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. Claim 8 is objected to because of an apparent typographical error in the term “Ig4,” where it appears that “IgG4” was intended. Appropriate correction or clarification is required.
3. 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.
4. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 11207349 (IDS), 11439665 (IDS), 11633430 (IDS), and 12448432.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of each of the above patents, which recite the instantly claimed bispecific CAR.
Specifically, each patent recites a bispecific CAR of SEQ ID NO: 16 (claim 1 of US ‘349, claim 1 of US ‘665, claim 1 of US ‘430, and claim 1 of US ‘432). The instant application is related to the above patents as a continuation, and as such contains the same disclosure.
The bispecific CAR of SEQ ID NO: 16, designated TN-OF-19 (p. 18-19 of the specification), comprises, in the N- to C-terminal direction (Fig. 1, p. 15-17, and the Sequence Listing):
CD8 signal peptide (i.e. a leader sequence) or SEQ ID NO: 8,
an scFv comprising VL (SEQ ID NO:4) and VH (SEQ ID NO:3) of anti-CD20 antibody ofatumumab,
an scFv comprising VH (SEQ ID NO:6) and VL (SEQ ID NO:5) of anti-CD19 antibody FMC63,
an IgG4 hinge region,
CD28 transmembrane domain of SEQ ID NO: 11,
4-1BB (CD137) co-stimulatory signaling region of SEQ ID NO: 12, and
CD3ζ cytoplasmic signaling domain of SEQ ID NO: 14.
Accordingly, the bispecific CAR of SEQ ID NO: 16 possesses all of the structural features recited in instant claims 1-10.
The refenced patents further recite immune cells (T cells or NK cells) comprising the CAR (claim 1 of US ‘349, claims 2-3 of US ‘665, claim 1 of US ‘430, and claim 4 of US ‘432). Nucleic acids and vectors encoding the CAR are inherent in these recitations.
US ‘349 (claims 1-5) and US ‘430 (claims 1-5) recite methods of treating B cell malignancies comprising administering the immune cells. US ‘665 (claim 4) and US ‘432 (claim 10) recite pharmaceutical compositions comprising the immune cells. Pharmaceutical compositions, by definition, are intended for administration to patients, and CD19 and CD20 were well-known targets for treating B cell malignancies; therefore, a method of treating cancer would be at once envisaged by, or obvious to, a parson of skill in the art.
5. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17911524, published as US 20230212255 (IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘524 for the same reasons as articulated in section 4 above, as they recite a bispecific CAR or SEQ ID NO: 16 (claim 12), T cells and NK cells expressing the CAR (claims 13-14), and methods of treating B-cell malignancies (claims 17-26).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17911502, published as US 20230104705 (IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of USSN ‘502.
Claim 10 of USSN ‘502 recites a bispecific CAR of the same structure as defined by instant claims 1-3, further comprising a transmembrane domain of SEQ ID NO: 11, a co-stimulatory signaling region of SEQ ID NO: 12, and a cytoplasmic signaling domain of SEQ ID NO: 14. Claim 14 of USSN ‘502 recites that the CAR further comprises a signal peptide and a hinge region. As addressed in section 4 above, all of these structural features are comprised in a CAR of SEQ ID NO: 16 and are within the scope of instant claims 4-9.
USSN ‘502 further recites T cells and NK cells expressing the CAR and pharmaceutical compositions comprising the cells (claims 16-18), which anticipate or make obvious instant claims 15-20, for the reasons articulated in section 4 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Conclusion: no claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644