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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/20/2025 has been entered.
Withdrawn Rejection
The rejection of claims 1, 3 and 9 under 35 U.S.C. 102(a)(1) is withdrawn in response to the amendments.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1-4, 6-10, 13-19 and 21-26 are pending; claims 16 and 18 are amended, claims 5, 11-12 and 20 are canceled; claim 8 is withdrawn. Claims 1-4, 6-7, 9-10, 13-19 and 21-26 are examined below.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 19 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.
Claims 6 and 13-16 recite “wherein the substance interacting specifically with the analyte is chemically bonded onto the magnetic layer through a one-step or multi-step reaction”.
However, it is not clear how the substance interacting specifically with the analyte is chemically bonded onto the magnetic layer because the particles comprise “a nonmagnetic layer…between the magnetic layer and the substance interacting specifically with the analyte”. Therefore, the presence of the nonmagnetic layer between the magnetic layer and the substance interacting specifically with the analyte would obstruct the substance interacting specifically with the analyte from being chemically bonded onto the magnetic layer. A person having ordinary skill in the art would therefore not recognize what is encompassed by the claimed invention.
Claim 19 recites “[t]he sensitized magnetic responsive particles according to claim 12…”. However, claim 12 is cancelled. Therefore, claim 19 is indefinite because it is not clear to what sensitized magnetic responsive particles is being referred. A person having ordinary skill in the art would not be able to recognize the metes and bounds of the claimed invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites “[t]he sensitized magnetic responsive particles according to claim 2, 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”. However, given that the sensitized magnetic responsive particles according to claim 2 already comprise 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 (claim 1), claim 10 appears to not be further limiting the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1, 3, 6-7, 9, 14, 16 and 18-19 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”) in view of Suetsuna et al. (CN 101299365 B)-Cite No. N. of PTO 892 1/21/2025 (hereinafter Suetsuna).
Regarding claims 1 and 3, 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 does not teach wherein the 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 have modified the teachings of Lundberg to include the nonmagnetic metal oxide in the nonmagnetic layer taught by Suetsuna 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 Lundberg is concerned with magnetic particles comprising a layer of metal. A person having ordinary skill in the art would have had a reasonable expectation of success because Suetsuna teaches that the nonmagnetic metal oxide improves adhesion and bonding property of the magnetic metal particle. Furthermore, both Suetsuna and Lundberg teach magnetic particles comprising a nonmagnetic coating.
Regarding claim 6, 14 and 16, although the claims are indefinite (see 112b rejection above) in the interest of compact prosecution, the claims are interpreted to recite “bonded onto the nonmagnetic layer”. Lundberg in view of Suetsuna teach the sensitized magnetic responsive particles according to claims 1 and 3 as discussed above.
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).
Regarding claims 7 and 18-19, although claim 19 is indefinite (see 112b rejection above) in the interest of compact prosecution, claim 19 is interpreted as reciting “according to claim 3”. Lundberg in view of Suetsuna teach the sensitized magnetic responsive particles according claims 1 and 3 as discussed above.
Lundberg further suggests wherein the substance interacting specifically with the analyte is bonded onto the nonmagnetic layer via one or multiple chemical bonds (paragraphs 123 and 126).
Regarding claim 9, Lundberg in view of Suetsuna teach the sensitized magnetic responsive particles according claim 1 as discussed above.
Lundberg further suggests 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).
Claims 2, 4, 10, 13, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg in view of Suetsuna 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 in view of Suetsuna address the sensitized magnetic responsive particles of claims 1 and 3 as discussed above.
Lundberg in view of Suetsuna fail 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 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.
Regarding claims 10 and 17, Lundberg in view of Suetsuna address the sensitized magnetic responsive particles of claim 2 as discussed above.
Lundberg further suggests 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 (paragraph 123), and wherein the substance interacting specifically with the analyte is bonded onto the nonmagnetic layer via one or multiple chemical bonds (paragraphs 123 and 126).
Regarding claims 13 and 15, although the claims are indefinite (see 112b rejection above) in the interest of compact prosecution, the claims are interpreted to recite “bonded onto the nonmagnetic layer”. Lundberg in view of Suetsuna 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, paragraph 126).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg in view of Suetsuna as applied to claim 1 above, and further in view of Ozaki et al. (JP 2005062087 A).
Regarding claim 21, Lundberg in view of Suetsuna teach the particles of claim 1 as discussed above.
Lundberg in view of Suetsuna fail 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 in view of Suetsuna 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 in view of Suetsuna teach the particles of claim 1 as discussed above.
Lundberg in view of Suetsuna are 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 in view of Suetsuna 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.
Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Lundberg i view of Suetsuna and Ozaki.
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 layer 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, and wherein the 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).
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 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 include the nonmagnetic metal oxide in the nonmagnetic layer taught by Suetsuna 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 Lundberg is concerned with magnetic particles comprising a metal layer. A person having ordinary skill in the art would have had a reasonable expectation of success because Suetsuna teaches that the nonmagnetic metal oxide improves adhesion and bonding property of the magnetic metal particle. Furthermore, both Suetsuna and Lundberg teach magnetic particles comprising a nonmagnetic coating.
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 in view of Suetsuna 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. 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 Suetsuna and 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).
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 13-19 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 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, 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 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, 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 (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 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 17-19, although claim 19 is indefinite (see 112b rejection above) in the interest of compact prosecution, claim 19 is interpreted as reciting “according to claim 1”. 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 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.
Claims 23 and 25-26 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).
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. 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.
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 10/20/2025 have been fully considered but they are not persuasive.
Applicant argues “[r]econsideration of this application, as amended, is respectfully requested, after consideration of the previously filed amendment” (page 7 paragraph 2). However, the amendments, i.e. cancelling claim 12 and amending claims 16 and 18 to depend from claims 1 and 3, respectively, fail to address the rejections set forth above (see above).
Applicant argued in the response after Final Rejection (9/19/2025) that “ [t]he Examiner states that paragraph [0117] of Lundberg teaches that "The functional groups may be enhanced to facilitate binding with target analytes". See page 4 of the Office Action. Applicant disagrees with this assertion. The "functional groups" described in paragraphs [0116] and [0117] of the connect the core particles with the magnetic particles bound to the surface of the core and do not seem to have any direct effect on binding of the analytes. …This argument also applies to the rejections of independent claims 3 and 23 (and any claims dependent thereon) as these rejections rely on an improper interpretation of the same claimed features and an improper application of Lundberg to the claims” (page 9 paragraph 4). However, new grounds of rejection are set forth, citing other embodiments of Lundberg, that more clearly teach “a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles” (see rejection above citing paragraph 126). Applicant further argued that “[t]here is no suggestion [in Lundberg] of the use of including "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" as recited in claim 5 (which has been incorporated into claim 1)” (page 10 paragraph 1). However, Suetsuna (CN 101299365 B)-Cite No. N. of PTO 892 1/21/2025 is relied upon for the teaching and motivation of using 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 (see rejection above). Applicant further argued that “[t]he properties required for the uses described in Shetsuda are different from the properties required the uses required in the present invention” (page 11 paragraph 1). However, this is not considered enough evidence to not have modified the teachings of Lundberg to incorporate the nonmagnetic layer of Suetsuna (CN 101299365 B). One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant further argued that "[t]he Examiner mentions improving oxidation resistance as a reason for making the suggested modification. However, improving oxidation resistance is not necessary for the particles described in Lundberg as evidenced by the fact that the Examples in Lundberg that have a functional group layer, such as a layer containing antibodies, attached to the surface thereof do not include such an additional non-magnetic layer between the antibodies and the Fe layer" (page 11 paragraph 2), "[n]either Lundberg nor Shetsuda suggest applying a silica coating to the magnetic layer and then applying antibodies on that silica coating. Even if these two references are considered in combination, such an arrangement is not suggested" (page 12 paragraph 1). However, the fact that the Examples in Lundberg that have a functional group layer, such as a layer containing antibodies, attached to the surface thereof do not include such an additional non-magnetic layer between the antibodies and the Fe layer is not evidence that modifying Lundberg to include said nonmagnetic layer would not be obvious to a person having ordinary skill in the art. Indeed, as stated above, Suetsuna (CN 101299365 B) is relied upon for the teaching and motivation of including said nonmagnetic layer, the motivation encompassing providing thermal stability and insulation thereby granting high saturation magnetization (see rejection above). Furthermore, the claims are not limited to a silica coating to the magnetic layer. Nevertheless, contrary to Applicant’s remark, Lundberg does teach a silica coating to the magnetic layer, see new citations of Lundberg above (see rejection above). Regarding the double patenting rejections, Applicant argued "that these rejections be held in abeyance until allowable subject matter is found" (page 12 last paragraph). However, no allowable subject matter is found.
Conclusion
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/Fernando Ivich/Examiner, Art Unit 1678
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677