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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/12/2026 on has been entered.
Status of the Claims
2. Claims 1-25 are the original claims filed on 2/23/2023. In the Preliminary Amendment of 2/23/2023, claims 1, 5-7, 9-12, 14-16, 18, 20-21 and 23 are amended and claims 19, 22 and 24-25 are canceled. In the Response of 1/8/2026, Claims 1-7, 9-17, 21 and 23 are amended and new claims 26-30 are added. In the RCE of 6/12/2026, Claims 1, 3, 5, 12, 13, 15, 17, 23, 27, 28, and 30 are amended
Claims 1-18, 20-21, 23 and 26-30 are the pending claims.
The Office Action contains new grounds for objection and rejection.
Priority
3. USAN 18/042,762, filed 02/23/2023, and having 1 RCE-type filing therein, is a National Stage entry of PCT/CN2021/ 114088, International Filing Date: 08/23/2021, claims foreign priority to CN PCT/CN2020/110841, filed 08/24/2020, and claims foreign priority to CN PCT/CN2020/141398, filed 12/30/2020.
Information Disclosure Statement
4. As of 6/18/2026, a total of five (5) IDS are filed: 2/23/2023; 1/29/2024; 10/14/2024; 3/17/2025; and 9/16/2025. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Claim Objections
5. The objection to Claims 1-18, 20-21, 23 and 26-30 because of informalities as items (a) through (k) in the Office Action of 3/13/2026 are withdrawn.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(a)
Written Description
6. The rejection of Claims 23 and 26-27 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Claim 23 is amended to refer to a bispecific antibody of claim 13.
Claim Rejections - 35 USC § 112(b)
7. The rejection of Claims 5(iii) and 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
a) Claim 5(iii) is amended to delete element (iii).
b) Claim 13 is amended to conclude with proper punctuation.
New Grounds for Objection
Specification
8. The disclosure is objected to because of the following informalities:
a) Amend the table shown on p. 25 of the specification filed on 1/8/2026 to include a number as shown for the other tables in the specification for consistency. Otherwise, Applicants are requested to explain why a table number is not needed. In addition, the subsequent table numbers require renumbering.
Appropriate correction is required.
Claim Objections
9. Claims 1-18, 20-21, 23 and 26-30 are objected to because of the following informalities:
a) Claims 1-4, 6-18, 20-21, 23 and 26-30 are objected to for omission of the ROR1 antigen being human. See Example 1 in the specification for the human ROR1. See claim 5(ii) that recites “a human ROR1 Ig-like domain.”
b) Amend claim 4 to replace the table format with conventional text for a Markush group. A practical way to define the invention is in words such as “selected from the group consisting of SEQ ID NOs: 8 and 9; 17 and 9; 10 and 13;…” MPEP 2173.05(s).
c) Amend claim 5 to replace “one or more” with “one or both” since the amended claim recites only two elements to choose from.
Appropriate correction is required.
New Grounds for Rejection
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.
10. Claim 9 is 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.
a) Claim 9 recites the limitation "the nucleic acid molecule encoding the isolated antibody or antigen-binding fragment thereof of claim 1". There is insufficient antecedent basis for this limitation in the claim. Claim 1 is not drawn to a nucleic acid much less a nucleic acid encoding the antibody or antigen-binding fragment.
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.
11. Claims 14-17 and 30 are 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.
All of the rejected claims depend from claim 12. Claim 12 establishes the invention as being bispecific for ROR1 and CD3 where a first antigen binding site specifically binds ROR1 and a second antigen binding site specifically binds CD3, where the VH/VL CDR1-3 for the ROR1 antigen-binding site are recited.
Claims 14-15 introduce the limitation in claim 14 for the “wherein” clause
“wherein the VLA-CL pairs with VHA-CH1 to form a first Fab that specifically binds a first antigen A, and VLB-CL pairs with VHB-CH1 to form a second Fab that specifically binds a second antigen B, and wherein the first antigen A is ROR1, and the second antigen B is CD3.”
The introduction of a first Fab that specifically binds ROR1 and a second Fab that specifically binds CD3 is a broadening limitation from the claims upon which they depend.
Claims 16-17 and 30 introduce the limitation in claim 16 for the “wherein” clause
“wherein VL is a light chain variable domain, CL is a light chain constant domain, VH is a heavy chain variable domain, CHI is a heavy chain constant domain, Fc is an immunoglobulin Fc region, wherein the VLA-CL pairs with VHA-CH1 to form a first Fab that specifically binds a first antigen A, and VLB-CL pairs with VHB-CH1 to form a second Fab that specifically binds a second antigen B, and wherein the first antigen A is ROR1, and the second antigen B is CD3.”
The introduction of a first Fab that specifically binds ROR1 and a second Fab that specifically binds CD3 is a broadening limitation from the claims upon which they depend.
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 requirements.
Conclusion
12. No claims are allowed.
13. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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