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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-3, 5, 9, 10, 14, 17, 21, 28, 32, 70, 92, 94, 97, 104, 113, 123, 127, 128, 133-136, 157, 162, 165, 169, 175, 177, 181, and 184, in addition to the species of SEQ ID NO: 58/compound #58 in the reply filed on 10/29/2025 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)).
On 1/20/2026, the Examiner placed a telephone call to Applicant’s representative, attorney Carol Laherty, to confirm the species election, as it was discovered that the elected compound #58 exhibited the same structure as compound #56 in claim 181 and, thus, it was unclear whether Applicant intended to elect #56 or #58; moreover, the structure of compound #56 matched SEQ ID NO: 56 and the structure of compound #58 matched SEQ ID NO: 58 in the Sequence Listing. Additionally, the peptide sequence listed in the Response to Election/Restriction Requirement recited a third sequence, SEQ ID NO: 57, which did not correspond to either compound #56 or #58. Attorney Laherty confirmed that SEQ ID NO: 58, also shown in Table 6a of the specification, was the intended elected species.
After search and examination, it was determined that SEQ ID NO: 58 was free of the art. The closest art is Bourne et al. (WO2015200916A2, published 12/30/2015; cited on IDS filed 6/13/2023). Bourne teaches a hepcidin analogue of Formula III/SEQ ID NO: 7, R1-X-Y-R2, wherein R1 can be isovaleric acid; R2 can be -OH; X is a peptide based upon the formula X1-X2-X3-X4-X5-X6-X7-X8-X9-X10 (formula IIia/SEQ ID NO: 8), wherein X1 can be Asp, Glu, Ala, Gly, Thr, Ida, pGlu, bbAsp, D-Asp, Tyr, Leu, or absent; X2 can be Thr; X3 can be His; X4 can be Dpa; X5 can be Pro; X6 can be Ala; X7 can be Ile; X8 can be Glu; X9 can be bhPhe; X10 can be Lys ([0041-0042]); and Y is a peptide wherein Y1-Y2 can be absent, Y3 can be Arg, and Y4-Y15 can be absent ([0042-0046]). Although other prior art renders the addition of Ahx_Palm to the Lys at position X10 (see art rejections below), neither Bourne nor the prior art provide teachings, suggestions, or motivations to substitute X1 for Lys as recited in SEQ ID NO: 58. Thus, SEQ ID NO: 58 is novel and non-obvious.
Therefore, in accordance with Markush practice, the species election was expanded to include SEQ ID NO: 56/compound #56, which reads on claim 181.
Claim Status
Claims 9, 10, 14, 17, 21, 28, 32, 97, 104, 113, 127, 135, 157, 162, 165, 169, 175, 177, 181, 184, 185, 186, 192, 197-204 are pending. Claims 9, 10, 14, 17, 21, 28, 32, 97, 104, 113, 127, 135, 157, 162, 165, 169, 175, 177, 184, 185, 186, 192, and 197-204 are hereby withdrawn as non-elected inventions (185, 186, and 192) and species (9, 10, 14, 17, 21, 28, 32, 97, 104, 113, 127, 135, 157, 162, 165, 169, 175, 177, 184, and 197-204). Claims 9, 10, 14, 17, 21, 28, 32, 97, 104, 113, 127, 135, 157, 162, 165, 169, 175, 177, 181, 184-186 are currently amended. Claims 197-204 are new. Claims 1-8, 11-13, 15-16, 18-20, 22-27, 29-31, 33-96, 98-103, 105-112, 114-126, 128-134, 136-156, 158-161, 163-164, 166-168, 170-174, 176, 178-180, 182-183, 187-191, 193-196 have been cancelled. Claim 192 was previously presented.
Priority
The present application is the 371 national stage entry of PCT/US21/43579, filed 7/28/2021, which claims priority to the provisional applications 63/169,527, 63/169,515, 63/169,533, all filed 4/1/2021, and 63/057,582, 63/057,577, 630/57,574, and 63/057,583, all filed 7/28/2020. The priority date of 7/28/2020 is acknowledged.
Information Disclosure Statement
The IDS’s filed on 6/13/2023, 9/14/2023, 11/15/2024, and 10/29/2025 are under consideration.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
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.
See Formulas II, IXa, and XXI on Pg 6; Formulas II-VIIIb on Pg 49-51; Formulas IXa-XXVIIId on Pg 53-56; Formula XXI on Pg 58; [00293]; Example 1C subtitle on Pg 111; [00439].
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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 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.
Specifically, the file size must be listed in bytes instead of kilobytes (KB).
Specification
The disclosure is objected to because of the following informalities: As indicated above, the specification includes amino acid sequences with 4 or more specifically defined and enumerated residues that require SEQ ID NO’s. 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 181 is 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.
The scope of claim 181 is indefinite because compounds #56 and #58 both display the same structure. The scope of the claim is also indefinite as the structure of compound #56 depicted in claim 181 is cyclized, whereas in the Sequence Listing the corresponding SEQ ID NO: 56 is not cyclized. For purposes of examination, the claim is being interpreted based upon the Sequence Listing, wherein the sequence is linear and not cyclized.
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 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 181 is rejected under 35 U.S.C. 103 as being obvious over Bourne et al. (WO2015200916A2, published 12/30/2015; cited on IDS filed 6/13/2023; referred to as Bourne1) in view of Bourne et al. (WO 2017117411 A1, published 7/6/2017; cited on IDS filed 6/13/2023; referred to as Bourne2).
Bourne1 teaches hepcidin, mini-hepcidin, analogues and uses thereof (Title). Bourne1 teaches a hepcidin analogue of Formula III/SEQ ID NO: 7, R1-X-Y-R2 ([0037]). R1 can be hydrogen, C1-C6 alkyl, C6-C12 aryl, C6-C12 aryl C1-C6 alkyl, or a C1-C20 alkanoyl, including PEGylated version thereof, alone or as spacers of any of the foregoing; in certain embodiments, R1 can be isovaleric acid ([00106]). R2 can be -OH ([0039-0040]). X is a peptide based upon the formula X1-X2-X3-X4-X5-X6-X7-X8-X9-X10 (formula IIia/SEQ ID NO: 8), wherein X1 can be Glu, X2 can be Thr, X3 can be His, X4 can be Dpa, X5 can be Pro, X6 can be Ala, X7 can be Ile, X8 can be D-Lys, X9 can be bhPhe, and X10 can be Lys ([0041-0042]). Y is a peptide wherein Y1-Y2 can be absent, Y3 can be Arg, and Y4-Y15 can be absent ([0042-0046]).
Bourne1 does not teach the addition of Ahx_Palm to Lys at position X10, which corresponds to position 11 of the instant SEQ ID NO: 56.
Bourne2 teaches hepcidin analogues with improved in vivo half-lives as well as pharmaceutical compositions and methods of use (Abstract). Bourne2 teaches various hepcidin analogues comprising a polypeptide of the general formula X-Y, wherein X comprises the sequence of X1-Thr-His-X4-Pro-X6-X7-X8-Phe-X10 (SEQ ID NO: 1) and Y comprises the sequence of Y1-Y2-Y3-Y4-Y5-Y6-Y7 (SEQ ID NO: 2; Pg 2, bottom paragraphs – bottom of Pg 5). In all formulas, X10 can be Lys (which corresponds to position X10 of Bourne1/position 11 in the instant SEQ ID NO: 56). In some embodiments, a hepcidin analogue comprises a half-life extension moiety conjugated at Lys X8 or X10 (Pg 6, top paragraphs and SEQ ID NO: 5 and SEQ ID NO: 6 structures; structures also seen on Pg 36). Bourne2 teaches that the linker can be Ahx and the half-life extension conjugate can be palmitic acid (palm; Pg 36, second and third paragraphs below structures depicted). Bourne further teaches embodiments wherein Ahx_Palm is conjugated to Lys at position X10, and these compounds display improved EC50 values relative to hepcidin (compare SEQ ID NO: 28-30 in Table 3 with hepcidin in Table 9).
Thus, regarding claim 181, Bourne1 teaches a hepcidin analogue with the sequence Isovaleric acid-Glu-Thr-His-Dpa-Pro-Ala-Ile-(D)Lys-bhPhe-Lys-Arg. Bourne2 teaches hepcidin analogues with improved in vivo half-lives and EC50 values wherein the analogues have Lys conjugated to Ahx_Palm at position X10, which corresponds to position X10 of the analogue taught by Bourne1/position 11 in the instant SEQ ID NO: 56. Based on these teachings, it would be prima facie obvious to conjugate Ahx_Palm to the Lys at position 10 of the analogue taught by Bourne1 in order to prolong its in vivo half-life. One would have a reasonable expectation of success as Bourne2 established that introducing Ahx_Palm at this position in similar hepcidin analogues improves the compound’s EC50 relative to hepcidin itself.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm 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, Melissa L Fisher can be reached at 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.
/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658