DETAILED ACTION
The following FINAL Office action is in response to Amendment filed on July 28, 2025 for application 16906946.
Acknowledgements
Claims 1-8 and 21-30 are pending.
Claims 1-8 and 21-30 have been examined.
Notice of Pre-AIA or AIA Status
The present application, filed on or after December 13, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
In response to the Applicant’s arguments and amendments, the rejections under 35 USC § 101 have been withdrawn.
Applicant’s arguments are moot under new grounds of rejection.
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 1-8 and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Belt et al. (US 20160117471 A1) (“Belt”) in view of Tran et al (US 20180326291 A1) (“Tran”) in further view of Raduchel et al. (US 10,231,077 B2)
Regarding Claims 1 and 21, Belt discloses:
a system for providing blockchain-based patient transactions ([0087] system may use the blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written, prescription being dispensed),
the system comprising: one or more computer-readable storage media configured to store a blockchain ([0008]),
a data Application Programming Interface (API) system comprising one or more processors configured to execute computer program instructions, wherein the configuration of the one or more processors to execute the computer program instructions includes configuration to spawn a first computer access configured to execute a first set of computer program instructions from the computer program instructions and to spawn a second computer process configured to execute a second set of computer program instructions from the computer program instructions, wherein the first computer process and the second computer process are spawned concurrently, wherein a combination of the first set of computer program instructions and the second set of computer program instructions is configured to perform programs steps comprising: ([0008] systems and computer program products for processing the lifecycle of the medication transaction; [0087] present system may use the blockchain to record the lifecycle of events related to medication lifecycle management; [0050] Prescription Processor may be configured to "listen" at the switch to determine the clinical information associated with messages that pass through the switch infrastructure in either real-time using an API (application programming interface)):
receive a request for a new blockchain transaction related to a patient, the query including patient identifying information associated with the patient ([0037] Electronic Medical Record systems (EMR's), [0052], 0087] present system may use the blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written, prescription being dispensed; Fig 4 # 400);
initiate a patient lookup query to determine whether a current patient electronic health record exists based on the patient identifying information ([0052] the members including ... patients ...may be provided a user interface to register with the system; [0037] Electronic Medical Record systems (EMR's), also known as Electronic Health Record, include the medical information relating to a patient in electronic or digital form. In exemplary embodiments, the EMR receives the prescription from the physician when it is prescribed; [0029] the platform may interface with one or more medical records created by a care giver or a-prescription service used by the care giver to determine that a prescription has been created; [0066] The system through the prescription processor may identify that the patient was prescribed a blood pressure medication; Fig 3 #302);
allow writing to the blockchain using the SPPID prior to completion of the new blockchain transaction ([0075], [0087], [0088]
allow reading information associated with the new blockchain transaction from the blockchain after completion of the new blockchain transaction; ([0075], [0087], [0088]
a client computer programmed to execute computer program instructions that, when executed, cause the client computer to ([0043] All medical claims including pharmacy/ medication I diagnostic / test / specialist pass through a computer network; [0048] computer memory in which is stored non-transitory machine-readable code, and a processor confi9ured to execute the code and perform the function):
receive a patient lookup query related to a patient from a client to determine whether the patient's electronic health record exists ([0037] Electronic Medical Record systems (EMR's), also known as Electronic Health Record, include the medical information relating to a patient in electronic or digital form. In exemplary embodiments, the EMR receives the prescription from the physician when it is prescribed; (0029] the platform may interface with one or more medical records created by a care giver or a-prescription service used by the care giver to determine that a prescription has been created; (0066] The system through the prescription processor may identify that the patient was prescribed a blood pressure medication; Fig 3 #302);
determine whether an entity operating the client computer can provide data, products and/or services related to a blockchain transaction ([0087] present system may use the blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written, prescription being dispensed; (0040] Dispensers may include pharmacies who provide the medication to a patient; [0029] When a prescription is requested to be filled at a dispenser [an entity], exemplary embodiments of the prescription management system receives a "fill" or a "refill" event and tracks that as part of the lifecycle. Therefore, the platform retrieves information from the switch as the pharmacy communicates to other providers, such as insurance companies to obtain authorizations to fill the prescription (determine whether an entity operating the client computer can provide data, products and/or services related to a blockchain transaction]); and
a blockchain API system comprising one or more processors programmed to execute computer program instructions that, when executed, cause the blockchain API system to ([0087] present system may use the blockchain to record the lifecycle of events related to medication lifecycle management; (0050] Prescription Processor may be configured to "listen" at the switch to determine the clinical information associated with messages that pass through the switch infrastructure in either real-time using an API (application programming interface):
generate the blockchain transaction and read and write records to and from the blockchain ([0075] applications can make use of technologies such as OAuth2 for authorizing applications to perform functions such as read and write data on behalf of patients into and out of the system; (0087] system writes a medical/medication lifecycle event to the blockchain); and
associate one or more smart contracts with the blockchain transaction ([0089] "smart contracts" where a contract can be digitally represented and executed when the conditions are met. So the contracts can be self-enforcing and self-executing and these would be tied to the events on the blockchain).
Belt does not explicitly disclose generating, by the API system, in response to a determination that a current patient electronic health record exists for the patient, a single purpose patient ID) (SPPID) associated with the patient electronic health record, wherein the SPPID) enables the electronic health record data blockchain system to use the SPPID instead of personable identifiable information of the patient including the patient identifying information; receive the SPPID to initiate a new blockchain transaction related to the patient on the blockchain without patient-identifying information.
However, Belt discloses the patient electronic health record ([0052] the members including ... patients ... may be provided a user interface to register with the system ... a user interface for providing additional information about the ... patient directly; [0037] Electronic Medical Record systems (EMR's), also known as Electronic Health Record, include the medical information relating to a patient in electronic or digital form. In exemplary embodiments, the EMR receives the prescription from the physician when it is prescribed) and initiate a new blockchain transaction related to the patient on the blockchain without patient-identifying information ([0058] When a patient permits
access to selecting information to the manufacturer, the information may be cleaned to remove any identifiable information. Therefore, manufacturers may receive anonymous information that maintains the privacy and confidences of the user).
Tran is also in the field of providing blockchain-based patient transactions ([0301] A Patient-Provider Relationship (PPR) Smart Contract is issued when one node from a trusted institution stores and manages medical records for the patient...The system formulates the appropriate SQL queries and uploads them to the PPR on the blockchain), teaches generate a single purpose patient ID (SPPID) associated with the patient electronic health record ([0333] The assets can be shared as an instance share by adding to the document a randomized identifier or nonce, similar to a one-time use watermark or serial number [single purpose patient ID], a unique asset (derived from the original source) is then generated for a particular access request) and receive the SPPID to initiate a new blockchain transaction related to the patient on the blockchain without patient-identifying information ([0333] The assets can be shared as an instance share by adding to the document a randomized identifier or nonce, similar to a one-time use watermark or serial number, a unique asset (derived from the original source) is then generated for a particular access request and included in a smart contract as an input for a particular request for the patient's health record information ... A patient can specify their acceptable terms to the smart contract. .de-identification thresholds or preferences; [0355] prescribing a medicament entitlement token with a blockchain identifier unique to a patient). Tran further teaches allow writing to the blockchain using the SPPID prior to completion of the new blockchain transaction ([0333], [0338]) and allow reading information associated with the new blockchain transaction from the blockchain after completion of the new blockchain transaction ([0338]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate a single purpose patient ID (SPPID), as disclosed in Tran, within the invention of Belt because it is an effective method of sharing sensitive medical data with different authorized institutions (Tran [0301]).
The combination of Belt/Tran does not disclose: prevent writing to the blockchain using the SPPID after completion of the new blockchain transaction.
Raduchel however discloses: prevent writing to the blockchain using the SPPID after completion of the new blockchain transaction ([Col. 15 lines 37-47]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate prevent writing to the blockchain using the SPPID after completion of the new blockchain transaction, as disclosed in Raduchel, within the invention of Belt because it provides a system for providing a healthcare provider with an electronic medical record of a patient, a recommendation, or an alert relating to the patient, based on an analysis of the patient's health data (Raduchel [abstract]).
Regarding Claim 2 and Claim 22, Belt/Tran/ Raduchel discloses as shown above.
Belt, as modified, further discloses, wherein the smart contract exchanges digital currency between the parties involved in the smart contract ([0087] The blockchain is an emerging technology that has gained notoriety recently as a result of its use as the underlying distribute databased for the Bitcoin virtual currency [digital currency]; [0043] All medical claims including pharmacy/medication/diagnostic/ tesVspecialist pass through a computer network and through several switches that are responsible for sending the claim/prescription to the proper payer for processing and eventual payment; [0089] contracts can be self-enforcing and self-executing and these would be tied to the events on the blockchain .. ."smart contracts" where a contract can be digitally represented and executed when the conditions are met. .. smart contract with caregivers may be "pay [exchanges digital currency] the care giver or nurse; [0041] network switches include those for exchanging information between any number of pharmacies and the payers, including insurance companies).
Regarding Claims 3 and 23, Belt/Tran/ Raduchel discloses as shown above.
Belt, as modified, does not explicitly disclose, wherein the digital currency includes utility tokens or vouchers.
However, Belt discloses digital currency ([0087] The blockchain is an emerging technology that has gained notoriety recently as a result of its use as the underlying distribute databased for the Bitcoin virtual currency).
Tran teaches wherein the digital currency includes utility tokens or vouchers ([0375] Each and every one of these stakeholders or network peers approved by the patient can easily join health blockchains as either nodes or buyer or seller of tokens or payments to gain access to patient data, utilizing a variety of open access methods and smart contracts that store and monitor real-time contractual conditions agreed to by and between various stakeholders; [0376]
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate the utility tokens or
vouchers, as disclosed in Tran, within the invention of Belt because it is an effective currency to use when the smart contract would
triggers a reward payment when goals are met near real-time to the patient's public bitcoin address (Tran [0376]).
Regarding Claims 4 and 24, Belt/Tran/ Raduchel discloses as shown above.
Belt, as modified, does not explicitly disclose, wherein the SPPID cannot be used to write information to the blockchain after a patient blockchain transaction is completed.
However, Belt discloses write information to the blockchain ([0087] Blockchain is an append-only ledger for transactions ([0087] present system may use the blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written ... system writes a medical/medication lifecycle event to the blockchain).
Tran teaches the SPPID cannot be used to write information to the blockchain after a patient blockchain transaction is completed ([0333] one-time use watermark or serial number [SPPID], a unique asset (derived from the original source) is then generated for a particular access request and included in a smart contract as an input for a particular request for the patient's health record information).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate the SPPID cannot be used to write information to the blockchain after a patient blockchain transaction is completed, as disclosed in Tran, within the invention of Belt because it is an effective protocol for maintaining secured transactions involving sensitive medical data (Tran (0301]).
Regarding Claims 5 and 25, Belt/Tran/ Raduchel discloses as shown above.
Belt, as modified, further discloses, wherein the blockchain API system can generate a notification when the blockchain transaction is generated ((0060] Data Analytics and Reporting module provide targeted insights for specific communities of interest available via ... AP l's in either near real-time, real-time, or batch modes. For example, the reporting module may provide ... notifications regarding medications; (0029] When a prescription is requested to be filled at a dispenser, exemplary embodiments of the prescription management system receives a "fill" or a "refill" event and tracks that as part of the lifecycle. Therefore, the platform retrieves information from the switch as the pharmacy communicates to other providers; [0087] use the blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written).
Regarding Claims 6 and 26 Belt/Tran/ Raduchel discloses as shown above.
Belt, as modified, further discloses, wherein the blockchain API system can transmit the notification to one or more providers ((0060] Data Analytics and Reporting module provide targeted insights for specific communities of interest available via ... APl's in either near real-time, real-time, or batch modes. For example, the reporting module may provide ... notifications regarding medications; (0087] use the blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written; (0024] If the prescription has been filled, at step 304, the platform may be configured to notify the appropriate
entities; (0029] When a prescription is requested to be filled at a dispenser, exemplary embodiments of the prescription management system receives a "fill" or a "refill" event and tracks that as part of the lifecycle. Therefore, the platform retrieves information from the switch as the pharmacy communicates to other providers; Fig 3 #304).
Regarding Claims 7 and 27, Belt/Tran/ Raduchel discloses as shown above.
Belt, as modified, further discloses, wherein the client computer can provide information to the blockchain API system regarding data, products and/or services related to the blockchain transaction ([0087] system may use the blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written, prescription being dispensed, picked up by a customer, not picked up in a certain amount of time, a prescription recently picked up and an external event occurring such as vital signs/heart rate increasing, a person found unconscious by paramedics or arrives at a hospital emergency room, and they have recently picked up a prescription ... system writes a medical/medication lifecycle event to the blockchain so that the system data can be decentralized and does not need to rely on a central database owned by only one entity).
Regarding Claims 8 and 28, Belt/Tran/ Raduchel discloses as shown above.
Belt, as modified, does not explicitly disclose, wherein the blockchain API system edits the blockchain transaction on the blockchain.
However, Belt discloses wherein the blockchain API system records the blockchain transaction on the blockchain ([0029] the dispenser/pharmacist may alter the original prescription by substituting a generic or different medication or recommend a different regimen. Any change in medication due to substitutions, interactions, etc. result in "change" events transmitted to the system for tracking; (0087] blockchain to record the lifecycle of events related to medication lifecycle management, including but not limited to a prescription being written, prescription being dispensed; Fig 4 # 400 and 403).
Tran teaches wherein the blockchain API system edits the blockchain transaction on the blockchain ([0379] The audit trail contains the following; (0380] An entry identifying the type of modification made to the database/record, such as additions, deletions, modifications).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate the edits, as disclosed in Tran, within the invention of Belt because it effectively maintains an automatic audit trail of all events and modifications made to the system secured by blockchain (Tran (0379]).
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Belt in view of Tran in view of Raduchel in further view of Ricciardi (US 2009/0208011 A1).
Regarding Claim 29, Belt/Tran/ Raduchel /Riccardi discloses as shown above.
Belt, as modified, does not explicitly disclose, wherein the cycle includes one or more of: the duration of the new block transaction related to the patient; a period of time including a periodic interval that is one of hourly, daily, weekly, and other configurable period of time; and a patient metric including one or more of a number of queries associated with the patient, a number of transactions associated with the patient, and other metric associated with the patient.
Ricciardi however discloses wherein the cycle includes one or more of: the duration of the new block transaction related to the patient; a period of time including a periodic interval that is one of hourly, daily, weekly, and other configurable period of time; and a patient metric including one or more of a number of queries associated with the patient, a number of transactions associated with the patient, and other metric associated with the patient [0024,0025]
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate discard the SPPID in response to completion of a cycle, as disclosed in Ricciardi, within the invention of Belt because it is an effective method for securing patient identity (Ricciardi [abstract]).
Regarding Claim 30, Belt/Tran/Riccardi discloses as shown above.
Belt, as modified, does not explicitly disclose, wherein the cycle includes one or more of: the duration of the new block transaction related to the patient; a period of time including a periodic interval that is one of hourly, daily, weekly, and other configurable period of time; and a patient metric including one or more of a number of queries associated with the patient, a number of transactions associated with the patient, and other metric associated with the patient.
Ricciardi however discloses wherein the cycle includes one or more of: the duration of the new block transaction related to the patient; a period of time including a periodic interval that is one of hourly, daily, weekly, and other configurable period of time; and a patient metric including one or more of a number of queries associated with the patient, a number of transactions associated with the patient, and other metric associated with the patient [0024,0025]
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate discard the SPPID in response to completion of a cycle, as disclosed in Ricciardi, within the invention of Belt because it is an effective method for securing patient identity (Ricciardi [abstract]).
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure, and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
US 20160335397 A1- discloses a method (200) involves accessing (202) a record of healthcare data. The information (PII) associated with persons to whom the healthcare data pertains is identified (204). The extracted portions of PII are encrypted (206). A source-specific identifier encoded in a manner specific to an organization associated with a first computer system and created with reference to hashed tokens is received. An association is stored between the source-specific identifier and the accessed record of healthcare data.
US 8917165 B2- discloses a method of detecting and re-personalizing RFID tags, comprising: obtaining a used single-use first anonymous ID (identification) from a RFID tag, the RFID tag comprising a memory divided into a first rewritable portion and a second rewritable portion, wherein said used single-use first anonymous ID is stored on the first rewritable portion; generating a single-use second new anonymous ID different from said used single-use first anonymous ID; and determining if contents of said first rewritable portion and said second rewritable portion agree; wherein, if said contents agree: using either contents of said first rewritable portion or contents of said second rewritable portion to lookup a subject's record in a database, unlinking said used single-use anonymous ID from the RFID tag after reading the used single-use first anonymous ID when said single-use second new anonymous ID is generated, and writing said single-use second new anonymous ID to said second rewritable portion of said memory of said RFID tag; and wherein if said contents disagree: individually using contents of said first rewritable portion and contents of said second rewritable portion to lookup said subject's record in said database, and writing said single-use second new anonymous ID to one of said first rewritable portion and said second rewritable portion having bad data stored thereon.
US 20210004490 A1- discloses an anonymous identifier, that is, the synchronization attribute may be generated as a single anonymous identifier that is generated by allowing only one personal identification attribute value to correspond to one cell, and multiple anonymous identifiers that are generated by allowing a plurality of personal identification attribute values to correspond to one cell.
US 20190156938 A1- discloses a method involves creating a cryptographic hash of prescription data and auxiliary information to create a unique identifier for prescription. The hash is recorded as an issue transaction (161) corresponding to the prescription. An acceptance message (208) indicating that a pharmacy platform (130) is willing to fill the prescription, is received from a pharmacy computing platform. The acceptance message is verified if the pharmacy platform corresponds to a pharmacy identity (ID) and the pharmacy is an authorized pharmacy. An accept transaction (164) on a blockchain (160) is recorded corresponding to the prescription, where the accept transaction includes the hash.
US 20190198144 A1- discloses a method involves receiving an indication of a prescription transaction for a patient, where the prescription transaction being recorded in a distributed ledger. A submission for dispensing the prescription is received for each of a set of pharmacies. An indication that the patient selects a pharmacy is received to dispense the prescription based on the submissions. An indication of the dispensing pharmacy is recorded in the distributed ledger, where the prescription transaction includes a smart contract that records in the distributed ledger and a submission selection transaction with a smart contract controls selecting of the pharmacy for dispensing the prescription.
US 20120323717 A1- discloses the OneID replaces the need to maintain hundreds of credentials for a single person (user names and passwords) with a single digital identity that is based on using two Elliptic Curve Cryptography (ECC-160) public key pairs (one pair for signing and authentication and the other pair for encryption). That digital identity is then used to authenticate to websites and other services both on-line and off-line. The authentication is peer-to-peer so there is no bottleneck or single point of failure. The use of two different keys (signing vs. encryption) is relatively rare today, yet it is core to the security and usability of some embodiments of the present invention. Accordingly, these key pairs are treated very differently in some embodiments.
US 20190034924 A1- discloses A method for verifying transactions is discussed. The method includes receiving a transaction request for performing a transaction between a user account and a merchant account. The method includes determining, based on authentication of the user account, a common identifier associated with the user account, the common identifier indicating the user account being authorized for use at a plurality of merchant accounts including the merchant account. The method includes determining a payment token for performing the transaction, the determining the payment token based on the common identifier and a user associated with the user account. The method also includes providing the payment token for completing the transaction.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA RAZA whose telephone number is (571)272-8128. The examiner can normally be reached 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John W Hayes can be reached at (571) 272-6708. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZEHRA RAZA/Examiner, Art Unit 3697
/JOHN W HAYES/Supervisory Patent Examiner, Art Unit 3697