Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 01/26/2026 has been entered. Claims 1, 3, and 5-7 are remain pending in the application. New grounds of rejections necessitated by amendments are discussed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, and 5-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, claim 1 recites “the blood” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to recite “the blood” as “blood”. Claims 3 and 5-7 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites “the centrifugation and automatic analysis” in line 5. There is insufficient antecedent basis for this limitation in the claim. It is suggested to recite “the centrifugation and automatic analysis” as “centrifugation and automatic analysis”. Claims 3 and 5-7 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites “a tip which moves up, down, left and right based on the round cartridge” in lines 7. The term “based on the round cartridge” is unclear. It is unclear if the tip is functioning to move in the directions with respect to the round cartridge or if the movement is dependent on the movement of the round cartridge. Claims 3 and 5-7 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, the term “long and thin” in lines 20-21 is a relative term which renders the claim indefinite. The term “long and thin” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 3 and 5-7 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites “the measurement value” in lines 24-25. There is insufficient antecedent basis for this limitation in the claim. Claims 3 and 5-7 are rejected by virtue of their dependency on claim 1.
Allowable Subject Matter
Claims 1, 3, and 5-7 would be allowable if rewritten or amended 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the closest prior art of Koyata (US 20080096285 A1; cited in the IDS filed 04/08/2024) teaches a method of automatically distinguishing whether a type of the blood is whole blood or blood plasma, or whether the whole blood or the blood plasma is not sucked into a tip (abstract; [0007] teaches a method of determining the kind of sample in an automated analyzer for plasma or whole blood) by using a reflective photosensor in an automatic immunoassay device ([0007] and Fig. 1 teaches an automated device; [0039] teaches a reaction system can be an immunoassay based; [0041] teaches reflection is detected with a photodetector to determine the kind of the sample; therefore, the kind of sample, i.e. whole blood or plasma, is determined by using a reflective photosensor in an automatic immunoassay device) including a cartridge (Fig. 1, cartridge 3) which is able to perform automatic analysis of a blood sample by having wells for performing the automatic analysis therein ([0029] and Fig. 1 teaches cartridges 3 including wells for samples and reagents for detection; [0037] teaches samples include blood; [0081] teaches automatic analysis of samples; therefore, the cartridge is able to perform automated analysis of a blood samples by having wells for performing the automated analysis therein) and a tip (Fig. 1, tips 4) which moves up and down based on the cartridge ([0029]), the method comprising:
mounting the tip above the cartridge ([0029] teaches wells are placed directly below the nozzles and tips, i.e. tips are mounted above the cartridge); and
determining whether a type of the blood is whole blood or blood plasma, or whether the whole blood or the blood plasma is not sucked by comparing blood non-suction data with blood suction data ([0071]-[0072] and table 2 teaches discrimination of whole blood form plasma by measuring the detected light, i.e. blood suction data, in comparison with the tip alone, i.e. blood non-suction data), wherein a light source is a long and thin light emitting diode (LED) ([0062] teaches an LED 11, which is interpreted as a long and thin LED), and a light receiving element is a charge coupled device (CCD) linear image sensor ([0064]-[0065] teaches an imaging processing system using a CCD camera, therefore incudes a CCD with at least a linear image sensor).
Koyata fails to teach: the automatic immunoassay device including a round cartridge which is able to simultaneously perform the centrifugation and automatic analysis of a blood sample by having a rotary drive unit and wells for simultaneously performing the centrifugation and automatic analysis therein; the tip which moves up, down, left and right based on the round cartridge, the method comprising:
installing the reflective photosensor below the round cartridge so a light receiving element receives light reflected from the light source on a surface of the wells;
mounting the tip above the round cartridge, and continuously measuring blood non- suction data in a range including a position where the blood is sucked by using the reflective photosensor, collecting the measured data and storing the collected data while the tip is raised; continuously measuring blood suction data by using the reflective photosensor while the tip is lowered and sucks the blood present in the range including the position where the blood is sucked from the round cartridge; and
determining whether a type of the blood is whole blood or blood plasma, or whether the whole blood or the blood plasma is not sucked by comparing the blood non-suction data with the blood suction data, wherein the light source is a long and thin light emitting diode (LED) disposed below the round cartridge in an axial direction of the cartridge, and the light receiving element is a charge coupled device (CCD) linear image sensor, installed in one row on the other side of the light source below the cartridge in the axial direction of the cartridge, wherein the determination is made by a slope, which is a ratio of the measurement value of the whole blood or blood plasma obtained by using the reflective photosensor to a height of the tip.
A reference Kim et al. (US 20170292967 A1; cited in the IDS filed 04/08/2024) teaches a modular automatic analyzer using a circular type cartridge enabling centrifugation to improve measurement accuracy of blood (abstract; [0002]). Kim teaches a quick analysis may be performed by rotating the circular type cartridge with a rotation drive unit and operating a tip lifting unit ([0065]). Kim teaches a tip lifting unit which picks up and moves a tip upward and downward ([0017]) and an X-axis conveying unit to move the circular type cartridge ([0017]). However Kim fails to teach or suggest all of the limitations of claim 1, specially, Kim fails to teach or suggest: the method comprising: installing the reflective photosensor below the round cartridge so a light receiving element receives light reflected from the light source on a surface of the wells; continuously measuring blood non-suction data in a range including a position where the blood is sucked by using the reflective photosensor, collecting the measured data and storing the collected data while the tip is raised; continuously measuring blood suction data by using the reflective photosensor while the tip is lowered and sucks the blood present in the range including the position where the blood is sucked from the round cartridge; and determining whether a type of the blood is whole blood or blood plasma, or whether the whole blood or the blood plasma is not sucked by comparing the blood non-suction data with the blood suction data, wherein the light source is a long and thin light emitting diode (LED) disposed below the round cartridge in an axial direction of the cartridge, and the light receiving element is a charge coupled device (CCD) linear image sensor, installed in one row on the other side of the light source below the cartridge in the axial direction of the cartridge, wherein the determination is made by a slope, which is a ratio of the measurement value of the whole blood or blood plasma obtained by using the reflective photosensor to a height of the tip.
A reference Wakatake et al. (US 4774055 A) teaches an automatic analysis apparatus (abstract; Fig. 1). Wakatake teaches installing a reflective photosensor (Fig. 6, optical sensor 632) below a round cartridge (Figs. 5-6, optical sensor 632 is below round reaction table 20) so a light receiving element receives light reflected from the light source on a surface of the wells (Fig. 6 teaches optical sensor 632, which includes a light receiving element, receives light from a light source 622 on a surface of a well 22). However, Wakatake fails to teach or suggest all of the limitations of claim 1.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 1, specifically the claimed combination of steps. Therefore, claim 1 is deemed allowed. Claims 3 and 5-7 are deemed allowed based on their dependency on claim 1.
Response to Arguments
Applicant’s arguments, see page 6, filed 01/26/2026, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(b) of 09/24/2025 have been withdrawn.
Applicant’s arguments, see pages 7-9, filed 01/26/2026, with respect to the rejection(s) of claims 1-7 under 35 U.S.C. 103, have been fully considered and are persuasive. The rejections under 35 U.S.C. 103 of 09/24/2025 have been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gibbons et al. (US 20120309636 A1) teaches systems, devices, and methods for point of care and distributed testing services for automated detection of analytes in a bodily fluid (abstract). Gibbons teaches the devices and methods disclosed herein are designed to identify the sample type (blood versus plasma and etc.) to measure the volume of sample early enough in the assay procedure to ensure an appropriate sample is used is an intended assay ([0015]).
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 HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
