DETAILED ACTION
The present office action represents a nonfinal action on the merits.
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 the priority date of provisional application 63/341,134 of 5/12/2022 and 371 of PCT/US2023/021816 of 5/11/2023.
Status of Claims
Claims 1-23 are pending.
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 1-23 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 1-11 are drawn to a computer-implemented method of managing biological samples, which is within the four statutory categories (i.e., process). Claims 12-17 are drawn to a non-transitory computer readable medium, which is within the four statutory categories (i.e., machine). Claims 18-23 are drawn to a computer-implemented system for managing biological samples, which is within the four statutory categories (i.e., machine).
Claims 1-11 recite a computer-implemented method of managing biological samples using a network of computing nodes, the method comprising:
receiving, at a processor of a computing node, a message request to store information relating to a biological sample taken from a subject;
extracting from the message request, using said processor, location information associated with the subject's stored physical biological sample;
obtaining, using the processor, data associated with a subject providing the stored sample;
appending, using the processor, a transaction to a blockchain stored on one or more computing nodes of said network, said transaction comprising information about the subject's biological sample stored, the associated location information of the subject's stored sample and the data associated with the subject;
receiving, using said processor, queries pertaining to stored biological samples; and
responding to said queries, using the processor, by accessing the information within one or more transactions appended to said blockchain.
Claims 12-17 recite a non-transitory computer readable medium comprising instructions that, when executed by at least one hardware processor, configure the at least one hardware processor to:
receive a message request to store information relating to a biological sample taken from a subject;
extract, from the message request, location information associated with the subject's stored physical biological sample;
obtain data associated with a subject providing the stored sample;
append a transaction to a blockchain stored on one or more computing nodes of said network, said transaction comprising information about the subject's biological sample stored, the associated location information of the subject's stored sample and the data associated with the subject;
receive queries pertaining to stored biological samples; and
respond to said queries by accessing the information within one or more transactions appended to said blockchain.
Claims 18-23 recite a computer-implemented system for managing biological samples using a network of computing nodes, the system comprising:
a memory storage device storing program instructions; and
a hardware processor having circuitry and logic to execute said program instructions to configure the network of computing nodes, the hardware processor coupled to said memory storage device and in response to executing said program instructions is configured to:
receive a message request to store information relating to a biological sample taken from a subject;
extract, from the message request, location information associated with the subject's stored physical biological sample;
obtain data associated with a subject providing the stored sample;
append a transaction to a blockchain stored on one or more computing nodes of said network, said transaction comprising information about the subject's biological sample stored, the associated location information of the subject's stored sample and the data associated with the subject;
receive queries pertaining to stored biological samples; and
respond to said queries by accessing the information within one or more transactions appended to said blockchain.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components (e.g., receiving patient information; managing patient information, in this case information relating to a biological sample taken from a subject). The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 2-11, 13-17, and 19-23 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. These limitations only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 12, and 18.
The dependent claims recite additional limitations, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 12, and 18.
The additional elements from independent claims 1, 12, and 18 include:
a blockchain stored on one or more computing nodes of said network (apply it, MPEP 2106.05(f)).
The additional elements from independent claim 1 include:
a network of computing nodes (apply it, MPEP 2106.05(f)).
a processor of a computing node (apply it, MPEP 2106.05(f)).
The additional elements from independent claim 12 include:
a non-transitory computer readable medium comprising instructions that, when executed by at least one hardware processor, configure the at least one hardware processor to (apply it, MPEP 2106.05(f)).
The additional elements in claim 18 include:
a computer-implemented system for managing biological samples using a network of computing nodes, the system comprising (apply it, MPEP 2106.05(f)).
a memory storage device storing program instructions (apply it, MPEP 2106.05(f)).
a hardware processor having circuitry and logic to execute said program instructions to configure the network of computing nodes, the hardware processor coupled to said memory storage device and in response to executing said program instructions is configured to (apply it, MPEP 2106.05(f)).
The dependent claims recite additional elements not included in the independent claims, including a device, which is recited at the apply it level. (apply it, MPEP 2106.05(f)).
These additional elements, in the independent claims are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “a network of computing nodes”, “a processor of a computing node”, “a blockchain stored on one or more computing nodes of said network”, “a non-transitory computer readable medium comprising instructions that, when executed by at least one hardware processor, configure the at least one hardware processor”, “a computer-implemented system for managing biological samples using a network of computing nodes, the system”, “a memory storage device storing program instructions”, “a hardware processor having circuitry and logic to execute said program instructions to configure the network of computing nodes, the hardware processor coupled to said memory storage device and in response to executing said program instructions”, “a device”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g., see Specification Paragraphs [0026]-[0030], [0032]-[0034], and [0070]-[0073] (See MPEP 2106.05(f)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., the Specification Paragraphs [0026]-[0030], [0032]-[0034], and [0070]-[0073] discloses that the additional elements (i.e., a network of computing nodes, a processor of a computing node, a blockchain stored on one or more computing nodes of said network, a non-transitory computer readable medium comprising instructions that, when executed by at least one hardware processor, configure the at least one hardware processor, a blockchain stored on one or more computing nodes of said network,, a computer-implemented system for managing biological samples using a network of computing nodes, the system, a memory storage device storing program instructions, a hardware processor having circuitry and logic to execute said program instructions to configure the network of computing nodes, the hardware processor coupled to said memory storage device and in response to executing said program instructions, a device, that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare, blockchain-based biological sample storage).
Dependent claims 2-11 , 13-17, and 19-23 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than systems, and methods for managing biological samples using a network of computing nodes.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves any other technology, and their collective functions merely provide conventional computer implementation.
The application, is an attempt to organize human activity, using systems, and methods for managing biological samples using a network of computing nodes. The inventive concept is blockchain-based biological sample storage, which is not patentable. Therefore, whether taken individually or as an ordered combination, claims 1-23 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-10 and 12-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White (U.S. Pat. No. 10923216 B1).
Regarding claim 1, White discloses a computer-implemented method of managing biological samples using a network of computing nodes, the method comprising (Column 2 lines 5-11 and Column 14 lines 27-33 discuss health status method executed by a processor includes receiving from a test system, by the processor, a representation of biological sample data; the data store data structures to enable a distributed ledger over various network nodes.):
receiving, at a processor of a computing node, a message request to store information relating to a biological sample taken from a subject (Column 2 lines 46-67 discuss health status platform includes a receiving component, having a processor and a data store, that receives a test result of a biological sample collected from a human patient.);
extracting from the message request, using said processor, location information associated with the subject's stored physical biological sample (Column 2 lines 53-67 and Colum 16 lines 20-24 discuss the platform implements a distributed ledger system that stores encrypted test results of the patient, and an end-to-end encryption system and the distributed ledger implements a data structure that includes various blocks holding a batch of individual transactions indicating block inclusion in the ledger.);
obtaining, using the processor, data associated with a subject providing the stored sample (Column 2 lines 46-59 discuss a health status platform includes a receiving component, having a processor that receives an identification and a verification of the patient.);
appending, using the processor, a transaction to a blockchain stored on one or more computing nodes of said network, said transaction comprising information about the subject's biological sample stored, the associated location information of the subject's stored sample and the data associated with the subject (Column 4 lines 60-67, Column 5 lines 28-33, and Column 14 lines 27-65 discuss receive test results, test type, timestamp that are protected with blockchain techniques and logs all interactions where health status was provided to third parties to provide a health history over time for the user; each network node stores a local copy of the distributed ledger.);
receiving, using said processor, queries pertaining to stored biological samples (Column 2 lines 46-67 discuss health status platform includes a receiving component, having a processor and a data store; a distributed ledger system that stores encrypted test results of the patient, and an end-to-end encryption system that receives encrypted venue access requests from a venue access manager.); and
responding to said queries, using the processor, by accessing the information within one or more transactions appended to said blockchain (Column 2 lines 46-67 discuss health status platform includes a receiving component, having a processor and a data store; a distributed ledger system that stores encrypted test results of the patient, and an end-to-end encryption system that receives encrypted venue access requests from a venue access manager and provides an encrypted certificate of origin to the venue access manager.).
Regarding claim 2, White discloses wherein obtaining data associated with the subject comprises:
receiving, by the processor, an electronic medical record having information relating to an identity of the subject providing the stored sample (Column 2 lines 6-11 discuss a health status method executed by a processor includes receiving from a test system, by a processor, a representation of biological sample data of a human sample collected from a human user and analyzed by the test system for identification of a presence of an infectious disease, and identification information identifying the user.); and
filtering, using the processor, the electronic medical record to extract patient information that does not reveal said subject identity (Column 2 lines 46-66 discuss a processor and a data store receive a test result and data merging component implements a distributed ledger that stores encrypted test results of the patient and the identification and verification of the patient.).
Regarding claim 3, White discloses wherein the filtering comprises one or more of:
removing subject identity information from predetermined data fields of said medical record or rendering as anonymous subject identity information in said predetermined data fields of said medical record (Column 2 lines 46-66 discuss data merging component implements a distributed ledger that stores encrypted test results of the patient and the identification and verification of the patient.).
Regarding claim 4, White discloses wherein responding to said queries comprises:
obtaining, using said processor, search words located at respective predetermined fields of a query (Column 20 lines 27-40 discuss the profile history includes an ID field, an agent ID field, and a site ID field, each profile stores its specific profile history along with the biometric data and other profile data, and the profile history can be recalled for auditing purposes at a later time to ensure the credibility of the stored data and the transaction history also may be stored to a user data segment of the PD memory, the ABK stores information associated with any transactions made with the ABK, such as the venue name, date of access, and purchase amount.);
linking, by said processor, one or more said transactions appended on said blockchain to said query based on said obtained search words (Column 19 lines 9-43 and Column 20 lines 27-40 discuss the profile history includes an ID field, an agent ID field, and a site ID field, each profile stores its specific profile history along with the biometric data and other profile data, and the profile history can be recalled for auditing purposes at a later time to ensure the credibility of the stored data and the transaction history also may be stored to a user data segment of the PD memory, the ABK stores information associated with any transactions made with the ABK, such as the venue name, date of access, and purchase amount.).
Regarding claim 5, White discloses further comprising:
providing a query response message, using the processor, for receipt at a device associated with a requestor, said query response message including information based on said linked one or more transactions (Column 2 lines 46-67 discuss health status platform includes a receiving component, having a processor and a data store; a distributed ledger system that stores encrypted test results of the patient, and an end-to-end encryption system that receives encrypted venue access requests from a venue access manager and provides an encrypted certificate of origin to the venue access manager.).
Regarding claim 6, White discloses wherein a received query relating to a biological sample comprises a request from a requestor to obtain a stored physical biological sample, said method further comprising:
locating on the blockchain, using the processor, a transaction associated with the requested stored physical biological sample (Column 5 lines 4-6, Column 20 lines 40-67, and Column 21 lines 1-20 discuss the distributed ledger may contain a block storing the user certification and Information is sent and received in an encrypted format or may be protected with blockchain techniques to ensure complete privacy of the user test results information.);
accessing, using the processor, from the located transaction associated with the requested stored physical biological sample, an information of a contact entity responsible for providing said stored biological sample (Column 20 lines 40-67 and Column 21 lines 1-20 discuss the distributed ledger may contain a block storing the user certification and Information is sent, for example, the user, operating PD, may attempt to purchase a concert ticket for a venue associated with the VAM, the user may be required to supply, or have supplied on behalf of the user, the user's health status, the HSS may operate to require the user to supply, or have supplied, a health certificate within a defined time window.); and
automatically sending, using the processor, a communication to the contact entity to initiate a packaging of the stored sample requested in the received request, said packaging suitable for conveyance of the biological sample to the requestor (Column 21 lines 1-16 and Column 21 lines 53-65 discuss the distributed ledger may contain a block storing the user certification and other data necessary to grant access to the concert venue, the first entity proceeds to determine if the key request is valid, then the first entity synthesizes a key as part of the operation, the first entity stores the key and any associated key data (e.g., key ID) in the distributed ledger, making the key accessible to any entity having access to the distributed ledger, for example, the user receives a message from the airline system prompting the user to provide a Sars-Cov2-test result before a boarding pass is issued, the user enters the HSS account ID, the user could provide the password to the HSS account to the airline, enabling the airline to provide valid credentials to the HSS (the DMS) for retrieval of the test certification; alternately, the user could wait to be contacted from the HSS to authorize release of the user's health certificate to the airline and the HSS provides a test certification to the airline that the user has a negative test result.).
Regarding claim 8, White discloses wherein said responding to said queries by accessing the information within one or more transactions comprises:
collecting, using the processor, information from each the one or more linked transactions pertaining to the obtained search words (Column 19 lines 9-43 and Column 20 lines 27-40 discuss the profile history includes an ID field, an agent ID field, and a site ID field, each profile stores its specific profile history along with the biometric data and other profile data, and the profile history can be recalled for auditing purposes at a later time to ensure the credibility of the stored data and the transaction history also may be stored to a user data segment of the PD memory, the ABK stores information associated with any transactions made with the ABK, such as the venue name, date of access, and purchase amount.); and
generating, using the processor, a response to the query message using the collected information (Column 21 lines 1-16 and Column 21 lines 53-65 discuss the user receives a message from the airline system prompting the user to provide a Sars-Cov2-test result before a boarding pass is issued, the user enters the HSS account ID, the user could provide the password to the HSS account to the airline, enabling the airline to provide valid credentials to the HSS (the DMS) for retrieval of the test certification; alternately, the user could wait to be contacted from the HSS to authorize release of the user's health certificate to the airline and the HSS provides a test certification to the airline that the user has a negative test result.).
Regarding claim 9, White discloses wherein a further query message request for information comprises:
a request for one or more available biological samples from subjects meeting a predetermined criterion (Column 21 lines 1-16 and Column 21 lines 53-65 discuss the user receives a message from the airline system prompting the user to provide a Sars-Cov2-test result before a boarding pass is issued, the user enters the HSS account ID, the user could provide the password to the HSS account to the airline, enabling the airline to provide valid credentials to the HSS (the DMS) for retrieval of the test certification; alternately, the user could wait to be contacted from the HSS to authorize release of the user's health certificate to the airline and the HSS provides a test certification to the airline that the user has a negative test result.).
Regarding claim 10, White discloses wherein said collecting, using the processor, information from each of the one or more transactions pertaining to the requested information further comprises:
identifying one or more transactions associated with subjects meeting the predetermined criteria (Column 19 lines 9-43 and Column 20 lines 27-40 discuss the profile history includes an ID field, an agent ID field, and a site ID field, each profile stores its specific profile history along with the biometric data and other profile data, and the profile history can be recalled for auditing purposes at a later time to ensure the credibility of the stored data and the transaction history also may be stored to a user data segment of the PD memory, the ABK stores information associated with any transactions made with the ABK, such as the venue name, date of access, and purchase amount.).
Claim 12, recites substantially the same limitations as claim 1 with exclusion of the processor and with the additional limitations in which White discloses a non-transitory computer readable medium comprising instructions that, when executed by at least one hardware processor, configure the at least one hardware processor to (Column 3 lines 5-15 discuss a health status system includes a distributed computing system that in turn includes a data store, one or more processors, and wireless and wired communication equipment, the data store including non-transitory-computer-readable media storing a program of instructions that, when executed by a processor, cause the processor to receive from a test system a representation of biological sample data of a human sample collected from a human user and analyzed by the test system for identification of a presence of an infectious disease, and identification information identifying the user.).
Claims 13 and 19, recite substantially the same limitations as claim 2.
Claims 14 and 20, recite substantially the same limitations as claim 3.
Claims 15 and 21, recite substantially the same limitations as claim 4.
Claims 16 and 22, recite substantially the same limitations as claim 5.
Claims 17 and 23, recite substantially the same limitations as claim 6.
Regarding claim 18, White discloses substantially the same limitations as claim 12 in addition to:
a computer-implemented system for managing biological samples using a network of computing nodes, the system comprising (Column 2 lines 46-67, Column 3 lines 1-34 and Column 14 lines 1-65 discuss health status system includes a distributed computing system for biological sample data and network node.):
a memory storage device storing program instructions (Column 14 lines 1-65 discuss health status system includes memory that includes transaction module that includes machine instructions.); and
a hardware processor having circuitry and logic to execute said program instructions to configure the network of computing nodes, the hardware processor coupled to said memory storage device and in response to executing said program instructions is configured to (Column 9 lines 41-46 Column 14 lines 1-65 discuss health status system with CPUs, network interface, program interface, and memory and program of instructions executed by a device.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over White in view of Uribe (U.S. Pat. No. 11915808 B1).
Regarding claim 7, White discloses further comprising:
sending, using the processor, a communication to the contact entity to reserve, for subsequent conveyance to the requestor, information for use by the requestor (Column 21 lines 1-16 and Column 21 lines 53-65 discuss the user receives a message from the airline system prompting the user to provide a Sars-Cov2-test result before a boarding pass is issued, the user enters the HSS account ID, the user could provide the password to the HSS account to the airline, enabling the airline to provide valid credentials to the HSS (the DMS) for retrieval of the test certification; alternately, the user could wait to be contacted from the HSS to authorize release of the user's health certificate to the airline and the HSS provides a test certification to the airline that the user has a negative test result.).
White does not explicitly disclose:
reserve, for subsequent conveyance to the requestor, the physical biological sample for use by the requestor.
Uribe teaches:
reserve, for subsequent conveyance to the requestor, the physical biological sample for use by the requestor (Column lines 7-51 discuss store biospecimen samples and donor authorize access to data.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify White to include, reserve, for subsequent conveyance to the requestor, the physical biological sample for use by the requestor, as taught by Uribe, in order to provide a kiosk that helps customers to buy DNA/RNA/microbiome/COVID-19 test kits in public places without revealing their identities but which allows customers to gather information about their bodies. (Uribe Column 1 lines 58-61).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over White in view of Niazi (U.S. Pat. No. 11894109 B1).
Regarding claim 11, White discloses wherein said predetermined criteria comprises:
a biological sample type from subjects of a certain geographic location (Column 10 lines 34-46 discuss test platform may provide the geographical location of user.).
White does not explicitly disclose:
predetermined criteria comprises: a biological sample type from subjects of a particular age group.
Niazi teaches:
predetermined criteria comprises: a biological sample type from subjects of a particular age group (Column 8 lines 20-43 discuss patient data includes age.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify White to include, predetermined criteria comprises: a biological sample type from subjects of a particular age group, as taught by Niazi, in order to ensure that mix-ups and errors in administration are reduced or eliminated. (Niazi Abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached on (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at (866)217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call (800)786-9199 (IN USA OR CANADA) or (571)272-1000.
/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686