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 without traverse of Group I, corresponding to claims 1 – 8 in the reply filed on 05/29/2026 is acknowledged.
Claims 9 – 14 are withdrawn from further consideration pursuant to 37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.
Claims 1 – 8 are under examination.
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application No. PCT/JP2022/025983, filed June 29, 2022. This application also claims priority to Japanese application JP2021-108757, filed on June 30, 2021.
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:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. FIGS 1A-1B. contain sequences that are not accompanied with sequences identifiers (i.e., “SEQ ID NO:X).
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
The file must be submitted in bytes not kilobytes.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 103
Claim(s) 1 – 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US20220025338A1, hereinafter, “Lee 1”), in view of Lee et al (Int J Mol Sci, Feb 2021, 10.3390/ijms22042003, hereinafter, “Lee 2”).
Lee 1 teaches nc886 is a human non coding RNA that suppresses IFN-B signaling and inflammation (Abstract). Lee 1 also teaches creating cell lines that express nc886 (Figure 2, Section: 4.1. Cell Lines, Viruses, Antibodies, and Other Reagents). Furthermore, Lee 1 teaches using multiple viruses, including SeV in different cell lines expressing nc886 to understand the role of nc886 on viral replication (Section, 2.1. nc886 Antagonizes the IFN-β Signaling, Discussion ¶3).
Regarding claim 1, Lee 1 teaches expressing nc886, a protein kinase R (PKR) inhibitory factor from a gene encoding nc886 operably linked to a regulatory sequence in a packaging cell (Section: 4.1. Cell Lines, Viruses, Antibodies, and Other Reagents). Lee 1 teaches the packaging cell are then exposed to Sendai Virus (SeV) in nc886 expressing cells (“Infection of Sendai virus (SeV) and respiratory syncytial virus (RSV) induced the IFN-β promoter, and this induction was weaker in nc886-expressing cells”).
Lee 1 does not teach recovering a negative-strand RNA virus from nc886 expressing cells.
However, Lee 2 teaches compositions that enhance oncolytic virus activity and increase virus production (Abstract). Lee 2 teaches that nc886 can promote virus replication to help virus production and that nc886 knockdowns result in decreased viral mRNA and protein (¶0005). Furthermore, Lee 2 teaches that nc886 expression creates a pro-viral environment (¶0020). Regarding claim 1, Lee 2 teaches recovering SeV from nc886 expressing cells after infection (Figure 1E).
Regarding claims 2 and 6, Lee 1 teaches the packaging cell expressing nc886 are exposed to Sendai Virus (SeV) in nc886 expressing cells (“Infection of Sendai virus (SeV) and respiratory syncytial virus (RSV) induced the IFN-β promoter, and this induction was weaker in nc886-expressing cells”).
Regarding claim 3, Lee 1 teaches expressing nc886 in packaging cells (Section: 4.1. Cell Lines, Viruses, Antibodies, and Other Reagents).
Regarding claim 4, Lee 2 teaches infecting nc886 expressing cells with SeV without a helper virus and collecting resulting SeV produced (Figure 1E).Lee 1 and Lee 2 are considered to be analogous to the claim invention because they both teach negative stand viruses in the context of nc886 expressing cells. Lee 1 teaches expressing nc886 in packaging cells followed by infecting the cells with SeV (Section: 4.1. Cell Lines, Viruses, Antibodies, and Other Reagents, Section 2.1. nc886 Antagonizes the IFN-β Signaling ¶2). Lee 2 teaches recovering SeV from nc886 expressing cells after infection (Figure 1E).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to infect cells that express nc886 operably linked to a regulatory sequence, as taught by Lee 1, and collect the resulting produced SeV, as taught by Lee 2, because doing so allow for increase viral production of SeV with less materials. One of ordinary skill in the art would have had a reasonable expectation of success in using nc886 expressing cells to produce SeV given that using SeV in nc886 expressing cells is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee 1 and Lee 2 as applied to claims 1 – 4, and 6 above, and further in view of Li et al (Nucleic Acids Res, 2015, 10.1093/nar/gkv1078, hereinafter, “Li”).
As discussed above, claims 1 – 4, and 6 were rendered prima facie obvious by Lee 1 and Lee 2. Lee 1 and Lee 2 teaches infecting nc886 expressing cells with SeV thereby producing more copies of SeV. However, the references fail to teach a SeV that encodes nc886 that infects and reproduces within nc886 expressing cells.
However, Li teaches the role of PKR in the host’s innate immunity against viral infections (Abstract). Li teaches expressing nc886, also known as vtRNA2-1, in different cells times and challenging the nc886 expressing cells with different viruses including the negative sense influenza A virus, HSV, and SeV (Abstract, Figure 8). Li also teaches that viruses encoding nc886 can be used to express nc886 in cells (Section: Construction of plasmids and generation of stable cell lines).
Regarding claim 5, Li teaches a lentiviral construct, pSIH-H1-GFP, that encodes nc886 (Section: Construction of plasmids and generation of stable cell lines).
Lee 1, Lee 2, and Li are considered to be analogous to the claim invention because they teach negative stand viruses in the context of nc886 expressing cells. Lee 1 teaches expressing nc886 in packaging cells followed by infecting the cells with SeV (Section: 4.1. Cell Lines, Viruses, Antibodies, and Other Reagents, Section 2.1. nc886 Antagonizes the IFN-β Signaling ¶2). Lee 2 teaches recovering SeV from nc886 expressing cells after infection (Figure 1E). Li teaches a lentiviral construct, pSIH-H1-GFP, that encodes nc886 (Section: Construction of plasmids and generation of stable cell lines).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to modify SeV as a viral vector to encode nc886 because doing so would predictably result in a cell that expresses nc886. As in the case of a lentivirus encoding nc886, a SeV encoding nc886 would result in the host cell expressing nc886 and would lead to advantageously increasing viral production. One of ordinary skill in the art would have had a reasonable expectation of success in using encoding nc886 in SeV given that nc886 as a transgene in viral vectors is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lee 1 and Lee 2 as applied to claims 1 – 4, and 6 above, and further in view of Coleman et al (US20170258890A1, hereinafter, “Coleman”).
As discussed above, claims 1 – 4, and 6 were rendered prima facie obvious by Lee 1 and Lee 2. While the references teach a method of producing negative-strand RNA virus in nc886 expressing cells, the references fail to teach expressing nc886 in Vero cells.
However, Coleman teaches table replication competent SeV vectors that are comprised of optimized HIV genes (Abstract). Coleman also teaches methods for make the viral vectors as well as cell lines that are designed for vaccine production (Abstract). Coleman teaches that multiple plasmids including those encoding for SeV and supporting plasmids such as NP, P, L, F and T7, among others can be used in a transfection system to produce viable SeV vectors (¶0057,0058).
Regarding claims 7 and 8, Coleman teaches Sendai virus can be express and replicate in Vero cells (¶0055). Coleman also teaches Vero cells can be used to produce SeV through individual plasmids and/or whole virus infection (¶0055-58).
Lee 1, Lee 2, and Coleman are considered to be analogous to the claim invention because they teach the use of SeV. Lee 1 teaches expressing nc886 in packaging cells followed by infecting the cells with SeV (Section: 4.1. Cell Lines, Viruses, Antibodies, and Other Reagents, Section 2.1. nc886 Antagonizes the IFN-β Signaling ¶2). Lee 2 teaches recovering SeV from nc886 expressing cells after infection (Figure 1E). Coleman teaches that multiple plasmids including those encoding for SeV and supporting plasmids such as NP, P, L, F and T7, among others can be used in a transfection system to produce viable SeV vectors in Vero cells (¶0055, 0057,0058).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to infect Vero cells, as taught by Coleman, that express nc886 operably linked to a regulatory sequence, as taught by Lee 1, and collect the resulting produced SeV, as taught by Lee 2, because doing so would allow for increase viral production of SeV with less materials in a cell line that achieves high titer. One of ordinary skill in the art would have had a reasonable expectation of success in using nc886 expressing Vero cells to produce SeV given that Vero cells as high titer producing cell substrate is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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/DANYAL HASSAN ALAM/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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