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 in the reply filed on February 10, 2026 is acknowledged.
Claims 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/10/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakata et al (EP 0613003 A1) (provided by applicant in IDS dated 1/17/2024).
With respect to claim 1 Sakata discloses a sample analysis method for analyzing a blood sample (See Pg. 3, lines 5-7 for discussion of the invention relating to a reagent for detecting malaria infected cells and an associated detection method), comprising:
obtaining, in one single test, optical signals generated by particles in a test sample solution after being irradiated by excitation light when the particles pass through an optical detection region of an optical detection apparatus one by one (See Pg. 9, lines 15-21 for discussion of utilizing optical means, particularly flow cytometry, to optically detect malaria infected cells stained with a fluorescent dye),
wherein the test sample solution is obtained by treating the blood sample with a hemolytic agent (See Pg. 9, line 12 for discussion of the erythrocytes being lysed), a first dye and a second dye (See Pg. 8, line 43 – Pg. 9, line 6; also see Pg. 7, lines 3-5),
the first dye being capable of staining leukocytes (See Pg. 10, lines 35-50 for discussion of a test solution with first and second dyes utilized to distinguish malaria infected erythrocytes from leucocytes), and
the second dye being capable of staining infected erythrocytes (See Pg. 10, lines 35-50 for discussion of a test solution with first and second dyes utilized to distinguish malaria infected erythrocytes from leucocytes), and wherein the optical signals comprise scattered light signals, first fluorescence signals corresponding to the first dye and second fluorescence signals corresponding to the second dye (See Pg. 9, lines 15-20 for discussion of using forward scattered light and fluorescent having the wavelength of 525nm or more);
obtaining optical information of leukocytes of the blood sample based on the first fluorescence signals and at least one type of the scattered light signals (See Pg. 10, lines 35-50 for discussion of leucocytes being detected in a region where the fluorescence is strong; See Figs. 2-3 and 7-8); and
obtaining optical information of infected erythrocytes of the blood sample based on the second fluorescence signals and at least one type of the scattered light signals (See Pg. 10, lines 35-50 for discussion of malaria infected erythrocytes being stained well by fluorescence; See Figs. 2-3 and 7-8; also See Pg. 9, lines 15-21).
With respect to claim 2 Sakata discloses that the optical signals are generated by the particles in the test sample solution after being irradiated by the excitation light at a signal wavelength when the particles pass through the optical detection of the optical detection apparatus one by one (See Pg. 9, lines 15-21).
With respect to claim 5 Sakata disclose identifying nucleated erythrocytes and/or immature leukocytes in the test sample solution based on the first fluorescence signals and at least one type of the scattered lights signals (See Pg. 10, lines 45-50).
With respect to claim 6 Sakata disclose counting infected erythrocytes in the test sample solution (See Pg. 10, lines 45-50 and lines 54-56).
With respect to claim 7 Sakata discloses that wherein a difference between wavelengths corresponds to respective peaks of an emission spectra and an excitation spectrum of at least one of the first dye and the second dye is greater than a predetermined threshold (See Pg. 9, lines 18-21 for discussion of the fluorescence having the wavelength of 525nm or more).
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.
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakata et al (EP 0613003 A1) in view of Narikawa et al (US 2010/0330565 A1).
With respect to claim 3 Sakata fails to disclose a step for classifying and/or counting leukocytes in the test sample solution based on the optical information of leukocytes.
Narikawa teaches a kit and method for measuring a sample which allow clearer discrimination and counting of nucleated erythrocytes and basophils from other types of leukocytes in the sample (See para. 0009). The blood cells stained in the staining step can be analyzed with a flow cytometer. The stained blood cells are applied with light when they are passing through a flow cell of the flow cytometer, thus allowing scattered light information and fluorescent information be obtained. The scattered light information is not specifically limited so long as it is scattered light measurable by conventional commercial flow cytometer, and includes the width of pulse, intensity and the like of scattered light such as forward scattered light (e.g. light-receiving angle of approximately 0 to 20 degrees), side scattered light (e.g. light-receiving angle of approximately 90 degrees) (See Para. 0111). The fluorescent information is obtained by applying light having an appropriate wavelength to the measurement sample and measuring the excited fluorescence. According to the fluorescent dye used, appropriate receiving wavelength can be selected. The fluorescence is emitted from nucleic acid and granules in the cells which are stained with the fluorescent dye (See Para. 0112). Based on thus measured scattered light and fluorescence, nucleated erythrocytes and basophils can be discriminated from other components and counted. This step preferably comprises, for example, (1) obtaining a scattergram having two axes of the fluorescent information and the forward scattered light information, (2) obtaining a scattergram having two axes of the forward scattered light information and the side scattered light information, and (3) analyzing the respective obtained scattergrams with an appropriate analytical software (See Para. 0114).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the method of detecting nucleated erythrocytes and basophils, such as taught by Narikawa, into the method of Sakata to ensure that the various cellular components can be discriminated from each other (See Para. 0114 of Narikawa).
With respect to claim 4 the combination of Sakata and Narikawa teaches that classifying and/or counting leukocytes in the test sample solution based on the optical information of leukocytes comprises:
Identifying basophils in the test sample solution and counting the leukocytes in the test sample solution based on the topical information of the leukocytes (See Paras. 0115-0117 of Narikawa).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 April 3, 2026
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