Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment after non-final office action filed July 6, 2026 is acknowledged. 1-43, 45-68, 72-73, 90-91 were cancelled, claims 44, 74-76, 79-83 was amended, claims 92-99 were newly added and claims 44, 69-71, 74-89, 92-99 are pending.
Election/Restrictions
The restriction was deemed proper and made final in the previous office action. Claims 87-88 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Claims 44, 69-71, 74-86, 89, 92-99 are examined on the merits of this office action.
Withdrawn Objections/Rejections
The rejection of claims 44, 67-86, 89-91 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed July 6, 2026.
The rejection of claims 73, 75-76, 79-81 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed July 6, 2026.
The rejection of claim 80 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, is withdrawn in view of amendment of the claims filed July 6, 2026.
Maintained/Revised Rejections\
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 44, 69-71, 74-77, 84-86, 89, 92-95, 97, 99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-17 US Patent No. 11453703 B2 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
US Patent No. 11453703 B2 claims “A heterotandem bicyclic peptide complex comprising:
(a) a first peptide ligand which binds to CD137 on an immune cell;
conjugated via a linker to
(b) a second peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is EphA2; wherein each of said peptide ligands comprises a polypeptide comprising three cysteine residues, separated by two loop sequences, and a molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that two polypeptide loops are formed on the molecular scaffold,
wherein the first peptide ligand is a CD137 binding bicyclic peptide ligands…and wherein the second peptide ligands were EphA2 (cancer binding) binding bicyclic peptide ligands” (see claim 1). US Patent No. 11453703 further claims wherein the scaffold is TATA (claim 3); wherein the peptide complex is a free acid (claim 4); pharmaceutically acceptable excipients (claim 5); SEQ ID NO:1 which is identical to instant SEQ ID NO:5 (CD137 peptide); N- and C-terminal modifications of the CD137 binding peptides (claim 6). US Patent No. 11453703 B2 further claims EphaA2 comprising SEQ ID NO:2 (claim 1) with N and C modifications 8 thus meeting the limitations of instant claims 44 and 93.
US Patent No. 11453703 B2 does not claim two or more second peptide ligands (i.e. two or more CD137 peptides) or including radiochelator/chromophore. However, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘703 by adding additional binding ligands in order to enhance binding affinity or targeting (to the cancer cell or immune cell), a well-known design choice with a reasonable expectation of success. Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘703 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells (claim 13) as this is a well-known design choice with a reasonable expectation of success.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-86, 89, 92, 97, 99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 US Patent No. 11306123 B2 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
US Patent No. 11306123 B2 claims “A heterotandem bicyclic peptide complex comprising:
(a) a first peptide ligand which binds to Nectin-4 and which has the sequence CiP[1Nal][dD]CiiM[HArg]DWSTP[HyP]WCiii (SEQ ID NO: 1); conjugated via an N-(acid-PEG3)-N-bis(PEG3-azide) linker to
(b) two second peptide ligands which bind to CD137 both of which have the sequence Ac-Ci[tBuAla]PE[D-Lys(PYA)]PYCiiFADPY[Nle]Ciii-A (SEQ ID NO: 2, which is instant SEQ ID NO:11);
or a pharmaceutically acceptable salt thereof,
wherein each of said peptide ligands comprise a polypeptide comprising three reactive cysteine groups (Ci, Cii and Ciii), separated by two loop sequences, and a molecular scaffold which is 1,1′,1″-(1,3,5-triazinane-1,3,5-triyl)triprop-2-en-1-one (TATA) and which forms covalent bonds with the reactive cysteine groups of the polypeptide such that two polypeptide loops are formed on the molecular scaffold;
wherein Ac represents acetyl, HArg represents homoarginine, HyP represents trans-4-hydroxy-L-proline, 1Nal represents 1-naphthylalanine, tBuAla represents t-butyl-alanine, PYA represents 4-pentynoic acid and Nle represents norleucine”. SEQ ID Nos:1-2 overlap with the sequences in instant claims 73-76, 79-80, 82-83. US Patent No. 11306123 B2 further claims free acid salt form (claim 3); pharmaceutically acceptable excipients (claim 4) and treating cancer (claim 16).
Furthermore, regarding instant claim 86, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘123 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-81, 84-86, 89, 92-95, 97-99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 US Patent No. 11332500 B2 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
US Patent NO. 11332500 B2 claims “A heterotandem bicyclic peptide complex comprising:
(a) a first peptide ligand which binds to a component present on a cancer cell; conjugated via a linker to
(b) a second peptide ligand which binds to a component present on an immune cell; wherein each of said peptide ligands comprise a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold, characterized in that said heterotandem bicyclic peptide complex comprises the following first and second peptide ligands” (claim 1). The peptides are EphaA2, CD137 or PDL1 binding peptides (claims 1, 9-13, 19) that over lap with the instant sequences. US Patent NO. 11332500 further claims TATA as the scaffold (claim 15); free acid salt (claim 16); pharmaceutically acceptable excipients (Claim 17)
US Patent NO. 11332500 does not claim two or more second peptide ligands (i.e. two or more CD137 peptides etc..) or including a chromophore or radiochelator. However, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘500 by adding additional binding ligands in order to enhance binding affinity or targeting (to the cancer cell or immune cell), a well-known design choice with a reasonable expectation of success.
Furthermore, regarding instant claim 86, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘500 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-71, 74-86, 89, 92-97, 99 are/remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 3, 5-15, 18, 21-24 and 46 of Co-pending Application No. 18/271593 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
Co-pending Application No. 18/271593 claims “A method of treating a cancer in a patient, comprising administering to said patient a therapeutically effective amount of a heterotandem bicyclic peptide complex, or a pharmaceutically acceptable salt thereof, and an immuno-oncology agent, wherein the heterotandem bicyclic peptide complex comprises:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on the cancer cell is Nectin-4, and the first peptide ligand comprises an Nectin-4 binding bicyclic peptide ligand; conjugated via a linker to (b) one or more CD137 binding bicyclic peptide ligands; wherein each of said peptide ligands comprise a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (claim 1). Co-pending Application No. 18/271593 further claims wherein the reactive groups are cysteine residues (claim 2); two or more CD137 binding bicyclic peptide ligands (claim 3); specific CD137 peptides that overlap with the instant claims (claims 5-6); wherein the heterotandem bicyclic peptide complex comprises two CD137 binding bicyclic peptide ligands, wherein both of said two CD137 binding bicyclic peptide ligands have the same peptide sequence which comprises Ac-(SEQ ID NO: 11)-A (herein referred to as BCY8928), or a pharmaceutically acceptable salt thereof (claim 9); Nectin-4 binding bicyclic peptide ligands that overlap with the instant claims (claim 10-11); TATA as the scaffold (claim 22). The CD137 and Nectin-4 (claims 7 and 10) binding peptides overlap with the sequences of the instant claims. Furthermore, the co-pending Application claims EphA2 binding peptides that overlap with the instant claims (claims 44, 93-96) (see claims 18, 21, reference to Table C).
Co-pending Application No. 18/271593 does not claim including a chromophore or radiochelator.
However, it would have been obvious to one of ordinary skill in the art to modify the composition of Co-pending Application No. 18/271593 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-71, 74-86, 89, 92, 99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US Patent No. 12435107 (previously referred to as Co-pending Application No. 18/424386 (reference application)). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
US Patent No. 12435107 claims “A method of synthesizing compound BCY11863”. THe compound of BCY11863 comprises one nectin-4 binding peptide (SEQ ID NO:1 is the same as instant SEQ ID NO:1) and two CD137 binding peptides (SEQ ID NO:2 is the same as instant SEQ ID NO:11) that are encompassed by the sequences of the instant claims and the full compounds of instant claims 82-83 with linkers. US Patent No. 12435107 further claims TATA (Claim 20). US Patent No. 12435107 does not claim that the compound is in a pharmaceutical formulation and in salt form for administration or including a radiochelator or chromophore. However, the main utility of the conjugate in US Patent No. 12435107 is to be used for treating cancer and it would have been obvious to include an acceptable excipient, including water, in using the conjugate for treating cancer. Furthermore, in the process of making the conjugate, the conjugate is in salt form.
Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘107 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-71, 74-77, 84-86, 89, 93-97, 99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 US Patent No. 11312749 B2 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
US Patent No. 11312749 B2 claims “A heterotandem bicyclic peptide complex comprising:
(a) a first peptide ligand which binds to EphA2 and which has the sequence A-[HArg]-D-Ci[HyP]LVNPLCiiLEP[d1Nal]WTCiii (SEQ ID NO: 1); conjugated via an N-(acid-PEG3)-N-bis(PEG3-azide) linker to
(b) two second peptide ligands which bind to CD137 both of which have the sequence Ac—Ci[tBuAla]PE[D-Lys(PYA)]PYCiiFADPY[Nle]Ciii-A (SEQ ID NO: 2);
or a pharmaceutically acceptable salt thereof,
wherein each of said peptide ligands comprise a polypeptide comprising three reactive cysteine groups (Ci, Cii and Ciii), separated by two loop sequences, and a molecular scaffold which is 1,1′,1″-(1,3,5-triazinane-1,3,5-triyl)triprop-2-en-1-one (TATA) and which forms covalent bonds with the reactive cysteine groups of the polypeptide such that two polypeptide loops are formed on the molecular scaffold;
wherein Ac represents acetyl, HArg represents homoarginine, HyP represents trans-4-hydroxy-L-proline, 1Nal represents 1-naphthylalanine, tBuAla represents t-butyl-alanine, PYA represents 4-pentynoic acid and Nle represents norleucine” (see claim 1)”. US Patent No. 11312749 B2 further claims wherein the peptide is in free acid form (claim 3); pharmaceutically acceptable excipient (claim 4). The CD137 peptides of US Patent. 11312749 B2 read on instant claims 73-76.
Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘749 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-71, 41-86, 89, 92, 99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 US Patent No. 11970553 B2 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
US Patent No. 11970553 B2 A method of treating cancer in a patient, comprising administering to the patient a heterotandem bicyclic peptide complex comprising:
(a) a first peptide ligand, which binds to Nectin-4 and which comprises the sequence CiP[1Nal][dD]CiiM[HArg]DWSTP[HyP]WCiii (SEQ ID NO: 1); conjugated via an N-(acid-PEG3)-N-bis(PEG3-azide) linker to
(b) two second peptide ligands, each of which binds to CD137 and each of which comprises the sequence Ac-Ci[tBuAla]PE[D-Lys(PYA)]PYCiiFADPY[Nle]Ciii-A (SEQ ID NO: 2);
or a pharmaceutically acceptable salt thereof,
wherein Ci, Cii and Ciii of SEQ ID NOs: 1 and 2 each from covalent bonds with a molecular scaffold comprising 1,1′,1″-(1,3,5-triazinane-1,3,5-triyl)triprop-2-en-1-one (TATA) thereby forming two polypeptide loops for each of SEQ ID NOs: 1 and 2; and
wherein Ac represents acetyl, HArg represents homoarginine, HyP represents trans-4-hydroxy-L-proline, 1Nal represents 1-naphthylalanine, tBuAla represents t-butyl-alanine, PYA represents 4-pentynoic acid and Nle represents norleucine.” US Patent No. 11970553 B2 further claims wherein the complex is a free acid (claim 10), in combination with a pharmaceutically acceptable excipient (claim 11). The Nectin-4 and CD137 peptides fall within the scope of instant claims 73-76, 79-81.
Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition of US Patent No. ‘553 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-71, 74-77, 84-86, 89, 93-97, 99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of Co-pending Application No. 17/590875 (reference application) (Now US Patent No. 12606594). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
Co-pending Application No. 17/590875 claims “A method of suppressing or treating cancer in a patient comprising administering to the patient a heterotandem bicyclic peptide complex, or pharmaceutically acceptable salt thereof, wherein the heterotandem bicyclic peptide complex comprises:(a) a first peptide ligand which binds to EphA2 and which has the sequence A-[HArg]- D-Ci[HyP]LVNPLCiLEP[d1Nal]WTCiii (SEQ ID NO: 1; BCY13118); conjugated via an N-(acid- PEG3)-N-bis(PEG3-azide) linker to (b) two second peptide ligands which bind to CD 137 both of which have the sequence Ac-CitBuAla]PE[D-Lys(PYA)]PYCiiFADPY[Nle]Ciii-A (SEQ ID NO: 2; BCY8928);wherein each of said peptide ligands comprise a polypeptide comprising three reactive cysteine groups (Ci,Ci and Ciii), separated by two loop sequences, and a molecular scaffold which is 1,1',1"- (1,3,5-triazinane-1,3,5-triyl)triprop-2-en-1-one (TATA) and which forms covalent bonds with the reactive cysteine groups of the polypeptide such that two polypeptide loops are formed on the molecular scaffold; wherein Ac represents acetyl, HArg represents homoarginine, HyP represents trans-4-hydroxy-L- proline, 1Nal represents 1-naphthylalanine, tBuAla represents t-butyl-alanine, PYA represents 4- pentynoic acid and Nle represents norleucine,and wherein the cancer cells express EphA2” (Claim 5). Co-pending Application No. 17/590875 further claims free acid salt form (Claim 13); in combination with an acceptable excipient (claim 14). The CD137 peptides of the co-pending application read on the CD137 peptides of instant claims.
Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition of Co-pending 17/590875 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-71, 74-86, 89, 92, 99 are/remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of Co-pending Application No. 18/710083 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
Co-pending AN18/710083 claims “solid pharmaceutical composition comprising BT7480, or a pharmaceutically acceptable salt thereof, Tris base, mannitol, and sodium hydroxide” (claim 1). Co-pending AN18/710083 further claims use in a pharmaceutical formulation (claims 14-18). BT7480 is a heterotandem bicyclic peptide complex comprising Nectin-4 binding peptide linked to two CD137 peptides via a linker (see paragraph 001 of specification) which falls within the scope and the sequences of the instant claims.
Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition of Co-pending 18/710083 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
Claims 44, 69-71, 74-86, 89, 92, 99 are/remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6, 21-46 Co-pending AN17/663169 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A tumor-targeted CD137 agonist which is a heterotandem bicyclic peptide complex or a pharmaceutically acceptable salt thereof comprising:(a) a first peptide ligand which binds to a component present on a cancer cell, wherein the component present on a cancer cell is Nectin-4, EphA2, or PD-L1; conjugated via a linker to (b) two or more second peptide ligands which bind to a component present on an immune cell, wherein the component present on an immune cell is CD137;wherein each of said the first peptide ligand and the two or more second peptide ligands comprises a polypeptide comprising at least three reactive groups, separated by at least two loop sequences, and a molecular scaffold which forms covalent bonds with the reactive groups of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold” (see claims 44, 90). The instant application further claims wherein the immune cell is WBCs, CD8 or CD4 (see claim 45); reactive groups of cysteine or cysteamine residues (see claim 73); wherein the two or more second peptide ligands comprise a CD137 binding bicyclic peptide ligand (see claim 44); CD137 binding peptide (SEQ ID Nos:5-12, 60-81) (claim 44, 75); SEQ ID NO:11 (claim 74); N- and C-terminal modifications of the CD137 peptide (claims 75-76, 97); wherein the cancer cell is HT1080, A549 etc… (Claim 77); Nectin 4 on the cancer cell (claim 78); nectin-4 binding bicyclic peptide ligand (claims 44, 79); Nectin-4 peptide ligand as the first ligand (SEQ ID Nos:1, 3-4, 14-23, see claims 44, 79-80, 82, Nectin-4:CD137(s)); TATA as the scaffold (claim 84); free acid salt thereof (Claim 85) and pharmaceutically acceptable excipients (claim 89, 91). The instant application claims specific agonists with linkers (see claims 82-83, 96). The instant application further claims EphaA2 binding peptides (see claims 44, 93-95); PDL-1 binding peptides (claims 44, 98) and c-terminal amides (see claim 99).
Co-pending Application 17/663169 claims A heterotandem bicyclic peptide complex comprising:(a) a first peptide ligand which binds to CD 137 on an immune cell;conjugated via a linker to (b) a second peptide ligand which binds to a component present on a cancer cell, wherein the component present on the cancer cell is Nectin-4; wherein each of said peptide ligands comprises a polypeptide comprising three cysteine residues, separated by two loop sequences, and a molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that two polypeptide loops are formed on the molecular scaffold, wherein the first peptide ligand is a CD 137 binding bicyclic peptide ligand comprising an amino acid sequence selected from:CiIEEGQYCiiFADPY[Nle]Ciii (SEQ ID NO: 1);Ci[tBuAla]PE[D-Ala]PYCiiFADPY[Nle]Ciii (SEQ ID NO: 3);CiIEEGQYCiiF[D-Ala]DPY[Nle]Ciii (SEQ ID NO: 4);Ci[tBuAla]PK[D-Ala]PYCiiFADPY[Nle]Ciii (SEQ ID NO: 5);Ci[tBuAla]PE[D-Lys]PYCiiFADPY[Nle]Ciii (SEQ ID NO: 6);Ci[tBuAla]P[K(PYA)][D-Ala]PYCiiFADPY[Nle]Ciii (SEQ ID NO: 7);Ci[tBuAla]PE[D-Lys(PYA)]PYCiiFADPY[Nle]Ciii (SEQ ID NO: 8);CiIEE[D-Lys(PYA)]QYCiiFADPY(Nle)Ciii (SEQ ID NO: 9); and[dCi] [dI] [dE] [dE] [K(PYA)] [dQ] [dY] [dCii] [dF] [dA] [dD] [dP] [dY] [dNle] [dCiii] (SEQ ID NO: 10); andwherein the second peptide ligand is a Nectin-4 binding bicyclic peptide ligand comprising an amino acid sequence selected from:CiP[1Nal][dD]CiiM[HArg]DWSTP[HyP]WCiii (SEQ ID NO: 15);CiP Clip[1Nal][dD]CiiM[HArg]D[dW]STP[HyP][dW]Ciii (SEQ ID NO: 16);14333899 Application No.: 17/663,169 3 Docket No.: B1701.70048US01 CiP[1Nal][dK](Sar10-(B-Ala))CiiM[HArg]DWSTP[HyP]WCiii (SEQ ID NO: 17); and CiPFGCiiM[HArg]DWSTP[HyP]WCiii (SEQ ID NO: 18); wherein Ci, Cii and Ciii represent first, second and third cysteine residues, respectively, Nle represents norleucine, tBuAla represents t-butyl-alanine, PYA represents 4-pentynoic acid, 1Nal represents 1-naphthylalanine, HArg represents homoarginine, HyP represents hydroxyproline, dD represents aspartic acid in D-configuration, Sar10 represents 10 sarcosine units, B-Ala represents beta-alanine, or a pharmaceutically acceptable salt of said heterotandem bicyclic peptide complex” (claim 1). Co-pending Application 17/663169 further claims CD137 binding peptides and Nectin-4 peptides that overlap with the instant claims (claims 6 and 21-22); N-terminal modifications (claim 28); TATA as the scaffold (Claim 32); free acid or salt (claim 33); pharmaceutical formulation (claim 34).
Co-pending AN17/663169 does not claim two or more second peptide ligands (i.e. two or more CD137 peptides) or including radiochelator/chromophore. However, it would have been obvious to one of ordinary skill in the art to modify the composition of Co-pending AN17/663169 by adding additional binding ligands in order to enhance binding affinity or targeting (to the cancer cell or immune cell), a well-known design choice with a reasonable expectation of success. Furthermore, it would have been obvious to one of ordinary skill in the art to modify the composition of Co-pending AN17/663169 by including a chromophore or radio chelator for visualization or therapeutic use in cancer cells as this is a well-known design choice with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicants respectfully request that they be held in abeyance pending reconsideration in view of the instant response. Thus, the rejection is maintained.
New Objections
Claims 44, 93 should be amended to remove the definition of “Palmitoyl Glu-Lys N3[PYA]” as the definition is not needed as this group is not found within the sequences.
New Rejections
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 44, 69-71, 74-86, 89, 92-99 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 44 recites “[Cysam]iii represents a third (iii) Cysam reactive group”. It is unclear whether this language requires third Cysam reactive group thereby implying that the presence of a first and 2nd Cysam reactive groups or whether the limitation is intended to identify a Cysam reactive group occupying the third reactive group position. Accordingly the meets and the bounds of the claimed peptide ligands cannot be determined with reasonable certainty. A suggested correction would be “[Cysam]iii represents a Cysam reactive group at the third (iii) reactive group position” if this is the intended meaning.
Claims 69-71, 74-86, 89, 92-99 are also rejected due to their dependence on claims 73 or 79 and not further clarifying this point of confusion.
Claim 44 from which claim 74 depends recites “two or more second peptide ligands” and further recites that the “two or more second peptide ligands each independently comprise a CD137-binding bicycli peptide ligand comprising a polypeptide comprising an amino acid sequence selected from” the recited sequences. Claim 74 recites “where in the CD 137 binding bicyclic peptide ligand comprises” the specified sequence. Because claim 44 provides 2 or more CD137 binding by cyclic peptide ligands that may be independently selected, it is unclear whether “the CD 137 binding by cyclic peptide ligand” of claims 74 refers to each of the two or more CD137 binding by cyclic peptide ligands, at least one of the two or more CD137 binding bicyclic peptide ligands, or some other subset thereof therefore the scope of claim 74 is indefinite.
Claim 44 from which claim 75 depends recites “two or more second peptide ligands” and further recites that the “two or more second peptide ligands each independently comprise a CD137-binding bicyclic peptide ligand comprising a polypeptide comprising an amino acid sequence selected from” the recited sequences. Claim 75 recites “where in the CD 137 binding bicyclic peptide ligand comprises” a sequence selected from the specified sequences. Because claim 44 provides 2 or more CD137 binding by cyclic peptide ligands that may be independently selected, it is unclear whether “the CD 137 binding by cyclic peptide ligand” of claims 75 refers to each of the two or more CD137 binding by cyclic peptide ligands, at least one of the two or more CD137 binding bicyclic peptide ligands, or some other subset thereof therefore the scope of claim 75 is indefinite. Furthermore, it is suggested that Claim 75 remove “an amino acid sequence selected from” given the sequences following include modified amino acid sequences. A suggested amendment to claim 75 would be “wherein the two or more CD137 binding bicyclic peptide ligands compriseare selected from:”
Claim 44 from which claim 76 depends recites “two or more second peptide ligands” and further recites that the “two or more second peptide ligands each independently comprise a CD137-binding bicyclic peptide ligand comprising a polypeptide comprising an amino acid sequence selected from” the recited sequences. Claim 76 recites “where in the CD 137 binding bicyclic peptide ligand comprises…” the specified sequence. Because claim 44 provides 2 or more CD137 binding by cyclic peptide ligands that may be independently selected, it is unclear whether “the CD 137 binding by cyclic peptide ligand” of claims 76 refers to each of the two or more CD137 binding by cyclic peptide ligands, at least one of the two or more CD137 binding bicyclic peptide ligands, or some other subset thereof therefore the scope of claim 76 is indefinite. A suggested amendment to claim 76 would be “wherein the two or more CD137 binding bicyclic peptide ligands compriseare…:”
Claim 44 from which claim 92 depends recites “two or more second peptide ligands” and further recites that the “two or more second peptide ligands each independently comprise a CD137-binding bicyclic peptide ligand comprising a polypeptide comprising an amino acid sequence selected from” the recited sequences. Claim 92 recites “where in the CD 137 binding bicyclic peptide ligand comprises…” the specified sequence. Because claim 44 provides 2 or more CD137 binding by cyclic peptide ligands that may be independently selected, it is unclear whether “the CD 137 binding by cyclic peptide ligand” of claims 92 refers to each of the two or more CD137 binding by cyclic peptide ligands, at least one of the two or more CD137 binding bicyclic peptide ligands, or some other subset thereof therefore the scope of claim 76 is indefinite. A suggested amendment to claim 92 would be “wherein the two or more CD137 binding bicyclic peptide ligands comprise
Claim 44 from which claim 97 depends recites “two or more second peptide ligands” and further recites that the “two or more second peptide ligands each independently comprise a CD137-binding bicyclic peptide ligand comprising a polypeptide comprising an amino acid sequence selected from” the recited sequences. Claim 97 recites “where in the CD 137 binding bicyclic peptide ligand comprises” the specified sequence. Because claim 44 provides 2 or more CD137 binding by cyclic peptide ligands that may be independently selected, it is unclear whether “the CD 137 binding by cyclic peptide ligand” of claims 97 refers to each of the two or more CD137 binding by cyclic peptide ligands, at least one of the two or more CD137 binding bicyclic peptide ligands, or some other subset thereof therefore the scope of claim 97 is indefinite. A suggested amendment to claim 97 would be “wherein the two or more CD137 binding bicyclic peptide ligands comprise
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 ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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