Prosecution Insights
Last updated: July 17, 2026
Application No. 18/746,810

IONIZABLE AMINE LIPIDS AND LIPID NANOPARTICLES

Non-Final OA §102§112§DP
Filed
Jun 18, 2024
Priority
Dec 20, 2021 — provisional 63/291,639 +2 more
Examiner
SONG, JIANFENG
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Beam Therapeutics Inc.
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
6m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
477 granted / 852 resolved
-4.0% vs TC avg
Strong +34% interview lift
Without
With
+33.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
53 currently pending
Career history
925
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
46.9%
+6.9% vs TC avg
§102
9.8%
-30.2% vs TC avg
§112
1.6%
-38.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 852 resolved cases

Office Action

§102 §112 §DP
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 invention group I, claims 1-3, 6, 20,22, 24-25, 29, 40 and 61, in the reply filed on 05/04/2026 is acknowledged. Claims 41-44, 50, 52 and 55-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/04/2026. Applicants further elect compound 7-21 in claims 61 as specific compound of formula (I). Compound 7-21 is free of art, and the examination moves to the next species compound 97 at the examiner’s choice. Claims 1-3, 6, 22, 24, 25, 29 read on the compound 97 and are under examination, claims 20, 40 and 61 do not read on compound 97 and are withdrawn from consideration. Claims 1-3, 6, 20,22, 24-25, 29, 40-44, 50, 52, 55-56 and 61 are pending, claims 1-3, 6, 22, 24, 25, 29 are under examination. Priority Acknowledge is made that this application is a Continuation Application of International Application No. PCT/US2022/053209, filed on December 16, 2022, which claims priority to U.S. Application No. 63/291,639, filed December 20, 2021, and U.S. Application No. 63/354,627, filed June 22, 2022. Information Disclosure Statement The information disclosure statement (IDS) submitted on 07/31/2025 and 05/04/2026 is being considered by the examiner. Claim Rejections - 35 USC § 112 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 40 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. Claim 40 recites Table 1 (of the specification), and the claim is incomplete and thus the scope and boundary of the claim is unclear. This is indefinite. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). MPEP 2173.05 (s). 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. Claim(s) 1-3, 6, 22, 24, 25, 29 are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Scully et al. (WO2020219876). The limitation is met by disclosing compound 97 (page 168, example 97). Compound 97 falls into applicant’s claimed compound of formula (I), in this case, L1 and L1’ are CH2; Y1 and Y1’ is C(=O); L2 and Y2 are absent, R is –(CH2)6-CH=CH-CH=CH-(CH2)4-CH3; L2’ is -CH2-CH2-, Y2’ is absent, R’ is -CH-(O(CH2)7CH3)2; X1 is O; X2 is –(CH2)2-N-(CH2CH3)2; X3 is hydrogen. PNG media_image1.png 239 700 media_image1.png Greyscale Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-3, 6, 22, 24, 25, 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12435035. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compound example 3 which would fall into applicant’s claimed compound of formula (i) is the highlighted CH2 is missed, the only difference between the prior art compound and the claimed compound is CH2, and since they are homolog, it is obvious to produce applicant’s claimed invention with reasonable expectation of success. MPEP 2144.09 II, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). PNG media_image2.png 205 337 media_image2.png Greyscale Claims 1-3, 6, 22, 24, 25, 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12268753. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compound 4-71 which would fall into applicant’s claimed compound of formula (i) is the highlighted CH2 is missed, the only difference between the prior art compound and the claimed compound is CH2, and since they are homolog, it is obvious to produce applicant’s claimed invention with reasonable expectation of success. MPEP 2144.09 II, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). PNG media_image3.png 278 809 media_image3.png Greyscale Claims 1-3, 6, 22, 24, 25, 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12435035. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compound claim 26 which would fall into applicant’s claimed compound of formula (i) is the highlighted CH2 is missed, the only difference between the prior art compound and the claimed compound is CH2, and since they are homolog, it is obvious to produce applicant’s claimed invention with reasonable expectation of success. MPEP 2144.09 II, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). PNG media_image4.png 226 633 media_image4.png Greyscale Claims 1-3, 6, 22, 24, 25, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-38 of copending Application No. 19058752 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compound of formula (VI) which would fall into applicant’s claimed compound of formula (i) is the highlighted CH2 is missed, the only difference between the prior art compound and the claimed compound is CH2, and since they are homolog, it is obvious to produce applicant’s claimed invention with reasonable expectation of success. MPEP 2144.09 II, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). PNG media_image5.png 297 769 media_image5.png Greyscale This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-3, 6, 22, 24, 25, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 19317946 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compound of example 1 which would fall into applicant’s claimed compound of formula (i) is the highlighted CH2 is missed, the only difference between the prior art compound and the claimed compound is CH2, and since they are homolog, it is obvious to produce applicant’s claimed invention with reasonable expectation of success. MPEP 2144.09 II, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). PNG media_image6.png 263 544 media_image6.png Greyscale This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-3, 6, 22, 24, 25, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 19209589 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compound of BLP4-71 which would fall into applicant’s claimed compound of formula (i) is the highlighted CH2 is missed, the only difference between the prior art compound and the claimed compound is CH2, and since they are homolog, it is obvious to produce applicant’s claimed invention with reasonable expectation of success. MPEP 2144.09 II, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). PNG media_image7.png 262 911 media_image7.png Greyscale This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-3, 6, 22, 24, 25, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 35 of copending Application No. 19540418 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches compound I (claim 35) which would fall into applicant’s claimed compound of formula (i) is the highlighted CH2 is missed, the only difference between the prior art compound and the claimed compound is CH2, and since they are homolog, it is obvious to produce applicant’s claimed invention with reasonable expectation of success. MPEP 2144.09 II, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). PNG media_image8.png 277 881 media_image8.png Greyscale This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5. 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, Brian-Yong Kwon can be reached at (571)272-0581. 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. /JIANFENG SONG/Primary Examiner, Art Unit 1613
Read full office action

Prosecution Timeline

Jun 18, 2024
Application Filed
Jul 02, 2026
Non-Final Rejection mailed — §102, §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12678398
ULTRAVIOLET LIGHT-BLOCKING COMPOSITION COMPRISING CENTIPEDE GRASS EXTRACT AND COSMETIC COMPOSITION COMPRISING SAME
3y 0m to grant Granted Jul 14, 2026
Patent 12661335
Halogenated Xanthene-Containing Topical Anti-Gram-Positive Bacterial Ophthalmic Composition and Method
3y 5m to grant Granted Jun 23, 2026
Patent 12661339
METHODS FOR TREATING OCULAR DEMODEX USING SPINOSAD FORMULATIONS
3y 4m to grant Granted Jun 23, 2026
Patent 12636410
TISSUE RESTORATION COMPOSITION
4y 0m to grant Granted May 26, 2026
Patent 12623000
COMPOSITION FOR TRANSPLANTATION OF ORGANOID
4y 1m to grant Granted May 12, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
90%
With Interview (+33.5%)
2y 7m (~6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 852 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month