Prosecution Insights
Last updated: July 17, 2026
Application No. 18/985,938

BIOLOGICAL SAMPLE ANALYZER CALIBRATION AND CONTROL

Non-Final OA §102
Filed
Dec 18, 2024
Priority
Dec 22, 2023 — provisional 63/614,240
Examiner
WILLIAMS, DON J
Art Unit
Tech Center
Assignee
Beckman Coulter Inc.
OA Round
1 (Non-Final)
84%
Grant Probability
Favorable
1-2
OA Rounds
1y 1m
Est. Remaining
89%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allowance Rate
754 granted / 899 resolved
+23.9% vs TC avg
Moderate +5% lift
Without
With
+5.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
11 currently pending
Career history
905
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
74.4%
+34.4% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
0.2%
-39.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 899 resolved cases

Office Action

§102
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 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. Claim(s) 1-2, 4-8, 11-12, 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wanders et al (US2023/0075298A1). As to claim 1, Wanders et al disclose (fig. 1) a system (apparatus, systems) for assessing (assesses), (abstract) a biological analyzer (visual analyzer, hematology analyzer), (paragraphs [0057]-[0058], [0164]), comprising: a flowcell (22); a projection region (43 or an illumination opening/window at a fixed and dependable location within the flowcell used to collect a precisely focused image of the ribbon sample stream 32 through resolution imaging device optics 46 defines a projection region), (paragraphs [0143], [0148]); a media source (25, 27 driven by metering pumps that move the PIOAL streams with injected sample fluid along flowpath) configured to project media (PIOAL, sample fluid) onto the projection region (43), (paragraphs [0139]-[0140]), wherein the media (32, PIOAL streams, sample fluid) includes a representation of at least one particle (microscopic particles, particles) within the flowcell (22), (paragraphs [0017], [0139], [0140]); an imaging device (24, 48) aligned with the projection region (43), wherein the imaging device (24, 48) is configured to capture (images are collected) at least one image (images) of the representation of the at least one particle (imaging microscopic particles); and a processor (18) configured to process the at least one image (images, pixel data) of the representation of the at least one particle (microscopic particles, particles), (paragraphs [0017], [0139]-[0140]) to assess (assess, assesses), (see abstract) a function of the biological analyzer (visual analyzer, hematology analyzer), (paragraphs [0160], [0164]). As to claim 2, Wanders et al disclose (fig. 1) the system (apparatus, systems), (paragraph [0057]) wherein the processor (18) is further configured to control a motor (54) to cause an objective lens (46) of the imaging device (24, 48) to move a predetermined distance (52, relative distance, displacement distance) along an optical axis (optical axis) after determining that the representation of the at least one particle (microscopic particles, particles) is in focus (focused, focus, autofocus), (paragraphs [0017], [0142], [0051], [0161]-[0162], [0164]). As to claim 4, Wanders et al disclose (fig. 1) the system (apparatus, systems), (paragraph [0057]) wherein the at least one particle (microscopic particles, particles) comprises a control particle (discrete or formed object dispersed in a fluid defines control particle), (paragraph [0117]). As to claim 5, Wanders et al disclose (fig. 1) the system (apparatus, systems), (paragraph [0057]), wherein the at least one particle (microscopic particles, particles) comprises a calibration particle (discrete or formed object dispersed in a fluid, measurable and detectable particles define calibration particle), (paragraph [0117]). As to claim 6, Wanders et al disclose (fig. 1C) the system (apparatus, systems), (paragraph [0057]) wherein the processor (18) is further configured to automatically adjust (processor moves the motor 54 to another position) an operation of the biological analyzer (100c) based on the assessed (assesses) function of the biological analyzer (100c), (paragraph [0164]). As to claim 7, Wanders et al disclose (fig. 1C) the system (apparatus, systems), (paragraph [0057]), wherein the at least one particle (microscopic particles, particles) comprises a plurality of particles (particles, blood cells, particle agent compositions) simulating a concentration (concentration) for a given type of particle (erythrocytes, reticulocytes, nucleated red blood cells, platelets, white blood cells), and wherein the assessed (assesses) function of the biological analyzer (100c) includes determining the concentration (concentration) from the images (images) of the plurality of particles (particles, blood cells, particle agent compositions), (paragraphs [0076]-[0078], [0080]-[0083], [0088]-[0089]). As to claim 8, Walters et al disclose (fig. 1C) the system (apparatus, systems), (paragraph [0057]), wherein the at least one particle (microscopic particles, particles) comprises a plurality of particles (particles, blood cells, particle agent composition) simulating a plurality of concentrations (concentrations) for a corresponding plurality of types of particle (erythrocytes, reticulocytes, nucleated red blood cells, platelets, white blood cells), and wherein the assessed (assessed) function of the biological analyzer (100c) includes determining the plurality of concentrations (concentrations) from the images (images) of the plurality of particles (microscopic particles, particles), (paragraphs [0076]-[0078], [0080]-[0083], [0088]-[0089]). As to claim 11, Walters et al disclose a method for assessing (assesses) a biological analyzer (visual analyzer, hematology analyzer), (paragraphs [0057], [0164]) comprising: providing projecting media (PIOAL, sample fluid, sheath fluid), the projecting media (PIOAL, sample fluid, sheath fluid) configured to project onto a projection region (43 or an illumination opening/window at a fixed and dependable location within the flowcell used to collect a precisely focused image of the ribbon sample stream 32 through resolution imaging device optics 46 defines a projection region), (paragraphs [0143], [0148]) with a media source (25, 27 driven by metering pumps that move the PIOAL with injected sample fluid along flowpath), wherein the media (PIOAL, sample fluid, sheath fluid) includes a representation of at least one particle (microscopic particles, particles) within a flowcell (22), (paragraphs [0139, [0140]); capturing, with an imaging device (24, 48) aligned with the projection region (43), at least one image (image) of the representation of the at least one particle (microscopic particles, particles), (paragraphs [0139]-[0140]); and processing, with a processor (18), the at least one image (image, pixel data) of the representation of the at least one particle (microscopic particles, particles) to assess (assesses) a function of the biological analyzer (visual analyzer, hematology analyzer), (paragraph [0160], [0164]). As to claim 12, Walters et al disclose (fig. 1) the method further comprising controlling, with the processor (18), a motor (54) to cause an objective lens (46) of the imaging device (24, 48) to move a predetermined distance (52, relative distance, displacement distance) along an optical axis (optical axis) after determining that the representation of the at least one particle (microscopic particles, particles, PIOAL) is in focus (focused, focus, autofocus), (paragraphs [0142, [0051], [0161]-[0162], [0164]). As to claim 14, Walters et al disclose (fig. 1) the method wherein the at least one particle (microscopic particles, particles) comprises a control particle (discrete or formed object dispersed in a fluid defines control particle), (paragraph [0117]). As to claim 15, Walters et al disclose (fig. 1) the method wherein the at least one particle (microscopic particles, particles) comprises a calibration particle (discrete or formed object dispersed in a fluid, measurable and detectable particles define calibration particle), (paragraph [0117]). As to claim 16, Walters et al disclose (fig. 1, fig. 1C) the method further comprising automatically adjusting (processor moves the motor 54 to another position), with the processor (18), an operation of the biological analyzer (100c) based on the assessed (assesses) function of the biological analyzer (100c), (paragraph [0164]). As to claim 17, Walters et al disclose (fig. 1) wherein the at least one particle (microscopic particles, particles) comprises a plurality of particles (particles, blood cells, particle agent compositions) simulating a concentration (concentration) for a given type of particle (erythrocytes, reticulocytes, nucleated red blood cells, platelets, white blood cells), and wherein the assessed (assess) function of the biological analyzer (100c) includes determining the concentration (concentration) from the images (images) of the plurality of particles (particles, blood cells, particle agent compositions), (paragraphs [0076]-[0078], [0080]-[0083], [0088]-[0089]). As to claim 18, Walters et al disclose (fig. 1, fig. 1C) the method wherein the at least one particle (microscopic particles, particles) comprises a plurality of particles (particles, blood cells, particle agent composition) simulating a plurality of concentrations (concentrations) for a corresponding plurality of types of particle (erythrocytes, reticulocytes, nucleated red blood cells, platelets, white blood cells), and wherein the assessed (assess) function of the biological analyzer (100c) includes determining the plurality of concentrations (concentrations) from the images (images) of the plurality of particles (microscopic particles, particles), (paragraphs [0076]-[0078], [0080]-[0083], [0088]-[0089]). Allowable Subject Matter Claims 3, 9-10, 13, 19-20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record fail to teach either singly or in combination wherein the flowcell is configured to not cause a fluid flow through the viewing zone while the imaging device captures the at least one image of the representation of the at least one particle, wherein the media includes video having a plurality of frames, wherein the plurality of frames includes a first set of frames and a second set of frames, wherein the first set of frames includes representations of a first group of particles simulating a first concentration for a given type of particle, wherein the second set of frames includes representations of a second group of particles simulating a second concentration for the given concentration, and wherein the assessed function of the biological analyzer includes determining the first concentration for the given type of particle and the second concentration for the given type of particle, and wherein the media includes video having a plurality of frames, wherein the plurality of frames includes a first set of frames and a second set of frames, wherein the first set of frames includes representations of a first group of particles simulating a first plurality of concentrations for corresponding types of particles, wherein the second set of frames includes representations of a second group of particles simulating a second plurality of concentrations for the corresponding types of particles, and wherein the assessed function of the biological analyzer includes determining the first plurality of concentrations and the second plurality of concentrations. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DON J WILLIAMS whose telephone number is (571)272-8538. The examiner can normally be reached M-F 8 a.m.-5 p.m.. 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, Georgia Epps can be reached at 571-272-2328. 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. /DON J WILLIAMS/Examiner, Art Unit 2878
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Prosecution Timeline

Dec 18, 2024
Application Filed
Jun 26, 2026
Non-Final Rejection mailed — §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

1-2
Expected OA Rounds
84%
Grant Probability
89%
With Interview (+5.2%)
2y 8m (~1y 1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 899 resolved cases by this examiner. Grant probability derived from career allowance rate.

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