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 .
Claim Status
Claims 23-57 are pending. All previously pending claims (original claims 1-22) were canceled, including previously withdrawn claims 11 and 16-22 and examined claims 1-10 and 12-15. Claims reading upon the originally elected species and invention were not identified1. Claims 31, 34-39, and 56-57 are withdrawn. Claims 23-30, 32-33, and 40-55 are presently considered.
Applicant is reminded that withdrawn claims should be indicated as “withdrawn” on claim listings (see, e.g., MPEP § 714(II)(C), 37 CFR 1.121(c)). MPEP § 714(II) states that “[i]f an amendment filed on or after July 30, 2003 does not comply with revised 37 CFR 1.121, the Office will notify applicants via a Notice of Non-Compliant Amendment that the amendment is not accepted. As a courtesy to Applicant, a Notice of Non-Compliant Amendment has not been mailed at this time.
Election/Restrictions
Applicant’s election of Group I and the species of Example 55 in the reply filed on 12/29/2025 was previously 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 originally elected species of Example 55 (see Spec. filed 2/02/2023 at Table 1 on 82) is understood to be the compound corresponding to CAS NO: 2761348-53-0, which has the structure of
Gua-Val-Hyp-IIe-Thr-Tyr-Pen-Asn-Arg-Dab-Thr-DDab-Lys-Cys-Dab-Arg-Tyr
Nter-P1 -P2- P3- P4- P5- P6- P7- P8- P9- P10- P11- P12- P13- P14- P15- P16
Wherein “Val” is at P1, and the amino group of P1 at the N-terminal is replaced with a guanidino group (Gua). Example 55 is understood to comprise a disulfide bridge between P6 and P13 per Table 1 at page 86 of the Specification filed 2/02/2023. The grey highlighted residues correspond to the residues limited by the proviso at claim 1. The originally elected species was understood to read upon previously pending claims 1-10 and 12-15 of Group I, but not previously pending claim 11. However, all previously pending claims were canceled in the Reply filed 6/10/2026; and Applicant failed to identify the claims reading upon the originally elected invention and species2.
Newly added claims 23-33, 40-55 are understood to correspond to original Group I (i.e., original claims 1-22); newly added claims 34-38 and 56-57 are directed to a “use”, “method of using”, or method of “treating” (non-elected Group II); and newly added claim 39 is directed to a process of preparation (non-elected Group III).
From among claims 23-33 and 40-55 corresponding to original Group I, it is noted that claims 23-30, 32-33, and 40-55 reasonably read upon the originally elected species, but claim 31 corresponds to previously withdrawn claim 11, and does not read upon the originally filed species.
Following extensive search and examination, the originally elected species has been deemed free of the prior art. Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination has been extended to the following species and structures:
Example 1 (CAS NO: 2761347-99-1; claim 30);
Example 2 (CAS NO: 2761348-00-7; claim 30);
Example 3 (CAS NO: 2761348-01-8; claim 30);
Example 4 (CAS NO: 2761348-02-9; claim 30);
Example 5 (CAS NO: 2761348-03-0; claim 30);
Example 6 (CAS NO: 2761348-04-1; claim 30);
Example 7 (CAS NO: 2761348-05-2; claim 30);
Example 8 (CAS NO: 2761348-06-3; claim 30);
Example 9 (CAS NO: 2761348-07-4; claim 30);
Example 10 (CAS NO: 2761348-08-5; claim 30);
Example 11 (CAS NO: 2761348-09-6; claim 30);
Example 12 (CAS NO: 2761348-10-9; claim 30);
Example 13 (CAS NO: 2761348-11-0; claim 30);
Example 14 (CAS NO: 2761348-12-1; claim 30);
Example 15 (CAS NO: 2761348-13-2; claim 30);
Example 16 (CAS NO: 2761348-14-3; claim 30);
Example 17 (CAS NO: 2761348-15-4; claim 30);
Example 18 (CAS NO: 2761348-16-5; claim 30);
Example 19 (CAS NO: 2761348-17-6; claim 30);
Example 20 (CAS NO: 2761348-18-7; claim 30);
Example 21 (CAS NO: 2761348-19-8; claim 30);
Example 22 (CAS NO: 2761348-20-1; claim 30);
Example 23 (CAS NO: 2761348-21-2; claim 30);
Example 24 (CAS NO: 2761348-22-3; claim 30);
Example 25 (CAS NO: 2761348-23-4; claim 30);
Example 26 (CAS NO: 2761348-24-5; claim 30);
Example 27 (CAS NO: 2761348-25-6; claim 30);
Example 28 (CAS NO: 2761348-26-7; claim 30);
Example 29 (CAS NO: 2761348-27-8; claim 30);
Example 30 (CAS NO: 2761348-28-9; claim 30);
Example 31 (CAS NO: 2761348-29-0; claim 30);
Example 32 (CAS NO: 2761348-30-3; claim 30);
Example 33 (CAS NO: 2761348-31-4; claim 30);
Example 34 (CAS NO: 2761348-32-5; claim 30);
Example 35 (CAS NO: 2761348-33-6; claim 30);
Example 36 (CAS NO: 2761348-34-7; claim 30);
Example 37 (CAS NO: 2761348-35-8; claim 30);
Example 38 (CAS NO: 2761348-36-9; claim 30);
Example 39 (CAS NO: 2761348-37-0; claim 30);
Example 40 (CAS NO: 2761348-38-1; claim 30);
Example 41 (CAS NO: 2761348-39-2; claim 30);
Example 42 (CAS NO: 2761348-40-5; claim 30);
Example 43 (CAS NO: 2761348-41-6; claim 30);
Example 44 (CAS NO: 2761348-42-7; claim 30);
Example 45 (CAS NO: 2761348-43-8; claim 30);
Example 46 (CAS NO: 2761348-44-9; claim 30);
Example 47 (CAS NO: 2761348-45-0; claim 30);
Example 48 (CAS NO: 2761348-46-1; claim 30);
Example 49 (CAS NO: 2761348-47-2; claim 30);
Example 50 (CAS NO: 2761348-48-3; claim 30);
Example 51 (CAS NO: 2761348-49-4; claim 30);
Example 52 (CAS NO: 2761348-50-7; claim 30);
Example 53 (CAS NO: 2761348-51-8; claim 30);
Example 54 (CAS NO: 2761348-52-9; claim 30);
Example 55 (CAS NO: 2761348-53-0; claim 30);
Example 56 (CAS NO: 2761348-54-1; claim 30);
Example 57 (CAS NO: 2761348-55-2; claim 30);
Example 58 (CAS NO: 2761348-56-3; claim 30);
Example 59 (CAS NO: 2761348-57-4; claim 30);
Example 60 (CAS NO: 2761348-58-5; claim 30);
Example 61 (CAS NO: 2761348-59-6; claim 30);
Example 62 (CAS NO: 2761348-60-9; claim 30);
Example 63 (CAS NO: 2761348-61-0; claim 30);
Example 64 (CAS NO: 2761348-62-1; claim 30);
Example 65 (CAS NO: 2761348-63-2; claim 30);
Example 66 (CAS NO: 2761348-64-3; claim 30);
Example 67 (CAS NO: 2761348-65-4; claim 30);
Example 68 (CAS NO: 2761348-66-5; claim 30);
Example 69 (CAS NO: 2761348-67-6; claim 30);
Example 70 (CAS NO: 2761348-68-7; claim 30);
Example 71 (CAS NO: 2761348-69-8; claim 30);
Example 72 (CAS NO: 2885957-47-9, claim 30)3;
Example 73 (CAS NO: 2761348-71-2; claim 30);
Example 74 (CAS NO: 2761348-72-3; claim 30);
Example 75 (CAS NO: 2761348-73-4; claim 30);
Example 76 (CAS NO: 2761348-74-5; claim 30);
Example 77 (CAS NO: 2761348-75-6; claim 30);
Example 78 (CAS NO: 2761348-76-7; claim 30);
Example 79 (CAS NO: 2761348-77-8; claim 30);
Example 80 (CAS NO: 2761348-78-9; claim 30);
Example 81 (CAS NO: 2761348-79-0; claim 30);
Example 82 (CAS NO: 2761348-80-3; claim 30);
Example 83 (CAS NO: 2761348-81-4; claim 30);
Example 84 (CAS NO: 2761348-82-5; claim 30);
Example 85 (CAS NO: 2761348-83-6; claim 30);
Example 86 (CAS NO: 2761348-84-7; claim 30);
Example 87 (CAS NO: 2761348-85-8; claim 30);
Example 88 (CAS NO: 2761348-86-9; claim 30);
Example 89 (CAS NO: 2761348-87-0; claim 30);
Example 90 (CAS NO: 2761348-88-1; claim 30);
Example 91 (CAS NO: 2761348-89-2; claim 30);
Example 92 (CAS NO: 2761348-90-5; claim 30);
Example 93 (CAS NO: 2761348-91-6; claim 30);
Example 94 (CAS NO: 2761348-92-7; claim 30);
Example 95 (CAS NO: 2761348-93-8; claim 30);
Example 96 (CAS NO: 2761348-94-9; claim 30);
Example 97 (CAS NO: 2761348-95-0; claim 30);
Example 98 (CAS NO: 2761348-96-1; claim 30);
Example 99 (CAS NO: 2761348-97-2; claim 30);
Example 100 (CAS NO: 2761348-98-3; claim 30);
Example 101 (CAS NO: 2761348-99-4; claim 30);
Example 102 (CAS NO: 2761349-00-0; claim 30);
Example 103 (CAS NO: 2761349-01-1; claim 30);
Example 104 (CAS NO: 2761349-02-2; claim 30);
Example 105 (CAS NO: 2761349-03-3; claim 30);
Example 106 (CAS NO: 2761349-04-4; claim 30);
Example 107 (CAS NO: 2761349-05-5 ; claim 30);
Example 108 (CAS NO: 2761349-06-6; claim 30);
Example 109 (CAS NO: 2761349-07-7; claim 30);
Example 110 (CAS NO: 2761349-08-8; claim 30);
Example 111 (CAS NO: 2761349-09-9; claim 30);
Example 112 (CAS NO: 2761349-10-2; claim 30);
Example 113 (CAS NO: 2761349-11-3; claim 30);
Example 114 (CAS NO: 2761349-12-4; claim 30);
Example 115 (CAS NO: 2761349-13-5; claim 30);
Example 116 (CAS NO: 2761349-14-6; claim 30);
Example 117 (CAS NO: 2761349-15-7; claim 30);
Example 118 (CAS NO: 2761349-16-8; claim 30);
Example 119 (CAS NO: 2761349-17-9; claim 30);
Example 120 (CAS NO: 2761349-18-0; claim 30);
Example 121 (CAS NO: 2761349-19-1; claim 30);
Example 122 (CAS NO: 2761349-20-4; claim 30);
Example 123 (CAS NO: 2761349-21-5; claim 30);
Example 124 (CAS NO: 2761349-22-6; claim 30);
Example 125 (CAS NO: 2761349-23-7; claim 30);
Example 126 (CAS NO: 2761349-24-8; claim 30);
Example 127 (CAS NO: 2761349-25-9; claim 30)4;
Example 128 (CAS NO: 2761349-26-0; claim 30);
Example 129 (CAS NO: 2761349-25-9; claim 30)5;
Example 130 (CAS NO: 2761349-27-1; claim 30);
Example 131 (CAS NO: 2761349-28-2; claim 30);
Example 132 (CAS NO: 2761349-29-3; claim 30);
Example 133 (CAS NO: 2761349-30-6; claim 30);
Example 134 (CAS NO: 2761349-31-7; claim 30);
Example 135 (CAS NO: 2761349-32-8; claim 30);
Example 136 (CAS NO: 2761349-33-9; claim 30);
Example 137 (CAS NO: 2761349-34-0; claim 30); and
Example 138 (CAS NO: 2761349-35-1; claim 30);
Upon search and examination these species, which correspond to the exact structures shown at claim 30 and Example 1-138 as shown at Table 1 of the corresponding specification (see Spec. filed 2/02/2023 at Table 1 at pages 80-86)6. Accordingly, all explicitly disclosed and claimed species corresponding to Examples 1-138 have been fully considered and deemed free of the prior art. The closest prior art is FR2733237A1, which discloses CAS NO. 187281-84-1 (i.e., VPIIYCNRRTGKCQRM; which corresponds to instant claim 1 wherein P1 is Val, P2 is Pro, P3 is Ile, P4 is Ile, P5 is Tyr, P6 is Cys, P7 is Asn, P8 is Arg, P9 is Arg, P10 is Thr, P11 is Gly, P12 is Lys, P13 is Cys, P14 is Gln, P15 is Arg, and P16 is Met; wherein only P11 does not satisfy the requirements of the genus of instant claim 1 because P11 is limited to cationic D-amino acids).
However, the pending claims have not been indicated as allowable at this time in view of remaining issues disclosed below. Furthermore, Examination has not proceeded beyond a proper Markush Grouping at this time.
Claims 34-39 and 56-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Claims 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Claims 23-30, 32-33, and 40-55 are presently examined.
Denial of Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, EP20020353.7 (filed 8/05/2020) fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Claims 23 and 30 are representative of the pending claim scope. Neither claim literally appears in the disclosure of EP20020353.7.
Accordingly, the priority document fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’231 through implicit or inherent disclosures.
Here, EP20020353.7 notably only discloses Examples 1-72 (see, e.g., EP’353 at Table I; compare with instant Table 1; compare EP’353 at claim 1 at P2 with instant claim 1 at P2). Accordingly, EP’353 provides no literal, inherent, or implicit support for the species and structures of Examples 73-138 or the scope of the genus of claim 23 and 30 as instantly claimed.
Accordingly, the priority document fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to EP20020353.7 (filed 8/05/2020) is denied for all claims, which have been accorded a priority date of 8/05/2021, which corresponds to the filing date of PCT/EP2021/025301 (filed 8/05/2021).
Information Disclosure Statement
No IDS was filed 6/10/2026.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111.
Newly added claims 23 and 30 are representative of the pending claim scope.
Claims 46-54 take the unusual form of “The pharmaceutical composition according to claim 32, wherein the compound is defined in claim [X]”, wherein claim 32 depends from independent claim 23, and wherein “[X]” refers to a dependent claim that is understood to depend from and further limit the scope of independent claim 23. The reference to a claim within a dependent claim is understood to be permissible per MPEP § 2173.05(f) so long as the test as MPEP § 608.01(n)(III) is satisfied. Here, claim 23 recites a broad genus, and the dependent claims “[X]” each depend directly (i.e., claims 28, 29, 30, 40, 44) or indirectly (i.e., claims 41, 42, 43, and 45 depend from claims 28, 29, 30, and 44 respectively) from claim 23 and each claim is understood to further limit the scope of claim 23 (i.e., claims 28, 29, 30, 40, 41, 42, 43, 44, and 45 each recite a subgenus of compounds within the scope of claim 23). Accordingly, the test as MPEP § 608.01(n)(III) is understood to be satisfied for purposes of 35 USC §112(d) because the claims reference a claim previously set forth (claim 32 and claim 23), then specify a further limitation of the subject matter claimed, namely a subgenus of claim 23 set forth in a dependent claim “[X]”.
Applicable claim interpretation is set forth below.
Claim Objections
Claims 23-30 and 40-45 are objected to because of the following informalities:
Claims 23-30 and 40-45 are objected to because they recite numerous chemical acronyms which should be completely spelled out at least once in the pending claims (e.g., NMeVal, Abu, tBuGly, Agp, Agb, Pic, Pen, etc., etc.).
Claims 23 and 24-26 are objected to because these claims contain confusing grammatical incongruities wherein enumerated elements within lists per position are separated by semicolons, commas, and various spacings in an inconsistent manner (e.g., claim 23 recites at P4 “…NMeVal, Nva; Phe, His, ….Nphe; Agb, Agp…”, wherein both commas and semicolons are utilized presumably in a single list of alternatives for the single position of P4).
Appropriate correction is required.
Withdrawn Claim Rejections
All prior rejections are withdrawn as moot in view of the cancellation of previously pending claims. Amendments filed 6/10/2026 have necessitated one or more new or revised rejections, which are set forth below.
New or Revised Claim Rejections
Improper Markush Grouping
Claims 23-29 are rejected on the basis that they each contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of instant claims 23-29 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The vast and highly varied genera and subgenera of claims 23-29 read upon and encompass numerous compounds lacking any common structural similarity (see, e.g., instant claims 23 and 25, noting that zero common structures are required to be present). Although dependent claims 24 and 26-29 recite narrower genera (claims 24 and 26-27 each require a P3 of Ile and P8 of Arg; and claims 28-29 each require a P3 of Ile, P5 of Tyr and P8 of Arg), these two or three defined positions do not reasonably define a “substantial structural feature that is essential to a common use” in view of the instant record (see, e.g., MPEP § 2117(II)). Furthermore, as peptidomimetics (see instant claim 23), the genus and subgenera of claims 23-29 are not limited to embodiments wherein “-” represents a normal peptide bond or embodiments having a normal peptide backbone; furthermore, as peptidomimetics that may include intramolecular bridges, the claim scope is not limited to linear embodiments. Furthermore, the claims encompass “tautomer, a rotamer, a salt, a hydrate or solvate” thereof. Accordingly, no common, consensus structure is recited and required at claims 23-29 that is essential to any common use, and therefore claims 23-29 are rejected as reciting improper Markush Groups.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
[NSDP Rejection 01]
Claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-17 of copending Application No. 18/294,227 (reference application, corresponding to US20240336654). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)).
Instant claims 1-9 and 12-15 and copending claims 1-17 materially and substantially overlap in scope. For example, claim 1 of each copending claim set reads upon 16-mer peptidomimetic compounds having the general structure of
P1P2P3P4P5P6P7P8P9P10P11P12P13P14P15P16
wherein P1 may be selected from an overlapping group including at least Ala, Gua-Val, Val, etc.;
wherein P2 may be selected from an overlapping group including at least Hyp, Pro, etc.;
wherein P3 may be selected from an overlapping group including at least Ile, etc.;
wherein P4 may be selected from an overlapping group including at least Dab, Dap, etc.;
wherein P5 may be selected from an overlapping group including at least Phe, His, Trp, Tyr, etc.;
wherein P6 may be selected from an overlapping group including at least Dab, Dap, Asp, Glu, HgI, etc.;
wherein P7 may be selected from an overlapping group including at least Ala, Abu, Ile, Asn, etc.;
wherein P8 may be selected from an overlapping group including at least Lys, Arg, etc.;
wherein P9 may be selected from an overlapping group including at least Dab, Cit, etc.;
wherein P10 may be selected from an overlapping group including at least Thr, AlloThr, etc.;
wherein P11 may be selected from an overlapping group including at least DLys, DOrn, DDab, etc.;
wherein P12 may be selected from an overlapping group including at least Ala, Agb, Lys, etc.;
wherein P13 may be selected from an overlapping group including at least Dab, Dap, etc.;
wherein P14 may be selected from an overlapping group including at least Dap, Dab, Lys, etc.;
wherein P15 may be selected from an overlapping group including at least Dap, Dab, etc.; and
wherein P16 may be selected from an overlapping group including at least Ala, Phe, Tyr, etc.;
Accordingly, the copending claim scopes are directed to overlapping subject matter, namely common peptidomimetics (compare instant claims 23-29, 32-33, 40-43, 46-47, 49-52, and 55 with App’227 at claim 1), and pharmaceutical formulations or medicaments comprising such peptidomimetics (compare instant claims 32-33, 46-47, 49-52, and 55 with App’227 at claims 12-17). In sum, under an anticipation analysis and/or obviousness analysis, the instant claims are not patentably distinct from the copending claim because the copending claims are directed to a materially and substantially overlapping genus of peptidomimetics (compare instant claim 23 with App’227 at claim 1).
Regarding additional subgenera at instant claims 24-29: although the subgenera defined at dependent claims 24-29 of the instant Applications ostensibly differ at a single position (e.g., the subgenera at instant claim 24 and copending claim 9 differs at P67), such differences cannot be said to patentably distinguish the pending claim scope in view of the guidance of each respective claim 1, which identifies functionally equivalent substitutions at that position, including one or more of the recited residues (e.g., at each claim 9, the claims reasonably inform artisans that Dap, Dab, and Asp could be utilized as functional equivalents at that position).
In sum, the differences between the reference claims and instant claims appear to be minor because both claim sets recite substantially and materially overlapping genera and subgenera defining products for use for the same purpose8, and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed” in a patent or copending application9 is clearly “yes”.
MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)).
Instant claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55 are either anticipated or otherwise rendered obvious in view of copending claims 1-9 and 11-17 because the claim scopes substantially and materially overlap as discussed above, an artisan would at once envisage the overlapping compounds (see, e.g., MPEP § 804(II)(B)(2)), and the differences among dependent claims amount to simple substitutions of equivalent amino acids set forth explicitly in the pending claim scope, wherein such substitution would merely yield predictable and expected results, namely antimicrobial peptidomimetics, and wherein the equivalence at that position is explicitly taught by the claims as a whole of the copending application (see, e.g., MPEP §§ 2143(I)(B), 2144.06(II)).
The reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary.
Accordingly, claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55 are provisionally rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[NSDP Rejection 02]
Claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 17-20 of copending Application No. 18019382 (reference application; corresponding to US20230295234). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Regarding instant claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55, generally, App’382 is directed to a subgenus of the instant claims that differ with respect to the instantly claimed compounds because US’234 claims peptidomimetics ranging in length from 17 to 19 residues in length, wherein the claimed sequences have a 1-3 residue N-terminal extension relative to the instantly claimed invention (compare instant claims with US’234 at claims). However, instant claims do not explicitly recite “consisting of” language or explicitly exclude embodiments having an N-terminal extension. Regarding instant claims 23-29, instant claim 23 is reasonably understood to encompass multiple overlapping species of copending claim 1, including peptidomimetic compounds comprising the structure of
P1P2P3P4P5P6P7P8P9P10P11P12P13P14P15P16
wherein P1 may be selected from an overlapping group including at least Val, etc.;
wherein P2 may be selected from an overlapping group including at least Hyp, etc.;
wherein P3 may be selected from an overlapping group including at least Ile, etc.;
wherein P4 may be selected from an overlapping group including at least Thr, etc.;
wherein P5 may be selected from an overlapping group including at least Tyr, etc.;
wherein P6 may be selected from an overlapping group including at least Pen, etc.;
wherein P7 may be selected from an overlapping group including at least Asn, etc.;
wherein P8 may be selected from an overlapping group including at least Arg, etc.;
wherein P9 may be selected from an overlapping group including at least Dab, etc.;
wherein P10 may be selected from an overlapping group including at least Thr, etc.;
wherein P11 may be selected from an overlapping group including at least DDab, etc.;
wherein P12 may be selected from an overlapping group including at least Lys, etc.;
wherein P13 may be selected from an overlapping group including at least Cys, Dab, Dap, etc.;
wherein P14 may be selected from an overlapping group including at least Dap, Dab, Lys, etc.;
wherein P15 may be selected from an overlapping group including at least Arg, Dap, Dab, etc.; and
wherein P16 may be selected from an overlapping group including at least Tyr, etc.;
Accordingly, the copending claim scopes are directed to species within the scope of instant claim 1, that differ from explicitly recited claim scope only in that at least a one residue N-terminal extension is present (see App’382 at claim 1 at position X1, noting that t and s may each be zero; compare instant claims 1-9 with App’382 at claims 1-14). Regarding instant claims 32-33, 46-47, 49-52, and 55, App’382 also discloses that the recited peptidomimetics may be utilized in pharmaceutical formulations or medicaments (compare instant claims 32-33, 46-47, 49-52, and 55 with App’382 at claims 17-20).
In sum, the differences between the reference claims and instant claims appear to be minor because both claim sets recite substantially and materially overlapping genera and subgenera defining products for use for the same purpose10, and the only ostensible difference is the presence of an additional N-terminal residue in the embodiments disclosed and claimed by App’382. However, the instant claims do not exclude N-terminal extensions, the additional N-terminal extension does not appear to impart any additional activity upon the embodiments of App’382, and the embodiments of App’382 satisfy the requirements of general formula (I) (compare instant claim 23 with App’382 at claims 1-14), or otherwise at most differ at a single position by the substitution of a functionally equivalent residue as taught at claim 1 (compare instant claims 23-29 with App’382 at claims 1-14). Therefore, the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed” in a patent or copending application11 is clearly “yes”.
MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Under an obviousness analysis, instant claims 23-29, 32-33, 40-43, 46-47, 49-52, and 55 are not patentably distinct from the copending claims under an obviousness analysis because the copending claims either fully encompass the instantly claimed peptidomimetics or otherwise differ by one simple substitutions of equivalent amino acids, wherein such substitution would merely yield predictable and expected results, namely antimicrobial peptidomimetics, and wherein the equivalence at that position is explicitly taught by the claims as a whole of the copending application (see, e.g., MPEP §§ 2143(I)(B), 2144.06(II)).
The reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary.
Accordingly, claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55 are provisionally rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[NSDP Rejection 03]
Claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, and 11-20 of copending Application No. 19/290,517 (reference application; corresponding to US20260042800). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Regarding instant claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55, instant claim 23 is reasonably understood to encompass multiple overlapping species of copending claims 1-5 and 7, including peptidomimetic compounds comprising the structure of
P1P2P3P4P5P6P7P8P9P10P11P12P13P14P15P16
wherein P1 may be selected from an overlapping group including at least Gua-Val;
wherein P2 may be selected from an overlapping group including at least Pro, or Hyp;
wherein P3 may be selected from an overlapping group including at least Ile;
wherein P4 may be selected from an overlapping group including at least Val(3OH);
wherein P5 may be selected from an overlapping group including at least Tyr;
wherein P6 may be selected from an overlapping group including at least Pen, Cys;
wherein P7 may be selected from an overlapping group including at least Asn, Leu, Ile, Ser, Dap, His;
wherein P8 may be selected from an overlapping group including at least Arg;
wherein P9 may be selected from an overlapping group including at least Dab, Dab(iPr), Lys, Arg;
wherein P10 may be selected from an overlapping group including at least Thr, Ser, etc.;
wherein P11 may be selected from an overlapping group including at least DDab, DDab(iPr), DArg;
wherein P12 may be selected from an overlapping group including at least Lys, Dab, Cit;
wherein P13 may be selected from an overlapping group including at least Cys, Pen;
wherein P14 may be selected from an overlapping group including at least Dab, Lys, Dab(iPr), Ser, Tyr;
wherein P15 may be selected from an overlapping group including at least Arg, Dab, Orn, Orn(iPr), Ser, Thr; and
wherein P16 may be selected from an overlapping group including at least Tyr, Nle, Cha;
Accordingly, the copending claim scopes substantially and materially overlap by claiming overlapping genera and subgenera comprising identical species. Regarding instant claims 32-33, 46-47, 49-52, and 55, App’517 also claims that the recited peptidomimetics may be utilized in pharmaceutical formulations or medicaments (compare instant claims 32-33, 46-47, 49-52, and 55 with App’517 at claims 8-9 and 11-20).
In sum, the differences between the reference claims and instant claims appear to be minor because both claim sets recite substantially and materially overlapping genera and subgenera defining products for use for the same purpose12, and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed” in a patent or copending application13 is clearly “yes”.
MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Here, under an anticipation analysis, instant claims 1-9 and 12-15 are rejected because the copending application claims the same compounds, having the same utility.
Accordingly, claims 23-29, 32-33, 40-42, 46-47, 49-52, and 55 are provisionally rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 6/10/2026 have been fully considered but they are not persuasive as explained below.
Regarding the improper Markush rejection: It is the Examiner’s understanding that Applicant acknowledges the Markush rejection (see, e.g., Reply filed 6/10/2026 at 24 at § III), but fails to address or explain how the newly added claims overcome the issues of record, which remain. Rather, Applicant only provides a conclusory allegation that that “The cancellation of the claims and the addition of the new claims render the rejections moot” (see id.), but fails to meaningfully identify how the amended claims address and overcome the rejection of record. Accordingly, Applicant's arguments amount to a general allegation that the claims overcome the rejection of record without specifically pointing out how the language of the newly added claims overcome the relevant issues by limiting the claim scope to require a “substantial structural feature that is essential to a common use” in view of the instant record (see, e.g., MPEP § 2117(II)). Therefore, such conclusory assertion is insufficient to overcome issues of record, and therefore the rejection is maintained as revised above.
Regarding the provisional obviousness-type double patenting rejections, it is the Examiner’s understanding that Applicant acknowledges the provisional NSDP rejections over copending applications App’227, App’382, and App’517 (see, e.g., Reply filed 6/10/2026 at 24 at § IV), but fails to address or explain how the newly added claims overcome the issues of record, which remain. Rather, Applicant only provides a conclusory allegation that that “The cancellation of the claims and the addition of the new claims render the rejections moot” (see id.), but the response fails to meaningfully identify how the new or amended claims overcome the rejections of record. Accordingly, Applicant's arguments fail to rebut the rejections of record because the conclusory statement amounts to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
All Examiner positions, holdings, and findings that were not specifically addressed or otherwise specifically disputed, are understood to be undisputed on the instant record.
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive. Therefore, the rejections are maintained as revised above, wherein all new or revised rejections were necessitated by Applicants cancellation of all previously pending claims and submission of new (amended) claims.
Allowable Subject Matter
Claims 30, 43-45, 48, and 53-54 are objected to as being dependent upon a rejected base claim, but would currently be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fehlbaum et al.14 discloses a 16-mer Thanatin variants comprising the sequence VPIIYCNRRTGKCQRM (see, e.g., Fehlbaum et al. at Fig. 1 on 1222, Table 1 at 1223 at “V16M”), which differs from the claim scope with respect to at least P5 and P11 as claimed
Merlino15 discloses glycine replacement techniques for use in antimicrobial peptides (see, e.g., Merlino at title, abs). Merlino discloses that a glycine residue in an antimicrobial peptide may be mutated to DLys or other amino acid residues (see, e.g., Merlino at Table 1 on 751).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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 G. 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.
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.
/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 See, e.g., Requirement mailed 10/29/2025 at 4, noting that a reply must identify claims readable on the elected species, including any claims subsequently added.
2 See, e.g., Requirement mailed 10/29/2025 at 4, noting that a reply must identify claims readable on the elected species, including any claims subsequently added.
3 Val-Hyp-lle-lle-Tyr-Asp-Asn-Arg-Dab-Thr-DDab-Lys-Dab-Dab-Arg-Tyr; CAS NO is associated with cyclic peptide structure.
4 Compounds at Example 127 and 129 are identical and directed to Val-Pro(4,4F2)-lle-Thr-Tyr-Pen-Asn-Arg-Dab-Thr-DDab-Lys-Cys-Dab-Arg-Tyr. This structure is associated with CAS No: 2761349-25-9, which shows an image of the correct structure, but incorrectly refers to position two as unmodified Proline in the sequence modification portion of the file.
5 See previous footnote.
6 See corresponding annotated WO 2022/028737 Al, having annotations with corresponding CAS NO. and Structure data appended at added pages 125-152.
7 E.g., App’277 limits P9 to Dab, DDab, Cit, Asn, or Ser; wherein the instant claims 29 limit P9 to Lys, Arg, Dab, or Dab(iPr).
8 See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences
9 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
10 See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences
11 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
12 See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences
13 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
14 Fehlbaum et al., Structure-activity analysis of thanatin, a 21-residue inducible insect defense peptide with sequence homology to frog skin antimicrobial peptides. Proc Natl Acad Sci U S A. 1996 Feb 6;93(3):1221-5. doi: 10.1073/pnas.93.3.1221. PMID: 8577744; PMCID: PMC40060; cited in IDS filed 7/17/2024 as Cite No. 4.
15 Merlino et. al., Glycine-replaced derivatives of [Pro3,DLeu9]TL, a temporin L analogue: Evaluation of antimicrobial, cytotoxic and hemolytic activities. Eur J Med Chem. 2017 Oct 20;139:750-761. doi: 10.1016/j.ejmech.2017.08.040. Epub 2017 Aug 21. PMID: 28863356; hereafter “Merlino”; cited in previous action.
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