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 II, claims 5-9 to be examined in the reply filed on 2/3/2026, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/1/2023, 10/31/2023, and 3/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). The sequences listed in Tables 5 and 6 have not been identified by SEQ ID Numbers. Applicant should check the application for other instances of non-compliance with the Nucleotide/Amino Acid Sequence rules that have been missed.
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 sequence identifiers, 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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. The sequences depicted in Figure 16B have not been identified by SEQ ID Numbers.
Required response – Applicant must provide:
Replacement and annotated 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 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.
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.
1. Claim(s) 5-7, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ju, Oct 2020, Cell Proliferation, vol 53, e12895, pages 1 to 12, (of record, IDS).
Ju, throughout the publication and abstract, and at pp. 2-4 of 12, and Figure 1, teaches the CHK1 inhibitor Rabusertib diluted into M16 medium, which was then used to treat mouse embryos in culture.
2. Claim(s) 5-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okuno, 30 Jun 2020, Cell Reports, vol 31, 107824, pages 1 to 15, plus suppl.
Okuno, throughout the publication and at pp. 7-8, bridging paragraph, and supplement p. e4, teach treatment to rescue mitotic entry by administering PF-477736. Okuno states:
It has previously been shown that DNA lesions generated in zygotes activate a checkpoint that prevents entry into mitosis. Zygotic nuclear F-actin was severely depolymerized by co-overexpressing actinR62D-HA-NLS and mCherry-Exp6, and in this condition, embryonic
development was impaired (Figures 3A and 3B). We then checked the cell-cycle progression in such nuclear F-actin-depolymerized zygotes. Embryos at the M phase were reduced
at 14 hpi by expressing mCherry-Exp6/actinR62D-HA-NLS, suggesting that mitotic entry was delayed after the disassembly of zygotic nuclear F-actin (42% versus 86%, Chk1-inhibitor (-) in
mCherry-Exp6/actinR62D-HA-NLS versus Chk1-inhibitor (-) in control; Figure 5D). The delayed mitotic entry was rescued by the treatment with PF-477736, a Chk1 inhibitor (75% versus 42%, Chk1-inhibitor (+) versus Chk1-inhibitor (-) in mCherry-Exp6/actinR62D-HA-NLS; Figure 5D). This rescue effect by the Chk1 inhibitor is specific in nuclear actin-depolymerized embryos since the accelerated mitotic entry by the inhibitor treatment was not observed in embryos overexpressed with control mRNA (73% versus 86%, Chk1-inhibitor (+) versus Chk1-inhibitor (-) in control, Figure 5D). The DNA damage checkpoint is activated when nuclear F-actin is depolymerized in zygotes, and therefore, zygotic nuclear F-actin ensures DDR for embryonic
development.
Okuno at p. 8, emphasis added, citation removed. Okuno, at Supplement p. e4, teach treatment of cultured embryos with 10 nM PF-477736, as in claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631