Prosecution Insights
Last updated: April 19, 2026
Application No. 17/914,044

MAGNETICALLY RESPONSIVE PARTICLES, AND IMMUNOASSAY METHOD AND IMMUNOASSAY REAGENT USING SAME

Non-Final OA §102§103§112§DP
Filed
Sep 23, 2022
Examiner
CHIN, CHRISTOPHER L
Art Unit
1677
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Sekisui Medical Co. Ltd.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
3y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
571 granted / 706 resolved
+20.9% vs TC avg
Strong +23% interview lift
Without
With
+23.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
14 currently pending
Career history
720
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
28.4%
-11.6% vs TC avg
§102
19.7%
-20.3% vs TC avg
§112
34.8%
-5.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 706 resolved cases

Office Action

§102 §103 §112 §DP
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 1-7 and 9-16 in the reply filed on 9/23/25 is acknowledged. Claims 8 and 17-20 are withdrawn from consideration; Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. JP 2020-053635 has been received. Claim Rejections - 35 USC § 112 4. 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. 5. Claims 2, 10, 11, and 13 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 2 is vague because it is not clear as to what the “magnetic separability is 40% or more” is relative to. 40% or more of the particles are separable relative to what? Claim Rejections - 35 USC § 102 6. 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. 7. 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. 8. Claim(s) 1, 2, 4, 9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Mizoguchi et al (JP2019082356A; herein referred to as Mizoguchi). Mizoguchi discloses a magnetic particle and detection/separation method, and specifically discloses that (see paragraphs [0066]-[0073], [0091]-[0092], [0097]-[0104], [0107]-[0126] of the description, and Table 1): a magnetic particle; (IV) particles with a masterbatch having a core made of a non-magnetic material such as a polymer or silica and a magnetic layer containing a magnetic material or a secondary aggregate thereof present on the surface of the core as a core, and a layer containing the aforementioned polymer as the shell, where particles of type (IV) are preferred because they have excellent magnetic response and the particle size can be uniformly controlled; the magnetic material is not particularly limited as long as it is a magnetic material, but typical examples include iron oxide-based substances, such as ferrite represented by MFe₂O₄ ([M=Co, Ni, Mg, Cu, Mn, Zn, or Li]0.5Fe0.5, etc.), magnetite represented by Fe₃O₄, and γ-Fe₂O₃; in particular, as magnetic materials having high saturation magnetization and low residual magnetization; the particles may be probe-bound particles (i.e., "a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particle" in the present application); the equivalent spherical specific surface area Sg (m²/g) is calculated as Sg = 6/(d·p), where p is the density (g/m³) of the magnetic particle, and d is the number average particle diameter (m) of the magnetic particle; when a polyacrylic acid is used as the core particle, it is known to those skilled in the art that the density of the polyacrylic acid is usually 1.18 g/cm² when the polyacrylic acid is used as the core particle. The density of the magnetic particle can be calculated from Table 1, and when Sg is 1.9 or less, the density of the magnetic layer is 2.0 (g/cm²) or more – appears to satisfy Expression 1 of claim 1. With respect to claim 2, the magnetic particles of Mizoguchi comprise the same materials as the instant particles, with the same properties, and thus will exhibit the same claimed magnetic separability. With respect to claims 4 and 11, Mizoguchi teach chemically linking analyte specific probes to the magnetic particles via functional groups, such as carbodiimide (see [0091] – [0092]). With respect to claim 9, [0092] – [0093] teach attaching antibodies or antigens to the magnetic particles. Thus, the disclosed magnetic particles could be used in solid phase immunoassays and be considered an immunoassay reagent. Claim Rejections - 35 USC § 103 9. 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. 10. Claims 6, 7, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mizoguchi et al (JP2019082356A; herein referred to as Mizoguchi). See above for the teachings of Mizoguchi. Mizoguchi differs from the instant invention in not teaching the magnetic particles having a coefficient of variation in a weight-average particle size of 15% or less or a coefficient of variation in a volume-average particle size of 20% or less. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (CCPA 1955). “No invention is involved in discovering optimum ranges of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. (Id. at 458, 105 USPQ at 236-237). The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. Since Applicants have not disclosed that the specific limitations recited in claims 6, 7, 13, and 15 are for any particular purpose, absent unexpected results, it would have been obvious for one of ordinary skill in the art to discover the optimum workable ranges of claimed coefficients of variation by normal optimization procedures known in the magnetic particle art. 11. Claims 3, 5, 10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mizoguchi et al (JP2019082356A; herein referred to as Mizoguchi) in view of Suetsuna et al. (CN 101299365 B; hereinafter Suetsuna). See above for the teachings of Mizoguchi. Mizoguchi differs from the instant invention in failing to teach a nonmagnetic layer comprises a nonmagnetic metal oxide and/or an organic metal compound. Suetsuna teaches a “core-shell type magnetic particle…wherein, comprises magnetic metal particle and an oxide coating layer” (Abstract). Suetsuna further teaches that the “coated magnetic metal particle surface oxide coating layer comprising at least one material as alkaline metal particles of nonmagnetic metal oxide or composite oxide. The oxide coating layer not only improves the oxidation resistance in the magnetic metal particle, and when the core-shell type magnetic particle by the oxide coating of the integrated component required for manufacturing these magnetic particles can be electrically separated mutually, improve the resistance of the component. Through improving the resistance component, can inhibit the eddy current loss under high frequency, improving magnetic permeability of high frequency characteristic” (paragraph 25). Suetsuna further teaches that the nonmagnetic metal oxide coating on the magnetic metal particles provides “thermal stability” and “can improve the adhesion and bonding property of the magnetic metal particle”, improving the magnetic metal particle (paragraph 26). Furthermore, Suetsuna teaches that the nonmagnetic metal oxide “has high insulating property. the result, through the insulating oxide coating the surface of the magnetic metal particle of high saturation magnetization, can inhibit eddy-current loss of the lower high-frequency main reason of loss, and can obtain a high anisotropic magnetic field of core-shell type magnetic particle” (paragraph 31). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the nonmagnetic metal oxide in the nonmagnetic layer taught by Suetsuna to the magnetic particles of Mizoguchi because Suetsuna teaches that a nonmagnetic coating of nonmagnetic metal oxide on top of the metal improves oxidation resistance, and provides thermal stability and insulation thereby granting high saturation magnetization and the magnetic particles of Mizoguchi comprise a layer of metal. A person having ordinary skill in the art would have had a reasonable expectation of success because Suetsuna and Mizoguchi are both directed to magnetic metal particles. With respect to claims 13-16, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (CCPA 1955). “No invention is involved in discovering optimum ranges of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. (Id. at 458, 105 USPQ at 236-237). The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. Since Applicants have not disclosed that the specific limitations recited in claims 12-16 are for any particular purpose, absent unexpected results, it would have been obvious for one of ordinary skill in the art to discover the optimum workable ranges of claimed coefficients of variation by normal optimization procedures known in the magnetic particle art. 12. Claims 1, 2, 4, 6, 9, 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg et al. (WO 2018/134374 A2; herein referred to as Lundberg). Lundberg suggests a sensitized magnetic responsive particles (“[t]his invention relates to monodisperse polymer particles useful in biological assays and other applications. The monodisperse polymer particles are magnetic” paragraph 1) comprising: magnetic responsive particles having a core particle and at least one magnetic layer disposed on the core particle, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof (“The base polymer particles are typically made by emulsion polymerisation or dispersion/precipitation polymerization” para. 2, “the polymer particles described herein comprise nanoparticulate magnetic material and / or superparamagnetic material, particularly superparamagnetic crystals” paragraph 119, “The superparamagnetic crystals of the polymer particles may be of any material capable of being deposited in superparamagnetic crystalline form on the polymer particles... The magnetic material may comprise, or be a metal oxide or alloy… iron-based metal nanoparticles and FeNi alloy nanoparticles” paragraph 120); and a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles (“the particles, which may be magnetic and/ or coated, may be bound to an affinity ligand the nature of which will be selected based on its affinity for a particular analyte whose presence or absence in a sample is to be ascertained. The affinity ligand may comprise any molecule capable of being linked to a particle which is also capable of specific recognition of a particular analyte. Affinity ligands include monoclonal antibodies,…” paragraph 126), wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles, or the sensitized magnetic responsive particles is 15% or less (“[i]t is an aim of the invention to provide monodisperse magnetic polymeric particles and methods of making monodisperse magnetic polymeric particles with a low coefficient of variation (CV) and/or low % polydispersity” paragraph 10, “By "monodisperse" is meant that for a plurality of particles (e. g. at least 100, more preferably at least 1000) the particles have a coefficient of variation (CV) of their diameters of less than 20%, for example less than 15%, typically of less than 10% and optionally of less than 8%, e.g. less than 5%...Such a determination of CV is performable on a CPS disc centrifuge” paragraph 58). Note that although Lundberg fails to use the language “weight-average particle size”, the teachings of a CV determination via “CPS disc centrifuge” anticipates a CV in a weight-average particle size because the specification paragraph 29 discloses that “[t]he CV value for the weight-average particle size in the invention is a value obtained with, for instance, a disc centrifugation-type particle size distribution analyzer ("DC24000UHR", manufactured by CPS Instruments, Inc.)”. Lundberg further teaches the average particle size of the magnetic responsive particles being 1 μm to 10 μm (“the particles may have an average diameter of at least 500 nm, e.g. at least 600 nm, optionally at least 800 nm” paragraph 109, “the particles may have an average diameter of not more than 10 μm” paragraph 110, “average diameters of from 0.5 μm to 10 μm, e.g. of from 0.8 μm to 5 μm” paragraph 111). Lundberg further teaches comprising a nonmagnetic layer between the magnetic layer and the substance interacting specifically with the analyte (“an embodiment, the polymer particles comprise a coating…The coating is typically provided on the outer surface of the particles…The coating may be polymer coating. The coating may be a silica coating” paragraph 123). Lundberg differs from the instant invention in failing to teach arriving at a weight and volume of the core and the whole particle that satisfies Expression 1 in claim 1. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (CCPA 1955). “No invention is involved in discovering optimum ranges of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. (Id. at 458, 105 USPQ at 236-237). The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”. Since Applicants have not disclosed that the weights and volume of the core and whole particle are for any particular purpose, absent unexpected results, it would have been obvious for one of ordinary skill in the art to discover the optimum workable ranges of the weights and volume of the core and whole particle to satisfy Expression 1 in claim 1. With respect to claim 2, the magnetic particles of Lundberg comprise the same materials as the instant particles, with the same properties, and thus will exhibit the same claimed magnetic separability. With respect to claim 9, Lundberg teaches an immunoassay reagent since the particles are sensitized with affinity ligands include monoclonal antibodies, polyclonal antibodies, antibody fragments” (paragraph 126). 13. Claims 3, 5, 10, 12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg et al. (WO 2018/134374 A2; herein referred to as Lundberg) in view of Suetsuna et al. (CN 101299365 B; hereinafter Suetsuna). Lundberg differs from the instant invention in not teaching a nonmagnetic layer comprises a nonmagnetic metal oxide and/or an organic metal compound. Suetsuna teaches a “core-shell type magnetic particle…wherein, comprises magnetic metal particle and an oxide coating layer” (Abstract). Suetsuna further teaches that the “coated magnetic metal particle surface oxide coating layer comprising at least one material as alkaline metal particles of nonmagnetic metal oxide or composite oxide. The oxide coating layer not only improves the oxidation resistance in the magnetic metal particle, and when the core-shell type magnetic particle by the oxide coating of the integrated component required for manufacturing these magnetic particles can be electrically separated mutually, improve the resistance of the component. Through improving the resistance component, can inhibit the eddy current loss under high frequency, improving magnetic permeability of high frequency characteristic” (paragraph 25). Suetsuna further teaches that the nonmagnetic metal oxide coating on the magnetic metal particles provides “thermal stability” and “can improve the adhesion and bonding property of the magnetic metal particle”, improving the magnetic metal particle (paragraph 26). Furthermore, Suetsuna teaches that the nonmagnetic metal oxide “has high insulating property. the result, through the insulating oxide coating the surface of the magnetic metal particle of high saturation magnetization, can inhibit eddy-current loss of the lower high-frequency main reason of loss, and can obtain a high anisotropic magnetic field of core-shell type magnetic particle” (paragraph 31). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the nonmagnetic metal oxide in the nonmagnetic layer taught by Suetsuna to the magnetic particles of Lundberg because Suetsuna teaches that a nonmagnetic coating of nonmagnetic metal oxide on top of the metal improves oxidation resistance, and provides thermal stability and insulation thereby granting high saturation magnetization and the magnetic particles of Lundberg comprise a layer of metal.. A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and Suetsuna are both directed to magnetic metal particles. Lundberg further suggests wherein the substance interacting specifically with the analyte is chemically bonded onto the nonmagnetic layer through a one-step or multi-step reaction (“coating is typically provided on the outer surface of the particles” paragraph 123, paragraph 126). 14. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lundberg et al. (WO 2018/134374 A2; herein referred to as Lundberg) as applied to claims 1 and 6 above, and further in view of Masuda et al (WO 2017204209; hereinafter Masuda). See above for the teachings of Lundberg. Lundberg differs from the instant invention in failing to teach a coefficient of variation in a volume-average particle size of the magnetic particles is 20% or less. Masuda teaches “composite particles…a ligand-containing solid phase carrier” (Abstract), having volume-average particle size of 20% or less (“[t]he composite particles according to an embodiment of the present invention preferably have a particle size variation coefficient (CV value) of 20% or less” paragraph 8). Masuda and Onogi explicitly teach that “volume” is referred to as “size” (“[t]he volume average particle size (hereinafter also simply referred to as “particle size”)” paragraph 4). Masuda teaches that the composite particles contain magnetic particles (“the “composite particle” is not particularly limited as long as it is a particle containing an organic polymer and inorganic nanoparticles, but is preferably a particle containing inorganic nanoparticles in the organic polymer. It is more preferable that the inorganic nanoparticles are dispersed in the matrix, and magnetic particles are particularly preferable” paragraph 1). Masuda teaches that “[w]hen the CV value is in the above range, composite particles with little variation and easily exhibiting desired characteristics can be easily obtained. Particularly, in the case of composite particles containing a magnetic substance, the magnetic separation is performed. It is preferable because the separation time hardly varies. (paragraph 9). Note that the particles having a volume-average CV value of 20% or less disclosed by Masuda are not limited on having a ligand or not (i.e., the particles being sensitized). Therefore, the teaching of volume-average CV value of 20% or less applies to both magnetic particles having a ligand or not (paragraph 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Lundberg in view of Suetsuna to rely on the volume-average CV being 20% or less taught by Masuda because Masuda teaches that having a coefficient of variation of 20% or less enables reproducible magnetic separations and Lundberg is concerned with magnetic particles. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Lundberg and Masuda teach sensitized magnetic responsive particles. Double Patenting 15. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 16. Claims 1-7 and 9-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7, 9, and 23 of copending Application No. 17/598,015 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims a sensitized magnetic responsive particle that anticipates or make obvious the instant invention. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Copending ‘015 claims: 1. Sensitized magnetic responsive particles comprising magnetic responsive particles having a core particle and at least one magnetic layer disposed on the core particle, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof; and a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles, wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles is 15% or less, the average particle size of the magnetic responsive particles being 1 µm to 10 µm, further comprising a nonmagnetic layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte. 2. The sensitized magnetic responsive particles according to claim 1, wherein the coefficient of variation in a volume-average particle size of the magnetic responsive particles is 20% or less. 3. Sensitized magnetic responsive particles comprising: magnetic responsive particles having a core particle and at least one magnetic layer disposed on the core particle, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof; and a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles, wherein a coefficient of variation in a weight-average particle size of the sensitized magnetic responsive particles is 15% or less, the average particle size of the magnetic responsive particles being 1 µm to 10 µm, further comprising a nonmagnetic layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte. 4. The sensitized magnetic responsive particles according to claim 1, wherein the coefficient of variation in a volume-average particle size of the magnetic responsive particles is 20% or less. 6. The sensitized magnetic responsive particle according to claim 1, wherein the substance interacting specifically with the analyte is chemically bonded onto the magnetic layer through a one-step or multi-step reaction. 7. The sensitized magnetic responsive particles according to claim 1, wherein the substance interacting specifically with the analyte is bonded onto the nonmagnetic layer via one or multiple chemical bonds. 9. An immunoassay reagent comprising the sensitized magnetic responsive particles according to claim 1. 23. Sensitized magnetic responsive particles comprising: magnetic responsive particles having a core particle, wherein the core particles have an average particle size of 0.5 to 10 µm and at least one magnetic layer disposed on the core particles, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof wherein the magnetic layer has a thickness of from 10 to 200 nm; and a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles, wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles is 15% or less, further comprising a nonmagnetic layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte. Copending ‘015 claims a particle that anticipates the physical limitations of the instant invention and thus will satisfy Expression 1 in instant claim 1. With respect to claim 2, the magnetic particles of copending ‘015 comprise the same materials as the instant particles, with the same properties, and thus will exhibit the same claimed magnetic separability. Conclusion 17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm. 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, Bao-Thuy Nguyen can be reached at 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. /CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677 2/1/2026
Read full office action

Prosecution Timeline

Sep 23, 2022
Application Filed
Feb 01, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
81%
Grant Probability
99%
With Interview (+23.0%)
3y 11m
Median Time to Grant
Low
PTA Risk
Based on 706 resolved cases by this examiner. Grant probability derived from career allow rate.

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