Office Action Predictor
Application No. 17/822,202

OLIGOMERIC COMPOUNDS COMPRISING BACKBONE CONSTRAINED MACROCYCLES

Non-Final OA §112
Filed
Aug 25, 2022
Examiner
GALSTER, SAMUEL LEONARD
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ionis Pharmaceuticals, INC.
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
3y 2m
To Grant
91%
With Interview

Examiner Intelligence

54%
Career Allow Rate
53 granted / 98 resolved
Without
With
+37.1%
Interview Lift
avg trend
3y 2m
Avg Prosecution
52 pending
150
Total Applications
career history

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
37.9%
-2.1% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
25.8%
-14.2% vs TC avg
Black line = Tech Center average estimate • Based on career data

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 . 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. This office action is a response to applicant’s communication submitted December 7, 2022, wherein claims 3-5, 9-11, 13, 24-26, 30, 32, and 41 were preliminarily amended, and claims 6-8, 12, 15-21, 27-29, 34-40, 42-53, and 55-63 were canceled. This application claims benefit of provisional application 63/237,082 filed August 25, 2021. Claims 1-5, 9-11, 13-14, 22-26, 30, 32-33, 41, and 54 are pending in this application. Claim Rejections - 35 USC § 112 (b) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 41 is 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. Regarding claim 41: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 41 recites the broad recitation “12-24” linked nucleosides, and the claim also recites “12-20, 16-20, 18-20, or 22-23” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Allowable Subject Matter Claims 1-5, 9-11, 13-14, 22-26, 30, 32-33 and 54 allowed. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Catana et al (J. Nucleic Acids, 2012, IDS filed December 7, 2022). Catana teaches the following known macrocyclic-constrained nucleotides PNG media_image1.png 384 722 media_image1.png Greyscale (pg. 3, figure 2). The closest macrocyclic-constrained nucleotide is represented by formula VII. While the art demonstrates the macrocyclic structures can be connected via saturated or unsaturated alkoxy chains, there is no teaching or suggestion to replace with alkoxy chains connecting phosphate groups with alkyl groups as recited by the oligomeric formulas in instant claims 1 and 22. It would be improper hindsight to suggest a person of ordinary skill in the art would have had the motivation to do so as there is no teaching or suggestion this would be beneficial for the purpose of acting as antisense modified oligonucleotides. Thus claims 1 and 22 are allowed. Wherein claims 1 and 22 cannot be anticipated or rendered obvious over the prior art dependent claims 2-5, 9-11, 13-14, 23-26, 30, 32-33 and 54 are similarly allowed. Conclusion Claims 1-5, 9-11, 13-14, 22-26, 30, 32-33 and 54 are allowed and claim 41 is rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 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, Scarlett Y Goon can be reached at 571-270-5241. 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. /S.L.G./Examiner, Art Unit 1693 /ERIC OLSON/Primary Examiner, Art Unit 1693
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Prosecution Timeline

Aug 25, 2022
Application Filed
Aug 05, 2025
Non-Final Rejection — §112
Apr 10, 2026
Response after Non-Final Action

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Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
91%
With Interview (+37.1%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 98 resolved cases by this examiner