BIODEGRADABLE LIPIDS FOR THE DELIVERY OF ACTIVE AGENTS

DETAILED ACTION Claims 20-72, submitted on August 9, 2024, are pending in the application and are rejected for the reasons set forth below. No claim is allowed, although the application would be allowable if a terminal disclaimer were to be submitted, as discussed below. Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions of the Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. 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 Election/Restrictions The requirement for restriction in the communication mailed on March 19, 2026 is hereby withdrawn. Applicant’s election thereof in the response submitted on August 5, 2026 is therefore moot. 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 possi-ble 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 provi-sions 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 accompa-nied 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 that 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 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 9,061,063 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘063 Patent claims the cationic lipid recited in the instant claims. See the ‘063 Patent at col. 547-48 (specifically, the third compound at this location in the Patent). Although the ‘063 Patent does not specifically claim the lipid nanoparticle of the instant claims (see instant claims 20 and 58, as well as the claims depending thereon) or the claimed method of modulating the expression of a target gene (see claim 50 and claims depending thereon), these compositions and methods would have been prima facie obvious when claim 18 of the ‘063 Patent is read in light of the corresponding written description of that subject matter elsewhere in the Patent. See, e.g., the ‘063 Patent at col. 35, ll. 40-55, which discloses lipid nanoparticles according to instant claim 20. PEG-modified lipid nanoparticles at disclosed, e.g., at col. 28, ll. 25-30, which suggests the subject matter of instant claim 21 and 33-37. The concentration limitations of the instant claims are suggested in the Patent at, e.g., col. 403, l. 50 – col. 404, l. 40. The use of DPPC and DSPC is suggested in the Patent at col. 404, ll. 1-3, which suggests the subject matter of instant claim 29. The use of cholesterol is disclosed in the Patent at col. 403, l. 13, which suggests the subject matter of instant claim 32. Various types of nucleic acids are disclosed in the Patent at, e.g., col. 406, ll. 10-50, which suggests the subject matter of instant claims 42-47, 52-57, 59-64, and 67-72. Pharmaceutical composi-tions are disclosed in the Patent at col. 406, l. 50 et seq., which suggest the compositions of instant claims 48-49 and 65. The examiner therefore concludes that the instant claims are prima facie obvious over the claims of the ‘063 Patent. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,687,448 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Although the ‘448 Patent does not specifically claim the cationic lipid of the instant claims, it nevertheless generically claims these lipids (see the “biodegradable cationic lipid” in claim 1 of the ‘448 Patent), and it discloses (see, e.g., the first compound in Table 2 at col. 423-44) the cationic lipid of the instant claims as an example of such a lipid. The instant claims are therefore prima facie obvious over the subject matter claimed in the ‘448 Patent. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 10,369,226 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,246,933 B1. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,382,979 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,400,158 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,590,229 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,612,657 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11633479 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,633,480 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,679,158 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,239,709 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,343,398 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,350,338 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Claims 20-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,364,762 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. 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. THEODORE R. HOWELL Primary Examiner Art Unit 1628 /THEODORE R. HOWELL/Primary Examiner, Art Unit 1628 October 7, 2026