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. Election/Restrictions Applicant’s election without traverse of : (species of Formula 1) and (species of lipid represented by R 51 -L-(OCH 2 CH 2 ) n -O-R 52 ) , in the reply filed on 12/08/2025 , is acknowledged. Claim Rejections - 35 USC § 103 - Obviousness 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. Claim (s) 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al (WO 2019/235635 A1, with an English translation provided by Tanabe et al (US 2021 / 0085604A1 )), in view of Almarsson et al (US 2022/0031631 A1). Tanabe taught compound s constituting lipid particles that achieve d nucleic acid encapsulation and delivery of nucleic acids. According to an aspect of Tanabe’s disclosure , a compound represented by Formula (1) was provided [abstract]: [see Tanabe at page 13 and the 2 nd compound]. Tanabe also taught sterol (e.g., cholesterol, at least one non-cationic lipid) [0356]. PEG and PEG-modified polymers were generally taught [0366 and 0368-0369]. Although Tanabe generally taught PEG and PEG-modified polymers , Tanabe was specifically silent as instantly elected. Nevertheless, Almarsson taught (e.g., PEG - stearate) [face page] as a high-purity PEG [abstract] that, when included within lipid particle compositions or formulations, the said compositions result ed in improved physical and biological properties, including being less susceptible to recognition and clearance by the body [0010-0012] . Since Tanabe taught delivery of nucleic acids with lipid particles generally comprised of PEG polymers, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Tanabe, PEG-stearate, as taught by Almarsson. The ordinarily skilled artisan would have been so motivated, because PEG-stearate is of a high purity, and when included within lipid particle compositions or formulations, therein results improved physical and biological properties of the composition , including being less susceptible to recognition and clearance by the body , as taught by Almarsson [0010-0012] . Tanabe, in view of Almarsson, reads on claims 1-2, 4, 6-7 and 11 . Claim 3 is rendered prima facie obvious because Tanabe taught the compound of Formula (1) at 20 mol % to 80 mol % [0353]. The instant claim 3 recites the lipid present at 30 to 70 mol %. Tanabe taught the lipid present at 20 mol % to 80 mol %. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A. Claims 5 , 9 and 10 are prima facie obvious because Tanabe taught cholesterol, as discussed, and sphingomyelin [0362], reading on non-ionic and zwitterionic, respectively. Sphingomyelin was taught at 3 mol % to 55 mol % [see ¶ 0364]. Further regarding the instant claim 10, the claim recites the zwitterionic lipid at 1 to 30 mol %. Tanabe taught sphingomyelin at 3 mol % to 55 mol %. A prima facie case of obviousness exists because of overlap, as discussed above. Claim 8 is rendered prima facie obvious because Tanabe taught cholesterol at 10 mol % to 60 mol % [0357]. The instant claim 8 recites non-ionic lipid at 10 to 60 mol %. Tanabe taught cholesterol at 10 mol % to 60 mol %. A prima facie case of obviousness exists because of overlap, as discussed above. Claim 12 is rendered prima facie obvious because Tanabe taught PEG and PEG-containing polymers included from 0.25 mol % to 12 mol % [0372]. The instant claim 12 recites the lipid represented by R 51 -L-(OCH 2 CH 2 ) n -O-R 52 present at 0.1 to 10 mol %. Tanabe taught PEG and PEG-containing polymers included from 0.25 mol % to 12 mol %. A prima facie case of obviousness exists because of overlap, as discussed above. Claim 13 is rendered prima facie obvious because Tanabe taught 0.01% to 50% by weight nucleic acid [0375]; the compound of Formula (1) at 20 mol % to 80 mol %. The Examiner notes that the instant claim 13 recites a weight ratio of lipid to nucleic acid. Tanabe disclosed the lipid of Formula (1) in mole % , and the amount of nucleic acid in weight %. It would be prima facie obvious to one of ordinary skill in the art to mathematically determine the amount of Tanabe’s lipid in weight, in order to obtain the weight ratio of the lipid to the nucleic acid, as recited. Claim 14 is rendered prima facie obvious because Tanabe taught pharmaceutically acceptable carriers [0398]. Claims 15-1 8 are rendered prima facie obvious because Tanabe taught pharmaceutical use to introduce a nucleic acid into a cell ; for delivery into a living body ; by rectal administration (e.g., a type of topical administration); nasal administration (e.g., reads on in vivo administration to the central nervous system) [0396 , 0399 ]. Claim 19 is rendered prima facie obvious because Tanabe taught nucleic acid delivery carriers [0401-0402]. Nonstatutory Double Patenting 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 . Claim s 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-14 of copending Application No. 17/743,584 . Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17/457,793. Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/884,577. Although the claims at issue are not identical, they are not patentably distinct from each other because the species (lipid composition comprising nonionic lipids, non-cationic lipids and nucleic acids) recited in the copending claims falls within the genus (lipid composition) recited in the claims of the instant application, and thus read on the instant claims. Th ese are provisional nonstatutory double patenting rejection s because the patentably indistinct claims have not in fact been patented. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT CELESTE A RONEY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-5192 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday; 8 AM-6 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, FILLIN "SPE Name?" \* MERGEFORMAT Sahana S Kaup can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /CELESTE A RONEY/ Primary Examiner, Art Unit 1612