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 ACTIONPriority
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 1-30 have an effective filing date of 07MAR2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 28JAN2026 is 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 1/28/2026, Applicant elected, without traverse:
Group I – 1-19, and 28-30
Species
A distinct species of epitope the HER2 antibody specifically binds to
Residues 474 to 553 of SEQ ID NO: 1
A distinct species of HER2 targeting therapy
Trastuzumab
A distinct species of immune checkpoint inhibitors
Pembrolizumab
Status of Claims
Claims 1-30 are currently pending and presented for examination on the merits.
Claims 13-14, and 20-27 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
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 1-12, 15-19, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 14 of U.S. Patent No. 11964024 ('024) in view of Bodyak et al (US 9555112 B2, IDS 01/28/2026) and Bodyak et al (US 20180271996 A1, Bodyak ‘996).
Claim 1 is not patentably distinct over claims 1, 9, and 14 of ‘024. Specifically, an antibody conjugated to a Formula (A).
‘024 does not specifically teach a HER2 antibody comprising SEQ ID NOs: 5,6,7 and 12,13,14. However, this deficiency is taught by Bodyak et al.
Bodyak et al teaches a HER2 antibody comprising SEQ ID NO: 13. A comparison of instant SEQ ID NOs: 5,6,7 and SEQ ID NO: 13 of Bodyak et al is shown below.
Instant SEQ ID NOs: 5,6,7 and SEQ ID NO: 13 of Bodyak et al.
Query Match 86.3%; Score 154.4; Length 117;
Best Local Similarity 42.5%;
Matches 34; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 FTFSSYSMN--------------YISSSSSTIYYADSVKG-------------------- 26
||||||||| |||||||||||||||||
Db 27 FTFSSYSMNWVRQAPGKGLEWVSYISSSSSTIYYADSVKGRFTISRDNAKNSLYLQMNSL 86
Qy 27 ------------GGHGYFDL 34
||||||||
Db 87 RAEDTAVYYCARGGHGYFDL 106
Bodyak et al teaches a HER2 antibody comprising SEQ ID NO: 14. A comparison of instant SEQ ID NOs: 12,13,14 and SEQ ID NO: 14 of Bodyak et al is shown below.
Instant SEQ ID NOs: 12,13,14 and SEQ ID NO: 14 of Bodyak et al.
Query Match 82.1%; Score 113.3; Length 108;
Best Local Similarity 37.3%;
Matches 28; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQSVSSSYLA---------------GASSRAT-------------------------- 19
|||||||||||| |||||||
Db 24 RASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIPDRFSGSGSGTDFTLTISRLEPED 83
Qy 20 ------QQYHHSPLT 28
|||||||||
Db 84 FAVYYCQQYHHSPLT 98
One of ordinary skill in the art would have been motivated to modify the conflicting claim 1 to recite Formula (A) conjugated to a HER2 antibody comprising SEQ ID NOs: 5,6,7 and 12,13,14 in view of Bodyak et al. The invention of the conflicting claims and Bodyak meets the limitation of claims 1, 9, and 14, because both ‘024 and Bodyak et al teach antibodies conjugated to Formula (A). One of ordinary skill in the art would have been motivated to make such a modification, because the resultant antibody-drug conjugate could be used in the treatment of HER2-expressing cancers.
With respect to claim 2, Bodyak et al teaches the antibody binds the epitope of the human HER2 residues 474 to 553 of SEQ ID NO: 38.
With respect to claims 3-10, Bodyak et al teaches the HER2-targeted therapy, trastuzumab [Figure 12].
With respect to claims 11-12, Bodyak et al teaches ado-trastuzumab emtansine [Column 32, line 67].
’024 does not specifically teach administering an immune checkpoint inhibitor. However, this deficiency is made up in the teachings of Bodyak (‘996).
With respect to claims 15-19, Bodyak (‘996) teaches a combination HER2-targeted antibody-drug conjugate administered with pembrolizumab [Claims 8-10]. Furthermore, the antibody is humanized [0159].
One of ordinary skill in the art would have been motivated to modify the conflicting claims to additionally administer pembrolizumab with the HERs-targeted STING conjugate to Formula (A), because Bodyak (‘996) teaches instant HER2 antibody comprising SEQ ID NOs: 5-6 and 12-14 conjugated to a drug with pembrolizumab.
With respect to claim 28-29, Bodyak et al teaches multiple formulations to improve transfer, delivery, and tolerance [Column 113, line 2-34].
With respect to claim 30, Bodyak et al teaches the combination in a kit [Column 31, line 25]. Bodyak et al further teaches the composition in a container, pack, or dispenser with instructions [Column 119, lines 9-11].
Claims 1-12, 15-19, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 8-9, and 24 of U.S. Patent No. 12156870 ('870) in view of Bodyak et al (US 9555112 B2, IDS 01/28/2026) and Bodyak et al (US 20180271996 A1, Bodyak ‘996).
Claim 1 is not patentably distinct over claims 1, 3-6, 8-9, and 24 of ‘870. Specifically, an antibody conjugated to a HER2-targeted STING conjugated to Formula (A). Wherein the HER2 antibody comprises SEQ ID NOs: 5-7 and 12-14.
With respect to claim 2, Bodyak et al teaches the antibody binds the epitope of the human HER2 residues 474 to 553 of SEQ ID NO: 38.
One of ordinary skill in the art would have been motivated to modify the conflicting claims 1, 3-6, 8-9, and 24 to recite that the HER2 antibody binds residues 474-553 of instant SEQ ID NO:1, because Bodyak et al teaches a HER2 antibody comprises SEQ ID NOs: 5-7 and 12-14 binds the epitope of the human HER2 residues 474 to 553 of SEQ ID NO: 38. One of ordinary skill in the art would have been motivated to make such a modification, because the resultant antibody-drug conjugate could be used in the treatment of HER2-expressing cancers.
With respect to claims 3-10, Bodyak et al teaches the HER2-targeted therapy, trastuzumab [Figure 12].
With respect to claims 11-12, Bodyak et al teaches ado-trastuzumab emtansine [Column 32, line 67].
’870 does not specifically teach administering an immune checkpoint inhibitor. However, this deficiency is made up in the teachings of Bodyak (‘996).
With respect to claims 15-19, Bodyak (‘996) teaches a combination HER2-targeted antibody-drug conjugate administered with pembrolizumab [Claims 8-10]. Furthermore, the antibody is humanized [0159].
One of ordinary skill in the art would have been motivated to modify the conflicting claims to additionally administer pembrolizumab with the HER2-targeted STING conjugate to Formula (A), because Bodyak (‘996) teaches instant HER2 antibody comprising SEQ ID NOs: 5-6 and 12-14 conjugated to a drug with pembrolizumab.
With respect to claim 28-29, Bodyak et al teaches multiple formulations to improve transfer, delivery, and tolerance [Column 113, line 2-34].
With respect to claim 30, Bodyak et al teaches the combination in a kit [Column 31, line 25]. Bodyak et al further teaches the composition in a container, pack, or dispenser with instructions [Column 119, lines 9-11].
Claims 1-12, 15-19, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18 of U.S. Patent No. 12440576 ('576) in view of Bodyak et al (US 9555112 B2, IDS 01/28/2026) and Bodyak et al (US 20180271996 A1, Bodyak ‘996).
Claim 1 is not patentably distinct over claims 1 and 18 of ‘576. Specifically, an antibody conjugated to a HER2-targeted STING conjugated to Formula (A). Wherein the HER2 antibody comprises SEQ ID NOs: 5-7 and 12-14.
With respect to claim 2, Bodyak et al teaches the antibody binds the epitope of the human HER2 residues 474 to 553 of SEQ ID NO: 38.
One of ordinary skill in the art would have been motivated to modify the conflicting claims 1 and 18 to recite that the HER2 antibody binds residues 474-553 of instant SEQ ID NO:1, because Bodyak et al teaches a HER2 antibody comprises SEQ ID NOs: 5-7 and 12-14 binds the epitope of the human HER2 residues 474 to 553 of SEQ ID NO: 38. One of ordinary skill in the art would have been motivated to make such a modification, because the resultant antibody-drug conjugate could be used in the treatment of HER2-expressing cancers.
With respect to claims 3-10, Bodyak et al teaches the HER2-targeted therapy, trastuzumab [Figure 12].
With respect to claims 11-12, Bodyak et al teaches ado-trastuzumab emtansine [Column 32, line 67].
’576 does not specifically teach administering an immune checkpoint inhibitor. However, this deficiency is made up in the teachings of Bodyak (‘996).
With respect to claims 15-19, Bodyak (‘996) teaches a combination HER2-targeted antibody-drug conjugate administered with pembrolizumab [Claims 8-10]. Furthermore, the antibody is humanized [0159].
One of ordinary skill in the art would have been motivated to modify the conflicting claims to additionally administer pembrolizumab with the HERs-targeted STING conjugate to Formula (A), because Bodyak (‘996) teaches instant HER2 antibody comprising SEQ ID NOs: 5-6 and 12-14 conjugated to a drug with pembrolizumab.
With respect to claim 28-29, Bodyak et al teaches multiple formulations to improve transfer, delivery, and tolerance [Column 113, line 2-34].
With respect to claim 30, Bodyak et al teaches the combination in a kit [Column 31, line 25]. Bodyak et al further teaches the composition in a container, pack, or dispenser with instructions [Column 119, lines 9-11].
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
Prosecution Insights