DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed 2/17/2026 has been placed of record in the file.
Claims 1, 8, and 15 have been amended.
Claims 5, 12, and 19 have been canceled.
Claims 1-4, 7-11, 14-18, and 20 are now pending.
The applicant’s arguments with respect to claims 1-4, 7-11, 14-18, and 20 have been fully considered but they are not persuasive as discussed below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/2026 has been entered.
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.
Claims 1-4, 7-11, 14-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Young et al. (U.S. Patent Application Publication Number 2020/0021444), hereinafter referred to as Young, in view of Pagani et al. (U.S. Patent Application Publication Number 2023/0224174), hereinafter referred to as Pagani.
Young disclosed techniques for managing analytical information using distributed ledgers. In an analogous art, Pagani disclosed techniques for file verification using a blockchain. Both systems are directed toward data storage and retrieval via blockchain records.
Regarding claim 1, Young discloses a computer implemented method, comprising: receiving analytical data from a laboratory analytical instrument, wherein the analytical data is generated based on an auditable parameter (paragraphs 37-39, device receives generated analytical information); accessing a record for the auditable parameter, wherein the record is in the form of a node of a sequence representing a chain of authority tracing the auditable parameter backwards to a previous auditable parameter (paragraph 46, distributed ledger application facilitates chain), the sequence having nodes secured by a cryptographic hash based on respective content of one or more preceding nodes (paragraph 71, Merkel tree), wherein the auditable parameter and a previous auditable parameter from one of the one or more preceding nodes are each associated with a quality gate that triggers a respective record to be created, the quality gate representing a transition in an analytical workflow where responsibility for the data being analyzed passes from one user to a different user (paragraph 44, generates record for event in audit trail, and paragraph 38, audit trail includes changes in users); cryptographically securing the record based on the chain of authority to generate a cryptographically secured record (paragraph 46, generates record in distributed ledger, and paragraph 30, distributed ledger uses cryptography); and associating the cryptographically secured record with the data (paragraph 46, distributed ledger is for data generated by particular instrument).
Young does not explicitly state that the sequence is a tree with each of the one or more preceding nodes representing a record of a different auditable parameter and at least one of the nodes of the tree serving as a parent node from which multiple branches derive. However, using a tree structure overlaid on a blockchain was well known in the art as evidenced by Pagani. Since the inventions encompass the same field of endeavor, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Young by adding the ability that the sequence is a tree with each of the one or more preceding nodes representing a record of a different auditable parameter and at least one of the nodes of the tree serving as a parent node from which multiple branches derive as provided by Pagani (see paragraph 13, tree structure where each node is different transaction and one parent node is root node). One of ordinary skill in the art would have recognized the benefit that utilizing a tree structure in this way would assist in ensuring software security and data integrity (see Pagani, paragraph 12).
Regarding claim 2, the combination of Young and Pagani discloses wherein the auditable parameter comprises an identification of at least one of a reagent, an instrument, a method, a calibration, or a quality control action (Young, paragraph 37, component information, operating methods, etc.).
Regarding claim 3, the combination of Young and Pagani discloses wherein the record is compliant with an audit requirement defined by a regulatory or scientific authority (Young, paragraph 52, regulatory approval).
Regarding claim 4, the combination of Young and Pagani discloses wherein the record traces back to a root comprising a standard, a pharmacopeia, a scientific paper, a regulation, or design data for a reagent or a part of the laboratory analytical instrument (Young, paragraph 51, implements verification against standard protocols).
Regarding claim 7, the combination of Young and Pagani discloses wherein at least one record along the chain of authority is maintained by a third party, and further comprising: receiving a request to access the at least one record; transmitting the request to the third party; receiving the at least one record in response to the request, the at least one record secured by a cryptographic hash; and validating the at least one record using the cryptographic hash (Young, paragraph 45, accesses records via APIs, and paragraph 30, hash provides assurance as to integrity).
Regarding claim 8, Young discloses a non-transitory computer-readable storage medium, the computer-readable storage medium including instructions that when executed by a computer, cause the computer to: receive analytical data from a laboratory analytical instrument, wherein the analytical data is generated based on an auditable parameter (paragraphs 37-39, device receives generated analytical information); access a record for the auditable parameter, wherein the record is in the form of a node of a sequence representing a chain of authority tracing the auditable parameter backwards to a previous auditable parameter (paragraph 46, distributed ledger application facilitates chain), the sequence having nodes secured by a cryptographic hash based on respective content of one or more preceding nodes (paragraph 71, Merkel tree), wherein the auditable parameter and a previous auditable parameter from one of the one or more preceding nodes are each associated with a quality gate that triggers a respective record to be created, the quality gate representing a transition in an analytical workflow where responsibility for the data being analyzed passes from one user to a different user (paragraph 44, generates record for event in audit trail, and paragraph 38, audit trail includes changes in users); cryptographically secure the record based on the chain of authority to generate a cryptographically secured record (paragraph 46, generates record in distributed ledger, and paragraph 30, distributed ledger uses cryptography); and associate the cryptographically secured record with the data (paragraph 46, distributed ledger is for data generated by particular instrument).
Young does not explicitly state that the sequence is a tree with each of the one or more preceding nodes representing a record of a different auditable parameter and at least one of the nodes of the tree serving as a parent node from which multiple branches derive. However, using a tree structure overlaid on a blockchain was well known in the art as evidenced by Pagani. Since the inventions encompass the same field of endeavor, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Young by adding the ability that the sequence is a tree with each of the one or more preceding nodes representing a record of a different auditable parameter and at least one of the nodes of the tree serving as a parent node from which multiple branches derive as provided by Pagani (see paragraph 13, tree structure where each node is different transaction and one parent node is root node). One of ordinary skill in the art would have recognized the benefit that utilizing a tree structure in this way would assist in ensuring software security and data integrity (see Pagani, paragraph 12).
Regarding claim 9, the combination of Young and Pagani discloses wherein the auditable parameter comprises an identification of at least one of a reagent, an instrument, a method, a calibration, or a quality control action (Young, paragraph 37, component information, operating methods, etc.).
Regarding claim 10, the combination of Young and Pagani discloses wherein the record is compliant with an audit requirement defined by a regulatory or scientific authority (Young, paragraph 52, regulatory approval).
Regarding claim 11, the combination of Young and Pagani discloses wherein the record traces back to a root comprising a standard, a pharmacopeia, a scientific paper, a regulation, or design data for a reagent or a part of the laboratory analytical instrument (Young, paragraph 51, implements verification against standard protocols).
Regarding claim 14, the combination of Young and Pagani discloses wherein at least one record along the chain of authority is maintained by a third party, and wherein the instruction further configure the computer to: receive a request to access the at least one record; transmit the request to the third party; receive the at least one record in response to the request, the at least one record secured by a cryptographic hash; and validate the at least one record using the cryptographic hash (Young, paragraph 45, accesses records via APIs, and paragraph 30, hash provides assurance as to integrity).
Regarding claim 15, Young discloses a computing apparatus comprising: a processor; and a memory storing instructions that, when executed by the processor, configure the apparatus to: receive analytical data from a laboratory analytical instrument, wherein the analytical data is generated based on an auditable parameter (paragraphs 37-39, device receives generated analytical information); access a record for the auditable parameter, wherein the record is in the form of a node of a sequence representing a chain of authority tracing the auditable parameter backwards to a previous auditable parameter (paragraph 46, distributed ledger application facilitates chain), the sequence having nodes secured by a cryptographic hash based on respective content of one or more preceding nodes (paragraph 71, Merkel tree), wherein the auditable parameter and a previous auditable parameter from one of the one or more preceding nodes are each associated with a quality gate that triggers a respective record to be created, the quality gate representing a transition in an analytical workflow where responsibility for the data being analyzed passes from one user to a different user (paragraph 44, generates record for event in audit trail, and paragraph 38, audit trail includes changes in users); cryptographically secure the record based on the chain of authority to generate a cryptographically secured record (paragraph 46, generates record in distributed ledger, and paragraph 30, distributed ledger uses cryptography); and associate the cryptographically secured record with the data (paragraph 46, distributed ledger is for data generated by particular instrument).
Young does not explicitly state that the sequence is a tree with each of the one or more preceding nodes representing a record of a different auditable parameter and at least one of the nodes of the tree serving as a parent node from which multiple branches derive. However, using a tree structure overlaid on a blockchain was well known in the art as evidenced by Pagani. Since the inventions encompass the same field of endeavor, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Young by adding the ability that the sequence is a tree with each of the one or more preceding nodes representing a record of a different auditable parameter and at least one of the nodes of the tree serving as a parent node from which multiple branches derive as provided by Pagani (see paragraph 13, tree structure where each node is different transaction and one parent node is root node). One of ordinary skill in the art would have recognized the benefit that utilizing a tree structure in this way would assist in ensuring software security and data integrity (see Pagani, paragraph 12).
Regarding claim 16, the combination of Young and Pagani discloses wherein the auditable parameter comprises an identification of at least one of a reagent, an instrument, a method, a calibration, or a quality control action (Young, paragraph 37, component information, operating methods, etc.).
Regarding claim 17, the combination of Young and Pagani discloses wherein the record is compliant with an audit requirement defined by a regulatory or scientific authority (Young, paragraph 52, regulatory approval).
Regarding claim 18, the combination of Young and Pagani discloses wherein the record traces back to a root comprising a standard, a pharmacopeia, a scientific paper, a regulation, or design data for a reagent or a part of the laboratory analytical instrument (Young, paragraph 51, implements verification against standard protocols).
Regarding claim 20, the combination of Young and Pagani discloses wherein at least one record along the chain of authority is maintained by a third party, and wherein the instructions further configure the apparatus to: receive a request to access the at least one record; transmit the request to the third party; receive the at least one record in response to the request, the at least one record secured by a cryptographic hash; and validate the at least one record using the cryptographic hash (Young, paragraph 45, accesses records via APIs, and paragraph 30, hash provides assurance as to integrity).
Response to Arguments
In the remarks, the applicant has argued that the combination of Young and Pagani does not disclose the newly added features of the independent claims. However, Young is seen to teach these features. The applicant is directed to the newly added citations in the above rejection.
Conclusion
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/Victor Lesniewski/Primary Examiner, Art Unit 2493