Prosecution Insights
Last updated: April 19, 2026
Application No. 17/685,582

QUALITY CONTROL METHOD OF SPECIMEN ANALYSIS SYSTEM AND SPECIMEN ANALYSIS SYSTEM

Final Rejection §103
Filed
Mar 03, 2022
Examiner
GERHARD, ALISON CLAIRE
Art Unit
1797
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Sysmex Corporation
OA Round
2 (Final)
10%
Grant Probability
At Risk
3-4
OA Rounds
3y 10m
To Grant
38%
With Interview

Examiner Intelligence

Grants only 10% of cases
10%
Career Allow Rate
2 granted / 21 resolved
-55.5% vs TC avg
Strong +29% interview lift
Without
With
+28.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
46 currently pending
Career history
67
Total Applications
across all art units

Statute-Specific Performance

§101
4.1%
-35.9% vs TC avg
§103
41.5%
+1.5% vs TC avg
§102
25.5%
-14.5% vs TC avg
§112
24.0%
-16.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 21 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 . Status of Claims Applicant's amendments to the claims filed 20 October 2025 have been entered. Applicant's remarks filed 20 October 2025 are acknowledged. Claims 14, 19 – 24, and 27 – 30 are in status “Currently amended.” Claims 31 – 33 are in status “New.” Claims 13, 15 – 18, and 25 – 26 are canceled. Claims 1 – 12 are withdrawn as due to non-elected subject material. Response to Arguments Applicant’s arguments, see Remarks page 10, filed 20 October 2025, with respect to the rejections under 112(b) have been fully considered and are persuasive in light of the amendments. The rejections of the claims have been withdrawn. Applicant’s arguments, Remarks page 11, filed 20 October 2025, with respect to the rejections of claims 14 and 19-30 under 102(a)(1) have been fully considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kawamura and further in view of Wasson et al. 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 14 and 19-24, and 27-33 are rejected under 35 U.S.C. 103 as being unpatentable over Kawamura (JP 2010121936 A, cited on the IDS filed 6 September 2022; A copy of the machine translation relied upon in this action has been attached) in view of Wasson et al (US 20140234949 A1; This is the PG Publication of US 10012664 B2, relied upon in the office action filed 19 May 2025). With regards to claim 14, Kawamura teaches; The claimed “a blood analysis system configured to perform a blood sample measurement and an automatic quality control measurement to ensure measurement accuracy of the blood sample measurement” has been read on the taught ([0016], “…the sample processing system 1 includes […] a blood cell analyzer 5…”; [0066], “…a quality control specimen measurement operation for automatically measuring a quality control specimen…”); The claimed “a plurality of blood cell analyzers each configured to measure a blood sample to analyze at least one CBC item and/or at least one white blood cell classification item” has been read on the taught ([0001], “The present invention relates to a sample processing system that transports samples to a plurality of measurement units that measure the samples.”; A plurality of measurement units reads on a plurality of blood cell analyzers.); The claimed “wherein the at least one CBC item is selected from the group consisting of WBC (white blood cell count), RBC (red blood cell count), HGB (hemoglobin content), HCT (hematocrit value), MCV (mean corpuscular hemoglobin concentration), PLT (platelet count), and a combination thereof, wherein the at least one white blood cell classification item is selected from the group consisting of NEUT # (neutrophil count), LYMPH # (lymphocyte count), MONO # (monocyte count), EO # (eosinophil count), BASO # (basophil count), and a combination thereof” has been read on the taught ([0042], “In addition, the detection unit 513 is configured to be capable of detecting HGB (hemoglobin) by the SLS-hemoglobin method, and to be capable of detecting WBC (white blood cells), NEUT (neutrophils), LYMPH (lymphocytes), EO (eosinophils), BASO (basophils), and MONO (monocytes)…”); The claimed “a supply apparatus configured to supply first containers each containing a quality control specimen and second containers each containing the blood sample” has been read on the taught ([0005], “…one embodiment of the sample processing system of the present invention comprises a measurement unit […] a quality control sample containing a predetermined amount of a predetermined component to be measured by the measurement unit, a transport unit that transports the quality control sample from the cooling unit to the transport unit…”); The claimed “wherein the quality control specimen contains blood cells of a predetermined concentration to be measured for the at least one CBC item and/or the at least one white blood cell classification item” has been read on the taught ([0019], “The quality control sample contains predetermined amounts of specific components such as red blood cells and white blood cells to be measured by the blood cell analyzer 5.”); The claimed “wherein each of the first containers is sealed with a first cap” and “wherein each of the second containers is sealed with a second cap” have been read on the taught ([0018], “…the sample container T is tubular and has an open top… the opening at the top end is sealed with a lid portion CP.”; [0019], “The quality control sample is contained in a container of the same shape as the sample container T and is sealed with a lid CP.”); The claimed “a rack transporter configured to transport a rack between the supply apparatus and the plurality of blood cell analyzers” has been read on the taught ([0021], “The transport mechanism 31 includes […] a rack transport section 35 which moves the sample rack L horizontally in a straight line in the direction of arrow X in the figure in order to supply the specimen to the measurement unit 51…”; [0021] describes several rack transport sections as part of transport mechanism 31, connecting different portions of the device.); The claimed “a storage comprising first holders each having a structure to hold one of the first containers in an upright position” has been read on the taught ([0018], “In the sample rack L, each specimen container T is held in a vertical position…”); The claimed “wherein the storage is configured to cool the first containers held in first holders” have been read on the taught ([0056], “The cooling unit 6 extracts specimen containers from the sample rack L transported on the rack transport path 302a of the conveyor 302, transfers them inside, and cools and stores them”); The claimed “a container transferer including a robotic arm, wherein the container transferer is configured to grasp the one of the first containers by the robot arm” has been read on the taught ([0043], “The sample container transport unit 515 is equipped with a hand unit 515a that can grip a sample container T.”); The claimed “wherein the blood analysis system comprises at least one processor programmed to automatically perform a quality control measurement by the plurality of the blood cell analyzers” has been read on the taught ([0059], “The system control device 8 is realized by a computer 8a.”; [0066], “…a quality control specimen measurement operation for automatically measuring a quality control specimen […] will be described.”; Computer 8a reads on at least one processor.); The claimed wherein “the at least one processor is programmed to cause the supply apparatus to retrieve at least one of the first containers from the first holders by the container transferer” and “transport the first container to at least one of the second holders in the upright position by the container transferer” have been read on the taught ([0069], “…the CPU 81a executes a process of transferring the quality control sample […] from the quality control sample storage unit 61 to a sample rack L […] by the transfer mechanism unit 63.”); The claimed wherein “the at least one processor is programmed to cause the rack transporter to transport the first rack to the plurality of blood cell analyzers” has been read on the taught ([0070], “Through this process, the quality control sample contained in the sample rack L is transported to the front of the measurement unit 51.”); The claimed wherein “the at least one processor is programmed to cause the plurality of blood cell analyzers to penetrate the first cap to aspirate the quality control specimen in the first container transported by the first rack and to measure the aspirated quality control specimen to obtain a measurement result of the at least one CBC item and/or the at least one white blood cell classification item” has been read on the taught ([0070], “The measurement unit 51 then takes in the quality control sample by gripping it with the hand portion 515a, and aspirates and measures the quality control sample.”; [0039], “…the suction tube penetrates the lid section CP of the specimen container T transported to the suction position, and is configured to suction the blood inside.”); The claimed “wherein the blood analysis system is configured to perform the blood sample measurement of the blood samples” has been read on the taught The claimed “wherein the supply apparatus is configured to supply a plurality of second racks each accommodating at least one of the second containers to the rack transporter” and wherein “the rack transporter is configured to transport the second racks, thereby distributing the second racks to the plurality of blood cell analyzers that have performed the quality control measurement” have been read on the taught ([0085], “…the CPU 81a executes the process of transporting the blood sample to the measurement unit 51 determined in step S29, similar to step S24.”; Step S24 is described in [0082], and includes the movement of a rack and the performing a measurement.); The claimed wherein “the plurality of blood cell analyzers are each configured to perform the blood sample measurement, wherein the blood sample measurement includes penetrating the second cap to aspirate the blood sample in the second container transported by the second rack and measuring the aspirated blood sample to obtain a measurement result of the at least one CBC item and/or the at least one white blood cell classification item” has been read on the taught ([0036], “The blood cell analyzer 5 includes a measurement unit 51 that measures a blood sample…”; [0039], “…the suction tube penetrates the lid section CP of the specimen container T transported to the suction position, and is configured to suction the blood inside.”). However, Kawamura does not explicitly disclose wherein the supply apparatus comprises a housing and a heater comprising second holders each having a structure to hold one of the first containers in the upright position, wherein the heater is configured to heat the first containers held in the second holders, wherein the at least one processor is programmed to heat the first container by the heater, or wherein the at least one processor is programmed to transport the heated first container to a first rack in the upright position and supply the first rack to the rack transporter. In the analogous art of blood specimen analyzers, Wasson et al teaches; The claimed “a blood analysis system” has been read on the taught ([0045], “…systems […] alone or in combination, are configured to detect from a sample a plurality of analytes… In an embodiments, systems are configured to draw a blood sample..."); “Wherein the supply apparatus comprises a housing” has been read on the taught ([0013], “…a system may comprise: a housing; and a plurality of modules within said housing…”); The claimed “a heater comprising second holders each having a structure to hold one of the first containers in the upright position” and “wherein the heater is configured to heat the first containers held in the second holders” have been read on the taught ([1327], “a system may include one or more thermal control unit.”; [1333], “…the thermal control unit can be a heater.”; [1338], “The thermal control unit may be in direct physical contact with a […] housing for a vessel…”; The housing for a vessel reads on the second holders. [1339] supports the samples being located within the vessels.). The claimed wherein the at least one processor is programmed to “heat the first container by the heater” has been read on the taught ([1388], “…the controller may change the temperature of a thermal control unit…”); The claimed wherein the at least one processor is programmed to “transport the heated first container to a first rack in the upright position and supply the first rack to the rack transporter” has been read on the taught ([1339], “One or more samples may be brought to and/or removed from the thermal control unit… The samples may be brought to and/or removed from the thermal control unit using any other automated process.”); Wasson et al also explicitly discloses thermally controlled storage, as read on the taught ([0549], “For example, one of the modules 701-704 may be replaced with one or more modules that provide a different hardware configuration such as but not limited to provide a thermal controlled storage chamber for incubation, storage between testing, and/or storage after testing.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood analysis system including a cooling unit and container transporter as taught by Kawamura with the sample heater as taught by Wasson et al. According to MPEP 2143(I)(D), applying a known technique to a known device ready for improvement to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Kawamura contains a “base” device upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains a known technique of a heater and sample holder that is applicable to the base device. One of ordinary skill in the art would have recognized that applying the known technique would yield the predictable result of a system which can heat a sample up to a consistent, desired temperature, and that this would result in an improved system with greater consistency in its measurements. Accordingly, the system of claim 14 is obvious over Kawamura in view of Wasson et al. With regards to claim 19, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura does not explicitly disclose wherein the heater is configured to heat the first containers for a predetermined time. Wasson et al additionally teaches; The claimed “wherein the heater is configured to heat the first containers for a predetermined time” has been read on the taught ([1329], “A desired target temperature may be programmed. The desired target temperature […] may be maintained over time.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Kawamura in view of Wasson et al with the heater operating over time as taught by Wasson et al, for the benefit of having a standardized laboratory protocol which would not result in overheating of the samples. With regards to claim 20, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura does not explicitly disclose wherein the heater comprises container holders, and the heater is configured to hold and heat the first containers in each of the container holders for a predetermined time. Wasson et al additionally teaches; The claimed “wherein the heater comprises container holders, and the heater is configured to hold and heat the first containers in each of the container holders for a predetermined time” has been read on the taught ([1329], “A desired target temperature may be programmed. The desired target temperature […] may be maintained over time.”; [1338], “…the thermal control unit may be in direct physical contact with a sample or sample holder.”; A desired target temperature which may vary over time reads on the heater configured to heat the second container for a predetermined time. The thermal control unit in direct physical contact with a sample holder reads on the heater comprising a container holder.) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Kawamura in view of Wasson et al with the heater comprising a container holder and operating over time as taught by Wasson et al, for the benefit of having a standardized laboratory protocol which would not result in overheating of the samples. With regards to claim 21, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura additionally teaches; The claimed “wherein, after a completion of the automatic quality control measurement in the blood cell analyzer, the rack transporter executes a process of returning the quality control specimens to the storage without heating” has been read on the taught ([0083], “In step S25, the CPU 81a executes a process of returning the quality control sample taken into the measurement unit 51 in step S24 from the measurement unit 51 to the sample rack L… the CPU 81a executes a process of transporting the sample rack L containing the quality control specimen to the front of the cooling unit 6…”). With regards to claim 22, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura additionally teaches; The claimed “wherein the quality control specimens are commonly used for the automatic quality control measurement by each of the plurality of blood cell analyzers” has been read on the taught ([0072], “…the CPU 81a determines whether or not the measurement of the quality control sample has been completed for all three measurement units 51.”; The measurement being completed for all three measurement units reads on the specimen being commonly used.). With regards to claim 23, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura additionally teaches; The claimed wherein “the plurality of blood cell analyzers are configured to independently measure the blood samples each other” has been read on the taught ([0037], “The information processing unit 52 is communicably connected to the three measurement units 51, 51, 51, and is capable of controlling the operations of these three measurement units 51, 51, 51, respectively.”; The operations of the three measurement units being controlled respectively reads on the blood cell analyzers being configured to independently measure the blood samples.). However, Kawamura does not explicitly disclose wherein the rack transporter is configured to transport the second racks to the plurality of blood cell analyzers such that a workload of the plurality of blood cell analyzers are distributed. Wasson et al additionally teaches; The claimed “wherein the rack transporter is configured to transport the second racks to the plurality of blood cell analyzers such that a workload of the plurality of blood cell analyzers are distributed” has been read on the taught ([1380], “…in order to reduce the total time necessary to perform or obtain data from multiple assays within the device or module, the controller may take into account other assays simultaneously being performed in the device or module, such that the use of each detection unit is optimized for the combination of all assays being simultaneously performed in the module or device.”; Optimizing the use of each detection unit reads on distributing the workload.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood analysis system including a plurality of blood cell analyzers as taught by Kawamura with the distributed workload configuration as taught by Wasson et al. According to MPEP 2143(I)(D), applying a known technique to a known device ready for improvement to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Kawamura contains a “base” device upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains the known technique of distributing the workload between detection units. One of ordinary skill in the art would have recognized that applying the known technique would yield the predictable result of a system which can send a sample to a free station, and that this would result in an improved system with higher throughput. Accordingly, the system of claim 23 is obvious over Kawamura in view of Wasson et al. With regards to claim 24, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura additionally teaches; The claimed wherein “the plurality of blood cell analyzers are configured to independently measure the blood samples to analyze the at least one CBC item and/or the at least one white blood cell classification item” has been read on the taught ([0037], “The information processing unit 52 is communicably connected to the three measurement units 51, 51, 51, and is capable of controlling the operations of these three measurement units 51, 51, 51, respectively.”; [0042] teaches the at least one CBC item and/or the at least one white blood cell classification item. The operations of the three measurement units being controlled respectively reads on the blood cell analyzers being configured to independently measure the blood samples.). With regards to claim 27, the system of claim 14 is obvious over Kawamura in view of NAME. Kawamura additionally teaches; The claimed wherein “after a completion of the automatic quality control measurement, the container transferer is configured to return the first container from the first rack to the storage” has been read on the taught ([0073], “In step S13, the CPU 81a executes a process of removing the measured quality control sample from the sample rack L transported to the front of the cooling unit 6 in step S12 using the transport mechanism unit 63 and transporting it into the quality control sample storage unit 61.”). With regards to claim 29, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura additionally teaches that multiple quality control samples are stored in the storage (see, for instance [0068], “…all quality control samples stored in the quality control sample storage unit…”), and that the quality control samples have concentration levels (see [0019], “The quality control sample contains predetermined amounts of specific components such as red blood cells and white blood cells to be measured by the blood cell analyzer.”). Kawamura additionally teaches that the rack transporter is configured to transport a rack housing multiple quality control specimen containers to the blood cell analyzer, as read on the taught ([0018], “The sample rack L is capable of holding 10 sample containers T arranged side by side.”; [0070], “…the quality control sample contained in the sample rack L is transported to the front of the measurement unit 51.”). However, Kawamura does not explicitly disclose the quality control specimen including a first-concentration-level-containing container containing a first quality control specimen of a first concentration level and a second-concentration-level-containing container containing a second quality control specimen of a second concentration level. Wasson et al additionally teaches; “A first quality control specimen of a first concentration level and a second quality control specimen of a second concentration level” has been read on the taught ([1698], “The calibration cartridge may consist of a series of standard fluids, which a properly calibrated system gives a known response to.”; A series of standard fluids reads on a first specimen and a second specimen of different concentration levels.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including multiple quality control samples and a rack transporter with the series of standard fluids as taught by Wasson et al. According to MPEP 2143(I)(D), applying a known technique to a known device ready for improvement to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Kawamura contains a “base” device upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains the known technique of a series of quality control fluids. One of ordinary skill in the art would have recognized that applying the known technique would yield the predictable result of an improved system which can calibrate across a range of test values. Accordingly, the system of claim 29 is obvious over Kawamura in view of Wasson et al. With regards to claim 30, the system of claim 29 is obvious over Kawamura in view of Wasson et al. Kawamura does not explicitly disclose wherein the heater is configured to heat the first-concentration-level containing container and the second-concentration-level-containing container. Wasson et al additionally teaches; The claimed “wherein the heater is configured to heat the first-concentration-level containing container and the second-concentration-level-containing container” has been read on the taught ([1327], “a system may include one or more thermal control unit.”; [1333], “…the thermal control unit can be a heater.”; [1338], “The thermal control unit may be in direct physical contact with a […] housing for a vessel…”; [1703], “…a device may monitor temperature and control its internal temperature. Temperature control may be useful for quality control.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood analysis system as taught by Kawamura with the sample heater configured to heat the quality control specimens as taught by Wasson et al. According to MPEP 2143(I)(D), applying a known technique to a known device ready for improvement to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Kawamura contains a “base” device upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains a known technique of a heater and sample holder that is applicable to the base device. One of ordinary skill in the art would have recognized that applying the known technique would yield the predictable result of a system which can heat a sample up to a consistent, desired temperature, and that this would result in an improved system with greater consistency in its measurements. Accordingly, the system of claim 30 is obvious over Kawamura in view of Wasson et al. With regards to claim 31, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura additionally teaches; The claimed “wherein the plurality of blood cell analyzers each comprises an agitation mechanism configured to agitate each of the first containers before penetrating the first cap to aspirate the agitated specimens” has been read on the taught ([0044], “The sample container T held by the hand section 515a is moved after the stirring is completed, and the held sample container T is inserted into the hole of the sample container setting section 515b… When the sample container setting section 515b moves to the aspirating position 511a, the sample aspirating section 511 aspirates the sample from the sample container T set therein.”). With regards to claim 32, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura does not explicitly disclose a controller programmed to compare results of measuring the quality control specimens with the upper limit value and lower limit value. Wasson et al additionally teaches; The claimed “a controller programmed to compare the results of measuring the quality control specimens with the upper limit value and lower limit value” has been read on the taught ([1694], “The device may be capable of performing one or more diagnostic step… If the results fall outside an expected range, a portion of the device may be cleaned and/or replaced. The results may also be useful for calibrating the device. On-board calibration and/or controls may occur without requiring human intervention.”; The results being within an expected range reads on comparing the results to an upper limit and lower limit value. The calibration occurring without human intervention reads on a controller being programmed to compare the results. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood analysis system as taught by Kawamura with the controller programmed to compare the results as taught by Wasson et al. According to MPEP 2143(I)(D), applying a known technique to a known device ready for improvement to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Kawamura contains a “base” device upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains a known technique of a controller programmed to compare the results of the quality control specimens that is applicable to the base device. One of ordinary skill in the art would have recognized that applying the known technique would yield the predictable result of an improved system which can produce reliable values within a range. Accordingly, the system of claim 32 is obvious over Kawamura in view of Wasson et al. With regards to claim 33, the system of claim 14 is obvious over Kawamura in view of Wasson et al. Kawamura additionally teaches; The claimed “wherein each first container comprises a tube containing the quality control specimen sealed with the first cap” has been read on the taught ([0019], “The quality control sample is contained in a container of the same shape as the sample container T and is sealed with a lid CP.”; [0018], “…the sample container T is tubular…”); The claimed “wherein each of the first holders is dimensioned to accommodate the tube, wherein each of the second holders is dimensioned to accommodate the tube” has been read on the taught ([0018], “The sample rack L is capable of holding 10 sample containers T arranged side by side.”). 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 ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. 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. /ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /ROBERT J EOM/Primary Examiner, Art Unit 1797
Read full office action

Prosecution Timeline

Mar 03, 2022
Application Filed
May 15, 2025
Non-Final Rejection — §103
Oct 09, 2025
Examiner Interview Summary
Oct 20, 2025
Response Filed
Jan 05, 2026
Final Rejection — §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12427514
PIEZOELECTRIC MICROPIPETTE
2y 5m to grant Granted Sep 30, 2025
Patent 12352766
IMMUNOASSAY METHOD FOR FREE AIM IN BIOLOGICAL SAMPLE, AND METHOD FOR DETECTING NASH IN SUBJECT
2y 5m to grant Granted Jul 08, 2025
Study what changed to get past this examiner. Based on 2 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

3-4
Expected OA Rounds
10%
Grant Probability
38%
With Interview (+28.6%)
3y 10m
Median Time to Grant
Moderate
PTA Risk
Based on 21 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month