LIPIDS FOR USE IN LIPID NANOPARTICLES

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 . DETAILED ACTION Status of the Claims Claims 1-6, 8-10, 13-22, 24-25, 28-29, 33-35 and 50 are pending. Claims 7, 11-12, 23, 26-27, 30-32, 36-49, and 51-54 are canceled. Claims 4-6, 8-10, 13-22, 24-29, 33-35 and 50 are amended. Claims 3-5, 8, 10, 13-15, 17, 21, 34-35 and 50 are withdrawn. Claims 1-2, 6, 9, 16, 18-20, 22, 24-25, 28-29 and 33 are included in the prosecution. Election/Restrictions Applicants’ election without traverse of Group I, claims 1-6, 8-10, 13-22, 24, 25, 28, 29, and 33 drawn to compounds in the reply filed on 04/03/2026 is acknowledged. Applicants’ election without traverse of species Formula Ia and compound I-7 on page 33 of the instant specification was confirmed during a phone call with the representative on 09/17/2026 as the species of claim 33 second from the bottom of page 10 of claims filed 08/27/2024. Summary of this discussion is provided in the interview summary initiated by the examiner. As such, claims 1-2, 6, 9, 16, 18-20, 22, 24-25, 28-29 and 33 read on the election. Accordingly, claims 3-5, 8, 10, 13-15, 17, 21, 34-35 and 50 are withdrawn as being directed to a non-elected group/species. Priority This application has PRO of 63508772 filed 06/16/2023. Information Disclosure Statement The Information Disclosure Statements (IDS) submitted on 4/03/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, this/these IDS(s) has/have been considered by the Examiner. Specification The use of the term “RiboMax” among the many commercially available kits named (e.g., see Spec., page 5, line 29), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Objections Claim 1 is objected to because of the following informalities: there appears to be an extraneous dash in line 4 in between superscript “1a” and the word “when.” In line 13 and in line 18 of the claim there appear to be extraneous periods “.” after a superscript letter, e.g., “-C(=O)OR2c.”. Appropriate correction is required. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 (a) are summarized as follows: Determining the scope and contents of the prior art. Ascertaining the differences between the prior art and the claims at issue. Resolving the level of ordinary skill in the pertinent art. 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 1-2, 6, 9, 16, 18-20, 22, 24-25, 28-29 and 33 are rejected under 35 U.S.C. § 103 as being unpatentable over Shariter et al. (WO 2019046809 A1). For convenience figures and structures associated with the elected species are provided below (number in the left column of the table indicates the number of the instant claim). 2 PNG media_image1.png 33 102 media_image1.png Greyscale PNG media_image2.png 199 133 media_image2.png Greyscale 9 PNG media_image3.png 34 80 media_image3.png Greyscale PNG media_image4.png 57 267 media_image4.png Greyscale 16 PNG media_image5.png 36 86 media_image5.png Greyscale PNG media_image6.png 21 95 media_image6.png Greyscale 18 PNG media_image7.png 21 274 media_image7.png Greyscale PNG media_image8.png 113 105 media_image8.png Greyscale 19 PNG media_image9.png 30 278 media_image9.png Greyscale PNG media_image10.png 117 429 media_image10.png Greyscale 20 PNG media_image11.png 25 168 media_image11.png Greyscale 22 PNG media_image12.png 23 353 media_image12.png Greyscale 24 PNG media_image13.png 20 356 media_image13.png Greyscale 25 PNG media_image14.png 20 445 media_image14.png Greyscale 28 PNG media_image15.png 18 336 media_image15.png Greyscale 29 PNG media_image16.png 23 476 media_image16.png Greyscale The Examiner notes that limitations following the term “optionally” will be considered optional. Therefore the limitations that follow the recited “optionally” are considered as being not required, e.g., instant claim 1, lines 6, 8 and the last line of the claim; instant claim 6, line 1. Shariter teaches a modified nucleic acid lipid nanoparticle that is used to form a nucleic acid lipid nanoparticle composition (paragraph [0005]). The lipids disclosed may be used in lipid nanoparticles for the delivery of therapeutics and/or prophylactics, such as a nucleic acid, to mammalian cells or organs (paragraph [00179]). Shariter teaches that in some embodiments, a subset of Formula (IL-I) includes those of Formula (IL-IA) (paragraphs [00180]-[00181]) provided below. PNG media_image17.png 164 310 media_image17.png Greyscale PNG media_image18.png 146 304 media_image18.png Greyscale In some embodiments, a subset of compounds of Formula (IL-I) includes those of Formula (IL-II) (paragraph [0183]), provided below. PNG media_image19.png 185 410 media_image19.png Greyscale Shariter discloses in paragraph [00183] that in the formula, 1 is selected from 1, 2, 3, 4 and 5; M1 [sic] is a bond or M'; R4 is hydrogen, unsubstituted C1-3 alkyl, or -(CH2)nQ, in which n is 2, 3, or 4, and Q is -OH, - NHC(S)N(R)2, -NHC(O)N(R)2, -N(R)C(O)R, -N(R)S(O)2R, -N(R)R8, - NHC(=NR9)N(R)2, -NHC(=CHR9)N(R)2, -OC(O)N(R)2, -N(R)C(O)OR, heteroaryl or heterocycloalkyl; M and M' are independently selected from -C(O)O-, -OC(O)-, -OC(O)-M'- C(O)O-, -C(O)N(R')-, -P(O)(OR')O-, -S-S-, an aryl group, and a heteroaryl group,; and R2 and R3 are independently selected from the group consisting of H, C1-14 alkyl, and C2-14 alkenyl. PNG media_image20.png 149 465 media_image20.png Greyscale Directly above is the elected species of the instant claims. As stated above, Shariter teaches R4 is -(CH2)nQ and when Q is -OH. Here the prior art reads on the elected species where it is highlighted in yellow above. Looking to paragraph [00183] of Shariter and (IL-II) when M and M1 is independently selected from -C(O)N(R’)- , this resembles the C(O)N portion of the elected species as indicated by the matching portions circled in red above in the elected species and in Sahriter’s (IL-II) below. As stated above when M and M' is independently selected from -C(O)O- (see paragraph [0180]), each R' is independently selected from the group consisting of C1-18 alkyl, C2-18 alkenyl, -R*YR", -YR", and H, and here the portions above and below circled in green would match. PNG media_image21.png 162 355 media_image21.png Greyscale Shariter discloses in paragraph [0184] that in one embodiment, the compounds of Formula (IL-I) are of Formula (IL-IIa) (see below) which resembles the elected species I-7. PNG media_image22.png 155 494 media_image22.png Greyscale It would have been obvious to one of ordinary skill in the art to optimize conventional working conditions to use the appropriate starting materials and reagents to obtain the desired result. This is deemed merely a matter of judicious selection and this type of modification would have been well within the purview of the skilled artisan. Conclusion Claims 1-2, 6, 9, 16, 18-20, 22, 24-25, 28-29 and 33 are rejected. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen A. Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached M-F, 9-5. 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, Ali Soroush can be reached at 571-272-9925. 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. /Karen A Ketcham/Examiner, Art Unit 1614 /ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614