DETAILED ACTION
Claims 1-8, 10-15, and 17-21 are pending.
Status of Claims
Claims 1-8, 10-15, and 17-21 are pending. Claim 1 has been amended. Claim 21 has been newly added.
Claims 1-8, 10-15, and 17-21 are under examination.
Withdrawn Claim Objections and/or Rejections
The rejection of claims 1-8, 10-15, and 17-20 under 35 USC 112(a) for failing to comply with the written description requirement as set forth on pp. 3-5 of the previous office action (filed on 08/25/2025) has been withdrawn in view of the amendments (filed on 12/23/2025).
The rejection of claims 1-8, 10-15, and 17-20 under 102(a)(1) and 102(a)(2) as being anticipated by Kim et al., as set forth on pp. 5-12 of the previous office action (filed on 08/25/2025) has been withdrawn in view of the amendments (filed on 12/23/2025).
The double patenting rejection of claims 1-8, 10-15, and 17-20 over 17487534 in view of Kim et al., as set forth on pp. 14-17 of the previous office action (filed on 08/25/2025) has been withdrawn in view of the amendments (filed on 12/23/2025).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
1.Claims 1-4, 10, 17 and 21 are under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wook et al., KR20090116142A (effectively filed on 05/06/2008) (translation provided via Google Patent) (IDS filed on 05/17/2021).
Regarding claim 1, Wook teaches a composite particle in an immunoassay (see page 2 teaching the use of the particle in surface plasmon resonance, a known type of immunoassay),
in which magnetic particles having an average particle size of 500 nm or less (see page 3 “wherein the size of the magnetic core was 3 ~ 5nm size”) and
gold particles having an average particle size of 500 nm or less are bound via an organic substance (see page 3 “the size of the gold nanoparticles (12) coated on the surface is 5 ~ 30nm.”, see abstract teaching the organic substance being an amine functional group),
wherein a value obtained by dividing average particle size of the gold particles by the average size of the magnetic particles (average particle size of the gold particles/average particle size of the magnetic particles) is 0.2 or more (see page 3 teaching the magnetic core being between 3-5 nm and the gold nanoparticle size being between 5-30 nm. Gold/Magnet= 5/3= 1.66, teaching the 0.2 or more limitation).
Regarding claims 2-4, Wook teaches the average particle size of at least one of the magnetic particles or the gold particles is less than 300 nm, less than 150 nm, and less than 100 nm (see page 3 “wherein the size of the magnetic core was 3 ~ 5nm size, the size of the gold nanoparticles (12) coated on the surface is 5 ~ 30nm.”).
Regarding claims 10 and 17, Wook teaches mixing a specimen that contains a test substance with a modified composite particle that is the composite particle for an immunochromatography according to claims 1 and 2 (see pages 1-2 teaching combining the gold and magnetic nanoparticle with a sample/test substance (bacteria)),
which is modified with a first binding substance binding to the test substance, to obtain a complex of the test substance in the specimen and the modified composite particle (see page 5 “After reacting the magnetic core gold nanoparticles prepared in Preparation Example 1 with ethanol in which 1 mM Mercaptohexadecanoic acid (MHDA) was dissolved, the magnetic core gold nanoparticles having MHDA-fixed magnetic core gold nanoparticles were separated and purified using a permanent magnet. After reacting 0.4 MN- (3-Dimethylaminopropyl) -N'-ethylcarbodiimide hydrochloride (EDC) with a solution of 0.1 M N-Hydroxysulfosuccinimide (NHS) for 5 minutes, a solution of PBS (pH7.4) containing 10 μg / ml of antibody was dissolved. The reaction was immobilized on the surface of the magnetic core gold nanoparticles by reacting for 2 hours. Then, the reaction with 0.1M Etanolamine for 30 minutes to remove the non-specific reaction, purified using a permanent magnet, and then magnetic-gold nanoparticles in which the antibody is immobilized in PBS buffer containing E. coli O157: H7 After the reaction was added for 1 hour and separated and purified using a permanent magnet…. E. coli O157: H7 adsorbed magnetic-gold nanoparticles can be detected up to 100 cells / ml, indicating that the detection limit is much lower.”);
collecting, using magnetism, the complex in the specimen obtained after the mixing step (see page 5 under detection of E. coli 0157: H7 using SPR);
spreading the complex collected in the collection step on an insoluble carrier having a reaction site at which a second binding substance binding to the test substance is immobilized (see page 5 under detection of E. coli 0157: H7 using SPR. The insoluble carrier being the glass substrate taught on page 5); and
trapping the complex at the reaction site of the insoluble carrier see page 5 under detection of E. coli 0157: H7 using SPR).
Regarding claim 21, Wook teaches wherein the value is 0.3 or more (see page 3 teaching the magnetic core being between 3-5 nm and the gold nanoparticle size being between 5-30 nm. Gold/Magnet= 5/3= 1.66, teaching the 0.3 or more limitation).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
2.Claims 5-8, 11-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wook as applied to claims 1-4, 10, 17, and 21 above, and in view of Kim et al., (US20140272945 A1) (IDS filed on 05/12/2021).
The teachings of Wook as applied to claims 1-4, 10, 17, and 21 are discussed in the 35 USC 102 rejection above.
Additionally, Wook teaches manufacturing the composite particle (see abstract) where the magnetic particle has an average particle size of 500 nm or less and the gold particles has an average particle size of 500 nm of less (see page 3 “wherein the size of the magnetic core was 3 ~ 5nm size, the size of the gold nanoparticles (12) coated on the surface is 5 ~ 30nm.”). Wook teaches the magnetic particles being bound by an organic substance (see abstract teaching the organic substance being an amine functional group),
mixing the magnetic particle and gold particles (see page 3 “As an example, a method of manufacturing a magnetic core containing iron oxide (Fe 3 O 4) as a main component is described first. First, NaOH, FeCl 2 · 4H 2 O, Fe 3 Cl 6· 4H 2 O, and HCl are mixed and mechanical stirrer The stirring is carried out, at which time the stirring speed is 2000 rpm, and the temperature is maintained for 30minutes while maintaining the temperature of 80 ℃. After the stirring is completed, the supernatant is separated using a permanent magnet, neutralized with HCl, washed with distilled water and ethanol, and dispersed with ethanol to form a magnetic core as a nanoparticle of iron oxide (Fe 3 O 4). Production is possible.”) (instant claim 8, instant claim 15).
Wook does not teach the average number of gold particles bound to one of the magnetic particles being less than 10 and less than 8 nor the second organic substance being bound to at least one selected from the group consisting of a chemical bond, an avidin-biotin interaction, a streptavidin-biotin interaction, a hydrophobic interaction, an electrostatic interaction, and an affinity interaction, and silver-amplifying the trapped complex subsequent to the trapping step.
Kim teaches wherein an average number of the gold particles bound to one of the magnetic particles via the organic substance is less than 10.0 and less than 8.0 (see fig. 1, figure 1 shows four gold particles attached to one magnetic particle) (instant claims 5-6, 12-13, and 19-20). Kim teaches wherein a surface of the magnetic particle is modified with a first organic substance, a surface of the gold particle is modified with a second organic substance, and the first organic substance and the second organic substance are bound via at least one selected from the group consisting of an avidin-biotin interaction (see [0003] “For example, there are a method using chemical and physical adsorption, a method for binding protein to a gold nanoparticle using cystein which is an amino acid specifically bound to gold, a method for producing a monomolecular film on a gold nanoparticle and then covalently binding protein to the gold nanoparticle using a functional group of the monomolecular film, and a method for adsorbing avidin protein on a surface of the gold nanoparticle and binding protein to which biotin is bound (ZHANG zhiFeng et al., Sci china ser B-Chem. 50(1):127-134, 2007), and the like.”) (instant claims 7-8, instant claim 14-15). Kim teaches silver-amplifying the trapped complex subsequent to the trapping step (see [0089] “A mixture for amplifying silver nanoparticle was prepared by mixing A (silver salt) solution and B (hydroquinone initiator) solution at a ratio of 1:1, and the mixture was dropped onto the filtration membrane for capturing microorganism of Experimental Example 2-1, and reacted at room temperature for about 10 minutes. As a result, as shown in FIG. 6, as a concentration of S. aureus became increased, sensitivity in measuring microorganism for each concentration was capable of being increased due to a bathochromic effect of BSA protein-coated MNP(CMX)-AuNP-anti-S. aureus mAb conjugate on the filtration membrane, through the amplification of silver nanoparticle.”) (instant claim 11, instant claim 18).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine magnetic core gold nanoparticles taught in Wook with the methods of manufacturing a bio-material conjugate taught by Kim. Kim provides motivation by teaching that silver amplifying the trapped complex is beneficial because it increases sensitivity (see [0089] and [0093]). Kim further provides motivation by teaching that coating a first nanoparticle having magnetic characteristics with protein, manufacturing a conjugate by absorbing a second nanoparticle having metallic characteristics onto the first nanoparticle, and absorbing a bio-material may be easily immobilized without performing an inconvenient modification step (see [0007]). The artisan would have reasonable expectation of success based on the cumulative disclosure of these prior art references at the time the instant application was filed.
Response to Arguments
The arguments filed on 12/23/2025 have been considered by the examiner.
On pp. 8-10 applicant argues that Kim does not teach the newly amended limitation of “wherein a value obtained by dividing average particle size of the gold particles by average particle size of the magnetic particles (average particle size of the gold particles/ average particle size of the magnetic particles) is 0.2 or more. However, Wook already teaches wherein a value obtained by dividing average particle size of the gold particles by the average size of the magnetic particles (average particle size of the gold particles/average particle size of the magnetic particles) is 0.2 or more (see page 3 teaching the magnetic core being between 3-5 nm and the gold nanoparticle size being between 5-30 nm. Gold/Magnet= 5/3= 1.66, teaching the 0.2 or more limitation).
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.
3.Claims 1-8, 10-15, and 17-20 are provisionally rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1, 3, 5-7, and 11 of copending Application
No. 17487534 in view of Wook et al., KR20090116142A (effectively filed on 05/06/2008) (translation provided via Google Patent) (IDS filed on 05/17/2021). Although the claims are not identical, they are not patentably distinct from each other for the reasons set forth below.
Regarding instant claim 1, ‘534 teaches a composite particle for an immunochromatography, in which magnetic particles having an average particle size of 500 nm
or less (see claim 6 of ‘534) and gold particles having an average particle size of 500 nm or
less are bound via an organic substance (see claims 5-6 of ‘534). ‘534 does not teach wherein a value obtained by dividing average particle size of the gold particles by the average size of the magnetic particles (average particle size of the gold particles/average particle size of the magnetic particles) is 0.2 or more.
Wook teaches wherein a value obtained by dividing average particle size of the gold particles by the average size of the magnetic particles (average particle size of the gold particles/average particle size of the magnetic particles) is 0.2 or more (see page 3 teaching the magnetic core being between 3-5 nm and the gold nanoparticle size being between 5-30 nm. Gold/Magnet= 5/3= 1.66, teaching the 0.2 or more limitation).
It would have been prima facia obvious to one of ordinary skill at the time of the instant application to modify the methods of ‘534 with the magnetic core gold nanoparticles taught by Wook. Wook provides motivation by teaching that the particle size can increase the reaction activity with the target and at the same time it can isolate and concentrate the target by the nature of magnetic particles (see page 2). The artisan would have reasonable expectation of success based on the cumulative disclosure of these prior art references at the time the instant application was filed.
Regarding instant claim 2, ‘534 teaches wherein an average particle size of at least one of the magnetic particles or the gold particles is less than 300 nm (see claim 6 of ‘534).
Regarding instant claim 3, ‘534 teaches wherein an average particle size of the at
least one of the magnetic particles or the gold particles is 150 nm or less (see claim 6 of ‘534).
Regarding instant claim 4, ‘534 teaches wherein an average particle size of the at
least one of the magnetic particles or the gold particles is less than 100 nm (see claim 6 of
‘534).
Regarding instant claims 5, 12, and 19 ‘534 teaches wherein an average number of
the gold particles bound to one of the magnetic particles via the organic substance is less than
10.0 (see claim 1 of ‘534).
Regarding instant claims 6, 13, and 20, ‘534 teaches wherein an average number of
the gold particles bound to one of the magnetic particles via the organic substance is 8.0 or less
(see claim 1 of ‘534).
Regarding instant claim 8, ‘534 teaches a method for manufacturing a composite
particle for an immunochromatography which is for manufacturing the composite particle for an
immunochromatography according to claim 1, the method comprising: a preparation step of
preparing modified magnetic particles that are magnetic particles modified with a first organic
substance and having an average particle size of 500 nm or less (see claims 1 and 6 of ‘534), and modified gold particles that are gold particles modified with a second organic substance and
having an average particle size of 500 nm or less (see claims 1 and 5-6 of ‘534); and a mixing
step of mixing the modified magnetic particles and the modified gold particles for binding of the
first organic substance of the modified magnetic particles and the second organic substance of
the modified gold particles via at least one selected from the group consisting of a chemical
bond, an avidin-biotin interaction, a hydrophobic interaction, an electrostatic interaction, and an
affinity interaction to obtain the composite particle for an immunochromatography (see claims 1
and 11 of ‘534).
Regarding instant claim 10, ‘534 teaches an immunochromatography method,
comprising: mixing a specimen that contains a test substance with a modified composite particle
that is the composite particle for an immunochromatography according to claim 1, which is
modified with a first binding substance binding to the test substance, to obtain a complex of the
test substance in the specimen and the modified composite particle (see claim 1 of ‘534);
collecting, using magnetism, the complex in the specimen obtained after the mixing step (see
claims 1 and 3 of ‘534); spreading the complex collected in the collection step on an insoluble
carrier having a reaction site at which a second binding substance binding to the test substance
is immobilized (see claim 1 of ‘534); and trapping the complex at the reaction site of the
insoluble carrier (see claim 1 of ‘534).
Regarding instant claim 11, ‘534 teaches further comprising: silver-amplifying the
trapped complex subsequent to the trapping step (see claims 1 and 7 of ‘534).
Regarding instant claims 7 and 14, ‘534 teaches wherein a surface of the magnetic
particle is modified with a first organic substance, a surface of the gold particle is modified with a
second organic substance, and the first organic substance and the second organic substance
are bound via at least one selected from the group consisting of a chemical bond, an avidin-
biotin interaction, a streptavidin-biotin interaction, a hydrophobic interaction, an electrostatic
interaction, and an affinity interaction (see claims 1 and 11 of ‘534).
Regarding instant claim 15, ‘534 teaches a method for manufacturing a composite
particle for an immunochromatography which is for manufacturing the composite particle for an
immunochromatography according to claim 2, the method comprising: a preparation step of
preparing modified magnetic particles that are magnetic particles modified with a first organic
substance and having an average particle size of 500 nm or less (see claims 1 and 6 of ‘534),
and modified gold particles that are gold particles modified with a second organic substance and
having an average particle size of 500 nm or less (see claims 1 and 5-6 of ‘534); and a mixing
step of mixing the modified magnetic particles and the modified gold particles for binding of the
first organic substance of the modified magnetic particles and the second organic substance of
the modified gold particles via at least one selected from the group consisting of a chemical
bond, an avidin-biotin interaction, a hydrophobic interaction, an electrostatic interaction, and an
affinity interaction to obtain the composite particle for an immunochromatography (see claims 1
and 11 of ‘534).
Regarding instant claim 17, ‘534 teaches an immunochromatography method,
comprising: mixing a specimen that contains a test substance with a modified composite particle
that is the composite particle for an immunochromatography according to claim 2, which is
modified with a first binding substance binding to the test substance, to obtain a complex of the
test substance in the specimen and the modified composite particle (see claim 1 of ‘534);
collecting, using magnetism, the complex in the specimen obtained after the mixing step (see
claims 1 and 11 of ‘534); spreading the complex collected in the collection step on an insoluble
carrier having a reaction site at which a second binding substance binding to the test substance
is immobilized (see claim 1 of ‘534); and trapping the complex at the reaction site of the
insoluble carrier (see claim 1 of ‘534).
Regarding instant claim 18, ‘534 teaches further comprising: silver-amplifying the trapped complex subsequent to the trapping step (see claims 1 and 7 of ‘534).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
On p. 10 of the arguments filed on 12/23/2025 applicant requests the rejection be held in abeyance until there is allowable subject matter in the application. This has been fully considered but is not found to be persuasive.
Applicant’s attention is respectfully directed to M.P.E.P. § 804(I)(B)(1), which states:
“A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.”
“As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995. (emphasis added)”.
Accordingly, the rejection is maintained and is expressly not held in abeyance.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678