Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 8/27/2024 wherein claims 1-68 were canceled and claims 69-82 were added.
Note(s): Claims 69-82 are pending.
Priority
This application is a CON of 17/556,316 filed 12/20/2021 (now US Patent No. 12,102,720); 17/556,316 is a CON of 16/790,407 filed 2/13/2020 (now US Patent No. 11,234,936);
16/790,407 is a CON of 16/452,353 filed 6/25/2019 (now US Patent No. 10,702,478);
16/452,353 is a CON of 15/887,693 filed 2/2/2018 (now US Patent No. 10,507,183);
15/887,693 is a CON of 15/651,832 filed 7/17/2017 (now abandoned);
15/651,832 is a CON of 14/124,615 filed 6/4/2014 (now US Patent No. 9,717,690);
14/124,615 is a 371 of PCT/US12/41663 filed 6/8/2012;
PCT/US12/41663 claims benefit to PRO 61/494,882 filed 6/8/2011; and
PCT/US12/41663 claims benefit to PRO 61/494,745 filed 6/8/2011.
Note(s): The earliest effective filing date is 6/08/2011 as the pending invention is fully supported by both provisional applications.
Claim Interpretation
Both independent claims 69 and 82 are directed to a pharmaceutical composition comprising trehalose and a lipid nanoparticle comprising mRNA, a cationic lipid, a PEG-modified lipid, a non-cationic lipid, and cholesterol as set forth therein.
Information Disclosure Statement
The information disclosure statements filed 8/27/2024; 6/13/2025; and 7/29/2025 were considered.
Double Patenting Rejection
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 69-75 and 77-82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,507,183. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a composition comprising trehalose and a lipid nanoparticle comprising mRNA, a cationic lipid, a PEG modified lipid (e.g., DMG-PEG2000), a non-cationic lipid (e.g., DOPE), and cholesterol wherein the form of the composition may be intravenous, oral, rectal, vaginal, transmucosal, sublingual, subdural, nasal, intramuscular, subcutaneous, intramedullar injection, intrathecal, intraventricular, intraperitoneal, intranasal, ophthalmic, and intraocular.
The claims differ in that some of the pending claims (see claims 72 and 78-81) disclose specific amounts of the designated amounts. It would have been obvious to modify claims such that they contain optimized amounts of the designated components that are present based on the teachings of MPEP 2144.05 which establishes that where the general conditions of a claim are disclosed, finding an optimal or workable range is common. The limitations of claims 72 and 78-81 further define ranges of having the components present in the effective pharmaceutical composition.
Hence, for the reasons supra, the pending invention is encompassed within the scope of the patented claims.
Claim Objection
Claim 76 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Comments/Notes
Claim 77 is a duplicate of claim 75.
The Examiner is aware of numerous applications with similar subject matter. However, while every effort has been made to review all applications containing overlapping subject matter, some applications may have been missed. Thus, Applicant is respectfully requested to submit all serial numbers of applications containing overlapping subject matter for review by the Examiner.
It should be noted that no prior art is cited against the pending claims. The closest art is Applicant’s own work which is cited in the double patenting rejection. In particular, the pending claims are distinguished over the prior art because the prior art neither anticipates nor renders obvious all of the components present in the composition.
Conclusion
Claims 69-75 and 77-82 are rejected. Claim 76 is objected.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 29, 2026
Prosecution Insights