light with sufficient energy that are absorbed by a region of brain tissue during a therapeutic period. Transcranial delivery of illuminating light can be performed with a plurality of light emitting devices mounted to the head wearable device that can also preferably include control and processing circuitry [0015] A computing device such as a tablet or laptop computer can be used to control diagnostic and therapeutic operations of the head worn device and other devices used in conjunction with a therapeutic session. [0062] The wearable device 50 may be paired with a user device (e.g., smartphone, smartwatch), which may provide instructions that may determine a frequency of transmitted light, the type of light (e.g., red light or infrared light), the meditations, and/or the linguistic inputs [0066] In some embodiments, the photobiomodulation device 110 can transmit and/or receive data from the computing device 150)
storage containing records of wellness data and treatment regimens, ([00157] A record of the therapeutic session is than communicated 910 for storage and further analysis. [00193] Once the user engages in the treatment, the SQD 3012 module records data on the effect of the treatment, and the PPM 3014 assesses the effectiveness of the treatment, recording all the activities back into the UPM 3002)
a server, equipped with a software client to facilitate communication between PBM devices and ([0015] A computing device such as a tablet or laptop computer can be used to control diagnostic and therapeutic operations of the head worn device and other devices used in conjunction with a therapeutic session. Such computing devices can store and manage patient data and generate electronic health or medical records for storage and further use. The computing device can be programmed with software modules…. The system can include a networked server to enable communication with remote devices [0062] The wearable device 50 may be paired with a user device (e.g., smartphone, smartwatch), which may provide instructions that may determine a frequency of transmitted light, the type of light (e.g., red light or infrared light), the meditations, and/or the linguistic inputs)
to record wellness data and treatment regimens ([00157] A record of the therapeutic session is than communicated 910 for storage and further analysis. [00193] Once the user engages in the treatment, the SQD 3012 module records data on the effect of the treatment, and the PPM 3014 assesses the effectiveness of the treatment, recording all the activities back into the UPM 3002)
at least one processor that operates to generate personalized treatment recommendations for each of the plurality of users, ([00146] In an alternative embodiment, the parameters can be set algorithmically or automatedly… the processor 155 of the remote computing device 150 can analyze and process the patient data [00175] The Reference Population Module (RPM) 3016 is the database containing all user profiles created within the UPM and is used as a calibration and testing sample for the Machine Learning Module 3018. [00176] The neuro-developmental assessment module (NDA) 3006 uses the user profile together with questionnaire data to assess the baseline and continuous performance of the child along attachment, playing, communication and language, and other behavioral factors using a range of metrics and scores the child's current state for each of the measures. As treatments are administered, the NDA scoring is updated and resulting recommendations modified. The NDA assessment together with the UPM data feed into the Personalized Treatment Module (PTM) [00177] The Personalized Treatment Module (PTM) 3004 leverages the cluster-treatment mapping data from the Machine Learning Module 3018 to create personalized plans for the Neuromodulation Treatment Module (NMT) 3008 and the Cognitive Programming Module (CPM) 3010. This includes physical device treatment duration, intensity, and frequency as well as specific cognitive treatment activity portfolios to be administered to the child)
wherein said recommendations are recorded ([00157] A record of the therapeutic session is than communicated 910 for storage and further analysis. [00193] Once the user engages in the treatment, the SQD 3012 module records data on the effect of the treatment, and the PPM 3014 assesses the effectiveness of the treatment, recording all the activities back into the UPM 3002)
wherein the artificial intelligence engine is configured to generate a personalized photobiomodulation treatment recommendation for a user based at least in part upon treatment outcome information associated with one or more other users; and (Steingold [0054] FIG. 32 is a block diagram for the machine learning model used in the machine learning module (MLM) to create personalized treatment clusters based on reference population data)
Steingold does not appear to teach the following however, Wright teaches it is old and well known in the art of data processing to:
a distributed ledger system; record data onto a distributed ledger system (Wright [0067] the systems described herein can be configured to allow importation of data from one or more external databases, including, for example, electronic health records (EHR) and/or blockchain databases. As used herein, blockchain database may refer to any distributed ledger database that is spread across several nodes or computing devices, wherein each node may copy and store an identical duplicate of the ledger, and wherein each node of a network may update itself independently)
where each record is cryptographically secured (Wright [0015] Some embodiments herein relate to a system, wherein the one or more hardware computer processors is further configured to execute the plurality of computer executable instructions in order to cause the system to generate a unique activation code that allows a patient to access the dynamic patient health reporting interface {unique activation code construed as cryptographic method}).
wherein any modification is appended to the ledger; (Wright [0102] the user can modify and/or approve treatment recommendations through, for example, an approval interface. In some embodiments, the approved and/or modified one or more reports can be stored in one or more report databases 626 and/or the healthcare data analysis and recommendation system patient chart. In some embodiments, as part of the report modification and/or approval, a user, at 628, can order additional diagnostic or laboratory tests or specific treatment, preventative measures, and the like. In some embodiments, these additional tests, treatments, and the like can be stored in the one or more EHR databases and/or blockchain database 618, report databases 626, and/or patient databases 612)
Therefore, it would have been obvious to one of ordinary skill in the art of data processing, before the effective filing date of the claimed invention, to modify Steingold to incorporate a distributed ledger system, recording data onto a distributed ledger system, where each record is cryptographically secured, and wherein any modification is appended to the ledger, as taught by Wright, in order to have a way to securely store and exchange data without a centralized authority while still approving of the data being added to storage. See Wright [0067], [0102].
Steingold-Wright does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein:
any modification is time-stamped (Tran [0348] Each of the datum captured is encoded with a distributed ledger or blockchain for subsequent verification and audit by the factory QA team, regulatory agency, product safety analyst, or consumers if needed. One exemplary Audit Trail complies with 21CFR Part 11. Preferably, the system maintains an automatic (non-user modifiable) audit trail of all events and modifications made to the system secured by blockchain. The audit trail contains the following: [0349] An entry identifying the type of modification made to the database/record, such as additions, deletions, modifications, review, etc. [0350] An entry identifying the user performing the modification to the database/record [0351] An entry noting the date/time of the database/record modification [0352] The date/time included in the audit trail should be retrieved from the server system clock, not the local system clock [0353] The entire database record being modified with the changed fields highlighted)
Therefore, it would have been obvious to one of ordinary skill in the art of data processing, before the effective filing date of the claimed invention, to modify Steingold-Wright, as modified above, to incorporate any modification is time-stamped, as taught by Tran, in order to maintain a proper audit trail of all events and modifications made to the blockchain. See Tran [0348].
Steingold-Wright-Tran does not appear to explicitly teach the following, however, Zhang teaches it is old and well known in the art of healthcare data processing to recite:
on the wellness database; wherein the wellness database further stores treatment outcome information associated with photobiomodulation treatments administered to a plurality of users; (Zhang [0254] A computing cloud is defined as a set of resources (e.g., processing, storage, or other resources) available through a network that can serve at least some traditional datacenter functions for an enterprise [0238] a database of treatment information aggregated from a plurality of patients)
wherein the artificial intelligence engine is configured to analyze the treatment outcome information to identify correlations between treatment parameters and treatment outcomes; (Zhang [0070] As used herein, “low level light therapy” (“LLLT”) is the use of light comprising a plurality of application parameters, such as emitted wavelength(s)… [0313] light to be delivered from PBM control module 2130, where that light source is in operational and optical communication with light guide 2520 and (optionally) light guides 2525 and 2565, which can be used to deliver additional energy or light at a different wavelength than light delivered by light guide 2520, or to transmit light beam 2555 from light therapy delivery liner 505 as beam 560 back to sensors [not shown] associated with PBM control module 2130 for analysis to determine, for example, tissue condition, treatment progress, compliance and dose-response [0214] the PBM control module can store and/or transmit to a remote device all information, including data and images from sensors, treatment progress input, patient profile data, as well as the prescribed treatment details in a data warehouse for further analysis with machine learning and artificial intelligence to improve human light therapy knowledge and understanding)
wherein the personalized photobiomodulation treatment recommendation comprises one or more photobiomodulation treatment parameters selected from the group consisting of wavelength, intensity, treatment duration, treatment frequency, pulse frequency, duty cycle, and treatment location. (Zhang [0070] As used herein, “low level light therapy” (“LLLT”) is the use of light comprising a plurality of application parameters, such as emitted wavelength(s), pulse frequencies, duty cycle/pulse width, intensity, individual treatment duration, total treatment duration, number of individual treatments during a total treatment regimen, time between individual treatments in a total treatment regimen, first LLLT administration time from an event (such as a surgery), time-course dosage, maintenance treatments, with the goal of optimal treatment, management, and/or cure of wounds or delay/reverse tissue degeneration at one or more locations on a patient in need of such treatment, management, or cure)
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify Steingold-Wright-Tran, as modified above, to incorporate on the wellness database; wherein the wellness database further stores treatment outcome information associated with photobiomodulation treatments administered to a plurality of users; wherein the artificial intelligence engine is configured to analyze the treatment outcome information to identify correlations between treatment parameters and treatment outcomes; wherein the personalized photobiomodulation treatment recommendation comprises one or more photobiomodulation treatment parameters selected from the group consisting of wavelength, intensity, treatment duration, treatment frequency, pulse frequency, duty cycle, and treatment location, as taught by Zhang, in order to improve light therapy knowledge and understanding. See Zhang [0214].
Regarding claim 2, Steingold-Wright-Tran-Zhang teaches the cloud-based wellness system of claim 1, and Tran further teaches wherein the software client includes programming instructions to automate the implementation of treatment regimens based on pre- defined criteria and using smart contracts. (Tran [0285] Patient A is in registration at a particular hospital. The PPLT is used to identify Patient A as belonging to a particular plan. The smart contracts in the blockchain automatically updates Patient A's care plan. The blockchain adds a recommendation to put Patient A by looking at the complete history of treatments by all providers and optimizes treat. For example, the system can recommend the patient be enrolled in a weight loss program after noticing that the patient was treated for sedentary lifestyle, had history of hypertension, and the family history indicates a potential heart problem. The blockchain data can be used for predictive analytics, allowing patients to learn from their family histories, past care and conditions to better prepare for healthcare needs in the future. [0132] Scripted clauses can also be configured to trigger on certain events. Variables can be defined in the smart contract, which persist through its entire lifetime). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 3, Steingold-Wright-Tran-Zhang teaches the cloud-based wellness system of claim 1, and Wright further teaches wherein the PBM devices communicate with each other, share wellness data, and coordinate treatment plans through the distributed ledger system. (Wright [0067] a blockchain database may be distributed across and managed by one or more peer-to-peer networks and may exist without a centralized authority or central server. In some embodiments, patient data can be acquired through utilization of an application programming interface (API) (e.g. ICD-10 code API, medication API, etc.). In some embodiments, utilization of one or more APIs may allow the systems described herein to interface with standardized medical databases and other sources of patient data. In some embodiments, one or more APIs are used to exchange data between an EHR database, blockchain database, external databases, and/or vendor databases to transfer data from one database to another). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 4, Steingold-Wright-Tran-Zhang teaches the cloud-based wellness system of claim 1, and Tran further teaches wherein the distributed ledger system includes a data permissions feature that allows users to grant or revoke data access permissions. (Tran [0290] With the advent of personal health trackers, new health plans are rewarding consumers for taking an active part in their wellness. The system facilitates open distribution of the consumers wellness data and protect it as PHR must be, and therefore prevent lock-in of consumers, providers and payers to a particular device technology or health plan. In particular, since PHR data is managed on the blockchain a consumer and/or company can grant access to a payer to this data such that the payer can perform group analysis of an individual or an entire company's employee base including individual wellness data and generate a risk score of the individual and/or organization). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 5, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Tran further teaches wherein the distributed ledger system is implemented as a blockchain that provides tamper-resistant storage of the wellness data and treatment regimens. (Tran [0254] the blockchain or a decentralized ledger to prevent subsequent alteration of the registration). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 6, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Tran further teaches wherein the server is configured to grant secure access to the distributed ledger system to authorized healthcare providers for real-time monitoring of the wellness data and treatment recommendations. (Tran [0290] With the advent of personal health trackers, new health plans are rewarding consumers for taking an active part in their wellness. The system facilitates open distribution of the consumers wellness data and protect it as PHR must be, and therefore prevent lock-in of consumers, providers and payers to a particular device technology or health plan. In particular, since PHR data is managed on the blockchain a consumer and/or company can grant access to a payer to this data such that the payer can perform group analysis of an individual or an entire company's employee base including individual wellness data and generate a risk score of the individual and/or organization). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 7, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Tran further teaches wherein the software client is configured to use cryptographic hashes for ensuring the integrity and authenticity of the wellness data and treatment recommendations recorded on the distributed ledger system. (Tran [0277] In one embodiment, the transaction 303 includes the recipient's address 324 (e.g., a hash value based on the receiver's public key), the Blockchain token 309 (i.e., a patient ID 328 and personally identifiable information such as Social Security 326), past medical institution relationship information 331 (if any), and optional other information 310…the sender's authenticity is verified and, after a proper chain of ownership is verified via the ledgers (as explained above), the receiver is recorded in the ledgers as the new Blockchain token 329 authorized owner of the medical information. Block 328 of FIG. 13G can point to off-chain storage warehouses containing the patient's medical history so that the current owner (or all prior owners) can access the patient medical information for treatment). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 8, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Steingold further teaches wherein the distributed ledger system includes a chronological history of wellness treatments created by timestamping of wellness data and treatment recommendations. (Steingold [0066] In some embodiments, the photobiomodulation device 110 can transmit and/or receive data from the computing device 150. For example, the photobiomodulation device 110 can transmit data to log information about a therapy session for a patient. Such data can include, for example, illumination patterns, total length of time, time spent in different phases of a therapy program, electroencephalogram (EEG) readings, and power levels used. The data can be transmitted and logged before, during, and after a therapy session. Similar data can also be received at the computing device 150 from the external EEG system 120' or the external light sensor array 122' in embodiments that utilize these components. In the stored data manipulation and/or visualization mode, the operating user can review the data logged from these sources and received at the computing device 150).
Regarding claim 9, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Tran further teaches wherein the distributed ledger system includes smart contracts to automate the execution of a set of predefined actions based on the wellness data and treatment recommendations. (Tran [0285] Patient A is in registration at a particular hospital. The PPLT is used to identify Patient A as belonging to a particular plan. The smart contracts in the blockchain automatically updates Patient A's care plan. The blockchain adds a recommendation to put Patient A by looking at the complete history of treatments by all providers and optimizes treat. For example, the system can recommend the patient be enrolled in a weight loss program after noticing that the patient was treated for sedentary lifestyle, had history of hypertension, and the family history indicates a potential heart problem. The blockchain data can be used for predictive analytics, allowing patients to learn from their family histories, past care and conditions to better prepare for healthcare needs in the future. [0132] Scripted clauses can also be configured to trigger on certain events. Variables can be defined in the smart contract, which persist through its entire lifetime). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 10, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Tran further teaches wherein the server is configured to query the distributed ledger system to fetch the most recent treatment recommendations for each PBM device. (Tran [0277] the sender's authenticity is verified and, after a proper chain of ownership is verified via the ledgers (as explained above), the receiver is recorded in the ledgers as the new Blockchain token 329 authorized owner of the medical information. Block 328 of FIG. 13G can point to off-chain storage warehouses containing the patient's medical history so that the current owner (or all prior owners) can access the patient medical information for treatment. [0302] Given a patient Health Blockchain wallet that stores all assets as reference ids to the actual data. These assets can be included in an automated smart contract for clinical study participation or any other data sharing agreement allowed by the patient… a particular request for the patient's health record information…. Attributes of the patient's data are also advertised and summarized as properties of the smart contract regarding the type of diagnosis and treatments available). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 12, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Wright further teaches wherein the server is configured to use the distributed ledger system to securely share the wellness data and treatment recommendations with other healthcare systems or platforms. (Wright [0067] a blockchain database may be distributed across and managed by one or more peer-to-peer networks and may exist without a centralized authority or central server. In some embodiments, patient data can be acquired through utilization of an application programming interface (API) (e.g. ICD-10 code API, medication API, etc.). In some embodiments, utilization of one or more APIs may allow the systems described herein to interface with standardized medical databases and other sources of patient data. In some embodiments, one or more APIs are used to exchange data between an EHR database, blockchain database, external databases, and/or vendor databases to transfer data from one database to another). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 13, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Wright further teaches wherein the server, PBM devices, and the distributed ledger system collectively form a peer-to-peer network for collaborative wellness management. (Wright [0067] a blockchain database may be distributed across and managed by one or more peer-to-peer networks and may exist without a centralized authority or central server. In some embodiments, patient data can be acquired through utilization of an application programming interface (API) (e.g. ICD-10 code API, medication API, etc.). In some embodiments, utilization of one or more APIs may allow the systems described herein to interface with standardized medical databases and other sources of patient data. In some embodiments, one or more APIs are used to exchange data between an EHR database, blockchain database, external databases, and/or vendor databases to transfer data from one database to another). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 14, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Steingold further teaches wherein the processor is further configured to use the wellness data stored on the distributed ledger over time to identify trends or patterns and make adjustments to the treatment recommendations accordingly. (Steingold [00191] the DNN generates quantitative frequency domain and time domain data that are used to characterize the results of the photobiomodulation therapy and can be used to guide modifications of the therapeutic plan for the patient [00129] A neural network can be used for example to tune the parameters employed for transcranial illumination of a child at a certain age range undergoing treatment for autism [0076] The database(s) 401 may be updated manually or automatically at any suitable time {where the storage of data on the distributed ledger is taught above}).
Regarding claim 15, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Tran further teaches wherein the server is configured to use consensus mechanisms in the distributed ledger system to validate new entries of wellness data and treatment recommendations. (Tran [0810] Each peer and miner independently validates the transaction before broadcasting it further or attempting to include it in a new block of transactions). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 16, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Tran further teaches wherein the distributed ledger system is configured to facilitate real-time auditing and regulatory compliance checks of the wellness data and treatment procedures. (Tran [0210] The global peer-to-peer network is an open platform that can deliver neutrality, reliability and security. The blockchains are auditable. Each individual operation or interaction, such as the provision of a new employee or the recording of outgoing stock, is perfectly recorded and archived. Auditing is thus as simple as joining the blockchain network, as this allows one to “replay” the operations of the past in order to reconstruct the history of the item from birth to the present. Combined with the absolute guarantees of authenticity for every interaction, strong and agile data systems can be facilitated that are at their core resilient to coercion and human factors. With blockchains, data can be accessed and verified by everyone, rather than solely by the original certifier [0827] The ledger, too, can be used for general health care management, such as supervising drugs, regulation compliance, testing results, and managing healthcare supplies). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 17, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Steingold further teaches further comprising a user interface on each PBM device for displaying the personalized treatment recommendations and corresponding wellness data stored on the distributed ledger system. (Steingold [00146] the automatically selected illumination and therapy session parameters (as well as other session parameters) can be displayed on the display associated with the computing device (step 622) [0076] The database(s) 401 may be updated manually or automatically at any suitable time {where the storage of data on the distributed ledger is taught above}).
Regarding claim 18, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Steingold further teaches wherein the PBM devices are wearable devices designed to deliver light therapy to different parts of the user's body as part of the wellness treatment. (Steingold [0066] In some embodiments, the photobiomodulation device 110 can transmit and/or receive data from the computing device 150. For example, the photobiomodulation device 110 can transmit data to log information about a therapy session for a patient. Such data can include, for example, illumination patterns, total length of time, time spent in different phases of a therapy program, electroencephalogram (EEG) readings, and power levels used. The data can be transmitted and logged before, during, and after a therapy session. Similar data can also be received at the computing device 150 from the external EEG system 120' or the external light sensor array 122' in embodiments that utilize these components [00151] Shown in FIG. 18B is a top view of a headset 850 that incorporates an EEG electrode array including EEG electrodes 855, 856 located at different locations around the head of the patient. As described in further detail below such an EEG sensor array can be integrated with a light emitter array positioned around the head of the patient at different separate locations, or partially or entirely collocated with the EEG electrodes).
Regarding claim 19, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Steingold further teaches wherein the server is further configured to coordinate the PBM treatments based on the personalized treatment recommendations (Steingold [00191] the DNN generates quantitative frequency domain and time domain data that are used to characterize the results of the photobiomodulation therapy and can be used to guide modifications of the therapeutic plan for the patient [00129] A neural network can be used for example to tune the parameters employed for transcranial illumination of a child at a certain age range undergoing treatment for autism [0076] The database(s) 401 may be updated manually or automatically at any suitable time {where securing and recording of data on the distributed ledger is taught above}).
Regarding claim 20, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and Zhang further teaches wherein the artificial intelligence engine is configured to analyze wellness data and treatment information to identify a subgroup of users that benefit from similar photobiomodulation treatment parameters and to generate a personalized photobiomodulation treatment recommendation based upon the identified subgroup.(Zhang [0086] Yet further, the devices and methods of the present invention can provide enhanced information about the course and effects of a LLLT treatment program in a single patient, and among a plurality of patients, thereby improving the ability to manage LLLT in a single patient or in a population of patients by use of data associated with medical indication, dosage, treatment compliance, progress, outcome, physiological conditions, among other information. Therefore, in some aspects, the inventions herein relate to the generation of information associated with an applied LLLT treatment or program from the patient who is undergoing treatment for one or more medical indications suitable for treatment with LLLT, and incorporation of at least some of that patient generated information into a subsequent treatment for that patient, for another patient or for a group of patients [0214] the PBM control module can store and/or transmit to a remote device all information, including data and images from sensors, treatment progress input, patient profile data, as well as the prescribed treatment details in a data warehouse for further analysis with machine learning and artificial intelligence to improve human light therapy knowledge and understanding). The motivation to combine the references is discussed above and incorporated herein.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Steingold-Wright-Tran-Zhang in view of Williams et al. (US 2019/0246463).
Regarding claim 11, Steingold-Wright-Tran-Zhang teaches the system of claim 1, and does not appear to explicitly teach the following, however, Williams teaches it is old and well known in the art of data processing wherein each PBM device is associated with a unique digital identity on the distributed ledger system, facilitating device-specific treatment customization and data tracking. (Williams [0283] LightPadOS, along with manufacturing data including pad identification data, i.e. the LED pad ID register, and manufacturing related LED configuration data [0291] Any number of authentication methods can be performed to establish a private network and approve a device's connection to the private network. These methods may involve symmetric or asymmetric encryption and key exchange, employing ‘certificate authority’ based identity confirmation through the exchange of digital CA-certificates, or exchanging cryptographic hash data to confirm a device holds the same shared secrets, meaning it was produced by a qualified manufacturer).
Therefore, it would have been obvious to one of ordinary skill in the art of data processing, before the effective filing date of the claimed invention, to modify Steingold-Wright-Tran-Zhang, as modified above, to incorporate wherein each PBM device is associated with a unique digital identity in the distributed ledger system, facilitating device-specific treatment customization and data tracking, as taught by Williams, in order to properly confirm a devices identity and track the device and thus the data coming from the device. See Williams [0291].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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