RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 08/10/2026, is acknowledged.
2. Claims 1-21 are pending.
3. Claims 7-18 and 20 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
4. Since Applicant canceled the elected cancel the elected amino acid substitutions, the Examiner has extended the search to cover position L128C of CH1 and position S121C of CL.
5. Claims 1-6, 19 and 21 are under examination as they read on a dimerized polypeptide comprising a heavy chain constant region 1 (CH1) and light chain constant region (CL), wherein CH1 and CL comprise natural-non-cysteine-to-cysteine amino acid substitutions and the species of (a) the amino acid substitutions (a) L128C of CH1 and position S121C of CL (b) the dimerized polypeptide is a monospecific antibody, (c) the antigen-binding protein further comprises a Fc region, wherein the Fc region is an IgG1 Fc region; and (d) the specific antigen target for the antigen-binding protein is PD-1.
6. The claim Amendment filed 08/10/2026 is objected to because the bullet numbering do not state form the number “1” for Example, in claim 1 bullet numbering starts at “i-2” and in claim 3 bullet numbering starts at “b-2”.
7. The following new ground of rejection is necessitated by the amendment submitted 08/10/2026.
8. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
9. Claims 1-4, 6, 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190248899.
The `899 publication teaches amino acid substitutions were introduced into the anti-PD1 antibody (monospecific) using a QuikChange Lightning multi site-directed mutagenesis kit (Agilent Technologies, cat no. 210516). To eliminate the disulfide bridge between C131 (HC) and C214 (LC), mutations in the HC and LC DNA constructs encoding antibodies with the alterations C131S (HC) and C214S (LC) were made. Further, DNA constructs encoding antibodies with the HC alteration L128C and the LC alteration S121C were made [0534].
The `899 publication focused on (1) substitutions at S131 and/or T180 in a CLκ domain that would promote an electrostatic interaction with the residue at position 147 in a CH1 domain (which may or may not have a substitution), (2) substitutions at T164 and/or S174 in a CLκ domain that would promote an electrostatic interaction with the residue at 168 in a CH1 domain (which may or may not have a substitution) [0526] .
Example 8 provides anti-PD1 antibody in PBS (composition with a carrier).
The reference teachings anticipate the claimed invention.
10. Claims 5 and 21 and 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.
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20150291703
[0045] Furthermore, the present invention provides the above method, antibody or composition wherein the non-natural disulfide bond is formed between at least one set of light chain cysteine-heavy chain cysteine selected from a) F116C-S134C, b) F116C-A141C, c) F118C-L128C, d) S121C-F126C, e) S121C-P127C, f) Q124C-F126C, g) S162C-F170C, h) S162C-P171C, i) S162C-V173C, j) F118C-L128C, k) E124C-F126C, l) T162C-F170C, m) T162C-P171C and n) T162C-V173C.
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12. 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 extension fee 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 date of this final action.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 23, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
