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 .
Status of Claims
The claim set submitted on 27 FEBRUARY 2026 is acknowledged and considered. In the claim set, Claims 1, 5, 7, 14 and 18 are ‘Currently Amended’; and Claims 2, 3, 4, 6, 8-13, 15-17 and 19 are ‘Original’ .
Current pending claims are Claims 1-19 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 27 FEBRAURY 2026, with respect to the objection to the specification, claim objection , and the 112(b) rejection have been fully considered and are persuasive. The objection to the specification, claim objection , and the 112(b) rejection has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because Applicant has amended the claims. The rejection below reflects the changes to the claims and relies in part to the previously applied reference.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over LE FILES, US Publication No. 2020/0003746 A1, submitted on the Information Disclosure Statement on 03 MAY 2023, US Patent Application Publications Cite No. 1, and further in view of CHAVAN, US Publication No. 2019/0239784 A1.
Regarding Claim 1, the reference LE FILES discloses an analysis system for analyzing a sample, abstract, detection system, Figure 1, detection system 10, [0042], the system comprising:
a central evaluation unit, Figure 1, detector unit 12, [0042];
a plurality of sensor modules that are exchangeable with one another, [0046], probes 12, Figure 1; and
at least one decentralized measuring unit having a communication connection via a terminal to the evaluation unit and being configured to accommodate the plurality of sensor modules that are exchangeable with one another, Figure 1, test item 14, [0042], wherein at least one of the evaluation unit and the at least one decentralized measuring unit are configured to determine at least one of an incidence, [0042], contaminant, a concentration and an amount of an analyte in the sample based on a measurement value measured in the sample by at least one of the sensor modules, [0042], and wherein the plurality of sensor modules differ with regard to a respective application specific configuration for determining at least one of chemical and biochemical information of the analyte in the sample, [0030, 0042], item 14, and wherein the measuring unit is configured to monitor a sensor module of the plurality of sensor modules, [0042] test item 14 is contact with probe 20, to determine whether the sensor module is in contact with a liquid sample , [0042].
The LE FILES reference disclose the claimed invention, but is silent in regards to the functionality of the measuring unit and its capabilities.
The CHAVAN reference discloses an analysis system for analyzing a sample, abstract, [0036], Figure 1, system 50 the system comprising:
a central evaluation unit, Figure 1, network 106, [0038];
a plurality of sensor modules that are exchangeable with one another, Figure 1, [0036], one or more analyte sensor 100; and
at least one decentralized measuring unit having a communication connection via a terminal to the evaluation unit and being configured to accommodate the plurality of sensor modules that are exchangeable with one another, Figure 1, phone 105/computer 109, [0036, 0037, 0039],
wherein at least one of the evaluation unit and the at least one decentralized measuring unit are configured to determine at least one of an incidence, a concentration and an amount of an analyte in the sample based on a measurement value measured in the sample by at least one of the sensor modules, [0036, 0037, 0039, 0046], concentrations in medium, wherein the plurality of sensor modules differ with regard to a respective suitability application-specific configuration for determining at least one of chemical and biochemical information of the analyte in the sample, [0036, 0039], one or more analyte levels, and wherein the measuring unit is configured to monitor a sensor module of the plurality of sensor modules to determine whether the sensor module is in contact with a liquid sample, [0039], if there is contact, a concentration, and monitoring information can be measured, and, in response to determining that the sensor module is immersed in the liquid sample, control the sensor module to capture the measurement value, [0021, 0026, 0036, 0039, 0062], sensor 100 can be subcutaneously implantable or it may be partially implantable, if the sensor is implantable or partially implantable, it is immersed in the blood sample to measure desired values.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of LE FILES with the measuring unit as taught by CHAVAN to determine if particular conditions are met and/or satisfied to continue on or respond with a proper step with the measurement/analysis to avoid any malfunctioning or mis-reading of values.
Additional Disclosures Included are: Claim 2: wherein the analysis system according to claim 1, wherein the plurality of sensor modules are each configured to determine different chemical or biochemical information, which are respective chemical or biochemical indicators for diseases or symptoms, LE FILES Figure 1, probe 20, [0046]; CHAVAN [0036, 0039]. ; Claim 3: wherein the analysis system according to claim 2, wherein the respective chemical or biochemical indicators are for detecting disease-specific features or parameters for detecting a viral infection, LE FILES [0022, 0046]. ; Claim 4: wherein the analysis system according to claim 1, wherein the at least one of the plurality of sensor modules is configurable with regard to the chemical or biochemical information to be detected by a selection of a subgroup of sensor elements accommodated in the at least one sensor module, LE FILES [0045, 0046]; CHAVAN Claims 16-19, [0039]. ; Claim 5: wherein the analysis system according to claim 1, wherein the at least one sensor module of the plurality of sensor modules is configured to transmit sensor data to the measuring unit that includes at least one of the measurement value measured by the sensor module, data specifying the sensor module, and data specifying a measurement carried out by sensor module, LE FILES Figure 1, probe 12 to test item 14, [0042-0046]; CHAVAN [0039]. ; Claim 6: wherein the analysis system according to claim 1, wherein the measuring unit further comprises a sensor station that has a communication connection to the terminal and is configured to be coupled with the at least one sensor module, LE FILES Figure 1, see arrows; CHAVAN Figure 1, [0037]. ; Claim 7: wherein the analysis system according to claim 1, wherein the measuring unit is configured to: operate in an initialization mode in which the measuring unit is configured to identify an accommodated sensor module and to check by a QR code whether the sensor module is authenticated for operation with the measuring unit , LE FILES [0066], or operate in a validation mode in which the measuring unit is configured to detect a proper status or operation of the sensor module, or operate in a measuring mode in which the sensor module is controlled to capture the measurement value, with the measuring unit changing into the measuring mode when the sensor module comes into contact with a sample or a patient, including when the sensor module is immersed in a liquid sample , LE FILES [0045, 0046], CHAVAN [0021, 0026, 0036, 0039, 0062]. ; Claim 8: wherein the analysis system according to claim 1, wherein the terminal is connected via a communication network to the evaluation unit, and the evaluation unit is comprised in a web server, LE FILES Figure 1, abstract, [0027, 0035], CHAVAN Figure 1, [0037, 0038]. ; Claim 9: wherein the analysis system according to claim 1, wherein the terminal comprises a user interface that is configured to capture application-specific input information from a user of the measuring unit, and the terminal is configured to transmit the application-specific input information to the evaluation unit, LE FILES Figure 2, interface 40, [0047], CHAVAN Figure 1, [0036-0040]. ; Claim 10: wherein the analysis system according to claim 1, wherein at least one of the evaluation unit and the measuring unit is configured to execute an analysis based on a mathematical model, LE FILES [0035, 0048], and wherein the central evaluation unit is configured to adapt the mathematical model based on previously captured measurement values and analysis results connected thereto, LE FILES [0035]. ; Claim 11: wherein the analysis system according to claim 1, further comprising: the central evaluation unit and at least one decentralized measuring unit that has a communication connection via a terminal to the evaluation unit, LE FILES Figure 1 and 2, wherein the measuring unit is configured to accommodate the plurality of sensor modules that are exchangeable with one another, LE FILES [0046], wherein at least one of the evaluation unit and the measuring unit is configured to determine the at least one of the incidence, LE FILES [0045, 0046], the concentration, LE FILES [0051], CHAVAN Figure 1, [0036-0041], and the amount of an analyte in the sample based on a measurement value measured in the sample by the sensor module, LE FILES [0037], and wherein the evaluation unit includes a programming interface for receiving data associated with analysis results from a point outside the analysis system and is configured to transmit data received via the programming interface selectively to individual measuring units in dependence on the measurement values captured by the measuring unit or the analysis results connected thereto, LE FILES Figure 1-4, [0035-0036]. ; Claim 12: wherein the analysis system according to claim 11, wherein the at least one of the plurality of sensor modules is configured to determine the at least one of the incidence, the concentration, and the amount of at least two different analytes in the sample, LE FILES [0037, 0045, 0046, 0051], CHAVAN [0037]. ; and Claim 13: wherein the analysis system according to claim 12, wherein the terminal is configured to provide an identifier associated with the analysis results that is displayed on a display screen of the terminal, LE FILES [0038, 0043], and at least one of the evaluation unit and the terminal is configured so that an additional terminal is configured to authenticate itself via the identifier and retrieve the data associated with the analysis results from the evaluation unit or the terminal, LE FILES [0044, 0066-0070], CHAVAN [0041, 0042, 0048]
Applicant’s invention is directed towards a system.
Regarding Claim 14, the LE FILES reference discloses an analysis system for determining chemical or biochemical information in a sample, abstract, detection system, Figure 1, detection system 10, [0042], the system comprising:
a central evaluation unit, Figure 1, detector unit 12, [0042]; and
at least one decentralized measuring unit that has a communication connection via a terminal to the central evaluation unit and is configured to accommodate a plurality of sensor modules that are exchangeable with one another, Figure 1, test item 14 connect to probes 12, [0042], wherein at least one of the evaluation unit and the measuring unit is configured to determine at least one of an incidence, a concentration, and an amount of an analyte in the sample based on a measurement value measured in the sample by at least one of the sensor modules, 0037, 0042, 0045, 0046, 0051].
The LE FILES reference disclose the claimed invention, but is silent in regards to the functionality of the measuring unit and its capabilities.
The CHAVAN reference discloses an analysis system for analyzing a sample, abstract, [0036], Figure 1, system 50 the system comprising:
a central evaluation unit, Figure 1, network 106, [0038];
at least one decentralized measuring unit having a communication connection via a terminal to the central evaluation unit and being configured to accommodate the plurality of sensor modules that are exchangeable with one another, Figure 1, phone 105/computer 109, [0036, 0037, 0039],
wherein at least one of the evaluation unit and the measuring unit are configured to determine at least one of an incidence, a concentration and an amount of an analyte in the sample based on a measurement value measured in the sample by at least one of the sensor modules, [0036, 0037, 0039, 0046], concentrations in medium, and wherein the measuring unit is configured to monitor a sensor module of the plurality of sensor modules to determine whether the sensor module is in contact with a liquid sample, [0039], if there is contact, a concentration, and monitoring information can be measured, and, in response to determining that the sensor module is immersed in the liquid sample, control the sensor module to capture the measurement value, [0021, 0026, 0036, 0039, 0062], sensor 100 can be subcutaneously implantable or it may be partially implantable, if the sensor is implantable or partially implantable, it is immersed in the blood sample to measure desired values.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of LE FILES with the measuring unit as taught by CHAVAN to determine if particular conditions are met and/or satisfied to continue on or respond with a proper step with the measurement/analysis to avoid any malfunctioning or mis-reading of values.
Additional Disclosures Included are: Claim 15: wherein the analysis system according to claim 14, wherein the at least one of the sensor modules has at least two sensor elements that are each configured to determine one measurement value and the at least one sensor module is configured to transfer the at least two measurement values to at least one of the decentralized measuring unit, the terminal, and the central evaluation unit, LE FILES [0045, 0046], CHAVAN [0036, 0039]. ; Claim 16: wherein the analysis system according to claim 15, wherein the at least one of the sensor modules is configured to select a subgroup of the at least two sensor elements in order to execute an application-specific analysis, LE FILES [0022, 0045-0047], CHAVAN [0036, 0039]. ; Claim 17: wherein the analysis system according to claim 15, wherein the decentralized measuring unit is configured to select a subgroup of the at least two sensor elements in order to execute an application-specific analysis, LE FILES [0030, 0045, 0046], CHAVAN [0036, 0039]. ; Claim 18: wherein the analysis system according to claim 15, wherein the terminal is configured to select a subgroup of the at least two sensor elements in order to execute an application- specific analysis, LE FILES [0030, 0045, 0046], CHAVAN [0036, 0039]. ; and Claim 19: wherein the analysis system according to claim 15, wherein the central evaluation unit is configured to select a subgroup of the at least two sensor elements in order to execute an application-specific analysis, LE FILES [0030, 0045, 0046], CHAVAN [0036, 0039], one or more analyte levels.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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