DETAILED 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 .
Claims 1-33, 36-37 and 44-50 are pending. Claims 45-46 and 50 are withdrawn. Claims 1-33, 36-37, 44 and 47-49 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-33, 36-37, 44 and 47-49 in the reply filed on 07/09/2026 is acknowledged. The species election of 5’ UTR SEQ ID NO: 101 and RNA molecule of SEQ ID NO: 90 is acknowledged.
Claims 45-46 and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/09/2026.
Information Disclosure Statement
The information disclosure statements filed 1/23/2026, 1/30/2026 and 03/31/2026 have been considered and initialed copies are enclosed.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). See page 212-213 and wherever else this issue may occur.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claim 7, 8-13, 24, 26 and 28 are objected to because of the following informalities:
In claim 7, 8 and 26, since nucleotides do not comprise sequence, line 2 should be corrected to recite “RNA molecule comprises a nucleotide sequence having the sequence set forth in SEQ ID NO: 66-75,”
In claim 28, “or of” is repeated. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7, 8, 9, 10-13, 24, 26 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7 recites “ 3' untranslated region comprises nucleotides having a sequence set forth in SEQ ID NO: 103 (3'UTR hHBB).” Claim 8 recites “ 3' UTR comprises nucleotides having a sequence set forth in SEQ ID NO: 103 (3'UTR_hHBB).” Claim 26 recites “the RNA molecule comprises nucleotides having the sequence set forth in SEQ ID NO:”. Nucleotides do not comprise a sequence, thus the metes and bounds of claims 7,8 and 26 are vague and indefinite. Nucleotides comprise a sugar moiety, a base moiety and a phosphate moiety. See the specification at p. 36 lines 21-24. Suggested wording “nucleotide sequence having a sequence set forth”.
Claim 24 depends on claims 1-23 and recites the limitation "…wherein the 5’ cap moiety is…". There is insufficient antecedent basis for this limitation in the claim because out of claims 1-23 only claim 23 recites that the RNA molecule further comprises a 5’ cap moiety.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. WO2021084429 05/06/2021 cited in IDS.
Anderson et al disclose a polynucleotide vectorpSB02307 (see page 2/51 of figures , fig1A ) encoding a mutant FimH polypeptide comprising an amino acid sequence that is 89.2% identical to SEQ ID NO: 83. See Appendix A.
Claim(s) 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donald et al. WO2021165928 08/26/2021 cited in IDS.
Donald et al disclose a polynucleotide vector pSB02307 (see page 2/54 of figures , fig1A ) encoding a mutant FimH polypeptide comprising an amino acid sequence that is 87.4% identical to SEQ ID NO: 81. See Appendix F.
Claim(s) 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. WO2021084429 05/05/2021 cited in IDS.
Anderson et al disclose a polynucleotide pSB02307 (see page 2/51 of figures , fig1A ) encoding a mutant FimH polypeptide comprising an amino acid sequence (SEQ ID NO: 6) that is 80.5% identical to SEQ ID NO: 77. See Appendix H.
Claim(s) 47 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Che et al. WO2023111907 filed 12/14/2022 cited in IDS.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Che et al disclose a polynucleotide (SEQ ID NO: 70 100% identical to SEQ ID NO: 76) encoding a mutant FimH polypeptide (SEQ ID NO: 71) comprising an amino acid sequence that is 100% identical to SEQ ID NO: 77. See Appendix G and p. 3/21 of figures, figure 2.
Claim(s) 48 and 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Che et al WO 2023/111907 6/22/2023 cited in IDS.
Claim 48 is assigned the effective filing date of the 63/649,495 provisional application filed 5/20/2024.
Che et al disclose a polynucleotide (SEQ NO:70, 100 % identical to SEQ ID NO: 117) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 117. See Appendix B.
Che et al disclose a polynucleotide (SEQ NO: 84, 74.4% identical to SEQ ID NO: 117) encoding a mutant fimH polypeptide comprising nucleic acid having a sequence set forth in SEQ ID NO: 117. See Appendix B.
Che et al disclose a polynucleotide (SEQ NO:72, 100 % identical to SEQ ID NO: 118) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 118. See Appendix C.
Che et al disclose a polynucleotide (SEQ NO:138, 99.5 % identical to SEQ ID NO: 118) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 118. See Appendix C.
Che et al disclose a polynucleotide (SEQ NO:72, 88 % identical to SEQ ID NO: 139) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 139. See Appendix D.
Claim 49: Chen et al disclose the polynucleotide of claim 148, wherein the polynucleotide encoding the mutant FimH polypeptide is transcribed from a nucleic acid sequence (SEQ ID NO: 85, 88.8% identical) set forth in SEQ ID NO: 138. See Appendix I for mRNA and DNA sequence.
Claim(s) 48 and 49 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Che et al WO 2023/111907 6/22/2023 cited in IDS.
Claim 48 is assigned the effective filing date of the 63/649,495 provisional application filed 5/20/2024. Claim 49 drawn to SEQ ID NO: 139 is assigned the effective filing date of the 63/649,495 provisional application filed 5/20/2024.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Che et al disclose a polynucleotide (SEQ NO:70, 100 % identical to SEQ ID NO: 117) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 117. See Appendix B.
Che et al disclose a polynucleotide (SEQ NO: 84, 74.4% identical to SEQ ID NO: 117) encoding a mutant fimH polypeptide comprising nucleic acid having a sequence set forth in SEQ ID NO: 117. See Appendix B.
Che et al disclose a polynucleotide (SEQ NO:72, 100 % identical to SEQ ID NO: 118) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 118. See Appendix C.
Che et al disclose a polynucleotide (SEQ NO:138, 99.5 % identical to SEQ ID NO: 118) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 118. See Appendix C.
Che et al disclose a polynucleotide (SEQ NO:72, 88 % identical to SEQ ID NO: 139) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 139. See Appendix D.
Claim 49: Chen et al disclose the polynucleotide of claim 148, wherein the polynucleotide encoding the mutant FimH polypeptide is transcribed from a nucleic acid sequence (SEQ ID NO: 85, 88.8% identical) set forth in SEQ ID NO: 138. See Appendix I for mRNA and DNA sequence.
Claim(s) 48 and 49 is/are rejected under 35 U.S.C. 102 (a)(1) AND (a)(2) as being anticipated by Adamo et al WO2023227608 11/30/2023.
Claim 48 is assigned the effective filing date of the 63/649,495 provisional application filed 5/20/2024. Claim 49 drawn to SEQ ID NO: 139 is assigned the effective filing date of the 63/649,495 provisional application filed 5/20/2024.
Adamo et al disclose a polynucleotide (SEQ NO: 605, 50 % identical to SEQ ID NO: 117) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 117. See Appendix E.
Adamo et al disclose a polynucleotide (SEQ NO: 1230, 79 % identical to SEQ ID NO: 118) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 118. See Appendix E.
Claim 48 and 49: Adamo et al disclose a polynucleotide (SEQ NO: 635, 69.6 % identical to SEQ ID NO: 138 and SEQ ID NO: 139) encoding a mutant fimH polypeptide comprising nucleic acids having a sequence set forth in SEQ ID NO: 139. See Appendix E.
Claim Rejections - 35 USC § 103
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14, 24-25, 28-33, 36-37 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adamo et al. US 20250345407 11-13-2025 filed 05-23-2023 in view of Bennett et al. WO2024154061 07-25-2024 with priority to 63/480,445 01-18-2023.
The applied reference has a common inventor and common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim 1: Adamo et al disclose an RNA molecule comprising (i) at least one open reading frame (ORF) encoding a fimbrial H antigen (FimH) polypeptide (see abstract, paragraph 2, paragraph 10 and paragraphs 56-69);;
(ii) a 5’ untranslated region (5’ UTR); (iii) a 3’ untranslated region (3’ UTR); and a polyA tail. See paragraph 10 and 169-217
Claim 7 and claim 8: the 3’ UTR disclosed by Adamo et al comprises nucleotides having a sequence e.g. “tttc” set forth in SEQ ID NO: 103. See SEQ ID NO: 67 of Adamo below.
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Claim 9: Adamo et al disclose the FimH polypeptide encoded by the RNA is full-length, truncated, fragment or variant thereof. See paragraphs 56-69 and 137-143.
Claim 10: Adamo et al disclose the FimH polypeptide encoded by the RNA molecule comprises at least one mutation. See paragraphs 56-69 and 137-143.
Claim 11-13: Adamo et al disclose the FimH polypeptide encoded by the RNA molecule has at least 97% identity to SEQ ID NO: 62 (see appendix L) or has 100% identity to SEQ ID NO: 62 (see appendix M), wherein the FimH polypeptide encoded by the RNA molecule is FimH-DSG triple mutant (G15A, G16A, V27A) (SEQ ID NO:62 – see Appendix M), or an immunogenic fragment thereof.
Claim 14. Adamo et al disclose the FimH polypeptide encoded by the RNA molecule is fused to a C-terminal membrane targeting domain such as a C-terminal heterologous transmembrane domain which promotes anchoring of the encoded FimH. See paragraphs 110-123.
Claim 24: Adamo et al disclose the RNA molecule of further comprises a 5' cap moiety is m7G(5')ppp(5')(2'OMeA)pG (paragraph 241).
Claim 25. Adamo et al disclose the poly-A tail comprises a sequence having SEQ ID NO: 92. For example, Adamo et al disclose the poly-A tail comprises 100, 200, 300, 400 or 500 adenosine nucleotide which all comprise SEQ ID NO: 92 which has 82 adenosine nucleotides. See paragraph 205-216.
Claim 28. Adamo et al disclose wherein the open reading frame comprises a G/C content of at least 55%, 60%, 65%, 70%, or 75%, or of or of about 50% to 75% or 55% to 70%. See paragraph 154,
Claim 29. Adamo et al disclose The RNA molecule wherein the encoded FimH polypeptide localizes in the cellular membrane (paragraph 71) or is secreted (paragraph 71, 102-104).
Claim 30: Adamo et al disclose the RNA molecule comprises at least one modified nucleotide. See paragraph 17.
Claim 31-33: Adamo et al disclose the wherein the modified nucleotide is pseudouridine (ⱷ), N1-methylpseudouridine (m1ⱷ), N1-ethylpseudouridine, 2-thiouridine, 4-thiouridine, 5-methylcytosine, 5-methyluridine, 2-thio-1-methyl-1-deaza-pseudouridine, 2-thio-1-methyl-pseudouridine, 2-thio-5-aza-uridine, 2-thio-dihydropseudouridine, 2-thio-dihydrouridine, 2-thio-pseudouridine, 4-methoxy-2-thio-pseudouridine, 4-methoxy-pseudouridine, 4-thio-1-methyl-pseudouridine, 4-thio-pseudouridine, 5-aza-uridine, dihydropseudouridine, 5-methoxyuridine and 2′-O-methyl uridine. See paragraph 249-253.
Claim 36: Adamo et al disclose a composition comprising the RNA molecule of
Claim 37. Adamo et al disclose the composition of claim 36, wherein lipid nanoparticle comprises at least one of a cationic lipid, a PEGylated lipid, a neutral lipid, and a steroid or steroid analog. See paragraph 399-457.
Claim 44. Adamo et al disclose the composition of claim 37, wherein the composition is a vaccine. See title, abstract and paragraph 363-364.
Adamo et al does not disclose that the 5’ untranslated region comprises a nucleic acid sequence at least 90% identical to a nucleic acid sequence set forth in SEQ ID NO: 101.
Bennett al (all portions cited are from the 63/480,445) disclose mRNA molecules and methods of stabilizing the mRNA molecule. See paragraph 1. The mRNA molecule comprises in the 5’>3”, the 5’ UTR, the mRNA coding sequence, a 3’ untranslated region and a polyadenyl sequence (polyA tail). Bennett et al disclose the 5’ UTR comprises a nucleic acid sequence (SEQ ID NO: 40) that is at 100% identical to the nucleic acid sequence set forth in SEQ ID NO: 101. See Appendix N for sequence alignment. See paragraph 4-5 and paragraph 165. Bennett et al disclose the 5’ UTR sequence is an optimized sequence designed to improve translation efficiency to ensure high levels of expression. See paragraph 3.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the mRNA molecule of Adamo et al by using the 5’UTR sequence of Bennett et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Bennett et al disclose the 5’ UTR sequence is an optimized sequence designed to improve translation efficiency to ensure high levels of expression.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adamo et al. US 20250345407 11-13-2025 filed 05-23-2023 and Bennett et al. WO2024154061 07-25-2024 with priority to 63/480,445 01-18-2023 as applied to claims 1-14, 16, 24-25, 28-33, 36-37 and 44 above, further in view of Che et al. WO 2023/111907 (published 06-22-2023) with priority to 63/384,607 filed 11/22/2022.
The combination of Bennett et al and Che et al does not teach that the C- terminal membrane targeting domain of the RNA molecule is DAFgpi .
Che et al disclose mRNA encoding FimH designed to localize to the cell surface by anchoring to the plasma membrane. The mRNA encodes fimH with a C-terminal GPI-anchor signal of human decay accelerating factor (DAF) protein (DAFgpi). See p.142 lines 34-38, p. 145 lines 1ines 16-20. Che et al discloses that cell surface expression of fimH via DAFgpi resulted in high titers of antibody when formulated in the lipid nanoparticle. See table 11 page 158.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the mRNA molecule of Adamo et al and Bennett et al such that the mRNA encoding the C-terminal membrane domain is DAFgpi as taught by Che et al, resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Che et al disclose that cell surface expression of fimH via DAFgpi resulted in high titers of antibody when formulated in the lipid nanoparticle.
Allowable Subject Matter
Claims 16-23 are 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.
Conclusion
Claims 1-15, 24-33, 36-37, 44 and 47-49 are rejected. Claims 45-46 and 50 are withdrawn. Claim 16-23 are objected to.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
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