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. Status of the Claims Claims 1- 7 are pending and examined herein. Priority This application, filed 10/05/2023, is a 371 of PCT/KR2021/016852, filed 11/17/2021, and claims benefit of REPUBLIC OF KOREA KR10-2021-0144086 filed on 10/26/2021. This priority is acknowledged and the claims examined herein are treated as having an effective filing date of 10/26/2021. Information Disclosure Statement The Information Disclosure Statement s filed on 01/30/2024 and 07/28/2025 are acknowledged and ha ve been considered. 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. Claim s 1, 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. Claim 1 recites “ A method for analyzing immune response using magnetic beads, including steps of: (a) dispersing magnetic beads in a detection chamber; and (b) collecting the magnetic beads and separating them from the detection chamber, and then performing an optical inspection on the detection chamber” . While the preamble of the claim recites analyzing an immune response, it is unclear how this could be done given that the body of the claim does not teach the presence of any cell/sample from which an immune response could be measured, and is therefore indefinite. In the broadest reasonable interpretation of the claim, an optical inspection is being performed on the detection chamber that contains no sample or analyte , and therefore an immune response cannot be analyzed . Claim 5 recites the limitation “ wherein the step (a) of dispersing the magnetic beads includes substeps of: FILLIN "Enter appropriate information" \* MERGEFORMAT (a-1) moving the washing tip from which the non-specific biological sample is washed away to the detection chamber together with the magnetic beam; … ". There is insufficient antecedent basis for this limitation in the claim. While claim 5 is dependent upon claim 4, claim 5 is adding further limitations to “step (a)” , which is recited in claim 1. However, the terms ”washing tip”, “biological sample” or “magnetic beam” are not recited in claim 1 and therefore claim 5 lacks antecedent support. Claim 6 has the same problem of insufficient antecedent basis. Claim 6 recites “ to the surface of the washing tip by placing the magnetic beam ”. While claim 6 is dependent upon claim 5, claim 6 is adding further limitations to “step (b)”, which is recited in claim 1. However, the terms ”washing tip” or “magnetic beam” are not recited in claim 1 and therefore claim 6 lacks antecedent support. Claim 7 is similar to claim 1 in that it is unclear how an immune response is being analyzed based on the content of the claim body. In step “(h)” the magnetic beads with the bound analyte are dispersed from the washing tip into the detection chamber. In the next step “(i)” these same beads in the detection chamber are then reattached to the wash tip, before being removed from the detection chamber in step “(j)” in which the optical inspection is performed on the chamber. There is no mention of an elution step, or anything in the claims indicating that the analyte which was bound to the magnetic beads were unbound and remained in the detection chamber prior to the removal of the beads. Together with the recitation that non-specific biological sample was washed away in step “(f)” it is unclear how an immune response could be analyzed when, based on the limitations of claim 7, there is no bound or unbound sample constituents remaining in the detection chamber when optical inspection occurs. Claim Rejections - 35 USC § 102 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" 1-3 are rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1) as being FILLIN "Insert either—clearly anticipated—or—anticipated—with an explanation at the end of the paragraph." \d "[ 3 ]" anticipated by Noh et al. (2019). “ Pipetting-based immunoassay for point-of-care testing: Application for detection of the influenza A virus ” . Scientific reports , 9 (1), 16661 , (herein referred to as Noh ). Regarding claim s 1 -3 , Noh teaches a method of pipetting-based immunoassay for point-of-care in vitro testing for infectious pathogens (abstract). The method uses streptavidin-coated magnetic beads (page 6, 6 th full paragraph) which were incubated with biotin-conjugated mouse anti-influenza A virus NP clone A3 to form a magnetic bead-capture antibody complex (page 7, 1 st full paragraph ) . Noh teaches that t he magnetic bead-capture antibody complex is placed into a reaction chamber ( “ Eppendorf tube ” ) with biological samples ( “ recombinant influenza NP protein, influenza A virus isolates, and clinical samples ” ) and an HRP-conjugated antibody and incubated in order to bind the target analyte ( “ influenza A virus NP ” ) in the samples incubated (page 7, 1 st full paragraph; Fig. 1). Noh teaches where reactant solution is then pipetted 10 times using a pipette tip with an attached magnetic ring and then discarded in a plate well. The beads bound with the target antigen from the solution are captured on the inside surface of the tip due to the attached magnetic ring and the magnetic force it creates (page 7, 3 r d full paragraph; Fig. 1). Noh teaches that t he bound beads are then washed by pipetting 10 times using PBS-T in second and third washing chambers ( 4 well plate wells, page 7, 3 rd full paragraph; Fig. 1). After removing the magnetic ring from the pipette tip, the bead-bound complexes are released from the tip when a TMB solution is pipetted 10 times into a fourth well/detection chamber (page 7, 3 rd full paragraph; Fig. 1). Noh teaches that o ptical analysis of the fourth well is then performed “ through colour development of the TMB solution, and the absorbance was measured spectrophotometrically at 650 nm ” (page 7, 3 rd full paragraph). Claim Rejections - 35 USC § 103 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. Claim s 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Noh as applied to claims 1-3 , and further in view of Fritchie et al. (U.S. Patent No. 8,222,048 ) ( referred to herein as Fritchie ) and Huergo et al. (2021). “Magnetic bead-based immunoassay allows rapid, inexpensive, and quantitative detection of human SARS-CoV-2 antibodies”. ACS sensors , 6 (3), 703-708. ( Published January 26, 2021, referred to herein as Huergo ) . Regarding instant claim 4 , Noh recites all of the limitations of claim 3 of the instant application, as well as a washing step to remove unbound non-specific biological sample attached to the washing tip . Noh recites that the washing steps are done by pipetting a washing solution ( PBS-T ) 10 times into the wells of a 4-well plate , with the magnetic beam being present in the tip of the pipette (page 7, 3 r d full paragraph; figure 1) . Regarding claim 5 , Noh teaches that following the washing step, the tip with the beads still attached via the magnets is moved to the detection chamber (plate well), at which point the magnetic ring is removed from the pipette tip (page 7, 3 rd full paragraph; figure 1). However, Noh does not recite that the washing step is achieved by “…repeatedly moving up and down the washing tip in the washing chamber ...”. Regarding claim 4, Fritchie teaches a plate-based laboratory automation system used for performing immunoassays (abstract). Fritchie teaches that this system uses “ inverse magnetic particle processing ” to transfer magnetic particles and immunoassay products between the wells of the plates (abstract). The magnetic particles are transferred using magnetic rods covered with plastic ti p combs which adhere the particles (column 28, lines 34-36). Fritchie teaches that in the capture, release, and wash steps, the magnetic rod and tip comb is moved up and down several times in the micro-wells which contain reagents such as washing solution (column 28, lines 60-61; column 29, lines 4-8; column 29, lines 11-20). However, Fritchie does not teach that the beads remain attached to the tip during wash. Huergo teaches the method of a magnetic bead-based immunoassay for use in the rapid quantitative detection of human antibodies against SARS-CoV-2 in a biological sample (abstract). Huergo teaches the use of magnetic beads coupled with a capture antibody which is incubated with a biological sample and a probe antibody (Fig. 2). Huergo teaches magnetic probes placed into PCR strips/tubes which provide the surface for the beads attach to (page 704, column 2, paragraph 1). Huergo teaches that once the beads are magnetically adhered to the magnetic extractor device, the device is repeatedly moved up and down into a chamber (plate well) containing a solution (SI video). However, Huergo does not teach that this occurs during the washing step . However, i t would have been obvious to person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method recited in Noh to repeatedly move the washing tip up and down in the washing chamber , as disclosed in Fritchie . as a matter of due to simple substitution. Fritchie does not teach that the beads remain adhered to the tip when it is moving up and down in the wash chamber. However, there is a finite number of possible ways to perform the wash step in such systems utilizing a magnet/probe to collect magnetic beads and transfer them to different chambers . Based on the method described in Huergo , it is known in the art to move the magnet/ probe up and down in a solution with the beads attached , there fore person of ordinary skill in the art could have pursued this known way and applied it to the method of Fritchie with a reasonable expectation of success. A skilled artisan would have been motivated to make this modification because an automated laboratory system for assays that uses the washing method recited in Fritchie and Huergo rather than the method recited in Noh , allows for a more simplified apparatus, due to the lack of need for positive displacement pumps ( Fritchie , column 5, lines 5-15). Furthermore, allowing the magnetic beads to remain attached to the magnetic tip/probe during the washing step would save time. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Noh in view of Fritchie and Huergo as applied to claims 4 and 5 above, and further in view of Kim et al. (2017) . “ Integrated magnetic bead–quantum dot immunoassay for malaria detection ” . ACS sensors , 2(6), 766-772 . ( referred to herein as Kim ) , as evidenced by Roth et al. (2019) . “ Improving the sensitivity of fluorescence‐based immunoassays by photobleaching the autofluorescence of magnetic beads ” . Small , 15 (3), 1803751. ( referred to herein as Roth ) . The teachings of Noh in view of Fritchie and Huergo are incorporated herein. Regarding claim 6 , Noh in view of Fritchie and Huergo teaches the separation of magnetic beads from a chamber by attaching the magnetic beads in the chamber to a wash tip which has a magnetic beam, and then removing the wash tip from the chamber. However, Noh in view of Fritchie and Huergo does not teach the removal of the magnetic beads from the detection chamber specifically. Regarding claim 6, Kim teaches an immunoassay method using magnetic beads for capture of an analyte for disease detection for point-of-care tests (abstract). Kim also teaches the removal of magnetic beads from the detection chamber (plate well) prior to analyte measurement via fluorescence (Fig. 1). It would have been obvious to person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Noh in view of Fritchie and Huergo to remove the magnetic beads from the detection well, as disclosed in Kim, in order to limit potential analytical interference caused by the autofluorescence of the magnetic beads , as evidenced by Roth (abstract). A person of ordinary skill would have had a reasonable expectation of success in removing the magnetic beads from the detection chamber, as such a removal technique is already taught by Noh, it is merely applying the technique to the detection chamber in addition for improvement to the base device. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Noh, Fritchie , Huergo and Kim in view of Guckenberger et al. (2016) . “ Magnetic system for automated manipulation of paramagnetic particles ” . Analytical chemistry , 88 (20), 9902-9907. (referred to herein as Guckenberger ). Regarding claim 7, Noh, Fritchie , Huergo and Kim recites all the limitations of claim 7 but does not recite moving the magnetic beam up or down within the hollow portion of the wash tip. However, Guckenberger teaches a magnetic system for automated manipulation of paramagnetic particles for cell, RNA, and DNA isolation (abstract) . Guckenberger teaches a system where paramagnetic particles can be collected, released, and resuspended in fluid multiple times in an automated format (abstract). This system consists of a hollow head with a capture magnet inside (Fig. 2). When the capture magnet is positioned at the bottom of the hollow head, the paramagnetic particles adhere to the head and are removed from the fluid , and when the magnet inside the head is raised, the paramagnetic particles are released/dispersed (Fig. 2). It would have been obvious to person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Noh, Fritchie , Huergo , and Kim to have a magnetic beam that move up or down within the hollow portion of the tip, as disclosed in Guckenberger , in order to allow for the capture and release of paramagnetic particles multiple times allowing for a singular or multiple wash steps ( Guckenberger , abstract). A skilled artisan would have been motivated to make this modification because Guckenberger teaches that this magnetic technology which allows for multiple wash protocols can result in “... up to a 28-fold improvement of purity ...” with regards to isolations ( Guckenberger , abstract). A person of ordinary skill would have had a reasonable expectation of success in utilizing this technology as taught by Guckenberger because it “ …is compatible with nearly any plate design, can be integrated into automated workflows, enables high-throughput formats, simplifies mechanical requirements, and is amenable to a range of analytes …” (abstract). Conclusion For all the reasons discussed above, claims 1-7 are rejected and therefore no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ALEXANDER JOSEPH HOFFMAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9080 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT PTA 7:30-5:00 M-F . 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, FILLIN "SPE Name?" \* MERGEFORMAT Bao-Thuy Nguyen can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-0824 . 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. /ALEXANDER J. HOFFMAN/ Examiner, Art Unit 1677 /BAO-THUY L NGUYEN/ Supervisory Patent Examiner, Art Unit 1677 March 17, 2026