DETAILED ACTION
Applicant’s amendment and response received on 8/6/26 has been entered. Claims 1-20 remain pending and under examination in this application. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Those sections of Title 35, US code, not included in this action can be found in a previous office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/26 is in compliance with the provisions of 37 CFR 1.97 and 1.98, and 37 CFR 1.17(p) and (v)(3). Accordingly, the information disclosure statement has been considered by the examiner, and an initialed and signed copy of the 1449 is attached to this action.
Claim Rejections - 35 USC § 112
The rejection of claims 1-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, is withdrawn in view of applicant’s arguments and the evidence provided in the Declaration under 37 CFR 1.132 by Jeffrey W. Schmidt (the Schmidt Declaration), and the Declaration under 37 CFR 1.132 by Timothy Pulham (the Pulham Declaration).
Specifically, applicant’s argument that the specification discloses the use of anti-CD19 CAR, including the FMC63 scFV present in the CAR utilized by the post-filing evidence discussed in the Pulham Declaration, by pointing to “US2013287748” and Sadelain et al. (2013) Canc. Discov., Vol. 3(4), 388-398 in paragraph 251, both incorporated by reference, is found persuasive in view of the Schmidt Declaration which states that “US2013287748” is equivalent to “US20130287748” or “US2013/0287747” as per the USPTO/s PPUBS Basic tool webpage instructions for Patent Publication number entry. As noted by applicant, “US2013287748/US20130287748” shows that a number of anti-CD19 CAR including anti-CD19 CAR comprising the FMC63 scFV and intracellular signaling domains comprising either a 4-1BB or CD28 costimulatory signaling domain, and a CD3zeta signaling domain, were known in the prior art. Further, applicant’s argument that the Pulham Declaration presents evidence of enablement which correlates with the claimed methods is also found persuasive. The Pulham Declaration discusses 3 post-filing publications marked as Exhibits B-D. Exhibit B- Mackensen et al. (2022) Nat. Med., Vol. 28, 2124-2132 and Supplementary Materials, discloses the treatment of 5 human patients with SLE comprising administering a dose of 1X10-6 autologous CD19 CAR T cells/kg via i.v. infusion to each patient, where the CD19 CAR comprises the FMC63 scFV, a CD8 derived hinge region, a TNFRSF19 derived transmembrane domain, a CD3zeta intracellular domain and a 4-1BB co-stimulatory domain (Mackensen et al., page 2124-2125, and Supplementary materials-methods). Mackensen et al. reports depletion of B cells, a decrease in anti-dsDNA antibodies, and remission of SLE according to DORIS criteria in all five treated patients (Mackensen et al., page 2124). While Mackensen et al. does not specifically disclose the ratio of CD4+ to CD8+ CD19 CAR T cells, Figure 1d appears to show a ratio of approximately 80% CD4 to 20% CD8 CAR+ T cells, i.e. approximately 4:1 CD4:CD8 T cells. Exhibit C- Mougiakakos et al. (2021) N. Engl. J. Med., Vol. 385, 567-569, is an earlier paper by the same research group as Mackensen et al. and discloses the treatment of a single human patient with refractory SLE involving the intravenous administration of 1.1X10-6 autologous CD19 CAR T cells/kg at a ratio of 3:1 CD4+ to CD8+ T cells (Mougiakakos et al., page 567). Mougiakakos et al. reported that following the i.v. infusion of the CD19 CAR T cells the patient exhibited a significant decrease in anti-dsDNA antibodies and other signs of serologic remission (Mougiakakos et al., page 569). The supplementary material accompanying Mougiakakos et al. further identifies the CD19 CAR as comprising the FMC63 scFV, a CD8 derived hinge region, a TNFRSF19 derived transmembrane domain, a CD3zeta intracellular domain and a 4-1BB co-stimulatory domain, which is the same CD19 CAR used in the Mackensen clinical trial (Mougiakakos et al. Supplementary Method 2.1). Exhibit D-Salmon (2002) Nat. Med., Vol. 28, 2009-2010- is a brief review of the Mackensen et al. paper published in the same issue of Nature Medicine. Thus, the post-filing evidence as discussed above, and further in view of the teachings of the specification, supports enablement of the methods as claimed.
Double Patenting
The provisional rejection of claims 1-20 under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 19/030,056, is withdrawn in view of applicant’s amendments to the claims. The claims have been amended such that the claims are no longer identical to the claims of the ‘056 application.
Applicant’s amendments necessitated the following new grounds of rejection.
Claims 1-20 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12-17, and 19-20 which are currently pending in copending Application No.19/030,056, hereafter referred to as the ‘056 application. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The claims currently pending in the ‘056 application recite a species of the instant claimed invention. The ‘056 application claims recite the same method of treating SLE as claimed with the exception that the CD4+ and CD8+ T cell are recited with the narrower limitations that the cells are from a sample comprising peripheral blood mononuclear cells, and that the dose of genetically engineered CD4+ and CD8+ T cells comprises at least 90% CD4+ and CD8+ T cells. It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann , 572 F.2d 312, 197 USPQ 5 (CCPA 1978). As such, the ‘056 patent claims, by reciting a species of the instant method claims, render obvious the instant claims as written.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,208,137, hereafter referred to as the ‘137 patent alone, or in view of Amrolia et al. (2006) Blood, Vol. 108, 1797-1808, is maintained.
The applicant requests that the rejection be held in abeyance until the indication of allowable subject matter. However, the instant rejection may not be held in abeyance. As set forth in MPEP 804, only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. A complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (B)(1)).
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,296,010 hereafter referred to as the ‘010 patent, alone or in view of Amrolia et al. (2006) Blood, Vol. 108, 1797-1808, is maintained.
The applicant requests that the rejection be held in abeyance until the indication of allowable subject matter. However, the instant rejection may not be held in abeyance. As set forth in MPEP 804, only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. A complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (B)(1)).
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 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.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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