Prosecution Insights
Last updated: April 19, 2026
Application No. 18/285,203

CONJUGATED HEPCIDIN MIMETICS

Non-Final OA §112
Filed
Sep 29, 2023
Examiner
COFFA, SERGIO
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Protagonist Therapeutics Inc.
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
2y 11m
To Grant
94%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
436 granted / 719 resolved
+0.6% vs TC avg
Strong +34% interview lift
Without
With
+33.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
61 currently pending
Career history
780
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
32.1%
-7.9% vs TC avg
§102
20.5%
-19.5% vs TC avg
§112
27.0%
-13.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 719 resolved cases

Office Action

§112
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. DETAILED ACTION Status of the Claims Claims 1-12, 18-19, 25, 27, 30, 77, 80, 123-124, 127, 129 and 134-135 are pending in this application. Claims 1-12, 18-19, 25, 27, 30, 77, 80, 123-124, 127, 129 and 134-135 are presently under consideration. Nucleotide and/or Amino Acid Sequence Disclosures Specific deficiency - This application contains sequence disclosures in accordance with 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 - 1.825. The sequence disclosures are located in paras [0030]-[0031], [00127]-[00129], [00142]-[00143], [00150]-[00151], [00153]-[00154], [00184], [00187]-[00188] and [00379], Table 2A and Table 6. Required response – Applicant must provide: A "Sequence Listing" part of the disclosure, as described above in item 1); as well as An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2) ; A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5) ; and A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4). If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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; If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide: A replacement CRF in accordance with 1.825(b)(6) ; and Statement according to item 2) a) or b) above. Claim Objection s Claim 124 should be rewritten to recite “….comprising or consisting of a peptide , wherein the peptide is selected from the group consisting of :” The claim should also be amended to strike out “or” after the description of compound ID# 50, and to replace the “or” after the description of compound ID# 51 with “and”. Appropriate correction is required. Claim Rejections Claims 123-124 are rej ected to because of the following informalities: Regarding the recitation of Table 2A in claim 123, see MPEP 2173.05(s)- Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola , 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Improper Markush Claims 1-12, 18-19, 25, 27, 30, 77, 80, 127, 129 and 134-135 are rejected under the judicially created basis of improper Markush group of alternatives. See 76 Fed. Reg. 7164-7166 (Feb. 9, 2011); In re Harnish , 631 F.2d 716m 721-22 (CCPA 1980); Ex parte Hosuzmi , 3 USPQ2d 1059m 1060 (Bd. Pat. App. & Int. 1984). For a M arkush grouping to be proper the species of the Markush group must share a ‘‘single structural similarity” and must share a common use. Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art recognized class. Here, compounds do not share a "single structural similarity.” The template portion of the claimed hepcidin analogue contain s different molecules that do not belong to the same recognized physical or chemical class and do not belong to the same art recognized class. For instance, the structural requirements of dapa are completely different from PEG (see description of L1). These molecules do not belong to the same recognized class . Therefore, the claims are rejected under the judicially created basis of improper Markush group of alternatives . 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 appl icant regards as his invention. Claim s 1-12, 18-19, 25, 27, 30, 77, 80, 123, 127, 129 and 134-135 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. Claim 1 recites “substituted His”, “N-substituted Gly”, “substituted Gly”, “substituted Phe ”, “substituted Dpa”, “substituted Pro”, etc. One of ordinary skill in the art would not know what is encompassed by said “substituted” amino acids. Furthermore, claim 1 defines various amino acids (e.g. DIP , Bip , Tic, bhTrp , 1-Nal, 2-Nal, Orn , etc.), which are not part of the peptide of Formula I’, thus making the claim unclear. Claims 6-7 recite “…according to claim 1, wherein Pro”. This phrase is indefinite. Claim 129 is drawn to a method for treating a disease of iron metabolism . Diseases of iron metabolism such as for e.g. anaemia , thalassemia , hemochromatosis , polycythemia , etc. represent opposite malfunctions in iron metabolism, thus it is unclear how the claimed hepcidin analogue can have opposite effects. Claims 2-12, 18-19, 25, 27, 30, 77, 80, 127, 129 and 134-135, which depend from claim 1, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 1 . Claim 123 recites “. . .and * represents that Peg11 is . ..”. It is noted that none of the peptides in Table 2A comprises an asterisk “ *”. Thus, it is unclear what is being claimed. Because it is impossible to determine what is being claimed in claims 1-12, 18-19, 25, 27, 30, 77, 80, 123, 127, 129 and 134-135, the claims have not been examined beyond pointing out issues with 112 second paragraph. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SERGIO COFFA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3022 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 6AM-4PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT MELISSA FISHER can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7430 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. 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. FILLIN "Examiner Stamp" \* MERGEFORMAT /SERGIO COFFA Ph.D./ Primary Examiner Art Unit 1658 /SERGIO COFFA/ Primary Examiner, Art Unit 1658
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Prosecution Timeline

Sep 29, 2023
Application Filed
Feb 25, 2026
Non-Final Rejection — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
61%
Grant Probability
94%
With Interview (+33.6%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 719 resolved cases by this examiner. Grant probability derived from career allow rate.

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