DETAILED ACTION
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 with traverse of the Species election between CRISPR/Cas13a and microRNA expression vector in the reply filed on 02 October 2025 is acknowledged. The traversal is on the ground(s) that the claimed invention of synergistic cooperation of DMP-controlled inhibition of iron export genes (FPN/LCN2) and iron nanoparticles is not obvious. This argument was not found persuasive; however, the search and examination has been extended to the species of microRNA expression vector due to the CRISPR/Cas13a expression vector of SEQ ID NO: 1 being free of the art.
Application Status
The Amendments and Remarks filed 06 July 2026 in response to the Office Action 28 January 2026 are acknowledged and have been entered. Claims 1, 3, 7 and 9 are amended,. Claims 2, 5, 11, and 13 have been cancelled. Claims 1, 3-4, 6-10, and 12 are pending and being examined on the merits.
Any rejection or objection not reiterated herein has been overcome by applicants claim amendments.
This office action contains new rejections necessitates by applicants claim amendments.
Priority
This application is a 371 PCT of CN2021/072025 filed 01/15/2021 and claims priority to application CN202010173472.2 filed 3/12/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that the specification (Table 3) still recites nucleic acid sequences that lack corresponding SEQ ID NOs. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 1, 4, and 6-9 is objected to because of the following informalities:
Claim 1 recites ”one or more selected from a CRISPR/Casl3a expression vector and a microRNA expression vector” which clearly makes the point that only one vector is required. The claim additionally recites “wherein the DNA sequence of the functional element of the CRISPR/Cas13a expression vector is shown in SEO ID NO.1; and the DNA sequence of the functional element of the microRNA expression vector is shown in SEO ID NO.2”. It would be remedial to change this language to recite “wherein, when the gene-interference vector comprises the CRISPR/Cas13a expression vector, the DNA sequence of the functional element is SEQ ID NO: 1; and when the gene-interference vector comprises the microRNA expression vector, the DNA sequence of the functional element is SEQ ID NO: 2”, as the use of “and” in this limitation can be read as requiring both vector types.
Regarding claim 4, it would be remedial to replace “the expression of the microRNA is controlled by the DMP promoter in the microRNA expression vector” with “and in the microRNA expression vector, the expression of the microRNA is controlled by the DMP promoter”.
Regarding claim 6, it would be remedial to replace “as a combined CRISPR/Casl3a or microRNA expression vector to express gRNA or microRNA targeting multiple genes” with “multiple gene-targeting gRNAs or microRNAs”.
It would be remedial to change “SEQ ID NO.” to “SEQ ID NO:” of claims 1, and 7-9.
Appropriate correction is required.
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 3 and 7-10 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 3 recites that the NF-κB-specific promoter is composed of NF-κB. A promoter is a composed of nucleotides and NF-κB is a protein complex composed of amino acids. It is unclear how a nucleotides can be composed of amino acids. (This rejection is maintained and not addressed in applicant’s remarks).
Claim 7 recites “wherein the iron metabolism and reactive oxygen species-related genes is selected from SEQ ID NO.7 and SEQ ID NO.8 , SEQ ID NO.9 and SEQ ID NO.10, SEQ ID NO. 11 and SEQ ID NO.12, SEQ ID NO.13 and SEQ ID NO.14 and SEQ ID NO.15 and SEQ ID NO.16 genes”. The claimed sequences are defined by the specification as being short microRNA target-binding sequences, not genes. Therefore, it is unclear if the claim is limiting the iron metabolism and reactive oxygen species-related genes, the microRNA, and/or the target region of the gene.
Claim 8 recites “the CRISPR/Cas13a or microRNA expression vector is configured to express gRNA or microRNA targeting a group of genes selected from SEQ ID NO.5, SEQ ID NO.6, SEQ ID NO.7 and SEQ ID NO.8 , SEQ ID NO.9 and SEQ ID NO.10, SEQ ID NO. 11 and SEQ ID NO.12, SEQ ID NO.13 and SEQ ID NO.14 and SEQ ID NO.15 and SEQ ID NO.16 genes”. The claimed sequences are defined by the specification as being short microRNA target-binding sequences, not genes or gRNA sequences. Therefore, it is unclear if the claim is limiting the iron metabolism and reactive oxygen species-related genes, the microRNA, and/or the target region of the gene.
Claim 9 recites “wherein target binding sequences of the gRNAs targeting SEQ ID NO.5 and SEQ ID NO.6 are 5'-CACCG CAAAG TGCCA CATCC GATCT CCC- 3' (SEQ ID NO.5) and 5'-TAACT CTTAA TGTTG CCCAG CGTGA ACT-3' (SEQ ID NO.6)…”. The claim later recites and defines two different sequences for SEQ ID NO:5 and SEQ ID NO:6. SEQ ID NO:5 and SEQ ID NO:6 are defined by the specification as being short microRNA target-binding sequences, not genes or gRNA sequences and comprises the sequences of 5'-TCTAC CTGCA GCTTA CATGA T-3' and 5'-TAATG TTGCC CAGCG TGAAC T-3', respectively. The recited sequences of 5'-CACCG CAAAG TGCCA CATCC GATCT CCC- 3' and 5'-TAACT CTTAA TGTTG CCCAG CGTGA ACT-3' are defined by the specification as being SEQ ID NO: 3 and SEQ ID NO: 4, respectively. Therefore, it is unclear if this recited limitation in the claim is limiting the genes, the gRNAs, the microRNA, and/or the target region of the gene.
Those claims identified in the statement of rejection but not explicitly referenced in the rejection are also rejected for depending from a rejected claim but failing to remedy the indefiniteness therein
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The expression vectors of SEQ ID NO: 1 and SEQ ID NO: 2 is found free of the art. SEQ ID NO: 1 is taught by the specification to the CRISPR/Cas13a expression vector (pDMP-Cas13a-U6-gRNA). While SEQ ID NO: 1 comprises the Southeast University’s NF-κB response sequence (5'-GGG AAT TTC CGG GGA CTT TCC GGG AAT TTC CGG GGA CTT TCC GGG AAT TTCC-3', SEQ ID NO.1) and the minimal promoter sequence (5'-TAG AGG GTA TAT AAT GGA AGC TCG ACTTCC AG- 3', SEQ ID NO.2) of the DMP promoter, comprises a sequence that is 99.6 identical to GenBank: AY623053.1 (GenBank: AY623053.1 Homo sapiens clone phU6A U6 small nuclear RNA, promoter region, 9/7/2005) who teaches a U6 promoter region, and comprises a sequence that is 90% identical to GenBank: MN812663.1 (GenBank: MN812663.1, Vector pAc-Cas13a, complete sequence, 2/29/2020), the prior art failed to teach and suggest arranging the components of a DMP promoter, Cas13a, U6 promoter, and a gRNA to arrive at SEQ ID NO:1.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530.
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, Jennifer Dunston can be reached at 571-272-2916. 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.
/TIFFANY NICOLE GROOMS/Examiner, Art Unit 1637
Prosecution Insights