9023DETAILED 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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 2-4 and 11; drawn to a mutated Ras RNA having mutation at 12th, 13th, 19th, 59th, 60th, 61th, 117th , and/or 146th positions of the amino acid residues of SEQ ID NO: 70) in the reply filed on 02/24/2026 is acknowledged. Claims 1-22, 24, 32, 35-37, 39-41, 53, 58-60, 70 and 75 are pending; claims 1, 5-10, 12-22, 24, 32, 35-37, 39-41, 53, 58-60, 70 and 75 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 2-4 and 11 are examined.
Claim Rejections - 35 USC § 103
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Petit et al. (WO2018102585- cited by Applicant) in view of Mukalel et al. (Nanoparticles for nucleic acid delivery: Applications in cancer immunotherapy. Cancer letters, 458, 102-112, 2019).
The claims are drawn to an isolated ribonucleic acid (RNA) comprising an open reading frame (ORF) encoding a Ras derived peptide, wherein the encoded Ras derived peptide comprises any one or more of the following mutations:
a phenylalanine (F) aligned to the 19th amino acid residue of SEQ ID NO: 70;
a threonine (T) aligned to the 59th amino acid residue of SEQ ID NO: 70;
an aspartic acid (D) aligned to the 60th amino acid residue of SEQ ID NO: 70;
an asparagine (N) aligned to the 117th amino acid residue of SEQ ID NO: 70; or
a T aligned to the 146th amino acid residue of SEQ ID NO: 70,
and the RNA further comprises another mutation:
D aligned to the 12th amino acid residue of SEQ ID NO: 70,
D aligned to the 13th amino acid residue of SEQ ID NO: 70;
F aligned to the 19th amino acid residue of SEQ ID NO: 70;
T aligned to the 59th amino acid residue of SEQ ID NO: 70;
D aligned to the 60th amino acid residue of SEQ ID NO: 70;
H aligned to the 61th amino acid residue of SEQ ID NO: 70;
N aligned to the 117th amino acid residue of SEQ ID NO: 70; or
T aligned to the 146th amino acid residue of SEQ ID NO: 70.
and wherein the RNA is encapsulated in a nanoparticle.
Petit et al. teaches personalized immunotherapy compositions comprising a recombinant Listeria strain comprising a nucleic acid comprising an open reading frame encoding a fusion polypeptide, wherein the fusion polypeptide comprises a PEST-containing peptide fused to one or more antigenic peptides, wherein each of the antigenic peptides comprises a cancer-specific neoepitope comprising a cancer-specific mutation found in a cancer sample from a subject but not in a healthy biological sample from the subject (abstract). One of the cancer-associated proteins RAS and
the antigenic peptides comprise 2 or more of the following recurrent cancer mutations: G12A; G12C; G12D; G12R; G12S; Gl2V; G13C; G13D; G13R; G13S; G13V; L19F; Q61K; Q61H; Q61L; Q61R; K117N; A146T; A146V; and A164G. The mutations can be in any order ([00165]). Nucleic acids (minigene constructs) encoding such recombinant fusion polypeptides are also disclosed. The nucleic acid can be in any form. The nucleic acid can comprise or consist of DNA or RNA, and can be single-stranded or double-stranded. The nucleic acid can be in the form of a plasmid, such as an episomal plasmid, a multicopy episomal plasmid, or an integrative plasmid. Alternatively, the nucleic acid can be in the form of a viral vector, a phage vector, or in a bacterial artificial chromosome. Such nucleic acids can have one open reading frame or can have two or more open reading frames (e.g., an open reading frame encoding the recombinant fusion polypeptide and a second open reading frame encoding a metabolic enzyme) ([00295]).
The reference is silent about encapsulating the RNA in a nanoparticle.
Mukalel et al. is representative for the state of the art at the time that the invention was filed. Nucleic acid therapeutics, including DNA, mRNA, and genome editing systems, hold significant potential as a form of immunotherapy due to its robust use in cancer vaccination, adoptive T-cell therapy, and gene regulation. However, these therapeutics must overcome numerous delivery obstacles to be successful, including rapid in vivo degradation, poor uptake into target cells, required nuclear entry, and potential in vivo toxicity in healthy cells and tissues. Nanoparticle delivery systems have been engineered to overcome several of these barriers as a means to safely and effectively deliver nucleic acid therapeutics to immune cells. The applications of nucleic acid therapeutics in cancer immunotherapy using nanoparticle platforms designed to deliver mRNA, DNA, and genome editing systems to enhance the potency and safety of these therapeutics were discussed (abstract).
it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have considered delivery procedures based on nanoparticles to deliver the mutant Ras RNAs of Petit et al. with a reasonable expectation of success. This is because the RNA mutants were known and used in the art and a skilled artisan would have used known and proven delivery method for therapeutic purposes.
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 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.
Claim 2-4 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 18/534557 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the provisional application, drawn to an isolated ribonucleic acid (RNA) comprising an open reading frame (ORF) encoding at least one Ras derived peptide and at least one oncogenic TP53 peptide, wherein the encoded Ras derived peptide comprises any one or more of the following mutations:
a phenylalanine (F) aligned to the 19th amino acid residue of SEQ ID NO: 70;
a threonine (T) aligned to the 59th amino acid residue of SEQ ID NO: 70;
an aspartic acid (D) aligned to the 60th amino acid residue of SEQ ID NO: 70;
an asparagine (N) aligned to the 117th amino acid residue of SEQ ID NO: 70;
or a T aligned to the 146th amino acid residue of SEQ ID NO: 70, and optionally wherein the Ras derived peptide further comprises any one or more of the following mutations:
a D aligned to the 12th amino acid residue of SEQ ID NO: 70,
a D aligned to the 13th amino acid residue of SEQ ID NO: 70;
or a histidine (H) aligned to the 61th amino acid residue of SEQ ID NO: 70, and wherein the RNA is encapsulated in a nanoparticle. Further the ORF may comprise a polynucleotide as in SEQ ID NO: 88. (Nota bene: the Sequence Numbers are identical).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647 18