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 1-25 are pending and being acted upon in this Office Action.
Priority
Applicant’ claim priority to provisional application 63/601,664, filed November 21, 2023, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 16, 2026 has been considered by the examiner and an initialed copy of the IDS is included with this Office Action.
Objection and Rejection Withdrawn
The objection to the specification is withdrawn in view of the amendment filed September 16, 2026.
The objection to claim 1 is withdrawn in view of the claim amendment.
The provisional rejection of claims 1-25 on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/259,821 (now Patent No. 12,723,089) is withdrawn in view of the terminal disclaimer filed in 19/259,821.
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).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,668,637. Although the claims at issue are not identical, they are not patentably distinct from each other because while the ‘637 patent issued from the application which served as the parent for the present case, the examined application was filed as a CON, not a DIV, and therefore no shield against double patenting that might be provided by 35 U.S.C 121 would be applicable here.
Instant application is a continuation of parent 19/259,911 application, which is now Pat No. 12668637), and the disclosure of parent application or patent fully discloses the claimed antibody and methods.
The reference SEQ ID NO: 62 is identical to the claimed SEQ ID NO: 62, see sequence alignment below.
Query Match 100.0%; Score 640; Length 120;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGYSFTGYTMNWVRQAPGQGLEWMGLINPSSGGTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGYSFTGYTMNWVRQAPGQGLEWMGLINPSSGGTYY 60
Qy 61 NQKFKDRVTMTRDTSISTAYMELSRLRSDDTAVYYCARLGDNYRGYFDYWGQGTTVTVSS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NQKFKDRVTMTRDTSISTAYMELSRLRSDDTAVYYCARLGDNYRGYFDYWGQGTTVTVSS 120
The reference SEQ ID NO: 65 is 100% identical to instant SEQ ID NO: 65, see sequence alignment below:
Query Match 100.0%; Score 561; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSFLSASVGDRVTITCRASQDVGTAVVWYQQKPGKAPKLLIDWASIRHTGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQLTQSPSFLSASVGDRVTITCRASQDVGTAVVWYQQKPGKAPKLLIDWASIRHTGVPS 60
Qy 61 RFSGSGSGTEFTLTISSLQPEDFATYYCQQYSTYLYTFGGGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTEFTLTISSLQPEDFATYYCQQYSTYLYTFGGGTKLEIK 107
19/672,116
US Patent No. 12,668,637
CDR-H1 SEQ ID NO: 14
GYTMN
GYTMN
CDR-H2 SEQ ID NO: 45
LINPSSGGTYYNQKFKD
LINPSSGGTYYNQKFKD
CDR-H3 SEQ ID NO: 22
LGDNYRGYFDY
LGDNYRGYFDY
CDR-L1 SEQ ID NO: 64
RASQDVGTAVV
RASQDVGTAVV
CDR-L2 SEQ ID NO: 28
WASIRHT
WASIRHT
CDR-L3 SEQ ID NO: 31
QQYSTYLYT
QQYSTYLYT
Heavy chain constant region
SEQ ID NO: 4
SEQ ID NO: 4
Light chain constant region
SEQ ID NO: 7
SEQ ID NO: 7
VH
SEQ ID NO: 62
SEQ ID NO: 62
VL
SEQ ID NO: 65
SEQ ID NO: 65
HC
SEQ ID NO: 97
SEQ ID NO: 97
LC
SEQ ID NO: 102
SEQ ID NO: 102
A person of skill in the art, reading the claims of the ‘637 patent, would look to the application and follow the ‘637 patent’s express instruction on how to make the product within the application, e.g., Examples 1, 4, Tables 8, B, C thereby arriving at the antibody that binds to KLRB1 of the examined claims.
Applicants’ arguments filed September 16, 2026 have been fully considered but are not found persuasive.
Applicant’s position is that the instant claims and the claims of the '911 application are directed to different antibodies. The Office cannot use the Specification of the '911 application in a nonstatutory double patenting rejection. MPEP 804(II)(B)(1).
In response, this application is a continuation of the parent application 19/259,911 (now U.S. Patent No. 12,668,637), not a divisional application. A continuation application filed under Section 120, is not entitled to the benefit of the safe harbor provision protections afforded by § 121’s safe harbor.” Amgen v. Roche, 580 F.3d 1340, 1354 (Fed. Cir. 2009). Thus, a continuation application drawn to subject matter that is separately patentable from the subject matter of the parent patent is vulnerable to an obviousness-type double patenting rejection from the USPTO and later patent challenge.
Instant application is a continuation of parent 19/259,911 application, which is now Pat No. 12668637), and the disclosure of parent application or patent fully discloses the claimed antibody and methods.
The submission of a terminal disclaimer in compliance with 37 CFR 1.321(b) is required to overcome a double patenting rejection because it seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982) and to prevent
unjustified timewise extension of patent term based on a judicially created doctrine grounded in public policy. “Fundamental to this doctrine is the policy that: ‘[t]he public should … be able to act on the assumption upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants which would have been obvious to those of ordinary skill in the art at the time the invention was made.’” In re Longi, 892-3, citing In re Zickendraht, 319 F.2d 225, 232 (CCPA 1963) (Rich, J., concurring), emphasis in original. See also Singer Mfg. Co. v. June Mfg. Co., 163 U.S. 169, 185 (1896). Without the protection of the safe harbor provision, these public policy concerns apply to all continuation applications and patents filed from a parent patent. See MPEP 1504.06.
A terminal disclaimer over the parent patent can be avoided by satisfying the requirements of a divisional application, where the divisional application is filed from a parent application with claims structured to trigger a restriction requirement. Alternatively, the Applicant can file separate applications to the different inventions where the separate applications do not share a priority claim, thus minimizing the risk of ODP. But in the absence of a restriction requirement and subsequent divisional application, a continuation application filed from a parent patent is an implicit admission that ODP applies to the resulting continuation patent.
For these reasons, the rejection is maintained.
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 PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on 9:00 a.m. to 6:30 p.m. The examiner can also be reached on alternate alternative Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Misook Yu, can be reached at 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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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641
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