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 .
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.
Withdrawn Rejection
The rejection of claims 6 and 13-16 under 35 U.S.C. 112b is withdrawn in response to the amendments.
The rejection of claim 10 under 35 U.S.C. 112d is withdrawn in response to the amendments.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/ JP2020/013207, filed 03/25/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 2019-058402, filed on 03/26/2019 in Japan.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Status of the Claims
Claims 1-4, 6-10, 13-18 and 21-30 are pending; claims 1, 3, 6-7, 10 13-18 and 23 are amended, claims 5, 11-12 and 19-20 are canceled; claim 8 is withdrawn. Claims 1-4, 6-7, 9-10, 13-18 and 21-30 are examined below.
New Rejection
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 1, 3, 6-7, 9-10, 14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lundberg et al. (WO 2018/134374 A2)-Cite No. N of PTO 892 5/20/2025 (“Lundberg”).
Regarding claims 1, 3 and 10, Lundberg teaches 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 and / or coated” paragraph 1) comprising: magnetic responsive particles having a core particle and at least one magnetic layer disposed on the core particle, and a nonmagnetic outermost surface layer, wherein said nonmagnetic outermost surface layer comprises a nonmagnetic metal oxide and/or an organic metal compound, 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, “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). Note that although Lundberg fails to use the language “wherein said nonmagnetic outermost surface layer comprises a nonmagnetic metal oxide nonmagnetic metal oxide”, the teaching of a silica coat on the outer surface of the particles inherently provides a “nonmagnetic outermost surface layer comprising a nonmagnetic metal oxide” because silica is silicone dioxide and the specification paragraph 39 discloses that “[t]he nonmagnetic metal oxide and/or the nonmagnetic organic metal compound preferably contain at least one selected from Si”. Therefore, the outer surface silica coat inherently provides a nonmagnetic outermost surface layer comprising a nonmagnetic metal oxide. Lundberg further teaches the magnetic responsive particles having a substance that specifically interacts with an analyte, the substance being supported on the nonmagnetic surface layer (“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).
Regarding claims 6-7, 14 and 16-18, Lundberg further teaches wherein the substance interacting specifically with the analyte is bonded or chemically bonded onto the nonmagnetic outermost surface layer through a one-step or multi-step reaction or via one or multiple chemical bonds (“coating is typically provided on the outer surface of the particles” paragraph 123, “A silica coating may be formed by reaction of silicates (e.g. Na2SiQ3) at a pH of less than about 11 in the presence of the polymer particles” para. 125, paragraph 126).
Regarding claim 9, Lundberg further teaches an immunoassay reagent comprising the sensitized magnetic responsive particle particles according to claim 1 (“[a]ffinity ligands include monoclonal antibodies, polyclonal antibodies, antibody fragments” paragraph 126).
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.
Claims 2, 4, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg et al. (WO 2018/134374 A2)-Cite No. N of PTO 892 5/20/2025 (“Lundberg”) as applied to claims 1 and 3 above, and further in view of Masuda and Onogi (WO 2017204209) Cite No. 8 of IDS filed 9/24/2021 (hereinafter Masuda).
Regarding claims 2 and 4, Lundberg teaches the sensitized magnetic responsive particles of claims 1 and 3 as discussed above.
Lundberg fails to teach volume-average particle size (that the CV is CV in a volume-average particle size).
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 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.
Regarding claims 13 and 15, Lundberg in view of Masuda teach the sensitized magnetic responsive particles according to claims 2 and 4 as discussed above.
Lundberg further teaches wherein the substance interacting specifically with the analyte is chemically bonded onto the nonmagnetic layer through a one-step or multi-step reaction (paragraph 123, para. 125 and paragraph 126).
Claims 21-22 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg as applied to claim 1 above, and further in view of Ozaki et al. (JP 2005062087 A).
Regarding claim 21, Lundberg teaches the particles of claim 1 as discussed above.
Lundberg fails to teach wherein the magnetic layer composed of a metal and/or metal oxide has a thickness of from about 10 to 200 nm.
Ozaki teaches “immunoassay particles in the fields of biochemistry and pharmaceuticals and an immunoassay method using the particles” (page 1 paragraph 2). Ozaki further teaches that “[t]he surface of the core particle of the present invention has a magnetic layer containing at least one of Fe .sub.2 O .sub.3 and Fe .sub.3 O .sub.4 , and an antigen or an antibody is bound to the surface of the particle having a polymer layer on the magnetic layer” (page 2 paragraph 4). Ozaki further teaches that “the thickness of the magnetic layer formed on the surface of the core particle is 0.005 to 20 μm, preferably 0.01 to 5 μm, and the thickness is preferably uniform. When the thickness of the magnetic layer is smaller than 0.005μm, the content of the magnetic body is decreased, and sufficient magnetic separation property cannot be obtained. When the thickness exceeds 20 μm, the strength of the magnetic layer is decreased, and the magnetic body The layer may be broken” (page 5 paragraph 5).
With regards to the claimed range of magnetic layer thickness, the prior art teaches a range of 10-5000 nm. In such a case, since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05.
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 to rely on the magnetic layer composed of a metal and/or metal oxide having a thickness of from about 10 to 200 nm taught by Ozaki because Ozaki teaches that this thickness is optimal for magnetic separation and integrity of the layer and Lundberg is concerned with magnetic particles and magnetic layers. A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer of a composed of a metal and/or metal oxide for immunoassays.
Regarding claim 22, Lundberg teaches the particles of claim 1 as discussed above.
Lundberg is silent regarding the core particles having an average particle size of from 1 to 5 μm.
Ozaki teaches that “[t]he average particle diameter of the core particles used in the present invention is 0.4 to 200 μm, preferably 0.8 to 100 μm, and more preferably 1.0 to 50 μm. … If the average particle diameter of the core particles is less than 1 μm, for example, the collision energy due to high-speed stirring of the particles is insufficient, and it becomes difficult to adsorb magnetic fine particles. On the other hand, when the average particle diameter of the core particles exceeds 200 μm, the characteristics as fine particles are lost” (page 3 paragraph 3).
Applicant is reminded that “where 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.” MPEP 2144.05.
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 to rely on the particle core having an average size from 1 to 5 μm taught by Ozaki because Ozaki teaches that a size of less than 1 μm causes the collision energy due to high-speed stirring of the particles insufficient to adsorb magnetic microparticles and if the particles are too large, the characteristics as fine particles are lost. A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer of a composed of a metal and/or metal oxide for immunoassays.
Regarding claims 27-28, Lundberg teaches the particles of claims 1 and 3 as discussed above.
Lundberg is silent regarding the thickness of the nonmagnetic layer.
Ozaki teaches wherein the nonmagnetic layer has a thickness of from 10 to 500 nm (“Next, a polymer layer (hereinafter also referred to as “first coating polymer layer”) formed on the surface of the mother particle produced as described above will be described” page 5 para. 7, “the thickness of the polymer layer is 0.005 to 20 μm, preferably 0.01 to 5 μm. The polymer layer preferably completely covers the magnetic layer…in order to form a particle surface suitable as immunoassay particles, the polymer layer is again formed on the coating polymer layer. (Hereinafter, the re-formed polymer layer is referred to as “second coating polymer layer”.) In this case, the first coating polymer layer is mainly intended to cover the magnetic layer, 2 The coating polymer layer can mainly be used for the introduction of functional groups to form a particle surface suitable as an immunoassay particle…The method for forming the second coating polymer layer can be performed basically in the same manner as the method for forming the first coating polymer layer)” page 7 paras. 6-8, “the second coating polymer layer can be made thinner than that of the first coating polymer layer, and is 0.005 to 5 μm, preferably 0.005 to 1 μm” page 9 para. 6). Note that although Ozaki fails to use the language “from 10 to 500 nm” the teaching of using two polymer layers each with a thickness of 5 to 5000 nm effectively provides a nonmagnetic layer of from 10 to 10000 nm. With regards to the claimed range of nonmagnetic layer thickness, the prior art teaches a range of 10-10000 nm. In such a case, since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05. Ozaki further suggests that a thickness of 10 to 500 nm for the nonmagnetic layer facilitates immunoassay applications, i.e. binding of antibodies or antigens to the surface of the particles (“In this case, the first coating polymer layer is mainly intended to cover the magnetic layer, 2 The coating polymer layer can mainly be used for the introduction of functional groups to form a particle surface suitable as an immunoassay particle” page 7 para. 7, “method for binding the antigen or antibody to the particles… proceeds easily by mixing the two at room temperature, and the desired product can be obtained. Moreover, the carbodiimide method in a peptide bond method can be employ |adopted for a chemical bond method” page 10 para. 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 to rely on the nonmagnetic layer having a thickness of from about 10 to taught by Ozaki because Ozaki teaches that this thickness is optimal for supporting antibodies on the surface, i.e. for immunoassay applications, and Lundberg is concerned with particles for analyte detection and immunoassay applications. A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer composed of a metal and/or metal oxide and a nonmagnetic layer for immunoassays.
Claims 23-26 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg as applied to claim 1 above, and further in view of Ozaki et al. (JP 2005062087 A).
Regarding claims 23 and 25-26, Lundberg teaches sensitized magnetic responsive particles (paragraph 1) comprising: magnetic responsive particles having a core particle, 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 (paragraphs 2 and 119-120); and a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles (paragraphs 126), wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles is 15% or less (paragraphs 10, and 58). Lundberg further teaches comprising a nonmagnetic outermost surface layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte (paragraph 123).
Lundberg is silent regarding the core particles having an average particle size of 0.5 to 10 μm, 1 to 10 μm, 1 to 5 μm, wherein the magnetic layer has a thickness of from 10 to 200 nm.
Ozaki teaches “immunoassay particles in the fields of biochemistry and pharmaceuticals and an immunoassay method using the particles” (page 1 paragraph 2). Ozaki further teaches wherein the core particles have an average particle size of 1 to 5 μm and wherein the magnetic layer has a thickness of from 10 to 200 nm (page 3 paragraph 3 and page 5 paragraph 5).
It would have been further 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 to rely on the particle core having an average size from 1 to 5 μm taught by Ozaki because Ozaki teaches that a size of less than 1 μm causes the collision energy due to high-speed stirring of the particles insufficient to adsorb magnetic microparticles and if the particles are too large, the characteristics as fine particles are lost for immunoassay applications. It would have further obvious to have modified the teachings of Lundberg to rely on the magnetic layer composed of a metal and/or metal oxide having a thickness of from about 10 to 200 nm taught by Ozaki because Ozaki teaches that this thickness is optimal for magnetic separation and integrity of the layer and Lundberg is concerned with magnetic particles and magnetic layers. A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer of a composed of a metal and/or metal oxide for immunoassays.
Regarding claim 24, Lundberg in view of Ozaki teach the particles of claim 23 as discussed above.
Lundberg further teaches wherein the magnetic responsive particles have an average particle size of from 0.5 to 10 μm (paragraphs 109-111).
Regarding claim 29, Lundberg in view of Ozaki teach the particles of claim 23 as discussed above.
Lundberg is silent regarding the thickness of the nonmagnetic layer.
Ozaki teaches wherein the nonmagnetic layer has a thickness of from 10 to 500 nm (page 5 para. 7, page 7 paras. 6-8, page 9 para. 6). Note that although Ozaki fails to use the language “from 10 to 500 nm” the teaching of using two polymer layers each with a thickness of 5 to 5000 nm effectively provides a nonmagnetic layer of from 10 to 10000 nm. Since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05. Ozaki further suggests that a thickness of 10 to 500 nm for the nonmagnetic layer facilitates immunoassay applications, i.e. binding of antibodies or antigens to the surface of the particles (page 7 para. 7, page 10 para. 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 Ozaki to rely on the nonmagnetic layer having a thickness of from about 10 to taught by Ozaki because Ozaki teaches that this thickness is optimal for supporting antibodies on the surface, i.e. for immunoassay applications, and Lundberg is concerned with particles for analyte detection and immunoassay applications. A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer composed of a metal and/or metal oxide and a nonmagnetic layer for immunoassays.
Regarding claim 30, Lundberg in view of Ozaki teach the particles of claim 29 as discussed above.
Lundberg further teaches wherein the specifically interacting substance is selected from proteins, peptides, amino acids, lipids, carbohydrates, DNA, RNA, receptors, haptens, biotin, and avidin (“[a]ffinity ligands include monoclonal antibodies, polyclonal antibodies, antibody fragments” paragraph 126).
Double Patenting
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.
Claims 1-4, 6-7, 9-10 and 13-18 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-20 of copending Application No. 17914044 in view of Lundberg.
Regarding claims 1 and 3, copending Application No. 17914044 recites a sensitized magnetic responsive particle comprising: a magnetic responsive particle having a core particle, at least one magnetic layer disposed on the core particle and a nonmagnetic outermost surface layer, 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 nonmagnetic surface layer, wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles is 15% or less, (claims 1, 3, 6 and 10).
Copending Application No. 17914044 fails to recite particles and the average size of the magnetic responsive particles being 1 µm to 10 µm and wherein a coefficient of variation in a weight-average particle size of the sensitized magnetic responsive particles is 15% or less.
Lundberg teaches sensitized magnetic responsive particles (paragraph 1) comprising: magnetic responsive particles having a core particle, at least one magnetic layer disposed on the core particles and a nonmagnetic outermost surface layer, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof (paragraphs 2,119-120 and 123); and a substance that specifically interacts with an analyte, the substance being supported on the nonmagnetic surface layer (paragraph 126), wherein a coefficient of variation in a weight-average particle size of the sensitized magnetic responsive particles is 15% or less (paragraphs 10 and 58). Lundberg further teaches the average size of the magnetic responsive particles being 1 µm to 10 µm (paragraphs 109-111). Lundberg further teaches that “[t]his invention relates to monodisperse polymer particles useful in biological assays and other applications…for instance biological assays or sequencing applications” (paragraphs 1-2).
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 copending Application No. 17914044 to rely on particles, being 1 µm to 10 µm and wherein a coefficient of variation in a weight-average particle size of the sensitized magnetic responsive particles or sensitized magnetic responsive particles is 15% or less taught by Lundberg because Lundberg suggests these limitations are useful in biological assays, thereby motivating a person having ordinary skill in the art to use the particles for biological assays as well as in “other applications” (paragraphs 1-2 of Lundberg). A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and copending Application No. 17914044 teach sensitized magnetic particles.
Regarding claims 2 and 4, copending Application No. 17914044 in view of Lundberg address claims 1 and 3 as discussed above.
Copending Application No. 17914044 further recites wherein the coefficient of variation in a volume-average particle size of the magnetic responsive particles is 20% or less (claim 7).
Regarding claim 6, copending Application No. 17914044 in view of Lundberg address claim 1 as discussed above.
Copending Application No. 17914044 further recites wherein the substance interacting specifically with the analyte is chemically bonded onto the magnetic layer through a one-step or multi-step reaction (claims 4 and 11-12).
Regarding claim 7, copending Application No. 17914044 in view of Lundberg address claim 1 as discussed above.
Copending Application No. 17914044 further recites wherein the substance interacting specifically with the analyte is bonded onto the nonmagnetic layer via one or multiple chemical bonds (claim 5).
Regarding claim 9, copending Application No. 17914044 in view of Lundberg address claim 1 as discussed above.
Copending Application No. 17914044 further recites an immunoassay reagent comprising the sensitized magnetic responsive particle according to claim 1 (claims 9 and 6).
Regarding claim 10, copending Application No. 17914044 in view of Lundberg address claim 2 as discussed above.
Copending Application No. 17914044 further recites 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 (claims 3 and 10).
Regarding claims 13-16, copending Application No. 17914044 in view of Lundberg address claims 1-4 and 7 as discussed above.
Copending Application No. 17914044 further recites wherein the substance interacting specifically with the analyte is chemically bonded onto the magnetic layer through a one-step or multi-step reaction (claims 4 and 11-12).
Regarding claims 17-18, copending Application No. 17914044 in view of Lundberg address claims 1-3 and 10 as discussed above.
Copending Application No. 17914044 further recites wherein the substance interacting specifically with the analyte is bonded onto the nonmagnetic layer via one or multiple chemical bonds (claim 5).
Claims 21-22 and 27-28 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-20 of copending Application No. 17914044 in view of Lundberg as applied to claim 1 above, and further in view of Ozaki.
Regarding claim 21, copending Application No. 17914044 in view of Lundberg fail to recite wherein the magnetic layer composed of a metal and/or metal oxide has a thickness of from about 10 to 200 nm.
Ozaki teaches “immunoassay particles in the fields of biochemistry and pharmaceuticals and an immunoassay method using the particles” (page 1 paragraph 2). Ozaki further teaches that “[t]he surface of the core particle of the present invention has a magnetic layer containing at least one of Fe .sub.2 O .sub.3 and Fe .sub.3 O .sub.4 , and an antigen or an antibody is bound to the surface of the particle having a polymer layer on the magnetic layer” (page 2 paragraph 4). Ozaki further teaches that “the thickness of the magnetic layer formed on the surface of the core particle is 0.005 to 20 μm, preferably 0.01 to 5 μm, and the thickness is preferably uniform. When the thickness of the magnetic layer is smaller than 0.005μm, the content of the magnetic body is decreased, and sufficient magnetic separation property cannot be obtained. When the thickness exceeds 20 μm, the strength of the magnetic layer is decreased, and the magnetic body The layer may be broken” (page 5 paragraph 5).
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 copending Application No. 17914044 in view of Lundberg to rely on the magnetic layer composed of a metal and/or metal oxide having a thickness of from about 10 to 200 nm taught by Ozaki because Ozaki teaches that this thickness is optimal for magnetic separation and integrity of the layer. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 17914044, Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer of a composed of a metal and/or metal oxide for immunoassays.
Regarding claim 22, copending Application No. 17914044 in view of Lundberg address claim 1 as discussed above.
Copending Application No. 17914044 in view of Lundberg fail to recite wherein the core particles have an average particle size of from 1 to 5 μm.
Ozaki teaches that “[t]he average particle diameter of the core particles used in the present invention is 0.4 to 200 μm, preferably 0.8 to 100 μm, and more preferably 1.0 to 50 μm. … If the average particle diameter of the core particles is less than 1 μm, for example, the collision energy due to high-speed stirring of the particles is insufficient, and it becomes difficult to adsorb magnetic fine particles .On the other hand, when the average particle diameter of the core particles exceeds 200 μm, the characteristics as fine particles are lost” (page 3 paragraph 3).
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 copending Application No. 17914044 in view of Lundberg to rely on the particle core having an average size from 1 to 5 μm taught by Ozaki because Ozaki teaches that a size of less than 1 μm causes the collision energy due to high-speed stirring of the particles insufficient to adsorb magnetic microparticles and if the particles are too large, the characteristics as fine particles are lost. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 17914044, Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer of a composed of a metal and/or metal oxide for immunoassays.
Regarding claims 27-28, copending Application No. 17914044 in view of Lundberg address the particles of claims 1 and 3 as discussed above.
Copending Application No. 17914044 in view of Lundberg are silent regarding the thickness of the nonmagnetic layer.
Ozaki teaches wherein the nonmagnetic layer has a thickness of from 10 to 500 nm (page 5 para. 7, page 7 paras. 6-8, page 9 para. 6). Since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05. Ozaki further suggests that a thickness of 10 to 500 nm for the nonmagnetic layer facilitates immunoassay applications, i.e. binding of antibodies or antigens to the surface of the particles (page 7 para. 7, page 10 para. 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 copending Application No. 17914044 in view of Lundberg to rely on the nonmagnetic layer having a thickness of from about 10 to taught by Ozaki because Ozaki teaches that this thickness is optimal for supporting antibodies on the surface, i.e. for immunoassay applications, and copending Application No. 17914044 in view of Lundberg is concerned with particles for analyte detection and immunoassay applications. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 17914044 in view of Lundberg and Ozaki teach sensitized magnetic particles comprising a magnetic layer composed of a metal and/or metal oxide and a nonmagnetic layer for immunoassays.
Claims 23, 25-26 and 29-30 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-20 of copending Application No. 17914044 in view of Ozaki.
Regarding claims 23 and 25-26, copending Application No. 17914044 recites a sensitized magnetic responsive particle comprising: a magnetic responsive particle 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 particle, wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles is 15% or less (claims 1 and 6), further comprising a nonmagnetic outermost surface layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte (claims 1, 3, 6 and 10).
Copending Application No. 17914044 fails to recite particles and wherein the core particles have an average particle size of 0.5 to 10 μm, 1 to 10 μm, 1 to 5 μm, and wherein the magnetic layer has a thickness of from 10 to 200 nm.
Ozaki teaches “immunoassay particles in the fields of biochemistry and pharmaceuticals and an immunoassay method using the particles” (page 1 paragraph 2). Ozaki further teaches wherein the core particles have an average particle size of 1 to 5 μm and wherein the magnetic layer has a thickness of from 10 to 200 nm (page 3 paragraph 3 and page 5 paragraph 5).
Applicant is reminded that “where 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.” MPEP 2144.05.
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 copending Application No. 17914044 to rely on particles core having an average size from 1 to 5 μm taught by Ozaki because Ozaki teaches that a size of less than 1 μm causes the collision energy due to high-speed stirring of the particles insufficient to adsorb magnetic microparticles and if the particles are too large, the characteristics as fine particles are lost for immunoassay applications. It would have further obvious to have modified the teachings of copending Application No. 17914044 to rely on the magnetic layer composed of a metal and/or metal oxide having a thickness of from about 10 to 200 nm taught by Ozaki because Ozaki teaches that this thickness is optimal for magnetic separation and integrity of the layer and copending Application No. 17914044 is concerned with magnetic particles and magnetic layers. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 17914044 and Ozaki teach sensitized magnetic particles comprising a magnetic layer of a composed of a metal and/or metal oxide for immunoassays.
Regarding claim 29, copending Application No. 17914044 in view of Ozaki address the particles of claim 23 as discussed above.
Copending Application No. 17914044 is silent regarding the thickness of the nonmagnetic layer.
Ozaki teaches wherein the nonmagnetic layer has a thickness of from 10 to 500 nm (page 5 para. 7, page 7 paras. 6-8, page 9 para. 6). Since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05. Ozaki further suggests that a thickness of 10 to 500 nm for the nonmagnetic layer facilitates immunoassay applications, i.e. binding of antibodies or antigens to the surface of the particles (page 7 para. 7, page 10 para. 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 copending Application No. 17914044 in view of Ozaki to rely on the nonmagnetic layer having a thickness of from about 10 to taught by Ozaki because Ozaki teaches that this thickness is optimal for supporting antibodies on the surface, i.e. for immunoassay applications, and copending Application No. 17914044 is concerned with particles for analyte detection and immunoassay applications. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 17914044 and Ozaki teach sensitized magnetic particles comprising a magnetic layer composed of a metal and/or metal oxide and a nonmagnetic layer for immunoassays.
Regarding claim 30, copending Application No. 17914044 in view of Ozaki teach the particles of claim 29 as discussed above.
Copending Application No. 17914044 further teaches wherein the specifically interacting substance is selected from proteins, peptides, amino acids, lipids, carbohydrates, DNA, RNA, receptors, haptens, biotin, and avidin (“immunoassay” claims 18-20). Note that although copending Application No. 17914044 fails to use the language “proteins, peptides, amino acids,”, the teaching of “immunoassay” provides a specifically interacting substance selected from proteins because an antibody is a protein that specifically interacts with a target.
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting over claims 1-20 of copending Application No. 17914044 in view of Ozaki as applied to claim 23 above, and further in view of Lundberg.
Regarding claim 24, copending Application No. 17914044 in view of Ozaki teach the particles of claim 23 as discussed above.
Copending Application No. 17914044 in view of Ozaki fail to recite wherein the magnetic responsive particles have an average particle size of from 0.5 to 10 μm.
Lundberg further teaches wherein the magnetic responsive particles have an average particle size of from 0.5 to 10 μm (paragraphs 109-111).
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 copending Application No. 17914044 to rely on particles, being 0.5 µm to 10 µm taught by Lundberg because Lundberg suggests this enables useful biological assays and other applications. A person having ordinary skill in the art would have had a reasonable expectation of success because both Lundberg and copending Application No. 17914044 teach sensitized magnetic particles.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 5/11/2026 have been fully considered but they are not persuasive.
Regarding the prior art rejections,
Applicant argues that “In the Lundberg, as described in the Examples section, antibodies are immobilized directly on the surface of the magnetic layer (Fe). Although the specification mentions that a silica coating may be provided (paragraphs [0235] to [0237]), in the actual Examples, antibodies are attached only to the Fe surface. Therefore, the cited document does not suggest forming a silica coating on the magnetic layer and then placing a substance that specifically interacts with an analyte, such as antibodies, on top of that silica coating” (page 9 last paragraph).
However, the fact that Lundberg does not teach the silica coating in the Examples is not suggesting not adding the silica coating. Nevertheless, contrary to Applicant’s remark, Lundberg also teaches the silica coating in the Examples (“Silica coating polymer particles
Example 60” para. 428). Note also that the amendments to the claims changed the scope of the claims such that the teachings of Lundberg are now considered to be a 102 reference (see new grounds of rejection set forth above). In short, the silica coating of Lundberg is now interpreted as the nonmagnetic outermost surface layer that is a nonmagnetic metal oxide (as per the specification paragraph 39). Contrary to Applicant’s remark, Lundberg does teach placing a substance that specifically interacts with an analyte, such as antibodies, on top of that silica coating (see paragraphs 123 and 126 of Lundberg and rejection above).
Applicant further argues that “Suetsuna is directed to high-frequency magnetic materials” (page 10 para. 3).
However, Suetsuna is no longer used for the rejections above.
Applicant further argues that “In the present invention, the nonmagnetic layer produces an unexpected result of preventing impurities from eluting from the particles, preventing magnetic material itself from eluting, and/or preventing impurities from eluting from the magnetic layer” (page 11 para. 2).
However, given that Lundberg anticipates the claims, the remarks by Applicant are not persuasive. Lundberg will necessarily exhibit the same alleged unexpected results because Lundberg’s particles contain the same recited structural features of the claimed particles.
Regarding the double patenting rejections,
Applicant argues that “Reconsideration is requested in view of the present claim amendments. Otherwise, Applicant requests that these rejections be held in abeyance until allowable subject matter is found” (page 12 para. 3).
However, no claim is allowed.
Conclusion
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.
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/Fernando Ivich/Examiner, Art Unit 1678
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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