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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/10/2025 has been entered.
Status of Claims
Claims 11, 13, 15-16, 41-42, and 45-46 are pending and under examination.
Withdrawn Rejections
In light of the amendments, the 35 U.S.C. 102(a) rejection over Dattagupta is hereby withdrawn.
In light of the amendments, the 35 U.S.C. 103 rejection over Dattagupta and Johannes et al. is hereby withdrawn.
In light of the abandonment to 17624418, the non-statutory double patenting rejection is hereby withdrawn.
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.
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 11, 13, 15-16 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Jungmann et al. (WO2015017586A1, published 02/5/2015) in view of Archer et al. (US20030073149A1, published 04/17/2003, IDS submitted on 06/08/2022, cite no. 1).
With respect to claims 11 and 13, Jungmann teaches compositions for imaging at high spatial resolution of targets (see abstract). Fig. 2 of Jungmann shows a composition for detecting a plurality of targets in a sample, the composition comprising: at least a first target recognizing antibody and a second target recognizing antibody, wherein the first antibody is conjugated to a first single stranded nucleic acid docking strand. Fig. 2 also shows a second antibody conjugated to a second single stranded nucleic acid docking strand and which have complementarity to an imager strand or an intermediate moiety wherein the intermediate moiety has a first domain that hybridizes to the docking strand and a second domain that hybridizes to an imager strand. Jungmann further teaches a method that can detect a plurality of targets (e.g., with each docking strand-imager strand pair corresponding to one target) and select at least 200 orthogonal different sequences to be used in these multiplexing methods (see pg. 3, lines 13-25). Jungmann teaches at least one protein-nucleic acid conjugate is bound to a target and at least one complementary labeled, optionally fluorescently, imager strand that is transiently bound to (or is capable of transiently binding to) the at least one protein-nucleic acid conjugate (see pg. 4, lines 20-27). Table 6 shows a plurality of imager strands for assaying. Jungmann further teaches contacting target species with different docking strands domain sequence and different lengths of those sequences (see pg. 37, lines 22-25 and Table 1). Jungmann teaches quenching in the assay (see pg. 2, lines 1-3).
Fig. 2 shows a method of making reagents for exchange imaging of a plurality of targets in a sample, the method comprising: providing a plurality of one or more docking strands, wherein the docking strands have complementarity to an imager strand or an intermediate moiety; providing at least a first target recognizing antibody and a second target recognizing antibody; combining the at least first and second target recognizing antibody with the MTAB-DM to form an Ab-MTAB-DM, wherein the MTAB-DM binds to an Fc region of the at least first and second antibody and wherein the first and second antibody are distinguished by at least the docking strand; combining a plurality of intermediate moieties with the Ab-MTAB-DM, wherein the intermediate moieties comprise a first domain that hybridizes to the docking strand and a second domain that hybridizes to an imager strand. Because Jungmann’s imager strand is a nucleic acid strand that hybridize to the docking strand and have all the structures of the first and second domains of the intermediate moiety, it would read on combining the intermediate moieties with Ab-MTAB-DM, as it would bind to the docking moiety of MTAB-DM. Note that the imager strand is not present in claims 11 and 13 (see claims 41 and 42).
Jungmann does not teach a monovalent antibody fragment that conjugates to the single stranded nucleic acid docking strands.
Archer teaches novel immunolabeling complexes and certain components of such complexes and teaches novel labeling proteins monovalent antibody fragments and the fragments are labeled Fab fragments of an anti-Fc antibody (see abstract and Fig. 1). Archer teaches that in Fig. 2 it represents biotinylated goat Fab anti-mouse Fc (see para. [0014]). Archer teaches that a particular advantage of the current labeling of target binding antibodies is that it provides for a novel method to directly label the antibodies in any solution containing primary amines or non-antibody proteins (see paras. [0060] and [0090]). Archer teaches the compositions include isolated immunolabeling complexes and isolated monovalent labeling proteins and the labels that are attached to the labeling proteins are directly detectable moieties which directly detectable moieties are optionally the same or different (see para. [0078]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assay compositions as taught by Jungmann with a monovalent antibody fragment as taught by Archer because Archer teaches that the advantage of labeling with monovalent antibody fragments is that it provides a direct labeling to the primary antibody. Therefore, it would have been obvious to the person to have simply used monovalent antibody fragment labeling because the primary antibodies do not need to be modified with linkers such as biotin for streptavidin binding, as the monovalent antibody fragment of Archer binds to the Fc region of the primary antibody.
The person would have a reasonable expectation of success in using monovalent antibody fragments to attach to the primary antibody of Jungmann because it has been well recognized to perform the assay with IgG antibody which contains an Fc region and Archer recognizes labeling with said fragments to the Fc region of the antibody for assay detection.
With respect to claims 15-16, Jungmann teaches hybridization of single stranded nucleic acid in Fig. 2. Jungmann does teach allowing automatic batch identification (see pg. 56, 7-9). Jungmann does not explicitly teach separately. However, it would have been obvious to have mixed the MTAB-DM with the intermediate moieties in the batch reaction or separately prior to the reaction because the intermediate moiety has domains that are designed to exclusively hybridize to a particular region of the docking strand and imager strand.
With respect to claim 41, Fig. 2 shows that the imager strand hybridized to the docking strand.
Claims 11, 13, 15-16, 41-42, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Jungmann et al. (WO2015017586A1, published 02/5/2015) in view of Archer et al. (US2003/0073149A1, published 04/17/2003, IDS submitted on 06/08/2022, cite no. 1) and Diehl et al. (WO2014/028538A2, published 02/20/2014, IDS submitted on 06/08/2022, cite no. 1).
Jungmann and Archer have been discussed above. The references do not teach an intermediate moiety wherein the intermediate moiety and imager strand are present in the reaction (claims 11, 13, 42, 45-46).
Diehl teaches methods for detecting a target in a sample with methods for detecting the location of at least two targets in a sample (abstract). Diehl teaches each target is detected, quantified, or bound to a primary antibody and a DNA-conjugated secondary antibody conjugated or covalently bound to a ssDNA tag (pg. 23, line 31- pg. 24, lines 1-5). Diehl teaches antibodies include variants such as single chain Fv proteins (see pg. 15, lines 12-15) (i.e., monovalent antibody fragment). Diehl teaches the dye can be conjugated to the nucleic acid strand (i.e., ssDNA) by a functional group that allows for incorporation into the nucleic acid strand (see pg. 25, lines 15-20 and pg. 26, lines 1-10). Figures 1(A-B) shows each intermediate moiety has a first domain that hybridizes to the docking strand and a second domain that hybridizes to an imager strand and the intermediate extends between the docking strand and the imager strand. Diehl teaches probe comprising one or more different fluorescent dyes (see pg. 7, lines 12-30).
However, it would have been obvious to the person before the effective filing date of the claimed invention to have attached the monovalent antibody fragment comprising a nucleic acid docking strand as modified by Jungmann and Archer with an intermediate moiety that comprises a first domain for docking strand and a second domain for imager strand as taught by Diehl because Diehl recognizes that additional nucleic acid strands can be employed to increase the number of different dyes used for detection in a reaction or to extend the distance between dye and the other elements of the surface. Because Jungmann recognizes the quenching (fluorescent OFF), it would have been obvious to the person to have added an intermediate nucleic acid as taught by Diehl that recognizes the docking strand and imager strand of Jungmann to produce fluorescent detection without quenching.
The person would have reasonably expected success in adding the intermediate moiety comprising the first domain and second domain in Jungmann’s composition because it has been well recognized in the art that single stranded nucleic acids are extendable through hybridization, as taught by Diehl and Jungmann.
With respect to claims 15-16, Jungmann teaches hybridization of single stranded nucleic acid in Fig. 2. Jungmann does teach allows automatic batch identification (see pg. 56, 7-9). As stated above, Jungmann does not teach intermediate moieties. Diehl teaches in Figures 1(A-B) that each intermediate moiety has a first domain that hybridizes to the docking strand and a second domain that hybridizes to an imager strand. Therefore, it would have been obvious to have mixed the MTAB-DM with the intermediate moieties in the batch reaction or separately because the intermediate moiety has domains that exclusively hybridize to a particular region of the docking strand and imager strand.
With respect to claim 41, Fig. 2 of Jungmann teaches further comprising imager strand hybridized to the docking strand.
Response to Arguments
Applicant’s arguments filed 09/10/2025 have been considered but are moot because Applicant’s amendments necessitated a new ground of rejection. None of the references were used in the previous office actions.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678