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, 4-5, 7-12, 14, 19-21, 24 and 26-30 are pending and being acted upon in this Office Action.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 24, 2025 has been considered by the examiner and an initialed copy of the IDS is included with this Office Action.
Specification
The substitute specification filed on November 24, 2025 will NOT be entered because the statement “no matter has been added to the specification” is missing, see MPEP 2163.06.
Objection and Rejection Withdrawn
The objection to claims 1, 5, 8, 9, and 14 is withdrawn in view of the claim amendment.
The rejection of claims 1, 3-12, 14, 19-21, 23-24, and 26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the claim amendment.
The written description and enablement rejections of claims 1, 3-12, 14, 19-21, 23-24, and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph are withdrawn in view of the claim amendment.
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, 4-5, 7-12, 14, 19-20, 24 and 26-30 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-12 of copending Application No. 18/029,075 (reference application). This is a provisional double patenting rejection because the patentably indistinct claims have not in fact been patented.
The subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows:
Copending claim 1 recites a pharmaceutical composition, comprising an anti-Claudin18.2 antibody drug conjugate and a buffer, wherein an anti-Claudin18.2 antibody in the anti-Claudin18.2 antibody drug conjugate comprises a heavy chain variable region and a light chain variable region, wherein: 1) the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 having amino acid sequences identical to those of a heavy chain variable region set forth in SEQ ID NO: 5, and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 having amino acid sequences identical to those of a light chain variable region set forth in SEQ ID NO: 6; or i1) the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 having amino acid sequences identical to those of a heavy chain variable region set forth in SEQ ID NO: 3, and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 having amino acid sequences identical to those of a light chain variable region set forth in SEQ ID NO: 4; the buffer is a histidine salt buffer, preferably a histidine-acetate buffer, which corresponds to instant claim 1.
Copending claim 2 recites the pharmaceutical composition according to claim 1, wherein the anti-Claudin18.2 antibody comprises a heavy chain variable region and a light chain variable region, wherein: i11) the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 set forth in SEQ ID NO: 15, SEQ ID NO: 16 and SEQ ID NO: 17, respectively, and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 set forth in SEQ ID NO: 18, SEQ ID NO: 19 and SEQ ID NO: 20, respectively; or iv) the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 set forth in SEQ ID NO: 9, SEQ ID NO: 10 and SEQ ID NO: 11, respectively, and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 set forth in SEQ ID NO: 12, SEQ ID NO: 13 and SEQ ID NO: 14, respectively; preferably, the anti-Claudin18.2 antibody comprises a heavy chain variable region and a light chain variable region, wherein: v) the heavy chain variable region is set forth in SEQ ID NO: 31, and the light chain variable region is set forth in SEQ ID NO: 29; or vi) the heavy chain variable region is set forth in SEQ ID NO: 26, and the light chain variable region is set forth in SEQ ID NO: 23; more preferably, the anti-Claudin18.2 antibody comprises: vii) a heavy chain set forth in SEQ ID NO: 49 and a light chain set forth in SEQ ID NO: 47, or vii) a heavy chain set forth in SEQ ID NO: 44 and a light chain set forth in SEQ ID NO: 4l, which corresponds to instant claim 1.
17/782980
18/029,075
SEQ ID NO: 15
SYWMH
SYWMH
SEQ ID NO: 16
MIHPNSGSTNYNEKFKG
MIHPNSGSTNYNEKFKGR
SEQ ID NO: 17
LKTGNSFDY
LKTGNSFDY
SEQ ID NO: 18
KSSQSLLNSGNQKNYLT
KSSQSLLNSGNQKNYLT
SEQ ID NO: 19
WASTRES
WASTRES
SEQ ID NO: 20
QNAYTYPFT
QNAYTYPFT
SEQ ID NO: 9
DYGIH
DYGIH
SEQ ID NO: 10
YISRGSSTIYYADTVKG
YISRGSSTIYYADTVKG
SEQ ID NO: 11
GGYDTRNAMDY
GGYDTRNAMDY
SEQ ID NO: 12
KSSQSLLNSGNQKNYLA
KSSQSLLNSGNQKNYLA
SEQ ID NO: 13
GASTRAS
GASTRAS
SEQ ID NO: 14
QNDLYYPLT
QNDLYYPLT
Copending claim 3 reproduced below:
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628
542
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588
535
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which corresponds to instant claim 1.
Therefore, the copending claims anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants’ requests that this rejection be held in abeyance until such time that allowable subject matter has been identified in this application is acknowledged. So the rejection is maintained.
Claims 1, 4-5, 7-12, 14, 19-20, 24 and 26-30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,428,478 (17/442,939). Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims differ only in scope. The instant claims are limited the drug in the ligand-drug conjugate to exatecan and various linkers whereas the copending claim is generic with respect to the drug in the antibody-drug conjugate. Thus instant claims (species) anticipate the copending claim (genus).
17/782980
12,428,478
SEQ ID NO: 15
SYWMH
SYWMH
SEQ ID NO: 16
MIHPNSGSTNYNEKFKG
MIHPNSGSTNYNEKFKGR
SEQ ID NO: 17
LKTGNSFDY
LKTGNSFDY
SEQ ID NO: 18
KSSQSLLNSGNQKNYLT
KSSQSLLNSGNQKNYLT
SEQ ID NO: 19
WASTRES
WASTRES
SEQ ID NO: 20
QNAYTYPFT
QNAYTYPFT
SEQ ID NO: 9
DYGIH
DYGIH
SEQ ID NO: 10
YISRGSSTIYYADTVKG
YISRGSSTIYYADTVKG
SEQ ID NO: 11
GGYDTRNAMDY
GGYDTRNAMDY
SEQ ID NO: 12
KSSQSLLNSGNQKNYLA
KSSQSLLNSGNQKNYLA
SEQ ID NO: 13
GASTRAS
GASTRAS
SEQ ID NO: 14
QNDLYYPLT
QNDLYYPLT
Applicants’ requests that this rejection be held in abeyance until such time that allowable subject matter has been identified in this application is acknowledged. So the rejection is maintained.
New Ground of Objection and Rejection Necessitated by Amendment filed November 24, 2025
Claim Objection
Claim 1 is objected to because of the following informalities: “n is a decimal”. There is no “T is 1 or 2” in the formula (Pc-L-Y-D).
Claim 10 is objected to because of the following informalities: “an amino acid sequence” should have been “the amino acid sequence”.
Claim 19 is objected to because of the following informalities:
A. the redundant “the ligand-drug conjugate of general formula (Pc-L-Y-D) or the pharmaceutically acceptable salt thereof is a ligand-drug conjugate of general formula (Pc-Lb-Y-D) or a pharmaceutically acceptable salt thereof” should be deleted.
B. “R5~R7” should have been “R5 to R7”.
It is suggested that claim 19 be amended to recite: “The ligand-drug conjugate of general formula (Pc-L-Y-D) or the pharmaceutically acceptable salt thereof according to claim 1, wherein the general formula (Pc-L-Y-D) is
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215
522
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Wherein: S1 is an integer from 2 to 8; Pc, R1, R2, R5 to R7 and n are as defined in claim 1.
Claim 21 is objected to because of the following informalities: “…according to claim 1, … wherein n is as defined in claim 1, and the antibodies h1902-5 and h1901-11 are as defined in claim 10” should have been depend from claim 10, wherein n is an integer from 1 to 10.
Claim 26 is objected to because of the following informalities: “tumor and cancer” at line 1 and 4 should have been “tumor or cancer”. Further “are” should have been “is”. Finally, “or” is missing between colon cancer, colorectal cancer.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-5, 7-12, 14, 19-20, 24 and 26-30 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 applicant regards as the invention.
The recitation of “t is 1 or 2” in claim 1 is indefinite because the formula (Pc-L-Y-D) does not have variable t. One of ordinary skill in the art would not reasonably be apprised of the metes and bounds of the invention. Deleting “t is 1 or 2” would obviate this rejection. Further, the recitation of n is a decimal in claim 1 is ambiguous and indefinite. As n can only be 0 or integer of from 1 to 10.
Claim 8 recites the limitation "…the heavy chain constant region … the light chain constant region…" in claim 1. There is insufficient antecedent basis for this limitations in the claim.
Regarding claim 26, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 4-5, 7, 9-12, 14, 19-20, 24, 27-30 are included in the rejection because they are dependent on rejected claim and do not correct the deficiency of the claim from which they depend.
Conclusion
No claim is 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 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