DETAILED ACTION
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 .
Applicant’s remarks, filed 3/16/2026, are acknowledged and entered into the record. Applicants amended claims 1, 11, 13 and 16-18, canceled claim 10, and added new claim 27, in the remarks of 3/16/2026.
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. The present application is drawn from PCT/EP2020/053780, filed 2/13/2020.
Status of Claims
Claims 1-9, 11-19 and 23-27 are being examined on the merits.
Claim Rejections – Withdrawn
Claim Rejections - 35 USC § 112
The rejection of Claim 10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. Applicants canceled claim 10, thereby obviating the rejection.
Claim Interpretation under 35 U.S.C. 112(f)
Applicants amended claim 13 to avoid it being interpreted under 35 U.S.C. 112(f). Specifically, applicants deleted “is capable of” from the claim.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3 under 35 U.S.C. 103 as being unpatentable over Tai et al., (from IDS of 10/21/2022, NPL cite No. 21; J. Exp. Med., Vol. 184, 1996), is withdrawn.
The rejection of claims 4-5, 7-12, 19 and 23-26 under 35 U.S.C. 103 as being unpatentable over Tai et al., (from IDS of 10/21/2022, NPL cite No. 21; J. Exp. Med., Vol. 184, 1996) as applied to claims 1-3 above, and further in view of Eckelman et al., (US 2019/0330366; published 10/31/2019), is withdrawn.
The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Tai et al., (from IDS of 10/21/2022, NPL cite No. 21; J. Exp. Med., Vol. 184, 1996) and Eckelman et al., (US 2019/0330366; published 10/31/2019) as applied to claims 1-5, 7-12, 19 and 23-26 above, and further in view of Ledbetter et al., (from IDS of 10/21/2025, FOR cite No. 1; published 10/11/1989), is withdrawn.
The rejection of claims 13-14 under 35 U.S.C. 103 as being unpatentable over Tai et al., (from IDS of 10/21/2022, NPL cite No. 21; J. Exp. Med., Vol. 184, 1996) and Eckelman et al., (US 2019/0330366; published 10/31/2019) as applied to claims 1-5, 7-12, 19 and 23-26 above, and further in view of Nielsen et al., (US 2011/0293579; published 12/1/2011), is withdrawn.
The rejection of claim 15 under 35 U.S.C. 103 as being unpatentable over Tai et al., (from IDS of 10/21/2022, NPL cite No. 21; J. Exp. Med., Vol. 184, 1996) and Eckelman et al., (US 2019/0330366; published 10/31/2019) as applied to claims 1-5, 7-12, 19 and 23-26 above, and further in view of Park et al., (US Patent 8,197,809; published 6/12/2012), is withdrawn.
The above rejections are withdrawn in view of applicant’s amendments to the claims. Specifically, applicants amended independent claim 1 to recite wherein the anti-CD9 binding domain of the bispecific antibody comprises the VH and VL CDRs 1-6 of SEQ ID NOs: 11-16, respectively. As the recited CDRs of an anti-CD9 binding domain are free of the prior art, the applied references no longer teach each and every limitation of the claims.
Claim Rejections – Maintained
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 1-4, 7-9, 11-16, 19 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-9, 12-13, 17 and 19-22 of copending Application No. 17/929,026 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of app ‘026 anticipate that of the instant claims.
App. ‘026 claims an anti-CD137 antibody having the VH CDRs of SEQ ID NOs: 3-5 and the VL CDRs of SEQ ID NOs: 6-8 (claim 1). App ‘026 also claims a CD137/CD9 bispecific antibody whereby the CD9 binding domain comprises the VH CDRs of SEQ ID NOs: 9-11 and the VL CDRs of SEQ ID NOs: 12-14. App ‘026 SEQ ID NOs: 3-8 are 100% identical to instant SEQ ID NOs: 11-16, respectively, of the CD137 binding domain CDRs; and app ‘026 SEQ ID NOs: 9-14 are 100% identical to instant SEQ ID NOs: 5-10, respectively, of the CD9 binding domain CDRs. Further, the anti-CD9 VH and VL of app ‘026 SEQ ID NOs: 19 and 21 are 100% identical to that of instant SEQ ID NOs: 21 and 23, respectively. Thus, app ‘026 teaches an identical CD137/CD9 antibody to that of the instant claims.
Specifically, the CD137/CD9 bispecific antibody of app ‘026 claims 1 and 12 anticipates instant claims 1-4; app ‘026 claims 2-3 anticipate instant claims 7-8; app ‘026 claims 5-6 anticipate instant claims 9 and 11; app ‘026 claims 7-9 anticipate instant claims 12-14 and possess the inherent properties of instant claim 15 (wherein the CD9 antibody binds CD9 Loop 2); app ‘026 claims 12 and 21-22 anticipate instant claims 16 and 27; the pharmaceutical composition of app ‘026 claim 13 anticipates instant claim 19; the methods of app ‘026 claims 17 and 19-20 anticipate instant claims 23-26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5, 7-9, 11-15, 17, 19 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 16-19 of copending Application No. 17/929,028 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of application ‘028 anticipate that of the instant claims.
App. ‘028 claims an anti-HVEM/anti-CD9 bispecific antibody (claim 1), wherein the antibody comprises the HVEM VH and VL of SEQ ID NOs: 15 and 17, respectively; and the CD9 VH and VL of SEQ ID NOs: 19 and 21, respectively. App ‘028 SEQ ID NOs: 15, 17, 19 and 21 are 100% identical, and thus also comprise the CDRs with 100% identity, to instant SEQ ID NOs: 31, 33, 21 and 23, respectively. Thus, app ‘028 claims an identical HVEM/CD9 bispecific antibody to that of the instant claims.
Specifically, the HVEM/CD9 bispecific antibody of app ‘028 claim 1 anticipates instant claims 1-3, 5 and 27; app ‘028 claims 2-10 anticipate instant claims 7-9 and 11-15; app ‘028 claim 11 anticipates instant claim 17; the pharmaceutical composition of app ‘028 claim 12 anticipates instant claim 19; the methods of app ‘028 claims 16-19 anticipate instant claims 23-26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-9, 11-15, 18-19 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 11-12, 17-20 and 22 of copending Application No. 17/929,029 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of application ‘029 anticipates that of the instant claims.
App. ‘029 claims an anti-CD7/anti-CD9 bispecific antibody (claim 1), wherein the antibody comprises the CD7 VH and VL of SEQ ID NOs: 15 and 17, respectively; and the CD9 VH and VL of SEQ ID NOs: 19 and 21, respectively. App ‘029 SEQ ID NOs: 15, 17, 19 and 21 are 100% identical, and thus also comprise the CDRs with 100% identity, to instant SEQ ID NOs: 41, 43, 21 and 23, respectively. Thus, app ‘029 claims an identical CD7/CD9 bispecific antibody to that of the instant claims.
Specifically, the CD7/CD9 bispecific antibody of app ‘029 claim 1 anticipates instant claims 1-3, 6 and 27; app ‘029 claims 2-4 anticipate instant claims 7-9; app ‘029 claims 6-9 anticipate instant claims 11-14 and 15 (wherein the CD9 antibody binds CD9 Loop 2); app ‘029 claim 11 anticipates instant claim 18; the pharmaceutical composition of app ‘029 claim 12 anticipates instant claim 19; the methods of app ‘029 claims 17-20 and 22 anticipate instant claims 23-26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Note that application 17/929029 was allowed on 4/8/2026, but has not yet issued.
Response to Arguments
Applicant's arguments filed 3/16/2026 have been fully considered but they are not persuasive. Applicants have asked that each of the NSDP rejections be held in abeyance until the remaining rejections are resolved (remarks, pg. 11).
In response the examiner states that the Office does not hold rejections in abeyance for any reason. Further, all the remaining rejections have been resolved, the rejections for NSDP are the only rejections remaining. Examiner also want to note that he is aware that applicants have filed a terminal disclaimer (TD) in each of the co-pending applications over the instant application. However, a TD is not a two-way disclaimer. Each TD specifies the application for which the terminal period is being disclaimed, over reference disclosures. Thus, if applicants wish to overcome the NSDPs of record, they would need to file a TD over each co-pending application to obviate each NSDP rejection on record.
Allowable Subject Matter
The VH and VL CDRs 1-6 of the anti-CD9 binding domain of amended claim 1 have been searched and are free of the prior art. Thus, instant claim 1, and the claims that depend from claim 1, would be allowable as written pending resolution of the NSDP rejections noted above.
Conclusion
No claims are 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 JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
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.
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/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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