DETAILED ACTION
Claims 1-2, 6, 10, 21-28 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/07/2025 has been entered.
Status of Claim
Claims 1-2, 6, 10, 21-28 are pending. Claim 1 has been amended. Claims 21-28 have been newly added.
Claims 1-2, 6, 10, and 21-28 are under examination.
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 1-2, 6, 10, and 21-28 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by (EP3115783A1) (IDS filed on 03/09/2022).
Regarding claim 1, Gouda teaches a linked body for fluorescent labeling agents (See
figure 1, the bonding group is component B and the probe is component 5. [0006] “The present
invention was made with a focus on this problem, and objects of the present invention are: to
provide a phosphor-integrated nanoparticle labeling agent which is capable of yielding a
sufficient signal intensity even when the final concentration of its phosphor-integrated
nanoparticle is low (e.g., 0.02 nM)”, [0052] “The phosphor-integrated nanoparticle 5 is a particle
in which phosphors are integrated. By using such a phosphor-integrated nanoparticle, the
amount of fluorescence emitted per molecule, that is, the brightness of a bright spot labeling a
prescribed biomolecule can be improved as compared to a single phosphor molecule.”)
comprising a probe molecule to a bonding group directly bonding to the probe molecule ([0046] “The phosphor-integrated nanoparticle 5 and the second binding group substance B may be bound by a direct bond or, as shown in Fig. 1, an indirect bond via other molecule.”, [0047] “Examples of a mode of directly binding the second binding group substance B to the phosphor-integrated nanoparticle 5 include, but not particularly limited to, covalent bonding, ionic bonding, hydrogen bonding, coordinate bonding, physical adsorption and chemical adsorption, which can be performed by a known method. From the standpoint of the binding stability, a bond with high bonding strength, such as a covalent bond, is preferred.”),
the probe molecule is configured to specifically bonded to the target substance by an antigen-antibody reaction, directly or indirectly via only one aptamer or one antibody (see figure 1, [0012], [0013], and [0019] teaching that the probe molecule (labeled 3) is configured to specifically bonded to the target substance (labeled 2) by an antigen-antibody (3: probe antigen or antibody, 2: antigen or antibody), directly or indirectly via only one antibody), and
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wherein a labeling ratio of the bonding group to the probe molecule is ≥3:1 (fig. 1 shows 4 bonding groups).
Regarding claim 2, Gouda teaches the linked body for fluorescent labeling agents
according to claim 1, wherein the labeling ratio of the bonding group to the probe molecule is
≤20:1 (fig. 1 component B is the bonding group, where there are 4 bonding groups. Component
5 of figure 1 is the probe).
Regarding claim 6, Gouda teaches the linked body for fluorescent labeling agents
according to claim 1, wherein the bonding group is at least one selected from the group
consisting of biotin, avidin, streptavidin, neutravidin, a hapten, and an anti-hapten antibody (fig.
2, [0034] “Referring to the specific example of a PEG linker shown in Fig. 2 (A), biotin is bound
to one end of the PEG linker (the right end of the molecule shown in Fig. 2(A)) and a maleimide
group is bound to the other end of the PEG linker (the left end of the molecule shown in Fig. 2
(A)). When the probe biological substance 3 such as an antibody is allowed to react with and
bound to the maleimide group at the end of this PEG linker, the length of the first hydrophilic
polymer-derived spacer (length of the spacer 1) is, as shown in Fig. 2(B), the length of the part
from the nitrogen atom of an amide bond and the oxygen atom of the next amide bond, which
corresponds to the part indicated by the bidirectional arrow.”).
Regarding claim 10, Gouda teaches the linked body for fluorescent labeling agents
according to claim 2, wherein the bonding group is at least one selected from the group
consisting of biotin, avidin, streptavidin, neutravidin, a hapten, and an anti-hapten antibody (fig.
2, [0034] “Referring to the specific example of a PEG linker shown in Fig. 2 (A), biotin is bound
to one end of the PEG linker (the right end of the molecule shown in Fig. 2(A)) and a maleimide
group is bound to the other end of the PEG linker (the left end of the molecule shown in Fig. 2
(A)). When the probe biological substance 3 such as an antibody is allowed to react with and
bound to the maleimide group at the end of this PEG linker, the length of the first hydrophilic
polymer-derived spacer (length of the spacer 1) is, as shown in Fig. 2(B), the length of the part
from the nitrogen atom of an amide bond and the oxygen atom of the next amide bond, which
corresponds to the part indicated by the bidirectional arrow.”).
Regarding claim 21, Gouda teaches a linked body for fluorescent labeling agents comprising a probe molecule and a bonding group directly bonding to the probe molecule (see [0006], see [0046], see [0052]), wherein the probe molecule consists of one selected from a group consisting of a nucleic acid aptamer, a peptide aptamer and an antibody (see [0019]), and a labeling ratio of the bonding group to the probe molecule is > 3:1 (fig. 1 shows 4 bonding groups).
Regarding claim 23, Gouda teaches wherein the bonding group is at least one selected from the group consisting of biotin, avidin, streptavidin, neutravidin, a hapten, and an anti-hapten antibody (see [0041], see [0042]).
Regarding claims 22, 24, 26, and 28, Gouda teaches the linked body for fluorescent labeling agents according to claim 1, wherein the labeling ratio of the bonding group to the probe molecule is ≤20:1 (fig. 1 component B is the bonding group, where there are 4 bonding groups. Component 5 of figure 1 is the probe).
Regarding claim 25, Gouda teaches a linked body for fluorescent labeling agents for labeling a target substance, comprising a probe molecule and a bonding group directly bonding to the probe molecule (see [0046], see [0047]), wherein the probe molecule consists of one selected from a group consisting of a nucleic acid aptamer, a peptide aptamer and an antibody, which is configured to be specifically bonded to the target substance by an antigen-antibody reaction, directly or indirectly via only one aptamer or one antibody, and a labeling ratio of the bonding group to the probe molecule is > 3:1 (see figure 1, [0012], [0013], and [0019] teaching that the probe molecule (labeled 3) is configured to specifically bonded to the target substance (labeled 2) by an antigen-antibody (3: probe antigen or antibody, 2: antigen or antibody), directly or indirectly via only one antibody).
Regarding claim 27, Gouda teaches wherein the bonding group is at least one selected from the group consisting of biotin, avidin, streptavidin, neutravidin, a hapten, and an anti-hapten antibody (see [0041], see [0042]).
Response to Arguments
The arguments filed on 11/07/2025 have been considered by the examiner.
On p. 6 applicant argues that Gouda fails to disclose the probe molecule being configured to specifically bond to the target substance by an antigen-antibody reaction, directly or indirectly via only one aptamer or one antibody. However, Gouda teaches antigen-antibody reactions (see [0079] – [0080]). Gouda teaches that the antigen-antibody reaction between the biomolecule (2) and the probe (3) is unlikely to be adversely affected (see [0097]), thus teaching that Gouda binds the probe and the target substance by an antigen-antibody reaction. Further, Gouda teaches that the probe is an antibody (see [0011], [0019], [0033]).
On pp. 7-8 applicant argues that the probe of Gouda does not consist of one selected from the group consisting of a nucleic acid aptamer, a peptide aptamer, and an antibody, but rather Gouda discloses that the phosphor-integrated nanoparticle (5) is a particle in which phosphors are integrated. However, Gouda’s integrated phosphor nanoparticle marking agent consists of a probe (an antigen or antibody ([0019]), a target biomolecule ([0013]), and a phosphor-integrated nanoparticle (5) (see [0012]). Thus, Gouda does teach the probe being an antibody (see [0019]).
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Conclusion
No claim is allowed.
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
/Ann Montgomery/Primary Examiner, Art Unit 1678