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
This application claims priority to applications CH01194/18, 17/281,887, CH01426/18, PCT/EP2019/076597 and PCT/EP2019/076597 and has a priority date of 01 October 2018.
Information Disclosure Statement
The IDS received 22 May 2024 has been considered by the Examiner.
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 1-15 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: The Statutory Categories:
Claims 1,8 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a computer system for determining the efficacy of a medical treatment, a method for determining efficacy of a medical treatment for a medical condition, and a computer program product comprising a non-transitory computer-readable medium having stored instructions to run the aforementioned method. All are within a statutory class for subject matter eligibility purposes.
Step 2A Prong One: The Abstract Idea
The limitations of (Claim 1 being representative) generating and storing […] an assessment […], related to collecting and processing health care data for determining the efficacy of the medical treatment for the medical condition: i) [….a…data…] contract, the […] contract comprising smart contract code and an assessment data structure, the assessment data structure defining […] for a data collection […] data records and data elements which relate to the medical treatment of a population for the medical condition and are to be collected from data sources providing health care data related to the medical treatment of the population, and ii) an assessment block to be generated and stored on the assessment […data structure…] using the data records and data elements collected, the assessment […] indicating outcomes actually achieved for the population by the medical treatment of the medical condition, the smart contract code being configured to control […] determining the efficacy of the medical treatment for the medical condition, upon an assessment […data structure…] being stored […] one the assessment […data structure…] using the outcome indicated in the assessment [..data structure…] for the population by the medical treatment of the medical condition; generating temporary blockchains for member of a reference population; and generating on each of the temporary […data structures…] a references smart […data structure…] related to the respective member of the reference population, the reference […data structure…] comprising: i) a smart contract […], and ii) a reference data structure, the reference data structure defining data records and data elements which relate to reference data from the respective member of the reference population to be considered in determining the efficacy of the medical treatment for the medical condition, the smart contract […] of the reference smart contract being configured to control […] to generate and store on the temporary […data structure…] and/or on the assessment […data structure…] a reference block, and the smart contract code of the assessment smart contract being configured to control […] the reference […data structure…] in determining the efficacy of the medical treatment for the medical condition as drafted, is a process that, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components.
The independent claims contain a variety of additional elements including a computer system, computer program product comprising a non-transitory computer readable medium, assessment blockchain having an assessment smart contract, smart contract code, and assessment block.
That is other than reciting the additional elements of computer system(s), one or more processors and a computer program product comprising a non-transitory computer readable medium the claimed invention amounts to managing personal behavior or interaction between people (i.e., a person following a series of rules or steps), which falls under certain methods of organizing human activity. For example, but for the general-purpose computer elements, the claims encompass a person manipulating data to determine the efficacy of a medical treatment in the manner described in the identified abstract idea, supra. The Examiner notes that “certain methods of organizing human activity” includes a person’s interaction with a computer (MPEP 2016.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong Two: Practical Application
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of computer system(s), one or more processors and a computer program product comprising a non-transitory computer readable medium that implements the identified abstract idea. These additional elements are not described by the applicant and are recited at a high-level of generality (i.e., a generic general-purpose computer or component thereof, see, e.g., para. 0034) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional elements of an assessment blockchain having an assessment smart contract, smart contract code, and assessment block. The assessment block chain having an assessment smart contract, smart contract code, and assessment block merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B: Significantly More
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of computer system(s), one or more processors and a computer program product comprising a non-transitory computer readable medium to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of an assessment blockchain having an assessment smart contract, smart contract code, and assessment block was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Dependent Claim Abstractions and Treatment of Dependent Additional Elements
Claims 2-8 and 10-16 is/are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim 2 merely describes receiving a rating level, generating a code, and determining the efficacy of the medical treatment. Claim 3 merely describes receiving an aggregation level for a population of patients and generating assessment data structure to define for the data collection system the aggregation level. Claim 4 merely describes receiving from one or more user and indication of a medical device and a medical drug to generate the assessment data structure configured to define for the data collection system data records and data elements which relate to the use of the medical device or medical drug, respectively, in the treatment of the medical condition, and to define the assessment block to indicate the outcome actually achieved by the use of the device or medical drug, respectively, for the treatment of the medical condition, using the outcome indicated in the assessment block for using the medical device or drug in treatment of the medical condition. Claim 5 merely describes generating smart contract code upon an assessment block being stored on the assessment blockchain. Claim 6 merely describes receiving indications of a provider of the medical treatment and a contract authority, and generating smart contract code to generate a data transaction between the contract authority and the provider of the medical treatment, depending on the efficacy. Claim 7 merely describes using one or more defined coding standards for generating the assessment data structure to define the data records, data elements, and the assessment block. Claim 9 merely describes receiving from one or more users a rating level for each of the expected outcomes; determining the efficacy of the medical treatment by rating the outcomes indicated in the assessment block, using the rating levels indicated for the expected outcomes, upon an assessment block being stored on the assessment blockchain. Claim 10 merely describes receiving from the one or more users an aggregation level for the population of patients, the aggregation level including at least one of: age, sex, geographic region, and body mass index; an degenerating the assessment data structure to further define the aggregation level at which the data records and data elements are to be collected from the data sources, and at which the assessment block is to indicate the outcomes actually achieved by the medical treatment of the medical condition. Claim 11 merely describes receiving from one or more users an indication of at least one of: a medical device and a medical drug, to be used in the medical treatment of the medical condition; generating the assessment data structure configured to define for the data collection system data records and data elements which relate to the use of the medical device or medical drug, respectively, in the treatment of the medical condition, and to define the assessment block to indicate the outcomes actually achieved by the use of the medical device or medical drug, respectively, in the treatment of the medical condition; and determining the efficacy of the medical device or medical drug, respectively, for the treatment of the medical condition, using the outcomes indicated in the assessment block for using the medical device or medical drug, respectively, in treatment of the medical condition. Claim 12 merely describes generating a data message, depending on the efficacy, upon a certain storage event occurring. Claim 13 merely describes receiving a certain indication, generating a transaction between the contract authority and the provider of the medical treatment, depending on the efficacy. Claim 14 merely describes using one or more defined coding standards for generating the assessment data structure to define for the data collection system the data records and data elements.
The dependent claims contain a number of additional elements, including: a computer system with processors, smart contract code and a blockchain. The computer system with processors was considered a generic computer or component thereof and was analyzed as such. The smart contract code and the blockchain generally link the judicial exception to a particular technological environment or field of use. Additional elements that generally link the judicial exception to a particular technological environment or field of use cannot serve to integrate the exception into a practical application or provide significantly more. See MPEP 2016.04(d)(l); MPEP 2016.05(h).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1,5-8,12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azaria (MedRec: Using Blockchain for Medical Data Access and Permission Management) in view of US 2017/0161439 A1 (hereafter Raduchel) in view of WO2015/118529 A1 (hereafter Kheifetz).
Regarding Claim 1
Azaria teaches:
A computer system for determining efficacy of a medical treatment for a medical condition, the system comprising one or more processors configured to perform the steps of: generating and storing on an assessment blockchain, related to collecting and processing health care data for determining the efficacy of the medical treatment for the medical condition: [Azaria teaches at pg. 25 a blockchain based system that gives comprehensive, immutable log and easy access to patients’ medical information across providers and treatment sites.]
i) an assessment smart contract, the assessment smart contract comprising smart contract code and an assessment data structure, the assessment data structure defining for a data collection system data records and data elements which relate to the medical treatment of a population for the medical condition and are to be collected from data sources providing health care data related to the medical treatment of the population, and [Azaria teaches at pg. 25 the use of blockchain structure applied to electronic medical records, which are interpreted as data records and data elements which relate to medical treatment of the population identified by Ramakrishnan. Azaria teaches at pg. 26 that the transaction-based state machine generalization of the blockchain is referred to as smart contracts.]
ii) an assessment block to be generated and stored on the assessment blockchain by the data collection system, using the data records and data elements collected, the assessment block indicating outcomes actually achieved for the population by the medical treatment of the medical condition, [Azaria teaches at pg. 25 a blockchain based system that gives comprehensive, immutable log and easy access to patients’ medical information across providers and treatment sites. Azaria teaches at pg. 30 pseudonymous property of transactions currently allows for data forensics, or inferring patterns of treatment from frequency analysis. Inferring patterns of treatment from frequency analysis indicates outcomes actually achieved for the population by the medical treatment of the medical condition.
Azaria may not explicitly teach:
the smart contract code being configured to control the one or more processors, such that the processors determine the efficacy of the medical treatment for the medical condition, upon an assessment block being stored by the data collection system on the assessment blockchain, using the outcomes indicated in the assessment block for the population by the medical treatment of the medical condition;
generating temporary blockchains for members of a reference population;
generating on each of the temporary blockchains a references smart contract related to the respective member of the reference population, the references smart contract comprising:
i) smart contract code,
and ii) a reference data structure, the reference data structure defining data records and data elements which relate to reference data from the respective member of the reference population to be considered in determining the efficacy of the medical treatment for the medical condition,
the smart contract code of the references smart contract being configured to control the one or more processors to generate and store on the temporary blockchain and/or on the assessment blockchain a reference block, and the smart contract code of the assessment smart contract being configured to control the one or more processors, such that the processors use the reference block in determining the efficacy of the medical treatment for the medical condition.
Raduchel teaches:
[…]
upon an assessment block being stored by the data collection system on the assessment blockchain, using the outcomes indicated in the assessment block for the population by the medical treatment of the medical condition; [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0331] sending/receiving a medical record request message. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions.]
generating temporary blockchains for members of a reference population; [Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. The teachings of Raduchel are interpreted to encompass generating temporary blockchains for members of the reference population taught by Anderson.]
generating on each of the temporary blockchains a references smart contract related to the respective member of the reference population, the references smart contract comprising: [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. Collectively, the teachings of Raduchel are interpreted to encompass generating on each of the temporary blockchains a references smart contract related to the respective member of the reference population (taught by Anderson below, the references smart contract comprising smart contract code and a reference data structure, the reference data structure defining data records and data elements which relate to reference data from the respective member of the reference population to be considered in determining the efficacy of the medical treatment for the medical condition, the smart contract code of the references smart contract being configured to control the one or more processors to generate and store on the temporary blockchain and/or on the assessment blockchain a reference block, and the smart contract code of the assessment smart contract being configured to control the one or more processors, such that the processors use the reference block in determining the efficacy of the medical treatment for the medical condition.]
i) smart contract code, [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository.]
and ii) a reference data structure, the reference data structure defining data records and data elements which relate to reference data from the respective member of the reference population to be considered in determining the efficacy of the medical treatment for the medical condition, [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. Collectively, the teachings of Raduchel are interpreted to encompass generating on each of the temporary blockchains a references smart contract related to the respective member of the reference population (taught by Anderson below), the references smart contract comprising smart contract code and a reference data structure, the reference data structure defining data records and data elements which relate to reference data from the respective member of the reference population to be considered in determining the efficacy of the medical treatment for the medical condition, the smart contract code of the references smart contract being configured to control the one or more processors to generate and store on the temporary blockchain and/or on the assessment blockchain, a reference block, and the smart contract code of the assessment smart contract being configured to control the one or more processors, such that the processors use the reference block in determining the efficacy of the medical treatment for the medical condition.]
the smart contract code of the references smart contract being configured to control the one or more processors to generate and store on the temporary blockchain and/or on the assessment blockchain a reference block, and the smart contract code of the assessment smart contract being configured to control the one or more processors, [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. Collectively, the teachings of Raduchel are interpreted to encompass generating on each of the temporary blockchains a references smart contract related to the respective member of the reference population (taught by Anderson below), the references smart contract comprising smart contract code and a reference data structure, the reference data structure defining data records and data elements which relate to reference data from the respective member of the reference population to be considered in determining the efficacy of the medical treatment for the medical condition, the smart contract code of the references smart contract being configured to control the one or more processors to generate and store on the temporary blockchain and/or on the assessment blockchain, a reference block, and the smart contract code of the assessment smart contract being configured to control the one or more processors, such that the processors use the reference block in determining the efficacy of the medical treatment for the medical condition.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the MedRec: Using Blockchain for Medical Data Access and Permission Management of Azaria to the records access and management of Raduchel with the motivation of reducing the difficulty and time used associated with the transfer of medical records (Raduchel at para. [0003]).
Azaria/Raduchel may not explicitly teach:
the smart contract code being configured to control the one or more processors, such that the processors determine the efficacy of the medical treatment for the medical condition,
such that the processors use the reference block in determining the efficacy of the medical treatment for the medical condition.
Kheifetz teaches:
the smart contract code being configured to control the one or more processors, such that the processors determine the efficacy of the medical treatment for the medical condition, [Kheifetz teaches at pg. 6 line 3-8 the data processor comprises a predictor model configured and operable for individualizing the data indicative of the disease progression models by utilizing the medical data of the specific patient, and creating a personalized disease progression model. Kheifetz teaches at pg. 6 line 6-8 such personalized disease progression model will be further simulated with respect to one or more endpoints to thereby evaluate the personalized disease progression for each treatment for the specific patient and the specific disease.]
such that the processors use the reference block in determining the efficacy of the medical treatment for the medical condition. [Kheifetz teaches at pg. 6 line 3-8 the data processor comprises a predictor model configured and operable for individualizing the data indicative of the disease progression models by utilizing the medical data of the specific patient, and creating a personalized disease progression model. Kheifetz teaches at pg. 6 line 6-8 such personalized disease progression model will be further simulated with respect to one or more endpoints to thereby evaluate the personalized disease progression for each treatment for the specific patient and the specific disease.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the MedRec: Using Blockchain for Medical Data Access and Permission Management of Azaria to the records access and management of Raduchel to the method and system for prediction of medical treatment effect of Kheifetz with the motivation of achieving personalized medicine, which is concerned with tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up (Kheifetz at pg. 1, line 8-10).
Regarding Claim 8 and 15
Due to their similarity to Claim 1, Claim 8 and Claim 15 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
Regarding Claim 5
Azaria/Raduchel/Kheifetz teach the computer system of claim 1. Azaria/Raduchel/Kheifetz further teach:
wherein the processors are further configured to generate smart contract code configured to control the one or more processors, such that the processors generate a data message, depending on the efficacy, upon an assessment block being stored on the assessment blockchain. [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0331] sending/receiving a medical record request message. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. Collectively, the teachings of Raduchel are interpreted to be a computer system with processors that are further configured to generate smart contract code configured to control the one or more processors, such that the processors generate a data message, depending on the efficacy, upon an assessment block being stored on the assessment blockchain for the particular assessment period.]
Regarding Claim 6
Azaria/Raduchel/Kheifetz teach the computer system of claim 1. Azaria/Raduchel/Kheifetz further teach:
, wherein the processors (11) are further configured to receive from the one or more users’ indications of a provider of the medical treatment and a contract authority; [Raduchel teaches at para. [0293] the user electronic device can share the electronic medical record with a healthcare exchange repository executed automatically by the user electronic device based on rules or conditions. Raduchel teaches at para. [0293] that the rules for sharing can be defined by the user, healthcare provider, or other stakeholders and will apply to the Healthcare Identity Graph data and actions. Finally, Raduchel teaches at para. [0293] smart contracts. This teaches receiving form one or more users’ indication of a provider of a medical treatment and a contract authority. ]
and to generate smart contract code (82) configured to control the one or more processors (11), such that the processors (11) generate a data transaction, between the contract authority and the provider of the medical treatment, depending on the efficacy, upon an assessment block (84) being stored on the assessment blockchain -84 for the particular assessment period. [Raduchel teaches at para. [0293] the user electronic device can share the electronic medical record with a healthcare exchange repository executed automatically by the user electronic device based on rules or conditions. Raduchel teaches at para. [0293] that the rules for sharing can be defined by the user, healthcare provider, or other stakeholders and will apply to the Healthcare Identity Graph data and actions. Finally, Raduchel teaches at para. [0293] smart contracts.]
Regarding Claim 7
Azaria/Raduchel/Kheifetz teach the computer system of claim 1. Azaria/Raduchel/Kheifetz further teach:
wherein the processors are further configured to use one or more defined coding standards for generating the assessment data structure to define for the data collection system the data records and data elements, and the assessment block. [Azaria teaches at pg. 25 the use of blockchain structure applied to electronic medical records, which are interpreted as a defined coding standard for generating the assessment data structure to define for the data collection system the data records and data elements and the assessment block which relate to medical treatment of the population identified by Ramakrishnan.]
Regarding Claim 12
Azaria/Raduchel/Kheifetz teach the method of claim 8. Azaria/Raduchel/Kheifetz further teach:
wherein the processors are further configured to generate smart contract code configured to control the one or more processors, such that the processors generate a data message, depending on the efficacy, upon an assessment block being stored on the assessment blockchain. [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0331] sending/receiving a medical record request message. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. Collectively, the teachings of Raduchel are interpreted to be a computer system with processors that are further configured to generate smart contract code configured to control the one or more processors, such that the processors generate a data message, depending on the efficacy, upon an assessment block being stored on the assessment blockchain for the particular assessment period.]
Regarding Claim 13
Azaria/Raduchel/Kheifetz teach the method of claim 8. Azaria/Raduchel/Kheifetz further teach:
further comprising the processors (11) receiving from the one or more users indications of a provider of the medical treatment and a contract authority; and generating smart contract code configured to control the one or more processors, such that the processors generate a data transaction, between the contract authority and the provider of the medical treatment, depending on the efficacy, upon an assessment block being stored on the assessment blockchain. [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0331] sending/receiving a medical record request message. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. Raduchel teaches at para. [0346] a block chain system that receives the share transaction, validates the transaction and then posts the transaction into a new block of transactions. Collectively, the teachings of Raduchel are interpreted to be a computer system with processors that are further configured to generate smart contract code configured to control the one or more processors, such that the processors generate a data message, depending on the efficacy, upon an assessment block being stored on the assessment blockchain for the particular assessment period.]
Regarding Claim 14
Azaria/Raduchel/Kheifetz teach the method of claim 8. Azaria/Raduchel/Kheifetz further teach:
further comprising the processors using one or more defined coding standards for generating the assessment data structure to define for the data collection system the data records and data elements, and the assessment block. [Azaria teaches at pg. 25 the use of blockchain structure applied to electronic medical records. This is interpreted as a defined coding standard for generating the assessment data structure to define for the data collection system the data records and data elements and the assessment block which relate to medical treatment of the population identified by Ramakrishnan.]
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azaria (MedRec: Using Blockchain for Medical Data Access and Permission Management) in view of US 2017/0161439 A1 (hereafter Raduchel) in view of WO 2015/118529 A1 (hereafter Kheifetz) in view of US 2010/0191071 A1 (hereafter Anderson).
Regarding Claim 9
Azaria/Raduchel/Kheifetz teach the method of claim 8. Azaria/Raduchel/Kheifetz further teach:
further comprising the processors receiving from the one or more users a rating level for each of the expected outcomes; [Raduchel teaches at para. [0190] a request to provide healthcare service for a particular condition, and that the application will rank the received vids. Raduchel teaches at para. [0194] ranking based on the safety record of the bidding healthcare providers within a particular healthcare network of a carrier including the number of post-procedure complications.]
Azaria/Raduchel/Kheifetz may not explicitly teach:
and generating smart contract code configured to control the one or more processors, such that the processors determine the efficacy of the medical treatment by rating the outcomes indicated in the assessment block, using the rating levels indicated for the expected outcomes, upon an assessment block being stored on the assessment blockchain.
Anderson teaches:
and generating smart contract code configured to control the one or more processors, such that the processors determine the efficacy of the medical treatment by rating the outcomes indicated in the assessment block, using the rating levels indicated for the expected outcomes, upon an assessment block being stored on the assessment blockchain. [Anderson teaches at para. [0148] that a computer system ranks the treatment options based on the results of previous patients having similar profiles to the current patient and the likelihood of success. The computer is interpreted as the user. Anderson teaches at para. [0122] output from blocks 236,238 and 240 may be routed to databases for storage.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the MedRec: Using Blockchain for Medical Data Access and Permission Management of Azaria to the records access and management of Raduchel to the method and system for prediction of medical treatment effect of Kheifetz to the methods and systems for diagnosing, treating, or tracking spinal disorders of Anderson with the motivation of improving systems and methods for diagnosing, treating, and/or tracking medical conditions (Anderson at para. [0001]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azaria (MedRec: Using Blockchain for Medical Data Access and Permission Management) in view of US 2017/0161439 A1 (hereafter Raduchel) in view of WO 2015/118529 A1 (hereafter Kheifetz) in view of US 2010/0191071 A1 (hereafter Anderson) in view of US 2017/0344580 A1 (hereafter King).
Regarding Claim 2
Azaria/Raduchel/Kheifetz teach the computer system of claim 1. Azaria/Raduchel/Kheifetz may not explicitly teach:
wherein the processors are further configured to receive from the one or more users a rating level for each of the expected outcomes;
and to generate smart contract code configured to control the one or more processors, such that the processors determine the efficacy of the medical treatment by rating the outcomes indicated in the assessment block,
using the rating levels indicated for the expected outcomes,
upon an assessment block being stored on the assessment blockchain.
Anderson teaches:
wherein the processors are further configured to receive from the one or more users a rating level for each of the expected outcomes; [Anderson teaches at para. [0148] that a computer system ranks the treatment options based on the results of previous patients having similar profiles to the current patient and the likelihood of success. The computer is interpreted as the user.]
and to generate smart contract code configured to control the one or more processors, such that the processors determine the efficacy of the medical treatment by rating the outcomes indicated in the assessment block, [Anderson teaches at para. [0131] a processor is programmed to accomplish the tasks discussed therein. Anderson teaches at para. [0131] that the processor will be part of a network, interpreted to be a blockchain. The processor of Anderson is interpreted to be generating a program code configured to control the one or more processors.]
using the rating levels indicated for the expected outcomes, [Anderson teaches at para. [0148] that a computer system ranks the treatment options based on the results of previous patients having similar profiles to the current patient and the likelihood of success. Anderson teaches at para. [0131] that the processor will be part of a network, interpreted to being stored on the assessment blockchain for the particular assessment period.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the MedRec: Using Blockchain for Medical Data Access and Permission Management of Azaria to the records access and management of Raduchel to the method and system for prediction of medical treatment effect of Kheifetz to the methods and systems for diagnosing, treating, or tracking spinal disorders of Anderson with the motivation of achieving improved systems and methods for diagnosing, treating, and/or tracking medical conditions (Anderson at para. [0001]).
Azaria/Raduchel/Kheifetz/Anderson may not explicitly teach:
upon an assessment block being stored on the assessment blockchain.
King teaches:
upon an assessment block being stored on the assessment blockchain. [King teaches at the Abstract a method for generating a segmented blockchain includes storing a first blockchain, the blockchain being comprised of blocks including a recent block, the recent block including a corresponding block header and transaction values. The definition of “recent” taught by King is interpreted as the “particular assessment period.”]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the MedRec: Using Blockchain for Medical Data Access and Permission Management of Azaria to the records access and management of Raduchel to the method and system for prediction of medical treatment effect of Kheifetz to the methods and systems for diagnosing, treating, or tracking spinal disorders of Anderson to the method and system for transferring trust across block chain segments of King with the motivation of allowing for changes in format without necessitating recreation of the entire blockchain (King at para. [0004]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azaria (MedRec: Using Blockchain for Medical Data Access and Permission Management) in view of US 2017/0161439 A1 (hereafter Raduchel) in view of WO 2015/118529 A1 (hereafter Kheifetz) in view of WO 2019/074191 A1 (hereafter Suk) in view of US 2019/0378597 A1 (hereafter) Ramakrishnan.
Regarding Claim 4
Azaria/Raduchel/Kheifetz teaches the computer system of one of claim 1. Azaria/Raduchel/Kheifetz further teaches:
[…]
to generate the assessment data structure configured to define for the data collection system data records and data elements which relate to the use of the medical device or medical drug, respectively, in the treatment of the medical condition, [Azaria teaches at pg. 25 the use of blockchain structure applied to electronic medical records, which are interpreted as a defined coding standard for generating the assessment data structure to define for the data collection system the data records and data elements and the assessment block which relate to medical treatment of the population identified by Ramakrishnan.]
[…]
and to generate smart contract code configured to control the one or more processors, such that the processors determine the efficacy of the medical device or medical drug, respectively, for the treatment of the medical condition, using the outcomes indicated in the assessment block for using the medical device or medical drug, respectively, in treatment of the medical condition. [Raduchel teaches at para. [0293] using rules called smart contracts in the course of sharing the electronic medical record with a healthcare exchange repository. Raduchel teaches at para. [0317] sharing Healthcare Identity Graph data and electronic medical record data will be shared with stakeholders for the purpose of executing a drug trial to understand the events that may have an impact of the efficacy and safety of the drug. Raduchel teaches at para. [0331] sending/receiving a medical record request message. Raduchel teaches at para. [0336] block chain system receives the share transaction, validates the transaction, and then posts the transaction into a new block of transactions, thereby emulating bitcoin transactions. Collectively, the teachings of Raduchel are interpreted to be a computer system with processors that are further configured to generate smart contract code (82) configured to control the one or more processors (11), such that the processors (11) generate a data message, depending on the efficacy, upon an assessment block (84) being stored on the assessment blockchain -84 for the particular assessment period.]
Azaria/Raduchel/Kheifetz may not explicitly teach:
wherein the processors (11) are further configured to receive from the one or more users an indication of at least one of: a medical device and a medical drug, to be used in the medical treatment of the medical condition;
and to define the assessment block to indicate the outcomes actually achieved by the use of the medical device or medical drug, respectively, in the treatment of the medical condition;
Suk teaches:
[…]
and to define the assessment block to indicate the outcomes actually achieved by the use of the medical device or medical drug, respectively, in the treatment of the medical condition; [Suk teaches at pg. 5 an input information receiving unit for receiving input information of a treatment method and patient state information (interpreted to mean the outcomes actually achieved by the use of the medical device or medical drug. Suk teaches at pg. 3 providing a cancer treatment prediction result which can identify the most appropriate cancer treatment. Suk teaches that the invention utilizes a database dictionary constructed by classifying cancer treatment types and various kind of treatment results into a semantic keyword form. This teaches receiving from one or more users, prior to performing the medical treatment of the medical condition, indications of a plurality of possible outcomes expected from the medical treatment of the medical condition.]
[…].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the MedRec: Using Blockchain for Medical Data Access and Permission Management of Azaria to the records access and management of Raduchel to the method and system for prediction of medical treatment effect of Kheifetz to the method and system for providing cancer treatment prediction result, method and system for providing treatment of Suk with the motivation of achieving a system and method for providing a cancer treatment prediction result using a data mining technique, and to a method and system for providing a cancer treatment prediction result which can identify the most appropriate cancer treatment method (Suk at pg. 3).
Azaria/Raduchel/Kheifetz/Suk may not explicitly teach:
wherein the processors (11) are further configured to receive from the one or more users an indication of at least one of: a medical device and a medical drug, to be used in the medical treatment of the medical condition;
Ramakrishnan teaches:
wherein the processors (11) are further configured to receive from the one or more users an indication of at least one of: a medical device and a medical drug, to be used in the medical treatment of the medical condition; [Ramakrishnan teaches at Figure 1 receiving a drug formulary at a specialty pharmacy to be used to treat patients. This teaches receiving from the one or more users an indication of at least one of a medical drug to be used in the medical treatment.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the MedRec: Using Blockchain for Medical Data Access and