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
Claim Objections
Applicant's arguments filed 06/09/2026 have been fully considered. Applicant argues that the amendment resolves the issue, and the objection should be overcome. In response to the amendment, the objection is withdrawn.
Rejection Under 112(b)
Applicant's arguments filed 06/09/2026 have been fully considered. Applicant argues that the amendment resolves the issue, and the rejection should be overcome. In response to the amendment, the rejection is withdrawn. However, the new amendments raise new 112(b) issues. See the updated rejection below for further clarification.
Rejection Under 101
Applicant's arguments filed 06/09/2026 have been fully considered.
Applicant argues that claims recite a technological process directly affecting operation of physical therapeutic equipment. The claim is not merely managing human interactions or relationships.
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. The claims are directed to following steps to processing wellness data in order to generate a personalized treatment plan and thus falls under managing personal behavior or interactions (i.e., following rules or instructions). See the updated rejection below for further clarification in light of the amendment.
Applicant argues that the claims integrate the concept into a practical application directed to the practical administration and control of photobiomodulation therapy rather than mere generation of information. The specification describes the invention as directed to improving operation and administration of a distributed therapeutic device network.
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. 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, distributed ledger, etc.,) are recited at a high level of generality and are used for their intended purposes. Therefore, the claims do not integrate the abstract idea into a practical application.
Applicant argues that the claims include significantly more that the abstract idea when evaluated in an ordered combination. The specific combination or technological components and operations create a distributed therapeutic treatment management architecture that is not conventional or generic. The ledger is not merely passive data repository but participates in management of treatment state across a distributed therapeutic device network.
In response to Applicant’s argument, as discussed above, the computer components are recited at a high level of generality and are used for their intended purposes. The claims recite the use of an existing distributed ledger. The problems related to the invention and discussed in the specification are patient health issues rather than technological in nature (i.e., directed to the distributed ledger). Therefore, the generally recited computer components are merely used to carry out the abstract idea.
Applicant argues that, like recognized by the Federal Circuit, the claims are directed to a specific technological solution and improvement in computer implemented systems by employing data analysis as part of a larger technological process involving synchronization and control of distributed therapeutic devices. Therefore, the claims are directed to a practical application and significantly more than the exception.
In response to Applicant’s argument, see response to arguments ii and iii above for reasons why the additional elements do not amount to practical application and are not significantly more than the abstract idea.
Rejection Under 103
Applicant's arguments filed 06/09/2026 have been fully considered.
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 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 in the rejection. See the updated rejection for further clarification.
Applicant argues that cited references fails to teach or suggest the dependent claims in view of claim 1’s amendment.
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 the claim 11 rejection uses impermissible hindsight reconstruction to reject the claims and provides no teaching or suggestion for the final modification.
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 the modification is provided below in the rejection. See the rejection for further clarification.
Applicant argues that newly added claims 18-20 further distinguish 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 amendments and are therefore moot. See the updated rejections for further clarification.
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 1-20 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 1 recites “synchronizing treatment regimens among the plurality of PBM devices based upon the personalized treatment recommendations; modifying one or more photobiomodulation treatment parameters of the plurality of PBM devices in accordance with the synchronized treatment regimens” in the amendment filed 06/09/2026. The specification discusses synchronizing treatments at [0025], however, the specification does not appear to disclose synchronization between a plurality of PBM devices but rather discloses synchronization among PBM devices and VR headsets and treatments associated with each device. Therefore, the amended limitation contains subject matter not described in the specification. Appropriate correction is required. The dependent claims are also rejected for inheriting the issues of the independent claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 1 recites the limitation “synchronizing treatment regimens among the plurality of PBM devices based upon the personalized treatment recommendations; modifying one or more photobiomodulation treatment parameters of the plurality of PBM devices in accordance with the synchronized treatment regimens” in the amendment filed 06/09/2026. It is unclear what treatments are being synchronized among the PBM devices when the specification does not appear to disclose synchronizing treatments among PBM devices but rather PBM device and VR headset device. See spec. at [0025]. Appropriate correction is required. The dependent claims are also rejected for inheriting the issues of the independent claim.
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 method, which is within the four statutory categories (i.e. process).
Step 2A of the Alice/Mayo Test - Prong One
The independent claim 1 recites an abstract idea. For example, claim 1 recites:
A method for providing coordinated wellness treatments using a plurality of photobiomodulation (PBM) devices, comprising:
collecting wellness data from each PBM device;
transmitting the collected wellness data to a server;
analyzing the wellness data to generate personalized treatment recommendations;
recording the wellness data and treatment recommendations onto a distributed ledger system;
communicating the personalized treatment recommendations to each PBM device;
synchronizing treatment regimens among the plurality of PBM devices based upon the personalized treatment recommendations;
modifying one or more photobiomodulation treatment parameters of the plurality of PBM devices in accordance with the synchronized treatment regimens; and
recording execution of the synchronized treatment regimens in the distributed ledger system.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (following rules or instructions to facilitate recommendations), but for the recitation of generic computer components. For example, but for the PBM devices, server, distributed ledger system, the limitations in the context of this claim encompass steps to follow in order to process wellness data for generating a personalized treatment recommendation, synchronizing and modifying treatments. 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 method for providing coordinated wellness treatments using a plurality of PBM devices, comprising: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
collecting wellness data from each photobiomodulation (PBM) device; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
transmitting the collected wellness data to a server; (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))
analyzing the wellness data to generate personalized treatment recommendations;
recording the wellness data and treatment recommendations onto a distributed ledger system; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
communicating the personalized treatment recommendations to each PBM device; and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
synchronizing treatment regimens among the plurality of PBM devices (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) based upon the personalized treatment recommendations;
modifying one or more photobiomodulation treatment parameters of the plurality of PBM devices (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) in accordance with the synchronized treatment regimens; and
recording execution of the synchronized treatment regimens in the distributed ledger system. (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
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 PBM devices, server, distributed ledger system, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0029], [0045], [0047], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of transmitting data 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 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 PBM devices, server, distributed ledger system, 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], see also Steingold et al. (WO 2022/197937) and Zhang (US 2019/0083809) which teaches the PBM devices; see Wright et al. (US 2020/0273579) which teaches distributed ledgers); using a server and distributed ledger system, 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)): transmitting data to a server, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i).
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.
Claims 1, 3-4, 8, 12, 16-17 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) and Kehr et al. (US 2003/0036683).
Regarding claim 1, Steingold discloses a method for providing coordinated wellness treatments using a plurality of PBM devices, comprising:
collecting wellness data from each photobiomodulation (PBM) device; transmitting the collected wellness data to a server; ([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. [00144] The data can be communicated 508 to the computing device such as the control tablet device and stored in the electronic medical record of the patient. This can be transmitted by communication networks to a hospital or clinic server for storage and further analysis as described herein [00174] The User Profile Module (UPM) 3002 receives all data related to the child's profile, including demographic data, neuro-developmental assessment data, health data, ongoing device data)
analyzing the wellness data to generate personalized treatment recommendations; ([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)
recording the wellness data and treatment recommendations ([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)
communicating the personalized treatment recommendations to each PBM device; and [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).
modifying one or more photobiomodulation treatment parameters of the plurality of PBM devices ([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)
Steingold does not appear to explicitly teach the following, however, Kehr teaches it is old and well known in the art of data processing to teach:
synchronizing treatment regimens among the plurality of PBM devices based upon the personalized treatment recommendations; (Kehr [0205] monitoring and managing outpatients, is the ability to readily and easily convert a complex medical treatment plan into a series of simple prompt-and-record events that get communicated to and from the patient through time, over multiple different devices, in a synchronized fashion [0221] Alarm-based medication events, educational content messages, alarm-based treatment instructions, questionnaires, and any other elements contained in the medical treatment plan or protocol can be delivered over time and space to all of the remote monitoring devices in a synchronized fashion. As the patient responds to a particular device by inputting data into the device, the database synchronously updates its patient file and the treatment regimen {PBM devices taught above})
modifying one or more treatment parameters of the plurality of devices in accordance with the synchronized treatment regimens; and (Kehr [0223] The database incorporating the treatment plan then uploads the modified plan to each patient's monitoring devices for use by the patient as directed by the real-time, self-selected, synchronized, database-linked method. [0228] The medical monitors capture data on medication compliance, health status, quality-of-life, physiologic status (e.g. blood pressure, EKG, pO2, pulse rate, weight, pulmonary function, etc.), and various measures of blood, serum, urine, and other laboratory tests. The medical monitors are linked to a database that updates and synchronizes the information presented to all of the monitors, and captures information from all of the monitors. Individual patient medical treatment plans may be remotely created, modified, or viewed in the database… for each device to record whether the patient is following the treatment plan [0251] The present invention describes methods and apparatus useful in remotely modifying a medical treatment protocol, to improve a patient's adherence to his or her medication regimen and medical treatment protocol through musical alarms. Individual patient medical treatment protocols may be remotely created and modified, and may include specific musical compositions that are audibly presented to the patient at pre-selected times over one or more medical monitoring devices used by the patient)
recording execution of the synchronized treatment regimens (Kehr [0221] Alarm-based medication events, educational content messages, alarm-based treatment instructions, questionnaires, and any other elements contained in the medical treatment plan or protocol can be delivered over time and space to all of the remote monitoring devices in a synchronized fashion. As the patient responds to a particular device by inputting data into the device, the database synchronously updates its patient file and the treatment regimen [0222] The events that are then prompted and recorded can be organized and managed in an event log as illustrated below, which corresponds with the appropriate fields of the database that is prepared to accept the events from the event log)
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 to incorporate synchronizing treatment regimens among the plurality of PBM devices based upon the personalized treatment recommendations; modifying one or more treatment parameters of the plurality of devices in accordance with the synchronized treatment regimens; and recording execution of the synchronized treatment regimens, as taught by Kehr, in order to “convert a complex medical treatment plan into a series of simple prompt-and-record events that get communicated to and from the patient through time, over multiple different devices, in a synchronized fashion” and to modify the treatment over time so as to improve patient adherence to their treatment plan. See Kehr [0205], [0251].
Steingold-Kehr does not appear to teach the following however, Wright teaches it is old and well known in the art of data processing to:
record data onto a distributed ledger system; recording data in the distributed ledger system ([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)
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-Kehr, as modified above, to incorporate recording data onto a distributed ledger system; recording data in the distributed ledger system, in order to store and exchange data without a centralized authority. See Wright [0067].
Regarding claim 3, Steingold- Kehr-Wright teaches the method of claim 1, and Wright further teaches wherein the step of recording involves the use of cryptographic methods to ensure the security and integrity of the wellness data and treatment recommendations. (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}).
Regarding claim 4, Steingold- Kehr-Wright teaches the method of claim 1, and Wright further teaches further comprising the step of managing user permissions for data access on the distributed ledger system. (Wright [0166] The network 1628 can allow the main server system 1602 to exchange data with one or more external databases 1632, EHR database and/or blockchain databases 1630, and one or more user access points 1634. The EHR database and/or blockchain database 1630 may store and provide, through the network, patient health data, including diagnostic and laboratory test results. The user access points 1634 can provide users with an interface to access and communicate with the main server system 1602, and to utilize the functional aspects of the system).
Regarding claim 8, Steingold- Kehr-Wright teaches the method of claim 1, and Steingold further teaches wherein the recording step includes timestamping the wellness data and treatment recommendations to create a chronological history of wellness treatments. (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 12, Steingold- Kehr-Wright teaches the method of claim 1, and Wright further teaches further comprising the step of using 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).
Regarding claim 16, Steingold- Kehr-Wright teaches the method of claim 1, and Steingold further teaches wherein the adjusting step includes making changes to the treatments based on an analysis of trends or patterns in the wellness data stored on the distributed ledger over time. (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 17, Steingold- Kehr-Wright teaches the method 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).
Claims 2, 5-7, 9-10, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Steingold- Kehr-Wright in view of Tran et al. (US 2019/0361917).
Regarding claim 2, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein further comprising the step of using smart contracts to automate treatment adjustments based on pre-defined criteria. (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).
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- Kehr-Wright, as modified above, to incorporate using smart contracts to automate treatment adjustments based on pre-defined criteria, as taught by Tran, in order to have protocols automatically run when triggered on certain events. This allows for the validation of inputs according to the terms of the plan defined in the smart contract. See Tran [0126], [0132], [0285]-[0287].
Regarding claim 5, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein the distributed ledger system is a blockchain that provides decentralized, tamper-resistant storage of the wellness data and treatment recommendations. (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- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein further comprising the step of granting 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- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein the recording step includes using cryptographic hashes to ensure the integrity and authenticity of the wellness data and treatment recommendations. (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 9, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein further comprising the step of using smart contracts in the distributed ledger system to automate the execution of certain 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- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein the communicating step includes querying 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 13, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein the distributed ledger system is used to facilitate interoperability and data synchronization between the PBM devices, the server, and any other connected health management systems. (Tran [0879] The devices can then query the contract, find out about the new firmware, and request it by its hash via a distributed peer-to-peer file system such as IPFS. Assuming the devices are configured so as to share the binary they got, a device that joins the network long after the manufacturer has stopped participating in it, can still retrieve the firmware update and be assured that it is the right file. [0999] The data can be stored as part of a blockchain secured data distribution. Blockchain distribution can provide benefits in a heterogeneous device environment, facilitate ad hoc device synchronization). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 14, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein the distributed ledger system is used 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 15, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to explicitly teach the following, however, Tran teaches it is old and well known in the art of data processing wherein further comprising the step of using 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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Steingold- Kehr-Wright in view of Williams et al. (US 2019/0246463).
Regarding claim 11, Steingold- Kehr-Wright teaches the method 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 in 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- Kehr-Wright, 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].
Claims 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Steingold- Kehr-Wright in view of Kutzko et al. (US 2020/0273578).
Regarding claim 18, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to teach the following, however, Kutzko teaches it is old and well known in the art of healthcare data processing to teach wherein the step of synchronizing treatment regimens among the plurality of PBM devices comprises utilizing the distributed ledger system to distribute a common treatment-regimen state to the plurality of PBM devices and to verify receipt of the common treatment-regimen state by each of the plurality of PBM devices before execution of the synchronized treatment regimens. (Kutzko [0134] In step 607, a smart contract 131 may be created for a selected therapy. A smart contract 131 is a computer protocol intended to digitally facilitate, verify, or enforce the negotiation or performance of a contract. Smart contracts 131 allow the performance of credible transactions without third parties. These transactions are trackable and irreversible. In some embodiments, a patient 101B and/or provider 101A may select a desired therapy that was returned in step 606. The therapy may be provided to the patient 101B and a record of the provision of the therapy may be stored in the blockchain database 113 of the virtual machine engine 151).
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- Kehr-Wright, as modified above, to incorporate wherein the step of synchronizing treatment regimens among the plurality of PBM devices comprises utilizing the distributed ledger system to distribute a common treatment-regimen state to the plurality of PBM devices and to verify receipt of the common treatment-regimen state by each of the plurality of PBM devices before execution of the synchronized treatment regimens, as taught by Kutzko, in order to track desired treatment steps that are provided to the patient. See Kutzko [0134].
Regarding claim 20, Steingold- Kehr-Wright teaches the method of claim 1, but does not appear to teach the following, however, Kutzko teaches it is old and well known in the art of healthcare data processing to teach further comprising verifying, through the distributed ledger system, completion of a synchronized treatment regimen by comparing treatment-execution records received from the plurality of PBM devices against the synchronized treatment regimen prior to generation of a subsequent treatment recommendation. (Kutzko [0131] an artificial intelligence module 152 may determine two possible therapies 127, such as a first therapy and a second therapy, and the artificial intelligence module 152 may rank the first and second possible therapies 127 by probability of the first and second possible therapies 127 being a successful treatment, wherein the probability of success is based on factors including patient compliance, the patient's existing condition or existing conditions, treatment cost, and historical success rate of the treatments as determined from information stored on the blockchain database. As a further example, the artificial intelligence module 152 may rank the second possible therapy 127).
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- Kehr-Wright, as modified above, to incorporate verifying, through the distributed ledger system, completion of a synchronized treatment regimen by comparing treatment-execution records received from the plurality of PBM devices against the synchronized treatment regimen prior to generation of a subsequent treatment recommendation, as taught by Kutzko, in order to best determine treatment compliance with the most successful treatment plan. See Kutzko [0131].
Claims 19 are rejected under 35 U.S.C. 103 as being unpatentable over Steingold- Kehr-Wright-Williams in view of Zhang (US 2019/0083809).
Regarding claim 19, Steingold- Kehr-Wright-Williams teaches the method of claim 11, but does not appear to teach the following, however, Zhang teaches it is old and well known in the art of healthcare data processing wherein the unique digital identity associated with each PBM device is used to retrieve device-specific treatment parameters from the distributed ledger system, and wherein the device-specific treatment parameters include at least one of treatment duration, light intensity, wavelength selection, pulse frequency, or treatment schedule. (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 [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 {where the distributed ledger is taught above]).
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- Kehr-Wright-Williams, as modified above, to incorporate wherein the unique digital identity associated with each PBM device is used to retrieve device-specific treatment parameters from the distributed ledger system, and wherein the device-specific treatment parameters include at least one of treatment duration, light intensity, wavelength selection, pulse frequency, or treatment schedule, as taught by Zhang, in order to improve light therapy knowledge and understanding. See Zhang [0214].
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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