Prosecution Insights
Last updated: April 19, 2026
Application No. 18/105,398

MONITORING ANALYSIS DEVICE AND MONITORING ANALYSIS METHOD

Final Rejection §102
Filed
Feb 03, 2023
Examiner
SIEFKE, SAMUEL P
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Shimadzu Corporation
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
3y 7m
To Grant
80%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
651 granted / 1031 resolved
-1.9% vs TC avg
Strong +17% interview lift
Without
With
+17.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
36 currently pending
Career history
1067
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
30.1%
-9.9% vs TC avg
§102
47.5%
+7.5% vs TC avg
§112
11.7%
-28.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1031 resolved cases

Office Action

§102
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 . Election/Restrictions Claims 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/3/25. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 2008008801 (herein after Yoshinari). Regarding claim Yoshinari discloses a monitoring analysis device comprising: an acquirer (mass analysis unit 13), an analyzer (ion detection unit 14), a pre-processor (data processing unit 15), and a controller (control unit 17); wherein the controller is programmed to (the control unit 17 controls the entire series of mass analysis processes, sample ionization, transport, and incidence of the sample ion beam to the mass analysis unit 13, mass separation process, ion detection and data processing; Mode for Inention): control the acquirer (mass analysis unit 13) to sequentially acquires reaction products produced by a reactor (ionization unit 12; the ionization unit sequentially produces reaction products which produces data that is collected by the mass analysis unit 13); control an analyzer (ion detection unit 14) to sequentially analyzes the reaction products acquired by the acquirer (mass analysis unit 13; this limitation does not further structurally limit the instant claims because the limitation is drawn to an intended use/process limitation of how a structure is used); control the pre-processor (data processing unit 15) that performs a pre-process to be performed before an analysis of the reaction products by the analyzer (data processing unit sets pre parameters for the analyzer prior to analysis); and controls the pre-processor such that the pre-process for a second analysis to be performed subsequently to a first analysis is performed during the first analysis by the analyzer (mode of invention first 3 paragraphs; mass spectrometry system using tandem mass spectrometer that repeats the selection, dissociation and measurement of the ion species in a plurality of stages; the second analysis is broadly interpreted as a second sample that is processed after the first sample is analyzed. The claim does not place a time limit between the first and second analysis). Regarding claim 2, the monitoring analysis device according to claim 1, wherein the acquirer (mass analysis unit 13) includes a sample acquisition container (structure which receives separated ion species) having an inner flow path and having first and second ports (a flow chamber that allows for mass spectroscopy) that respectively communicate with the inner flow path, a first flow path that guides a reaction product produced by the reactor to the first port of the sample acquisition container, and a second flow path that guides a reaction product to outside of the sample acquisition container from the second port of the sample acquisition container. Regarding claim 3, the monitoring analysis device according to claim 2, wherein the pre-process includes a cleaning process of cleaning the acquirer (this limitation does not further structurally limit the instant claim), and the pre-processor includes a cleaner, and the controller is programmed to control the cleaner to perform the cleaning process (buffer gas that is added as a precursor gas; the controller controls all aspects of the system as disclosed in claim 1). Regarding claim 4, the monitoring analysis device according to claim 3, wherein the cleaner is configured to clean the first flow path, the second flow path and the inner flow path of the sample acquisition container, and the controller is programmed to control the cleaner to cause a cleaning liquid to flow through the first flow path, the inner flow path of the sample acquisition container and the second flow path (buffer gas that is added as a precursor gas; the controller controls all aspects of the system as disclosed in claim 1). Regarding claim 5, the monitoring analysis device according to claim 4, wherein the cleaner further includes a first switching valve provided in the first flow path, and a second switching valve provided in the second flow path (valves are inherently provided within a mass spectrometer for controlling the flow of sample to and from the system), the first switching valve is configured to be selectively switchable to a first state in which a reaction product is flowable from the reactor to the first port or a second state in which an inflow of a reaction product from the reactor to the first port is preventable and a cleaning liquid is flowable to the first port through the first flow path, the second switching valve is configured to be selectively switchable to a third state in which a reaction product is flowable from the second port to the reactor or a fourth state in which an outflow of a reaction product from the second port to the reactor is preventable and a cleaning liquid is dischargeable from the second port through the second flow path, and the controller is programmed to control the cleaner to switch the first switching valve to the second state and switches the second switching valve to the fourth state during acquisition of a reaction product from the reactor, and switches the first switching valve to the second state and switches the second switching valve to the fourth state during the cleaning process (buffer gas that is added as a precursor gas; the controller controls all aspects of the system as disclosed in claim 1 including the valves for allowing the liquids and gas to move throughout the system). Regarding claim 6, the monitoring analysis device according to claim 1, including a filtering processor that removes impurities of the reaction product between the reactor and the acquirer (pretreatment system 11). Regarding claim 7, the monitoring analysis device according to claim 1, wherein the pre-process includes a reaction-product process to be performed before an analysis by the analyzer for improvement of analysis accuracy on the reaction product that has been acquired by the acquirer, and the pre-processor includes a reaction-product processor that performs the reaction-product process; and the controller is programmed to control the reaction-product processor to perform the reaction product process (the controller controls all the functions of the system as disclosed in claim 1). Regarding claim 8, the monitoring analysis device according to claim 7, wherein the reaction-product process includes a re-dissolving process of promoting re- dissolution of the reaction product by applying physical vibration to the reaction product the controller is programmed to control the reaction-product processor to perform the re-dissolving process (the controller controls all the functions of the system as disclosed in claim 1). Regarding claim 9, the monitoring analysis device according to claim 7, wherein the reaction-product process includes a clenching process of suppressing reaction progress of the reaction product; the controller is programmed to control the reaction-product processor to perform the clenching process (the controller controls all the functions of the system as disclosed in claim 1). Regarding claim 10, the monitoring analysis device according to claim 7, wherein the reaction-product process further includes a diluting process of diluting the reaction product the controller is programmed to control the reaction-product processor to perform the diluting process (the controller controls all the functions of the system as disclosed in claim 1). Regarding claim 11, the monitoring analysis device according to claim 7, wherein the reaction-product process includes a gas-liquid separating process of separating the reaction product into gas and liquid the controller is programmed to control the reaction-product processor to perform the gas-liquid separating process (the controller controls all the functions of the system as disclosed in claim 1). Regarding claim 12, the monitoring analysis device according to claim 7, wherein the reaction-product process includes an adding process of adding a standard sample to the reaction product in order to enable creation of a calibration curve in the analyzer the controller is programmed to control the reaction-product processor to perform the adding process (the controller controls all the functions of the system as disclosed in claim 1). Response to Arguments Applicant's arguments filed 12/16/25 have been fully considered but they are not persuasive. Applicant argues, “Yoshinari does not describe that, while multiple dissociation/mass spectrometry is performed on one subject of analysis, a pre-process is performed for another subject of analysis to be performed. That is, Yoshinari does not describe "to control the pre- processor such that the pre-process for a second analysis to be performed subsequently to a first analysis is performed during the first analysis by the analyzer." The broadest reasonable interpretation of claim 1 requires a second analysis to be performed after the first analysis and the pre-processor for the second analysis is performed during the first analysis by the analyzer. Yoshinari discloses that a preprocess is performed by the preprocessor. Before carrying out the sample analysis, an analysis measurement is performed on a specific substance, and from the result, an optimization tuning of the analysis conditions of the apparatus is performed. After that, during the mass analysis of the sample to be analyzed, the analysis conditions are set based on a constant or fixed conditional expression. In such a device tuning method, for example, when the concentration of the sample changes in time series, the optimal analysis conditions may fluctuate during sample analysis. This implies that the pre-process for a second analysis to be performed subsequently to a first analysis is performed during the first analysis by the analyzer. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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Prosecution Timeline

Feb 03, 2023
Application Filed
Sep 19, 2025
Non-Final Rejection — §102
Nov 20, 2025
Interview Requested
Dec 02, 2025
Applicant Interview (Telephonic)
Dec 02, 2025
Examiner Interview Summary
Dec 16, 2025
Response Filed
Mar 24, 2026
Final Rejection — §102 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
63%
Grant Probability
80%
With Interview (+17.0%)
3y 7m
Median Time to Grant
Moderate
PTA Risk
Based on 1031 resolved cases by this examiner. Grant probability derived from career allow rate.

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