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
Claim Status
Applicant's amendment filed on January 21, 2026 has been received and entered.
Claims 4-5, 8-9, 12-13, and 18 have been amended.
Claims 1-3, 6-7, and 14-17 have been canceled.
Claim 11 was previously canceled.
Claims 4-5, 8-10, 12-13, and 18 are pending and under consideration.
Priority
This application is a 371 of PCT/JP2021/043538 filed November 29, 2021 which claims the benefit of foreign applications JAPAN 2020-198044 filed November 30, 2020 and JAPAN 2021-110912 July 2, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
However, Applicant is reminded that support for the claimed invention cannot be determined because the foreign priority documents provided for JP2020-198044 and JP2021-110912 are not in English. Applicant cannot rely upon the certified copies of the foreign priority applications to overcome any prior art rejection because translations of said applications have not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. Failure to provide certified translations may result in no benefit being accorded for the non-English applications.
Claim Objections
In view of the Applicant’s amendment, the previous objections to the claims are withdrawn.
Claim Rejections - 35 USC § 112
In view of the Applicant’s amendment, the previous rejections to the claims under 35 U.S.C. 112(b) and 35 U.S.C. 112(a) have been withdrawn.
Claim Rejections - 35 USC § 102 & 35 USC § 103
In view of the Applicant’s amendment, the previous rejections to the claims under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 have been withdrawn.
Double Patenting
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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.
Double Patenting - Withdrawn
The previous rejections of the instant claims on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,981,747 has been withdrawn.
The terminal disclaimer filed on January 21, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,981,747 has been reviewed and is accepted. The terminal disclaimer has been recorded. As such the rejection(s) have been withdrawn.
Double Patenting - Maintained/Updated
The following are updated grounds of rejection necessitated by Applicant’s claim amendments filed January 21 ,2026. Applicant’s arguments relevant to the updated grounds of rejection will be addressed below.
Claims 4-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,122,846.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to the identical anti-HER2 heavy and light chain variable domain amino acid sequences recited in the instant claims.
Specifically, the issued patent recites an antigen binding domain recognizing HER2 comprising VH CDR amino acid sequences of SEQ ID NOs: 1-3 and VL CDR amino acid sequences of SEQ ID NOs: 4-6 which are 100% identical to the VH and VL variable region CDR amino acid sequences as recited in claim 4 part (ii). As such, the instant claimed invention is anticipated by the claims of the issued patent.
Claims 4, 8-10, 12-13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,122,846, in view of Mathieu et al. (US 2018/0094056) (“Mathieu”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to the identical anti-HER2 heavy and light chain variable domain amino acid sequences recited in the instant claims.
Specifically, the issued patent recites an antigen binding domain recognizing HER2 comprising VH CDR amino acid sequences of SEQ ID NOs: 1-3 and VL CDR amino acid sequences of SEQ ID NOs: 4-6 which are 100% identical to the VH and VL variable region CDR amino acid sequences as recited in claim 4 part (ii).
The instant claims differ from the issued claims in that they do not explicitly teach conjugation to a cytotoxic agent, nucleic acids encoding the antibody-binding fragment, pharmaceutical compositions, methods for antibody selection, or treatment of cancer.
Mathieu teaches anti-HER2 antibodies and antibody fragments, such as scFvs [0014-0015] for the treatment of a HER2 positive cancer [0290]. Mathieu also teaches nucleic acids encoding said antibodies [0256]. The antibody can be conjugated to one or more cytotoxic agents [0271]. The antibody or ADC can be formulated in a pharmaceutical composition [0282]. Mathieu carried out a series of binding assays with human PBMCs to test the antibodies affinity for their HER2 target [0334].
It would have been obvious to one of ordinary skill in the art that the antibody-binding fragment disclosed in the issued patent could be formulated as an ADC or a pharmaceutical composition for the treatment of cancer as evidenced by Mathieu. A skilled artisan could easily synthesize nucleic acid constructs for recombinant production of anti-HER2 antibodies based on the amino acid sequences disclosed by the issued patent. As such, the instant claimed invention is an obvious modification of the claims of the issued patent in view of Mathieu.
Response to Arguments
Applicant has argued on page 9 of the reply received January 21, 2026, that the nonstatutory double patenting rejections of the instant claims over the claims 1-2 of US Patent No. 12,122,846 should be withdrawn because the present claims are directed to an antibody, while the issued claims are directed to a CAR.
Applicant’s arguments were considered, but they were not deemed persuasive.
The issued patent is directed to a CAR comprising an antigen-binding domain against HER2 comprising the identical CDR regions as the antibody recited in the instant claims. Claim 2 of the issued patent discloses the antigen-binding fragment is an scFv.
The instant claims are drawn to an anti-HER2 antibody or antigen-binding fragment thereof. The instant specification discloses antibody-binding fragments may be in the form of an scFv [0018] and the antibody or antigen-binding fragment can be used to target cancer cells [0033].
The function of the CAR disclosed in the issued patent is to target cells expressing HER2 comprising the identical antigen-binding fragment recited in the instant claims. As such, the claims of the issued patent anticipate the presently claimed invention, and the rejection is maintained.
MPEP § 804(II) states 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).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645