DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1, 3, 5, 12, 16, 39 and 43 are pending upon entry of amendment filed on 11/5/25.
The previous version of claim set filed on 6/26/25 is deemed truncated and new non-final rejection reflecting the current status of claims is set forth herein.
Claims 1, 3, 5, 12, 16, 39 and 43 are under consideration in the instant application.
3. In light of Applicants’ amendment and the response filed on 11/5/25, the rejection under 35 U.S.C.102(a)(1)(2) and (a)(1)(2) (see sections 5-7 of the office action mailed on 8/6/25) has been withdrawn.
4. The following rejections remain.
5. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 1, 3, 5, 12, 16, 39 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 7, 9, 28, 43, 52-53, 63, 67, 69, 72, 79-80, 83, 84, 86 and 90-91 of U.S. Application No. 16/862,358 (now issued U.S. Pat. 11,701,428)
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘358 application recite a method of treating hematologic malignancy in a subject comprising administering CD123 immunoconjugate with the CD123 antibody set forth in the SEQ ID NO:3-4 and IGN (DGN-549C and G4723) as in claim 1 of the instant application. Note the administrations cycles are identical as well.
As Applicant has requested that the double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
7. Claims 1, 3, 5, 12, 16, 39 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 29, 44 and 112 of U.S. Application No. 18/328,288 (US2014/003371).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘288 application recite a method of treating hematologic malignancy in a subject comprising administering CD123 immunoconjugate with the CD123 antibody set forth in the SEQ ID NO:3-4 and IGN (DGN-549C and G4723) as in claim 1 of the instant application. Note the administrations cycles are identical as well.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the ‘288 publication has the later filing date, this rejection is not only remaining issue and the rejection is currently maintained.
8. No claims are allowable.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Yunsoo Kim
Patent Examiner
Technology Center 1600
March 16, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641