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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4, 6-7, 9-11, 13-17, 19-20, 23, 26, 28, and 30) in the reply filed on 03/26/26 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/20/24 & 02/11/25 has been acknowledged and considered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a reaction cell and a transfer portion” in claim 1must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Qi et al (CN 111542744 A hereinafter “Qi”) in view of Gill et al (US Patent No. 5,891,734 hereinafter “Gill”).
Regarding claims 1 and 20; Qi discloses a sample analyzer and an animal reticulocyte testing method (100 @ figure 1: e.g., the blood analyzer 100 at least comprises a sampling device 110, a sample preparation device 120, a detection device 130, a display device 140 and a control device 150…a method for checking the number of blood cells in the peripheral blood of the human body by a blood cell analyzer, and the ratio and shape of the blood cells. A blood cell analyzer is a device capable of detecting cells in blood, white blood cell (White Blood Cell, WBC), red blood cell (RedBlood Cell, RBC), platelet (Platelet, PLT), nucleated red blood cell (Nucleated Red BloodCell, NRBC), reticulocyte (Reticulocyte, Ret) and other particles for counting and classifying, inspection), comprising:
a sampling apparatus (110 @ figure 1: e.g., the sampling device 110 has a suction pipe (e.g., sampling needle) with suction nozzle and has a driving part; the driving part is used for driving the suction pipe to quantitatively absorb the blood sample to be detected through the suction pipe nozzle) configured to collect a blood sample of a target animal and transfer the blood sample to a sample preparation apparatus (120 @ figure 1);
the sample preparation apparatus (120 @ figure 1) having a reaction cell and a transfer portion (figure 1: e.g., Sample preparation device 120 has at least one reaction cell and reagent supply device (not shown), the at least one reaction tank is used for receiving the blood sample to be detected by the sampling device 110; the reagent supply device provides the processing reagent to the at least one reaction tank, so that the blood sample to be detected by the sampling device 110 and the processing reagent provided by the reagent supply device are mixed in the reaction tank, so as to prepare the sample liquid to be detected), wherein the reaction cell is configured to provide a reaction site for the blood sample to react with a treatment reagent related to reticulocyte testing (figure 1: e.g., the reagent supply device comprises a first reagent supply part for supplying white blood cell reagent, the leukocyte reagent such as capable of dissolving erythrocyte in blood sample and capable of distinguishing different leukocyte types of hemolytic agent, optionally also comprising a fluorescent reagent capable of staining the white blood cell. In some embodiments, the reagent supply device comprises a second reagent supply part for supplying red blood cell reagent, the red blood cell reagent such as diluent. In some other embodiments, the reagent supply device comprises a third reagent supply part for supplying hemoglobin reagent, the hemoglobin reagent is capable of dissolving erythrocyte in blood sample, releasing hemoglobin in the red blood cell and converting hemoglobin into hemolytic agent of ferrihemoglobin), to prepare a sample fluid to be tested, and the transfer portion (figures 1-3: e.g., Specifically, the sampling device 110 after absorbing the blood sample by the driving device drives and moves to the sample preparation device 120 of the reaction tank, the absorbed blood sample is injected into the reaction tank. The conveying pipeline in the reaction tank through the diluted solution treatment of the sample liquid to be detected to the sheath flow impedance detecting part 132, namely is conveyed to the flow chamber 1321) is configured to transfer the sample fluid to be tested in the reaction cell to a testing apparatus (130 @ figure 1);
the testing apparatus (130 @ figure 1) configured to test the sample fluid to be tested, to obtain an optical pulse signal of cells in the sample fluid to be tested (col.12 lines 34-61); and
a control apparatus (150 @ figures 1 and 3-4) communicatively connected to the sample preparation apparatus (120 @ figures 1 and 3) and the testing apparatus (130 @ figure 1). See figures 1-16.
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Zheng et al discloses all of feature of claimed invention except for the control apparatus configured to: determine an animal type of the target animal, and determine a first target reticulocyte incubation time corresponding to the target animal based on the animal type of the target animal; control an incubation time of the sample fluid to be tested in the sample preparation apparatus based on the first target reticulocyte incubation time, wherein the incubation time comprises reaction duration of the sample fluid to be tested in the reaction cell and/or transfer duration of transferring the sample fluid to be tested to the testing apparatus by the transfer portion; and obtain, based on the optical pulse signal of the cells in the sample fluid to be tested, a testing result of reticulocytes in the sample fluid to be tested. However, Gill teaches that it is known in the art to provide the control apparatus (60, 98 @ figures 1-2) configured to:
determine an animal type of the target animal (col.7 lines 3-20 and col.51 line 60 to col.52 line 7: e.g., the AOS 98 determines that a sample is available for aspiration. This is based either on operator activation of a pushbutton or a command from an autoloader mechanism. All the information known by the analyzer 64 about the sample is sent to the data station 68. The data station 68 responds with information about the required measurements to be performed on the sample. Based upon this response, and in conjunction with the state of the analyzer 64 (i.e. reagents, incubations, flow sequence aspiration enable/disable flags), the AOS determines whether or not to proceed with sample aspiration), and determine a first target reticulocyte incubation time corresponding to the target animal based on the animal type of the target animal (col.52 lines 8-65: e.g., When the incubation is started, the AOS starts an incubation timer associated with a particular incubation site 132. A sample identifier, sample type, and incubation time are also associated with each incubation site 132. The AOS updates the active incubation timers periodically and recognizes the completion of incubation intervals. When complete, the AOS continues the execution of the flow sequence for that test. The AOS reports the total incubation time of each incubated sample and the incubation site number (position) as part of the data accumulated for each test on each sample…The flow sequence interpreter allows flow sequences to initiate event count and data collection intervals. Data generated during the data collection interval is automatically sent to the data station 68 by the AOS. The data sent to the data station 68 preferably includes at least the sample identifier, hardware counters, list mode data, and incubation time (if any). Count types preferably include: CBC: complete blood count including all hematology measurements except those related to reticulocytes and RETICS);
control an incubation time of the sample fluid to be tested in the sample preparation apparatus based on the first target reticulocyte incubation time (col.59 lines 25-49: e.g., After an appropriate incubation period (about 25 seconds with the preferred reagent described previously) or immediately upon mixing, the mixture of diluted blood and retic reagent is transported to optical flow cell 170. This transportation process can be timed to provide sufficient incubation time for the staining of the reticulocytes, i.e., 25 seconds), wherein the incubation time comprises reaction duration of the sample fluid to be tested in the reaction cell and/or transfer duration of transferring the sample fluid to be tested to the testing apparatus (analyzer module 64 @ figure 1 and 43 and col.26 lines 9-23: e.g., The analyzer 64 may be provided with an autoloader (not shown) for automatically transporting sample tubes to the analyzer 64 for processing. Such an autoloader may include a holder which retains up to about 100 sample tubes of various sizes. A presenter which sequentially presents the sample tubes to the analyzer 64 for aspiration is operatively connected with the autoloader. A mixer which mixes the sample just before sample aspiration may also operatively associated with the autoloader. A bar code reader for reading the bar code label on each tube can also operatively be associated with the autoloader and operatively connected to the system controller to input sample information into the system controller) by the transfer portion; and
obtain, based on the optical pulse signal of the cells in the sample fluid to be tested (figure 43 and col.4 lines 6-25: e.g., In fluorescence flow cytometry, a suspension of previously stained or fluorescently labelled particles, typically cells in a blood or other biological fluid sample, is transported through a flowcell where the individual particles in the sample are illuminated with one or more focused light beams. One or more detectors detect the interaction between the light beam(s) and the labeled particles flowing through the flowcell. Commonly, some of the detectors are designed to measure fluorescent emissions, while other detectors measure scatter intensity or pulse duration), a testing result of reticulocytes in the sample fluid to be tested (col.20 lines 25-39: e.g., The combined reagent/reticulocyte aliquot is then directed to an optical flow cell 170 of the automated analyzer 60. Thereafter the reagent/reticulocyte aliquot is passed through an illuminated sensing zone 300 essentially one cell at a time to cause fluorescence and scattered light events. These events are detected and the number of reticulocytes present in said sample are determined therefrom).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine the sample analyzer and the animal reticulocyte testing method of Qi with limitation above as taught by Gill for the purpose of enables improved gating of the reticulocyte cells, provides more rapid permeation of cell membranes, and possesses an optical absorption maximum closely aligned with the emission maximum of an argon laser.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Qi in view of Gill as applied to claim 1 above, and further in view of Zheng et al (US Patent No. 11,125,687 hereinafter “Zheng”).
Regarding claim 2; Qi in view of Gill combination discloses all of feature of claimed invention except for a human-computer interaction apparatus, wherein the human-computer interaction apparatus is communicatively connected to the control apparatus, and is configured to receive animal type indication information, the animal type indication information carrying the animal type; and send the animal type indication information to the control apparatus; and when performing the step of determining an animal type of the target animal, the control apparatus is specifically configured to determine the animal type carried by the animal type indication information as the animal type of the target animal. However, Zheng teaches that it is known in the art to provide a human-computer interaction apparatus (148 @ figure 14B) is communicatively connected to the control apparatus (146 @ figure 14B), and is configured to receive animal type indication information, the animal type indication information carrying the animal type (col.13 lines 28-55: e.g., the blood cell analyzer 14 further comprises a display device 148, and the display device 148 is connected to the processor 146 for displaying the fragmented red blood cell population. Specifically, the fragmented red blood cell population can be visually distinguished, for example, with a color or a shape, or by drawing a boundary or an outline, etc); and send the animal type indication information to the control apparatus (146 @ figure 14B); and when performing the step of determining an animal type of the target animal, the control apparatus (146 @ figure 14B) is specifically configured to determine the animal type carried by the animal type indication information as the animal type of the target animal (col.13 lines 28-55: e.g., the optical information comprises forward scattered light, and the processor 146 is specifically configured to classify and/or count at least one kind of reticulocytes, white blood cells, and platelets according to the forward scattered light signals and the fluorescence signals…. Col.14 lines 53-63: e.g., Specifically, the processor 146 calculates the count ratio of the fragmented red blood cell population to the red blood cell population according to the count value of the fragmented red blood cell population and the count value of the red blood cell population). It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine the sample analyzer of Qi with limitation above as taught by Zheng for the purpose of improving identification accuracy of fragmented red blood cells, so as to improve counting accuracy of the fragmented red blood cells.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Qi in view of Gill as applied to claim 1 above, and further in view of Waugh et al (US 2019/0290695 hereinafter “Zheng”).
Regarding claim 19; Qi in view of Gill combination discloses all of feature of claimed invention except for the control apparatus is further configured to preset at least two different reticulocyte incubation times. However, Waugh teaches that it is known in the art to provide the control apparatus (paragraph [0058]: e.g., The flow of liquid may be performed manually, or it may be controlled using a computer platform, such as an Arduino micro-controller system) is further configured to preset at least two different reticulocyte incubation times (paragraphs [0110]-[0111]: e.g., the mean sphericity of freshly prepared reticulocytes (green bar) was not significantly different from that of 24-hour-old reticulocytes incubated at 4° C. (yellow). On the contrary, the 24-hour-old reticulocytes that had been incubated at room temperature (orange bar) and at 37° C. (red bar) indicated greater sphericity. The sample incubated at 37° C. for 48 hours (purple) exhibits the highest sphericity…and [0120]: e.g., the sphericity values of cells from four different conditions were tested: reticulocytes before and after microfluidic treatment, reticulocytes left in the same conditions but without mechanical stimulation, and reticulocytes kept refrigerated until the other measurements were completed). It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine the sample analyzer of Qi with limitation above as taught by Waugh for the purpose of improving devices and methods for producing viable red blood cells.
Allowable Subject Matter
Claims 3-4, 6-7, 9-11, 13-17, 23, 26, 28, and 30 are 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, taken alone or in combination, fails discloses or render obvious a sample analyzer comprising all the specific elements with the specific combination including when performing the step of determining a first target reticulocyte incubation time corresponding to the target animal based on the animal type of the target animal, the control apparatus is specifically configured to: determine a reticulocyte incubation time corresponding to the animal type of the target animal from a plurality of preset correspondences between reticulocyte incubation times and animal types, and use the determined reticulocyte incubation time as the first target reticulocyte incubation time corresponding to the target animal in set forth of claim 3.
The prior art of record, taken alone or in combination, fails discloses or render obvious a sample analyzer and an animal reticulocyte testing method comprising all the specific elements with the specific combination including further comprising a human-computer interaction apparatus communicatively connected to the control apparatus, wherein the control apparatus is further configured to: determine, based on the testing result, a fragmentation status of the reticulocytes in the sample fluid to be tested; and if the fragmentation status meets a preset condition, control the human-computer interaction apparatus to output prompt information for indicating an abnormal fragmentation amount of the reticulocytes in set forth of claims 6 and 23.
The prior art of record, taken alone or in combination, fails discloses or render obvious a sample analyzer and an animal reticulocyte testing method comprising all the specific elements with the specific combination including further comprising a human-computer interaction apparatus communicatively connected to the control apparatus, wherein the control apparatus is further configured to determine, in response to a staining abnormality instruction input by the user based on the human-computer interaction apparatus, a third target reticulocyte incubation time that is longer than the first target reticulocyte incubation time, and control the human-computer interaction apparatus to display the third target reticulocyte incubation time in set forth of claims 13 and 30.
The prior art of record, taken alone or in combination, fails discloses or render obvious a sample analyzer comprising all the specific elements with the specific combination including further comprising a human- computer interaction apparatus communicatively connected to the control apparatus, wherein the control apparatus is further configured to display an incubation time adjustment interface in response to a staining abnormality instruction input by the user based on the human-computer interaction apparatus, wherein the incubation time adjustment interface comprises a plurality of reticulocyte incubation times corresponding to the animal type of the target animal, and at least one of the plurality of reticulocyte incubation times is longer than the first target reticulocyte incubation time in set forth of claim 15.
The prior art of record, taken alone or in combination, fails discloses or render obvious a sample analyzer comprising all the specific elements with the specific combination including further comprising a human- computer interaction apparatus communicatively connected to the control apparatus, wherein the control apparatus is further configured to determine, in response to a staining abnormality instruction input by the user based on the human-computer interaction apparatus, a third target reticulocyte incubation time that is longer than the first target reticulocyte incubation time, and control the incubation time of the sample fluid to be tested in the sample preparation apparatus based on the third target reticulocyte incubation time, to obtain another testing result of the reticulocytes in the sample fluid to be tested in set forth of claim 17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
1) Fernandez De Castro et al (US 2021/0199682) discloses a sample preparation instrument with an integrated device for estimating a concentration of white blood cells in a specimen is described. The sample preparation instrument receives a specimen for which a sample is to be prepared for analysis.
2) Ye (US 2019/0371434) discloses a blood cell analysis method and a blood cell analyzer are provided. In the method and analyzer, characteristic information of white blood cell fragments is obtained based on side scattered light information and fluorescence information, characteristic information of platelets is obtained based on forward scattered light information and fluorescence information and then a count value for the platelets is acquired based on the characteristic information of the platelets and the characteristic information of the white blood cell fragments
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANG H NGUYEN whose telephone number is (571)272-2425. The examiner can normally be reached M-F.
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/SN/
April 16, 2026
/SANG H NGUYEN/ Primary Examiner, Art Unit 2877
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