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 6/23/2026 has been placed of record in the file.
No claims have been amended.
The applicant states that claims 1-5, 7-12, 14-18, and 20 are pending. However, claims 5 and 12 were previously canceled by the applicant.
Claims 1-4, 7-11, 14-18, and 20 are 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.
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:
<Argument 1>
The combination of Young and Pagani does not disclose the features of independent claim 1 because it does not disclose “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” as recited in claim 1.
<Argument 2>
The combination of Young and Pagani does not disclose the features of independent claim 1 because it does not disclose “accessing a record for the auditable parameter, wherein the record is in the form of a node of a tree representing a chain of authority tracing the auditable parameter backwards to a previous auditable parameter, the tree having nodes secured by a cryptographic hash based on respective content of one or more preceding nodes, each of the one or more preceding nodes representing a record of a different auditable parameter, at least one of the nodes of the tree serving as a parent node from which multiple branches derive” as recited in claim 1.
<Argument 3>
There is no motivation to combine the teachings of Young and Pagani.
<Argument 4>
The combination of Young and Pagani does not disclose the features of dependent claim 20 because it does not disclose “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” as recited in claim 20.
In response to argument 1, the combination of Young and Pagani does disclose the features as recited in claim 1. The rejection cites Young, paragraph 38, which shows that the audit trail includes an event of a change in users, and paragraph 44, which shows that a record is generated for each event in the audit trail. This is seen to meet the limitation at hand as Young clearly discloses a record creation for a change-in-users event. Here the applicant argues that “the claimed quality gate is a proactive, affirmative workflow milestone, not a passive system log entry.” However, such a distinction is not clear in the claim language. In the claims, the term “quality gate” is defined by its function, ie. it is something, anything, that triggers record creation. The applicant describes Young as “a system that passively records system events,” but any such system would meet the language of a “quality gate” as claimed and Young’s system clearly creates a record based on occurrence of the event. It is further unclear how the applicant’s comments about a “per-node quality gate structure” relate to the claim language. In Young, for example, recordation of a change in user would provide for records in the sequence with recordation of different users. The applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to argument 2, the combination of Young and Pagani does disclose the features as recited in claim 1. The rejection cites Young, paragraph 46, which shows a series of records in a distributed ledger, and Pagani, paragraph 13, which shows a distributed ledger with a tree structure where each node is a different transaction and one parent node is the root node. This is seen to meet the limitation at hand as the combination of Young and Pagani clearly discloses a series of records managed in a tree structure. The applicant argues that “Pagani’s tree nodes are file records organized for software security, not records of qualitatively distinct auditable parameters organized for quality control traceability.” However, Young has been cited as already disclosing the type of records as claimed. The teachings of Pagani have been added merely to show one additional particular sequence structure of linked records. Here the applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Under the subsequent subheading, the applicant argues that Pagani is not concerned with “records of qualitatively different auditable parameters representing a quality control chain of authority.” Again, Young has been cited as already disclosing the type of records as claimed.
In response to argument 3, there is motivation to combine the teachings of Young and Pagani as described in the rejection. The rejection cites Pagani, paragraph 12, which shows that utilizing tree structures in distributed ledgers could enhance security and integrity in the applicable system. It is maintained that this would have been sufficient motivation for one of ordinary skill in the art to utilize an alternate chaining structure (ie. Pagani’s tree structure) in the distributed ledger of Young as both Young and Pagani are concerned with maintaining data integrity within the distributed ledger and the larger related network system. The applicant argues that “the stated motivation addresses a problem that does not arise in Young’s system,” but Young is clearly also concerned with data integrity as the applicant readily admits. The applicant also argues that “the stated motivation is borrowed from Pagani’s unrelated software-security objective,” but the concept of data integrity within a distributed ledger is still transferable to the system of Young separate from the type of records within the ledger. The applicant also argues that the combination “would not produce the specifically claimed result,” but the features of “file-verification” in Pagani are not being sought out in the combination of the prior art. As described in the response to argument 2 above, the teachings of Pagani have been added in the combination merely to show a particular sequence structure of linked records, where one sequence of linked records has already been described by Young.
In response to argument 4, the combination of Young and Pagani does disclose the features as recited in claim 20. The rejection cites Young, paragraph 45, which shows the ability to access records not stored locally, and paragraph 30, which shows the use of hashing for data integrity. This is seen to meet the limitation at hand as the combination of Young and Pagani clearly discloses the ability to request and receive access to the distributed ledger, where the records of the ledger are secured by cryptographic hash. Here the applicant argues that the records of the claims “are independently maintained by external third parties, requiring the apparatus to actively solicit those records and then independently verify their integrity upon receipt using their cryptographic hash.” This seems to imply third parties that are “external” to the distributed ledger, but this concept remains unclear, both in the remarks and in the claim language. The “third party” of the claim could be any entity separate from the requestor, including the system at large or the distributed ledger itself. Again, the applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Victor Lesniewski/Primary Examiner, Art Unit 2493
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