Office Action 2: Notice of Allowance (2025-02-26)

CLAIMS:
Listing of Claims.

Amendments to Claims:

1\. (Currently Amended) An antibody or an antigen-binding fragment thereof, comprising three light chain complementarity determining regions and three heavy chain complementarity determining regions, wherein (1) the three light chain complementarity determining regions of the antibody or the antigen- binding fragment thereof comprise an LCDR1 set forth in SEQ ID NO: 5, an LCDR2 set forth in SEQ ID NO: 6 and an LCDR3 set forth in SEQ ID NO: 7, and the three heavy chain complementarity determining regions of the antibody or the antigen-binding fragment thereof comprise an HCDR1 set forth in SEQ ID NO: 8, an HCDR2 set forth in SEQ ID NO: 9 and an HCDR3 set forth in SEQ ID NO: 10,
or (2) the three light chain complementarity determining regions of the antibody or the antigen- binding fragment thereof comprise an LCDR1 set forth in SEQ ID NO: 11, an LCDR2 set forth in SEQ ID NO: 12 and an LCDR3 set forth in SEQ ID NO: 13, and the three heavy chain complementarity determining regions of the antibody or the antigen-binding fragment thereof comprise an HCDR1 set forth in SEQ ID NO: 14, an HCDR2 set forth in SEQ ID NO: 15 and an HCDR3 set forth in SEQ ID NO: 16.

2\. (Currently Amended) The antibody or an antigen-binding fragment thereof of claim 1, wherein the antibody or the antigen-binding fragment thereof comprises a light chain variable region set forth in SEQ ID NO: 1, and a heavy chain variable region set forth in SEQ ID NO: 2.

3\. (Previously Presented) The antibody or the antigen-binding fragment thereof of claim 1, further comprising a heavy chain constant region set forth in SEQ ID NO: 17.

4\. (Previously Presented) A chimeric antigen receptor (CAR), comprising the antibody or the antigen-binding fragment thereof of claim 1.

5\. (Previously Presented) The chimeric antigen receptor of claim 4, sequentially comprising the antigen-binding fragment, an extracellular hinge region, a transmembrane region and an intracellular signaling region.

6\. (Previously Presented) A nucleic acid, wherein the nucleic acid encodes the antibody or the antigen-binding fragment thereof of claim 1, or a chimeric antigen receptor comprising the antigen-binding fragment.

7\. (Previously Presented) A pharmaceutical composition, comprising the antibody or the antigen-binding fragment thereof of claim 1.

8\. (Cancelled)

9\. (Currently Amended) A method of treating cancer, the method comprising administering to a subject in need thereof the antibody or antigen-binding fragment thereof of claim 1.

10\. (Previously Presented) The method of claim 9, wherein the cancer is a Claudinl8.2- positive cancer.

11\. (Currently Amended) The antibody or antigen-binding fragment thereof of claim 1, wherein the three light chain complementarity determining regions of the antibody or the antigen- binding fragment thereof comprise an LCDR1 set forth in SEQ ID NO: 5, an LCDR2 set forth in SEQ ID NO: 6 and an LCDR3 set forth in SEQ ID NO: 7, and the three heavy chain complementarity determining regions of the antibody or the antigen-binding fragment thereof comprise an HCDR1 set forth in SEQ ID NO: 8, an HCDR2 set forth in SEQ ID NO: 9 and an HCDR3 set forth in SEQ ID NO: 10.

12\. (Currently Amended) The antibody or antigen-binding fragment thereof of The antibody or antigen-binding fragment thereof of

wherein the three light chain complementarity determining regions of the antibody or the antigen- binding fragment thereof comprise an LCDR1 set forth in SEQ ID NO: 11, an LCDR2 set forth in SEQ ID NO: 12 and an LCDR3 set forth in SEQ ID NO: 13, and the three heavy chain complementarity determining regions of the antibody or the antigen-binding fragment thereof comprise an HCDR1 set forth in SEQ ID NO: 14, an HCDR2 set forth in SEQ ID NO: 15 and an HCDR3 set forth in SEQ ID NO: 16.

13\. (Currently Amended) The antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or the antigen-binding fragment thereof comprises a light chain variable region set forth in SEQ ID NO: 3, and a heavy chain variable region set forth in SEQ ID NO: 4.

14\. (Previously Presented) The antibody or antigen-binding fragment thereof of claim 1, further comprising a heavy chain constant region set forth in SEQ ID NO: 18.

15\. (Previously Presented) The chimeric antigen receptor of claim 5, wherein the extracellular hinge region is a CD8 hinge region, the transmembrane region is a CD8 transmembrane region, and the intracellular signaling region is 4-1BB and CD3(.

16\. (Previously Presented) A cell, wherein the cell expresses the antibody or antigen-binding fragment thereof of claim 1.

17\. (Previously Presented) A cell, wherein the cell expresses the CAR of claim 4.

18\. (Previously Presented) A cell, wherein the cell comprises the nucleic acid of claim 6.

19\. (Currently Amended) A method of treating cancer, the method comprising administering to a subject in need thereof the cell of claim 17.

20\. (Previously Presented) A method of detecting Claudin18.2, the method comprising

contacting a sample with the antibody or antigen-binding fragment thereof of claim 1.

21\. (Previously Presented) The method of claim 9, wherein the cancer is selected from the group consisting of gastric cancer, pancreatic cancer, esophageal cancer, lung cancer, ovarian cancer, head and neck cancer, bladder cancer, cervical cancer, sarcoma, cytoma, colon cancer, kidney cancer, colorectal cancer, liver cancer, melanoma, breast cancer, myeloma, neuroglioma, leukemia and lymphoma.

OFFICE ACTION:
DETAILED ACTION
Applicant’s reply filed on 12/4/2024 is acknowledged and entered.
Applicant’s supplemental response filed on 2/7/2025 is entered.
Claims 1-7 and 9-21 are pending. Claim 8 is canceled.
Claims 1-7 and 9-21 are allowed.
EXAMINER’S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Applicant’s representative Jia Zhu on Feb 4, 2025.
The application has been amended as follows:
Amendments to the Claims
In claim 1, 	line 1, after the term “thereof”, the phrase --which binds to Claudin18.2-- has 			been added.
In claim 16, 	line 1, the term “A cell” has been changed to --An isolated cell--.
In claim 17, 	line 1, the term “A cell” has been changed to --An isolated cell--.
In claim 18, 	line 1, the term “A cell” has been changed to --An isolated cell--.
In claim 19, 	line 2, after the term “claim 17”, the phase --, wherein the cell is a T cell or 			NK cell-- has been added.
REASONS FOR ALLOWANCE
6.	The 35 USC 112(a) and art rejections in the last office action mailed on 9/10/2024 are withdrawn in view of applicant’s amendments.
The nonstatutory double patenting rejection is withdrawn as the instant application has an earlier patent term filing date.
7.

APPLICANT REBUTTAL: REMARKS
SEQUENCE LIST
ING
Applicant submits, through Patent Center, a substitute Sequence Listing and an
amendment to replace the last-filed Sequence Listing with the substitute Sequence Listing. The sequence listing was prepared from sequences contained in the specification as filed and as such includes no new matter.
I hereby state that the content of the Sequence Listing, submitted in accordance with 37 CFR §§1.821(c) and (e), respectively, is disclosed in the originally filed application, and as such, does not go beyond the original disclosure.
SPECIFICATION
Pursuant to 37 C.F.R. § 1.125, Applicants submit a substitute specification encompassing changes being made to the specification filed on October 6, 2021, and amended on May 9, 2022. The substitute specification added SEQ ID NO identifiers in appropriate places and added a sequence listing paragraph pursuant to 37 CFR 1.823. No new matter has been introduced by this substitution to the Specification. Applicants request entry of the substitute specification. Also attached is a marked-up version showing the changes that have been made.
INTERVIEW SUMMARY
Applicant thanks Examiner Hong Sang for participating in a telephone interview with Applicant's representative Jay Zhu on January 31, 2025. During the interview, the participants discussed potential Examiner's amendments to the claims, deficiencies in the sequence listing file, and potential specification amendments. As requested by the Examiner, Applicant submits herein a substitute sequence listing and substitute specification.
No fees are believed to be due, however, please apply any necessary charges or credits to Deposit Account 06-1050, referencing the above attorney docket number.
Respectfully submitted,