DETAILED ACTION
Status
This communication is in response to the application filed on 19 December 2024. Claims 1-22 are pending and presented for examination.
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 .
Priority
Applicant’s claim for the benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/559,816, filed on 29 February 2024, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 28 May 2025 and 18 August 2025 were filed after the mailing date of the application on 19 December 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Examiner’s Note
The Examiner notes that “secure enclave” (as at claim 1) is not actually defined in the specification, but since it is described as storing a private key (at Applicant ¶ 0010) and/or biometric information (at Applicant ¶ 0012), and may be erased . (at Applicant ¶ 0010), this is understood to be a memory of any sort or type (and not necessarily a hardware component, it may apparently be just a segmented data location).
The Examiner notes that claim 21 recites “a physician authorizing or creating a treatment plan for a user using a device in a blockchain network”, where this is interpreted as NOT claiming the physician, but rather that this means “authorizing or creating, by a physician, a treatment plan for a user”
The Examiner notes that claims 2-8 indicate “an anti-tampering module configured to detect a tampering attempt in the treatment device”. However, the specification indicates that:
“Anti-tampering functionality includes physical intrusion detection, sensors to detect environmental changes (such as temperature and pressure), voltage and frequency monitoring, light detection, etc. The anti-tampering functionality can detect changes of temperatures, pressure, voltage, frequency, light etc., and create alarms if they are not within a specified range” (at Applicant ¶ 0010), and
“Anti-tampering block 125 is used for intrusion detection and may include sensors to detect changes in device temperature, pressure, voltage, frequency, and light level” (at Applicant ¶ 0012), and
“Environmental Sensors: to detect unusual temperature or pressure changes, indicating attempts to tamper with the device through extreme environmental conditions” (at Applicant ¶ 0019), and
Similar indications at Applicant ¶¶ 0101-0107).
Therefore, in light of the specification, the “tampering” apparently does not actually require any active tampering attempt – the term “tampering” also means or includes any reason for any environmental or supply issue or variance, such as power surges or outages, turning a light switch on or off, resetting or problems associated with a thermostat, air conditioning, or heating system, etc. There is no indication of any detection or determination as to why the temperature, pressure, voltage, frequency, or light sensing is out of range or beyond a threshold – the light of the specification apparently merely ASSUMES that this is due to tampering, but the actual system described merely detects the indicated measurements and does NOT detect any actual tampering. As such, “a tampering attempt” is interpreted to include any variation in temperature, pressure, voltage, frequency, or light of the environment of the device.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an anti-tampering module” at claims 2-8, and both “a communication module” and “a user authentication module” at claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 1-10 and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation "the treatment device" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-10 depend from claim 1, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 2-10 are also indefinite for the above basis.
Independent claim 1 also recites “causing the at least one processor to … retrieve data … from a blockchain or data availability source; request authorization for a selected one of the one or more treatments from the blockchain; and in response to receiving authorization from the blockchain, cause the device to execute the selected treatment based on data specifying the selected treatment.” Per the claim, the data source may be either 1) a blockchain, or 2) a data availability source; however, the request authorization and receiving authorization elements apparently indicate that the authorization must be from the blockchain (and, then, NOT from the data availability source.
This can be interpreted several ways:
That “data availability source” is merely a pseudonym for “blockchain” (there is no description at all regarding what is meant by “data availability source” and
That either the blockchain or the data availability source can be used to retrieve data, but that the authorization request and receiving authorization need not occur when the data is received from the data availability source, or
That blockchain must be used, although the data may be retrieved from a/the data availability source, or
That blockchain must be used (and NOT the data availability source) since the authorization request and received authorization must be via blockchain.
For purposes of examination, the Examiner is interpreting this as using either blockchain or a data availability source at all elements.
Claims 2-10 depend from claim 1, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 2-10 are also indefinite for this basis.
Claims 2-8 and 10 all recite a “module”, claims 2-8 reciting “an anti-tampering module” and claim 10 reciting both “a communication module” and “a user authentication module”. Applicant ¶ 0100 (as submitted, 0124 as published) indicates that “aspects of the present disclosure may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “module,” a “system,” or a “computer.” In addition, any hardware and/or software technique, process, function, component, engine, module, or system described in the present disclosure may be implemented as a circuit or set of circuits.
Therefore, it is indefinite whether the modules claimed are merely software or require hardware components.
Claims 3-10 depend from claim 2, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 3-10 are also indefinite for this basis.
Claim 21 recites the limitation "the user’s treatment device" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites “a physician authorizing or creating a treatment plan for a user using a device in a blockchain network”; however, it is unclear if or whether the “using a device in a blockchain network” is referring to the physician or to the user, or to both.
Claim 22 recites the limitation "the wellness treatment recipe" in line 5. There is insufficient antecedent basis for this limitation in the 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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a device (claims 1-10), system (claims 11-20), and methods (claims 21-22), which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a device comprising: a secure enclave; at least one processor executing an application, the application when executed, causing the at least one processor to at least: generate a request for one or more treatments to be executed by the treatment device; retrieve data specifying the one or more treatments from a blockchain or data availability source; request authorization for a selected one of the one or more treatments from the blockchain; and in response to receiving authorization from the blockchain, cause the device to execute the selected treatment based on data specifying the selected treatment.
Independent claim 11 recites a system comprising: a treatment device; a control client and a physician client, wherein the treatment device, control client and physician client communicate with a first and a second smart contract in a network
Independent claim 21 recites a method comprising: a physician authorizing or creating a treatment plan for a user using a device in a blockchain network; the user’s treatment device in the blockchain network further: generating a request for a treatment list; receiving treatment list or prescribed treatment list for the user; requesting a prescription treatment recipe from the prescription treatment list; requesting and receiving authorization for the prescription treatment; sending a payment for the authorized prescription recipe; and receiving the prescription treatment recipe and performing the treatment as per the treatment recipe.
Independent claim 22 recites a method comprising of a treatment device of a user in a blockchain network: requesting a treatment list and receiving treatment list from a blockchain network; requesting a treatment recipe from the treatment list; sending a payment to the blockchain network for the treatment recipe; receiving the wellness treatment recipe; and performing the treatment on the user as per the treatment recipe
The dependent claims (claims 2-10 and 12-20) appear to be encompassed by the abstract idea of the independent claims since they merely indicate detecting tampering attempt(s) (claim 2) via temperature, pressure, voltage, frequency, and/or light sensors (claims 3-5), initiating erasure, an alarm, or shutdown upon a tampering indication (claims 6-8), storing a private key and decrypting messages (claim 9), a communication module, a user authentication module, a blockchain client, and a transcranial ultrasound hardware used for ultrasound targeting and stimulation (claim 10), data received (i.e., a treatment list, characteristics, and price) as accessed by a smart contract (claim 12), executing a blockchain transaction (claim 13), authorization from a smart contract (claim 14), retrieving and performing a treatment recipe from a second smart contract (claim 15), modifying a treatment cost, configuration, or list with a second smart contract (claim 16), a physician executing a/the blockchain transaction (claim 17), and/or using Ethereum and/or Solana Virtual Machines for smart contracts (claims 18-20).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The Examiner notes that the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Certain methods of organizing human activity (e.g. fundamental economic principles or practices such as hedging, insurance, mitigating risk; commercial or legal interactions such as agreements, contracts, legal obligations, advertising, marketing or sales activities/behaviors, or business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions); and
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion).
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are using a device comprising: a secure enclave (i.e., a memory); at least one processor executing an application, the application when executed, causing the at least one processor to [perform activities] to be executed by the treatment device; using blockchain (at claim 1), a system comprising: a treatment device; a control client and a physician client, wherein the treatment device, control client and physician client communicate with a first and a second smart contract in a network (at claim 11), using a device in a blockchain network and the user’s treatment device (at claim 21), and a treatment device of a user in a blockchain network (at claim 22).
There is no indication of any change or improvement to the devices, computers, technology, blockchain, blockchain network, or any other technology areas.
As such, these additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
Regarding whether the claims effect a particular treatment or prophylaxis for a disease or medical condition, MPEP § 2106.04(d)(2) indicates that
One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter.
(at MPEP § 2106.04(d)(2))
Examiners should keep in mind that in order to qualify as a ‘treatment’ or ‘prophylaxis’ limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition” and that “The treatment or prophylaxis limitation must be ‘particular,’ i.e., specifically identified so that it does not encompass all applications of the judicial exception(s)
(at MPEP § 2106.04(d)(2)a.).
The indications of performing the treatment are very generalized – literally appearing to encompass any and all treatments of any type via any treatment device(s). Only dependent claim 10 designates any particular device or treatment (i.e., “a transcranial ultrasound hardware used for ultrasound targeting and stimulation”). However, even at claim 10, the device itself nor the operation of the device, nor the treatment being or to be applied appears changed – the price, list, and/or recipes of treatments (i.e., controls, settings, dosage, etc. that Applicant terms a “recipe” – see Applicant ¶¶ 0039 (as submitted, 0039-0045 as published) is apparently not changed, but merely the source of information is, per the claims, sourced from blockchain rather than from other possible sources. This is to say that the treatment and/or prophylaxis (if a treatment per the claims is viewed as proactively preventing) itself does not change, but apparently only the source of information regarding a/the price, list, and/or recipes is changed.
Claims 11-14 and 16-20 do not recite treatments as being made.
Therefore, the claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶ 0102 (as submitted, 0126 as published) indicates the activities as able to be performed via a general purpose computer and/or a general purpose processor.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
NOTICE
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giordano et al (U.S. Patent Application Publication No. 2017/0300627, hereinafter Giordano).
Claim 11: Giordano discloses a system comprising:
a treatment device ((see Giordano at least at, e.g., ¶ 0071, “other types of smart contracts may exist on the network 200 as well. For example, a medical device 218 may be given an identity on the network 200 and may be assigned a device smart contract 218SC”; citation hereafter by number only);
a control client (0078, “FIG. 4 depicts a flow of transactions, calls, and smart contract executions in an example process 400 for sending medical records to a patient or other user in a distributed network. … The physician 402 may also generate an invoice for services rendered and any other costs associated with the diagnostic. Each record generated by the physician 402, or an agent of the physician 402, can be uploaded to a storage system that makes medical records available to authorized users”) and
a physician client (0057, “a computer 102 that belongs to a doctor may both store medical records created by the doctor for his or her patients and may also maintain an instance of the distributed ledger”, 0058, “when a doctor creates a medical record that is added to a patient's smart contract, the medical record may initially be hosted by one or more computers associated with the doctor that created the record”), wherein the treatment device, control client and physician client communicate with a first and a second smart contract in a network (0003, “The ledger may include blocks of transactions that indicate actions that have been taken on the network since its genesis. In some implementations, the ledger also stores program modules, referred to as smart contracts, which allow participants in a distributed medical records management network to interact with the ledger and with each other. For example, doctors, patients, pharmacists, and insurers may be issued role-specific smart contracts that allow the participants to invoke various records management events on the network”).
Claim 12: Giordano discloses the system of claim 11, wherein the treatment device requests and receives a treatment list, treatment characteristics, and prices from the system, wherein the treatment list, treatment characteristics and prices are accessed through a second smart contract (0003, “The ledger may include blocks of transactions that indicate actions that have been taken on the network since its genesis. In some implementations, the ledger also stores program modules, referred to as smart contracts, which allow participants in a distributed medical records management network to interact with the ledger and with each other. For example, doctors, patients, pharmacists, and insurers may be issued role-specific smart contracts that allow the participants to invoke various records management events on the network”).
Claim 13: Giordano discloses the system of claim 11, wherein the treatment device executes a blockchain transaction that pays for the wellness treatment or prescribed treatment to system; and upon successful completion of the blockchain transaction the second smart contract is altered (0064, “a ‘patient’ smart contract may enable a user to access medical records of the user (but not of other users), to add authorizations for doctors or other parties to access all or some of the user's medical records, to remove authorization of parties to access all or some of the user's medical records, to send valid prescriptions to a pharmacist for filling, to pay bills to an insurer or doctor or other medical provider, and to adjust user account settings”, 0045, “the computer 102—and every other node in the network that maintains a copy of the ledger 106—may update the ledger 106”).
Claim 14: Giordano discloses the system of claim 11, wherein the treatment device requests and receives authorization from a first smart contract for a treatment of a user or patient (0040, “The computer 102 may perform various functions, including maintaining a distributed ledger 106 and providing a terminal that allows its user to interact with the ledger 106, broadcast transactions to other nodes in the network, send and receive medical records from a storage system 112, create, review, and modify medical records if authorized, communicate with other users in the network, or perform a combination of these functions”).
Claim 15: Giordano discloses the system of claim 11 wherein the treatment device retrieves a treatment recipe from a second smart contract and performs the treatment on the user using the treatment recipe retrieved (0071, “the doctor may determine that one or more settings on the medical device 218 that affect the patient's treatment (e.g., CPAP pressure levels) require adjustment. The doctor, through his or her smart contract, may broadcast a transaction to the network addressed to the medical device's smart contract 218SC. Once the transaction is verified, the medical device's smart contract 218SC may adjust a treatment parameter for the patient accordingly. Due to the architecture of the network and transparency of transactions among nodes, the adjusted treatment can be effected efficiently and securely while minimizing risk of unauthorized users tampering with the medical device 218”).
Claim 16: Giordano discloses the system of claim 11, wherein the control device modifies a second smart contract stored on the blockchain; the modification is associated with a cost of a treatment, a configuration of a treatment, or a treatment list (0003, “The ledger may include blocks of transactions that indicate actions that have been taken on the network since its genesis. In some implementations, the ledger also stores program modules, referred to as smart contracts, which allow participants in a distributed medical records management network to interact with the ledger and with each other. For example, doctors, patients, pharmacists, and insurers may be issued role-specific smart contracts that allow the participants to invoke various records management events on the network”, 0071, “the doctor may determine that one or more settings on the medical device 218 that affect the patient's treatment (e.g., CPAP pressure levels) require adjustment. The doctor, through his or her smart contract, may broadcast a transaction to the network addressed to the medical device's smart contract 218SC. Once the transaction is verified, the medical device's smart contract 218SC may adjust a treatment parameter for the patient accordingly. Due to the architecture of the network and transparency of transactions among nodes, the adjusted treatment can be effected efficiently and securely while minimizing risk of unauthorized users tampering with the medical device 218”).
Claim 17: Giordano discloses the system of claim 11, wherein the physician using a physician device executes a blockchain transaction with a first smart contract that creates a prescription treatment or an authorization for a user or patient (0078, “FIG. 4 depicts a flow of transactions, calls, and smart contract executions … that include a diagnosis of the ailment, lab results related to the diagnostic, and a prescription that the physician 402 has written for the patient 412 for medication to treat the ailment”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (U.S. Patent Application Publication No. 2020/0082933, hereinafter Lu) in view of Bálint (U.S. Patent Application Publication No. 2021/0064605, hereinafter Bálint).
Claim 1: Lu discloses a device comprising:
a secure enclave (see Lu at least at, e.g., ¶¶ 0038, memory, where since 0014 indicates used “a blockchain network for a secure and transparent pre-authorization process”, the memory is considered a secure enclave ; citation hereafter by number only) ;
at least one processor executing an application (0070-0073, SaaS, PaaS, AaaS, and IaaS applications as performing the indicated activities), the application when executed, causing the at least one processor to at least:
generate a request for one or more treatments to be executed by the treatment device (0028, “ Blockchain technology may consist of a shared log of events that may be kept in blocks of data that are passed to the next transaction in linear order. Thereafter, the transaction (i.e., pre-authorization and authorization) may be noted in the ledger. For example, Pre-Authorization Party A is the patient's primary care physician, Pre-Authorization Party B is a medical specialist and Pre-Authorization Party C is the insurance company. Each party, A, B and C, may need to provide authorization and consensus in order for the patient to seek medical care from the medical specialist (i.e., Pre-Authorization Party B). Once a consensus is reached, the block may be appended to the blockchain and the transaction may be noted in the ledger”, 0029, “Pre-authorization transaction requests and responses may not be tampered with on a blockchain system which may reduce errors and increase the security of the pre-authorization process”, 0030, “A pre-authorization system running on blockchain allows pre-authorization requests and authorization decisions to be traceable);
retrieve data specifying the one or more treatments from a blockchain or data availability source (0028, “ Blockchain technology may consist of a shared log of events that may be kept in blocks of data that are passed to the next transaction in linear order. Thereafter, the transaction (i.e., pre-authorization and authorization) may be noted in the ledger. For example, Pre-Authorization Party A is the patient's primary care physician, Pre-Authorization Party B is a medical specialist and Pre-Authorization Party C is the insurance company. Each party, A, B and C, may need to provide authorization and consensus in order for the patient to seek medical care from the medical specialist (i.e., Pre-Authorization Party B). Once a consensus is reached, the block may be appended to the blockchain and the transaction may be noted in the ledger”, 0029, “Pre-authorization transaction requests and responses may not be tampered with on a blockchain system which may reduce errors and increase the security of the pre-authorization process”, 0030, “A pre-authorization system running on blockchain allows pre-authorization requests and authorization decisions to be traceable);
request authorization for a selected one of the one or more treatments from the blockchain (0028, “ Blockchain technology may consist of a shared log of events that may be kept in blocks of data that are passed to the next transaction in linear order. Thereafter, the transaction (i.e., pre-authorization and authorization) may be noted in the ledger. For example, Pre-Authorization Party A is the patient's primary care physician, Pre-Authorization Party B is a medical specialist and Pre-Authorization Party C is the insurance company. Each party, A, B and C, may need to provide authorization and consensus in order for the patient to seek medical care from the medical specialist (i.e., Pre-Authorization Party B). Once a consensus is reached, the block may be appended to the blockchain and the transaction may be noted in the ledger”, 0029, “Pre-authorization transaction requests and responses may not be tampered with on a blockchain system which may reduce errors and increase the security of the pre-authorization process”, 0030, “A pre-authorization system running on blockchain allows pre-authorization requests and authorization decisions to be traceable); and
Lu, however, does not appear to explicitly disclose in response to receiving authorization from the blockchain, cause the device to execute the selected treatment based on data specifying the selected treatment. Where Lu teaches that “other patients with similar symptoms and ailments whom have had successful treatments may be analyzed and may be useful for the current patient” (Lu at 0023) – indicating that treatment is performed and recorded, Lu is not explicit regarding the device executing the treatment. Bálint, though, teaches using blockchain to store, receive, and update data in relation to treatment and treatment validation (Bálint at 0009-0013), where “a medical device is provided that is at least partially implantable. The medical device includes an application component configured to apply a therapeutic treatment and/or stimulation signals to a patient” (Bálint at 0007). Therefore, the Examiner understands and finds that to have the device execute the treatment is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to ensure the correct treatment is applied or performed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the blockchain use of Giordano with the device executing treatment in Bálint in order to have the device execute the treatment so as to ensure the correct treatment is applied or performed.
The rationale for combining in this manner is that to have the device execute the treatment is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to ensure the correct treatment is applied or performed as explained above.
Claims 21 and 22 are rejected on the same basis as claim 1 above since Lu in view of Bálint discloses a method comprising the same or highly similar activities as at claim 1 above – claim 21 being parallel to claim 1 and claim 22 being broader but covering the same activities (see Lu in view of Bálint as cited above).
Claims 2-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Bálint in further view of Felber et al. (U.S. Patent Application Publication No. 2021/0069425, hereinafter Felber) .
Claim 2: Lu in view of Bálint discloses the device of claim 1, but does not appear to explicitly disclose further comprising an anti-tampering module configured to detect a tampering attempt in the treatment device. As noted above, “a tampering attempt” is described only as encompassing detecting environmental conditions (not the actual tampering), where Applicant apparently assumes or defines that a variation or problem is construed to be a tampering attempt. Felber, though, teaches “medical devices designed for performing medical treatment, monitoring medical treatment” within an IoT (Internet of Things) network (Felber at 0018) where “the sensor 122 can be configured to include in addition to the sensor configured to detect a signal indicating the amount of medicament an environmental sensor. The environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor. In some implementations, multiple sensors 122 can be included in the injection device 102 of FIG. 1 at different locations to detect medicament amount associated data and/or to increase an accuracy of a result associated with the sensor measurements” (Felber at 0027) and including a power management module to control voltages used (Felber at 0037). Therefore, the Examiner understands and finds that to sensor monitor a device environment including temperature, light, and voltage is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to help detect that the correct medicament amount is accurately provided.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the blockchain use of Lu in view of Bálint with the environment sensor monitoring indicated in Felber in order to sensor monitor a device environment including temperature, light, and voltage so as to help detect that the correct medicament amount is accurately provided..
The rationale for combining in this manner is that to sensor monitor a device environment including temperature, light, and voltage is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to help detect that the correct medicament amount is accurately provided.as explained above.
Claim 3: Lu in view of Bálint in further view of Felber discloses the device of claim 2, wherein the anti-tampering module comprises one or more sensors to detect a temperature or pressure change exceeding a respective threshold (Felber at 0018, 0027, 0037, as at the combination above and using the rationale as combined above).
Claim 4: Lu in view of Bálint in further view of Felber discloses the device of claim 2, wherein the anti-tampering module comprises one or more sensors to monitor abnormal voltage or frequency levels indicating interference with electrical operation of the treatment device (Felber at 0018, 0027, 0037, as at the combination above and using the rationale as combined above).
Claim 5: Lu in view of Bálint in further view of Felber discloses the device of claim 2, wherein the anti-tampering module comprises one or more light sensors that detect light exposure internal to the treatment device (Felber at 0018, 0027, 0037, as at the combination above and using the rationale as combined above).
Claim 6: Lu in view of Bálint in further view of Felber discloses the device of claim 2, wherein the application, when executed, causes the one or more processors to initiate erasure of a secure enclave upon receiving an indication of tampering from the anti-tampering module.
Claim 7: Lu in view of Bálint in further view of Felber discloses the device of claim 2, wherein the application, when executed, causes the one or more processors to initiate an alarm upon receiving an indication of tampering from the anti-tampering module (Bálint at 0036, as at the combination above and using the rationale as combined above).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Bálint in further view of Felber in still further view of Iwasawa et al. (U.S. Patent Application Publication No. 2024/0189048, hereinafter Iwasawa).
Claim 8: Lu in view of Bálint in further view of Felber discloses the device of claim 2, but does not appear to explicitly disclose wherein the application, when executed, causes the one or more processors to initiate a device shutdown upon receiving an indication of tampering from the anti-tampering module. Iwasawa, though, teaches “A medical system 1A and a medical apparatus” (Iwasawa at 0093), where power to a wire can be cut off based on dynamic “threshold values … due to the influence of a surrounding environment (temperature, humidity, etc.), the threshold values can vary depending on an operation timing even on the same apparatus (Iwasawa at 0123), such that “connection unit Wc functions as a breakaway mechanism or a separation mechanism that cuts off connection (coupling, drive transmission) between a drive source and a wire member in a case where load exceeding a predetermined threshold value acts on a drive wire due to malfunction of the drive source or external force on the catheter” (Iwasawa at 0124). Therefore, the Examiner understands and finds that to shut down a device based on environmental data exceeding a threshold is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to function as a breakaway (i.e., protect the device and/or patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the blockchain use of Lu in view of Bálint in further view of Felber with the environmental shut down indicated in Iwasawa in order to shut down a device based on environmental data exceeding a threshold so as to function as a breakaway (i.e., protect the device and/or patient).
The rationale for combining in this manner is that to shut down a device based on environmental data exceeding a threshold is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to function as a breakaway (i.e., protect the device and/or patient) as explained above.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Bálint in further view of Hjelm et al. (U.S. Patent Application Publication No. 2016/0254904, hereinafter Hjelm).
Claim 9: Lu in view of Bálint discloses the device of claim 1, but does not appear to explicitly disclose wherein the secure enclave stores a private key used for signing and decrypting of messages from and to the device respectively and the contents of the secure enclave cannot be retrieved or revealed. Hjelm, though, teaches “Secure memory 135 (i.e., a non-transitory computer-readable medium) may store a public/private key pair, where the private key of the public/private key pair cannot be accessed or retrieved by device processing unit …. The digital certificates may include a Public Key Infrastructure (PKI) digital certificate (i.e., “public key certificate”) obtained using PKI mechanisms. A “digital certificate” includes an electronic “pass” that allows device 100 to exchange information securely over network 230 (shown in FIG. 2) using PKI” (Hjelm at 0020). Therefore, the Examiner understands and finds that to sign and decrypt using a private key that cannot be retrieved or revealed is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to exchange information securely.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the blockchain use of Lu in view of Bálint with the PKI indicated in Hjelm in order to sign and decrypt using a private key that cannot be retrieved or revealed so as to be able to exchange information securely.
The rationale for combining in this manner is that to sign and decrypt using a private key that cannot be retrieved or revealed is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to be able to exchange information securely as explained above.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Bálint in further view of Tyler et al. (U.S. Patent Application Publication No. 2015/0151142, hereinafter Tyler) .
Claim 10: Lu in view of Bálint discloses the device of claim 1, further comprising a communication module (Lu at 0041-0042), a user authentication module (Bálint at 0033, as at the combination above and using the rationale as combined above), a blockchain client (Lu at 0028-0030), but does not appear to explicitly disclose a transcranial ultrasound hardware used for ultrasound targeting and stimulation. Tyler, though, teaches “methods and systems for transcranial ultrasound neuromodulation” (Tyler at 0002), where “ultrasound waves are delivered transcranially with a plurality of high ultrasound frequencies in order to localize the focused beam to a target site of decreased size, and the plurality of high ultrasound frequencies interfere at the target site to generate one or more low frequencies in order to stimulate the neuronal tissue with the one or more low frequencies” (Tyler at 0016), including more specifics regarding targeting and stimulation (Tyler at 0018, 0022, 0025, 0027, 0029), where “The effective targeting of transcranial ultrasound neuromodulation as described herein can provide beneficial results and be used to identify and target one or more regions of the brain” (Tyler at 0049). Therefore, the Examiner understands and finds that to target and stimulate using transcranial ultrasound is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to localize the focused beam and generate one or more low frequencies in order to stimulate the neuronal tissue.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the blockchain use of Lu in view of Bálint with the transcranial ultrasound of Tyler in order to target and stimulate using transcranial ultrasound so as to localize the focused beam and generate one or more low frequencies in order to stimulate the neuronal tissue.
The rationale for combining in this manner is that to target and stimulate using transcranial ultrasound is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to localize the focused beam and generate one or more low frequencies in order to stimulate the neuronal tissue as explained above.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Giordano in view of Witchey et al. (U.S. Patent No. 12,462,246, hereinafter Witchey).
Claim 18: Giordano discloses the system of claim 11, but does not appear to explicitly disclose wherein the blockchain comprises Ethereum, and the authorization is provided via smart contract code running on the Ethereum Virtual Machine (at claim 18) or wherein the blockchain comprises Solana, and the authorization is provided via smart contract code running in a Solana Virtual Machine (at claim 19). Witchey, though, teaches “existing record-keeping system technologies, including systems from Ethereum, Chia networks, Solana, Polygon etc., minting DATs as NFTs or otherwise executing smart contract operations incur operation costs. For example, Ethereum charges “gas,” which is a fee provided in Ether tokens to motivate processing of the corresponding operation by Ethereum nodes running the Ethereum virtual machines” (Witchey at column:lines 39:45-52; citation hereafter by number only) and “At the time of this writing, Solana and Polygon have more attractive fee structures supporting minting or managing NFTs, but have less infrastructural support for oracles” (Witchey at 40:7-10). Since Solana, as a virtual machine is an Ethereum Virtual Machine (see Jain below at pertinent prior art not explicitly relied upon), the Examiner understands and finds that to provide the smart contract via an Ethereum or Solana Virtual Machine is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide more infrastructure support and/or reduce fees.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the blockchain use of Giordano with the Ethereum and Solana use of Witchey in order to provide the smart contract via an Ethereum or Solana Virtual Machine so as to provide more infrastructure support and/or reduce fees.
The rationale for combining in this manner is that to provide the smart contract via an Ethereum or Solana Virtual Machine is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to provide more infrastructure support and/or reduce fees as explained above.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Giordano in view of Neureuter, Jack, The Rise of Layer 2 Scaling on Ethereum, dated 11 May 2023, downloaded 25 March 2026 from https://www.fidelitydigitalassets.com/research-and-insights/rise-layer-2-scaling-ethereum#:~:text=The%20most%20popular%20types%20of,an%20increase%20in%20transaction%20throughput (hereinafter Neureuter).
Claim 20: Giordano discloses the system of claim 11, but does not appear to explicitly disclose wherein the blockchain is a layer-2 chain settling to Ethereum. Neureuter, however, teaches that “active users and applications using the Ethereum network has grown drastically over time. This pushes Ethereum’s current scalability towards its upper bound and drives up the costs associated with routine network transactions” (at p. 2), and “Ethereum’s current roadmap is fixated primarily around increasing the overall Ethereum network and ecosystem’s scalability. This scaling roadmap consists of two main upgrades: direct on-chain scaling upgrades, which have shifted in focus over time, and indirect off-chain scaling upgrades” (Id.), where
Creating additional base layer throughput can also be done without design changes to a network’s base layer itself. Instead, off-chain solutions allow for transactions to occur in a separate environment from the main chain. The most popular off-chain scaling solution, and the main subject of this paper, are Layer 2 networks.
Layer 2 solutions inherit their security from the underlying Ethereum consensus. These networks have a primary goal of increasing transaction speed, reducing base layer network congestion (thereby lowering individual transaction costs), while inheriting decentralization and security from the underlying layer 1 blockchain.4 Layer 2 networks allow for additional scalability, while not forcing design upgrades or tradeoffs onto the layer 1 blockchain and largely isolating any potential risks to solely the users of that layer 2 scaling protocol.
(Id. at 5-6).
Therefore, the Examiner understands and finds that to use a layer-2 chain settling to Ethereum is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to increase transaction speed, reduce base layer network congestion, and lower individual transaction costs, while inheriting decentralization and security from the underlying layer 1 blockchain.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the blockchain use of Giordano with the layer-2 blockchain use indicated in Neureuter in order to use a layer-2 chain settling to Ethereum so as to increase transaction speed, reduce base layer network congestion, and lower individual transaction costs, while inheriting decentralization and security from the underlying layer 1 blockchain.
The rationale for combining in this manner is that to use a layer-2 chain settling to Ethereum is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to increase transaction speed, reduce base layer network congestion, and lower individual transaction costs, while inheriting decentralization and security from the underlying layer 1 blockchain as explained above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Solana.com, EVM vs. SVM: Smart Contracts, undated, downloaded 24 March 2026 from https://solana.com/developers/evm-to-svm/smart-contracts, indicating the page enables someone to “Learn the differences between Ethereum and Solana smart contracts” (at p. 1).
Jain, Shray, An Introduction to the Solana EVM, dated 5 August 2022, downloaded 24 March 2026 from https://www.alchemy.com/overviews/solana-evm, indicating that
A virtual machine is a building block of a virtualized computing resource that exhibits nearly all the same functionality as a computer, including running applications and operating systems. This concept of the virtual machine is not novel. The technology is used across numerous technology ecosystems.
The largest smart contract development platform, Ethereum, uses an Ethereum Virtual Machine (EVM) to run smart contracts on a globally distributed network of nodes. Because there are a lot of developers building Ethereum applications, EVM-compatible blockchains, and people using Ethereum, creating a Solana EVM to make Ethereum smart contracts compatible with Solana's rust-based blockchain is advantageous.
(at p. 1).
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685