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 .
Claims 3, 5, 17 and 37-46 are pending and being acted upon in this Office Action.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 38-46 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,739,160. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of issued patent are drawn to the same binding protein as instant claims. Although the preamble of instant claims recite multispecific, however, the body of the instant claims comprise a first functional antigen binding site that binds to just target antigen A (monospecific as opposed to multispecific).
Issued claim 1 recites a binding protein comprising: at least one pseudoFab portion comprising (1) a first VL domain (VLa) paired with a first VH domain (VHa) to form a first functional antigen binding site that binds target antigen A; and (2) a first stabilized knockout VH domain (VHX) paired with a first stabilized knockout VL domain (VLX) to form a first stabilized knockout domain, wherein the VLX/VHX pair is selected from the group consisting of:
VLX comprising an amino acid sequence of SEQ ID NO: 76 and VHX comprising an amino acid sequence of SEQ ID NO: 77, which corresponds to instant claim 39;
ii) VLX comprising an amino acid sequence of SEQ ID NO: 76 and VHX comprising an amino acid sequence of SEQ ID NO: 78. which corresponds to instant claim 40; and
iii) VLX comprising an amino acid sequence of SEQ ID NO: 76 and VHX comprising an amino acid sequence of SEQ ID NO: 79, which corresponds to instant claim 41.
Issued claim 2 recites a binding protein comprising: at least one pseudoFab portion comprising (1) a first VL domain (VLa) paired with a first VH domain (VHa) to form a first functional antigen binding site that binds target antigen A; and (2) a first stabilized knockout VH domain (VHX) paired with a first stabilized knockout VL domain (VLX) to form a first stabilized knockout domain, wherein:
(a) the VHX comprises one or more inactivating mutations of Y33A, R50E, R59E, and Y105A as set forth in SEQ ID NO: 2, and a cysteine substitution of G44C as set forth in SEQ ID NO: 2, which corresponds to instant claim 42 (i); and
(b) the VLX comprises a cysteine substitution of Q100C as set forth in SEQ ID NO: 1, which corresponds to instant claim 42 (ii).
Issued claim 3 recites a binding protein comprising: at least one pseudoFab portion comprising (1) a first VL domain (VLa) paired with a first VH domain (VHa) to form a first functional antigen binding site that binds target antigen A; and (2) a first stabilized knockout VH domain (VHX) paired with a first stabilized knockout VL domain (VLX) to form a first stabilized knockout domain, wherein:
(a) the VHX comprises a cysteine substitution of G44C as set forth in SEQ ID NO: 3, which corresponds to instant claim 42 (i) wherein the instant SEQ ID NO: 3 comprises Y33A/R50E/R59E/Y105A substitution; and
(b) the VLX comprises a cysteine substitution of Q100C as set forth in SEQ ID NO: 1, which corresponds to instant claim 42 (ii).
Issued claim 4 recites a binding protein comprising: at least one pseudoFab portion comprising (1) a first VL domain (VLa) paired with a first VH domain (VHa) to form a first functional antigen binding site that binds target antigen A; and (2) a first stabilized knockout VH domain (VHX) paired with a first stabilized knockout VL domain (VLX) to form a first stabilized knockout domain, wherein:
(a) the VHX comprises a cysteine substitution of G44C as set forth in SEQ ID NO: 4, which corresponds to instant claim 42 (i) as set forth in SEQ ID NO: 4 wherein SEQ ID NO: 4 having R50E/R59E substitution); and
(b) the VLX comprises a cysteine substitution of Q100C as set forth in SEQ ID NO: 1, which corresponds to instant claim 42 (ii).
Issued claim 5 recites a binding protein comprising: at least one pseudoFab portion comprising (1) a first VL domain (VLa) paired with a first VH domain (VHa) to form a first functional antigen binding site that binds target antigen A; and (2) a first stabilized knockout VH domain (VHX) paired with a first stabilized knockout VL domain (VLX) to form a first stabilized knockout domain, wherein:
(a) the VHX comprises a cysteine substitution of G44C as set forth in SEQ ID NO: 5, which corresponds to instant claim 42 (i) as set forth in SEQ ID NO 5 wherein SEQ ID NO:5 comprises Y33A/Y105A substitution; and
(b) the VLX comprises a cysteine substitution of Q100C as set forth in SEQ ID NO: 1, which corresponds to instant claim 42(ii).
Issued claim 6 recites a binding protein comprising: at least one pseudoFab portion comprising (1) a first VL domain (VLa) paired with a first VH domain (VHa) to form a first functional antigen binding site that binds target antigen A; and (2) a first stabilized knockout VH domain (VHX) paired with a first stabilized knockout VL domain (VLX) to form a first stabilized knockout domain, wherein the VLX/VHX pair is selected from the group consisting of: (i) a VLX comprising an amino acid sequence that is at least 85% identical to SEQ ID NO: 76, and comprising a cysteine substitution of Q100C, and a VHX comprising an amino acid sequence that is at least 85% identical to SEQ ID NO: 77, and comprising amino acid substitutions Y33A, R50E, R59E, and Y105A and a cysteine substitution of G44C; ii) a VLX comprising an amino acid sequence that is at least 85% identical to SEQ ID NO: 76, and comprising a cysteine substitution of Q100C, and a VHX comprising an amino acid sequence that is at least 85% identical to SEQ ID NO: 78, and comprising amino acid substitutions R50E and R59E and a cysteine substitution of G44C; and iii) a VLX comprising an amino acid sequence that is at least 85% identical to SEQ ID NO: 76, and comprising a cysteine substitution of Q100C, and a VHX comprising an amino acid sequence that is at least 85% identical to SEQ ID NO: 79, and comprising amino acid substitutions Y33A and Y105A and a cysteine substitution of G44C, which corresponds to instant claim 38.
Issued claim 32 recites the binding protein of claim 6, wherein the binding protein comprises separate proteins chains selected from one of the following groups:
(a) VHa-CH1-L1-VHb-L2-VHX and VLa-CL and VLb-L3-VLX, which corresponds to instant claims 43 and 45;
(b) VHa-L2-VHX-L1-VHb-CH1 and VLa-L3-VLX and VLb-CL, which corresponds to instant claims 44 and 46;
(c) VHa-CH1-L1-VHa-CH1 and VHb-L2-VHX-L3-VHb-L4-VHX and two chains VLb-L5-VLX and two chains VLa-CL; which corresponds to instant claims 43 and 45,
wherein the chains of (a) and (b) can be present once or twice, and
wherein L1, L2, L3, L4 and L5 are linkers, which are independently the same or different.
A person of skill in the art, reading the claims of the ‘160 patent, would look to the patent and follow the ‘160 patent’s express definition of binding molecule to include multispecific binding protein, (see title, see abstract, col. 2, line 14-15) and a second functional antigen binding site that binds target antigen B, see col. 3, lines 8-37, in particular.
Applicant's arguments filed March 9, 2026 have been fully considered but they are not persuasive. Applicant’s position is that claim 38 and 42 have been amended to recites “a second functional antigen binding site that binds target antigen B”. Applicant notes a typographical error in this rejection. Claims 38-42 (not claims 37-42) because claim 37 depends from claim 37.
In response, the Examiner thanks Applicant for pointing out the typographical error and the issue has been corrected. The amendment to claims 38 and 42 is acknowledged. The amendment does not place the claims in condition for allowance because a terminal disclaimer is required since the issued patent defines binding molecule to include multispecific antibody, see title, see abstract, col. 2, line 14-15); the ‘160 patent claims and teaches a second functional antigen binding site that binds target antigen B, see col. 3, lines 8-37, in particular.
Regarding new claims 43-46, issued claim 32 recites the binding protein of claim 6, wherein the binding protein comprises separate proteins chains selected from one of the following groups:
(a) VHa-CH1-L1-VHb-L2-VHX and VLa-CL and VLb-L3-VLX, which corresponds to instant claims 43 and 45;
(b) VHa-L2-VHX-L1-VHb-CH1 and VLa-L3-VLX and VLb-CL, which corresponds to instant claims 44 and 46;
(c) VHa-CH1-L1-VHa-CH1 and VHb-L2-VHX-L3-VHb-L4-VHX and two chains VLb-L5-VLX and two chains VLa-CL;
wherein the chains of (a) and (b) can be present once or twice, and
wherein L1, L2, L3, L4 and L5 are linkers, which are independently the same or different.
The VHb is expected to pair with VLb.
For these reasons, the rejection is maintained.
Conclusion
Claims 3, 5, 17 and 37 are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on M-Th 9-6:30; alternate F 9-5:30 EST.
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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641
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