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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 4, 2025, has been entered.
Applicant’s amendment filed August 4, 2025, is acknowledged and has been entered. Claims 1, 11-13 and 28 have been amended.
Claims 1-6, 11-15, 18, 20-21, 25-26, 28 and 35-36 are pending in the application.
Claims 35-36 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1-6, 11-15, 18, 20-21, 25-26, 28 are under examination.
Grounds of Rejection Withdrawn
Applicant’s amendment has obviated or rendered moot the grounds of rejection set forth in the previous Office action.
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)(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.
(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.
Claims 1-6, 11-12 and 28 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Sentman et al (WO 2017/058752 A1).
With respect to claims 1-6 and 28, Sentman et al disclose a chimeric antigen receptor (CAR) comprising an antibody scFv antigen specific binding domain, a spacer domain (hinge), a transmembrane domain, and an intracellular signaling region of CD28, CD132 and CD3 zeta or Fc gamma (see pages 18, and 24-26).
Therefore, the products of Sentman et al are deemed to anticipate the claimed products absent a showing otherwise.
Claim Rejections - 35 USC § 103
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 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 13-15, 18, 20-21 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al (WO 2015/123642 A1, of record), Rudensky et al (WO 2017/218850 A1, of record) and Lifshitz et al (Autoimmunity, 49(6):388-396, 2016, of record).
Cooper et al disclose a chimeric antigen receptor (CAR) comprising an antibody scFv antigen specific binding domain, a spacer domain (hinge), a transmembrane domain, and an intracellular signaling region, the signaling region comprising a primary signaling domain and a second signaling domain, wherein the second signaling domain comprises signaling domains of CD28 and 4-1BB and a signaling domain of CD3 zeta or Fc gamma (see pages 12, 17, 26 and 28-29). Cooper et al disclose that the CAR signaling domain may be from CTLA-4 to provide an inhibitory signal (see page 10-11). Cooper et al disclose such CARs in T cells (see page 1).
Cooper et al does not disclose CD4+CD25+ CD127-, FOXP3+ and Helios+ Treg cells.
Rudensky et al disclose Treg cells that have been modified to express a CAR for treatment of autoimmunity or inflammation (see pages 34-36 and 59). Rudensky et al disclose that CD4, CD25 and Foxp3 are cell markers for Tregs (see pages 46 and 59). Rudensky et al disclose using a CD127 antibody for flow cytometry of the cells (see page 39).
Lifshitz et al disclose CD4+CD25+ CD127Low, FOXP3+ and Helios+ Treg cells to bring up the level of Tregs in patients with an autoimmune disease and that another stable marker of Tregs activity is negative CD127 (see abstract, page 389 and 394-395).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to make CD4+CD25+ CD127-, FOXP3+ and Helios+ Treg cells that express CARs of Cooper et al that comprise an antibody scFv antigen specific binding domain, a spacer domain (hinge), a transmembrane domain, and an intracellular signaling region, the signaling region comprising a primary signaling domain and a second signaling domain, wherein the second signaling domain comprises signaling domains at least two of CD28, 4-1BB and CTLA-4 and a signaling domain of CD3 zeta or Fc gamma because one of skill would recognize that such a combination is combining prior art elements according to known methods to yield predictable results. Furthermore, since a stable marker of Tregs activity is negative CD127 and the other markers are known Treg markers there would be an advantage of using stable CD4+CD25+ CD127-, FOXP3+ and Helios+ Treg cells to express CARs that target autoimmune diseases as taught by Rudensky et al to treat autoimmune diseases.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
February 25, 2026