Prosecution Insights
Last updated: October 02, 2026
Application No. 18/546,959

DIAGNOSTIC LABORATORY SYSTEMS AND METHODS OF OPERATING

Final Rejection §102§Other
Filed
Aug 17, 2023
Priority
Feb 18, 2021 — provisional 63/150,876 +1 more
Examiner
KWAK, DEAN P
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Siemens Healthineers AG
OA Round
2 (Final)
59%
Grant Probability
Moderate
3-4
OA Rounds
9m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allowance Rate
394 granted / 671 resolved
-6.3% vs TC avg
Strong +37% interview lift
Without
With
+37.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
84 currently pending
Career history
732
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
36.3%
-3.7% vs TC avg
§102
28.0%
-12.0% vs TC avg
§112
26.7%
-13.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 671 resolved cases

Office Action

§102 §Other
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 . Claim Rejections - 35 USC § 102 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claim(s) 26-30 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Holmes (US 2014/0170735 A1). Regarding claim 26, Holmes teaches: 26. A diagnostic laboratory system (systems of sample collection, sample preparation, assay, and/or detection for accurate diagnoses, ongoing monitoring, and guidance of treatment; Fig. 3; ¶ 0007), comprising: a module capable of performing a function on an item in the module (see i.e., Devices may comprise one or more module. A module may be capable of performing one or more, two or more, or all three of a sample preparation step, assay step, and/or detection step. FIG. 3 shows an example of a module 300. A module may comprise one or more, two or more, or three or more of a sample preparation station 310, and/or an assay station 320, and/or a detection station 330. In some embodiments, multiple of a sample preparation station, assay station, and/or detection station are provided. A module may also include a fluid handling system 340. ¶ 0479); a plurality of sensors, each of the plurality of sensors capable of monitoring the function on the item and generate sensor data in response to monitoring (see i.e., A module (300) may include one or more detection stations (330). A detection station may include one or more sensors that may detect visual/optical signals, infra-red signals, heat/temperature signals, ultraviolet signals, any signal along an electromagnetic spectra, electric signals, chemical signals, audio signals, pressure signals, motion signals, or any other type of detectable signals. The sensors provided herein may or may not include any of the other sensors described elsewhere herein. [...] A detection station may contain, for example, a spectrophotometer, a PMT, a photodiode, a camera, an imaging device, a CCD or CMOS optical sensor, or a non-optical sensor. In some embodiments, a detection station may contain a light source and optical sensor. In some embodiments, a detection station may contain a microscope objective and an imaging device. ¶ 0489); and a computer capable of : check an operational status of a first sensor (see i.e., a controller determines a current device state by using a first sensor feedback in trying to correct a detected error or malfunction ¶ 1390; see also a first detection station comprising an optical sensor ¶ 0229) of the plurality of sensors; receive sensor data from at least one other sensor of the plurality of sensors that differs from the first sensor (see i.e., a second detection station comprising a light source and an optical sensor ¶ 0229; the controller may change the temperature of a thermal control unit, modify the rotation speed of a centrifuge, determine a protocol to run on a particular assay sample, move a vessel and/or tip, or dispense and/or aspirate a sample. In some embodiments, based on the signals from the sensors, the controller may maintain one or more condition of the device. ¶ 1390; multiple types of sensors or detection units may be used for measuring the same property and may provide a way of verifying a measured property or as a coarse first measurement which can then be used to refine the second measurement ¶ 1392; the controller may have a hardware and/or software module which may process one more sensor signals in a mutually-dependent or independent manner to interpret the signals for the controller ¶ 1391); and scale sensor data generated by the first sensor in response to the operational status and the sensor data received from the at least one other sensor to generate revised sensor data (see i.e., the controller processes sensor signals in a mutually-dependent or independent manner interpreting sensor signals from multiple types of sensors or detection units for verification or as a coarse first measurement which is then used to refine a second measurement, and therefore refines for generating revised sensor data, Fig. 3, ¶ 1391, 1392, 1412, 1413; sensors may be useful in providing feedback in trying to correct a detected error or malfunction. ¶ 1390; temperature sensors on the pipette may automatically trigger an adjustment in the required piston movement, to correct for temperature fluctuations. In general, modules where feedback regarding performance is available, may auto-correct for any changes over time. ¶ 1701; Feedback such as this helps in reducing catastrophic failures, and allows for real-time correction. ¶ 1890). Regarding claims 27-30, Holmes teaches: 27. The diagnostic laboratory system of claim 26, wherein the computer is further configured to impute the sensor data of the first sensor in response to the operational status and the sensor data received from the at least one other sensor (see i.e., the controller processes sensor signals in a mutually-dependent or independent manner interpreting sensor signals from multiple types of sensors and thus imputes the dynamic resource allocation based on real-time feedback when a resource is functionally unavailable, Fig. 3, ¶ 1391, 1392, 1412, 1413). 28. The diagnostic laboratory system of claim 26, wherein at least one of the plurality of sensors is a pressure sensor capable of measuring pressure of a liquid during an aspiration process or a dispense process (see i.e., one or more sensors provide pressure data to a control system and based on the signals from sensors, the controller dispenses and/or aspirates a sample, ¶ 0852, 1390). 29. The diagnostic laboratory system of claim 26, wherein at least one of the plurality of sensors is an imaging device capable of capturing an image of the item, the image comprising image data (see i.e., module 300 includes an assay station 320 comprising a cytometer, and a detection station 330 comprising a camera, an imaging device, a CCD, or a CMOS optical sensor, for digital imaging comprising collections of images or video, each outputting image data, ¶ 0479, 0482, 0489, 1372). 30. The diagnostic laboratory system of claim 26, wherein the computer is configured to receive user input, and wherein the computer is configured to scale the sensor data generated by the first sensor in response to the user input (see i.e., a graphical user interface GUI enables a subject to interact with device, such as operator input to instruct the device to run calibrations, also including a processing protocol adjustable by a user for a particular use, or modified or updated while the protocol is in use, ¶ 1444, 1513, 1557, 1698). Response to Arguments Applicant's arguments filed 07/21/2026 have been fully considered but they are not persuasive. The amendments have been considered and 35 USC § 112 rejections have been withdrawn. In response to the Applicant's argument that Holmes does not teach “a computer configured to: check an operational status of a first sensor of the plurality of sensors; receive sensor data from at least one other sensor of the plurality of sensors that differs from the first sensor; and scale sensor data generated by the first sensor in response to the operational status and the sensor data received from the at least one other sensor to generate revised sensor data”, Examiner disagrees. Holmes teaches, among other things, check an operational status of a first sensor (see i.e., a controller determines a current device state by using a first sensor feedback in trying to correct a detected error or malfunction ¶ 1390; see also a first detection station comprising an optical sensor ¶ 0229) of the plurality of sensors; receive sensor data from at least one other sensor of the plurality of sensors that differs from the first sensor (see i.e., a second detection station comprising a light source and an optical sensor ¶ 0229; the controller may change the temperature of a thermal control unit, modify the rotation speed of a centrifuge, determine a protocol to run on a particular assay sample, move a vessel and/or tip, or dispense and/or aspirate a sample. In some embodiments, based on the signals from the sensors, the controller may maintain one or more condition of the device. ¶ 1390; multiple types of sensors or detection units may be used for measuring the same property and may provide a way of verifying a measured property or as a coarse first measurement which can then be used to refine the second measurement ¶ 1392; the controller may have a hardware and/or software module which may process one more sensor signals in a mutually-dependent or independent manner to interpret the signals for the controller ¶ 1391); and scale sensor data generated by the first sensor in response to the operational status and the sensor data received from the at least one other sensor to generate revised sensor data (see i.e., the controller processes sensor signals in a mutually-dependent or independent manner interpreting sensor signals from multiple types of sensors or detection units for verification or as a coarse first measurement which is then used to refine a second measurement, and therefore refines for generating revised sensor data, Fig. 3, ¶ 1391, 1392, 1412, 1413; sensors may be useful in providing feedback in trying to correct a detected error or malfunction. ¶ 1390; temperature sensors on the pipette may automatically trigger an adjustment in the required piston movement, to correct for temperature fluctuations. In general, modules where feedback regarding performance is available, may auto-correct for any changes over time. ¶ 1701; Feedback such as this helps in reducing catastrophic failures, and allows for real-time correction. ¶ 1890). Applicant is thanked for their thoughtful amendments to the claims. 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 DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST. 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, CHARLES CAPOZZI can be reached at (571)270-3638. 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. /DEAN KWAK/Primary Examiner, Art Unit 1798 DEAN KWAK Primary Examiner Art Unit 1798
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Prosecution Timeline

Aug 17, 2023
Application Filed
Apr 22, 2026
Non-Final Rejection mailed — §102, §Other
Jul 21, 2026
Response Filed
Sep 01, 2026
Final Rejection mailed — §102, §Other (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
59%
Grant Probability
96%
With Interview (+37.1%)
3y 10m (~9m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 671 resolved cases by this examiner. Grant probability derived from career allowance rate.

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