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 without traverse of the species compound 2001 (SEQ ID NO: 24) in the reply filed on 8/12/2026 is acknowledged.
Claim Status
Claims 1-16 and 18-19 are pending. Claims 3, 5, 9, 12, and 14 are hereby withdrawn as non-elected species. Claims 4-7, 10-16, and 18-19 are amended. Claim 17 is cancelled.
Priority
The instant application is the 371 national stage entry of PCT/EP2022/050294, filed 1/7/2022, which claims priority to the foreign application EP21150562, filed 1/7/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date of 1/7/2021 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/5/2023, 7/25/2024, and 1/12/2026 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:
1. 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.
Specifically, see: Pg 70, second to last line (compound 2017); Pg 71, structure; Pg 168, middle of the final paragraph; Table 8, each compound’s amino acid sequence needs a SEQ ID NO
2. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
3. 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Pg 87, second to last sentence of the first paragraph). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www, or other browser-executable code. See MPEP § 608.01.
The use of the terms Talabostat (Pg 6, second paragraph, first line), PrepSolv (Pg 157, Example 1, Solvents section), and TentaGel (Pg 157, Abbreviations; 159, last paragraph; Pg 160, Resin loading, section paragraph) which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 11 and 15 is objected to because of the following informalities: Both claims list amino acid sequences with 4 or more specifically defined and enumerated residues (the peptide structures claimed), each of which require SEQ ID NO’s. However, there are no SEQ ID NO’s listed in either claim. See MPEP 2422 and 37 C.F.R. 1.821. Appropriate correction is required.
Claim Interpretation
Claim 7 recites that each amino acid in the claimed peptide is selected from a group of amino acids or derivatives thereof. “Derivatives” is being interpreted based upon Table 6, where the claim encompasses only these derivatives.
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.
Claims 1-2, 4, 6-8, 10-11, 13, 15-16, and 18-19 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, in regard to the identity of amino acid Xaa6, recites “a heteroaromatic L-□-amino acid” on Pg 5. The scope of the claim is indefinite because it is unclear what “a heteroaromatic L-□-amino acid” refers to. For purposes of examination, the claim will be interpreted as consisting of an aromatic or heteroaromatic L-α-amino acid. Further, by virtue of their dependency on claim 1, claims 2, 4, 6, 16, and 18-19 are also rejected.
Claims 4, 6, 8, 13, 16, and 18 are further rejected as indefinite. In each of these claims, the scope is unclear because of the inclusion of the phrase “preferably”. For instance, claim 4 recites the blocking group Abl is selected from the group consisting of Ra1-C(O)-, Ra1-S(O2)-, Ra1-NH-C(O)- and Ra1-O-C(O)-… preferably the blocking group Abl is hexanoyl, Buca-, Buur or pentyl sulfonyl, preferably the blocking group is hexanoyl or Buur (emphasis added). The recitation of each “preferably” narrows the scope of the claim, thus making it unclear whether the scope of claim 4 is inclusive of Ra1-C(O)-, Ra1-S(O2)-, Ra1-NH-C(O)- and Ra1-O-C(O)- or limited to hexanoyl, Buca-, Buur or pentyl sulfonyl or limited to hexanoyl or Buur. For purposes of examination, the claim is being interpreted as inclusive of Ra1-C(O)-, Ra1-S(O2)-, Ra1-NH-C(O)- and Ra1-O-C(O)-.
With regards to claims 6, 8, 13, 16, and 18, these claims are also being interpreted based upon their broadest scope.
Further, claim 13 recites the limitation "the C-terminal amino acid of any one of peptide of Formulae LI-LIV" in the second to last line. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of Formulae LI-LIV in either claim 1 or 13.
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.
Claims 1, 2, 4, 6-8, 10-11, 13, 15-16, and 18-19 are rejected under 35 U.S.C. 103 as being obvious over Osterkamp et al. (US20220315554A1, effectively filed 7/8/2019) in view of Schumacher et al. (In Situ Maleimide Bridging of Disulfides and a New Approach to Protein PEGylation. Bioconjugate Chem. 16 February 2011; 22 (2): 132–136.).
Osterkamp teaches a cyclic peptide with the following formula:
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, wherein an N-terminal modification group A is attached to Xaa1, wherein each and any one of Xaa1-7 is a residue of an amino acid, Yc has the structure:
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(pyrazine), and wherein the N-terminal modification group A is either a blocking group Abl or an amino acid Aaa (Abstract; [0074]).The formulas for residues Xaa1-7 and their variables are identical to those recited in the instant claims (see, for instance, claim 1).
The only difference between the teachings of Osterkamp and the instant claims is the sulfur atoms of the Cys residues are not connected via a disulfide bond or through a maleimide group as is recited in instant claim 1.
Schumacher teaches the development of cyclic peptides through introduction of a maleimide group that can be further PEGylated:
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122
226
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(Abstract, Figure 1). Schumacher teaches that introduction of dithiophenolmaleimides into cyclic peptides comprising Cys residues can be effectively employed in situ with a reducing agent to ensure rapid sequestration of the free cysteine residues. This will serve to limit the problems associated with reducing disulfide bonds to afford free cysteines for bioconjugation, such as protein unfolding, aggregation, and disulfide scrambling. Schumacher also suggests that the use of bridging reagents via in situ protocols will preclude many of the previous limitations of disulfide modification, broadening the scope of proteins that can be manipulated in this manner (Pg 136, left column, “Conclusion”).
Based on the teachings of Osterkamp and Schumacher, with respect to claim 1 it would have been prima facie obvious to substitute a known element for another to obtain predictable results. Osterkamp teaches compounds that are identical to the instantly claimed compounds; the only difference between the compounds taught by Osterkamp and the instantly claimed compounds is that those of Osterkamp are cyclized via Cys residues through a pyrazine group instead of a maleimide group. However, Schumacher teaches that a maleimide group can also be used to cyclize peptides through their Cys residues. Thus, one skilled in the art would have recognized the two groups are functionally interchangeable for cyclizing peptides. Therefore, one could substitute the pyrazine group for the maleimide group, leading a predictable, cyclized peptide.. See MPEP 2143(I)(B).
Further, it would be prima facie obvious to try substituting the pyrazine group for the maleimide group. As described above, it was known in the art that both the pyrazine group and the maleimide group could engage the sulfur atoms of Cys residues to cyclize a peptide. Therefore, one skilled in the art looking to cyclize a peptide structure through Cys residues would have recognized the shared functionality and interchangeability of both groups. One would have had a reasonable expectation of success given that both groups have been used previously by others to cyclize proteins through Cys residues. See MPEP 2143(I)(E).
Regarding claim 2, as stated above, Schumacher teaches the nitrogen of the maleimide group can be attached to a hydrogen atom or PEG (Abstract, Figure 1).
Regarding claim 4, Osterkamp teaches the blocking group Abl is selected from the group consisting of Ra1—C(O)—, Ra1—S(O2)—, Ra1—NH—C(O)— and Ra1—O—C(O)—; wherein Ra1 is (C1-C8)alkyl optionally substituted by up to two substituents each and independently selected from the group consisting of OH, F, COOH, (C3-C8)cycloalkyl, aryl, heteroaryl and (C3-C8)heterocycle, and wherein in (C1-C8)alkyl one of the —CH2-groups is optionally replaced by —S— or —O—. Osterkamp also teaches the blocking group Abl is hexanoyl or pentyl sulfonyl, preferably blocking group Abl is hexanoyl (claims 9 and 10).
Regarding claim 6, Osterkamp teaches Xaa1 is a D-amino acid residue selected from the group consisting of cys, hcy and pen, or Xaa1 is an L-amino acid residue selected from the group consisting of Cys, Hcy and Pen (claim 13).
Regarding claims 7 and 8, wherein Xaa2 is an amino acid residue selected from the group consisting of Pro, Gly, Nmg and their derivatives, wherein Xaa3 is an amino acid residue selected from the group consisting of Pro, Hyp, Tfp, Cfp, Dmp, Aze and Pip, and their derivatives, wherein Xaa4 is an amino acid residue selected from the group consisting of Thr, Hse, Asn, Gln and Ser, and their derivatives, wherein Xaa5 is an amino acid residue selected from the group consisting of Gln and Glu, and their derivatives, wherein Xaa6 is an amino acid residue of any one of formulae (VIIIa), (VIIIb), (VIIIc) and (VIIId):
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wherein R6a and R6b are each and independently selected from the group consisting of H, methyl, ethyl, propyl and isopropyl, R6c represents from 0 to 3 substituents, each such substituent being each and independently selected from the group consisting of Cl, F, Br, NO2, NH2, CN, CF3, OH, OR6d and C1-C4 alkyl, R6d is selected from the group consisting of methyl, ethyl, propyl, and isopropyl, and s is 0 or 1, and/or wherein Xaa7 is an amino thiol residue selected from the group consisting of Cys, Cysol, AET, Hcy, cys and hcy (claim 14).
Regarding claims 10, 11, and 15, Osterkamp teaches the species
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(claim 28), which is rendered obvious in view of Schumacher as described above.
Regarding claim 13, Osterkamp teaches the peptide is selected from the group
consisting of peptides of formula (XXXa-f),
Xaa10-Xaa11-Xaa12-Xaa13-Xaa14-Xaa15-Xaa16 (XXXa)Xaa10-Xaa11-Xaa12-Xaa13-Xaa14-Xaa15 (XXXb)Xaa10-Xaa11-Xaa12-Xaa13-Xaa14 (XXXc)Xaa10-Xaa11-Xaa12-Xaa13 (XXXd)Xaa10-Xaa11-Xaa12 (XXXe)Xaa10-Xaa11 (XXXf)
whereinXaa10 is Asp, asp, Bal, Gly, Gab, Ser, Nmg, Bhf. Lys, Ttds or BhkXaa11 is His, his, Lys, Ttds, Arg, Ape or Ala,Xaa12 is Phe, Nmf, Tic, Aic, Ppa, Mpa, Amf, Nmf, phe, Lys, Ape, Ttds and PpaXaa13 is Arg, Lys, Ape, Ttds or arg,Xaa14 is Asp, Ala, asp, Lys, Ape or Ttds,
Xaa15 is Ttds, Ape or Lys, andXaa16 is Lys or Ape, wherein, optionally,Xaa11 and Xaa12 together form a single amino acid selected from the group consisting of Gab, Pamb, Cmp, Pamb, Mamb, and, optionally,Xaa10, Xaa11 and Xaa12 form together a single amino acid selected from the group consisting of Gab, Pamb, Cmp, Pamb, and Mamb,under the proviso that in the peptides of formulae (XXXa-f) Ape, if present, is the C-terminal building block ([0169-0170]).
Regarding claim 16, Osterkamp teaches the compound comprises a diagnostically active nuclide or a therapeutically active nuclide, wherein, preferably, the diagnostically active nuclide is a diagnostically active radionuclide, more preferably selected from the group consisting of 43Sc, 44Sc, 51Mn, 52Mn, 64Cu, 67Ga, 68Ga, 86Y, 89Zr, 94mTc, 99mTc, 111In, 152Tb, 155Tb, 201Tl, 203Pb, 18F, 76Br, 77Br, 123I, 124I, 125I, preferably 43Sc, 44Sc, 64Cu, 67Ga, 68Ga, 86Y, 89Zr, 99mTc, 111In, 152Tb, 155Tb, 203Pb, 18F, 76Br, 77Br, 123I, 124I, 125I and most preferably 64Cu, 68Ga, 89Zr, 99mTc, 111In, 18F, 123I, and 124I and wherein the therapeutically active nuclide is a therapeutically active radionuclide, more preferably selected from the group consisting of 47Sc, 67Cu, 89Sr, 90Y, 153Sm, 149Tb, 161Tb, 177Lu, 188Re, 188Re, 212Pb, 213Bi, 223Ra, 225Ac, 226Th, 227Th, 131I, 211At, preferably 47Sc, 67Cu, 90Y, 177Lu, 188Re, 212Pb, 213Bi, 225Ac, 227Th, 131I, 211At and most preferably 90Y, 177Lu, 225Ac, 227Th, 131I and 211At (claim 29).
Regarding claim 18, Osterkamp teaches composition, preferably a pharmaceutical composition, wherein the composition comprises a compound according to claim 1 and a pharmaceutically acceptable excipient ([0001]; claim 31).
Regarding claim 19, Osterkamp teaches a kit comprising a compound according to the first aspect, including any embodiment thereof, one or more optional excipient(s) and optionally one or more device(s), whereby the device(s) is/are selected from the group comprising a labeling device, a purification device, a handling device, a radioprotection device, an analytical device or an administration device ([0340]; claim 32).
Double Patenting
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.
Claims 1-2, 4, 6-8, 10-11, 15-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31, 47, and 48 of copending Application No. 17/571,067 (‘067; claim set filed on 9/19/2025) in view of Schumacher et al. (In Situ Maleimide Bridging of Disulfides and a New Approach to Protein PEGylation. Bioconjugate Chem. 16 February 2011; 22 (2): 132–136.).
The only difference between the instant claims and the claims of copending Application No. ‘067 is the pyrazine group used to cyclize the peptide through its Cys residues.
As described above, Schumacher teaches the development of cyclic peptides through Cys residues connected to a maleimide group.
Based on these teachings, it would have been prima facie obvious to substitute a known element for another to obtain predictable results. Schumacher teaches peptide cyclization through Cys residues in conjunction with a maleimide group. One skilled in the art would have recognized the pyrazine group of copending Application No. ‘067 could functionally be substituted for a maleimide group, leading to predictable results. See MPEP 2143(I)(B).
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4, 6-8, 10-11, 15-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 8-20 of copending Application No. 19/678,220 (‘220; claim set filed 5/15/2026) in view of Schumacher et al. (In Situ Maleimide Bridging of Disulfides and a New Approach to Protein PEGylation. Bioconjugate Chem. 16 February 2011; 22 (2): 132–136.).
The only difference between the instant claims and the claims of copending Application No. ‘220 is the pyrazine group used to cyclize the peptide through its Cys residues.
As described above, Schumacher teaches the development of cyclic peptides through Cys residues connected to a maleimide group.
Based on these teachings, it would have been prima facie obvious to substitute a known element for another to obtain predictable results. Schumacher teaches peptide cyclization through Cys residues in conjunction with a maleimide group. One skilled in the art would have recognized the pyrazine group of copending Application No. ‘220 could functionally be substituted for a maleimide group, leading to predictable results. See MPEP 2143(I)(B).
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4, 6-8, 10-11, 15-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 19/727,051 (‘051; claim set filed 7/1/2026) in view of Schumacher et al. (In Situ Maleimide Bridging of Disulfides and a New Approach to Protein PEGylation. Bioconjugate Chem. 16 February 2011; 22 (2): 132–136.).
The only difference between the instant claims and the claims of copending Application No. ‘051 is the pyrazine group used to cyclize the peptide through its Cys residues.
As described above, Schumacher teaches the development of cyclic peptides through Cys residues connected to a maleimide group.
Based on these teachings, it would have been prima facie obvious to substitute a known element for another to obtain predictable results. Schumacher teaches peptide cyclization through Cys residues in conjunction with a maleimide group. One skilled in the art would have recognized the pyrazine group of copending Application No. ‘051 could functionally be substituted for a maleimide group, leading to predictable results. See MPEP 2143(I)(B).
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4, 6-8, 10-11, 15-16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 14-16, 19-27, 29-33, 38-45, 47-54, 58-64, and 66-71 of copending Application No. 19/801,063 (‘063; claim set filed 9/8/2026) in view of Schumacher et al. (In Situ Maleimide Bridging of Disulfides and a New Approach to Protein PEGylation. Bioconjugate Chem. 16 February 2011; 22 (2): 132–136.).
The only difference between the instant claims and the claims of copending Application No. ‘063 is the pyrazine group used to cyclize the peptide through its Cys residues.
As described above, Schumacher teaches the development of cyclic peptides through Cys residues connected to a maleimide group.
Based on these teachings, it would have been prima facie obvious to substitute a known element for another to obtain predictable results. Schumacher teaches peptide cyclization through Cys residues in conjunction with a maleimide group. One skilled in the art would have recognized the pyrazine group of copending Application No. ‘063 could functionally be substituted for a maleimide group, leading to predictable results. See MPEP 2143(I)(B).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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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.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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