Prosecution Insights
Last updated: July 17, 2026
Application No. 18/722,234

BIOLOGICAL FLUID ANALYSER WITH ADAPTIVE APERTURE DEVICE

Final Rejection §103
Filed
Jun 20, 2024
Priority
Dec 23, 2021 — EU 21217281.1 +1 more
Examiner
DOUMBIA, MOHAMED
Art Unit
2877
Tech Center
2800 — Semiconductors & Electrical Systems
Assignee
Radiometer Medical Aps
OA Round
2 (Final)
72%
Grant Probability
Favorable
3-4
OA Rounds
11m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allowance Rate
57 granted / 79 resolved
+4.2% vs TC avg
Strong +31% interview lift
Without
With
+30.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
14 currently pending
Career history
90
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
93.0%
+53.0% vs TC avg
§102
3.3%
-36.7% vs TC avg
§112
3.3%
-36.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 79 resolved cases

Office Action

§103
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 . Response to Amendment The Amendment filed January 30, 2026 has been entered. Response to Arguments Claims 1-18 are allowable. However, claims 19-20 are rejected over Weiss (US20120086795A1) in view Nagai (US20080187951A1). Claim 1 determines a characteristic of the fluid sample and then performs aperture control based off that characteristic. None of that is present in claim 19. Weiss in combination with Nagai teaches or makes obvious every limitation of claim 19 as explained below. Specifically, Weiss discloses an imaging system (microscope illumination system), and a controller configured to control an aperture device according to aperture configurations, and Nagai teaches a biological fluid analysis with an imaging system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weiss by incorporating a biological fluid analysis in order to apply oblique illumination microscopy to the biological fluid analysis for accurate classification of microscopic objects 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 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weiss (US20120086795A1) in view Nagai (US20080187951A1). Regarding claim 19, Weiss teaches: an imaging system (microscope illumination system 1) comprising: a light source assembly (2) configured to emit light, a first lens assembly (13 and 14) configured to direct the light from the light source assembly (fig. 1, [0052]-[0053]), an aperture device (8) configured to apply an aperture to allow light from the first lens assembly to pass through the aperture in order to indirectly define a probing light ([0052]) ; and a controller (40) configured to control the aperture device according to an aperture configuration, wherein the aperture device, in response to a first aperture control signal, is configured to apply the aperture with a first aperture configuration, and wherein the aperture device, in response to a second aperture control signal, is configured to apply the aperture with a second aperture configuration, wherein the controller is further configured to apply the aperture to the light with the first aperture configuration, with the second aperture configuration or both with the first aperture configuration and the second aperture configuration, by decentring the aperture from an optical axis of the imaging system ([0006], [0063], claim 1), but fails to disclose a biological fluid analyzer, the imaging system defining a probing volume configured to receive the probing light and configured to receive a container comprising a prepared biological fluid sample. However, Nagai teaches disclose a biological fluid analyzer (hematological analyzer) (Abstract), the imaging system defining a probing volume configured to receive the probing light and configured to receive a container (43a, fig. 6) comprising a prepared biological fluid sample ([0049]). 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 Weiss by incorporating a biological fluid analyzer, the imaging system defining a probing volume configured to receive the probing light and configured to receive a container comprising a prepared biological fluid sample in order to apply oblique illumination microscopy to the biological fluid analysis for accurate cell classification (Nagai: [0068]) in microscopy. Regarding claim 20, Weiss, when modified by Nagai, teaches the biological fluid analyzer according to claim 19, but fails to disclose wherein one or more of the apertures with the first aperture configuration or the aperture with the second aperture configuration has an aperture shape, the aperture shape being oval, rectangular or squared. However, the use of oval, rectangular or squared apertures in optical systems is a well-known design choice. 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 Weiss by incorporating wherein one or more of the apertures with the first aperture configuration or the aperture with the second aperture configuration has an aperture shape, the aperture shape being oval, rectangular or squared in order to tailor the beam profile or match the geometry of a sample or a detector to improve detection. Allowable Subject Matter Claims 1-18 are allowed. The following is an examiner’s statement of reasons for allowance: Regarding claim 1: The prior art of record (Piette (US 20240003810 A1), Behrend (US20110222059 A1) and Weiss (US20120086795A1)), taken alone or in combination, fails to teach or disclose “wherein the controller is configured to determine a characteristic of the prepared biological fluid sample and to thereby select the first aperture control signal or the second aperture control signal based on the characteristic and thereby drive the aperture device to form the first aperture configuration or the second aperture configuration in accordance with the selected aperture control signal”. Claims 2-15 are allowed due to dependency to claim 1. Regarding claim 1, Piette teaches a biological fluid analyzer comprising: an imaging system (Abstract, [0085]) comprising: a light source assembly (1540) configured to emit light ([0100]), a first lens assembly (1520) configured to direct the light from the light source assembly ([0100]), an aperture device (spinning disk 1504) configured to apply an aperture to allow light from the first lens assembly to pass through the aperture in order to indirectly define a probing light ([0099]-[0100] the pinholes are aperture to allow the light to pass , defining the “probing light” that illuminates discrete spot on the sample, [0109] Multiple disks may be deployed in the imaging instrument so that selection from among the disks may be performed by the user or automatically by the multi-detection system), the imaging system defining a probing volume configured to receive the probing light and configured to receive a container comprising a prepared biological fluid sample ([0086]-[0087] the space where the well is interrogated by the probing light is the probing volume), but fails to disclose a controller configured to control the aperture device according to an aperture configuration, wherein the aperture device, in response to a first aperture control signal, is configured to apply an aperture with a first aperture configuration, and wherein the aperture device, in response to a second aperture control signal, is configured to apply an aperture with a second aperture configuration. However, Behrend (US20110222059 A1) from the same field of endeavor teaches a controller (aperture controller 3906) configured to control the aperture device according to an aperture configuration, wherein the aperture device, in response to a first aperture control signal, is configured to apply an aperture with a first aperture configuration, and wherein the aperture device, in response to a second aperture control signal, is configured to apply an aperture with a second aperture configuration ([0296] “the aperture controller 3906 is operably coupled to an aperture device 3909. In an embodiment, the aperture controller 3906 is operable to modulate an effective numerical aperture. The aperture controller 3906 modulates the effective numerical aperture associated with a collection zone 3912 by manipulating a plurality of pixels of a liquid crystal display device 3910 associated with the aperture device 3909” changing the pixel pattern in response to a control is the very definition of applying a first and a second configuration) Neither of the references teaches that the controller determines a characteristic of the prepared biological fluid sample itself, and then select between aperture control signals based on that determined characteristics of the sample. Regarding claim 16: The prior art of record (Piette (US 20240003810 A1), Behrend (US20110222059 A1), Ono (US 20180152610 A1) and Weiss (US20120086795A1) whether considered individually or in combination, do not render obvious the claim subject matter: “a biological fluid analyzer comprising wherein the aperture device includes a first portion and a second portion collectively defining the aperture, the first portion and second portion being separate and concentric to each other”. Claims 17-18 are allowed due to dependency to claim 16. Regarding claim 16, Piette teaches a biological fluid analyzer comprising: an imaging system (Abstract, [0085]) comprising: a light source assembly (1540) configured to emit light ([0100]), a first lens assembly (1520) configured to direct the light from the light source assembly, an aperture device (spinning disk 1504) configured to apply an aperture to allow light from the first lens assembly to pass through the aperture in order to indirectly define a probing light ([0099]-[0100] the pinholes are aperture to allow the light to pass , defining the “probing light” that illuminates discrete spot on the sample, [0109] Multiple disks may be deployed in the imaging instrument so that selection from among the disks may be performed by the user or automatically by the multi-detection system) the imaging system defining a probing volume configured to receive the probing light and configured to receive a container comprising a prepared biological fluid sample ([0086]-[0087] the space where the well is interrogated by the probing light is the probing volume). Behrend (US20110222059 A1) from the same field of endeavor teaches a controller (aperture controller 3906) configured to control the aperture device according to an aperture configuration, wherein the aperture device, in response to a first aperture control signal, is configured to apply the aperture with a first aperture configuration, and wherein the aperture device, in response to a second aperture control signal, is configured to apply the aperture with a second aperture configuration ([0296] “the aperture controller 3906 is operably coupled to an aperture device 3909. In an embodiment, the aperture controller 3906 is operable to modulate an effective numerical aperture. The aperture controller 3906 modulates the effective numerical aperture associated with a collection zone 3912 by manipulating a plurality of pixels of a liquid crystal display device 3910 associated with the aperture device 3909” changing the pixel pattern in response to a control is the very definition of applying a first and a second configuration). Ono teaches wherein the aperture device includes a first portion (first stop) and a second portion (second stop), the first portion and second portion being separate and concentric to each other ([0020], [00198]); and a controller (liquid crystal driver) configured to control the aperture device according to an aperture configuration, wherein the aperture device, in response to a first aperture control signal, is configured to apply the aperture with a first aperture configuration, and wherein the aperture device, in response to a second aperture control signal, is configured to apply the aperture with a second aperture configuration ([0020], [0164], [0237]). In Ono, the first and second stops collectively control the blocking region, not by defining two concentric portions that together constitute the aperture. Furthermore, Piette and Ono are not analogous art. Piette is directed to confocal imaging, while Ono is directed to a dual-lens camera having a first optical system and a second optical system having imaging characteristics different from each other are combined concentrically. There is no obviousness to apply Ono’s stop to biological fluid analysis. 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 MOHAMED DOUMBIA whose telephone number is (571)272-8266. The examiner can normally be reached M-F 8:30-5:00 PM ET. 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, Michelle Iacoletti can be reached at 571-272-3995. 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. /MOHAMED DOUMBIA/Examiner, Art Unit 2877 /Michael A Lyons/Primary Examiner, Art Unit 2877
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Prosecution Timeline

Jun 20, 2024
Application Filed
Dec 02, 2025
Non-Final Rejection mailed — §103
Jan 27, 2026
Applicant Interview (Telephonic)
Jan 28, 2026
Examiner Interview Summary
Jan 30, 2026
Response Filed
Jun 08, 2026
Final Rejection mailed — §103 (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
72%
Grant Probability
99%
With Interview (+30.6%)
3y 0m (~11m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 79 resolved cases by this examiner. Grant probability derived from career allowance rate.

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