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 .
Priority
This application is a U.S. national phase of International Application No. PCT/CN2021/089729, filed on 04/25/2021, which further claims priority to People’s Republic of China Application No. CN202010344676.8, filed 04/27/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
The Amendment, filed on 02/20/2026, is acknowledged in which:
Claims 1-6, 8-9, 11-14, 22, and 24 are canceled.
Claims 7 is currently amended.
Claims 10, 15, 17-21, 23, and 25-33 were previously presented.
Claim 16 is original.
Claims 7, 10, 15-21, 23, and 25-33 are pending in the instant application and are examined on the merits herein.
Withdrawn Rejections
Applicant’s arguments, see Remarks (pg 9), filed 02/20/2026, with respect to the rejections of record of claims 7, 15-21, and 23 under 35 USC 112(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an additional species within scope of the instant claims without sufficient written description.
New Claim Rejections - 35 USC § 112(a)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7, 15-21, and 23 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim 7 is drawn to a bispecific antibody targeting human Claudin 18.2 (CLDN18.2) and PD-L1 proteins, comprising specific sequences for CLDN18.2 VH and VL domains and an anti-PD-L1 VHH moiety. The claim encompasses a genus of CLDN18.2 antibodies wherein the pairing of VH and VL domains are any one of the sequences listed (summarized in table below).
SEQ ID NOs:
Clone
VH
VL
CDRs
(1)
31, 32, 33, or 34
28, 29, or 30
90-95
(2)
4, 5, or 6
1, 2, or 3
72-77
(3)
11, 12, or 13
7, 8, 9, or 10
72-73 & 78-81
(4)
17, 18, or 19
14, 15, or 16
72-73 & 82-85
(5)
24, 25, 26, or 27
20, 21, 22, or 23
72-73 & 86-89
MPEP 2163.I1.A.3.a.ii. states that the written description requirement for claimed genus may be satisfied through a sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.
However, QP14451439 (VH/VL pairing of SEQ ID NOs: 13 and 7) within scope of genus within claim 7(3) does not successfully bind to CLDN18.2 despite identical CDRs as evidenced by the instant specification (Figure 5). Therefore this species prima facie does not have sufficient written description (In re Ehrreich, 590 F.2d 902, 907, 200 USPQ 504, 508 (CCPA 1979)). As dependent claims 15-21, and 23 do not resolve this issue they are also deemed to not meet written description requirements.
To overcome this rejection examiner recommends amending claim 7 to remove the species at issue. The following is presented to the applicant for consideration:
7. [unchanged text]…
(3) the amino acid sequence of the heavy chain variable region (VH) of the anti- human claudin18.2 antibody moiety is as shown in SEQ ID NO: 11 or SEQ ID NO: 12
Or
the amino acid sequence of the heavy chain variable region (VH) of the anti- human claudin 18.2 antibody moiety is as shown in SEQ ID NO: 13; and the amino acid sequence of the light chain variable region (VL) of the anti-human claudin 18.2 antibody moiety is as shown in SEQ ID NO: 8, SEQ ID NO: 9 or SEQ ID NO: 10;
…[unchanged text]…
Allowable Subject Matter
Claimed VH/VL sequences (with sufficient written description) are free from prior art.
Claims 10 and 25-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 7, 15-21, and 23 are rejected; claims 10 and 25-26 are objected to; and claims 27-33 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH SUNSHINE whose telephone number is (571)270-7417. The examiner can normally be reached M-Th & Second Friday 8:30am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANNAH SUNSHINE/Examiner, Art Unit 1647
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683