DETAILED ACTION
The present Office Action is responsive to the Amendment received on April 20, 2026.
Preliminary Remark
Claims 5-8, 10, 14-19, 22, and 23 are canceled.
Claims 24-33 are new.
Claim Rejections - 35 USC § 101
The rejection of claims 1-18 and 20 under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, as discussed in the Office Action mailed on January 2, 2026 is withdrawn in view of the Amendment received on April 20, 2026.
Claim Rejections - 35 USC § 112
The rejection of claims 1-18, 20, and 21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter, made in the Office Action mailed on January 2, 2026 is withdrawn in view of the Amendment received on April 20, 2026.
The scope of enablement rejection of claims 1-9, 11-18, 20, and 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as discussed in in the Office Action mailed on January 2, 2026 is withdrawn in view of the Amendment received on April 20, 2026.
The written description rejection of claims 1, 3, 5, 7, 9-14, 16, 18, 20, and 21 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as failing to comply with the written description requirement made in the Office Action mailed on January 2, 2026 is withdrawn in view of the Amendment received on April 20, 2026.
Rejection – New Grounds, Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 4, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is indefinite for reciting the phrase, “the step (a)(2)” because there lacks an antecedent basis for the step (a)(2) for the phrase to refer to “the step (a)(2)” as well as the parent claim not providing a context of step (a)(1).
The Office suggests amending the claim to recite the phrase, “… method according to claim 1, additionally determining the methylation status of one or more CpG sites selected from the group consisting of …”.
Claim 4 is also rejected for the same issues and the same suggestion is made.
Claim 20 is now indefinite because it is unclear whether the “therapy” being recommended is the CAR T-cell identified from step (c) (of the amended claim 1) or a completely different therapy. For the purpose of prosecution, the therapy has been construed as the treatment with the CAR T-cell or a population thereof (from claim 1(c)).
Conclusion
Claims 1, 2, 9, 11-13, 21, and 24-33 are allowable.
Claims satisfy the patent eligibility under 35 U.S.C. 101 because the claims actively recites the step of isolating an identified candidate CAR T-cells or a population thereof based on the method that identifies CAR T-cells which provides a benefit to a subject of interest based on the harvested and manipulated data, thereby actively applying the judicial exception into a practical application.
The Office also notes that the methylation status of the CpGs in the CAR T-cells and the correlation to a subject’s response to CAR T-cell therapy is not a naturally occurring phenomenon. This is because the CpG status is not determined from a naturally existing in the T-cell of the subject, but the T cells which have been infused with CAR1. Therefore, the CpG status of CAR T-cells are not from a naturally existing product (i.e., not a judicial exception).
The prior art does not teach or suggest for a method of predicting a subject’s response to autologous CAR T-cell therapy based on the methylation status of the recited CpGs in CAR T-cells. While the prior art teaches looking at gene expression profiles of the CAR T-cells between varying responders and non-responders (Fraietta et al., Nature Medicine, 2018, pages 1-16; IDS ref), or looking at certain gene disruptions that regulate methylation (Fraietta et al., Nature, 2018, pages 1-27; IDS ref) which result in an improvement of CAR T-cell therapy, none of the teachings teach the presently recited CpG sites and their methylation status to a subject’s propensity to respond to CAR T-cell therapy.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 June 22, 2026
/YJK/
1 “CAR” is Chimeric Antigen Receptors that is engineered fusing heavy and light chain variable regions of a monoclonal antibody directed against an antibody to TCRs (T-cell receptors), see Majzner et al. (Cancer Discovery, October 2018, pages 1-9).
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