DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/15/25 are in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
Priority
Claim Foreign application app# 2022-125217 priority and also acknowledge that this case is a 371 of PCT/JP2023/019184.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claim 1, 4, 9, and 12 term “storage unit” it is recited in the claims using the placeholder “unit” to stores…. Therefore, this element is construed to cover the corresponding structure described in the specification and equivalents thereof.
Claim 1-8, term "control unit" invoke 35 U.S.C 112(f) interpretation. The claim limitation 'control unit' is interpreted under 35 U.S.C. 112(f) because the term 'unit' is a generic placeholder that does not impart sufficient structure to perform the recited function of 'sets a unique identifier... replaces related information... and controls a plurality of records'. The claim language does not provide the physical structure or specific steps (algorithm) necessary to perform this function. Therefore, this element is construed to cover the corresponding structure described in the specification and equivalents thereof.
Claim 1, term "analyzing unit" invoke 35 U.S.C 112(f) interpretation. The claim limitation 'analyzing unit' is interpreted under 35 U.S.C. 112(f) because the term 'unit' is a generic placeholder that does not impart sufficient structure to perform the recited function of 'analyzes a sample'. The claim language does not provide the physical structure or specific steps (algorithm) necessary to perform this function. Therefore, this element is construed to cover the corresponding structure described in the specification and equivalents thereof.
Claim 5 (and 7, 8), term "display unit" invoke 35 U.S.C 112(f) interpretation. The claim limitation 'display unit' is interpreted under 35 U.S.C. 112(f) because the term 'unit' is a generic placeholder that does not impart sufficient structure to perform the recited function of 'displays information including the related information... or displays information except the related information'. The claim language does not provide the physical structure or specific steps (algorithm) necessary to perform this function. Therefore, this element is construed to cover the corresponding structure described in the specification and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Analyzing unit (Hardware)
The specification states, “The analyzing unit 50 includes a sample disk 2, a reaction disk 8, a reagent disk 17, and peripheral devices thereof,” directly describing the analyzing unit as a collection of physical, mechanical components. This explicit listing of tangible hardware parts demonstrates that the analyzing unit is hardware. Refer par. 0020
Control Unit (Hardware)
Based on paragraph [0024], the control unit is physical hardware consisting of a processor and memory. It functions by executing software program code.
Storage Unit
Term is interpreted as storage device (e.g., local HDD/SSD and/or remote cloud-backed storage, par. 0024, 0077) that store the recited database/log.
Display Unit
Both terms are clear under BRI based on the specification.
The "display unit" is physical hardware, specifically component 12 in Fig. 1 connected to the control unit [0024].
A "display mode" is a distinct software state controlling how information appears on that hardware, distinctively defined as either a "first display mode" (user mode showing patient IDs) or a "second display mode" (service mode showing identifiers instead) [0070-0071].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the personal information of the log" in the phrase "deleting the related information and the personal information of the database, and the related information and the personal information of the log." There is insufficient antecedent basis for this limitation in the claim.
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.
Subject Matter Eligibility Rejection 35 U.S.C. § 101
Claims 1–16 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception (an abstract idea) without reciting elements that integrate the exception into a practical application or provide an inventive concept amounting to significantly more than the exception itself.
Step 1: Statutory Categories Analysis
The claims are directed to statutory subject matter, encompassing the following statutory categories:
· Process (Claims 9–16): The language reciting "storing, in a storage unit, a database," "setting a unique identifier," and "outputting the database and the log" defines a series of acts or steps, aligning with the definition of a process in MPEP § 2106.03.
· Machine (Claims 1–8): The language reciting "an analyzing unit that analyzes a sample," "a storage unit that stores a database," and "a control unit" describes a concrete thing consisting of parts, aligning with the definition of a machine in MPEP § 2106.03.
Having confirmed the claims are directed to statutory subject matter, the analysis proceeds to Prong One.
Step 2A, Prong One: Judicial Exception Analysis
Step 2A, Prong One verifies whether a claim recites a specific judicial exception before determining if that exception is integrated into a practical application under Prong Two. As explained in MPEP 2106.04, subsection II, a claim "recites" a judicial exception when the judicial exception is "set forth" or "described" in the claim.
Inventive Concept Overview
The whole invention is related to anonymized data tracing via unique identifiers. Refer to the Specification at paragraphs [0008–0010] and [0044–0058] for further details.
More specifically, Claims 1–16 are directed to a judicial exception because they recite the abstract idea of managing medical data records through unique identifier synchronization and redaction. Under the Broadest Reasonable Interpretation (BRI), the claims recite a series of data management steps, including storing linked patient information, tagging records, matching or replacing identifiers across files to maintain traceability, and deleting sensitive information, that constitute a mental process of observation, evaluation, and judgment.
Independent Claims Recite the Following Non-Bold Parts
Claim 1.
An analyzer comprising:
an analyzing unit that analyzes a sample;
a storage unit that stores a database in which related information linked to personal information of a patient having supplied the sample, and sample information of the sample to be analyzed by the analyzing unit, an analysis result of the sample by the analyzing unit, or the personal information of the patient are stored in a corresponding manner and a log including the related information;
and
a control unit that sets a unique identifier for each record of the database, sets, for the related information of the log, the identifier set for the related information of the database which is the same as the related information of the log, and after deleting the related information of the database and the related information of the log, outputs the database and the log to an external device.
Note: The bolded portions represent additional elements evaluated in Prong Two and Step 2B. The non-bolded portions represent the abstract idea.
Claim Abstract Classification Rationale
Under their Broadest Reasonable Interpretation (MPEP § 2111), the independent claims recite the abstract idea of organizing and tracking anonymized data records by substituting personal tracking keys with non-personal identifiers across a database and a corresponding activity log. This process aligns with the following abstract idea category:
Certain Method of Organizing Human Activity (MPEP § 2106.04(a)(2)(II)): This category includes certain descriptions of managed workflows and interactions. The independent claims recite "setting a unique identifier for each record," "setting... for the log, the identifier... the same as the related information of the database," and "deleting the related information." These steps describe a managed workflow of interaction with data records to satisfy administrative privacy requirements. The specification supports this, stating: "all information including personal information... and related information... linked to the personal information must be deleted (hidden)" (Spec., para. [0006]) and "an object thereof is to provide an analyzer... that output information by which a database and a log can be traced" (Spec., para. [0008]). This shows the invention is centered on an administrative policy for data handling (privacy compliance) rather than a technical solution to a technical problem in computer or analyzer functionality.
Manual Replication Scenario (Human Equivalence)
The abstract nature of the claims is reinforced because the entire process is analogous to fundamental human activities of record-keeping and redaction. While a computer may perform these steps faster, the underlying process remains an abstract organization of information:
Storage: A hospital clerk maintains a physical ledger (database) of patient samples and a separate notebook (log) of lab activities.
Identifier Assignment: When a new sample arrives, the clerk assigns a unique "Ticket Number" to the ledger entry.
Synchronization: The clerk cross-references the notebook against the ledger. Finding a matching Sample ID, the clerk writes the corresponding "Ticket Number" into the notebook.
Redaction & Output: To satisfy privacy rules, the clerk uses a black marker to delete the patient names and original Sample IDs from both the ledger and the notebook, then hands the sanitized copies to a third-party reviewer.
This human-led workflow mirrors every functional limitation of the claims, demonstrating that the invention is directed to an organizational method of handling data that can be performed mentally or through manual clerical acts.
Dependent Claims Analysis (Prong One)
The dependent claims are also directed to an abstract idea by further narrowing the cognitive or administrative steps.
Claims 2 and 10 (Replacing): Specifies replacing as the mechanism of substitution. This is a Mental Process refinement of the substitution judgment. No new additional elements are added.
Claims 3 and 11 (Deleting Personal Info): Extends the redaction judgment to include personal fields such as name. This is a Mental Process: a judgment about which additional fields are sensitive. No new additional elements are added.
Claims 4 and 12 (Accumulation Database): Recites a data retention rule to keep records. This is a Mental Process: a judgment to preserve records in a secondary ledger. No new hardware is added as a database is a functional organization of data.
Claims 5 and 13 (Display Classification): Recites categorizing records for display. This is a Mental Process: an evaluation and classification judgment.
Claims 6 and 14 (Sample Type ID): Specifies encoding sample type in the ID. This is a Mental Process: a judgment on formatting. No new hardware is added.
Claims 7 and 15 (Display Modes): Recites conditional display based on user role. This is a Mental Process: a judgment about what information to show based on context.
Claims 8 and 16 (Button Inactivation): Recites enabling or disabling access. This is a Mental Process: a judgment to permit or deny access based on user role.
Having established that Claims 1–16 recite abstract ideas falling within the Mental Process grouping, the analysis proceeds to Step 2A, Prong Two to determine whether the additional elements (e.g., storage unit, analyzing unit, external device, display unit, button) integrate the abstract idea into a practical application.
Step 2A, Prong Two: Integration into a Practical Application
Step 2A, Prong Two evaluates whether the additional elements in the claim, considered both individually and as a combination, integrate the judicial exception into a practical application by providing a meaningful limitation beyond the exception itself. In this case, the additional hardware and interface elements fail to provide such integration because they merely provide a generic environment for executing the abstract privacy-compliance workflow.
Evaluation of independent Claims 1 and 9 Additional Elements
Analyzer, Control Unit, and Storage Unit: The recitation of an analyzer, analyzing unit, storage unit, and external device fails to integrate the abstract idea.
Evaluation of independent Claims 1 and 9 Additional Elements
Analyzing Unit: The recitation of an "analyzing unit that analyzes a sample" represents "insignificant extra-solution activity" (MPEP 2106.05(g)). The analyzing unit functions as a "means of data gathering" (MPEP 2106.05(h)) to provide the raw information that the abstract idea then organizes. Furthermore, it "generally links" the invention to the field of biological sample analysis without improving the actual chemistry or mechanics of the assay itself.
Storage Unit and Control Unit: The recitation of these elements fails to integrate the exception because they represent a "generic environment" (MPEP 2106.05(h)) for executing the abstract logic. The specification admits the control unit has the "hardware structure of a general information processing device" (Spec., para. [0024]), indicating the computer is merely a tool used to perform the data substitution.
When viewed as a whole, the combination of these elements simply provides a standard laboratory computer system performing its expected functions of gathering data and applying an administrative privacy policy to that data
Dependent Claims Analysis
The dependent claims add only minor limitations that fail to provide the necessary integration.
Claims 2, 3, 10, and 11: These claims do not recite new additional elements beyond those already analyzed in the independent claims. Instead, they merely narrow the abstract idea of privacy-governance by specifying the method of substitution ("replacing") and the category of data to be redacted ("personal information"). Because these limitations refine the judicial exception itself without adding non-abstract hardware or improving computer functionality beyond off-the-shelf capabilities, they do not integrate the idea into a practical application.
Claims 4 and 12: These claims add a database for accumulation, which is a fails to improve computer functionality (a) limitation. While this specifies a redundant storage rule, it does not recite a new physical component or improve the technical functioning of the storage unit, merely narrowing the administrative record-keeping rule for historical auditability (h).
Claims 5, 13, 7–8, and 15–16: These claims add display modes, a display unit, and inactivating a button, which are generic user-interface limitations that serve as a mere field-of-use limitation (h). They govern the presentation of information to the user through standard interface logic rather than improving the internal functioning of the display or the analyzer hardware.
Claims 6 and 14: These claims add sample-type characters to the identifier, which is a data-formatting instruction (f) that does not overcome the abstract character of the underlying labeling process.
When viewed as a whole, the combination of these elements in the dependent and independent claims does not integrate the abstract idea because they only specify the types of data being handled or the generic interface through which the data is viewed, neither of which results in a technical advancement.
Because the claims are directed to an abstract idea without integrating it into a practical application, the analysis proceeds to Step 2B.
Step 2B: Inventive Concept Analysis
Step 2B evaluates whether the additional elements, considered both individually and as an ordered combination, amount to significantly more than the judicial exception by reciting an inventive concept. According to MPEP 2106, this step determines if the claim possesses an "inventive concept" that transforms the abstract idea into a patent-eligible application. The additional elements identified in Step 2A do not overcome Step 2B because they represent general-purpose components performing their typical functions as described in the applicant's own specification.
Evaluation of independent Claims 1 and 9 Additional Elements
Analyzing Unit Hardware: The analyzing unit (hardware for measuring samples) is evaluated separately from the computer logic. This hardware fails to provide an inventive concept because the specification admits it is conventional to couple a computer with an analyzer: "The analyzer is connected to a host computer... for the purpose of centralized control" (Spec., para. [0002]). The use of a biological assaying device to gather data for a computer is a well-understood, routine, and conventional (WURC) activity in the laboratory field. (Karan-CN_103619255 , See at least, [0002] analyte monitoring device as a medical diagnostic device to determine the analyte level of the sample and [0110] obtain information of at least one analyte about body, Maetzier -US20100287477A1, [abstract],An analyzer is coupled to an control computer and has a control application program which receives control data, sends analytical data, and generates a host screen image. Steimle, [Col. 3, ll. 25-40], The term ‘lab device’ as used herein encompasses any analyzer and any other laboratory device related to a sample to be analyzed or a receptacle of a sample, …)
Control Unit and Storage Unit: These elements consist of a "general information processing device" (Spec., para. [0024]) performing "mere instructions" (MPEP 2106.05(f)). Utilizing a standard computer to search, match, and replace data strings (unique identifiers) is a fundamental computer function and does not constitute an inventive concept.
As a whole, the combination of a conventional analyzer and a general-purpose computer to execute an administrative privacy-redaction workflow is not enough. The ordered combination (collect data → apply proxy IDs → redact → export) follows the standard, expected path of data processing for privacy compliance.
Dependent Claims Analysis
The dependent claims fail to provide an inventive concept because they either lack new additional elements or merely recite insignificant activities that do not amount to significantly more than the exception.
(Claims 2, 3, 10, and 11): These claims do not recite new additional elements beyond those already evaluated in the independent claims. Instead, as explained in Prong One, they merely narrow the abstract idea of privacy-governance by specifying the method of substitution ("replacing") and the category of data to be redacted ("personal information"). Because these limitations refine the judicial exception itself without introducing non-abstract hardware, they do not contribute to an inventive concept and remain directed to the same abstract idea identified in Step 2A, Prong One.
(Claims 4 and 12): These claims add an accumulation database, which is a fails to improve computer functionality (a) step. The specification confirms this is a standard storage implementation where "the storage unit 15 stores databases DB1 to DB7" and the "control unit 30 does not execute the operation" to change the record, effectively utilizing off-the-shelf "HDD or SSD" storage to satisfy an administrative rule (Spec., para. [0024], [0050]).
(Claims 5, 13, 7–8, and 15–16): These claims add display modes, a display unit, and inactivating a button, which is a mere field-of-use limitation (h). The specification describes this as a way to "prevent personal information from leaking to the serviceman" (Spec., para. [0073]), which the MPEP 2106.05(g) classifies as insignificant pre-solution or post-solution activity that does not transform the abstract rule of access control into a technical achievement.
(Claims 6 and 14): These claims add sample-type characters to the identifier, which is MPEP § 2106.05(f) - Mere Instructions. The specification admits "for control purposes, the identifier has an incrementable configuration" (Spec., para. [0044]), which is a basic data-labeling instruction that narrows the abstract idea without providing a technical improvement to the underlying system.
As a whole, the combination of dependent claims and additional elements is not enough because each element merely implements an administrative rule using the "general information processing device" admitted in the specification.
The claims are directed to an abstract idea and lack an inventive concept as the additional elements provide nothing significantly more than the judicial exception itself. Therefore, Claims 1–16 are rejected under 35 U.S.C. § 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8, 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Karan - CN_103619255 and further in view of Landi- US7519591
Claim 1
Karan teaches, An analyzer comprising:
an analyzing unit that analyzes a sample; (Karan, See at least, [0002] analyte monitoring device as a medical diagnostic device to determine the analyte level of the sample and [0110] obtain information of at least one analyte about body))
a storage unit that stores a database in which related information linked to personal information of a patient having supplied the sample, and sample information of the sample to be analyzed by the analyzing unit, an analysis result of the sample by the analyzing unit, or the personal information of the patient are stored in a corresponding manner and a log including the related information; (Karan, See at least, [0181] analyte monitoring device is the tissue forming consistent field structure with recording data and [0218] log image display reading the recorded and related to the reading of user associated data)
and
a control unit that sets a unique identifier for each record of the database,
sets, for the related information of the log, the identifier set for the related information
of the database which is the same as the related information of the log, (Karen, See at least, 0141 electronic device 1110 of control logic or microprocessor; 0181 data organization in the remote device forming table, the table may be organized into records; 0458 each log entry display with corresponding log entries associated with the date 3606 and time 3608; 0180 test data from the analyte monitoring device 1501 synchronized to the remote data storage device 1505)
Karen discloses an electronic device control logic or microprocessor that manages analyte monitoring data. This data is organized into records within tables on a remote device, which functions as a database, and is also stored as log entries on the monitoring device. Each log entry is uniquely identified by its associated date and time. During the synchronization process, the control unit creates a copy of the test data on the remote storage device, ensuring the identifying information remains consistent across the field structures of both the log and the database. This functional synchronization effectively sets the same unique identifier for both the database record and the related log information, establishing the required link for historical traceability.
and
after .
(Karan, See at least, data organization in the remote device forming table... records may be divided into predefined fields... field data residing in the analyte monitoring device... into a format compatible with the remote device... logic structure of the records in the two systems may be different Paragraph [0181], selecting the test data (including the stored measurement values) stored in downloaded to remote device Paragraph [0174], log image display reading the recorded and related to the reading of user associated data Paragraph [0218], and masking mode... without displaying the obtained reading to the user... stored in the device... physician... can download data Paragraph [0261]).
Karan reads on, a data management protocol involving the conversion and transmission of stored records (database/log) to a separate computing unit (external device), wherein the data structure or specific fields (related information) are modified, converted, or concealed (deleted) during the transfer or display process. Reference Applicant Language, See at least, Paragraph [0009] after deleting the related information of the database... outputs the database, and Paragraph [0006] must be deleted (hidden).
Karan describes an analyte monitoring system that connects to a "remote device" (external device) like a PC to transfer data. Per Karan, this process involves "data conversion" where the "field data residing in the analyte monitoring device" is transformed into a "format compatible with the remote device," explicitly noting that the "logic structure of the records in the two systems may be different" (Paragraph [0181]). Under the Broadest Reasonable Interpretation (BRI), this conversion and change in logic structure reads on "deleting" the original "related information" (the specific local data fields, formats, or associations) from the database/log structure before or during the output to the external device. Furthermore, Karan teaches a "masking mode" (Paragraph [0302]) where data is "hidden" (which Applicant equates to "deleted" in Paragraph [0006]) from the user but is "downloaded" (outputted) to a physician's external device.
35 U.S.C 103 Rational:Karan teaches all disclosed limitations above, however in the limitation, after deleting the related information of the database and the related information of the log, outputs the database and the log to an external device, does not explicitly mention “delating”, for compact prosecution even when applicant in par. 0006 use “deleted (hidden)” and by Karan describe a "masking mode" where data is "hidden" (para. [0261], [0302]) and "data conversion" where the "logic structure of the records... may be different" (para. [0181]), Karan does not explicitly recite "deleting" the information before outputting to an external device.
Landi teaches the bolded Missing Element of deleting (removing/purging) related information, describing the process of de-identification as "removing the patient identifying information from the patient data record to generate a de-identified data record" (Claim 1, abstract, Col.2, ll. 40-55) and further stating that "database elements that include patient identifying information... are purged from the structured patient records" (Col. 11, ll. 51-Col.12, ll. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Karan with Landi because both references are directed to the field of medical data management and share the purpose of protecting patient privacy during data transmission. Karan notes that the system is used to "transfer data" to a "remote device (external device)" (para. [0181]) and includes a "masking mode" to hide data from users while allowing downloads to a physician (para. [0261]). Landi specifically addresses the "legal responsibility for protecting patient privacy" when sharing records (Col. 1, ll. 45-57) and provides the technical solution of de-identification through removal. A PHOSITA would have been motivated to integrate Landi’s explicit purging/removing (deleting) step into Karan’s data output protocol to ensure that the "related information" (identifying data) is permanently removed from the data set before it is "downloaded" (Karan, para. [0261]) to an external device, thereby meeting the strict privacy requirements described by Landi.
The combination makes the full limitation obvious because Landi’s purging process provides the specific "deleting" mechanism missing in Karan’s output phase. A PHOSITA would integrate the deleting (removal) of identifying data into the system of Karan, which already converts data into a "format compatible with the remote device" (para. [0181]), to achieve the benefit of absolute data privacy compliance. Landi teaches that this is necessary because "organizations cannot release or otherwise disclose patient data records that contain patient identifying information" (Col. 1, ll. 43-54) and that the specific solution is to ensure "patient identifying information has been removed" (para. [0012]).
A PHOSITA would have had a reasonable expectation of success because the technical integration of data purging into a standard transfer protocol is a routine data management task. Landi demonstrates that the removal process is a standard step in data processing, stating it can be "performed manually, or using automated methods" (Col.5 ll. 30-47). Since Karan already utilizes "control logic or a microprocessor" (para. [0141]) to perform "data conversion" and modify the "logic structure of the records" (para. [0181]), the addition of a routine "delete" or "purge" command to those existing conversion algorithms is technically straightforward and relies on conventional software execution.
Claim 2
Karan teaches, The analyzer according to Claim 1, wherein, by
Karan et al., See at least, Paragraph 0180 synchronization between the remote device 1505 and the date and time of the analyte monitoring device 1501; 0181 user interface application can be reading the test data from the analyte monitoring device and write it to remote device 1505 on the table and Paragraph 0180 further synchronization between the remote device 1505 and the date and time of the analyte monitoring device 1501 ; 0458-459 each log entry display with corresponding log entries associated with the date 3606 and time 3608)
Karan et al. describe a process where information from one device is matched to the correct place in another device so both use the same reference for each record. This matches the Applicant’s description: (Paragraph 0055 à control unit 30 searches the log with the sample ID and the information such as the rack ID… and replaces the matched sample ID with an identifier corresponding to the sample ID.”).
Karen discloses a control unit that functionally performs a synchronization process between a local monitoring device and a remote storage database 1505. Under the Broadest Reasonable Interpretation (BRI) informed by Applicant Para 0055, the step of replacing is satisfied by a synchronization process that updates local log entries to match master database records. Karen discloses that synchronization reconciles the local device with the remote device to maintain a consistent field structure. In this technical context, the act of synchronizing date and time parameters between the two devices functions to update the local relative data with the master database timestamp, which serves as the identifier. This reconciliation effectively replaces the local un-synchronized information with the specific identifier set in the database, ensuring that both the log and the database utilize the same unique reference for record alignment and historical traceability.
35 U.S.C 103 Rationale:
Karen in combination with Landi teaches claim 1, and Karan also teaches that each log entry is associated with identifying information such as a "date 3606 and time 3608" (para. [0458]). However, Karan fails to explicitly disclose the step of replacing the related information of the log with the identifier set for the related information of the database. While Karan teaches synchronization to maintain consistency and record alignment, Karan does not explicitly recite the control unit performing an overwrite or "replacing" operation where a local log's relative data is substituted with a master identifier generated by or residing in the database.
Landi teaches the bolded Missing Element of replacing data with specific identifiers, describing a process wherein the system can "optionally replace de-identified data with readable strings mapped to encrypted IDs" (Abstract; FIG. 3) and further teaches that identifiers are used to "replace the various pieces of de-identified patient data in a de-identified data record" (Col. 6, ll. 45-54). Landi explicitly discloses that de-identification involves a specific step of "replacing" identifying information with a unique identifier to ensure historical traceability while maintaining privacy.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Karan with Landi because both references address the technical challenge of managing and aligning data records across multiple storage locations (local log vs. remote database). Karan teaches the need for "synchronization" (para. [0180]) to ensure that "data organization in the remote device" forms a "consistent field structure" with the local device (para. [0181]). Landi provides the specific data-management technique of "mapping Encrypted ID to a Study ID" (Col.4, ll. 55-63) and then "replacing" (fig.3) the data in the records with these specific identifiers. A PHOSITA would have been motivated to utilize Landi’s "replacing" technique within Karan’s synchronization protocol to ensure that once a record is matched between the log and the database, the log is updated with the master identifier from the database. This substitution ensures perfect record alignment and avoids the data corruption that can occur if local and remote devices use different or unsynchronized reference pointers.
The combination makes the full limitation obvious because Landi’s "replacing" logic fills the functional gap in Karan’s synchronization process. A PHOSITA would integrate the replacing step into the system of Karan, which already matches local records to database tables (para. [0181]), to achieve the benefit of absolute record for historical traceability.
A PHOSITA would have had a reasonable expectation of success because "replacing" a variable or data field with a synchronized value is a fundamental operation in microprocessor control logic. Karan already discloses an "electronic device 1110 of control logic or microprocessor" (para. [0141]) and a user interface application capable of "writing" data to the remote device (para. [0181]). Landi confirms that replacing data with identifiers is a standard data processing task. Integrating a command to overwrite a local log entry with a database identifier involves routine software programming that a PHOSITA would be fully capable of implementing using the existing microprocessor disclosed by Karan.
Claim 3
Karan in combination with Landi teaches, The analyzer according to Claim 1, wherein
the control unit further deletes the personal information of the patient in the database
and outputs the database and the log to the external device. (Karan et al., See at least, Paragraph 0146 modifying, replacing or adjusting... analyte related data storage... modifying the transmission data type and Paragraph 0138 electronic device 1110 wirelessly communicate analyte related data... to the remote terminal 1170. Landi, see at least Col. 12, ll. 1-10, patient data elements corresponding to the 18 specified attributes in the Safe Harbor list are purged from the structured patient records)
The data management architecture in Karan is configured to modify and replace elements of the analyte data storage specifically for external communication. By modifying the transmission data type before sending the information to the remote terminal, the system ensures that the identifying patient content is not included in the output. Under the Broadest Reasonable Interpretation of MPEP 2111, this act of replacing or adjusting the data storage to hide or remove identifying fields during external communication performs the identical function of deleting personal information from the database record in view of Landi.
Claim 11
Karan in combination with Landi teaches, The information output method according to Claim 9, wherein outputting the database and the Log includes outputting the database and the log to the external device after deleting the related information and the personal information of the database, and the related information and the personal information of the log. (Karan, par. 0624, 0181, 0152, 0778, 0458, 0146, 0593)
Karan anticipates the claimed method because it describes a healthcare technology environment where measurement data is associated with specific identifiers and then transmitted to a remote terminal. The specific limitation regarding the "deletion" of information is found in Karan’s disclosure of selective file creation and the modification of transmission data types.
Because Karan teaches that identifying patient data (Name/ID) is stored but then provides a mechanism to generate external outputs "without storing" or by "modifying" those specific data entries, a person of ordinary skill in the art would recognize this as the identical method of stripping/deleting PII (Personally Identifiable Information) before external communication.
Note: Claim 11 was include here because dependent of claim 9 that is very similar than claim 1, and claim 11 is different from claim 3.
Claim 4
Karan in combination with Landi teaches, The analyzer according to Claim 1, wherein
the storage unit further stores a database for accumulation in which the analysis result of the sample by the analyzing unit and the related information are stored in a corresponding manner, (Karan et al., See at least, Paragraph 0180 further synchronization between the remote device 1505 and the date and time of the analyte monitoring device 1501 and Paragraph 0181 user interface application can be reading the test data from the analyte monitoring device and write it to remote device 1505 on the table.)
Karen read on, replacing interpreted as updating data to match a master reference and the identifier interpreted as a unique code or timestamp used to link records across different devices, Reference Applicant Language, See at least, [0055] control unit 30 searches the log with the sample ID... and replaces the matched sample ID with an identifier corresponding to the sample ID - applicant spec.
Karen uses a synchronization process to make sure a handheld device and a main database stay exactly the same. When they sync, the system updates the local device's info with a master timestamp or ID from the database, which functionally replaces the old local data with the new shared ID. This ensures both the log and the database use the exact same unique identifier to track the same record.
and
the control unit, when a record is to be added to the database, adds a record corresponding to the record to the database for accumulation, (Karan et al., See at least, Paragraph 0181 user interface application can be reading the test data from the analyte monitoring device and write it to remote device 1505 on the table.)
Karen read on, adds a record interpreted as the functional operation of mirroring, replicating, or writing a data entry from a primary source to a secondary archive during a synchronization event
Karen’s control unit triggers a write operation that automatically replicates new test data into a remote table structure 1505. This synchronization logic mirrors local entries in a secondary archive, ensuring every record created on the device has a corresponding entry in the accumulation repository. By reading and writing data across devices, Karen functionally adds the mirrored records required for long-term storage.
and
when the record is to be deleted from the database, keeps the record corresponding to
the record in the database for accumulation. (Karan et al., See at least, Paragraph 0166 when the firmware updating device, keeping the current device setting and testing history and Paragraph 0112 electronic device may have 8 hours of memory... when it is for reading, the whole 8 hours is transferred.)
Karan et al. read on, a data retention policy or archival logic where historical records are preserved in a long-term repository even if the primary source data is overwritten, cleared, or modified during a system update.
The management software described in Karan includes a specific function for maintaining the integrity of historical data during system modifications or firmware updates. By explicitly stating that testing history is kept during updates, the system demonstrates the ability to preserve accumulation records regardless of changes to the primary active system state.
Claim 5
Karan in combination with Landi teaches, The analyzer according to Claim 1, wherein the control unit controls a plurality of records in the database in a manner to classify the records into records to be displayed on a display unit and records not to be displayed on the display unit. (Karan et al., See at least, Paragraph 0261 the device can display the masking mode screen... the user can obtain a reading sensor, without displaying the obtained reading to the user and Paragraph 0302 when it is the device set to masking mode... picture 398 does not provide the obtained reading to the user.)
Karan et al. read on, the logical categorization of data entries into distinct sets defined by active operating modes or visibility permissions where specific records are suppressed from the user interface while others remain visible.
The prior art architecture implements a masking mode that allows the analyzer to process measurement records without outputting the results to the display screen. This software configuration effectively classifies database records into two groups: those that are accessible for user browsing and those that are specifically hidden from the interface to prevent data disclosure.
Claim 6
Karan in combination with Landi teaches, The analyzer according to Claim 1, wherein the identifier includes a character or sign indicating a type of the sample. (Karan et al., See at least, Paragraph 0329 test strip may include identifying elements... so that device can identify the type of test strip and Paragraph 0526 system information menu 2166... displays such as... sensor ID... sensor software... sensor number... test number.)
Karen read on, type of the sample interpreted as the category of specimen being analyzed (e.g., blood, control solution) and character or sign interpreted as any alphanumeric marker or digital code that categorizes data.
Karen discloses that the system identifies the "type of test strip" using identifying elements and assigns a "test number" and "sensor ID." Under the BRI, identifying the strip type is functionally equivalent to identifying the sample type because specific hardware/strips are dedicated to specific specimens (e.g., blood vs. control fluid).
Claim 7
Karan in combination with Landi teaches, The analyzer according to Claim 1, wherein
the control unit, in a first display mode, displays information including the related information on a display unit (Karan et al., See at least, Paragraph 0777 receiving operation according to a masking mode indication of analyte sensor scan, and the sensor reading is displayed on the display of the analyte monitoring device.)
Karan et al. read on, a primary software-defined operational state where the system renders active measurement data and its associated metadata visible to the user on a graphical interface.
The monitoring device in the prior art functions in a standard mode where sensor readings are processed and immediately shown on the display screen for user interaction. This normal operation baseline provides the information and related measurement details to the viewer, fulfilling the structural and functional requirements of a first display mode.
and
in a second display mode, displays information except the related information on the
display unit. (Karan et al., See at least, Paragraph 0261 the device can display the masking mode screen... the user can obtain a reading sensor, without displaying the obtained reading to the user and Paragraph 0776 receiving operation according to the masking mode indication of analyte sensor scanning... sensor reading is not displayed on the display.)
Karan et al. read on, a restricted or modified interface configuration that intentionally suppresses or hides specific sensitive data fields from the screen while maintaining the underlying data processing.
The prior art architecture implements a specific masking mode designed to prevent the disclosure of obtained readings to the user.
Claim 8
Karan teaches, The analyzer according to Claim 7, wherein
the control unit, in the first display mode, displays on the display unit a button to show the personal information, and shows the personal information on the display unit according to selection with the button, (Para [0592] describes a "trigger element" for "reader mode screen selection"; Para [0593] describes partition 5058 where the user can "set name and patient ID"). Selection of this button shows the personal information (Karan Para [0593])
Karan et al. read on, a software interface that renders an interactive icon or menu component which, upon being toggled by a user, commands the system to navigate to and display patient specific identifiers such as a name or medical ID number.
and
in the second display mode, prohibits reference to the personal information, or
inactivates the button. (Karan et al., See at least, Paragraph 0455 Since the device in masking mode does not allow browsing sensor readings, the summary screen associated with obtained data is unavailable and Paragraph 0597 limiting feature access... access settings need password or code.)
Karan et al. read on, a restricted operational state where access to specific data screens is blocked, rendered unavailable, or requires authentication, effectively disabling the standard navigation mechanisms to those fields.
The prior art architecture implements a masking mode (second display mode) designed to restrict information access.
Note: Claim 9 – 16 are rejected with claims 1-8 for being very similar.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DAMIAN RUIZ whose telephone number is (571)272-0409. The examiner can normally be reached 0800-1800.
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684