DETAILED ACTION
Status of the Claims
1. Claims 1-20 are pending.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-6 and 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Anal. Chem. 2021, 93, 5327-5333).
Claims 1 and 3. Wang et al. teach a production method for an electrochemiluminescence nanoprobe (electrochemiluminescent polymer dots; see abstract), the method comprising:
synthesizing a Pdots nanoparticle by polymerizing a conjugated polymer and a copolymer molecule (polymerizing N-polymer and PSMA to make N-Pdots; see Scheme 1); and
modifying a resulting Pdots nanoparticle using an oligonucleotide chain modified with a quencher molecule (modifying Pdot with BHQ2(quencher)-DNA205; see Scheme 1).
Claim 4. Wang et al. teach the conjugated polymer and the copolymer molecule are synthesized into the Pdots particle by a nanocoprecipitation method (see Page 5328, Experimental section).
Claim 5. Wang et al. teach the quencher molecule is a Black Hole Quencher (BHQ2; see Scheme 1).
Claim 6. Wang et al. teach the oligonucleotide chain is single-stranded DNA (single strand DNA used as probe 205; see scheme 1).
Claim 9. Wang et al. teach an electrochemiluminescence nanoprobe being a Pdots nanoparticle into which a conjugated polymer and a copolymer molecule are polymerized (polymerizing N-polymer and PSMA to make N-Pdots as electrochemiluminescence nanopore; see Scheme 1), the Pdots nanoparticle being modified with an oligonucleotide chain modified with a quencher molecule (modifying Pdot with BHQ2-DNA205; see Scheme 1).
Claims 10 and 11. Wang et al. teach an electrochemiluminescence sensor being a working electrode (ECL array comprising Au-coated ITO electrode; see page 5329, Preparation of an ECL Imaging array) on which an electrochemiluminescence nanoprobe that is a Pdots nanoparticle into which a conjugated polymer and a copolymer molecule are polymerized has been dropped (polymerized N-polymer and PSMA is dropped onto the array; see page 5329, Preparation of an ECL Imaging array), the Pdots nanoparticle being modified with an oligonucleotide chain modified with a quencher molecule (modifying Pdot with BHQ2-DNA205; see Scheme 1).
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.
Claim(s) 2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. as applied to claim 1 above, and further in view of Luo et al. (ACS Appl. Mater. Interfaces 2019, 11, 27363-27370).
Claim 2. Wang et al. teach the conjugated polymer is N-polymer i.e. (thiadiazole based polymer, PF-DBT5) but do not teach conjugated polymer is one of PDHF, PFO, PPE, MEH-PPV, PFPV, PFBT, CN-PPV, PF-DBT5, and PBOC. However, Luo et al. teach electrochemiluminescence assay comprised of Pdots made up of PFBT (conjugated polymer) and PSMA to detect miRNA using DNA probes (see page 27364, col. 1 and 2).
Since, Wang et al. and Luo et al. are to same field of endeavor i.e. electroluminescence Pdots, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Luo et al. teaching to substitute PF-DBT5 copolymer of Wang et al. with PFBT copolymer because simple substitution of one known element for another is likely to be obvious when predictable results are achieved. (see MPEP § 2143, B.).
Claim 8. Wang et al. do not teach in the oligonucleotide chain is double-stranded DNA. However, Luo et al. teach electrochemiluminescence assay (ECL assay) comprised of Pdots and double strand DNA as probes (S1 and BHQ-S2) to detect miRNA (see page 27364, col. 1 and 2 and scheme 1).
Since, Wang et al. and Luo et al. are to same field of endeavor i.e. ECL assay, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Luo et al. teaching to use double stranded DNA as the oligonucleotide in Wang et al. ECL assay because selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. (see MPEP § 2144.07).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. as applied to claim 1 above, and further in view of Zhang et al. (Anal. Chem. 2021,93, 6857-6864).
Claim 7. Wang et al. do not teach the single-stranded DNA is single-stranded DNA having a hairpin structure. However, Zhang et al. teach ECL assay using Pdots conjugated with single stranded DNA hairpin linked with BHQ as the probe for detection of miRNA (see Scheme 2 and page 6861, col. 1).
Since, Wang et al. and Zhang et al. are to same field of endeavor i.e. ECL assay, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Zhang et al. teaching to use hairpin DNA as the oligonucleotide in Wang et al. ECL assay because selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. (see MPEP § 2144.07).
Claim(s) 12-15, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Anal. Chem. 2021, 93, 5327-5333) in view of Li et al. (ACS Sens. 2020,970-977).
Claims 12-14. Wang et al. teach an electrochemiluminescence detection method comprising:
performing enzymatic reaction by adding a sample to be measured to enzyme catalytic system containing a guide nucleic acid capable of being bound to a target nucleic acid (enzymatic digestion reaction is done by adding target sample to DSN enzyme and containing probe 205 capable of being bound to target sample; see Scheme 1 B and page 5329, col. 1); and
performing sample detection by adding a reaction solution obtained at the performing enzymatic reaction to a working electrode on which an electrochemiluminescence nanoprobe that is a Pdots nanoparticle (sample from enzymatic reaction is added to working electrode onto which probe 205 i.e. Pdot is disposed; see page 5329, col. 1), into which a conjugated polymer and a copolymer molecule are polymerized (polymerized N-polymer and PSMA is dropped onto the array; see page 5329, Preparation of an ECL Imaging array), the Pdots nanoparticle being modified with an oligonucleotide chain modified with a quencher molecule, has been dropped and by collecting and analyzing an electrochemiluminescent signal (modifying Pdot with BHQ2-DNA205 for analyzing electrochemiluminescent signal; see Scheme 1).
Wang et al. do not teach enzymatic reaction comprises a Cas enzyme. However, Li et al. teach integrating Cas 12a enzyme and DSN enzyme for efficient signal amplification to make ultrasensitive biosensor for detecting DNA and enhance fluorescence signal output upon activation (see abstract and page 975, section Multiplexed Detection of miRNAs).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Li et al. teaching to add Cas enzyme during the enzymatic reaction in Wang et al. method to increase signal amplification of target sample and enhance fluorescence output.
Claim 15. Wang et al. teach the oligonucleotide chain in the electrochemiluminescence nanoprobe is single-stranded DNA (DNA (single strand DNA used as probe 205; see scheme 1).
Claim 18. Wang et al. teach kit for electrochemiluminescence detection, the kit comprising: an enzyme reaction solution containing an enzyme catalytic system containing a guide nucleic acid capable of being bound to a target nucleic acid (enzymatic digestion reaction solution comprising DSN enzyme and probe 205 capable of being bound to target sample; see Scheme 1 B and page 5329, col. 1); and a detection chip including an electrochemiluminescence nanoprobe fixed on a working electrode, the electrochemiluminescence nanoprobe being a Pdots nanoparticle (working electrode onto which probe 205 i.e. Pdot is disposed; see page 5329, col. 1), into which a conjugated polymer and a copolymer molecule are polymerized (polymerized N-polymer and PSMA; see page 5329, Preparation of an ECL Imaging array), the Pdots nanoparticle being modified with an oligonucleotide chain modified with a quencher molecule (modifying Pdot with BHQ2-DNA205 for analyzing electrochemiluminescent signal; see Scheme 1).
Wang et al. do not teach enzyme in the enzyme reaction is Cas enzyme.
However, Li et al. teach integrating Cas 12a enzyme and DSN enzyme for efficient signal amplification to make ultrasensitive biosensor for detecting DNA and enhance fluorescence signal output upon activation (see abstract and page 975, section Multiplexed Detection of miRNAs).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Li et al. teaching to add Cas enzyme during the enzymatic reaction in Wang et al. method to increase signal amplification of target sample and enhance fluorescence output.
Claim 20. Examiner is not going to give much weight to the word “disposable." Any structure could be constructed to be disposable.
Wang et al. teach the detection chip is a disposable Pdots disposable detection chip with a screen-printed three-electrode sheet used as the working electrode (electrode is comprised of three layers (chromium, gold and ITO); see Preparation of ECL Imaging Array). Electrode being screen-printed is considered product by of process limitation. The cited prior art teaches all of the positively recited structure of the claimed apparatus or product. The determination of patentability is based upon the apparatus structure itself. The patentability of a product or apparatus does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. (see MPEP § 2113).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. and Li et al. as applied to claim 12 above, and further in view of Zhang et al. (Anal. Chem. 2021,93, 6857-6864).
Claim 16. Wang et al. do not teach the single-stranded DNA is single-stranded DNA having a hairpin structure. However, Zhang et al. teach ECL assay using Pdots conjugated with single stranded DNA hairpin linked with BHQ as the probe for detection of miRNA (see Scheme 2 and page 6861, col. 1).
Since, Wang et al. and Zhang et al. are to same field of endeavor i.e. ECL assay, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Zhang et al. teaching to use hairpin DNA as the oligonucleotide in Wang et al. ECL assay because selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. (see MPEP § 2144.07).
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. and Li et al. as applied to claim 12 and 18 above, and further in view of Luo et al. (ACS Appl. Mater. Interfaces 2019, 11, 27363-27370).
Claims 17 and 19. Wang et al. do not teach in the oligonucleotide chain is double-stranded DNA and EXO III enzyme is used for performing enzyme reaction. However, Luo et al. teach electrochemiluminescence assay (ECL assay) comprised of Pdots and double strand DNA as probes (S1 and BHQ-S2) and EXO III enzyme for two-step amplification to detect miRNA (see page 27364, col. 1 and 2 and scheme 1).
Since, Wang et al. and Luo et al. are to same field of endeavor i.e. ECL assay, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Luo et al. teaching to use double stranded DNA as the oligonucleotide in Wang et al. ECL assay because selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. (see MPEP § 2144.07) and adding EXO III enzyme in enzymatic reaction to promote dual signal amplification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GURPREET KAUR whose telephone number is (571)270-7895. The examiner can normally be reached M-F 9:30-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GURPREET KAUR/
Primary Examiner
Art Unit 1759