Prosecution Insights
Last updated: October 02, 2026
Application No. 18/440,188

CLEAVABLE LINKER-CONTAINING IONIZABLE LIPIDS AND LIPID CARRIERS FOR THERAPEUTIC COMPOSITIONS

Non-Final OA §102§103
Filed
Feb 13, 2024
Priority
Feb 13, 2023 — provisional 63/445,266
Examiner
HOLLOMAN, NANNETTE
Art Unit
1612
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Flagship Pioneering Inc.
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
4m
Est. Remaining
84%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
482 granted / 794 resolved
+0.7% vs TC avg
Strong +23% interview lift
Without
With
+22.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
31 currently pending
Career history
817
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
56.1%
+16.1% vs TC avg
§102
17.3%
-22.7% vs TC avg
§112
18.6%
-21.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 794 resolved cases

Office Action

§102 §103
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 . Response to Election/Restrictions Applicant's election with traverse of Group I, claims 1-6 and new claims 38-56, and the specie Lipid 18, one page 12, column 2, compound 2 of claim 6 in the reply filed on 06/04/2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement is improper, since Group II claims depend directly from the Group I claims, meaning Group II claims necessarily require all of the features of Group I claims. Furthermore, there is a clear chain of dependency across all groups wherein every claims in Groups II-V traces back to the Group I compounds, which minimizes the actual search burden on the Examiner. This is not found persuasive because while Group II claims necessarily require all of the features of Group I, Group I does not require all the features of Group II. There is an examination and search burden for these patentably distinct inventions/species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. The requirement is still deemed proper and is therefore made FINAL. Claims 2-5, 7, 11-13, 17-19, 25, 29-31, and 37-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions/specie, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/04/2026. 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. Claim(s) 1 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (CN114763324A, disclosed by applicant). Chen et al. disclose compound LP-C3 PNG media_image1.png 134 484 media_image1.png Greyscale which meets the limitation of the compounds of claim 6, p. 9, column 2, last compound and claim 6, p. 10, column 1, first compound. The compounds are anticipated by the reference. Claim Rejections - 35 USC § 103 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (WO 2017049245, disclosed by applicant). Benenato et al. disclose compounds that meet the limitation of the claimed elected lipid 18 compound. Benenato et al. disclose a compound of formula (IIb) PNG media_image2.png 136 454 media_image2.png Greyscale (reference claim 117). Benenato et al. disclose R4 is selected from –(CH2)nQ and –(CH2)nCHQR; wherein Q is 5 or 6 membered heterocycloalkyl containing at least one nitrogen ring atom and is optionally substituted with one or more substituents selected from amino (NH2) (reference claims 103 and 119). One of ordinary skill in the art could at once envisage the subject matter within the instant claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 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, Sahana S. Kaup can be reached at 571-272-6897. 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. /NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612
Read full office action

Prosecution Timeline

Feb 13, 2024
Application Filed
Jun 30, 2026
Non-Final Rejection mailed — §102, §103 (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
61%
Grant Probability
84%
With Interview (+22.8%)
3y 0m (~4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 794 resolved cases by this examiner. Grant probability derived from career allowance rate.

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