DETAILED ACTION 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 2. 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 cited rejections 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. 3. Response s to Election/Restriction filed on 10/ 30 /2025 and 11/25/2025 are acknowledged. 4. Claim filed on 11/25/2025 is acknowledged. 5. Claims 1-14, 16, 18-23, 26-32, 34-39, 41-58, 60-62, 65, 67-69 and 72-79 have been cancelled . 6. Claims 15, 17, 24, 25, 33, 40, 59, 63, 64, 66, 70 and 71 are pending in this application. 7. Claims 66 and 71 are withdrawn from consideration pursuant to 37 CFR 1.142(b) , as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claim 25 is withdrawn from consideration as being drawn to non-elected species. 8. Claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are under examination. Election/Restrictions 9 . Applicant’s election of Group 1 ( claims 1, 2, 8, 11, 15, 17, 24, 25, 33, 40, 59, 63, 64 and 70 ) and election of SEQ ID NO: 2 with the structure Isovaleric acid-D-T-H-[Dpa]-P-C-I-(D)Lys-bhPhe-[Lys(Ahx-Palm)]-R-C-NH 2 as species of hepcidin analogue in the repl ies filed on 10/30/2025 and 11/25/2025 are acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The requirement is made FINAL in this office action. Group 1 is drawn to a hepcidin analogue comprising: (a) a peptide according to Formula IIa, or a peptide dimer comprising two peptides according to Formula IIa, or a pharmaceutically acceptable salt or solvate thereof; or (a) a peptide according to Formula IIb, or a peptide dimer comprising two peptides according to Formula IIb, or a pharmaceutically acceptable salt or solvate thereof; and a pharmaceutical composition comprising such hepcidin analogue or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable carrier, excipient or vehicle . A search was conducted on the elected species; and prior art was found . Claim 25 is withdrawn from consideration as being drawn to non-elected species. Claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are examined on the merits in this office action. Claim Interpretations 1 0 . With regards to the limitations recited in instant claims 40 and 59, claims 40 and 59 depend on claim 15 and include all the limitations of instant claim 15. Therefore, for the purpose of this examination, the Examiner is interpretating the hepcidin analogue or pharmaceutically acceptable salt or solvate thereof recited in instant claims 40 and 59 is the one recited in instant claim 15 with further limitations on the PEG recited in instant claim 15. Thus, the elected species of hepcidin analogue reads on instant claims 40 and 59. Sequence Non-Compliance 1 1 . This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims. In the instant case, instant specification discloses Ref. Cmpd. 1 and Ref. Cmpd. 2 on page 60, Table 3A and page 109, Table 7; and peptides H 2 N-S-K-G-C-Lys-NH 2 and Isovaleric Acid-D-T-H-F-P-Cys(R')-Ile-Lys(IsoGlu_Palm)-F-E-P-R-OH on page 75, paragraph [00182] of instant specification. However, these peptides are not in the sequence listing filed on 1/27/2023 . All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database. Objections 1 2 . The specification is objected to for the following minor informality: The instant specification discloses Ref. Cmpd. 1 and Ref. Cmpd. 2 on page 60, Table 3A and page 109, Table 7; and peptides H 2 N-S-K-G-C-Lys-NH 2 and Isovaleric Acid-D-T-H-F-P-Cys(R')-Ile-Lys(IsoGlu_Palm)-F-E-P-R-OH on page 75, paragraph [00182] of instant specification. However, these peptides are not in the sequence listing filed on 1/27/2023 ; and they are missing the respective sequence identifier. Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d). 1 3 . The specification is objected to for the following minor informality: The specification recites various peptides on pages 57-59, Table 2; pages 60-73, Tables 3A-3C; and many others throughout the specification. However, these peptides disclosed in instant specification are inconsistent with those disclosed in the sequence listing filed on 1/27/2023. These peptides disclosed in instant specification have -NH 2 group at the C-terminus, while they have -OH group at the C-terminus in the filed sequence listing. Applicant is required to correct this error. Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01). 1 4 . Claim 1 5 is objected to for the following minor informality: Applicant is suggested to amend claim 1 5 as “ …Y2 is an amino acid or absent, and wherein : i) the peptide of Formula IIa or Formula IIb is… ”. 1 5 . Claim 17 is objected to for the following minor informality: Applicant is suggested to amend claim 17 as “… wherein: (a) B7(L1Z) is -N(H)C[CH 2 N(H)L1Z](H)-C(O)-; (b) B7(L1Z) is -N(H)C[CH 2 CH 2 CH 2 CH 2 N(H)L1Z](H)-C(O)-; (c) B5(L1Z) is -N(H)C[CH 2 N(H)L1Z](H)-C(O)-; (d) B5(L1Z) is -N(H)C[CH 2 CH 2 CH 2 CH 2 N(H)L1Z](H)-C(O)-; or (e) B5 is (D)Lys ”. In the instant case, component (a) recited in instant claim 1 7 includes components (b) and (c); and component (d) recited in instant claim 1 7 includes components (e) and (f). 1 6 . Claim 24 is objected to for the following minor informality: Applicant is suggested to amend claim 24 as “… comprising a peptide according to Formula IIIa or IIIb:… or a peptide dimer thereof, or a pharmaceutically acceptable salt or solvate thereof , wherein R 1 ,… ”. 1 7 . Claim 33 is objected to for the following minor informality: Applicant is suggested to amend claim 33 as “… wherein L1 is absent, isoGlu, Ahx, isoGlu-Ahx, PEG, PEG-Ahx, or isoGlu-PEG-Ahx ”. 1 8 . Claim 40 is objected to for the following minor informality: Applicant is suggested to amend the “CH2” recited in instant claim 40 as “CH 2 ”. Furthermore, claim 40 recites the formula of the same peg group in duplicate form, for example, 2peg4, 1peg8 and many others. Applicant is suggested to remove one of the duplicate formulae . In addition, Applicant is suggested to amend claim 40 as “…PEG is 1Peg11, and 1Peg11 is… or PEG is 2Peg12, and 2Peg12 is …”. 19 . Claim 59 is objected to for the following minor informality: Applicant is suggested to amend claim 59 as “… when PEG is attached to Lys, the -C(O)- of PEG is attached to N ε of Lys …”. Rejections Claim Rejections - 35 U.S.C. § 112 paragraph (b) 2 0 . 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. 2 1 . Claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 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 pre-AIA the applicant regards as the invention. 2 2 . Claim 1 5 recites “J is absent, any amino acid , or a peptide chain consisting of 1 -5 amino acids, wherein each amino acid of the peptide chain is independently selected from Pro, (D)Pro, hydroxyPro, hydroxy(D)Pro, Arg, MeArg, Lys, (D)Lys, Lys(Ac), (D)Lys(Ac), Ser, MeSer, Sar, and Gly” . In the instant case, when J is a peptide chain consisting of 1 amino acid , it needs to be one specific amino acid selected from the recited Markush group . Therefore, it is unclear that when J is 1 amino acid , whether J can be any amino acid or is limited to the specific amino acid recited Markush group. Furthermore, claim 15 recites “i) the peptide of Formula IIa or Formula IIb is optionally PEGylated on one or more of R 1 , B5, bhF, B7, J, Y2, or R 2 ”. In the instant case, one of B5 and B7 in the peptide of Formula IIa or Formula IIb is attached to L1Z, and L1 can be PEG. And it is well known in the art that PEG is also a half-life extension moiety. Therefore, it is unclear that when PEG is attached to one of B5 and B7 in the peptide of Formula IIa or Formula IIb, the attached PEG is L1, Z or part of the optional PEGylation. In addition, claim 15 recites “iii) the peptide of Formula IIa or Formula Ilb optionally comprises an isovaleric acid moiety conjugated to the N-terminal Asp residue”. In the instant case, R 1 recited in instant claim 15 can be C 1 -C 20 alkanoyl, which includes an isovaleric acid moiety. Therefore, it appears such recitation is a preferred embodiment. Taken all these together, the metes and bounds of instant claim 1 5 is vague and indefinitely. Because claims 17, 24, 33, 40, 59, 63, 64 and 70 depend from indefinite claim 1 5 , and none of the dependent claims clarifies the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. 2 3 . Claim 59, which depends on claim 15, recites the limitation “when PEG is attached to Palm, the -N(H)- of PEG is attached to -C(O)- of Palm”. There is insufficient antecedent basis for this limitation in the claim. Claim 15 does not mention “Palm”. It is not clear to what the said phrase is referring. Claim Rejections - 35 U.S.C. § 112 paragraph (d) 2 4 . The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of 35 U.S.C. 112 (pre-AIA), fourth paragraph: Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA)], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 2 5 . Claim s 17 and 24 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 2 6 . Claim 17 depends on claim 1 5 ; and claim 17 recites “ …(a) B7(L1Z) is -N(H)C[CH 2 (CH 2 CH 2 CH 2 ) m N(H)L1Z](H)-C(O)-; and wherein m is 0 or 1; (b) B7(L1Z) is -N(H)C[CH 2 N(H)L1Z](H)-C(O)-…(d) B5(L1Z) is -N(H)C[CH 2 (CH 2 CH 2 CH 2 ) m N(H)L1Z](H) -C(O)-; and wherein m is 0 or 1; (e) B5(L1Z) is -N(H)C[CH 2 N(H)L1Z](H)-C(O)-… ”. However, B7 in B7(L1Z) recited instant claim 15 is limited to Lys or D-Lys; and B5 in B5(L1Z) recited instant claim 15 is limited to Lys, D-Lys, NMeLys, Dap, or Dap-Dap . Therefore, the scope of the hepcidin analogue or pharmaceutically acceptable salt or solvate thereof recited in instant claim 17 is broader than the scope of the hepcidin analogue or pharmaceutically acceptable salt or solvate thereof recited in instant claim 1 5 . Claim 17 does not further limit the scope of the hepcidin analogue or pharmaceutically acceptable salt or solvate thereof recited in claim 1 5 ; therefore, claim 17 is improper dependent forms for failing to further limit the subject matter of claim 1 5 . 2 7 . Claim 24 depends on claim 15; and claim 24 recites “R 1 -Asp-Thr-His-Dpa-Pro-Cys-Ile-(D)Lys-bhF-N(H)C[CH 2 N(H)L1Z](H)-C(O)-J-Y1-Y2-R 2 (IIIa)”. However, B7 in B7(L1Z) recited instant claim 15 is limited to Lys or D-Lys. Therefore, the scope of the hepcidin analogue or pharmaceutically acceptable salt or solvate thereof recited in instant claim 24 is broader than the scope of the hepcidin analogue or pharmaceutically acceptable salt or solvate thereof recited in instant claim 15. Claim 24 does not further limit the scope of the hepcidin analogue or pharmaceutically acceptable salt or solvate thereof recited in claim 15; therefore, claim 24 is improper dependent forms for failing to further limit the subject matter of claim 15. Claim Rejections - 35 U.S.C. § 102(a)(1) 2 8 . 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. 29 . Claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bourne et al (WO 2019/157268 A1, filed with IDS) . The instant claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are drawn to a hepcidin analogue comprising: (a) a peptide according to Formula IIa, or a peptide dimer comprising two peptides according to Formula IIa, or a pharmaceutically acceptable salt or solvate thereof; or (a) a peptide according to Formula IIb, or a peptide dimer comprising two peptides according to Formula IIb, or a pharmaceutically acceptable salt or solvate thereof; and a pharmaceutical composition comprising such hepcidin analogue or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable carrier, excipient or vehicle . Bourne et al , throughout the patent , teach hepcidin analogues with improved in vivo half lives, and a pharmaceutical composition comprising such hepcidin analogue and a pharmaceutically acceptable carrier, excipient or vehicle; wherein the hepcidin analogue can be compound 177 with the structure Isovaleric Acid-D-T-H-[Dpa]-P-C- I -(D)Lys-bhPhe-[L y s _ Ahx _ Palm]-R-C-NH 2 , for example, Abstract; page 10, paragraph [0035]; and compound 177 on page 86 . It reads on instant SEQ ID NO: 2 with the structure Isovaleric acid-D-T-H-[Dpa]-P-C-I-(D)Lys-bhPhe-[Lys(Ahx-Palm)]-R-C-NH 2 as the elected species of hepcidin analogue . And it meets the limitations of instant claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 . Furthermore, the MPEP states the following: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A , 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) ( s ee MPEP § 2131.02). Since the reference teaches all the limitations of instant claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 ; the reference anticipates instant claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 . 30. Please note : In the instant case, Bourne et al (WO 2019/157268 A1, filed with IDS) is also qualified as a prior art reference under 35 U.S.C. 102(a)(2). Therefore, claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are rejected under 35 U.S.C. 102(a)( 2 ) as being anticipated by Bourne et al (WO 2019/157268 A1, filed with IDS) based on the teachings as set forth in Section 29 above . Obviousness Double Patenting 3 1 . 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp . 3 2 . Claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1- 18 of US patent 12234300 B2 (10/30/2025 IDS, Patent doc# 002) . 3 3 . Instant claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are drawn to a hepcidin analogue comprising: (a) a peptide according to Formula IIa, or a peptide dimer comprising two peptides according to Formula IIa, or a pharmaceutically acceptable salt or solvate thereof; or (a) a peptide according to Formula IIb, or a peptide dimer comprising two peptides according to Formula IIb, or a pharmaceutically acceptable salt or solvate thereof; and a pharmaceutical composition comprising such hepcidin analogue or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable carrier, excipient or vehicle . 3 4 . Claims 1-18 of US patent 12234300 B2 are drawn to a peptide or a peptide dimer thereof, wherein the peptide comprises or consists of SEQ ID NO: 158, 159, 165, 166 or 175, and wherein the peptide is cyclized via a disulfide bond between two cysteines; a pharmaceutical composition comprising the peptide or peptide dimer thereof of claim 1, and a pharmaceutically acceptable carrier, excipient or vehicle; methods of using such peptide or a peptide dimer; and a device comprising such pharmaceutical composition for delivery of the peptide or peptide dimer thereof to a subject, optionally orally. The a peptide or a peptide dimer thereof and the pharmaceutical composition recited in claims 1-18 of US patent 12234300 B2 meet the limitation s of the hepcidin analogue and the pharmaceutical composition recited in instant claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 . 3 5 . For the same/similar reasoning/rational as the rejection set forth in Sections 3 2 - 3 4 above, instant claims 15, 17, 24, 33, 40, 59, 63, 64 and 70 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 57-67 of co-pending Application No. 19/ 019120 (10/30/2025 IDS, Patent doc# 008) . Th is is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LI N KOMATSU whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3534 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 8am-4pm EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LI N KOMATSU/ Primary Examiner, Art Unit 1658