Prosecution Insights
Last updated: August 17, 2026
Application No. 19/169,955

QUANTITATIVE FLOW CYTOMETRY LIGHT SCATTER DETECTOR ALIGNMENT

Non-Final OA §102§103
Filed
Apr 03, 2025
Priority
Apr 10, 2024 — provisional 63/632,452
Examiner
CARLSON, JOSHUA MICHAEL
Art Unit
Tech Center
Assignee
Becton, Dickinson and Company
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
1y 6m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allowance Rate
50 granted / 85 resolved
-1.2% vs TC avg
Strong +38% interview lift
Without
With
+37.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
27 currently pending
Career history
119
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
53.7%
+13.7% vs TC avg
§102
10.2%
-29.8% vs TC avg
§112
31.2%
-8.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 85 resolved cases

Office Action

§102 §103
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 statement(s) (IDS) was/were filed on 10 July 2025 and 02 October 2025. The submissions are in compliance with the provisions of 37 CFR 1.97, and therefore are considered by the examiner. Specification The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1, 6-7, 13, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2025/0164769 A1 by Sergei Kuehn et al. (herein after “Kuehn”). Regarding claim 1, Kuehn discloses a method of determining an alignment adjustment for a light scatter detector system of a flow cytometer (Kuehn [0061] discloses a biomedical illumination device 100 comprising a focusing system 114, within a flow cytometry application; [0097] discloses a method of beam alignment where detection light path, sample stream, and excitation light path are mutually intersected; detector output pulses are monitored to determine a degree of needed alignment in order to find maximum signal strength [determining alignment for detector system of flow cytometer]; [0057] the maximum signal from detectors are disclosed as being forward scattering detectors [light scatter detector system]), the method comprising: (a) generating control data by the flow cytometer (Kuehn [0097] discloses using labeled fluorescence beads to determine whether the system is aligned, where data generated by the fluorescence beads is known in the art as being for calibration purposes and is “control data by the flow cytometer” here); (b) determining a quantitative metric of the alignment for the light scatter detector system based on the control data (Kuehn [0097] discloses determining whether amplified detector output pulses are symmetric and reach a maximum intensity, where nonsymmetric pulses indicates misalignment of at least some of the components of the optical arrangement [both symmetry of detector output pulses and intensity of detector signals are “quantitative metrics of the alignment for the detector system” – since they’re based on data obtained by fluorescence beads, they are based on the control data]); and (c) determining the alignment adjustment for the light scatter detector system based on the quantitative alignment metric (Kuehn [0097] has disclosed that the alignment process comprises arriving at a state where a maximum signal on the detector is achieved; various optical depth of fields within the optical system (see fig. 7 and [0067] for configurations of optical system components, lenses L1-L3, resulting in different beam profiles) are adjusted while monitoring the intensity of the detector on an oscilloscope in order to achieve maximum intensity and tightness; the “alignment adjustment” is embodied by the adjustment to the depth of fields of optical components, and is inherently “determined” since it is applied to the optical system). Regarding claim 6, Kuehn discloses the method according to claim 1, and further teaches the method wherein the light scatter detector system comprises a side scatter detector, a forward scatter detector, or both (Kuehn [0057] discloses the alignment routine as described above wherein maximum signal from a forward scattering sensor is obtained during beam alignment [light scatter detector system comprises a forward scatter detector]). Regarding claim 7, Kuehn discloses the method according to claim 1, and further teaches the method wherein generating the control data comprises: i) irradiating a bead with the flow cytometer (Kuehn [0097] and as disclosed within claim 1, during beam alignment the goal is to bring the excitation light path, detection light path, and sample stream into mutual intersection, where labelled fluorescence beads are used for the alignment to obtain a maximum signal on the detector [fluorescence beads within the sample stream (and/or flow cell or reference cell [0095]) are irradiated with excitation light and the detector detects scattered light); and ii) measuring a data signal generated by the light scatter detector system (Kuehn [0097] discloses monitoring the raw data signal from the detector via oscilloscope, where the detector can be a forward scattering sensor [measuring a data signal generated by the light scatter detector system]). Regarding claim 13, Kuehn discloses the method according to claim 1, and further teaches the method comprising providing the alignment adjustment to a user (Kuehn [0073] discloses an input device such as a keyboard, touch screen, etc. and an output device such as a display – the output device provides information on current settings for the calibration, or performed adjustments on beam steering [providing alignment adjustment to a user, where the user is viewing the displayed information]). Regarding claim 18, Kuehn discloses the method according to claim 1, and further teaches the method further comprising adjusting the light scatter detector system based at least in part on the alignment adjustment (Kuehn [0097] has disclosed the alignment processes comprises arriving at a state where a maximum signal on the detector is achieved, and that optical depth of fields are adjusted while monitoring the intensity of the detector to achieve maximum intensity and tightness; the optical depth of fields are physically adjusted based on the discrepancy between a current state and the maximum intensity – therefore, the light scatter detector system is adjusted based at least in part on the alignment adjustment having been determined through detector intensity monitoring). 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. Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kuehn in view of US 2017/0059470 A1 by Norio Hasegawa (herein after “Hasegawa”). Regarding claim 2, Kuehn discloses the method according to claim 1, but is silent to the method wherein determining the quantitative alignment metric comprises calculating a collection angle based on the control data. However, Hasegawa does address this limitation. Kuehn and Hasegawa are considered to be analogous to the present invention because they are methods of operation within particle detection devices including flow cytometers and/or samples flowing within a flow channel. Hasegawa discloses the method according to claim 1, “wherein determining the quantitative alignment metric comprises calculating a collection angle based on the control data” (Hasegawa [0007]-[0008] discloses a method for the detection of a fluorescent particle, wherein coordinates are identified relative to reference points, including an angle formed between the coordinate axis of a fluorescent light observing device [light scatter detector, see [0003] and [0046] for detection of scattered light from the particle]; [0009] this angle is used to enable identification of coordinates for the fluorescent particle in the coordinate system of a material analyzing device, including a Raman or infrared spectroscope, or electron beam microanalyzer - the angle formed between coordinate axis of the light observing device and the reference points). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein determining the quantitative alignment metric comprises calculating a collection angle based on the control data as suggested by Hasegawa for the advantage of enabling the identification of coordinates unique to the identified particles, and enables a means for correction of misaligned sample support structures, including a glass slide (Hasegawa [0058]) or a liquid containing flow cell (Hasegawa [0053]). Regarding claim 3, Kuehn when modified by Hasegawa discloses the method according to claim 2. Kuehn is silent to the method according to claim 2, wherein the collection angle is calculated with respect to an interrogation point of the flow cytometer. However, Hasegawa does address this limitation. Hasegawa discloses the method according to claim 2, “wherein the collection angle is calculated with respect to an interrogation point of the flow cytometer” (Hasegawa [0008] discloses identifying an angle formed between the coordinate axis of a fluorescent light observing device and reference points associated with the particle [the particle is within an interrogation area of the flow cytometer, and thus the collection angle being between the observing device and reference points associated with a particle, i.e. “collection angle is calculated with respect to an interrogation point of the flow cytometer”]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the collection angle is calculated with respect to an interrogation point of the flow cytometer as suggested by Hasegawa for the advantage of enabling the identification of coordinates unique to the identified particles, and enables a means for correction of misaligned sample support structures, including a glass slide (Hasegawa [0058]) or a liquid containing flow cell (Hasegawa [0053]). Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kuehn in view of Hasegawa, and further in view of CN 101498646 B by Han-Rong Shao et al. (herein after “Shao”). Regarding claim 4, Kuehn when modified by Hasegawa discloses the method according to claim 2, but is silent to the method comprising wherein the collection angle is calculated using a light scattering model. However, Shao does address this limitation. Kuehn, Hasegawa, and Shao are considered to be analogous to the present invention because they are methods of operation within particle detection devices including flow cytometers and/or samples flowing within a flow channel. Shao discloses the method according to claim 2, “wherein the collection angle is calculated using a light scattering model” (Shao [0095]-[0097] discloses a calculation of scattering collection angle for detector units within a flow cytometry system, where the calculation is based on the collection angle is a function of [0030] detector height D above optical axis and the distance f between the scattering source and a collimating lens [collection angle is calculated via light scattering model]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn in view of Hasegawa to incorporate wherein the collection angle is calculated using a light scattering model as suggested by Shao for the advantage of enabling the use of detection systems which reduce the system cost and reduce the size of the footprint for the cytometer (Shao [0044]-[0046]) while providing a means for calculation of the collection angles of said detection systems. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kuehn in view of Hasegawa, in view of Shao, and further in view of US 2020/0278285 A1 by Jay A Berzofsky et al. (herein after “Berzofsky”). Examiner notes the reference Berzofsky was cited by applicant was cited in the IDS filed 10 July 2025. Regarding claim 5, Kuehn when modified by Hasegawa and Shao discloses the method according to claim 4, but is silent to the method wherein the light scattering model comprises a Mie light scatter model. However, Berzofsky does address this limitation. Kuehn, Hasegawa, Shao, and Berzofsky are considered to be analogous to the present invention because they are methods of operation within particle detection devices including flow cytometers and/or samples flowing within a flow channel. Berzofsky discloses the method according to claim 4, “wherein the light scattering model comprises a Mie light scatter model” (Berzofsky [0060] and figs. 32-33 disclose the relationship between a particles diameter and the amount of light scattering collected due to Mie resonances in the particle’s angular scattering distribution, dependent on the collection angle of an SSC detection system 144 – therefore, Mie resonances [i.e. a Mie light scatter model] at least partially inform an identification of collection angle (and other component geometric characteristics like slit aperture geometry, etc.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn in vie of Hasegawa and Shao to incorporate wherein the light scattering model comprises a Mie light scatter model as suggested by Berzofsky for the advantage of enabling an increase in scattering signal as the particles diameters increase, allowing an accurate extrapolation of size utilizing Mie resonance positions (Berzofsky [0060]). Claims 8, 14-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kuehn in view of US 2026/0016389 A1 by Katsutoshi Tahara (herein after “Tahara”). Regarding claim 8, Kuehn discloses the method according to claim 1 but is silent to the method according to claim 1 wherein the control data is generated for a plurality of beads, the plurality of beads comprising a first bead and a second bead larger than the first bead. However, Tahara does address this limitation. Kuehn and Tahara are considered to be analogous to the present invention because they are directed to alignment, calibration, or adjustment methods within particle detection devices including flow cytometers. Tahara discloses the method according to claim 1, “wherein the control data is generated for a plurality of beads, the plurality of beads comprising a first bead and a second bead larger than the first bead” (Tahara [0045] and fig. 3 discloses a processing example for a flow of specifying particles having predetermined characteristics [i.e. calibration beads, as is disclosed by Kuehn] where a two sample bead types including 3µm and 10µm [plurality of beads, first bead 3µm smaller than the second bead 10µm]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the control data is generated for a plurality of beads, the plurality of beads comprising a first bead and a second bead larger than the first bead as suggested by Tahara for the advantage of enabling calibration and adjustment processing for a sample with a plurality of particle populations, or kinds of particles having different characteristics (Tahara [0055]) – it is typical for flow cytometry sample to comprise a plurality of particle populations. Regarding claim 14, Kuehn discloses the method according to claim 13, but is silent to the method wherein the alignment adjustment comprises a software alignment adjustment. However, Tahara does address this limitation. Tahara discloses the method according to claim 13, “wherein the alignment adjustment comprises a software alignment adjustment” (Tahara [0028] discloses that during sensitivity calibration, an analog adjustment of the detector takes place, including changing a circuit gain or internal gain of the detection device wherein [0030] the detection device includes an MPPC (multi pixel photon counter) or the like, where [0036] discloses additional detector types including APDs (avalanche photodiodes), and/or a CCD or CMOS [changing the various gains being a software alignment adjustment]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the alignment adjustment comprises a software alignment adjustment as suggested by Tahara for the advantage of enabling sensitivity calibration for analog detection schemes, and achieving a desired signal to noise ratio for the detector (Tahara [0028]). Regarding claim 15, Kuehn when modified by Tahara discloses the method according to claim 14. Kuehn is silent to the method according to claim 14, wherein the software alignment adjustment comprises a collection angle calibration value, a trigger threshold value, a trigger channel option, a detector setting option, a pulse processing option, or any combination thereof. However, Tahara does address this limitation. Tahara discloses the method according to claim 14, “wherein the software alignment adjustment comprises a collection angle calibration value, a trigger threshold value, a trigger channel option, a detector setting option, a pulse processing option, or any combination thereof” (Tahara [0028] discloses that during sensitivity calibration, an analog adjustment of the detector takes place, including changing a circuit gain or internal gain of the detection device, wherein [0030] the detection device includes an MPPC (multi pixel photon counter) or the like, where [0036] discloses additional detector types including APDs (avalanche photodiodes), and/or a CCD or CMOS [the adjustment of the various gains disclosed in [0028] being a detector setting option, as claimed]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the software alignment adjustment comprises a collection angle calibration value, a trigger threshold value, a trigger channel option, a detector setting option, a pulse processing option, or any combination thereof as suggested by Tahara for the advantage of enabling sensitivity calibration for analog detection schemes, and achieving a desired signal to noise ratio for the detector (Tahara [0028]). Regarding claim 19, Kuehn discloses the method according to claim 18. Kuehn is silent to the method according to claim 18, wherein adjusting the light scatter detector system comprises performing a software alignment adjustment. However, Tahara does address this limitation. Tahara discloses the method according to claim 18, “wherein adjusting the light scatter detector system comprises performing a software alignment adjustment” (Tahara [0028] discloses that during sensitivity calibration, an analog adjustment of the detector takes place, including changing a circuit gain or internal gain of the detection device wherein [0030] the detection device includes an MPPC (multi pixel photon counter) or the like, where [0036] discloses additional detector types including APDs (avalanche photodiodes), and/or a CCD or CMOS [changing the various gains being a software alignment adjustment]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein adjusting the light scatter detector system comprises performing a software alignment adjustment as suggested by Tahara for the advantage of enabling sensitivity calibration for analog detection schemes, and achieving a desired signal to noise ratio for the detector (Tahara [0028]). Regarding claim 20, Kuehn when modified by Tahara discloses the method according to claim 19. Kuehn is silent to the method according to claim 19, wherein the software alignment adjustment comprises a collection angle calibration value, a trigger threshold value, a trigger channel option, a detector setting option, a pulse processing option, or any combination thereof. However, Tahara does address this limitation. Tahara discloses the method according to claim 19, “wherein the software alignment adjustment comprises a collection angle calibration value, a trigger threshold value, a trigger channel option, a detector setting option, a pulse processing option, or any combination thereof” (Tahara [0028] discloses that during sensitivity calibration, an analog adjustment of the detector takes place, including changing a circuit gain or internal gain of the detection device, wherein [0030] the detection device includes an MPPC (multi pixel photon counter) or the like, where [0036] discloses additional detector types including APDs (avalanche photodiodes), and/or a CCD or CMOS [the adjustment of the various gains disclosed in [0028] being a detector setting option, as claimed]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the software alignment adjustment comprises a collection angle calibration value, a trigger threshold value, a trigger channel option, a detector setting option, a pulse processing option, or any combination thereof as suggested by Tahara for the advantage of enabling sensitivity calibration for analog detection schemes, and achieving a desired signal to noise ratio for the detector (Tahara [0028]). Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kuehn in view of Tahara, and further in view of US 2024/0142460 A1 by Eitan Lerner et al. (herein after “Lerner”). Regarding claim 9, Kuehn when modified by Tahara discloses the method according to claim 8, but is silent to the method wherein the plurality of beads have a diameter of 50 nm to 3000 nm. However, Lerner does address this limitation. Kuehn, Tahara, and Lerner are considered to be analogous to the present invention because they are directed to alignment, calibration, or adjustment methods within particle detection devices including flow cytometers. Lerner discloses the method according to claim 8 “wherein the plurality of beads have a diameter of 50 nm to 3000 nm” (Lerner [0057] and figs. 2D-2E disclose the use of fluorescent beads with diameters of 1,000 nm, 500 nm, and 100 nm, fulfilling the range of bead diameters claimed). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn in view of Tahara to incorporate wherein the plurality of beads have a diameter of 50 nm to 3000 nm as suggested by Lerner for the advantage of utilizing a variety of fluorescent nanobeads for purposes of calibration, where a higher degree of accuracy is obtained for a plurality of particle sizes (Lerner [0057]). Regarding claim 10, Kuehn when modified by Tahara and Lerner discloses the method according to claim 9. Kuehn when modified by Tahara is silent to the method according to claim 9, wherein the plurality of beads have a diameter of 100 nm and 1200 nm. However, Lerner does address this limitation. Lerner discloses the method according to claim 9 “wherein the plurality of beads have a diameter of 100 nm to 1200 nm” (Lerner [0057] and figs. 2D-2E disclose the use of fluorescent beads with diameters of 1,000 nm, 500 nm, and 100 nm, fulfilling the range of bead diameters claimed). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn in view of Tahara to incorporate wherein the plurality of beads have a diameter of 100 nm to 1200 nm as suggested by Lerner for the advantage of utilizing a variety of fluorescent nanobeads for purposes of calibration, where a higher degree of accuracy is obtained for a plurality of particle sizes (Lerner [0057]). Claims 16-17 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kuehn in view of US 2014/0152986 A1 by Michael Trainer (herein after “Trainer”). Examiner notes the reference Trainer was cited by applicant in the IDS filed 02 October 2025. Regarding claim 16, Kuehn discloses the method according to claim 13, but is silent to the method wherein the alignment adjustment comprises a hardware alignment adjustment. However, Trainer does address this limitation. Kuehn and Trainer are considered to be analogous to the present invention because they are directed to alignment, calibration, or adjustment methods within particle detection devices including flow cytometers. Trainer discloses the method according to claim 13, “wherein the alignment adjustment comprises a hardware alignment adjustment” (Trainer [0151] and fig. 1 disclose a plurality of slits between a pair of detectors and a flow cell (slit 115 between flow cell and detector pair 112/113 and slit 114 between flow cell and detector pair 110/111), where the slit constitutes a piece of hardware; [0154] discloses the adjustment of the position of the slits to achieve a desired crossover of detector fields of view [adjustment of slit position being a “hardware alignment adjustment”]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the alignment adjustment comprises a hardware alignment adjustment as suggested by Trainer for the advantage of enabling a means for obtaining a shared alignment between a plurality of detectors, and reducing edge effects for particles passing near the edge of an illumination beam (Trainer [0154]). Regarding claim 17, Kuehn when modified by Trainer discloses the method according to claim 16. Kuehn is silent to the method according to claim 16, wherein the hardware alignment adjustment comprises an aperture adjustment distance, an aperture adjustment angle, a detector adjustment distance, a detector adjustment angle, or any combination thereof. However, Trainer does address this limitation. Trainer discloses the method according to claim 16, “wherein the hardware alignment adjustment comprises an aperture adjustment distance, an aperture adjustment angle, a detector adjustment distance, a detector adjustment angle, or any combination thereof” (Trainer [0154], as noted within claim 16 above, discloses the adjustment of slit position in order to achieve a desired crossover of detector fields of view; as a slit is a type of aperture, the adjustment to slit position here is an “aperture adjustment distance”, reading on the claim). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the hardware alignment adjustment comprises an aperture adjustment distance, an aperture adjustment angle, a detector adjustment distance, a detector adjustment angle, or any combination thereof as suggested by Trainer for the advantage of enabling a means for obtaining a shared alignment between a plurality of detectors, and reducing edge effects for particles passing near the edge of an illumination beam (Trainer [0154]). Regarding claim 21, Kuehn discloses the method according to claim 18, but is silent to the method wherein adjusting the light scatter detector system comprises performing a hardware alignment adjustment. However, Trainer does address this limitation. Trainer discloses the method according to claim 18, “wherein adjusting the light scatter detector system comprises performing a hardware alignment adjustment” (Trainer [0151] and fig. 1 disclose a plurality of slits between a pair of detectors and a flow cell (slit 115 between flow cell and detector pair 112/113 and slit 114 between flow cell and detector pair 110/111), where the slit constitutes a piece of hardware; [0154] discloses the adjustment of the position of the slits to achieve a desired crossover of detector fields of view [adjustment of slit position being a “hardware alignment adjustment”]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein adjusting the light scatter detector system comprises performing a hardware alignment adjustment as suggested by Trainer for the advantage of enabling a means for obtaining a shared alignment between a plurality of detectors, and reducing edge effects for particles passing near the edge of an illumination beam (Trainer [0154]). Regarding claim 22, Kuehn when modified by Trainer discloses the method according to claim 21. Kuehn is silent to the method according to claim 21, wherein the hardware alignment adjustment comprises adjusting a position and/or orientation of an optical adjustment component of the flow cytometer. However, Trainer does address this limitation. Trainer discloses the method according to claim 21, “wherein the hardware alignment adjustment comprises adjusting a position and/or orientation of an optical adjustment component of the flow cytometer” (Trainer [0154] discloses the adjustment of slit position in order to achieve a desired crossover of detector fields of view – the adjustment of the slit position is “adjusting a position of an optical adjustment component of the flow cytometer”, given the slit’s purpose of making an optical adjustment within the flow cytometer). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuehn to incorporate wherein the hardware alignment adjustment comprises adjusting a position and/or orientation of an optical adjustment component of the flow cytometer as suggested by Trainer for the advantage of enabling a means for obtaining a shared alignment between a plurality of detectors, and reducing edge effects for particles passing near the edge of an illumination beam (Trainer [0154]). Documents Considered but not Relied Upon The following document(s) were considered but not relied up on for the rejection set forth in this action: US 2004/0217256 A1 by William E Ortyn et al. which discloses an autofocus system for a flow imaging system, related to determining an alignment adjustment for a flow cytometer as claimed. US 5,540,494 A by Norman B. Purvis, Jr. et al. which discloses a plurality of steps which are taken to characterize sizing parameters of a flow cytometer, including calibration curves, and utilizes calibration beads. US 2011/0267604 A1 by Jared E Swalwell which discloses a flow cytometer with an automatic continuous alignment correction feature, related to the claimed adjustment alignment. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA M CARLSON whose telephone number is (571)270-0065. The examiner can normally be reached Mon-Fri. 8:00AM - 5:00PM. 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, Tarifur R Chowdhury can be reached at (571) 272-2287. 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. /JOSHUA M CARLSON/Examiner, Art Unit 2877 /TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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Prosecution Timeline

Apr 03, 2025
Application Filed
Jul 23, 2026
Non-Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
59%
Grant Probability
96%
With Interview (+37.6%)
2y 10m (~1y 6m remaining)
Median Time to Grant
Low
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