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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 84, 86-88, 92-112, and 114-134 have an effective filing date of 23APR2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/24/2026 and 6/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 6/24/2026, Applicant elected:
Group I, claims 84-115
Species
VHCDR 1-3 SEQ ID NOs: 21, 22, and 15 and VLCDR 1-3 of SEQ ID NOs: 24, 25, and 26
Mc-VC-PAB
Cytotoxic agent
Status of Claims
Claims 84, 86-88, 92-112, and 114-134 are currently pending and presented for examination on the merits.
Claims 116-117, 123, 125, 132, and 134 are withdrawn from further consideration by Examiner under 37 CFR 1.1.42(b) as being drawn to a non-elected invention.
Claims 84, 86, and 88 are amended.
Claims 118-134 are new.
Claims 1-83, 85, 89-91, and 113 are canceled.
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.
Claims 84, 92-112, 114-11 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.
Claim 84 recites, “a heavy chain variable (VH) region and a light chain variable (VL) region, the VH region comprising complementarity determining regions HCDR1, HCDR2 and HCDR3, and the VL region comprising LCDR1, LCDR2 and LCDR3, wherein the VH and VL regions have amino acid sequences set forth in SEQ OD NO:21, SEQ ID NO:22, SEQ ID NO:15, SEQ ID NO:24, SEQ ID NO:25 and SEQ ID NO:26.”. It is unclear what the claimed sequence is. Examiner recommends adding “, respectively” after the listed CDRs.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 84, 86-88, 92, 95-101, 114-115, 118-121, 124, 126-131, and 133 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 10-12, 14-17, 91, 96, and 120-121 of copending Application No. 19/123,878 ('878) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 84, 86-88, 93, 94, 106, 111, 112, 119, 120, 122, 126, and 127 are not patentably distinct from claims 1, 3-6, and 120 of Application ‘878. Specifically, a binding agent (and conjugate) that binds CD70 comprising SEQ ID NOs: 7 and 8 (see conflicting claims 3, 91, and 96). A comparison of SEQ ID NOs: 7 and 8 of the instant claims and SEQ ID NOs: 7 and 8 of ‘878 are shown below.
Instant SEQ ID NO: 7 and SEQ ID NO: 7 of ‘878.
Query Match 100.0%; Score 655; Length 122;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQESGPGLVKPSETLSLTCTVSGGSVSSDYYYWSWIRQPPGKGLEWLGYIYYSGSTN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQESGPGLVKPSETLSLTCTVSGGSVSSDYYYWSWIRQPPGKGLEWLGYIYYSGSTN 60
Qy 61 YNPSLKSRVTISVDTSKNQFSLKLRSVTTADTAVYYCARGDGDFLGVCFDYWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YNPSLKSRVTISVDTSKNQFSLKLRSVTTADTAVYYCARGDGDFLGVCFDYWGQGTLVTV 120
Qy 121 SS 122
||
Db 121 SS 122
Instant SEQ ID NO: 8 and SEQ ID NO: 8 of ‘878.
Query Match 100.0%; Score 553; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIFDASNRATGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIFDASNRATGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPLTFGGGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPLTFGGGTKVEIK 107
Claim 92 is not patentably distinct from claim 7 of ‘878. Specifically, the VH and he VL regions comprise human framework regions.
Claim 95 is not patentably distinct from claim 10 of ‘878. Specifically, the biding agent further comprises a heavy chain constant region.
Claim 96 is not patentably distinct from claim 11 of ‘878. Specifically, the heavy chain constant region is of the IgG isotype.
Claim 97 is not patentably distinct from claim 12 of ‘878. Specifically, the heavy chain constant region is an IgG1 constant region.
Claim 98 is not patentably distinct from claim 14 of ‘878. Specifically, the IgG1 constant region has the amino acid sequence set forth in SEQ ID NO: 28.
Claim 99 is not patentably distinct from claim 15 of ‘878. Specifically, the binding agent further comprises a light chain constant region.
Claim 100 is not patentably distinct from claim 16 of ‘878. Specifically, the light chain constant region is of the kappa isotype.
Claim 101 is not patentably distinct from claim 17 of ‘878. Specifically, the kappa isotype has the amino acid sequence set forth in SEQ ID NO: 29.
Claims 108-110 and 129 are not patentably distinct from claim 119 of ‘878. Specifically, the conflicting claim recites various drug-antibody ratios.
Claims 114-115, 122, and 131 are not patentably distinct from claim 121 of ‘878. Specifically, the binding agent and a pharmaceutically acceptable carrier.
Claim 118 is not patentably distinct from claim 96 of ‘878. Specifically, the cytotoxic agent is exatecan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 102-105, 107, 121, 124, 128, 130, and 133 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 10-12, 14-17, 91, 96, and 120-121 of copending Application No. 19/123,878 ('878), as applied to claims 84, 86-88, 93, 94, 106, 111, 112, 119, 120, 122, 126, and 127 in view of Chen et al. (US PG PUB 2016/0096893, publication date: 04/07/2016).
With respect to the instant claims 102, 107, 121, and 128, the conflicting claims do not teach or suggest L234A and L235A Fc region mutations; however at [0303], Chen et al. teach that L234A and L235A Fc region mutations result in the down-modulation of antibody-dependent cellular cytotoxicity (ADCC). Therefore it would have been prima facie obvious to modify the conflicting claims to comprise L234A and L235A Fc region mutations, as the resultant binding agent would be expected to exhibit reduced ADCC, which would be advantageous in settings where reduced ADCC is desired.
With respect to the instant claims 103-105, at [0321], Chen et al. teach that antigen-binding molecules may be prepared by introducing nucleic acid vectors into host cells and culturing said host cells.
With respect to the instant claims 124, 130, and 133, as indicated above, claim 121 of ‘878 recites a binding agent and a pharmaceutically acceptable carrier, and claim 119 of ‘878 recites various drug-antibody ratios.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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