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 .
Claims 1-15 are pending.
Applicant's election with traverse of antibody drug conjugate (ADC) that read on (A) VA as the particular linker, (B) y is 8 as a particular antibody drug conjugate of formula [Ab]-[Z-L-R-X]y in the reply filed on July 24, 2026 is acknowledged. The traversal is on the ground(s) that searching for and considering the various ADC constructs disclosed in the instant application would not place an undue burden on the Examiner.
Species Restriction Withdrawn
Upon reconsideration in view of the elected species of linker succinimidocaproyl-valine-alanine-aminomethyl (SC-VA-AM) is free of prior art, the species restriction is hereby withdrawn.
Claims 1-15, drawn to an antibody drug conjugate (ADC) of formula [Ab]-Z-L-R-X]y, are being acted upon in this Office Action.
Priority
Applicant’ claim priority to provisional application 63/589,590, filed Oct 11, 2023, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 30, 2025 and April 15, 2025 have been considered by the examiner and an initialed copy of the IDS is included with this Office Action.
Drawings
The drawings were received on June 30, 2025. These drawings are acceptable.
Specification
The substitute specification filed February 6, 2026 has been entered.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objection
Claims 1-15 are objected to because of the following informality: the bracket [ ] should be deleted because the “[ ]” itself can be read by the printer as deletion.
Claim 1 is further objected to because of the following informalities:
the claim uses the abbreviation DXd without first defining it. To clarify the claim, applicant should first spell out the full term before using an abbreviation. Given the subject matter of the specification, the examiner presumes that "DXd" stands for "Deruxtecan". Appropriate correction is required.
“(GGGG)(SEQ ID NO: 161)…(GGVG)(SEQ ID NO: 163) and …(GGVA)(SEQ ID NO: 162)” should have been “(GGGG) as set forth in SEQ ID NO: 161…(GGVG) as set forth in SEQ ID NO: 163 and …(GGVA) as set forth in SEQ ID NO: 162.” Appropriate correction is required.
Claim 8 is objected to because of the following informality: “wherein [Ab] comprises an HCV…and an LCV…” should have been “wherein the HCV… and the LCV…”.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-15 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 34-35, 41-46 of copending Application No. 19/117,740. Although the conflicting claims are not identical, they are not patentably distinct from each other because copending ADC comprises the same antibody conjugated to the same drug DXd via the same linker as instant claims as below.
Claim 34 recites an antibody drug complex (ADC) comprising an antibody or antigen-binding fragment thereof conjugated via a linker to a means for killing a cell inhibiting microtubule polymerization or a means for inhibiting topoisomerase I, wherein the antibody or antigen-binding fragment thereof comprises a binding region comprising six complementarity determining regions, heavy chain (HC) CDR1, HC CDR2, HC CDR3, light chain (LC) CDR1, LC CDR2, and LC CDR3, and wherein: HC CDR1 comprises SEQ ID NO: 11; HC CDR2 comprises SEQ ID NO: 12; HC CDR3 comprises SEQ ID NO: 13; LC CDR1 comprises SEQ ID NO: 14; LC CDR2 comprises SEQ ID NO: 15; and LC CDR3 comprises SEQ ID NO: 16; or HC CDR1 comprises SEQ ID NO: 49;HC CDR2 comprises SEQ ID NO: 50;HC CDR3 comprises SEQ ID NO: 51; LC CDR1 comprises SEQ ID NO: 52;LC CDR2 comprises SEQ ID NO: 53; and LC CDR3 comprises SEQ ID NO: 54, which corresponds to instant claim 1.
19/098,802
19/117,740
SEQ ID NO: 11
GYAMS
GYAMS
SEQ ID NO: 12
TISSGGTYIYYPDSVKG
TISSGGTYIYYPDSVKG
SEQ ID NO: 13
LGGDNYYEYFDV
LGGDNYYEYFDV
SEQ ID NO: 14
RASKSVSTSGYSYMH
RASKSVSTSGYSYMH
SEQ ID NO: 15
LASNLES
LASNLES
SEQ ID NO: 16
QHSRELPFT
QHSRELPFT
35. (Previously Presented) The ADC of claim 34, wherein the antibody or antigen-binding fragment thereof comprises: a HC variable domain having at least 80% sequence identity to SEQ ID NO: 9, and a LC variable domain having at least 80% sequence identity to SEQ ID NO: 10, which corresponds to instant claim 8.
36. (Previously Presented) The ADC of claim 34, wherein the antibody or antigen-binding fragment thereof comprises: a HC variable domain having at least 80% sequence identity to SEQ ID NO: 47, and a LC variable domain having at least 80% sequence identity to SEQ ID NO: 48.
37. (Currently Amended) The ADC of claim 34, wherein the means for killing a cell inhibiting topoisomerase I comprises a toxin and the linker and toxin covalently bound to a thiol sulphur (S) of the antibody or antigen-binding fragment thereof have the following structure:
38. (Currently Amended) The ADC of claim 37, wherein the drug to antibody er antigen-binding fragment thereof ratio (DAR) of the ADC is an integer selected from 6-12, which corresponds to instant claims 9-10.
41. (Currently Amended) The ADC of claim 34, wherein the means for killing a cell inhibiting topoisomerase I comprises a toxin and the toxin comprises a camptothecin derivative.
42. (Previously Presented) The ADC of claim 41, wherein the camptothecin derivative comprises any one of exatecan, GAB-exatecan, DXd, or SN38.
43. (Previously Presented) The ADC of claim 34, wherein the linker comprises a cleavable linker (generic).
44. (Previously Presented) The ADC of claim 43, wherein the linker is cleavable by a cathepsin or a glucuronidase.
45. (Previously Presented) The ADC of claim 34, wherein the linker is selected from the group consisting of:
succinimidocaproyl-valine-citroline para-aminobenzyloxycarbonyl (SC-VC-PAB);
succinimidocaproyl-valine-alanine para-aminobenzyloxycarbonyl (SC-VA-PAB);
succinimidocaproyl-glycine-glycine-phenylalanine-glycine-aminomethyl (SC-GGFG-AM);
succinimidocaproyl-glycine-glycine-glycine-glycine-aminomethyl MC-GGGG-AM);
succinimidocaproyl-glycine-glycine-valine-alanine-aminomethyl (SC-GGVA-AM);
succinimidocaproyl-glycine-glycine-valine glycine-aminomethyl (SC-GGVG-AM);
succinimidocaproyl-valine-alanine-aminomethyl (SC-VA-AM);
succinimidocaproyl-valine-alanine (SC-VA);
succinimidocaproyl-glycine-glycine-valine-alanine (SC-GGVA); and
succinimidocaproyl-(SC-MAC-glucuronide), which corresponds to instant claims 1-2, 4, 5, 6, 11, 13-15.
Claims 3 and 12 are included because the reference also teaches valine-citrulline (VA), see para. [0187], [0192], [0205].
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Closest Prior art
Okamoto et al (Xenobiotica 50(10): 1242-1250, 2020; PTO 1449) teaches antibody-drug conjugate (ADC), comprising an anti-HER2 antibody (Ab) conjugated to a toxin or camptothecin derivative, such as DXd via a cleavable linker; the topoisomerase inhibitor DXd is bound to cysteine (aka thiol sulphur S) residues in the antibody an enzymatically cleavable linker, see entire document, abstract, p. 1243, Discussion, in particular.
Okamoto teaches that the antibody-linker-drug having the claimed structure:
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Okamoto teaches that the conjugate has a drug to antibody ratio (DAR) of 7 to 8, which is within the claimed range of 6-12, see p. 1243, right col.
However, Okamoto does not teach the claimed cleavable linker succinimidocaproyl-glycine-glycine-glycine-glycine-aminomethyl (SC-GGGG-AM);
succinimidocaproyl-glycine-glycine-valine-alanine-aminomethyl (SC-GGVA-AM);
succinimidocaproyl-glycine-glycine-valine glycine-aminomethyl (SC-GGVG-AM);
succinimidocaproyl-valine-alanine-aminomethyl (SC-VA-AM) and
succinimidocaproyl-valine-alanine-aminomethyl (SC-VC-AM).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on 9:00 a.m. to 6:30 p.m. The examiner can also be reached on alternate alternative Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Misook Yu, can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-272-0839.
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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641
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