DETAILED ACTION
Claims 1-2, 6, 10, and 21-28 are pending.
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.
Claims 1-2, 6, 10, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Gouda (EP3115783A1) (IDS filed on 03/09/2022), in view of Okada et al., (EP2755026B1).
Instant claim 1 recites “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, wherein the probe molecule 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”.
Instant claim 21 recites “A linked body for fluorescent labeling agents comprising a probe molecule and a bonding group directly bonding to the probe molecule, wherein the probe molecule consists of one selected from a group consisting of a nucleic acid aptamer, a peptide aptamer and an antibody, anda labeling ratio of the bonding group to the probe molecule is > 3:1”.
Instant claim 25 recites “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, 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”.
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.”),
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
wherein a labeling ratio of the bonding group to the probe molecule is ≥3:1 (fig. 1 shows 4 bonding groups) (instant claims 1, 21, and 25).
Gouda teaches 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]) (instant claims 21 and 25).
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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 (see fig. 1 component B is the bonding group, where there are 4 bonding groups. Component 5 of figure 1 is the probe) (instant claims 2, 22, and 26). 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] “the first binding group substance A is, for example, avidin, biotin, streptavidin, NeutrAvidin, a hapten or an anti-hapten antibody”) (instant claims 6, 10, 23-24, and 27-28).
Gouda does not explicitly teach the probe molecule directly binding to a bonding group.
Odaka teaches the probe molecule directly binding to a bonding group (see [0055] teaching the probe and binding group includes a biotinylated probe, where the binding group of biotin is directly bonded to the probe) (instant claims 1, 21, and 25).
It would have been obvious to one of ordinary skill in the art at the time of the instant applications filing to combine the labeling agent taught by Gouda with the probe molecule taught by Odaka. Odaka provides motivation for the bonding group being directly bound to the probe by teaching that the biotin labeled probe allows for one to prepare the probe in advance, thus saving time (see [0057]). Odaka teaches that bonding the probe with the bonding group is a technique used in the art at the time of the instant application (see [0053] – [0055]). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive.
On pp. 2-4 applicant argues that Gouda does not teach the bonding group and probe being directly bonded. Gouda teaches that the linker is biotinylated (see [0149]), but does not explicitly state that the bonding group and probe are directly bound.
Odaka teaches that the probe is directly bonded to the first binding group (see [0055]). Odaka teaches that the first binding group (which can be biotin, avidin, or streptavidin) can be directly bonded to the probe, such that the probe is biotinylated (see [0055]).
Thus, Odaka teaches the probe and bonding group being bonded directly.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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