DETAILED ACTION
This action is in reply to papers filed 6/18/2026. Claims 15 and 23-35 are pending and examined herein.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240277764A1, Published 8/22/2024.
Moot/Withdrawn Rejection(s)
The 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, of claims 17-22 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 is moot in view of the cancellation of claims 17-22.
The 35 U.S.C. 102(a) rejection of claims 15, 23 and 26-27 as being anticipated by Liu et al. (J Immunol 1 April 2011; 186 (1_Supplement): 48.7.; Ref 86 in IDS filed 8/15/23) is withdrawn in view the amendments made to independent claim 15.
The 35 U.S.C. 103(a) rejection of claims 16-19 as being unpatentable over Liu et al. (J Immunol 1 April 2011; 186 (1_Supplement): 48.7.; Ref 86 in IDS filed 8/15/23) as applied to claims 15, 23 and 26-27 and further in view of Tey et al. (Biol Blood Marrow Transplant. 2007 May 29;13(8):913–924.) is withdrawn in view the amendments made to independent claim 15.
The 35 U.S.C. 103(a) rejection of claims 9, 16-17 and 20-22 as being unpatentable over Liu et al. (J Immunol 1 April 2011; 186 (1_Supplement): 48.7.; Ref 86 in IDS filed 8/15/23) as applied to claims 15, 23 and 26-27 and further in view of Sangiolo et al. (Gene Therapy volume 14, pages1549–1554 (2007).) is withdrawn in view the amendments made to independent claim 15..
The 35 U.S.C. 103(a) rejection of claims 24-25 as being unpatentable over Liu et al. (J Immunol 1 April 2011; 186 (1_Supplement): 48.7.; Ref 86 in IDS filed 8/15/23) as applied to claims 15, 23 and 26-27 and further in view of Fardin et al. (Mol Cancer. 2010 Jul 12;9:185.) is withdrawn in view the amendments made to independent claim 15.
The 35 U.S.C. 103(a) rejection of claims 28- as being unpatentable over Liu et al. (J Immunol 1 April 2011; 186 (1_Supplement): 48.7.; Ref 86 in IDS filed 8/15/23) as applied to claims 15, 23 and 26-27 and further in view of Paul, S. (PgPub US20050063945A1, Published 3/24/2005) is withdrawn in view the amendments made to independent claim 15..
Maintained Rejection(s)
The 35 U.S.C. 112 (pre-AIA ) scope of enablement rejection of claims 15 and 23-33 is maintained. Applicant’s arguments will be addressed following maintained rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 and 23-33 remain and new claims 34-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a metastatic neuroblastoma in a patient in need thereof, wherein said method comprises administering a therapeutically effective number of engineered natural killer T-cells comprising a viral vector encoding at least IL-15, wherein the administered cells engraft at a site at or near the neuroblastoma, does not reasonably provide enablement for treatment of any cancer with a viral vector that does not encode for at least IL-15. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. The rejection is maintained for the reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: Applicant does not agree, but solely in the interest of compact prosecution in the submitted claims focus the cytokine on being IL-15. Applicant asserts that such methods are applicable to any type of cancer, given that it is well within the skill of an ordinary person in the art to extrapolate the teachings in the specification to all types of cancer. A patent is not required to teach, and preferably illustrate, every possible species falling within the scope of a claimed genus. Enablement is satisfied if person of skill can practice the full scope of the claim without undue experimentation. Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569 (Fed. Cir. 1984). One working example in one cancer type, combined with adequate guidance, may be sufficient to enable the genus "cancer" if the skilled artisan could extrapolate to other types without undue burden.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. As noted in the previous office action by Metelitsa et al., despite the progress in the understanding of NKT-cell biology and their role in tumor immunity, many important questions remain unanswered that impedes translation of NKT-cell anti-tumor potential into effective immunotherapies in cancer patients. Specifically, in order to determine whether a certain tumor can be targeted for direct NKT-cell cytotoxicity, primary tumors need to be screened for CD1d expression on the surface of tumor cells. Metelitsa notes that so far only a few types of solid tumors in humans have been characterized for CD1d expression. However, Metelitsa cautions that there could be a heterogeneity of CD1d expression within the same type of tumor like we observed in medulloblastoma so that only a subset of patients may have CD1d-positive tumors. The functional status of CD1d expression (e.g. the ability to present αGalCer to NKTs) on the tumor cells need to be tested using established cell lines of the same tumor type or short-term cultures of primary tumor cells when it is possible. Those types of cancer that express functional CD1d could be targeted for direct NKT-cell cytotoxicity using either synthetic NKT ligands or/and ex-vivo expanded NKTs (paragraph bridging Pg. 6 and Pg. 7).
As elaborated upon by Metelitsa- a named inventor in instant application- there exists heterogeneitiety within the same tumor. Therefore, is absolutely an undue burden on the part of the artisan to extrapolate the teachings in the specification to all types of cancer.
Because Applicant’s arguments are not found persuasive, the rejection is maintained.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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