Prosecution Insights
Last updated: October 04, 2026
Application No. 18/462,141

LIPIDS FOR USE IN LIPID NANOPARTICLE FORMULATIONS

Non-Final OA §102§103
Filed
Sep 06, 2023
Priority
Sep 07, 2022 — provisional 63/404,463
Examiner
PACKARD, BENJAMIN J
Art Unit
1612
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Acuitas Therapeutics Inc.
OA Round
1 (Non-Final)
67%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
82%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
894 granted / 1341 resolved
+6.7% vs TC avg
Strong +16% interview lift
Without
With
+15.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
44 currently pending
Career history
1389
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
47.9%
+7.9% vs TC avg
§102
16.1%
-23.9% vs TC avg
§112
15.6%
-24.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1341 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 . Election/Restrictions Applicant’s election without traverse of Group I, claims 1-3, 7, 15-17, 26, 30, 32, 35, 39, 42, 43, 49, 52, 53, 57, 64, and 72, as well as the species being the 6th compound in claim 72 in the reply filed on 5/6/2026 is acknowledged. Claims 74 and 91 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 39, 43, 52, 53, and 67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. 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. Claims 1-3, 7, 15-17, 26, 30, (52, 53 withdrawn), 64, 74, and 91 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tam et al (WO2021/030701). While the search has not expanded beyond the elected species, for the benefit of compact prosecution, the following compound is used in the obviousness rejection below and anticipates some of the claims. PNG media_image1.png 106 494 media_image1.png Greyscale pg 318 This reads on the instant claims where R2 is –(C=O)OR7, R7 is a substituted C2 alkyl (with an alkyl chain substitution), X is C5 alkylene, R3 is H, n1 is 2, L1a/b are C5 alkyl, and R1a/b are -C(=O)O-R4a/b, and R4a/b are substituted alkyl chains. Claim Rejections - 35 USC § 103 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. Claims 1-3, 7, 15-17, 26, 30, 32, 35, 42, 49, 57, 64, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Tam et al (PCT/US2020/04607). Tam et al teaches the following lipids: Compound XII-4 at pg 340: PNG media_image2.png 124 510 media_image2.png Greyscale and compound I-5 at pg 252: PNG media_image3.png 152 552 media_image3.png Greyscale . The compounds illustrate the various lipid structures possible. Taking the lipid I-5, it would have been obvious to substitute one of the methane groups on the terminal nitrogen with the chain from XII-4 attached to the tertiary nitrogen. PNG media_image4.png 130 340 media_image4.png Greyscale + PNG media_image5.png 86 112 media_image5.png Greyscale The only difference then would be the length of the alkyl chains, which are taught to vary in sizefrom R1-R6 (pg 28). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex. 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. /BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
Read full office action

Prosecution Timeline

Sep 06, 2023
Application Filed
Jul 14, 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
67%
Grant Probability
82%
With Interview (+15.6%)
2y 11m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1341 resolved cases by this examiner. Grant probability derived from career allowance rate.

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