Prosecution Insights
Last updated: May 29, 2026
Application No. 17/759,944

METHODS AND COMPOUNDS FOR THE TREATMENT OF GENETIC DISEASE

Non-Final OA §102
Filed
Aug 10, 2023
Priority
Feb 03, 2020 — nonprovisional of 62/969,644 +2 more
Examiner
HAVLIN, ROBERT H
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Design Therapeutics Inc.
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
80%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
534 granted / 1022 resolved
-7.7% vs TC avg
Strong +27% interview lift
Without
With
+27.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
95 currently pending
Career history
1129
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
36.8%
-3.2% vs TC avg
§102
14.2%
-25.8% vs TC avg
§112
32.7%
-7.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1022 resolved cases

Office Action

§102
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 . Priority This application is a 371 of PCT/US2021/016481 (02/03/2021) PCT/US2021/016481 has PRO 63/135,476 (01/08/2021) PCT/US2021/016481 is a 371 of 62/969,644 (02/03/2020). Nucleotide and/or Amino Acid Sequence Disclosures Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted: 1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying: a. the name of the XML file b. the date of creation; and c. the size of the XML file in bytes; or 2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying: a. the name of the XML file; b. the date of creation; and c. the size of the XML file in bytes. SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS: Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because the specification includes sequences, for example Table 6 of the specification. Required response - Applicant must provide: • A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3); o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4) 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(a)(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 o A statement that the substitute specification contains no new matter. Election/Restrictions Applicant's election without traverse of Group I, claims 71-87, in the reply filed on 4/6/26 is acknowledged. Applicant also elected the following species of compound 29: PNG media_image1.png 195 1237 media_image1.png Greyscale stated by Applicant as reading on claims 71, 73-80, 85 and 87. The Examiner further determined claim 85 wherein the 2nd terminus is formula 12-A does not read on the elected species’ 1,2,3,6-tetrahydropyridin-4-yl ring because it is not an aryl or heteroaryl as required by “Ring C” in claim 85. Thus, claims 71, 73-80 and 87 read on the elected species. As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987). Accordingly, claims 72, 81-86 are hereby withdrawn. Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02. 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 71, 73-80, and 87 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ansari et al. (US20180280541). Ansari teaches “agents having a formula A-L-B, wherein -L- is a linker; A- is a Brd4 binding moiety; and —B is a nucleic acid binding moiety, such as a polyamide or complementary oligonucleotide, that specifically binds to the target oligonucleotide sequence” where the oligonucleotide sequence is “selected from the group consisting of CGG , CTG , and CCTG” (Abstract, claim 1). Ansari teaches agent 4 shown below (Fig. 17, annotated analogously to the elected species and to the instant claim 71): PNG media_image2.png 239 762 media_image2.png Greyscale where A is the Brd4 group “JQ1” described below: PNG media_image3.png 182 365 media_image3.png Greyscale and Ansari describes JQ1 as ([0088]): JQ1 is one example of a selective small - molecule bromodomain inhibitor. Specifically, JQ1 is a thieno-triazolo-1,4-diazepine that displaces bromodomain and extra terminal (BET) family members (e.g., Brd4) from chromatin by competitively binding to the acetyl - lysine recognition pocket. (Delmore, et al., Cell, 146(6): 904-917 (2011). Ansari’s 4 corresponds to claim 71’s first terminus (4’s right hand side, “1st term”), second terminus (4’s left hand side, “2nd term”, JQ1), and oligomeric backbone (4’s middle comprising 8-unit PEG, “linker”). Thus, the claims are anticipated. Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm. 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, Kortney Klinkel can be reached at (571) 270-5293. 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. /ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Aug 10, 2023
Application Filed
May 07, 2026
Non-Final Rejection mailed — §102 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
52%
Grant Probability
80%
With Interview (+27.2%)
2y 9m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1022 resolved cases by this examiner. Grant probability derived from career allowance rate.

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