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 .
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 1-21 and 30-31 in the reply filed on 06/24/2026 is acknowledged.
Claims 22-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/24/2026.
Status of the Claims
Claims 22-29 have been withdrawn in response to Applicant’s election. Claims 1-21 and 30-31 are pending and examined herein.
Priority
This application, filed 08/04/2023, claims benefit of PRO 63/395,632, filed 08/05/2022. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 08/05/2022.
Information Disclosure Statement
The Information Disclosure Statements filed 01/11/2024 and 06/24/2026 are acknowledged and have been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the identification oligonucleotide" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution, claim 6 will be interpreted to be dependent upon claim 5, which introduces “an identification oligonucleotide”; however, appropriate correction is required.
Claim 19 recites the limitation “detecting the two or more fluorescent dyes” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution, claim 19 will be interpreted to be dependent upon claim 15, which introduces “two or more fluorescent dyes”; however, 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 1-4, and 8-14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2016/0153973, “DEVICE AND METHOD OF RAPID LINKER MEDIATED LABEL-BASED IMMUNOASSAYS” (published 06/02/2016, referred to herein as Smith).
Regarding claims 1 and 8, Smith teaches a method of detecting a protein biomolecule in a sample (para. 0008, lines 13-16) comprising contacting the sample with a solid support comprising a first biomolecule-specific binding agent, i.e. a capture antibody, attached to the support and a second biomolecule-specific binding agent, i.e. a detection antibody, attached to the support with a cleavable linker (para. 0012, lines 5-10). Smith teaches the binding of the first and second binding agents to the analyte to form a complex, then cleaving the cleavable linker to detach the detection antibody from the support (Figure 2, para. 0012, lines 11-17) and detecting the cleaved complex via the detectable moiety on the solid support (para. 0042, lines 1-9).
Regarding claims 2 and 9, Smith teaches that the second biomolecule-specific binding agent comprises a detectable moiety, i.e. a detection agent (para. 0041, lines 1-6), which is HRP enzyme (para. 0029, lines 1-2).
Regarding claims 3 and 4, Smith teaches that the cleavable linker comprises a polynucleotide sequence (para. 0054, lines 1-4).
Regarding claims 10 and 11, Smith teaches that the cleaving agent is a sequence-specific nuclease (para. 0086, lines 6-11), which is a restriction enzyme.
Regarding claims 12, 13 and 14, Smith teaches that the first and second biomolecule-specific binding agents are antibodies (para. 0045, lines 1-4), which can each be monoclonal or polyclonal (para. 0039, lines 1-4).
Claims 1-9, 12-13, 18, 20-21, and 30-31 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2022/0315983 A1, “INTEGRATION OF A PROTEIN COLOCALIZATION DEVICE (PCD) ONTO A MICROFLUIDIC DEVICE” (filed 03/30/2022, priority to 03/31/2021, referred to herein as Bowen).
Regarding claims 1 and 30, Bowen teaches a method of detecting a biomolecule in a sample (para. 0005, lines 1-2) comprising contacting a solid support with a sample comprising a first biomolecule-specific binding agent, i.e. a capture molecule, attached to the solid support (para. 0005, lines 4-6), and a second biomolecule-specific binding agent, i.e. a detector molecule, attached to the solid support (para. 0005, lines 6-7) via a cleavable linker (para. 0005, lines 9-11), forming a complex comprising the capture and detector molecules bound to the target, i.e. forming a “stable state” complex (para. 0005, lines 11-15). Bowen teaches cleaving the linker forming a cleaved complex to detach the detector molecule from the solid support (para. 0005, lines 17-21), and detecting the analyte on the cleaved complex attached to the solid support (para. 0005, lines 21-23). Bowen teaches amplifying the detector barcode via hybridization (para. 0168, lines 11-16). Bowen teaches that the analyte target can be a protein, peptide, or lipid (para. 0007, lines 14-16).
Regarding claims 2, 8, and 9, Bowen teaches a detecting detectable moiety label, i.e. a signaling element, attached to the detector molecule (para. 0015, lines 51-53) with a primer (para. 0181, lines 1-10).
Regarding claims 3 and 4, Bowen teaches the cleavable linker comprises a polynucleotide sequence (para. 0019, lines 24-29).
Regarding claim 5, Bowen teaches that cleaving the cleavable linker generates an identification oligonucleotide, i.e. a detector barcode, which comprises a portion of the polynucleotide sequence (para. 0010, lines 22-26 and para. 0147, lines 1-6).
Regarding claims 6 and 7, Bowen teaches amplifying and detecting the products from the detector barcode (para. 0168, lines 11-16).
Regarding claims 12 and 13, Bowen teaches that the capture molecule (para. 0107, lines 7-8) and the detector molecule (para. 0109, lines 7-8) are each antibodies.
Regarding claim 18, Bowen teaches that the solid support is a polystyrene particle (para. 0141, lines 1-8).
Regarding claims 20 and 21, Bowen teaches that the first binding agent, i.e. the capture molecule, comprises a substrate polynucleotide barcode, i.e. a capture barcode (para. 0010, lines 12-15) and detecting the capture barcode (para. 0121, lines 1-10).
Regarding claim 31, Bowen teaches that the cleavable linker is covalent (para. 0010, lines 48-53).
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 15-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bowen in view of US 7,445,844 B2, “PRECISION FLUORESCENTLY DYED POLYMERIC MICROPARTICLES AND METHODS OF MAKING AND USING SAME” (patent dated 11/04/2008, referred to herein as Chandler).
Regarding claims 15-17 and 19, Bowen teaches the use of a polystyrene particle solid support (para. 0141, lines 1-8). Bowen teaches the multiplex detection of analytes in a sample (para. 0123, lines 1-9).
However, Bowen does not teach the use or detection of a particle comprising two or more fluorescent dyes of the claimed families (claim 16) or the specifically claimed dyes of claim 17.
Chandler teaches the use of microparticles comprising the two fluorescent squaraine dyes l ,3-bis[(l ,3-dihydro-l ,3,3-trimethyl-2H-indol-2-ylidene )methyl ]-2,4-dihydroxycyclobutenediylium, bis(inner salt) and 2-(3,5-dimethylpyrrol-2-yl)-4-(3,5-dimethyl-2Hpyrrol-2-ylidene )-3-hydroxy-2-cyclobuten-l-one (col. 8, lines 8-13). Chandler teaches that these multicolored dyes are useful for the analysis of multiple analytes during multiplex analysis using biospecific capture agents (col. 6, line 56 to col. 7, line 3). Chandler teaches that these particles can be used to pool multiple samples together for analysis (col. 14, lines 49-61).
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 Bowen by using the specific microparticles taught by Chandler. An artisan would have been motivated to use these specific beads with a reasonable expectation of success because, as taught by Chandler, these beads further facilitate the multiplex analysis of biological samples in immunoassays (col. 166, lines 15-27 and Abstract, lines 5-11), such as the multiplex assay using polystyrene microparticles taught by Bowen.
Conclusion
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 24, 2026
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