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 .
Detailed Action
This action is in response to the papers filed February 17, 2026.
Claim Listing
The claim listing filed 02/17/2026 is acknowledged.
Claims 2-3, 10, 16-18, 23-39 have been cancelled.
Claims 1, 4-9, 11-15, 19-22, 40-43 are pending.
Claims 19-22, 40-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1, 4-9, 11-15 are under examination.
Non-compliance with 37 CFR 1.121(c):
The claim listing filed 02/17/2026 does not comply with the requirements of 37 CFR 1.121(c). In this case, claims 40-43 are listed with the identifier “New” when, in fact, claims 40-43 were previously presented in the prior claim listing filed 10/31/2023. While Applicant’s reply has been accepted in this case, Applicant is respectfully reminded to comply with the requirements of 37 CFR 1.121(c) when making amendments to the claims in order to avoid the issuance of a Notice of Non-responsive Amendment, which would delay prosecution and potentially have an adverse effect on any patent term adjustment should the claims proceed to issue.
Election/Restrictions
Applicant’s reply filed 02/17/2026 to the Requirement for Restriction/Election mailed 12/23/2025 is acknowledged.
Applicant elected without traverse of the invention of:
Group 1, drawn to an isolated nucleic acid molecule, and a vector comprising thereof;
(A) a nucleic acid sequence comprising the 3’ UTR according to SEQ ID NO: 9, the 3’ SL according to SEQ ID NO: 1, the xrRNA according to SEQ ID NO: 2, and the srRNA dumbbell according to SEQ ID NO: 4, wherein the virus is Dengue virus type 2; and
(B) a transgene encoding a miRNA.
Claims 19-22, 40-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Priority
The instant application 18/547,332 was filed on 08/21/2023. This application is a national stage of international application PCT/US2022/017647 filed 02/24/2022, claiming priority based on U.S. Provisional Patent Application 63/153,985 filed 02/26/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/21/2023, 08/23/2023 and 04/02/2025 have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, or by applicant in an information disclosure statement (IDS), they have not been considered.
Sequence Compliance
The specification and drawings are objected to for the following reasons:
Appropriate action is required so that the sequences disclosed in the specification comply with the sequence rules as discussed in MPEP 2421, MPEP 2422, and 37 CFR 1.821 through 1.825. The following sections of the specification fail to comply with the sequence rules:
Figures 1B, 1C, 1D and 2A.
The sequence rules embrace all unbranched nucleotide sequences with ten or more nucleotide bases and all unbranched, non-D amino acid sequences with four or more amino acids, provided that there are at least 10 "specifically defined" nucleotides or 4 "specifically defined" or amino acids. The rules apply to all sequences in a given application, whether claimed or not. All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database. See MPEP 2421.02.
Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier, either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers in the Brief Description is clear.
Applicant should carefully review the entire specification to ensure compliance with the sequence rules. Applicant should provide a corresponding sequence identifier (SEQ ID NO) with every appearance of a sequence embraced by the sequence rules. If a sequence embraced by the sequence rules is lacking a corresponding sequence identifier (SEQ ID NO) in the instant Sequence Listing, Applicant should provide the sequence in a substitute computer readable form (CRF) copy and a substitute paper copy of the Sequence Listing, as an amendment specifically directing its entry into the application. Applicant should also provide a statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R.1.821(e) or 1.821(f) or 1.821(g) or 1.825(b) or 1.825(d). Applicant should provide a statement indicating any changes made to the Sequence Listing. Appropriate action is required in reply to this Office action. See attached PTO-2301.
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.
(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, 8-9, 11-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0359978 A1 to Kieft et al.
Kieft is relevant prior art for disclosing various applications of RNA sequences derived from the genomic RNA of flaviviruses (FVs) and the application of such features in combination with heterologous sequences. See, Abstract.
Kieft teaches an isolated nucleic acid molecule comprising a transgene (ORF) and one or more FV genetic elements, wherein the FV genetic elements include 3’ UTRs, sfRNA elements, xrRNA elements, DB elements, and 3’ SL elements. See, e.g., par. 8-9, 75-78, 105-111; Figures 1-2.
PNG
media_image1.png
846
669
media_image1.png
Greyscale
PNG
media_image2.png
307
665
media_image2.png
Greyscale
For these reasons, Kieft anticipates the isolated nucleic acid molecule of claim 1.
Regarding dependent claim 8, Kieft teaches that the FV genetic elements are derived from Dengue virus type 2 (DENV2). See, e.g., par. 78, 107.
Regarding dependent claims 9, 11-12, Kieft teaches the transgene encodes an RNA or miRNA, and a promoter is operably linked to the transgene. See, e.g., par. 39, 58, 60, 70, 107.
Regarding dependent claim 13, Kieft teaches that FV genetic elements are positioned 3’ and/or 5’ of the transgene ORF.
Regarding dependent claim 14, Kieft teaches a vector comprising the isolated nucleic acid molecule. See, e.g., par. 107.
For these reasons, dependent claims 8-9, 11-12 and 14 are also anticipated by Kieft.
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.
Claims 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0359978 A1 to Kieft et al., as applied to claims 1, 8-9, 11-12 and 14 above; in view of GenBank U61246.1, “Dengue virus type 2 Thai isolate ThNH-29/93 3’ terminal non-coding region”, entered: 11-Sep-1997, available from: National Library of Medicine (US), National Center for Biotechnology Information, webpage: www.ncbi.nlm.nih.gov/nuccore/u61246.
Kieft does not disclose the nucleic acid sequences for Dengue virus type 2 (DENV2), as claimed in claims 4-5 and 7.
GenBank U61246.1 is relevant prior art for teaching the 3’ terminal non-coding region of DENV2. GenBank U61246.1 provides a sequence comprising a 3’ UTR having 98.6% identity to SEQ ID NO: 9 (nucleic acids 10273-10723), the 3’ SL according to SEQ ID NO: 1 (nucleotides 346-451), and the sfRNA DB according to SEQ ID NO: 4 (nucleotides 182-248).
See alignments for SEQ ID NO: 4, SEQ ID NO: 1 and SEQ ID NO: 9 below, respectively:
PNG
media_image3.png
727
562
media_image3.png
Greyscale
PNG
media_image4.png
111
540
media_image4.png
Greyscale
PNG
media_image5.png
818
552
media_image5.png
Greyscale
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of Kieft by using a sequence comprising a 3’ UTR having 98.6% identity to SEQ ID NO: 9, the 3’ SL according to SEQ ID NO: 1 and the sfRNA DB according to SEQ ID NO: 4, as found in GenBank U61246.1, with a reasonable expectation of success because Kieft discloses that the nucleic acid molecules comprise one or more 3’ UTRs, 3’ SL elements and DB elements derived from DENV2, and, therefore, one of ordinary skill in the art would have sought the previously disclosed sequences for said genetic elements, such as found in GenBank U61246.1, when constructing Kieft’s nucleic acid molecule.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0359978 A1 to Kieft et al., as applied to claims 1, 8-9, 11-12 and 14 above; in view of GenBank AF489932.1, “Dengue Virus Type 2 strain BR64022, complete genome”, entered: 27-Mar-2002, available from: National Library of Medicine (US), National Center for Biotechnology Information, webpage: www.ncbi.nlm.nih.gov/nuccore/AF489932.
Kieft does not disclose the nucleic acid sequences for Dengue virus type 2 (DENV2), as claimed in claim 6.
GenBank AF489932.1 is relevant prior art for teaching the genome sequence of DENV2. GenBank AF489932.1 provides a sequence comprising the xrRNA according to SEQ ID NO: 2 (nucleotides 10298-10367). See alignment for SEQ ID NO: 2 below:
PNG
media_image6.png
231
631
media_image6.png
Greyscale
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of Kieft by using a sequence comprising the xrRNA according to SEQ ID NO: 2, as found in GenBank AF489932.1, with a reasonable expectation of success because Kieft discloses that the nucleic acid molecules comprise one or more xrRNA elements derived from DENV2, and, therefore, one of ordinary skill in the art would have sought the previously disclosed sequences for said genetic elements, such as found in GenBank AF489932.1, when constructing Kieft’s nucleic acid molecule.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0359978 A1 to Kieft et al., as applied to claims 1, 8-9, 11-12 and 14 above; in view of Lukashev et al. (2016). “Viral vectors for gene therapy: current state and clinical perspectives” Biochemistry (Moscow), 81(7), 700-708.
Kieft does not disclose that the vector is a viral vector, as claimed in claim 15.
Lukashev is relevant prior art for disclosing viral vectors, including adenoviral vectors, lentiviral vectors and adeno-associated viral vectors, as effective tools for gene delivery. Unprotected nucleic acids are not stable for a long time in a biological environment, and nucleic acids are not able to enter by itself into the cytoplasm or nucleus of a cell. See Abstract; pg. 700-704.
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of Kieft by using an adenoviral vector, lentiviral vector or adeno-associated viral vector for gene transfer, as taught by Lukashev, with a reasonable expectation of success because such viral vectors are effective tools for gene delivery, permit entry of a nucleic acid molecule into cytoplasm or nucleus of a cell, and provide greater stability relative to unprotected nucleic acid molecules.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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, James D Schultz can be reached at (571)272-0763. 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.
/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
Prosecution Insights