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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 3/06/2026 has been entered. Applicant indicates on the Request for Continued Examination (RCE) Transmittal, that the response of 3/06/2026 be considered.
Claim status
Applicant has amended Claim 289.
Claims 289-290, 292-298 are under consideration.
Information Disclosure Statement
Applicant has filed Information Disclosure Statements on 3/06/2026 that have been considered. The signed and initialed PTO Forms 1449 are mailed with this action.
Withdrawn Claim Objections
The prior objections to Claims 289 been withdrawn due to applicant’s amendment.
Withdrawn 35 USC § 112(a)
The prior rejection of Claims 289-290 and 292-298 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments, and the declaration filed by Dr. Micah Benson filed 7/30/2024.
The prior rejection of Claims 289-290 and 292-298 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating cancer in a human subject comprising administering an effective amount of modified human CD8+ T cells with reduced expression of ZC3H12A mediated by a CRISPR indel is withdrawn in light of Applicant’s amendments, and the declaration filed by Dr. Micah Benson filed 7/30/2024.
Terminal Disclaimer
The terminal disclaimer filed on 3/06/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11,608,500 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Double Patenting
The prior rejection of Claims 289, 292-298 on the grounds of nonstatutory double patenting over claims 1-20 of U.S. Patent No. 11,608,500 (Benson et al., Patented 3/21/2023), in view of Wardell et al. (US 10,537,595, panted 1/21/2020, see IDS filed 3/13/2023) is withdrawn in light of Applicant’s terminal disclaimer
New 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 289-290, 292-293, 298 are rejected on the grounds of nonstatutory double patenting over claims 1-14, and 21 of U.S. Patent No. 11,111,493 (Benson et al., Patented 9/07/2021)
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the claims of the cited patent are drawn to a composition of CD8+ T cells used in the instantly claimed method. There is no unobvious step in the process (i.e., administering), and instantly claimed process of treating cancers is the intended use of the claimed composition of the cited patent as taught by the specification.
Since the instant application method claims are obvious over cited patent composition claims, said claims are not patentably distinct.
Claims 294-297 are rejected on the grounds of nonstatutory double patenting over claims 1-14, and 21 of U.S. Patent No. 11,111,493 (Benson et al., Patented 9/07/2021) in view of Wardell et al. (US 10,537,595, patented 1/21/2020, see IDS filed 3/13/2023)
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the claims of the cited patent are drawn to a composition of CD8+ T cells used in the instantly claimed method. There is no unobvious step in the process (i.e., administering), and instantly claimed process of treating cancer is the intended use of the claimed composition of the cited patent as taught by the specification.
However, one difference between the patented composition of TIL is the instant claims are more specific to the type of cancers treated by the patented TILs.
Nevertheless, the use of modified CD8+ TILs to treat cancer was well known in the art. Specifically, Wardell et al. teach methods of treating cancers such as leukemia, melanoma, head and neck (HNSCC), and lung cancers comprising administering TILs that are CD8+ as adoptive cell therapy (col 5-6, Examples 3, 22, 23, 26-28).
Accordingly it would have been obvious to have claimed CD8+ TILs treat the genus of cancers at taught by Wardell with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Wardell teaches cancers respond better to CD8+ TILs (Examples 22 & 27).
Since the instant application method claims are obvious over cited patent composition claims in view of Wardell, said claims are not patentably distinct.
Claims 289, 292-298 are rejected on the grounds of nonstatutory double patenting over claims 1-16 of U.S. Patent No. 11,421,228 (Benson et al., Patented 8/23/2022), in view of Wardell et al. (US 10,537,595, patented 1/21/2020, see IDS filed 3/13/2023)
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the claims of the cited patent are drawn to a composition of TILs used in the instantly claimed method. There is no unobvious step in the process (i.e, administering), and instantly claimed process of treating cancers is the intended use of the claimed composition of the cited patent as taught by the specification.
However, one difference between the patented composition of TIL and the instant claims are more specific to the type of TILs as being CD8+.
Nevertheless, the use of modified CD8+ TILs to treat cancer was well known in the art. Specifically, Wardell et al. teach methods of treating cancers such as leukemia, melanoma, head and neck (HNSCC), and lung cancers comprising administering TILs that are CD8+ as adoptive cell therapy (col 5-6, Examples 3, 22, 23, 26-28).
Accordingly it would have been obvious to have claimed CD8+ TILs treat the genus of cancers at taught by Wardell with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Wardell teaches cancers respond better to CD8+ TILs (Examples 22 & 27).
Since the instant application method claims are obvious over cited patent composition claims in view of Wardell, said claims are not patentably distinct.
Provisional Statutory Double Patenting
Claims 289, 292, 294-297 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 199, 258-263 of copending Application No. 16/781,732 in view of Wardell et al. (US 10,537,595, patented 1/21/2020, see IDS filed 3/13/2023). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the claims of the cited application are drawn to a composition of TILs used in the instantly claimed method. There is no unobvious step in the process (i.e., administering), and instantly claimed process to treat cancers is the intended use of the claimed composition of the cited application as taught by the specification.
However, one difference between the patented composition of TIL and the instant claims are more specific to the type of TILs as being CD8+.
Nevertheless, the use of modified CD8+ TILs to treat cancer was well known in the art. Specifically, Wardell et al. teach methods of treating cancers such as leukemia, melanoma, head and neck (HNSCC), and lung cancers comprising administering TILs that are CD8+ as adoptive cell therapy (col 5-6, Examples 3, 22, 23, 26-28).
Accordingly it would have been obvious to have claimed CD8+ TILs treat the genus of cancers at taught by Wardell with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Wardell teaches cancers respond better to CD8+ TILs (Examples 22 & 27).
Since the instant application method claims are obvious over cited application composition claims in view of Wardell, said claims are not patentably distinct.
Claims 289, 292, 294-297 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 26, and 1, 14-15 of copending Application No. 17/802,080 in view of Wardell et al. (US 10,537,595, patented 1/21/2020, see IDS filed 3/13/2023). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the claims of the cited application are drawn to a composition of TILs made by a process using a CRISPR gRNA used in the instantly claimed method. There is no unobvious step in the process (i.e., administering), and instantly claimed process to treat cancers is the intended use of the claimed composition of the cited application as taught by the specification.
However, one difference between the patented composition of TIL and the instant claims are more specific to the type of TILs as being CD8+.
Nevertheless, the use of modified CD8+ TILs to treat cancer was well known in the art. Specifically, Wardell et al. teach methods of treating cancers such as leukemia, melanoma, head and neck (HNSCC), and lung cancers comprising administering TILs that are CD8+ as adoptive cell therapy (col 5-6, Examples 3, 22, 23, 26-28).
Accordingly it would have been obvious to have claimed CD8+ TILs treat the genus of cancers at taught by Wardell with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Wardell teaches cancers respond better to CD8+ TILs (Examples 22 & 27).
Since the instant application method claims are obvious over cited application composition claims in view of Wardell, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631