DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I and certain species in the reply filed on 4/29/2026 is acknowledged.
Claims 5, 6, 8, 9, 13, 14, 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/29/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 11, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ivanova et al (US 20050064467 A1).
Ivanova et al teach therapeutic cells comprising episomal expression vectors encoding a therapeutic gene of interest (e.g. an antibody) and a promoter with an S/MAR element upstream of the promoter. See the abstract, ¶’s [0011], [0020], [0092]-[0093], [0139] and Fig. 1B in particular. The S/MAR element nearest the EBP promoter in Fig. 1B is considered “upstream” of both the EBP promoter and the CMV promoter of the A1/A2 transgenes. The vectors may also include a marker, e.g., puromycin resistance (Fig. 1B). The cells may be mammalian, e.g. CHO or 293 (¶ [0049]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7, 11, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivanova et al (US 20050064467 A1) as applied to claims 1-3, 7, 11, 12 above, and further in view of Harbottle et al (WO 2019/057773, cited by applicants, 3/28/2019, US 2021/0403941 A1 is referenced below).
The teachings of Ivanova et al are as above and applied as before. Ivanova et al do not teach the use of T cell receptor (TCR) as a therapeutic transgene.
Harbottle et al teach the use of episomal S/MAR-comprising expression vectors, and cells comprising such, to deliver therapeutic TCRs in the treatment of disease. See the abstract, ¶’s [0011], [0023].
The claimed cells are essentially disclosed by Ivanova et al with the exception of the TCR transgene limitation. The ordinary skilled artisan, seeking to prepare therapeutic cells or compositions, would have been motivated to use a TCR transgene with the cells and vectors of Ivanova et al because Harbottle et al teaches them to be a well-known type of transgene that has utility for therapeutic T or NK cells. It would have been obvious for the skilled artisan to do this because of the known benefit of generating therapeutic cells and compositions for administration as taught by Ivanova and Harbottle et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Claim(s) 1-4, 7, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivanova et al (US 20050064467 A1) and Harbottle et al (WO 2019/057773) as applied to claims 1-4, 7, 11, 12 above, and further in view of Xinxiang Medical (CN 107868781, cited by applicants, 4/3/2018).
The teachings of Ivanova and Harbottle et al are as above and applied as before. These references do not teach the use of S/MAR having at least 70% identity to SEQ ID NO: 3.
Xinxiang Medical teaches the use of an S/MAR element (SEQ ID NO: 2) having 83% identity to instant SEQ ID NO: 3 for improving expression vectors in, e.g. CHO cells.
The claimed cells are essentially disclosed by Ivanova and Harbottle et al with the exception of the SEQ ID NO: 3 limitation. The ordinary skilled artisan, seeking to prepare therapeutic cells comprising expression vectors, would have been motivated to use SEQ ID NO: 2 of Xinxiang Medical with the cells and vectors of Ivanova and Harbottle et al because Xinxiang Medical teaches SEQ ID NO: 2 to be a well-known type of S/MAR that has utility for improving expression in CHO cells. It would have been obvious for the skilled artisan to do this because of the known benefit of generating therapeutic cells and compositions for administration as taught by Ivanova, Xinxiang Medical and Harbottle et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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