Office Action Predictor
Application No. 17/853,688

SAMPLE ANALYZING SYSTEM, METHOD AND CELL IMAGE ANALYZING DEVICE

Final Rejection §103§112§DP
Filed
Jun 29, 2022
Examiner
RAMIREZ, ALEX
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Shenzhen Mindray Bio-Medical Electronics Co., LTD.
OA Round
2 (Final)
79%
Grant Probability
Favorable
3-4
OA Rounds
3y 4m
To Grant
99%
With Interview

Examiner Intelligence

79%
Career Allow Rate
90 granted / 114 resolved
Without
With
+23.3%
Interview Lift
avg trend
3y 4m
Avg Prosecution
43 pending
157
Total Applications
career history

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
42.9%
+2.9% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
31.5%
-8.5% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§103 §112 §DP
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 Status Claims 52-71 are pending with claims 52-71 being examined. Claims 1-51 are canceled. Response to Amendment As to the claim amendments and remarks filed on 11/28/2025, the previous 112(b) rejection stands rejected. Applicant addressed claims 52 line 2, 58 line 2 and claims 69-70 however, claims 52 line 12, 53, 55, 57, 58 and 70 were not addressed. As to the claim amendments and remarks, the examiner has found applicants arguments not persuasive. Therefore, the previous rejection has been modified to address the claim amendments. Claim Rejections - 35 USC § 103 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 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 58-60, 62, 67-68 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Nakaya et al. (US 20070076190 A1; hereinafter “Nakaya” previous of record). Regarding claim 58, Nakaya teaches a sample analysis system (Nakaya; [0025] “examination system”), comprising: a blood cell analyzer (Nakaya; fig. 1. 3) configured to test at least one sample to obtain a test result of the at least one sample (Nakaya; [0047]), wherein the at least one sample is a blood sample or a body fluid sample (Nakaya; Title); a controller (Nakaya; fig. 1. 6) configured to obtain the test result of the at least one sample (Nakaya: [0061]); a smear preparation apparatus configured to prepare a smear for a sample to be analyzed by a cell image analysis apparatus, so as to obtain the smear of the sample to be analyzed (Nakaya; [0070]); and the cell image analysis apparatus configured to image and analyze the smear of the sample to be analyzed, so as to obtain cell images of the sample to be analyzed and an analysis result of the cell images (Nakaya; [0076]); wherein the controller is further configured to: select an analysis mode of the cell image analysis apparatus based on at least one of the test result and sample information of the sample to be analyzed (Nakaya; fig. 16. S5-6, S8-9), wherein the analysis mode comprises at least one of a white blood cell analysis mode, a red blood cell analysis mode, and a platelet analysis mode, or a combination of at least two of aforesaid modes (Nakaya; [0118]); after selecting the analysis mode, select an imaging condition based on the test result of the sample to be analyzed; and control the cell image analysis apparatus to image the smear of the sample to be analyzed according to the selected imaging condition under the selected analysis mode (Nakaya; fig. 16. S5-6, S8-9). Nakaya teaches a controller (Nakaya; fig. 1. 6) that includes a memory for storing blood analysis results (Nakaya; [0061]) and capable of selecting an analysis mode (Nakaya; [0118]). Examiner notes that the claims are drawn to an apparatus and not to a process. It would have been obvious to select an imaging condition based on the test result of the sample to be analyzed; and control the cell image analysis apparatus to image the smear of the sample to be analyzed according to the selected imaging condition under the selected analysis mode in order to prepare the correct smear sample. Regarding claim 59, Nakaya teaches the sample analysis system of claim 58 (see above), wherein the imaging condition is related to at least one of: a number of cell images to be captured, an imaging range, an imaging position, a power of an objective lens for imaging, and a focus range (Nakaya; [0107]). Regarding claim 60, Nakaya teaches the sample analysis system of claim 58 (see above), wherein the controller is further configured to select the imaging condition based on a value of at least one type of cells in the test result of the sample to be analyzed, wherein the value of the at least one type of cells comprises at least one of a number, a volume or a proportion of the type of cells (Nakaya; [0049]). Regarding claim 62, Nakaya teaches the sample analysis system of claim 58 (see above), wherein the controller is configured to: if the test result of the sample to be analyzed comprises abnormality information related to red blood cells, select the red blood cell analysis mode or a combination mode comprising the white blood cell analysis mode (Nakaya; fig. 3, 4 and [0062]-[0067]); and wherein the abnormality information related to red blood cells comprises at least one of red blood cell aggregation, fragmented red blood cells, and a red blood cell volume being less than a preset volume (Nakaya; [0060] “blood cell number information”). Examiner will interpret blood cell number information as “red blood cell volume.” Examiner notes Nakaya [0064]-[0065] teaches the white cell abnormal cell (WBC) information includes nucleated red blood cells (NRBC) since red blood cells (RBC) do not normally have nucleus). Regarding claim 67, Nakaya teaches the sample analysis system of claim 58 (see above), wherein the controller is further configured to: select a combination mode of the white blood cell analysis mode, the red blood cell analysis mode and the platelet analysis mode, if a white blood cell count, a hemoglobin concentration, and a platelet count in the test result of the sample to be analyzed are all lower than respective preset thresholds; or wherein the controller is configured to: select the analysis mode based on the sample information (Nakaya; [0063]); and selecting the analysis mode based on the sample information comprises: select a combination mode of the white blood cell analysis mode, the red blood cell analysis mode and the platelet analysis mode (Nakaya; fig. 11 and fig. 17), if the sample information indicates that the sample to be analyzed is from a pediatric department and there is no historical medical record. Nakaya teaches a controller configured to select a combination mode of red or white blood cell analysis or platelet analysis, based on the sample information. Where the sample is provided from or the sample’s historical medical record is a matter of intended use. Regarding claim 68, Nakaya teaches the sample analysis system of claim 58 (see above), wherein the controller is configured to: determine whether preset abnormality information is present in the test result of the sample to be analyzed (Nakaya; [0060]); and select a first imaging condition if a first type of abnormality information is present; or select a second imaging condition different from the first imaging condition if a second type of abnormality information is present (Nakaya; fig. 11. S2-3 to S2-6). Regarding claim 70, Nakaya teaches a sample analysis system (Nakaya; [0025] “examination system”), comprising: a blood cell analyzer (Nakaya; fig. 1. 3) configured to test at least one sample to obtain a test result of the at least one sample (Nakaya; [0047]), wherein the at least one sample is a blood sample or a body fluid sample (Nakaya; Title); a controller (Nakaya; fig. 1. 6) configured to obtain the test result of the at least one sample (Nakaya: [0061]); a smear preparation apparatus configured to prepare a smear for a sample to be analyzed by a cell image analysis apparatus, so as to obtain the smear of the sample to be analyzed (Nakaya; [0070]); and the cell image analysis apparatus configured to image and analyze the smear of the sample to be analyzed, so as to obtain cell images of the sample to be analyzed and an analysis result of the cell images (Nakaya; [0076]); wherein the controller is further configured to: if the test result of the sample to be analyzed indicates presence of abnormal cells, adjust a number of cells to be located and imaged based on a proportion of the abnormal cells (Nakaya; [0090]-[0091]). Claim Rejections - 35 USC § 103 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 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 52-56, 61, 63-64 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Nakaya et al. (US 20070076190 A1; hereinafter “Nakaya” previous of record) in view of Zahniser et al. (US 20120183198 A1; hereinafter “Zahniser”). Regarding claim 52, Nakaya teaches a sample analysis system (Nakaya; [0025] “examination system”), comprising: a blood cell analyzer (Nakaya; fig. 1. 3) configured to test at least one sample to obtain a test result of the at least one sample (Nakaya; [0047]), wherein the at least one sample is a blood sample or a body fluid sample (Nakaya; Title); a controller (Nakaya; fig. 1. 6) configured to obtain the test result of the at least one sample (Nakaya: [0061]); a smear preparation apparatus configured to prepare a smear for a sample to be analyzed by a cell image analysis apparatus, so as to obtain the smear of the sample to be analyzed (Nakaya; [0070]); and the cell image analysis apparatus configured to image and analyze the smear of the sample to be analyzed, so as to obtain cell images of the sample to be analyzed and an analysis result of the cell images (Nakaya; [0076]); wherein the controller is further configured to: if a value of at least one type of cells in the test result of the sample to be analyzed is less than a preset threshold, control the cell image analysis apparatus to image the smear of the sample to be analyzed under a first imaging condition, so as to obtain images of the at least one type of cells (Nakaya; [0091]); if the value of the at least one type of cells in the test result of the sample to be analyzed is not less than the preset threshold, control the cell image analysis apparatus to image the smear of the sample to be analyzed under a second imaging condition that is different from the first imaging condition, so as to obtain images of the at least one type of cells (Nakaya; fig. 11. S2-3, S2-5 and S2-6). Nakaya fails to teach a number of cell images to be captured by the cell image analysis apparatus under the first imaging condition is greater than that of cell images to be captured under the second imaging condition. However, Zahniser teaches the analogous art of sample analysis system (Zahniser; fig. 6. 600 and [0054] “process 600 can be used for performing image analysis”) wherein the system acquires a first pair of images and a second image of the specimen (Zahniser; fig. 6. 602) a number of cell images to be captured by the cell image analysis apparatus under the first imaging condition is greater than that of cell images to be captured under the second imaging condition (Zahniser; [0056] “a pair of images including a reference image of a specimen can be acquired on the first imaging station, and a second image of the specimen on the second imaging station. To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Nakaya’s number of cell images to be captured by the cell image analysis apparatus under the first imaging condition to be greater than that of cell images to be captured under the second imaging condition as taught by Zahniser because Zahniser teaches a pair of images including a reference image of a specimen can be acquired on the first imaging station, and a second image of the specimen on the second imaging station (Zahniser; [0056]). This would allow to perform image analysis at the first imaging station and relocate the selected objects on the second imaging station using reference images from the first imaging station (Zahniser; [0054]). Regarding claim 53, modified Nakaya teaches the sample analysis system of claim 52 (see above), wherein the value of the at least one type of cells comprises at least one of: a count value, a volume, or a proportion of the at least one type of cells (Nakaya; [0049]). Regarding claim 54, modified Nakaya teaches the sample analysis system of claim 52 (see above), wherein the first imaging condition and the second imaging condition are different from each other in at least one of imaging range size and imaging position (Nakaya; [0102] the first imaging condition (100 count) differs from the second imaging condition (300 count) in imaging range). Regarding claim 55, modified Nakaya teaches the sample analysis system of claim 52 (see above), wherein the value of the at least one type of cells comprises at least one of a white blood cell count, a red blood cell count, and a platelet count (Nakaya; [0102]) “white blood cell imaging”). Regarding claim 56, modified Nakaya teaches the sample analysis system of claim 52 (see above), wherein an imaging range of the cell image analysis apparatus for imaging the smear under the first imaging condition is larger than that for imaging the smear under the second imaging condition (Nakaya; [0102]); and/or wherein an imaging position of the cell image analysis apparatus for imaging the smear under the first imaging condition is different from that for imaging the smear under the second imaging condition. Regarding claim 61, Nakaya teaches the sample analysis system of claim 58 (see above), wherein the controller is configured to: if the test result of the sample to be analyzed comprises abnormality information related to white blood cells, select the white blood cell analysis mode or a combination mode comprising the white blood cell analysis mode (Nakaya; fig. 13. S3 1-3 and [0090]-[0091]); and the controller is further configured to: select a first imaging condition if the abnormality information related to white blood cells includes that a white blood cell count is lower than a first preset threshold or that abnormal cells related to white blood cells are present (Nakaya; fig. 13 and [0094]-[0095]); select a second imaging condition if the white blood cell count in the sample to be analyzed is not lower than the first preset threshold and there are no abnormal cells related to white blood cells (Nakaya; [0093]-[0094]). Nakaya fails to teach a number of white blood cell images to be captured corresponding to the first imaging condition is greater than that of white blood cell images to be captured corresponding to the second imaging condition. However, Zahniser teaches the analogous art of sample analysis system (Zahniser; fig. 6. 600 and [0054]) that includes a controller that communicates with the imaging systems vis known communication protocols between the imaging stations (Zahniser; [0025]) wherein a number of white blood cell images to be captured corresponding to the first imaging condition is greater than that of white blood cell images to be captured corresponding to the second imaging condition (Zahniser; [0033] “system 100 can use the images obtained at a first imaging station to count white blood cells), and (Zahniser; [0056] “a pair of images including a reference image of a specimen can be acquired on the first imaging station, and a second image of the specimen on the second imaging station). Examiner notes that Zahniser’s controller includes a computer, central processing unit, hard drive, memory and other hardware components (Zahniser; [0025]), and that Zahniser’s controller has the capability to be configured to perform the claimed limitations. To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Nakaya’s controller to be configured to have a number of white blood cell images to be captured corresponding to the first imaging condition is greater than that of white blood cell images to be captured corresponding to the second imaging condition as taught by Zahniser because Zahniser teaches obtaining images of at a first imaging station to obtain a white blood cell count (Zahniser; [0033]) wherein the first imaging condition is greater than that of white blood cell images to be captured corresponding to the second imaging condition (Zahniser; [0056]). This would allow to select a portion of the white blood cell population to revisit under high magnification for further classification (Zahniser; [0033]). Examiner notes that the second imaging station is the high magnification imaging station (Zahniser; [0054]). Regarding claim 63, Nakaya teaches the sample analysis system of claim 62 (see above) to include a controller (see above), Nakaya fails to teach the controller is further configured to: control the cell image analysis apparatus to image a tail portion of the smear, if the abnormality information related to red blood cells comprises red blood cell aggregation. However, Zahniser teaches the analogous art of sample analysis system (Zahniser; fig. 6. 600 and [0054]) that includes a controller that communicates with the imaging systems via known communication protocols between the imaging stations (Zahniser; [0025]) wherein controlling the cell image analysis apparatus to image a tail portion of the smear, if the abnormality information related to red blood cells comprises red blood cell aggregation (Zahniser; [0025] teaches the imaging system is controlled by a computer, and imaging a portion of the smear (Zahniser; [0033]). It would have been obvious to control the image analysis to image a tail portion of the smear if the abnormality information related to blood cells comprises red blood cell aggregation as this would allow to identify any blood clots in the smear. Examiner notes that Zahniser’s controller has the capability to be configured to perform the claimed limitations. To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Nakaya’s controller to control the cell image analysis apparatus to image a tail portion of the smear because Zahniser; [0025] teaches the imaging system is controlled by a computer, and imaging a portion of the smear (Zahniser; [0033]). This would allow to choose an regions of the specimen or certain cells of interest (Zahniser; [0033]). Regarding claim 64, Nakaya teaches the sample analysis system of claim 62 (see above) to include a controller (see above). Nakaya further teaches the white cell abnormal cell (WBC) information includes nucleated red blood cells information (NRBC) since red blood cells (RBC) do not normally have nucleus [0064]-[0065]) Nakaya fails to teach the controller is configured to: control the cell image analysis apparatus to image red blood cells in a small area on the smear, if the red blood cell volume is less than the preset volume. However, Zahniser teaches the analogous art of sample analysis system (Zahniser; fig. 6. 600 and [0054]) that includes a controller that communicates with the imaging systems via known communication protocols between the imaging stations (Zahniser; [0025]) wherein controlling the cell image analysis apparatus to image red blood cells in a small area on the smear, if the red blood cell volume is less than the preset volume. (Zahniser; [0025] teaches the imaging system is controlled by a computer, and imaging a portion of the smear (Zahniser; [0033]). It would have been obvious to control the image analysis system to image a small area of the smear if the red blood cell volume is less than the preset volume as this would allow to identify any abnormalities in the smear. Examiner notes that Zahniser’s controller has the capability to be configured to perform the claimed limitations. To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Nakaya’s controller to control the cell image analysis apparatus to image a small area of the smear because Zahniser teaches imaging a small area of the smear (Zahniser; [0025]),and the imaging system is controlled by a computer, and imaging a portion of the smear (Zahniser; [0033]). This would allow to choose an regions of the specimen or certain cells of interest (Zahniser; [0033]). Allowable Subject Matter Claims 57, 65-66, 69 and 71 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims, and to overcome the non-statutory double patenting rejection. The following is an examiner’s statement of reasons for allowance: In addition to the remarks of record, the instant claims define over the prior art because the cited prior art does not teach or suggest: Claim 57 recites the sample analysis system of claim 52 wherein the at least one type of cells comprises platelets, and the controller is further configured to: control the cell image analysis apparatus to use the first imaging condition, if a platelet count in the test result of the sample to be analyzed is less than a corresponding preset threshold; or control the cell image analysis apparatus to use the second imaging condition, if the platelet count in the test result of the sample to be analyzed is not less than the corresponding preset threshold; wherein an imaging position of the cell image analysis apparatus for imaging the smear under the first imaging condition comprises a tail portion and/or an edge portion of the smear; and an imaging position for imaging the smear under the second imaging condition comprises a body portion of the smear. Claim 65 recites the sample analysis system of claim 58, wherein the controller is configured to: if the test result of the sample to be analyzed comprises abnormality information related to platelets, select the platelet analysis mode or a combination mode comprising the platelet analysis mode, wherein the abnormality information related to platelets comprises at least one of platelet aggregation and a platelet count being lower than a second preset threshold; and the controller is further configured to: select a first imaging condition if the platelet count is lower than the second preset threshold; select a second imaging condition if the platelet count is not lower than the second preset threshold, wherein the first imaging condition and the second imaging condition are different from each other in imaging position or imaging range. Claim 66 recites the sample analyzer of claim 65, wherein the imaging range corresponding to the first imaging condition is larger than that corresponding to the second imaging condition; or the imaging position corresponding to the first imaging condition comprises a tail portion and/or an edge portion of the smear; and the imaging position corresponding to the second imaging condition comprises a body portion of the smear. Claim 69 recites the sample analysis system of claim 68, wherein the first type of abnormality information comprises abnormal cell prompt or alarm information, and the first imaging condition comprises selecting a first objective lens to image the smear of the sample to be analyzed; the second type of abnormality information comprises information about a cell classification proportion abnormality, and the second imaging condition comprises selecting a second objective lens to image the smear of the sample to be analyzed, wherein a power of the first objective lens is higher than that of the second objective lens; or wherein the first type of abnormality information includes that a proportion of abnormal cells is less than a preset proportion, the second type of abnormality information includes that a proportion of abnormal cells is not less than a preset proportion, and a number of white blood cell images to be captured corresponding to the first imaging condition is less than that of white blood cell images to be captured corresponding to the second imaging condition. Claim 71 recites the sample analysis system of claim 70, wherein the abnormal cells comprise nucleated red blood cells; and adjusting a number of cells to be located and imaged based on a proportion of the abnormal cells comprises adjusting a number of white blood cells to be located and imaged based on a proportion of the nucleated red blood cells, wherein the higher the proportion of the nucleated red blood cells, the larger the number of white blood cells to be located; or wherein the abnormal cells comprise blast cells; and adjusting a number of cells to be located and imaged based on a proportion of abnormal cells comprises adjusting a number of cells to be located and imaged based on a proportion of the blast cells, wherein the higher the proportion of the blast cells, the smaller the number of cells to be located and imaged; and the lower the proportion of blast cells, the larger the number of cells to be located and imaged. Response to Arguments Applicant’s arguments, filed on 11/28/2025, with respect to the prior art rejection(s) have been fully considered and are not persuasive. The rejections have been modified in accord with the amendment. With respect to the rejection of claim 58 over Nakaya. Applicant argues Nakaya does not determine an analysis mode from a group consisting of white blood cell analysis mode, red blood cell analysis mode, a platelet analysis mode and a combination of at least two of the aforesaid modes. Examiner disagrees. Nakaya [0118] referring to the analysis mode illustrated in figure 16 teaches the device receives imaging condition information related to blood cell count number. Nakaya teaches analyzing a blood sample smear (Nakaya; Abstract). It is known in the art that a blood sample smear analyzes red and white blood cells and platelets. Applicant also argues the white blood cell mode in Nakaya is not selected based on analysis result of the blood sample to be analyzed by the image obtainer but rather based on received imaging conditions. Examiner disagrees. Nakaya teaches a blood cell analyzer that includes a controller, a smear preparation apparatus and a cell image analysis apparatus. Nakaya teaches a controller (Nakaya; fig. 1. 6) that includes a memory for storing blood analysis results (Nakaya; [0061]) and capable of selecting an analysis mode (Nakaya; [0118]). Examiner notes that the claims are drawn to an apparatus and not to a process. Applicant further argues the analysis mode is firstly selected from a plurality of analysis modes and then an imaging condition is selected. Examiner notes that Nakaya teaches a controller that includes a Nakaya’s controller is capable of selecting based on analysis result of the blood sample to be analyzed by the image obtainer but rather based on received imaging conditions. Examiner notes that the claims are drawn to an apparatus and not to a process. With respect to claim 70. Applicant argues Nakaya does not teach if the test result of the sample to be analyzed indicates presence of abnormal cells, adjust the number of cells to be located and imaged based om a portion of the abnormal cells. Examiner disagrees. Nakaya teaches a controller capable of obtaining results of a sample to be analyzed and detect and adjust the number of cells (Nakaya; [0090]-[0091]). Examiner notes Nakaya teaches all the apparatus elements of claim 70. Examiner also notes that the claims are drawn to an apparatus and not to a process. With respect to the rejection of claims 52-56, 61 and 63-64 over Nakaya in view of Zahniser. Applicant argues claim 52 distinguishes over Nakayama in view of Zahniser in that “in the case where a value of at least one typer of cells in the test result of the sample to be analyzed is less than a preset threshold, is greater than that of cell images to be captured in the case where the value of the at least one type of cells in the test result of the sample to be analyzed is not less than the preset threshold.” Examiner disagrees. Applicant discloses [0011]-[0012], [0020], [0029], [0047] “the controller is configured to control the cell image analysis to smear the sample and analyze under first or second imaging conditions to the preset threshold.” Nakayama teaches a controller capable of controlling the cell image analysis to smear the sample and analyze under first or second imaging conditions to the preset threshold. 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 ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00. 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) 272-1295. 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. /A.R./Examiner, Art Unit 1798 /CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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Prosecution Timeline

Jun 29, 2022
Application Filed
Jul 25, 2025
Non-Final Rejection — §103, §112, §DP
Nov 28, 2025
Response Filed
Dec 08, 2025
Interview Requested
Dec 15, 2025
Applicant Interview (Telephonic)
Dec 18, 2025
Examiner Interview Summary
Jan 28, 2026
Final Rejection — §103, §112, §DP
Apr 09, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
79%
Grant Probability
99%
With Interview (+23.3%)
3y 4m
Median Time to Grant
Moderate
PTA Risk
Based on 114 resolved cases by this examiner