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
Status of the Claims
1. Claims 1-6 are the original claims filed 4/30/2020. In the Response of 10/12/2020, Claim 1 is amended. In the Reply filed 4/6/2021, Claims 3 and 6 are amended, claims 1-2 and 4-5 are canceled, and new claims 7-8 are added. In the Response of 10/21/2021, Claim 3 is amended and new Claims 9-32 are added. In the Response of 12/12/2022, Claim 23 is amended and Claims 17-22 are canceled. In the Response of 7/18/2023, Claims 3 and 11 are amended and claims 9-10, 13 and 15 are canceled. In the Response of 11/3/2023, Claim 23 is amended and claims 30 and 32 are canceled. In the Response of 3/24/2024, Claims 3, 11 and 23 are amended and claims 14, 16, 29 and 31 are canceled. In the Response of 10/8/2025, claims 3, 11 and 23 are amended. In the Response of 1/23/2026, Claims 3, 11, 23-25, and 27-28 are amended. In the Response of 5/26/2026, Claim 23 is amended.
Claims 3, 6-8, 11-12, and 23-28 are pending.
This Office Action contains new grounds for objection. The amendment of claims rejoins instant clams under outstanding grounds for rejection.
The Office Action is final.
Priority
2. USAN 16/863,948, filed 04/30/2020, and having 4 RCE-type filing therein, is a Continuation of PCT/US2019/057741, filed 10/23/2019, PCT/US2019/057741 Claims Priority from Provisional Application 62/807,363, filed 02/19/2019, PCT/US2019/ 057741 Claims Priority from Provisional Application 62/773,839, filed 11/30/2018, PCT/US2019/057741 Claims Priority from Provisional Application 62/749,662, filed 10/23/2018.
Information Disclosure Statement
3. As of 6/3/2026, a total of nine (9) IDS are filed: 10/12/2020; 12/12/2022; 7/18/2023; 11/3/2023; 2/5/2024; 3/24/2025; 10/8/2025; 1/23/2026; and 5/26/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Rejections
Double Patenting
4. The rejection of Claims 3, 8, and 11 on the ground of nonstatutory double patenting as being unpatentable over claims 21-22 of U.S. Patent No. 10882915 is withdrawn.
Applicants’ specification teaches an example of an anti-CD45 antibody: “Ab5 refers to a monoclonal antibody directed against CD45 (i.e., an anti-CD45 antibody)” at [0713]; and “a monoclonal antibody directed against CD45 (i.e., Ab5 (an anti-CD45 antibody))” at [0715].
Claim Rejections - 35 USC § 112(b)
5. The rejection of Claims 23-28 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Claim 23 is amended to properly conclude in the identification of the subject matter to which the IgG antibody binds, i.e., CD45.
Claim Rejections - 35 USC § 112(a)
Written Description
6. The rejection of Claims 3, 6-8, 11-12, and 23-28 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’ specification teaches an example of an anti-CD45 antibody: “Ab5 refers to a monoclonal antibody directed against CD45 (i.e., an anti-CD45 antibody)” at [0713]; and “a monoclonal antibody directed against CD45 (i.e., Ab5 (an anti-CD45 antibody))” at [0715].
Claims 23-28 are amended to recite CD45.
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.
7. The provisional rejection of Claims 3, 6-8, 11-12, and 23-28 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, 32-34, 37-38 of copending Application No. 17/507,456 (reference application US 20220175946) is maintained.
The original grounds for the provisional nonstatutory double patenting rejection for the ref claims (see Office Action of 4/8/2025) was based on the ref claim set of 2/28/2022. Subsequently, and in the ref claim set of 5/5/2025, the generic claim 1 was amended to recite the cell surface molecule or the antigen to which the ADC binds is to CD45 and to identify the ADC comprising a monoclonal antibody and a cytotoxin. Ref claim 21 that depends from ref claim 1 is amended to the cell surface molecule as CD45. Ref claims 32-34 and 38-39 depend from claim 21. In the ref claim set of 10/14/2025, claim 37 is amended to depend from claim 1.
The instant claims are examined for the most recent claim set of the reference application from 10/14/2025:
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Instant claims 3, 6-8, 11-12 and 23-28 correspond to an anti-CD45 IgG antibody comprising a modified Fc region of SEQ ID NO: 15 comprising amino acid substitutions L234A, L235A, D265C and H435A, and an ADC conjugate to a cytotoxin.
The instant claims are not provided safe harbor under 35 USC 121.
The provisional rejection is maintained.
New Grounds for Objection
Claim Objections
8. Claims 23-28 are objected to because of the following informalities:
a) Amend claim 23 to recite “wherein the pharmaceutically acceptable carrier comprises.”
b) Amend the preamble of clams 24-28 to recite “The
Appropriate correction is required.
Conclusion
9. No claims are allowed.
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM. 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, Wu Julie can be reached on 571-272-5205. 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.
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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