DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of selected species in the reply filed on April 29, 2026 is acknowledged.
Claims Summary
Claim 117 is directed to a carrier-formulated mRNA comprising at least one coding sequence encoding an influenza HA stem polypeptide. The specification teaches that carrier systems encapsulate or complex mRNA (see paragraph [0544] of the published application US 2024/0181037 A1). (Thus, the carrier-formulated mRNA does not comprise a carrier such as water, since water does not encapsulate or complex mRNA.) The carrier is a LNP (claim 118), comprising a PEG-modified lipid at around 0.5 to 15 molar %, a non-cationic lipid at around 5 to 25 molar %, a sterol at around 25 to 55 molar %, and an ionizable cationic lipid at around 20 to 60 molar. The ionizable cationic lipid has the formula III, or a pharmaceutically acceptable salt, tautomer or stereoisomer thereof. Formula III:
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88
218
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The L, R, G groups and the elected species are:
L1 is -O(C=O)-;
L2 is -O(C=O)-;
G1 is unsubstituted C1-C12 alkylene;
G2 is unsubstituted C1-C12 alkylene;
G3 is C1-C24 alkylene;
R1 is C6-C24 alkyl
R2 is C6-C24 alkyl;
R3 is O-R5; and
R5 is H
The mRNA comprises at least one additional coding sequence which encodes a protein nanoparticle, ferritin, or bacterial ferritin (claim 120). The influenza HA stem polypeptide is derived from influenza A (claim 121), subtype H1 (claim 122), or subtype H10 (claim 123). In another embodiment, the mRNA comprises to or more coding sequences, each encoding an influenza HA stem polypeptide on separate mRNA molecules (claim 124). The stem polypeptide is derived from subtype H1 or subtype H10 (claim 125), or, subtypes H1 and H7, but not H10 (claim 126), or, subtypes H1 and H10, but not subtype H7 (claim 127). The mRNA comprises at least one chemical modification, N1-methylpseudouridine and/or pseudouridine (claim 130).
Also claimed is an immunogenic composition comprising the carrier-formulated mRNA with at least one pharmaceutically acceptable carrier (claim 131), and a vaccine comprising the immunogenic composition (claim 132). Claim 133 is directed to a kit or kit of parts comprising the carrier-formulated mRNA. Claim 134 is directed to a method of treating or preventing a disorder, comprising applying or administering to a subject in need thereof the carrier-formulated mRNA (claim 134). Claim 135 is directed to a method of eliciting an immune response against an influenza virus, comprising applying or administering to a subject in need thereof the carrier-formulated mRNA, the immunogenic composition or the vaccine.
Claim Rejections - 35 USC § 102
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.
Claims 117-127 and 130-135 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ciaramella and Huang (WO 2018/170245 A1, of record in the IDS filed 8/8/2024, “Ciaramella”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Ciaramella discloses influenza vaccines comprising mRNA comprising an open reading frame encoding at least one influenza HA2 stem antigen from, for example, H1N1 A/Puerto Rico/8/1934, or H10N8 A/JX346/2013, formulated in a LNP (see page 3, lines 3-5, pages 40-41, bridging paragraph, and Table 16) (claims 117, 118 and 121-123). The LNP comprises a molar ratio of about 0.5-15% PEG-modified lipid, about 25-55% sterol, about 5-25% non-cationic lipid, and about ionizable 20-60% cationic lipid (see page 8, lines 22-24, and claim 38) (claim 119). Ciaramella’s Compound 10 (see page 127) meets the limitations of the elected species (claim 119). The mRNA comprises pseudouridine chemical modification (see page 64, lines 11-16) (claim 130). Ciaramella discloses immunogenic compositions and vaccines comprising the mRNA with LNP and a pharmaceutically acceptable carrier (see pages 2-3, bridging paragraph, and page 30, lines 3-6) (claims 131 and 132). Also disclosed are ferritin sequences for fusions to enable particle formation, kits, methods of treating and preventing disease, and inducing an immune response against influenza virus (see page 191, lines 16-17, page 72, lines 17-20, and page 73, lines 9-10) (claims 120 and 133-135).
Ciaramella discloses a combination vaccine comprising mRNA encoding at least one antigenic polypeptide protein or portion thereof of a first influenza virus, and at least another one from a second influenza virus, formulated in a single LNP or on separate LNPs for co-administration (see pages 2-3, bridging paragraph) (claim 124). The combination vaccines comprise multiple coding sequences from different subtypes (see page 3, last paragraph) (claims 126 and 127, aspect of three or more coding sequences). Ciaramella discloses selecting from all subtypes, including H1-H18 (see page 3, last paragraph, and page 30, first full paragraph) (claim 125). Considering the combinations of subtypes available, some combinations will include H7 but not H10, while other combinations will not include H7 nor H10 (claims 126-127). Therefore, the claimed embodiments are anticipated by the prior art.
Double Patenting
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 117, 118, 131, 133 and 134 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 95, 96, 115, 117 and 118 of copending Application No. 18/283,632 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 117, 118, 131, 133 and 134 of this application is patentably indistinct from claims 95, 96, 115, 117 and 118 of copending Application No. 18/283,632. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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 120-123, 130, 132 and 135 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 95, 96, 99, 101-104 and 113-119 of copending Application No. 18/283,632 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims are directed to carrier-formulated mRNA comprising at least one coding sequence encoding an influenza HA stem polypeptide, wherein the carrier is an LNP, and further comprises ferritin. The copending claims employ stem polypeptides from influenza A Group 1, or influenza A Group 2, encompassing subtypes H1-H18. The copending claims encompass chemical modifications, such as pseudouridine, as well as embodiments of vaccines.
Copending claim 135 is directed to a method of eliciting an immune response, but does not specify that the immune response is against influenza as in instant claim 135. However, it would have been obvious to have claimed this specific feature since the vaccine comprises an influenza antigen. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 119 and 124-127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 95, 96, 99, 101-104 and 113-119 of copending Application No. 18/283,632 (reference application) as applied to claim 117 above, and further in view of Ciaramella and Huang (WO 2018/170245 A1, of record in the IDS filed 8/8/2024, “Ciaramella”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Copending claims 97 and 98 are directed to embodiments wherein the LNP comprises a PEG-modified lipid, a non-cationic lipid, a sterol and a non-ionizable cationic lipid. The copending claims do not specify the molar percentages of the components, nor the formula of the ionizable cationic lipid. However, these features would have been obvious to have claimed in view of the teachings of Ciaramella.
Ciaramella discloses influenza vaccines comprising mRNA comprising an open reading frame encoding at least one influenza HA2 stem antigen from, for example, H1N1 A/Puerto Rico/8/1934, or H10N8 A/JX346/2013, formulated in a LNP (see page 3, lines 3-5, pages 40-41, bridging paragraph, and Table 16). The LNP comprises a molar ratio of about 0.5-15% PEG-modified lipid, about 25-55% sterol, about 5-25% non-cationic lipid, and about ionizable 20-60% cationic lipid (see page 8, lines 22-24, and claim 38). Ciaramella’s Compound 10 (see page 127) meets the limitations of the elected species.
Instant claims 124-127 are directed to embodiments wherein two or more coding sequences, or three or more coding sequences for HA stem polypeptides are encoded on separate mRNA molecules, as well as embodiments wherein the combinations of influenza subtypes include H7 and exclude H10, or exclude both H7 and H10. The copending claims are not directed to these embodiments. However, it would have been obvious to have claimed these embodiments in view of Ciaramella’s teachings, with a reasonable expectation of success. Ciaramella discloses a combination vaccine comprising mRNA encoding at least one antigenic polypeptide protein or portion thereof of a first influenza virus, and at least another one from a second influenza virus, formulated on separate LNPs for co-administration (see pages 2-3, bridging paragraph). The combination vaccines comprise multiple coding sequences from different subtypes (see page 3, last paragraph). Ciaramella discloses selecting from all subtypes, including H1-H18 (see page 3, last paragraph, and page 30, first full paragraph). Considering the combinations of subtypes available, some combinations will include H7 but not H10, while other combinations will not include H7 nor H10.
Conclusion
No claim is allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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