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
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/15/2026 has been entered.
Status of the Claims
2. Claims 1-27 are the original claims filed on 8/10/2022. In the Preliminary Amendment of 8/10/2022, claims 4-8, 10-11, 15-16, 18-19, and 22-25 are amended and claims 9, 17 and 26-27 are canceled. In the Response of 8/21/2025, claims 1, 7, 10, 12, 18, and 20 are amended and claims 21-22 are cancelled. In the Response of 1/15/2026, Claims 1-8, 10-12, 14-15, 18-20, and 25 are amended and Claim 13 is cancelled.
Claims 1-8, 10-12, 14-16, 18-20 and 23-25 are all the claims.
This Office Action contains new grounds for objection and rejection.
Priority
3. USAN 17/798,873, filed 08/10/2022, and having 1 RCE-type filing therein, is a National Stage entry of PCT/CN2021/ 076482, International Filing Date: 02/10/2021, and claims foreign priority to CN 202010086516.8, filed 02/10/2020.
Information Disclosure Statement
4. As of 2/11/2026, a total of four (4) IDS are filed: 8/10/2022; 2/1/2024; 12/9/2024; and 1/15/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objection
Specification
5. The objection to the disclosure because of informalities is withdrawn.
-) The specification is amended to replace “tumor antigen” with “cell surface antigen” in [0057 and 0058]. The species of CD3 antigen corresponds to a cell surface antigen. Original description support for “cell surface antigen” is found in the original specification at [0057; 0058; 0159]. Original description support for “cell surface antigen” and CD3 is found in the original specification at [0159].
Claim Objections
6. The objection to Claims 1-8, 10-16, 18-20 and 23-25 because of informalities is moot for canceled claim 13 and withdrawn for the pending claims.
a) Claims 1-8, 10-16, 18-20 and 23-25 are amended to recite the antibody comprises a binding domain: “A claudin 18.2 (CLDN18.2) antibody binding domain.”
b) Claim 14 is amended to replace “tumor antigen” with “cell surface antigen”. The species of CD3 antigen corresponds to a cell surface antigen. Original description support for “cell surface antigen” is found in the original specification at [0057; 0058; 0159].
c) Claim 25 is amended to recite “comprising culturing the host cell of claim 24 under conditions for the expression of the antibody, and isolating the antibody produced by the host cell from the culture.”
New Grounds for Objection
Claim Objections
7. Claims 6-8, 10-12, and 14 are objected to because of the following informalities:
a) Claims 6-8, 10-12, and 14 are objected to for inconsistency.
Claim interpretation
“binding domain”: the specification provides a specific example for the meaning of a binding domain as regards an antibody:
[0139] The present application relates to anti-CLDN18.2 antibodies. In certain embodiments, the present application provides an anti-CLDN18.2 antibody, comprising at least 1, 2, 3, 4, 5 or 6 hypervariable regions (HVRs) or binding domains referred to as complementarity determining regions (CDRs)…”
Claims 6-8, 10-12, and 14 are drawn to structures that are not consistent with the binding domain as defined in the specification. For example, the binding domain by definition cannot be a larger than the structure it consists of, namely, “is a chimeric antibody, a humanized antibody, or a fully human antibody (Claim 6); “is a full-length antibody” (Claim 7); “is an IgG antibody” (Claim 8); “is a Fab, a Fab'-SH, a Fv, scFv or a (Fab')2 (Claim 10); and “is a multispecific antibody or a bispecific antibody” (Claim 11). Replacing “is” with “comprises” or “comprising” could overcome the objection.
b) Claim 7 is redundant for reciting “that binds to CLDN18.2.”
Appropriate correction is required.
New Grounds for Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claim 25 is rejected 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, or for failing to include all the limitations of the claim upon which it depends.
a) Claim 25 in both the preamble and the body of the claim is broader in scope than the claim from which it depends. Claim 25 recites “an antibody” (line 1) and “the antibody” (lines 2-3) whilst claim 24 is more narrowly drawn to the host expressing the polynucleotide sequence encoding the CLDN18.2 antibody binding domain of claim 1. Amending claim 25 to replace “antibody” with “CLDN18.2 antibody binding domain” could overcome the rejection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirement.
Conclusion
9. Claims 1-5, 15-16, 18-20, and 23-24 are allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643