Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-9 are pending and examined herein.
Priority
This application, filed 05/29/2024, is a CON of PCT/JP2022/040458, filed 10/28/2022, which claims benefit of JAPAN 2021-196185, filed 12/02/2021. This claim to priority is acknowledged and the claims examined herein are treated as having an effective filing date of 12/02/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 05/29/2024, 05/29/2024, 10/25/2024, and 07/01/2024 are acknowledged and have been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites “the region is defined of an inner surface” instead of “the region is defined as an inner surface”. Appropriate correction is required.
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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2006/0014172 A1, “APTAMER-NANOPARTICLE CONJUGATES AND METHOD OF USE FOR TARGET ANALYTE DETECTION” (published 01/19/2006, referred to herein as Muller).
Regarding claims 1-3, Muller teaches an analysis method for a target substance, comprising mixing a conjugate to bind to the target, i.e. a detector probe, with the sample to produce a mixture, then bringing the mixture into contact with a second binding substance to bind to the target, i.e. the capture aptamer, attached to a base, i.e. a substrate (para. 0008, lines 1-6). Muller teaches removing the unbound target and conjugates by washing (para. 0144, lines 15-16). Muller teaches detecting a phenomenon caused by the label on the detector probe (para. 0014, lines 1-4). Muller teaches that the first binding substance, i.e. detector probe, comprises a nucleic acid aptamer (para. 0008, lines 1-3). Muller teaches the base, i.e. the substrate, is provided in each of a plurality of regions, i.e. spots, and a plurality of capture probes for different targets are attached in an array of spots (para. 0016, lines 1-7). Muller teaches that the regions are defined as the inner surface of a well (para. 0155, lines 11-12), which is a partition wall. Muller teaches that the base is a bead, which is granular (para. 0016, lines 1-2).
Regarding claim 4, Muller teaches that the target is a protein or nucleic acid (para. 0084, lines 1-7).
Regarding claim 5, Muller teaches that the label is fluorescent, luminescent, or a nanoparticle (para. 0082, lines 5-9).
Regarding claim 6, Muller teaches detecting a phenomenon that is fluorescent, luminescent, or, phosphorescent, among others (para. 0018, lines 1-11).
Regarding claim 7, Muller teaches that the first binding substance and the labeled substance include a chemical substituent, wherein the first binding substance is fused to the labeled substance by streptavidin-biotin interaction (para. 0098, lines 23-25).
Regarding claim 8, Muller teaches that the second binding substance and the base include a chemical substituent, wherein the second binding substance is fixed to the base by streptavidin-biotin interaction (para. 0079, lines 1-11).
Regarding claim 9, Muller teaches that the phenomenon is detected using a light-receiving device, i.e. a photosensor (para. 0052, lines 1-8).
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 1-6 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of copending Application No. 18/677,250 (referred to herein as ‘250) in view of Kingsmore et al., “Multiplexed protein profiling on antibody-based microarrays by rolling circle amplification” Current Opinion (published 2003, referred to herein as Kingsmore).
Regarding claims 1 and 2 of the instant application, ‘250 discloses an analysis method for a target substance comprising mixing a conjugate including a nucleic acid, i.e. a binding substance comprising a nucleic acid label region, with a sample including the target, removing the unbound conjugate, and detecting a phenomenon caused by the nucleic acid label using a rolling circle amplification method (‘250 claim 1).
However, ‘250 does not disclose bringing the mixture into contact with a second binding substance fixed to a base wherein the base is a plurality of regions, the target substance to which the second binding substance binds is different among the regions in the inner surface of a container wherein the base is the inner surface of the container and the regions are separated by a partition wall.
Regarding instant claims 1, 3, and 5, Kingsmore teaches an analysis method for a target substance comprising an array with a second binding substance fixed to a base, i.e. a capture antibody (p. 74, col. 1, para. 2, lines 1-4, Figure 1 legend, lines 1-4). Kingsmore teaches capturing the target onto the base wherein the is a plurality of regions, the target substance to which the second binding substance binds is different among the regions in the inner surface of a container wherein the base is the inner surface of the container and the regions are separated by a partition wall, i.e. the Teflon mask (Figure 1 legend, lines 1-4). Kingsmore teaches using a fluorescent labelling to detect the target (p. 75, col. 2, para. 2, lines 4-8).
It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to modify the method taught by ‘250 by using it with an array, as taught by Kingsmore. An artisan would have been motivated to make this modification with a reasonable expectation of success because, as taught by Kingsmore, rolling circle amplification-based detection assays are “attractive for multiplexed microarray immunoassays because RCA productions remain localized at the microarray spot, and sensitivity improvements are typically ~1000-fold (p. 74, col. 2, para. 2, lines 4-9).
Regarding instant claim 4, ‘250 discloses the target is a protein, sugar, nucleic acid, lipid, or low molecular weight compound (‘250 claim 6).
Regarding instant claims 6 and 9, ‘250 discloses the phenomenon is production of hydrogen ions (‘250 claim 2) measured with a pH meter (’250 claim 3).
Claims 7 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of copending Application No. 18/677,250 (referred to herein as ‘250) in view of Kingsmore, as applied to claim 1 above, and further in view of Muller.
Regarding claims 7 and 8, ‘250 in view of Kingsmore teaches the use of a first binder attached to an oligonucleotide label and a second binder attached to a surface.
However, ‘250 in view of Kingsmore does not teach the use of chemical substituent to attach the label to the first binder or to attach the second binder to a surface.
Muller teaches that a chemical substituent, such as biotin, may be used to attach labels to detection binders (para. 0098, lines 23-25) and to attach capture molecules to surfaces (para. 0079, lines 1-11) for the purposes of making an oligonucleotide array.
It would have been obvious to one of skill in the art before the effective filing date to make the array taught by ‘250 in view of Kingsmore with the use of chemical substituents, such as biotin, for attaching the label to the first binder and attaching the capture binder to the surface, as taught by Muller. This is considered to be Combining Prior Art Elements According to Known Methods to Yield Predictable Results (See MPEP 2043(I)(A)). An artisan would recognize that the use of chemical substituents to attach these components is a known method which performs the known function of predictably attaching molecular components together for use in biochemical assays.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Seo et al., “Aptamer-based sandwich-type biosensors” (published 03/13/2017) is a review that describes the state of the art of aptamer-based sandwich biosensors prior to the effective filing date of the claimed invention.
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 10, 2026
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