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 .
Applicant’s arguments and amendments filed on 4/12/2026 have been entered.
While claims 1-8, 18 and 46-49 were previously indicated as allowable, upon further search and consideration the teachings of Lotem et al. would provide the necessary teachings for the sequences set forth in SEQ ID NOs: 1-8. Accordingly. the finality of the Final Rejection action mailed on 3/24/2026 is withdrawn and prosecution is hereby reopened.
Claims 11 and 20 have been amended.
In view of Applicant’s amendments the 112(b) rejection is withdrawn.
Claims 1-8, 11, 18, 20 and 46-49 are examined in the instant application.
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.
Claims 1, 3-8, 11, 18, 20 and 46-49 is/are rejected under 35 U.S.C. 103 as being obvious over Kim et al. (US 2022/0257655 A1, published 4/18/2022) in view of Solders et al. (2017, Stem Cell Int., pgs. 1-15) and Lotem et al. (WO 2024/023826 A1, priority date of 7/28/2022).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Kim et al. teach a cell composition comprising MAIT cells expressing an exogenous TCR (parags. 7, 20, 162, 171 and 174).
Kim teaches that the TCR is capable of specific binding to an HLA-2 presented epitope (parag. 113).
Regarding claims 3 and 18, Kim continues that the MAIT cells are adapted for ACT (para. 414).
Regarding claim 4, Kim teaches that composition can comprise 109 MAIT cells (parag. 480).
Regarding claim 6, Kim teaches that the TCR recognizes a tumor antigen (parag. 519).
Regarding claims 7 and 8, Kim teaches that the tumor antigen is NY-ESO-1 (parag. 7).
Kim does not teach:
Placental-derived MAIT cells and Vα7.2+CD161high cells; and
SEQ ID NOs: 1-8.
Regarding placental-derived MAIT cells, Solders et al. teach that the placenta is a
significant source for MAIT cells (see Abstract).
Regarding claim 5 and Vα7.2+CD161high cells, Solders teaches that MAIT cells can be identified by this TCR combination (pg. 5 col.2 parag. 2).
(ii) Regarding SEQ ID NOs 1-8 and claims 11, 20 and 46-49, Lotem et al. teach an isolated T cell receptor comprising an α chain (SEQ ID NO: 17) and a β chain (SEQ ID NO: 18) which are 100% identical to instant SEQ ID NO: 7 (comprising instant SEQ ID NOs: 1-3) and instant SEQ ID NO: 8 (comprising instant SEQ ID NOs: 4-6) respectively.
Claim 4 and SEQ ID NO: 17 in ‘826 (α chain).
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Claim 5 and SEQ ID NO: 18 in ‘826 (β chain)
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Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Kim regarding a cell composition comprising MAIT cells with the teachings of Solders regarding placental-derived MAIT cells and with the teachings of Lotem regarding instant SEQ ID NOs: 1-8 to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to derive MAIT cells from the placenta since Solders teaches that the placenta is a rich source of MAIT cells. Further motivation is provided by Lotem teaching identical amino acid sequences for a TCR comprising the sequences set forth in SEQ ID NOs: 1-8.
There would have been a reasonable expectation of success that the MAIT cells of Kim could be derived from the placenta since Solders teaches isolating MAIT cells from the placenta.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2022/0257655 A1, published 4/18/2022) in view of Solders et al. (2017, Stem Cell Int., pgs. 1-15) and Lotem et al. (WO 2024/023826 A1, priority date of 7/28/2022) as applied to claims 1, 3-8, 11, 18, 20 and 46-49 above, and further in view of Solders et al. (2017, Scientific Reports, Vol. 7, pgs. 1-13).
Kim, Solders and Lotem are relied upon in teaching placental-derived composition comprising MAIT cells.
Kim, Solders and Lotem do not teach:
IVB-derived MAIT cells.
Regarding claim 2 and IVB-derived MAIT cells, Solders et al. teach that MAIT
cells can be derived from IVB (see Abstract).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Kim, Solders and Lotem regarding a cell composition comprising placental-derived MAIT cells with the teachings of Solders regarding IVB-derived MAIT cells to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to derive MAIT cells from IVB since Solders teaches that IVB is a source of MAIT cells.
There would have been a reasonable expectation of success that the MAIT cells of Kim could be derived from IVB since Solders teaches isolating MAIT cells from IVB.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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