Prosecution Insights
Last updated: October 25, 2026
Application No. 18/001,241

COMPOUNDS AND METHODS FOR REDUCING MSH3 EXPRESSION

Final Rejection §112
Filed
Dec 08, 2022
Priority
Jun 11, 2020 — provisional 63/038,024 +4 more
Examiner
SHIN, DANA H
Art Unit
1635
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ionis Pharmaceuticals Inc.
OA Round
2 (Final)
27%
Grant Probability
At Risk
3-4
OA Rounds
0m
Est. Remaining
54%
With Interview

Examiner Intelligence

Grants only 27% of cases
27%
Career Allowance Rate
316 granted / 1174 resolved
-33.1% vs TC avg
Strong +27% interview lift
Without
With
+26.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
87 currently pending
Career history
1276
Total Applications
across all art units

Statute-Specific Performance

§101
5.0%
-35.0% vs TC avg
§103
28.0%
-12.0% vs TC avg
§102
12.0%
-28.0% vs TC avg
§112
34.1%
-5.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1174 resolved cases

Office Action

§112
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 . Status of Application/Amendment/Claims This Office action is in response to the communications filed on July 27, 2026. Currently, claims 8, 10, 12-20, 23-29, 32-33, 44, 46, and 49-53 are pending in the instant application. Claims 49-53 are withdrawn from further consideration as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 8, 10, 12-20, 23-29, 32-33, 44, and 46 are under examination on the merits in the instant application. The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. Response to Arguments and Amendments Withdrawn Rejections Any rejections/objections not repeated in this Office action are hereby withdrawn. New Objections/Rejections Necessitated by Amendment Claim Objections Claim 8 is objected to because of the following informalities: the semicolon following “2” should be deleted. Appropriate correction is required. Claim 10 is objected to because of the following informalities: the semicolon following “2690” should be deleted. Appropriate correction is required. Claim Rejections - 35 USC § 112 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 8, 10, 12-20, 23-29, 32-33, 44, and 46 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. Clams 8, 10, 12-20, 23-29, 32-33, 44, and 46 as currently amended are drawn to “a modified oligonucleotide consisting of 12 to 30” nucleotides “comprising at least 15,…contiguous nucleobases”. It is noted that it is structurally impossible for the oligonucleotide “consisting of 12” nucleotides in length, for instance, to comprise at least 15 nucleotides. Hence, the instant claims recite structurally conflicting/impossible limitations, thereby rendering the structure of the claimed oligonucleotide indefinite. Claim 12 recites that the modified oligonucleotide of claim 8 has the sequence that is at least 85% complementary to an equal length portion of SEQ ID NO:2. However, the modified oligonucleotide consisting of 12-30 nucleotides is now required to comprise “at least 15,…, or at least 20 contiguous nucleobases complementary to an equal length portion” of SEQ ID NO:2. It is unclear how a 15-mer modified oligonucleotide, for instance, comprising 15 contiguous nucleotides complementary to a 15-mer of SEQ ID NO:2 can be less than 100% complementary to the equal length (15) of SEQ ID NO:2. That is, less than 100% sequence complementarity no longer makes sense for certain lengths as currently amended as opposed to previously presented claims that recited a minimum oligonucleotide length of 12 and shorter (e.g., at least 10) contiguous nucleobases that are complementary to an equal length portion in SEQ ID NO:2. Hence, the claim recites structurally conflicting limitations, thereby rendering the claim indefinite. Claim 20 recites that the modified oligonucleotide is required to comprise at least 15 contiguous nucleobases complementary to an equal length (15) of SEQ ID NO:2 has a minimum of 1 base in each of the 5’ region and the 3’ region and a minimum of 6 nucleosides in the central region, thereby resulting in an 8-mer length for the nucleobase sequence. The length ranges in the three recited regions do not structurally correspond to the minimum length (15) that is currently required to be complementary to the target, thereby rendering the claim indefinite. Allowable Subject Matter SEQ ID NOs:744, 837, 943, 971, 1068, and 2690 recited in claim 10 are found free of the prior art searched and of record. Conclusion No claim is 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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm. 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, RAM SHUKLA can be reached at 571-272-0735. 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. /DANA H SHIN/Primary Examiner, Art Unit 1635
Read full office action

Prosecution Timeline

Dec 08, 2022
Application Filed
Jan 28, 2026
Non-Final Rejection mailed — §112
Jul 27, 2026
Response Filed
Oct 15, 2026
Final Rejection mailed — §112 (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

3-4
Expected OA Rounds
27%
Grant Probability
54%
With Interview (+26.9%)
3y 4m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1174 resolved cases by this examiner. Grant probability derived from career allowance rate.

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