DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 56-75 are pending upon entry of amendment filed on 11/26/25.
3. Applicant’s IDS filed on 11/19/24, 2/21/25, 6/4/25, 6/26/24, 11/29/25 and 5/13/26 have been acknowledged.
The non-English foreign patent documents have been considered to its extent to English abstract.
4. The oath filed on 11/19/24 has been acknowledged.
5. 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 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.
6. 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.
7. Claim(s) 56-75 is/are rejected under 35 U.S.C. 102(a)(1)and (a)(2) as being anticipated by U.S. Pat 10,653,780 (IDS reference).
The ‘780 patent teaches lipid nanoparticles comprising nucleic acid, about 40 mol % ionizable cationic lipid DLin-KC2, 10 % DSPC, 40% cholesterol and 10% PEG-DMG (col. 26, claims 1-10).
As is seen in claims 58-65, the PEG conjugated lipid is PEG-DMG, the prior art D-Lin-KC2 reads on claimed phospholipid with different acyl lengths as in claim 69. Further, additional phospholipid is DSPC as well as DPPS (note col. 23). Further, the ’780 patent teaches nucleic acid is mRNA (note col. 28). Additionally, the ‘780 patent teaches non-cationic lipid prefers acyl groups of lauroyl, myristoyl, palmitoyl, stearoyl or oleoyl (col. 23). Therefore, the reference teachings anticipate the claimed invention.
8. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Pat 12,064,479.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘479 patent recite a nucleic acid lipid nanoparticle composition comprising a mRNA nucleic acid encapsulated in lipid nanoparticles comprising a cholesterol with N/P ratio of 4-7, two or more phospholipids and PEG containing conjugated lipid amount of 0.5-2.5mol %.
10. Claims 56-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Application 18/673,689.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘689 application recite a nucleic acid lipid nanoparticle composition comprising a mRNA nucleic acid encapsulated in lipid nanoparticles comprising a cholesterol with N/P ratio of 4-7, two or more phospholipids and PEG containing conjugated lipid amount of 0.5-2.5mol %.
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Yunsoo Kim
Patent Examiner
Technology Center 1600
July 21, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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