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 .
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-14 are drawn to methods, claims 15-16 are drawn to systems, and claim 17 is drawn to a non-transitory computer readable medium, each of which is within the four statutory categories.
Step 2A(1)
Representative claim 1 recites the elements of:
A method for controlling the handling of a biological material by a plurality of biological material handling apparatuses, the method implemented by a processor executing computer program instructions stored in memory and comprising:
receiving, from one of:
a first apparatus of the plurality of apparatuses,
a device associated with a user interface for inputting data relating to biological material, and
a biological material packaging device,
status information for the biological material and identification information identifying a smart contract associated with the biological material;
querying a cryptographically secured distributed ledger using the identification information to retrieve the smart contract associated with the biological material, including a current status of the smart contract;
based on the retrieved smart contract and current status of the smart contract, querying a data storage location to retrieve executable instructions, wherein the data storage location is not a secure distributed ledger;
executing the executable instructions to cause the processor to at least:
process the status information, wherein the processing includes: validating the status information, and determining a part or parts of the status information to store on the distributed ledger; and
write to the distributed ledger to: store the determined part or parts of the status information, and update the status of the smart contract.
The preceding underlined limitations amount to a form of managing personal behavior or relationships or interactions between people and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Specifically, these elements set out a process of tracking the status and handling of a biological material by using stored rules for the handling process and the current portion of the handling process taking place in order to validate that the handling process is being adhered to, and recording that information. These are analogous to what could be performed by an individual monitoring the handling of a biological material and following a protocol for such handling.
Independent claim 15 recites similar limitations and also recites an abstract idea under the same analysis.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 recites the additional elements of a) a processor executing computer program instructions stored in memory, and recited as implementing the subsequent functions, b) a first apparatus of a plurality of biological material handling apparatuses, a device associated with a user interface for inputting data relating to biological material, and a biological material packaging device, each recited as a possible source of the status information, c) a smart contract associated with the biological material, recited as retrieved along with its status and used to retrieve the executable instructions, and d) a cryptographically secured distributed ledger recited as storing the smart contract, the status information, and the determined part of the status information.
Claim 15 recites, in addition to those listed above with respect to claim 1, the additional element of a coordination system comprising the processor and memory storing computer program instructions and recited as performing the subsequently recited data processing functions.
Paragraphs 21 and 40 of the specification describe a coordination system having a processor and memory storing executable instructions. No further disclosure is provided of structure associated with the processor or the memory. Each of the processor, memory, and coordination system are construed accordingly as encompassing generic computing elements.
Paragraph 28 describes the plurality of biological material handling apparatuses as including any of cryopreservation apparatuses, thawing apparatuses, transport apparatuses, storage apparatuses, and other devices. Paragraph 29 further describes the biological material handling apparatuses as including a processor, a communication module, and a data store, where the processor controls operation of the apparatus and generates status information.
Paragraphs 22 and 26 describe an input device and user interface in terms of its function of receiving user input data. No further disclosure is provided of the device or interface. The user device is construed accordingly as encompassing generic interface devices.
Paragraphs 46 and 48 describe the packaging device as including a processor, a communication module, a data store, and a communication module, where the processor collects sensor data and generates status information.
Paragraph 25 describes the smart contract, stating that “a given smart contract template 123 defines a set of rules in the form of milestones and corresponding subprocesses that are to take place in relation to biological material” where “[e]ach smart contract template 123 may correspond to a respective kind or category of biological material and/or a process related to a kind or category of biological material.” Paragraph 60 further describes the status of the smart contract as “indicat[ing] a "current" milestone and/or subprocess, defined by the smart contract 124, which is currently taking place or is next to take place in relation to the associated biological material.” The smart contract is construed accordingly as stored programmatic instructions or software.
Paragraph 23 describes the distributed ledger as “preferably a secure distributed ledger, and more preferably a cryptographically secured distributed ledger” such as a blockchain network.
Each of the above elements, interpreted within the context of their role within the claim, amounts to mere instructions to apply functions within the abstract idea using machines or computers as tools. The first apparatus of a plurality of biological material handling apparatuses, the device associated with a user interface, and the biological material packaging device are each recited as providing the status information for the biological material and identification information, and those functions are disclosed with respect to each device as being performed by generic processors and communication interfaces. Similarly, the smart contract is recited within the claim as used to query the data storage location for executable instructions and then updated, and is disclosed as “a set of rules in the form of milestones and corresponding subprocesses that are to take place in relation to biological material” while the status constitutes the current milestone or subprocess, i.e. the smart contract is being used to store the handling process and protocol and the current milestone. The cryptographically secured distributed ledger is simply recited as used to store the smart contract as well as portions of the status information, and is disclosed broadly as general types of distributed ledgers. These elements are not sufficient to integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 15 only recite the processor, memory, biological material handling apparatuses, device associated with a user interface, biological material packaging device, smart contract, cryptographically secured distributed ledger, and coordination system as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 2 recites storing the received status information. These limitations fall within the scope of the abstract idea as set out above.
Claim 2 further recites the additional element of a data lake used to store the received status information.
Paragraph 43 describes a data lake as “a data storage location in which the coordination system 108 stores status information and identification information received from any of the input device 112, plurality of apparatuses 102 and packaging device 126.” Paragraph 44 further states that the data lake can “include any suitable data storage mechanisms, such as local data stores, cloud storage, or distributed file systems (DFS) (e.g., InterPlanetary File System (IPFS)).” The data lake is therefore construed as encompassing generic computer storage elements.
The recited data lake amounts to mere instructions to apply functions within the abstract idea using computers as tools. The data lake is recited at a high level of generality as used to store the received status information and is disclosed broadly as any of a number of computer storage devices. This element is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 3 recites wherein the status information includes monitoring information for the biological material. These limitations fall within the scope of the abstract idea as set out above.
Claim 4 recites wherein the monitoring information includes at least one of temperature monitoring information, location monitoring information, volume monitoring information, and cell count information. These limitations fall within the scope of the abstract idea as set out above.
Claim 5 recites wherein the status information includes information about one or more previous handling steps taken in relation to the biological material. These limitations fall within the scope of the abstract idea as set out above.
Claim 6 recites wherein the biological material includes at least one of: whole blood; blood components; stem cells; modified cells; gametes; organs; and tissues. These limitations fall within the scope of the abstract idea as set out above.
Claim 7 recites determining one or more commands or one or more computer executable instructions to be executed by a second apparatus of the plurality of apparatuses. These limitations fall within the scope of the abstract idea as set out above. Examiner notes that the preceding limitations only recite a determination step and do not actually recite execution of the one or more commands or one or more computer executable instructions by a second apparatus of the plurality of apparatuses.
Claim 7 recites the additional element of transmitting the commands or computer executable instructions to the second apparatus.
However, transmitting the commands or computer executable instructions to the second apparatus only amounts to insignificant extra-solution activity, such as in the form of insignificant application. This limitation does not place meaningful limits on the claim and is only nominally related to the invention, especially given that the one or more commands or one or more computer executable instructions are not recited as actually being executed.
The above limitation also constitutes well-understood routine and conventional activity in the form of transmitting data over a network.
The element of transmitting the commands or computer executable instructions to the second apparatus therefore is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more.
Claim 8 recites the additional elements of wherein the commands or computer executable instructions are for controlling the second apparatus. These limitations fall within the scope of the abstract idea as set out above. Examiner notes that this limitation only describes the intended purpose or function of the commands or computer executable instructions, and does not positively recite controlling the second apparatus.
Claim 8 further recites the additional element of the second apparatus being one of the following: a cryopreservation apparatus for cryopreserving the biological material; a thawing apparatus for thawing the biological material; a transport apparatus for transporting the biological material; a storage apparatus for storing the biological material; a cell counter apparatus for counting cells of the biological material.
Paragraph 28 describes the plurality of biological material handling apparatuses in the same terminology as the claim as including any of cryopreservation apparatuses, thawing apparatuses, transport apparatuses, storage apparatuses, and cell counter apparatuses. Paragraph 29 further describes the biological material handling apparatuses as including a processor, a communication module, and a data store, where the processor controls operation of the apparatus and generates status information.
The above additional elements only amount to mere instructions to apply functions within the abstract idea using computers as tools. The second apparatus is only recited in the claim as performing the function of receiving transmitted commands or instructions, and those functions are disclosed with respect to each device as being performed by generic processors and communication interfaces regardless of the type of apparatus. These elements are not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 9 recites the additional elements of wherein at least one apparatus of the plurality of apparatuses is configured to host at least one node of the distributed ledger.
Paragraph 38 describes the biological material handling apparatuses hosting a node of the distributed ledger, but does not provide further detail beyond the node requiring processing and storage capacity. Paragraph 23 describes nodes of the distributed ledger, stating that “[t]he nodes 122 are organized as a peer-to-peer network in which each node 122 may connect to one or more of the other nodes 122 using a peer-to-peer communication protocol.” The nodes themselves are construed as software operating on computer hardware.
These elements only amount to mere instructions to apply functions within the abstract idea using computers as tools. Specifically, the apparatus is only recited at a high level of generality as “configured to host” at least one node, and the node and act of hosting are only disclosed broadly in the specification. Using the at least one apparatus to perform storage/processing functions associated with “hosting” the node is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 10 recites the additional elements of determining that the second at least one apparatus has sufficient processing and storage capacity to host the at least one node and execute the one or more commands or computer executable instructions, and in response allowing the second at least one apparatus to host the at least one node. These limitations fall within the scope of the abstract idea as set out above. Examiner notes that above limitations only positively recite the function of making the determination of the sufficiency of the second at least one apparatus, and do not positively require a step of using the second at least one apparatus to perform computing functions for hosting the node.
Claim 11 recites receiving historical status information and historical identification information; comparing the historical status information and historical identification information with previously received status information and identification information to determine whether the previously received status information should be updated with the historical status information; and in response to determining that the previously received status information should be updated with the historical status information, updating the previously received status information by storing an additional entry recording the historical status information. These limitations fall within the scope of the abstract idea as set out above.
Claim 11 recites the additional elements of a) the first biological material handling apparatus and the biological material packaging device as used to provide the historical status information and historical identification information, and b) the distributed ledger as used to store the historical status information.
As cited above, paragraph 29 further describes the biological material handling apparatuses as including a processor, a communication module, and a data store, where the processor controls operation of the apparatus and generates status information. Paragraphs 46 and 48 describe the packaging device as including a processor, a communication module, a data store, and a communication module, where the processor collects sensor data and generates status information.
Paragraph 23 describes the distributed ledger as “preferably a secure distributed ledger, and more preferably a cryptographically secured distributed ledger” such as a blockchain network.
The above elements amount to mere instructions to apply functions within the abstract idea using computers as tools. Each of the first biological material handling apparatus and biological material packaging device are only recited as performing the function of providing the historical status information and historical identification information, and those functions are disclosed with respect to each device as being performed by generic processors and communication interfaces. The distributed ledger is recited as used to perform the function of storing the historical status information, and is disclosed broadly as general types of distributed ledgers. These elements are not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 12 recites receiving historical status information and historical identification information; determining from the historical identification information that the historical status information has not been previously received; and storing the historical status information. These limitations fall within the scope of the abstract idea as set out above.
Claim 12 recites the additional elements of a) the first biological material handling apparatus and the biological material packaging device as used to provide the historical status information and historical identification information, and b) the distributed ledger as used to store the historical status information.
As cited above, paragraph 29 further describes the biological material handling apparatuses as including a processor, a communication module, and a data store, where the processor controls operation of the apparatus and generates status information. Paragraphs 46 and 48 describe the packaging device as including a processor, a communication module, a data store, and a communication module, where the processor collects sensor data and generates status information.
Paragraph 23 describes the distributed ledger as “preferably a secure distributed ledger, and more preferably a cryptographically secured distributed ledger” such as a blockchain network.
The above elements amount to mere instructions to apply functions within the abstract idea using computers as tools. Each of the first biological material handling apparatus and biological material packaging device are only recited as performing the function of providing the historical status information and historical identification information, and those functions are disclosed with respect to each device as being performed by generic processors and communication interfaces. The distributed ledger is recited as used to perform the function of storing the historical status information, and is disclosed broadly as general types of distributed ledgers. These elements are not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 13 recites a method for controlling the handling of an extracted biological material from its initial extraction to its ultimate use, the handling involving multiple stages, the method including executing the method of claim 1 at a plurality of the multiple stages. Examiner refers to the analysis provided above with respect to elements of the method of claim 1 falling within the scope of the abstract idea and elements which constitute additional elements. The limitations reciting executing the method at a plurality of the multiple stages fall within the scope of the abstract idea.
Claim 14 recites wherein the method of claim 1 is executed at each of the multiple stages. Examiner refers to the analysis provided above with respect to elements of the method of claim 1 falling within the scope of the abstract idea and elements which constitute additional elements. The limitation reciting executing the method at each of the multiple stages falls within the scope of the abstract idea.
Claim 16 recites a coordination system for controlling the handling of a biological material, the coordination system including: at least one processor; and a memory storing computer program instructions, which when executed by the at least one processor cause the coordination system to perform a method as claimed in claim 1. Examiner refers to the analysis provided above with respect to elements of the method of claim 1 falling within the scope of the abstract idea and elements which constitute additional elements. The elements reciting the at least one processor and a memory storing computer program instructions executed by the at least one processor constitute additional elements, and follow the same analysis set out for those elements above in the analysis of claims 1 and 15.
Claim 17 recites A non-transitory, machine-readable storage medium having computer program instructions, which when executed by at least one processor of a coordination system cause the coordination system to perform a method as claimed in any one of claim 1.
Examiner refers to the analysis provided above with respect to elements of the method of claim 1 falling within the scope of the abstract idea and elements which constitute additional elements. The elements reciting the at least one processor and non-transitory, machine-readable storage medium storing computer program instructions executed by the at least one processor constitute additional elements, and follow the same analysis set out for the processor and memory elements above in the analysis of claims 1 and 15.
Claims 1-17 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-9, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al (US Patent Application Publication 2020/0311666) in view of Hawashin et al, Blockchain-Based Management of Blood Donation (hereinafter Hawashin).
With respect to claim 1, Gray discloses the claimed method for controlling the handling of a biological material by a plurality of biological material handling apparatuses, the method implemented by a processor executing computer program instructions stored in memory ([7], [40], [167], [170], and [173]) and comprising:
receiving, from one of: a first apparatus of the plurality of apparatuses, a device associated with a user interface for inputting data relating to biological material, and a biological material packaging device, status information for the biological material (Figure 1, [7], [40]-[44], [48] and [51] describe receiving data on the environmental conditions of the material from sensors, including on the material package; [69], [76], and [80] describe each item having a unique ID, and that item having a unique blockchain, i.e. identifying a contract);
querying a cryptographically secured distributed ledger to retrieve the smart contract associated with the biological material ([8], [86], [87], [136], and [141] describe a cryptographically secure distributed ledger storing smart contracts and accessing a smart contract associated with a particular item);
based on the retrieved smart contract, querying a data storage location to retrieve executable instructions, wherein the data storage location is not a secure distributed ledger ([51], [66], and [86]-[88] describe querying the blockchain for the smart contract and an external system implementing threshold comparisons, i.e. executing instructions stored not on the blockchain);
executing the executable instructions to cause the processor to at least:
process the status information, wherein the processing includes: validating the status information, and determining a part or parts of the status information to store on the distributed ledger (Figures 5A-5C, [51], [65], [73], [83], and [86] describe determining whether the environmental conditions violate associated thresholds); and
write to the distributed ledger to: store the determined part or parts of the status information (Figure 4, [8], [65], [73], and [83] describe writing the sensor data to the distributed ledger);
but does not expressly disclose:
receiving identification information identifying a smart contract associated with the biological material and querying the distributed ledger using the identification information;
retrieving a current status of the smart contract;
querying the data storage location based on the current status of the smart contract; and
updating the status of the smart contract.
However, Hawashin teaches that it was old and well known in the art of biological materials handling before the effective filing date of the claimed invention to receive identification information identifying a smart contract associated with the biological material and querying the distributed ledger using the identification information (§V(B) describes an Ethereum node mapping the Ethereum address of the blood unit to its smart contract), and retrieve a current status of a smart contract, query a data storage location based on the current status of the smart contract, and update the status of the smart contract (Abstract and §V(A) describe a blockchain-based smart contract having a plurality of states set out in the bloodunitstate variable, where different code is executed based on the current state and the state is updated based on transit of the sample through the process).
Therefore it would have been obvious to one of ordinary skill in the art of biological materials handling before the effective filing date of the claimed invention to modify the system of Gray to retrieve the status of a smart contract, query a data storage location based on the current status of the smart contract, and update the status of the smart contract as taught by Hawashin since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gray already discloses the smart contract and querying data storage locations based on the smart contract, and to further retrieve a current status of a smart contract, query a data storage location based on the current status of the smart contract, and update the status of the smart contract as taught by Hawashin would perform those same functions in Gray, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 3, Gray/Hawashin teach the method of claim 1. Gray further discloses:
wherein the status information includes monitoring information for the biological material ([7], [40]-[44], [48] and [51] describe receiving data on the environmental conditions of the material from sensors).
With respect to claim 4, Gray/Hawashin teach the method of claim 3. Gray further discloses:
wherein the monitoring information includes at least one of temperature monitoring information, location monitoring information (Figure 10, [14], [40], and [46] describe the sensors including thermometers and GPS sensors), volume monitoring information, and cell count information.
With respect to claim 5, Gray/Hawashin teach the method of claim 1. Gray further discloses:
wherein the status information includes information about one or more previous handling steps taken in relation to the biological material ([48] describes the status information being stored and then transmitted intermittently).
With respect to claim 6, Gray/Hawashin teach the method of claim 1. Gray does not expressly disclose wherein the biological material includes at least one of: whole blood; blood components; stem cells; modified cells; gametes; organs; and tissues.
However, Hawashin teaches that it was old and well known in the art of biological materials handling before the effective filing date of the claimed invention to have biological materials include whole blood and blood components (Abstract and §V(A) describe a blockchain-based system for tracking blood products).
Therefore it would have been obvious to one of ordinary skill in the art of biological materials handling before the effective filing date of the claimed invention to modify the combination of Gray and Hawashin to have the biological materials include whole blood and blood components as taught by Hawashin since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gray and Hawashin already teach biological materials, and having the biological materials include whole blood and blood components as taught by Hawashin would perform those same functions in Gray and Hawashin, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 7, Gray/Hawashin teach the method of claim 1. Gray further discloses wherein executing the executable instructions further causes the processor to:
determine one or more commands or one or more computer executable instructions to be executed by a second apparatus of the plurality of apparatuses and transmit the commands or computer executable instructions to the second apparatus ([62], [63], [67], [136], and [137] describe sending instructions to the navigation control computer of the vehicle to control its destination).
With respect to claim 8, Gray/Hawashin teach the method of claim 7. Gray further discloses:
wherein the commands or computer executable instructions are for controlling the second apparatus ([62], [63], [67], [136], and [137] describe sending instructions to the navigation control computer of the vehicle to control its destination), and the second apparatus is one of the following:
a cryopreservation apparatus for cryopreserving the biological material;
a thawing apparatus for thawing the biological material;
a transport apparatus for transporting the biological material ([42] and [44] describe a vehicle used to transport the material);
a storage apparatus for storing the biological material;
a cell counter apparatus for counting cells of the biological material.
With respect to claim 9, Gray/Hawashin teach the method of claim 1. Gray further discloses:
wherein at least one apparatus of the plurality of apparatuses is configured to host at least one node of the distributed ledger (Figure 2 element 211, [62]-[65], and [151] describe the vehicle hosting a blockchain module).
With respect to claim 13, Gray in view of Hawashin teach the claimed method for controlling the handling of an extracted biological material from its initial extraction to its ultimate use, the handling involving multiple stages, the method including executing the method of claim 1 at a plurality of the multiple stages ([45], [53], and [54] describe transportation of the item as including a plurality of stages such as shipment to a warehouse and shipment to final destination. Examiner refers to the citations to Gray and Hawashin provided above with respect to claim 1).
With respect to claim 14, Gray/Hawashin teach the method of claim 13. Gray further discloses
wherein the method of claim 1 is executed at each of the multiple stages ([45], [53], and [54] describe transportation of the item as including a plurality of stages such as shipment to a warehouse and shipment to final destination. Examiner refers to the citations to Gray and Hawashin provided above with respect to claim 1).
With respect to claim 15, Gray discloses the claimed system for controlling the handling of a biological material comprising:
a plurality of biological material handling apparatuses (Figure 1 and [41]-[44] describe a plurality of apparatuses including containers and vehicles);
a coordination system including: a processor for executing computer program instructions; and a memory storing computer program instructions for execution by the processor ([7], [40], [167], [170], and [173]);
a cryptographically secured distributed ledger storing a smart contract associated with the biological material ([8], [86], [87], [136], and [141] describe a cryptographically secure distributed ledger storing smart contracts and accessing a smart contract associated with a particular item); and
a data storage location that is not a secure distributed ledger for storing retrievable computer-executable instructions ([51] and [66] describe a remote system having computing resources capable of executing aspects of the delivery service);
wherein the computer program instructions stored in the memory include instructions which, when executed by the processor, cause the coordination system to:
receive status information for the biological material, from one of a first apparatus of the plurality of apparatuses; a device associated with a user interface for inputting data relating to the biological material; and a biological material packaging device (Figure 1, [7], [40]-[44], [48] and [51] describe receiving data on the environmental conditions of the material from sensors, including on the material package; [69], [76], and [80] describe each item having a unique ID, and that item having a unique blockchain, i.e. identifying a contract),
query the distributed ledger to retrieve the smart contract and a current status of the smart contract ([8], [86], [87], [136], and [141] describe a cryptographically secure distributed ledger storing smart contracts and accessing a smart contract associated with a particular item); and
query the data storage location based on the smart contract to retrieve computer-executable instructions ([51] and [86]-[88] describe querying the blockchain for the smart contract and an external system implementing threshold comparisons, i.e. executing instructions stored not on the blockchain); and
wherein the computer executable instructions stored in the data storage location include instructions which, when executed by the processor, cause the coordination system to:
process the status information by validating the status information; and determining a part or parts of the status information to store on the distributed ledger (Figures 5A-5C, [51], [65], [73], [83], and [86] describe determining whether the environmental conditions violate associated thresholds); and
write to the distributed ledger to store the determined part or parts of the status information (Figure 4, [8], [65], [73], and [83] describe writing the sensor data to the distributed ledger);
but does not expressly disclose:
receiving identification information identifying a smart contract associated with the biological material and querying the distributed ledger using the identification information;
retrieving a current status of the smart contract;
querying the data storage location based on the current status of the smart contract; and
updating the status of the smart contract.
However, Hawashin teaches that it was old and well known in the art of biological materials handling before the effective filing date of the claimed invention to receive identification information identifying a smart contract associated with the biological material and querying the distributed ledger using the identification information (§V(B) describes an Ethereum node mapping the Ethereum address of the blood unit to its smart contract), and retrieve a current status of a smart contract, query a data storage location based on the current status of the smart contract, and update the status of the smart contract (Abstract and §V(A) describe a blockchain-based smart contract having a plurality of states set out in the bloodunitstate variable, where different code is executed based on the current state and the state is updated based on transit of the sample through the process).
Therefore it would have been obvious to one of ordinary skill in the art of biological materials handling before the effective filing date of the claimed invention to modify the system of Gray to retrieve the status of a smart contract, query a data storage location based on the current status of the smart contract, and update the status of the smart contract as taught by Hawashin since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gray already discloses the smart contract and querying data storage locations based on the smart contract, and to further retrieve a current status of a smart contract, query a data storage location based on the current status of the smart contract, and update the status of the smart contract as taught by Hawashin would perform those same functions in Gray, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 16, Gray discloses the claimed coordination system for controlling the handling of a biological material, the coordination system including:
at least one processor and a memory storing computer program instructions, which when executed by the at least one processor cause the coordination system to ([7], [40], [167], [170], and [173] disclose the system including processors and memory storing instructions) perform a method as claimed in claim 1 (Examiner refers to the citations to Gray and Hawashin provided above with respect to claim 1).
With respect to claim 17, Gray discloses the claimed non-transitory, machine-readable storage medium having computer program instructions, which when executed by at least one processor of a coordination system cause the coordination system ([7], [40], [167], [170], and [173] disclose the system including non-transitory media, processors, and memory storing instructions) to perform a method as claimed in any one of claim 1 (Examiner refers to the citations to Gray and Hawashin provided above with respect to claim 1).
Claims 1, 3-9, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al (US Patent Application Publication 2020/0311666) in view of Hawashin et al, Blockchain-Based Management of Blood Donation (hereinafter Hawashin) as applied to claim 1, and further in view of Lin et al, Blockchain For Health Data and Its Potential Use in Health IT and Health Care Related Research (hereinafter Lin).
With respect to claim 2, Gray/Hawashin teach the method of claim 1. Gray does not expressly disclose wherein executing the executable instructions further cause the processor to store the received status information to a data lake.
However, Lin teaches that it was old and well known in the art of biological materials handling before the effective filing date of the claimed invention to store medical data off-blockchain in a data lake (§V(a) describes storing medical data off the blockchain in a separate data lake).
Therefore it would have been obvious to one of ordinary skill in the art of biological materials handling before the effective filing date of the claimed invention to modify the combination of Gray and Hawashin to store the received data, i.e. the status information, in a data lake as taught by Lin since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gray and Hawashin already teach receiving and storing the status information, and using a data lake for storage as taught by Lin would perform those same functions in Gray and Hawashin, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claims not Presently Rejected Under 35 USC 102/103
Claims 10-12 are not presently rejected under the closest prior art of record cited herein.
Conclusion
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/Gregory Lultschik/Examiner, Art Unit 3682
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