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
Applicant’s amendment filed August 26, 2026, is acknowledged and has been entered. Claims 1, 12, 14 and 28 have been amended. Claims 20, 21, 25 and 26 have been canceled.
Claims 1-6, 11-15, 18, 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Claims 35-36 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.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 and 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Grounds of Rejection Withdrawn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.
New Claim Rejections
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.
Claims 1-6, 11-12 and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mackall et al (US 2019/0183932 A1).
With respect to claims 1-6, 11 and 28, Mackall et 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 comprising CD28, TACI/TNFRSF13B and CD3 zeta or Fc gamma (see pages 2 and 22-23). With respect to claims 1 and 12, Mackall et 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 comprising CD28, LAG3 and CD3 zeta or Fc gamma (see pages 2 and 22-23).
Therefore, the products of Mackall et 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 1-6, 11-15, 18 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al (WO 2015/123642 A1, of record), Mackall et al (US 2019/0183932 A1), 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 signaling domain of CD3 zeta or Fc gamma (see pages 12, 17, 26 and 28-29).
Cooper et al does not disclose a CAR comprising a TACI/TNFRSF13B or LAG3 signaling domain or CD4+CD25+ CD127-, FOXP3+ and Helios+ Treg cells.
Mackall et 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 comprising CD28, TACI/TNFRSF13B and CD3 zeta or Fc gamma (see pages 2 and 22-23). Mackall et 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 comprising CD28, LAG3 and CD3 zeta or Fc gamma (see pages 2 and 22-23)
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 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 comprising CD28, TACI/TNFRSF13B and CD3 zeta or Fc gamma or CD28, LAG3 and CD3 zeta or Fc gammabecause 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.
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 extension fee 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 date of this final action.
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 Mon-Fri.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
October 2, 2026
