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 .
Response to Election/Restriction filed on May 13, 2026 is acknowledged.
Claims 1-2, 13-14, 20, 25, 34, 77, 81-82, 124, 126, 205-208 and 218 are pending in this application.
Restriction
Applicant’s election of Group 1 in the reply filed on May 13, 2026 is 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)). Restriction is deemed to be proper and is made FINAL in this office action. Claims 206-208 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant indicates claims 1, 2, 13, 14, 20, 25, 34, 77, 81, 82, 124, 126, 205 and 218 read on the elected species. Claims 1, 2, 13, 14, 20, 25, 34, 77, 81, 82, 124, 126, 205 and 218 are examined on the merits in this office action.
Objections
5. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present invention provides hepcidin analogues with...” at line 1 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract may be amended to recite, “Hepcidin analogues…are described.”
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. MPEP § 608.01.
Rejections
Double Patenting
6. 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.
7. Claims 1, 2, 13, 14, 20, 25, 34, 77, 81, 82, 124, 126, 205 and 218 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-13 and 15-20 of copending Application No. 18/355992 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Instant claims are drawn to:
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648
616
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766
594
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(see claim 1);
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744
538
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(see claim 218, SEQ ID NO: 101, for example). Instant SEQ ID NO: 101 is exactly the same as copending SEQ ID NO: 46, for example.
9. Copending claims are drawn to:
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676
702
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(see claims 1-2, for example);
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158
642
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852
674
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(see claim 8, for example, see SEQ ID NO: 46).
10. Instant claims are drawn to hepcidin analogs and copending claims are drawn to a method of treating sickle cell disease with the hepcidin analogs of instant application. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa, since the hepcidin analog of instant application are used in the method of treating.
11. Claims 1, 2, 13, 14, 20, 25, 34, 77, 81, 82, 124, 126, 205 and 218 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/872323 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Instant claims are drawn to:
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648
616
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766
594
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(see claim 1);
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744
538
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(see claim 218, SEQ ID NO: 101). Instant SEQ ID NO: 101 is exactly the same as copending SEQ ID NO: 46, for example.
13. Copending claims are drawn to:
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692
680
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(see claims 1-2);
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244
640
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870
674
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672
670
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(see claim 8, SEQ ID NO; 46, for example).
14. Instant claims are drawn to hepcidin analogs and copending claims are drawn to a method of treating sickle cell disease with the hepcidin analogs of instant application. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa, since the hepcidin analog of instant application are used in the method of treating.
CLOSEST ART
15. The closest art is Bourne et al (US 2017/0313754, filed with IDS). Bourne et al teach hepcidin analogs, such as Isovaleric acid-ETHFPCIKFEPPRSKEWVCK-NH2 (SEQ ID NO: 526), pGlu-THFPCRKF-NH2 (SEQ ID NO: 527), Isovaleric acid-DTHFPCIKFEPRS-K(Octanoic acid)-EWVCK-NH2 (SEQ ID NO: 525) and so on.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
6/18/2026
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