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
The amendment filed July 18, 2024, is acknowledged and has been entered. Claims 1-25 have been canceled. Claims 26-36 have been newly added.
Claims 26-36 are pending and are under examination.
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 obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 26-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent 11,590,170. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The claims of the patent are drawn to cells comprising CARs that bind CD22 comprising the instant SEQ ID NOs on instant claims 26 and 27 and CD19 comprising the instant SEQ ID NOs on instant claims 29 and 30 (see claim 1). Claim 5 recites making a cell by introducing a nucleic acid that encodes the CARs. Claims 3-4 further recites using a cell comprising said CARs that binds CD22 comprising the instant SEQ ID Nos to treat leukemia or lymphoma.
Furthermore, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. (see MPEP 804). In this case, it is noted that columns 1-5 of the patent recites that cells comprising CARs of the invention can be used to kill cells expressing CD22 and CD19. Furthermore, such cells would need to be made before they were administered so methods of making the cells would be considered an obvious variation of the patented claims.
Accordingly, the claims in the patent would be seen as not patentably distinct from the instant claims because of the claimed overlapping subject matter of the patent and the instant claims.
Claims 26-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US Patent 11,963,981. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The claims of the patent are drawn to CARs that bind CD22 comprising the instant SEQ ID NOs on instant claims 26 and 27 and CD19 comprising the instant SEQ ID NOs on instant claims 29 and 30 (see claims 6, 7 and 14) and cells comprising the CARs (see claims 11-14). Claim 10 recites making a cell by introducing a nucleic acid that encodes the CAR. Claim 16 further recites using a CAR that binds CD22 comprising the instant SEQ ID Nos to treat leukemia or lymphoma.
Furthermore, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. (see MPEP 804). In this case, it is noted that columns 1-5 of the patent recites that cells comprising CARs of the invention can be used to kill cells expressing CD22 and CD19. Furthermore, such cells would need to be made before they were administered so methods of making the cells would be considered an obvious variation of the patented claims.
Accordingly, the claims in the patent would be seen as not patentably distinct from the instant claims because of the claimed overlapping subject matter of the patent and the instant claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRAD DUFFY whose telephone number is (571)272-9935. The examiner can normally be reached Mon-Fri.
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, Julie Wu can be reached at 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.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
July 7, 2026
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