DETAILED ACTION
This action is in reply to papers filed 02/12/2026.
Claims 1-5, 7-10, and 21 are pending and examined herein. Claim 21 is new.
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 previously elected without traverse of Group I, drawn to claims 1-10, and Species B (claims 4 and 14) in the reply filed on 08/26/2025. Claims 11-15 and 17-20 are withdrawn from further consideration as being drawn to a nonelected invention.
Withdrawn Objection(s) and Rejection(s)
The objection to the drawings filed 11/28/2022 is withdrawn in light of the replacement sheets filed 02/12/2026.
The objection to claim 1 is withdrawn in light of amendments to the claim, which replace Arabic numerals with Roman numerals for enumeration within claim 1.
The objection to claim 7 is withdrawn in light of amendments to the claim, which clarify the numbering schemes used in claim 7 and independent claim 1.
The rejection of claim 4 under 35 U.S.C. 112(b) is withdrawn in light of amendment to the claim, which obviates the prior basis of the rejection.
The rejection of claim 8 under 35 U.S.C. 112(b) is withdrawn in light of amendment to the claim, which obviates the basis of the rejection regarding insufficient antecedent basis for the term “suicide gene.”
The cancellation of claim 6 renders any objections and rejections thereof moot.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 7-10 remain rejected, and new claim 21 is rejected, under 35 U.S.C. 102(a)(2) as being anticipated by Clarke (US 2023/0062612 A1, effective filing date 01/17/2020).
Clark discloses a hypoimmunogenic human stem cell comprising deletions of MHC class I human leukocyte antigens (reads on HLA class I of claim 1), MHC class II human leukocyte antigens (reads on HLA class II of claim 1), and CIITA (claim 4) (para 24-25, 117-118), thereby eliminating surface expression of MHC class I molecules in the cells (para 375) (claim 2). MHC class I, or HLA class I, includes HLA-A, HLA-B, and HLA-C (para 259) (claim 3). Clarke discloses an embodiment of the hypoimmunogenic stem cell, which may be a pluripotent stem cell or a differentiated cell thereof (claim 10), wherein the cell has been modified to conditionally express HLA-E (reads on HLA class Ib), HLA-G (reads on HLA class Ib), PD-L1, PD-L2, and ß2 microglobulin (para 319) (claims 1, 5).
Clarke discloses an embodiment of the hypoimmunogenic cells that comprise a “suicide gene,” or a “safety switch” (para 326) (claim 7). Clarke discloses that the safety switch transgene and hypoimmunity gene is integrated into a safe harbor locus selected from the group consisting of an AAVS1 locus, a CCR5 locus, or a Rosa 26 locus (para 101, 107) (claims 8-9).
Clarke discloses that in some embodiments, the isolated human cell comprises deletion or reduced expression of ß2 microglobulin (para 24, 118), indicating that the deletion or reduced expression of ß2 microglobulin in said cell is optional, and therefore the existence of embodiments in which said cell comprises an endogenous gene encoding ß2 microglobulin that is not deficient in expression (claim 21).
Response to Arguments
Claim Rejections - 35 USC § 102
Applicant argues: Applicant has amended claim 1, upon which claims 2-10 depend, to require that the cell comprises an exogenous gene encoding ß2 microglobulin. As described in the specification at paragraph 0085, "the idea of further introducing an exogenous gene encoding ß2-microglobulin into a cell having endogenous ß2-microgloublin was never conceived, and no such example has been reported." Likewise, Clarke et al. neither teaches nor suggests such a cell.
In response: Applicant’s arguments have been fully considered, but are not persuasive. First, as set forth in the rejection of amended claim 1 under 35 USC 102, Clarke discloses a hypoimmunogenic human cell comprising an exogenous gene encoding ß2 microglobulin. Therefore, Clarke anticipates amended claim 1.
Furthermore, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a hypoimmunogenic human cell comprising an endogenous gene encoding ß2 microglobulin) are not recited in rejected claims 1-5 and 7-10. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Finally, although new claim 21 does recite this limitation, Clarke anticipates this limitation, as set forth above in the rejection of claim 21 under 35 USC 102.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RISA TAKENAKA/Examiner, Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632